The Disposable Endoscope Valve Sets is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector.

Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction. whilst preventing inflow of air.
Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
Auxiliary Water Connector: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

Device Description

The Disposable Endoscope Valves Set is a collection of several sterile units, it is intended for single-use and supplied sterile. The subject device is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector.

The Suction Valve component of the Disposable Endoscope Valves Set is designed to be attached to the suction port of the endoscope, allowing the user to aspirate excess fluids or other debris obscuring the endoscopic image.
The Air/Water Valve component of the Disposable Endoscope Valves Set is designed to be attached to the air/ water port of the endoscope, the activation of the air/ water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.
The Biopsy Valve component of the Disposable Endoscope Valves Set is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The Auxiliary Water Connector component of the Disposable Endoscope Valves Set is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve that prevents the backflow of water or biomaterials from the endoscope to the sterile water bottle.

AI/ML Overview

The provided text is a 510(k) summary for the Disposable Endoscope Valves Set (AF series). It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance testing. It does not describe a study involving human-in-the-loop performance, expert readers, or AI assistance for image interpretation. Therefore, many of the requested elements are not applicable to the information contained in this document.

Here's an analysis based only on the provided text:

Preamble:
The document describes a medical device (Disposable Endoscope Valves Set) that physically controls fluids and gases during endoscopic procedures. It is not a device that performs AI-assisted image analysis or requires human interpretation of images for its function. Consequently, specific criteria related to AI performance, human reader studies (MRMC), or a comprehensive test set with ground truth established by experts for diagnostic accuracy are not found in this regulatory submission. The studies described are engineering and performance validation tests for the physical device.

1. A table of acceptance criteria and the reported device performance

The document lists performance tests conducted, but does not provide a formal table of acceptance criteria with corresponding performance data. Instead, it states that "Non-clinical testing...was conducted to verify that the subject device met all design specifications, demonstrated safety and essential performance...". The individual tests are listed, implying that the acceptance criterion for each was successful completion.

Summary of Performance Tests Implemented (Implied Acceptance: "Met All Specifications"):

Component Tested	Performance Tests Implemented	Implied Acceptance Criteria & Reported Performance
Suction Valve	- Endoscope Compatibility	Passed (met all design specifications)
	- Depression Force	Passed (met all design specifications)
	- Leakage Test	Passed (met all design specifications)
	- Suction Flow	Passed (met all design specifications)
Air/Water Valve	- Endoscope Compatibility	Passed (met all design specifications)
	- Air flow rate	Passed (met all design specifications)
	- Water flow rate	Passed (met all design specifications)
	- Leakage Test	Passed (met all design specifications)
	- Depression Force	Passed (met all design specifications)
	- Backflow Performance Test	Passed (met all design specifications)
Biopsy Valve	- Endoscope Compatibility	Passed (met all design specifications)
	- Leakage Test	Passed (met all design specifications)
Auxiliary Water Connector	- Endoscope Compatibility	Passed (met all design specifications)
	- Leakage Test	Passed (met all design specifications)
	- Water Flow Rate	Passed (met all design specifications)
	- Backflow Performance Test	Passed (met all design specifications)

Other Non-Clinical Testing:

Biocompatibility: In accordance with ISO 10993 series (MTT Cytotoxicity, Skin Sensitization, Skin Irritation, Acute Systemic Toxicity, Pyrogen Test).
Sterilization Validation: In accordance with ISO 11135, ISO 11737-2, ISO 10993-7, USP <85>.
Shelf Life and Sterile Barrier System: In accordance with ASTM F1980, ISO11607-1, ISO11607-2, ASTM F 1929, ASTM D 3078, DIN 58593-6, ASTM F88/F88M, ASTM D4169.

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each "bench-A" performance test. It mentions that "performance tests were implemented on both the subject device and the predicate device," implying a comparative, laboratory-based testing approach.

