The device is intended to provide access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

Device Description

The Seal Reusable biopsy valve is composed of a cylindrical base and a connected cap. The device is designed to mount easily and seal securely on the biopsy port of endoscopes. It allows passage of instruments or devices of up to 3.2 mm in diameter. providing a seal both during use and following removal of the device. The Seal reusable biopsy valve is compatible with Olympus series 160, 180, and 190. Fujinon series 530. 590, and 600, and Fuse gastrointestinal endoscopes.

To use the device, the operator positions the device onto the instrument channel, pushing down on the cap and pressing the valve on the port until it fits snugly. Instruments of up to 3.2 mm in diameter may then be passed through the slit in the diaphragm of the valve. The deformation of the material provides a seal around the introduced device. After the procedure, the instrument is withdrawn prior to removal of the biopsy seal from the port. Users are instructed to remove the cap from the seal prior to pre-cleaning.

By maintaining a seal at the biopsy port, the device allows irrigation access while allowing insufflation to be maintained, and it minimizes leakage of biomaterial from the biopsy port during the endoscopic procedure.

The Seal reusable biopsy valve is provided non-sterile. It does not bear single-use labeling, and includes steps for cleaning and disinfection in the instructions for use (see section 13, proposed labeling).

AI/ML Overview

Here's an analysis of the provided text regarding the Seal Biopsy Valve - reusable, focusing on the acceptance criteria and the study proving it:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state specific pass/fail acceptance criteria (e.g., minimum seal pressure, maximum leakage rate). Instead, it relies on a general statement of equivalency to a predicate device and positive outcomes from a suite of tests.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Performance:	Benchtop functional performance testing: "All test results passed, demonstrating that the device is safe and effective in comparison with predicate devices." (Implied: device effectively provides access for instruments, maintains insufflation, and minimizes biomaterial leakage as intended).
Cleaning Effectiveness:	Laboratory validation testing of the cleaning instructions: "All test results passed..." (Implied: cleaning instructions are effective in preparing the device for reuse).
Disinfection Effectiveness:	Laboratory validation testing of the high-level disinfection instructions: "All test results passed..." (Implied: high-level disinfection instructions are effective in preparing the device for reuse).
Biocompatibility:	Biocompatibility testing in conformance with ISO 10993-1: "All test results passed..." (Implied: the device materials are not harmful to biological systems).
Substantial Equivalence:	Intended use, design, materials, and labeling are all substantially equivalent to the predicate (Seal Single Use biopsy valve K111821). The principle of operation is the same. Materials (Thermoplastic elastomer for predicate, silicone for new device) are considered equivalent in elastic properties.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size for any of the non-clinical tests (benchtop functional performance, cleaning validation, HLD validation, biocompatibility testing). It only states that the tests were performed.

The data provenance is retrospective in the sense that the studies were performed specifically for this 510(k) submission, but the source of the data (e.g., patient data, specific lab environment) is not detailed beyond being "benchtop" and "laboratory validation." No geographical data provenance is provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for the test set. The tests described are laboratory and benchtop evaluations of the device's physical and biological properties.

4. Adjudication Method for the Test Set

No adjudication method is described, as the tests performed are primarily objective measurements against predefined (but not explicitly stated in the document) criteria, not subjective assessments requiring expert consensus.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is typically used for AI-powered diagnostic tools or systems where human performance is enhanced by the AI. The Seal Biopsy Valve is a mechanical accessory, not an AI device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

A standalone performance evaluation (algorithm only) was not performed because this device is a mechanical accessory and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would have been established by:

Engineering Specifications/Performance Standards: For benchtop functional performance, the "ground truth" would be the device meeting predefined engineering specifications related to sealing, instrument passage, and maintaining insufflation.
Industry Standards (e.g., ISO 10993-1): For biocompatibility, the ground truth is conformance to the requirements outlined in ISO 10993-1.
Validated Cleaning/Disinfection Protocols: For cleaning and high-level disinfection, the "ground truth" would be the successful reduction of microbial load and removal of organic soil based on established and validated laboratory protocols.

