Steris Ascendo Submucosal Lifting Agent Operating instructions

Brand
Steris
Model
Ascendo Submucosal Lifting Agent
Type
Operating instructions
ASCENDO™ submucosal lifting agent
Reorder No. BX00712934
INSTRUCTIONS FOR USE
PRODUCT DESCRIPTION
The ASCENDO™ submucosal lifting agent is a solution used for
submucosal lift of polyps, adenomas, early-stage cancers or other
gastrointestinal mucosal lesions prior to excision with a snare or
endoscopic device in gastrointestinal endoscopic procedures. The main
materials of the solution are sodium hyaluronate, Methylene Blue and
normal saline. It is provided in a prefilled 5 mL syringe. It is steam
sterilized and disposable. This device is not made with natural rubber
latex.
INTENDED PATIENT
The ASCENDO™ submucosal lifting agent should be used where there
is a need to lift polyps, adenomas, early-stage cancers or other
gastrointestinal mucosal lesions prior to excision with a snare or
endoscopic device, during an endoscopic procedure.
INTENDED USE
The ASCENDO™ submucosal lifting agent is intended for use in
gastrointestinal endoscopic procedures for submucosal lift of polyps,
adenomas, early-stage cancers or other gastrointestinal mucosal
lesions prior to excision with a snare or endoscopic device.
CONTRAINDICATION
Do not use for patients who are sensitive to any of the materials
contained in the ASCENDO™ submucosal lifting agent.
WARNINGS AND PRECAUTIONS
• The clinician injecting the ASCENDO™ submucosal lifting agent
must be experienced in the administration technique.
• When inserting the needle, the needle tip should be inserted
diagonally (approx. 20° to 45°) right beneath the mucosa. If the
needle tip is inserted vertically into the mucosa, there is a risk that
it would penetrate the serosa.
• The maximum dosage is 50 mL per patient.
• The product compatibility with other device substances has not
been tested.
• The effects of the ASCENDO™ submucosal lifting agent sustain
within 60 minutes.
• Products with opened syringe caps should be used immediately.
Do not reuse the remainder.
• Do not use if the packaging, syringe, or the Luer-lock cap is
damaged.
• Do not use if the solution is not translucent, shows any signs of
opalescence, or contains floating or precipitated visible particles.
• Do not use if the solution is not blue.
• Do not reuse the ASCENDO™ submucosal lifting agent. It can
cause side effects like an inflammation, infection and etc.
• Do not inject the ASCENDO™ submucosal lifting agent into the
blood vessels directly.
• Do not use for pregnant or lactating women or children under 18
years of age.
• Don’t contact unspecified substances during use.
• Do not use this medical device with disinfectants containing
quaternary ammonium salts (e.g., Benzalkonium chloride). This
may cause a precipitate.
• Do not attempt to reuse, reprocess, refurbish, remanufacture or
resterilize this device. The device is not designed nor is it intended
to be reused, reprocessed, refurbished, remanufactured, or
resterilized. Performing such activities on this disposable medical
device presents a safety risk to patients (i.e., compromised device
integrity, cross-contamination, infection).
• After use, the product may have a potential biohazard. Handle and
dispose of in accordance with hospital, local, and administrative
laws, and regulations.
DOSAGE AND ADMINISTRATION
The ASCENDO™ submucosal lifting agent can be injected through an
endoscope via a normal, commercially available endoscopic injection
needle (e.g.: a 2.3 mm x 230 cm endoscopic injection needle) having a
needle diameter of 23 gauge (23G) or smaller (not provided with the
device).The administered dose of the ASCENDO™ submucosal lifting
agent should be determined based on the dimensions of the lesion to
be removed. Inject into the submucosa the amount of the ASCENDO™
submucosal lifting agent needed to form a submucosal cushion of
optimal height and shape for the lesion to be removed. During the
procedure do not exceed a total dose of 50 mL per patient, either in
single or in multiple administrations.
PREPARATION
-
Endoscopic injection needle (23G recommended)
-
ASCENDO™ submucosal lifting agent
DIRECTIONS
1. Remove syringe from packaging.
2. Unscrew tip cap of the syringe.
3. Expel the air from the syringe.
4. Securely screw the Luer-lock syringe directly to a suitable sterile
endoscopic injection needle.
5. Prime the endoscopic injection needle with the ASCENDO™
submucosal lifting agent and expel any air.
6. Inject a small volume of the solution to determine the amount of
force needed to inject the ASCENDO™ submucosal lifting agent.
7. Retract the needle.
8. Introduce the endoscopic injection needle through the working
channel of the endoscope.
9. Place the needle properly at the lesion to be excised and inject
the needle diagonally (approx. 20° to 45 °) into the submucosa.
10. Inject 1 to 2 mL into the injection site. (In this case, the lesion is
raised to 3-10 mm.)
11. When injected correctly, the blue color appears immediately at
the injection site.
12. Check for leaks when injecting, stop injection if there is leakage,
and carefully insert the needle into the submucosa.
13. If necessary, inject the solution several times around the base of
the lesion to sufficiently elevate it, and then polypectomy or
endoscopic resection or dissection is performed.