Sample Size: Not explicitly stated for each test, but implied to be sufficient for engineering validation.
Data Provenance: Laboratory testing, likely conducted by the manufacturer (Alton (Shanghai) Medical Instruments Co. Ltd.) in China, as part of their regulatory submission for the U.S. FDA. The tests are non-clinical, likely prospective validation tests performed on newly manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a physical instrument, not an AI or diagnostic imaging device that requires expert-established ground truth from medical images. The "ground truth" for its performance is engineering specifications and physical measurements, not clinical diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human reader studies or for training/validating AI models with subjective interpretations (e.g., radiology image interpretation). This document describes the engineering performance validation of a physical device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC study is not applicable as this is a physical medical instrument (endoscope valves), not a diagnostic algorithm or AI-assisted interpretation tool. The document explicitly states "N/A, no clinical studies are available for the subject device."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical set of valves, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this device's performance relates to its physical and functional specifications (e.g., flow rates, leakage prevention, depression force, material compatibility, sterility, shelf life). These are established through engineering standards and testing, not clinical outcomes or expert consensus on medical images.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established in this context.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

October 1, 2024

Alton (Shanghai) Medical Instruments Co. Ltd Johnny Song R&D Engineer No.24 Building Jinshao Rd.1688, Baoshan District Shanghai, Shanghai 200949 China

Re: K241285

Trade/Device Name: Disposable Endoscope Valves Set (AF series) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: May 7, 2024 Received: August 29, 2024

Dear Johnny Song:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Shanil P. Haugen -S

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K241285

Device Name Disposable Endoscope Valves Set (AF series)

Indications for Use (Describe)

Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction. whilst preventing inflow of air.
Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
Auxiliary Water Connector: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. SUBMITTER

Name: Alton (Shanghai) Medical Instruments Co. Ltd.

Address: No.24 Building, JinShao Rd. 1688, Baoshan District, 200949 Shanghai, P. R.

China

Name of contact person: Vivian Li

Position: Director of Quality Department

Tel: +86 21 56771811

Fax: +86 21 66307823

Mail: vivian@alton.com.cn

Date prepared: 2024-09-27

II. Identification of Subjective Device

Device trade name: Disposable Endoscope Valves Set (AF series) Regulation Name: Endoscope and accessories Regulation number: 21CFR 876.1500 Regulation class: 2 Review Panel: Gastroenterology/Urology Product Code Description: Endoscope Channel Accessory Product code: ODC

III. Identification of Predicate device

Predicate Submission Number: K220884 Trade/Device Name: Disposable Endoscope Valve Sets Regulation Name: Endoscope and accessories Regulation Number: 21 CFR 876.1500 Regulatory Class: 2 Review Panel: Gastroenterology/Urology Product Code Description: Endoscope Channel Accessory Product Code: ODC

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IV. Device description

The Suction Valve component of the Disposable Endoscope Valves Set is designed to be attached to the suction port of the endoscope, allowing the user to aspirate excess fluids or other debris obscuring the endoscopic image.
The Air/Water Valve component of the Disposable Endoscope Valves Set is designed to be attached to the air/ water port of the endoscope, the activation of the air/ water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.
The Biopsy Valve component of the Disposable Endoscope Valves Set is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The Auxiliary Water Connector component of the Disposable Endoscope Valves Set is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve that prevents the backflow of water or biomaterials from the endoscope to the sterile water bottle. And there were no prior submissions for the subject devices.

V. Indication for use

The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector.

Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.

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Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
Auxiliary Water Connector: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