No pathology, expert consensus (in the clinical sense), or outcomes data was used for establishing ground truth for this device's non-clinical testing.

8. The Sample Size for the Training Set

There is no training set mentioned or applicable, as this is a physical medical device, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

Summary

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Seal Biopsy Valve - reusable

EndoChoice, Inc.

K132776 . pg 1 of 3

510(k) Summary Seal Biopsy Valve - Reusable

1. Company Identification

DEC 2 0 2013

EndoChoice, Inc. 11800 Wills Road Alpharetta, GA 30009 Telephone (678) 708 4743 FAX (678) 567 8218 Establishment Registration: 300759133

2. Contact Person

Daniel Hoefer Regulatory Affairs Manager

3. Device Name

Trade name:	Seal Biopsy Valve - reusable
Common/Usual Name:	Biopsy Valve
Classification name:	Endoscopic irrigation/suction system

4. Device Classification

Product Code:	OCX
Regulation Number:	876.1500
Class:	II
Classification Panel:	Gastroenterology/Urology

5. Intended Use

Reusable Seal Biopsy valves are intended to provide access for endoscopic device passage and exchange, help minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure, maintain insufflation, and provide access for irrigation.

6. Device Description

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The deformation of the material provides a seal around the introduced device. After the procedure, the instrument is withdrawn prior to removal of the biopsy seal from the port. Users are instructed to remove the cap from the seal prior to pre-cleaning.

7. Substantial Equivalence

7.1. Predicate devices

The Seal reusable biopsy valve is substantially equivalent to the Seal Single Use biopsy valve (K11821) manufactured by EndoChoice. The intended use, design, materials and labeling are all substantially equivalent.

7.2. Intended Use

The indications for use the device under review is the same as the predicate device Seal single-use biopsy valve (K111821) manufactured by EndoChoice. Each device is indicated for use to provide access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

7.3. Technical Characteristics

Each of the three devices is comprised of a cylindrical main body and attached cap, and is designed to fit snugly on the biopsy port of a gastro-intestinal endoscope. The principle of operation of each is the same - an instrument is passed through a slit in a diaphragm, with the deformation of the elastomer creating a seal.

Materials are equivalent. The predicate Seal single-use biopsy valve is composed of Thermoplastic elastomer, which has similar elastic properties to silicone.

7.4. Performance Characteristics

The steps for operator use of each of the devices are equivalent. The device is manually pressed onto the biopsy port of the endoscope, sealing the channel and allowing for the passage of instruments while maintaining the seal and preventing a loss of insufflation.

8. Non-clinical testing

The following non-clinical testing has been performed on the Seal Biopsy valve reusable:

i .
、" ●
                          Benchtop functional performance testing
・・・
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August 30, 2013
!

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Seal Biopsy Valve - reusable

. � Laboratory validation testing of the cleaning instructions
. Laborator validation testing of the high-level disinfection instructions
Biocompatibility testing in conformance with ISO 10993-1. .

All test results passed, demonstrating that the device is safe and effective in comparison with predicate devices.

9. Conclusion

. : :: . "

The Seal Biopsy Valve - reusable is substantially equivalent to the predicate devices listed above. It is the same or equivalent in terms of design, intended use, materials, and labeling.

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

December 20, 2013

EndoChoice, Inc. Daniel Hoefer Regulatory Affairs Manager 11810 Wills Road Alpharetta, GA 30009

Re: K132776

Trade/Device Name: Seal " Biopsy Valve - reusable Regulation Number: 21 CFR 876.1500 Regulation Name: Biopsy Valve Regulatory Class: Class II Product Code: OCX Dated: November 26, 2013 Received: November 27, 2013

Dear Daniel Hoefer,

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 (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 11 (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. 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

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Page 2- Daniel Hoefer

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (2) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Elaine Blyskun

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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Indications for Use

510(k) Number (if known): K132776

Device Name: Seal Biopsy Valve - reusable

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In-Vitro-Diagnostio-Devices (OFVD)

Page I of 1

Elair

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.