The Single-Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

Device Description

The Seal Single-Use Biopsy valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Single-Use Biopsy Valve provides surgical instruments with sealable access to the working channel port of an endoscope. The valve consists of an attached cap and valve body with a circular opening. The cap is pre-perforated, and ensures instrument access and removal is tight and leak-free.

The valve is designed with a hollow body with a distal end that releasably attaches to the inlet port of the working channel. The valve body provides a flexible diaphragm seal that separates the body into a proximal chamber and distal chamber. The distal chamber secures onto the endoscope, while the proximal chamber secures the cap. Instruments are inserted through the cap and chambers, through the diaphragm seal, and into the endoscope. The diaphragm seal Is configured such that a seal is formed due to deformation of the elastomer around an instrument when it is inserted through the opening, preventing fluids from passing through the biopsy valve.

The cap serves two primary functions. One function of the cap is to provide an additional seal around surgical instruments to prevent leakage. The second function is to allow modification of pressure during insufflation by opening the cap, allowing gasses to flow from the endoscope, and out of the biopsy valve.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Seal Single-Use Biopsy Valve:

The provided text (K133734) is a 510(k) Summary for a Seal Single-Use Biopsy Valve device, which is a modification of a previously cleared device (K111821). The document primarily focuses on demonstrating substantial equivalence to the predicate device, rather than detailed performance studies with clinical outcomes or human-in-the-loop assessments.

Therefore, many of the requested criteria in your prompt are not applicable or cannot be extracted from this type of regulatory submission. This document highlights bench testing and biocompatibility testing to demonstrate that the modified device performs as well as the predicate device.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (Modified Device)
Pressure Integrity	1 minute pressure test at 10 PSI – with device in biopsy valve	Pass
Pressure Integrity	1 minute pressure test at 10 PSI – with device in biopsy valve (re-listed)	Pass
Pressure Integrity	1 minute pressure test at 10 PSI after removing device from biopsy valve	Pass
Biocompatibility	Cytotoxicity (in accordance with 21 CFR, Part 58)	No safety or efficacy concerns
Biocompatibility	Sensitization (in accordance with 21 CFR, Part 58)	No safety or efficacy concerns
Biocompatibility	Intracutaneous injection test (in accordance with 21 CFR, Part 58)	No safety or efficacy concerns
Biocompatibility	System injection test (in accordance with 21 CFR, Part 58)	No safety or efficacy concerns
Material	Thermoplastic elastomer	Thermoplastic elastomer (Matches predicate)
Valve Inner Diameter	Designed to be 7.1 mm (vs. 7 mm predicate)	7.1 mm
Endoscope Compatibility	Olympus series 160, 180, and 190; Fujinon series 530, 590, and 600; EndoChoice Fuse	Compatible with listed endoscopes
Slit Accommodation	Accommodates devices up to 3.2 mm (Matches predicate)	Up to 3.2 mm
Overall Height	Reduction in overall height for improved fit	Improved fit confirmed (implied by design change)

Study Details (Based on provided text)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test (e.g., how many biopsy valves were pressure tested). However, "bench testing" was performed.
- Data Provenance: The testing appears to be conducted in a laboratory setting ("bench testing," "laboratory biocompatibility testing"). No country of origin is specified, but given the submission to the FDA, it's likely relevant to US regulatory standards. It is a retrospective analysis in the sense that the results are being presented after the tests were conducted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes performance and biocompatibility testing of a medical device, not a diagnostic or AI-assisted device where expert ground truth is typically established for image or data interpretation. The "ground truth" here is the physical measurement or chemical reaction in the bench and biocompatibility tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 are used for establishing ground truth in clinical studies involving interpretation of data (e.g., radiology reads). This document focuses on physical and biological performance tests.
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. This is a single-use biopsy valve, not an AI-assisted diagnostic device. Therefore, no MRMC study was conducted or is relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a mechanical component (biopsy valve), not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Established physical and biological testing standards. For pressure tests, the "ground truth" is a pass/fail criterion based on maintaining pressure at 10 PSI for 1 minute. For biocompatibility, the ground truth is determined by established laboratory protocols and thresholds for cytotoxicity, sensitization, etc., as per 21 CFR Part 58.
The sample size for the training set:
- Not Applicable. This device does not involve a training set as it is not an AI/ML-based device.
How the ground truth for the training set was established:
- Not Applicable. See point 7.