14. Dispose the empty or used syringes properly and store the unused
syringes inside the container.
USES
The ASCENDO™ submucosal lifting agent is a submucosal injectable
composition to be used in endoscopic resection procedures in the upper
and the lower gastrointestinal tract, such as the esophagus, the
stomach, the intestine and the rectum. The ASCENDO™ submucosal
lifting agent is injected into the submucosa, beneath the lesion to be
excised.
The ASCENDO™ submucosal lifting agent is designed to provide a
submucosal cushion of optimal height and duration, allowing the
endoscopist an easy and safe resection procedure: polypectomy,
endoscopic mucosal resection (EMR), hybrid EMR and endoscopic
submucosal dissection (ESD).
The ASCENDO™ submucosal lifting agent does not require any
special apparatus or equipment, and it is designed to be used with the
most common endoscopic resection devices.
The solution has physicochemical properties suitable for injection in the
target site via a normal, commercially available endoscopic injection
needle (e.g.: a 2.3 mm x 230 cm endoscopic injection needle) having a
needle diameter of 23 gauge (23G) or less (not provided with the device).
The syringes are supplied with a female Luer-lock closure, to be
subsequently connected to the endoscopic injection needle with male
Luer-lock connection fitting.
Following injection into the submucosa the ASCENDO™ submucosal
lifting agent reconfigures to occupy the interstitial space and forms a
colored submucosal cushion of optimal height, that pushes the mucosa
away from submucosal layer, allowing for an easy resection procedure.
The ASCENDO™ submucosal lifting agent as a colored translucent
solution, helps to clarify the area where it is injected, to assist the
clinician in visualizing the margins of the target lesion and performing
the resection procedure, thereby decreasing the risk of damaging the
external muscular layer, which could lead to perforation.
STORAGE AND SHELF LIFE
Store at room temperature.
Protect from light. Store away from direct light.
Do not freeze. Do not use if packaging is damaged. Sterile product for
single use only. Do not use after expiration date.
Shelf life is 2 years.
ISSUE DATE
IFU0902USAC(Rev.0) / 12.Jan. 2023
Warning: An issued or revision date for these instructions is included
for the user’s information. In the event two years has elapsed between
this date and product use, the user should contact STERIS Endoscopy
to determine if additional information is available.
Unless otherwise indicated, all marks denoted with ® or ™ are
registered with the U.S. Patent and Trademark Office, or are trademarks
owned by STERIS Corporation.
Serious incidents that have occurred in relation to this medical device
should be reported to STERIS Endoscopy and competent authority in
the country where the incident occurred.
US Endoscopy, a wholly owned subsidiary of STERIS Corporation.
Manufactured for US Endoscopy
5976 Heisley Road
Mentor, OH 44060
1(800)/ 548-4873
www.steris.com
A subsidiary of STERIS Corporation
Symbols
SDO (If
applicable)
Symbol and
Reference
Title of Symbol
Meaning of Symbol
ISO 15223-1
Medical Devices
– Symbols to be
used with
medical device
labels, labelling,
and information
to be supplied
5.1.3
Date Of
Manufacture
Indicates the date
when the medical
device was
manufactured
5. 1.4
Use By
Indicates the date after
which the medical
device is not to be
used.
5.1.5
Batch Code
Indicates the
manufacturer’s batch
code
5.1.6
Catalog Number
Indicates the
manufacturer’s
catalogue number
5.1.11
Country of
Manufacture –
Republic of Korea
Country of
Manufacture is
Republic of Korea
5.2.5
Sterilized using
steam or dry heat
Indicates a medical
device that has been
sterilized using steam
or dry heat
5.2.6
Do Not Re-Sterilize
Indicates a medical
device that is not to be
resterilized
5.2.8
Do not use if
package is
damaged
Do not use if the
product sterile barrier
system or its
packaging is
compromised
5.2.14
Single sterile
barrier system with
protective
packaging outside
Indicates a single
sterile barrier system
with protective
packaging outside
5.3.2
Keep away from
sunlight
Indicates a medical
device that needs
protection from light
sources
5.4.1
Biological Risks
Indicates that there are
potential biological
risks
5.4.2
Do not reuse
Indicate a medical
device
that is intended for a
single procedure
5.4.3
Consult
instructions for use
Indicates the need for
the user to consult
instructions for use
5.4.4
Caution
Consult instructions for
use for cautionary
information
5.6.3
Non-pyrogenic
Indicates a medical
device that is non-
pyrogenic
5.7.7
Medical device
Indicates the item is a
medical device
5.7.10
Unique Device
Identifier
Indicates the unique
device identifier
21 CFR 801.109
(b) (1)
N/A
Caution: Federal law (U.S.A.) restricts this
device to sale and use by or on the order of a
physician.
N/A
N/A
Contents
Number of
devices/kits within
packaging
N/A
N/A
Do not Freeze
Do not freeze the
product.
N/A
N/A
Store at room
temperature
Store the product at
room temperature
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Steris Ascendo Submucosal Lifting Agent Operating instructions

Brand
Steris
Model
Ascendo Submucosal Lifting Agent
Type
Operating instructions
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