GELPOINT PATH

K110792 · Applied Medical Resources Corp. · FER · May 23, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K110792
• Device Name: GELPOINT PATH
• Applicant: Applied Medical Resources Corp.
• Product Code: FER · Gastroenterology, Urology
• Decision Date: May 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The GelPOINT Path is indicated for multiple instrument or camera access through the anus for rectal procedures such as TEMS (Transanal Endoscopic Micro Surgery), flap revision and fistula repair.

Device Story

GelPOINT Path is a sterile, single-use, disposable transanal surgical access device. It provides a port for multiple laparoscopic instruments or cameras into the rectal cavity and lower sigmoid colon. The device features an introducer for insertion, three trocars (accommodating 5-10mm instruments), and a detachable cap for specimen removal. It includes insufflation and smoke evacuation capabilities. Used in clinical settings by surgeons during rectal procedures; the device is sutured to the patient for retention. It allows for flexible articulation of instruments outside the anus, facilitating surgical access and maintaining insufflation pressure throughout the procedure.

Clinical Evidence

Bench testing only. Testing confirmed substantial equivalence to the predicate device regarding maximum insufflation flow rate, sealing capability to maintain insufflation, and rectal retention.

Technological Characteristics

Flexible polymer construction; three-port access system; insufflation and smoke evacuation ports; compatible with standard laparoscopic instruments; sterilized via radiation.

Indications for Use

Indicated for patients undergoing rectal procedures, including TEMS, flap revision, and fistula repair, requiring transanal access for instruments or cameras.

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.

Predicate Devices

• Covidien SILS™ Port (K103253)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Applied Medical, along with the number K110792. The Applied Medical logo is in bold, black font, with the word "Applied" stacked on top of the word "Medical". To the right of the logo is a black triangle with three curved lines inside of it.

#### 510(k) SUMMARY

SUBMITTED BY: Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA, 92688 [phone]

MAY 2 3 2011

CONTACT PERSON: Frans VandenBroek Principal Specialist. Regulatory Affairs [phone] [phone] (FAX)

DATE OF PREPARATION: April 25, 2011

TRADE NAME: GelPOINT Path Transanal Access Platform

COMMON NAME: Transanal surgical access device

CLASSIFICATION NAME: Endoscope and Accessories, Gastroenterology and Urology Devices, 21CFR 876.1500, product code FER.

PREDICATE DEVICE: Covidien SILS™ Port. K103253

DEVICE DESCRIPTION: The GelPOINT Path is a sterile, single use, disposable surgical instrument designed to provide multiple instrument or camera access into the rectal cavity and lower sigmoid colon. The device is used in concert with standard laparoscopic instruments and is substantially equivalent to the predicate device in intended use, concept, function and performance.

INTENDED USE: The GelPOINT Path is indicated for multiple instrument or camera access through the anus for rectal procedures such as TEMS (Transanal Endoscopic Micro Surgery), flap revision and fistula repair.

#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

The GelPOINT Path is technologically similar to the predicate device in that both designs:

- Have insufflation capability �
- . Have 3 ports that can seal against insufflation pressure as instruments are inserted
- Can accommodate standard laparoscopes and laparoscopic instruments ●
- Have a flexible construction that allows articulation of instrumentation
- . Are made of various polymers
- May be sutured to the patient to assist retention
- . Have smoke evacuation capability

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The GelPOINT Path is technologically different from the predicate device in that:

- Instrumentation placed through GelPOINT Path may be articulated over a greater range . of motion because the device's flexible component is outside the anus. The predicate device's flexible component is inside the rectum.
- GelPOINT Path uses an introducer to facilitate insertion; the predicate device is . compressed during insertion.
- GelPOINT Path's three trocars can accommodate instruments ranging from 5 to 10mm. . The predicate's three trocars can accommodate three 5mm instruments or two 5mm and one 12mm instruments.
- . GelPOINT Path's cap may be detached from the access channel. This allows removal of specimens that are too large to be removed through the three trocars.
- GelPOINT Path is sterilized via radiation; the predicate is sterilized via Ethylene Oxide. .

### DISCUSSION OF NONCLINICAL TESTS SUBMITTED:

Applied Medical created a dedicated test method to confirm substantial equivalence of the GelPOINT Path device to the Covidien SILS Port predicate. These tests focused on:

- . Maximum insufflation flow rate capability
- . Sealing capability to allow and maintain insufflation
- . Establishing retention in the rectum

## CONCLUSIONS DRAWN FROM TESTING:

The Applied Medical GelPOINT Path device is substantially equivalent in performance to the Covidien SILS Port device in:

- . Establishing rapid insufflation
- Maintaining insufflation pressures as normal leakage occurs throughout the procedure .
- Retention in the rectum .

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

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

Applied Medical Resources Corp. c/o Mr. Jeffrev D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive RESEARCH TRIANGLE NC 27709

MAY 2 3 2011

Re: K110792

Trade/Device Name: GelPOINT Path Transanal Access Platform Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FER Dated: May 4, 2011 Received: May 12, 2011

Dear Mr. Rongero:

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 v 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. 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

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) 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

K 110792 Not yet assigned 510(k) Number (if known):

Device Name: GelPOINT Path Transanal Access Platform

- The GelPOINT Path is indicated for multiple instrument or camera Indications for Use: access through the anus for rectal procedures such as TEMS (Transanal Endoscopic Micro Surgery), flap revision, and fistula repair.
Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vorne M. Whang

tive, Gastro-Renal, and

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