US ENDOSCOPY DISTAL ATTACHMENT CAP

K140315 · United States Endoscopy Group, Inc. · OCX · Apr 4, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K140315
• Device Name: US ENDOSCOPY DISTAL ATTACHMENT CAP
• Applicant: United States Endoscopy Group, Inc.
• Product Code: OCX · Gastroenterology, Urology
• Decision Date: Apr 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The US Endoscopy Distal Attachment Cap has been designed to the distal end of the endoscope to facilitate endoscopic therapy. The US Endoscopy Distal Attachment Cap is intended for the following. - Gastrointestinal mucosal resection (endoscopic mucosal resection) . - Keeping the suitable depth of the endoscope's view field ●

Device Story

The US Endoscopy Distal Attachment Cap is a mechanical accessory designed to attach to the distal tip of an endoscope. It functions by maintaining a consistent distance between the endoscope lens and the mucosal tissue, thereby preserving a suitable depth of field during endoscopic procedures. It is used by physicians in clinical settings to facilitate endoscopic mucosal resection (EMR). The device provides a stable view and physical spacing, assisting the clinician in performing therapeutic interventions on the gastrointestinal tract.

Clinical Evidence

bench testing only

Technological Characteristics

Mechanical distal attachment cap for endoscopes. Designed for attachment to the distal end of an endoscope to maintain field of view depth and facilitate mucosal resection.

Indications for Use

Indicated for patients undergoing endoscopic therapy, specifically gastrointestinal mucosal resection, and for maintaining a suitable depth of field during endoscopic procedures.

Regulatory Classification

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.

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of an abstract caduceus, a symbol often associated with medicine and healthcare.

#### Public Health Service

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

April 4, 2014

United States Endoscopy Group, Inc. Sagar D. Pimpalwar Regulatory Affairs Specialist 5976 Heisley Road Mentor, OH 44060

Re: K140315

> Trade/Device Name: The US Endoscopy Distal Attachment Cap Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: February 7, 2014 Received: February 10, 2014

Dear Sagar D. Pimpalwar,

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 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 - Sagar D. Pimpalwar

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 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/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/MedicalDeyices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/6 description: The image shows the name "Benjamin Bisher-S" in a bold, sans-serif font. The name is written in black ink on a white background. The letters are evenly spaced and the name is easy to read. The text appears to be a logo or a nameplate.

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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United States Endoscopy Group, Inc.

SIntki Premarket Notification! 7 The US Endoscopy Distel Attach

## INDICATIONS FOR USE

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: The US Endoscopy Distal Attachment Cap

## Indications for Use:

The US Endoscopy Distal Attachment Cap has been designed to the distal end of the endoscope to facilitate endoscopic therapy.

The US Endoscopy Distal Attachment Cap is intended for the following.

- Gastrointestinal mucosal resection (endoscopic mucosal resection) .
- Keeping the suitable depth of the endoscope's view field ●

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Benjamin Fisher-S |
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| 2014.04.04 14:57:58 -04'00' |

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <div> <img src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAUAAAAFCAYAAACNbyblAAAAHElEQVQI12P4//8/AyUYw0hE8NqgZGogZgZhRgZAQpNwIBY6O4wAAAAASUVORK5CYII="/> </div> |
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OR

| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
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