Summary

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K133734 Page1of4

510(k) Summary

Seal Single-Use Biopsy Valve

December 5, 2013

1. Company Identification

EndoChoice, Inc. 11810 Wills Road Alpharetta, GA 30009 Telephone: 678-708-4773 Fax: 678-567-8218 Establishment Registration: 300759133

Contact Person 2.

Janna Babson Regulatory Affairs Associate

3. Device Name

Commercial Name:	Seal Single-Use Biopsy Valve
Common/Usual Name:	Biopsy Valve
Classification Name:	Endoscopic, irrigation/suction system

4. Device Classification

Product Code:	OCX
Regulation Number:	876.1500
Class:	11
Review Panel:	Gastroenterology/Urology

5. Intended Use:

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6. Device Description:

7. Substantial Equivalence:

The device submitted for review is a modification of the Biopsy Valve (K111821). Changes to the device include a modification in material, and a change in dimensions. Both the modified and unmodified device is composed of thermoplastic elastomers. The modified device also has a reduction in overall height of the biopsy valve to provide an improved fit between the cap and body, as well as the valve to the instrument port.

The modified device is identical in terms of intended use, operating principle, performance, technology, energy used, and packaging.

Characteristic	Single-Use Biopsy Valve(Unmodified)	Single-Use Biopsy Valve(Modified)
510(k) number	K111821	Pending
Indications for Use	Biopsy valves are intended toprovide access for endoscopicdevice passage and exchange,helps maintain sufflation,minimizes leakage of biomaterialfrom biopsy port throughout theendoscopic procedure, andprovides access for irrigation.	Biopsy valves are intended toprovide access for endoscopicdevice passage and exchange,helps maintain sufflation,minimizes leakage of biomaterialfrom biopsy port throughout theendoscopic procedure, andprovides access for irrigation.

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Characteristic	Single-Use Biopsy Valve(Unmodified)	Single-Use Biopsy Valve(Modified)
Material	Thermoplastic elastomer	Thermoplastic elastomer
Valve Inner Diameter	7 mm	7.1 mm
Endoscopecompatibility	OlympusFujinonEndoChoice Fuse	Olympus series 160, 180, and 190endoscopes.Fujinon series 530, 590, and 600endoscopes.EndoChoice Fuse endoscopes.
Removable capwith slit	Yes	Yes
Slit accommodatedevices	Up to 3.2 mm	Up to 3.2 mm
Packaging	Individually packaged plastic pouch	Individually packaged plastic pouch
Performance testing:
• 1 minutepressure test at10 PSI – withdevice in biopsyvalve	Pass	Pass
• 1 minutepressure test at10 PSI – withdevice in biopsyvalve	Pass	Pass
• 1 minutepressure test at10 PSI afterremovingdevice frombiopsy valve	Pass	Pass

8. Non-Clinical Testing:

The modified device has undergone both bench testing of performance and laboratory biocompatibility testing for cytotoxicity, sensitization, intracutaneous injection test, and system injection test, in accordance with 21 CFR, Part 58. The modified Single-Use Biopsy Valve results in no safety or efficacy concerns regarding biocompatibility or performance. Likewise, in conformance with 21 CFR 807.92(b)(3), the modified device performs as well as the predicate in all testing performed.

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9. Conclusion:

The modified Single-Use Biopsy Valve is substantially equivalent to the unmodified predicate device listed above in performance, technical characteristics, biocompatibility, and intended use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting another, with flowing lines suggesting movement or support.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 19, 2014

EndoChoice, Inc. Janna Babson Regulatory Affairs Associate 11810 Wills Road Alpharetta, GA 30009

Re: K133734

Trade/Device Name: Biopsy Valve Regulation Number: 21 CFR$ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: February 21, 2014 Received: February 24, 2014

Dear Janna Babson,

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 prodicate 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 (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. 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.

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.

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Page 2 - Janna Babson

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K133734

Device Name Single-Use Biopsy Valve

Indications for Use (Describe)

The Single-Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from biopsy port throughout the endoscopic procedure, and provides access for irrigation.

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

[ Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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.