Attribute	Subject device	Predicative device (K220884)	Discussion/Conclusion
Manufacturer	Alton (Shanghai) MedicalInstruments Co. Ltd	SML Med-Tech Solutions Limited	/
Trade name	Disposable Endoscope Valves Set(AF series)	Disposable Endoscope Valve Sets	/
Regulation name	Endoscope and accessories	Endoscope and accessories	Same
Regulatory Class	II	II	Same
Product code	ODC	ODC	Same
Clinical characteristics
Indications for use	The Disposable Endoscope ValveSets is a collection of severalsterile units. It is intended to befitted to multiple endoscopeworking channels/ports to controlthe flow of fluids, gases and othermaterials. It includes an Air/WaterValve, a Suction Valve, a BiopsyValve and an Auxiliary WaterConnector.	The Disposable Endoscope Valve SameSets is a collection of several sterileunits. It is intended to be fitted tomultiple endoscope workingchannels/ports to control the flowof fluids, gases and other materials.It includes an Air/Water Valve, aSuction Valve, a Biopsy Valve andan Auxiliary Water Connector.- Air/Water Valve: This unit isintended to be fitted to anendoscope air/water channel tocontrol the inflow of medical gasesand water, whilst preventingback-flow.- Suction Valve: This unit isintended to be fitted to anendoscope suction channel tocontrol the operations of suction,whilst preventing inflow of air.- Biopsy Valve: This unit isintended to be fitted to an	Same
Attribute	Subject device	Predicative device (K220884)	Discussion/Conclusion
	intended to be fitted to anendoscope biopsy port to preventleakage of gases and body fluidsduring an endoscopic procedure.- Auxiliary Water Connector: Thisunit is intended to provideirrigation via sterile water supplyduring GI endoscopic procedureswhen used in conjunction with anirrigation pump.	endoscope biopsy port to preventleakage of gases and body fluidsduring an endoscopic procedure.- Auxiliary Water Connector: Thisunit is intended to provide irrigationvia sterile water supply during GIendoscopic procedures when usedin conjunction with an irrigationpump.
Compatibleendoscopes	AF-DVS3-O, AF-DVS4-O,AF-BVC-O: Olympus® 140/ 160/180/ 190/ 240/ 260/ 290 Series GIEndoscopeAF-DVS3-P, AF-DVS4-P,AF-BVC-P: Pentax® 90/ i10 GIEndoscopeAF-DVS3-F, AF-DVS4-F,AF-BVC-F: Fujifilm® 700 SeriesGI Endoscope	SML002_LP01_AW: Olympus®140/160/ 180/ 190/ 240/ 260/ 290Series GI EndoscopeSML001_PT01_AW: Pentax®90/i10 GI EndoscopeSML003_FJ01_AW: Fujifilm® 700Series GI Endoscope	Same
General technological characteristics
Devicecomposition andspecifications	AF-DVS3-O: Air/Water Valve+Suction Valve+ Biopsy ValveAF-DVS4-O: Air/Water Valve+Suction Valve+ Biopsy Valve+Auxiliary Water ConnectorAF-BVC-O: Biopsy ValveAF-DVS3-P: Air/Water Valve+Suction Valve+ Biopsy ValveAF-DVS4-P: Air/Water Valve+Suction Valve+ Biopsy Valve+Auxiliary Water ConnectorAF-BVC-P: Biopsy ValveAF-DVS3-F: Air/Water Valve+Suction Valve+ Biopsy ValveAF-DVS4-F: Air/Water Valve+Suction Valve+ Biopsy Valve+Auxiliary Water ConnectorAF-BVC-F: Biopsy Valve	SML002: Air/Water Valve+ SuctionValve+ Biopsy Valve+ AuxiliaryWater ConnectorSML001: Air/Water Valve+ SuctionValve+ Biopsy ValveSML003: Air/Water Valve+ SuctionValve+ Biopsy Valve	Same
Principleof	Biopsy Valve: The Biopsy valve	Biopsy Valve: The Biopsy valve	Same
Attribute	Subject device	Predicative device (K220884)	Discussion/Conclusion
	port to prevents gas and liquid	port to prevents gas and liquid from
	from overflowing from the forcepsport, the cross cutting on the	overflowing from the forceps port,the cross cutting on the surface can
	surface can reduce frictionbetween the instrument and the	reduce friction between theinstrument and the forceps port.
	forceps port.Air/Water Valve: The principal	Air/Water Valve: The principal axisof Air/Water valve is equipped with
	axis of Air/Water valve isequipped with different sizes of	different sizes of sealing rings,which use spring to control advance
	sealing rings, which use spring tocontrol advance and retreat, and	and retreat, and control the watersupply and air supply function of
	control the water supply and airsupply function of endoscope in	endoscope in endoscopic surgery.Suction Valve: The principal axis of
	endoscopic surgery.Suction Valve: The principal axis	Suction valve is equipped withdifferent sizes of sealing rings,
	of Suction valve is equipped withdifferent sizes of sealing rings,	which use spring to control advanceand retreat, and endoscope suction
	which use spring to controladvance and retreat, and	function in endoscopic surgery.Auxiliary Water Connector: The
	endoscope suction function inendoscopic surgery.	principal axis of Auxiliary WaterConnector is equipped with sealing
	Auxiliary Water Connector: Theprincipal axis of Auxiliary Water	rings, which used to preventleakage. One end is connected to an
	Connector is equipped withsealing rings, which used to	irrigation pump and the other to apipe. It acts as a connector through
	prevent leakage. One end isconnected to an irrigation pump	which water passes.
	and the other to a pipe. It acts as aconnector through which water
	passes.
Material	Air/Water Valve: ABS, SiliconeRubber, TPE, Stainless steel 304	Air/Water Valve: ABS, SiliconeRubber, TPE, Stainless steel 304	Same
	Suction Valve: ABS, PC, SiliconeRubber, Stainless steel 304	Suction Valve: ABS, PC, SiliconeRubber, Stainless steel 304
	Biopsy Valve: Silicone Rubber	Biopsy Valve: Silicone Rubber
	Water Connector: PC, SiliconeRubber	Water Connector: PC, SiliconeRubber
Sterilization	Ethylene Oxide sterilization	Ethylene Oxide sterilization	Same
Attribute	Subject device	Predicative device (K220884)	Discussion/Conclusion
Single use/reuse	For single use	For single use	Same
Shelf life	3 years	Not known	Different,seediscussion 1

