← Product Code [OCX](/productcode/OCX) · K132776

# SEAL BIOPSY VALVE - REUSABLE (K132776)

_Endochoice, Inc. · OCX · Dec 20, 2013 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K132776

## Device Facts

- **Applicant:** Endochoice, Inc.
- **Product Code:** [OCX](/productcode/OCX.md)
- **Decision Date:** Dec 20, 2013
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Indications for 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.

## Device Story

Reusable biopsy valve; cylindrical base with cap; mounts on gastrointestinal endoscope biopsy port. Operator manually positions device on port. Diaphragm slit allows passage of instruments up to 3.2 mm diameter. Elastomer material deforms to create seal around instruments; maintains insufflation; minimizes biomaterial leakage; allows irrigation. Used in clinical settings by endoscopists. Device is non-sterile; requires cleaning and high-level disinfection between uses.

## Clinical Evidence

Bench testing only. Performance validated via functional benchtop testing, cleaning instruction validation, high-level disinfection instruction validation, and biocompatibility testing per ISO 10993-1. No clinical data presented.

## Technological Characteristics

Cylindrical base and cap design; elastomer construction. Compatible with Olympus (160, 180, 190), Fujinon (530, 590, 600), and Fuse endoscopes. Accommodates instruments up to 3.2 mm. Non-sterile; reusable; requires manual cleaning and high-level disinfection.

## Regulatory 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.

## Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:

1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
   1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
   2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
   3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

## Predicate Devices

- Seal Single Use biopsy valve ([K111821](/device/K111821.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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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

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.

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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.

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).

# 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
・・・
      ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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:

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.

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

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