VI. Comparison of technological characteristics with the predicate device

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K241285

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K241285

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Discussion on differences between the subject device and the predicate device

Discussion 1: Although shelf life between the subject device and the predicate device is different, sterile process validation and shelf-life validation including performance test are performed on the subject device according to relevant standards, such differences will not affect the safety and effectiveness of the subject device.

VII. Summary of substantial equivalence discussion

Based on the above comparison table, the subject device and the predicate device are totally same on design features and performance specifications. There are no differences on device composition, specification and component material used as well on both devices. the only differences between the subject device and the predicate device are the sterile barrier system and other packages used for both devices. As all sterile process validation and shelf-life validation including performance test, transportation simulated test and biocompatibility tests are performed on the subject device according to relevant standards, such differences between the subject device and the predicate device do not affect the safety and effectiveness of the subject device when used as labeled.

VIII. Summary of Non-clinical Data

Non-clinical testing for Disposable Endoscope Valves Set was conducted to verify that the subject device met all design specifications, demonstrated safety and essential performance based on current applicable standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed.

A Biocompatibility

The biocompatibility evaluation for the Disposable Endoscope Valves Set was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing

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within a risk management process"" September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

MTT Cytotoxicity Test: ISO 10993-5:2009, Biological evaluation of medical . devices -- Part 5: Tests for In Vitro cytotoxicity
Skin Sensitization Test, Skin Irritation Test: ISO 10993-10:2010, Biological . evaluation of medical devices -- Part 10: Tests for irritation and sensitization
. Acute Systemic Toxicity Test and Pyrogen Test: ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

A Sterilization Validation

The EO sterilization of the Disposable Endoscope Valves Set has been validated according to the following applicable standards:

ISO11135:2014+A1:2018 Sterilization of medical device- validation and . routine control of ethylene oxide sterilization
ISO 11737-2:2019 Sterilization of Medical Device-Microbiological . methods-part 2: Tests of sterility performed in the validation of a sterilization process
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: ● Ethylene oxide sterilization residuals
USP <85> Bacterial endotoxins test .
A Shelf Life and Sterile Barrier System

Shelf Life and Sterile Barrier System of the Disposable Endoscope Valves Set has been validated according to the following applicable standards:

ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier . Systems for Medical Devices
. ISO11607-1:2019 Packaging for terminally sterilized Medical Device Part 1: Requirement for materials, sterile barrier systems and packaging systems
. ISO11607-2:2019 Packaging for terminally sterilized Medical Device Part 2: Validation Requirement for forming, sealing and assembly process
ASTM F 1929-15: Standard Test Method for Detecting Seal Leaks in Porous . page 7 of 9

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Medical Packaging by Dye Penetration

ASTM D 3078-02(2013): Standard Test Method for Determination of Leaks . in Flexible Packaging by Bubble Emission
DIN 58593-6: 2016 Sterilization - Sterile Supply - Part 6: Microbial Barrier Testing of Packaging Materials for Medical Devices Which Are to Be Sterilized
. ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM D4169-16 Standard practice for performance testing of shipping ● containers and systems (DC-13, Level II)
Performance Data Bench A

The performance tests were implemented on both the subject device and the predicate device to demonstrate substantial equivalence according to the specific product specification as below listed:

Suction Valve:

Endoscope Compatibility
Depression Force
Leakage Test
Suction Flow

Air/Water Valve:

Endoscope Compatibility
Air flow rate
Water flow rate
Leakage Test
Depression Force
Backflow Performance Test

Biopsy Valve:

Endoscope Compatibility
Leakage Test

Auxiliary Water Connector:

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Endoscope Compatibility
Leakage Test
Water Flow Rate
Backflow Performance Test
A Performance Data – Animal

N/A, no animal studies are available for the subject device.

IX. Summary of Clinical Data

N/A, no clinical studies are available for the subject device.

X. Conclusions

In conclusion, the technological characteristics, features, specifications, materials, principle of operation, and intended use of the subject device substantially equivalent to the predicate devices quoted above. The differences between the subjective device and its predicate devices do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that the subject device is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.