GelPOINT Path Transanal Access Platform

K171701 · Applied Medical Resources Corp. · FER · Jul 20, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K171701
• Device Name: GelPOINT Path Transanal Access Platform
• Applicant: Applied Medical Resources Corp.
• Product Code: FER · Gastroenterology, Urology
• Decision Date: Jul 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

Device Story

GelPOINT Path is a transanal access platform inserted into the anal canal to provide access to the rectum and lower sigmoid colon for transanal endoscopic surgery. The device consists of an access channel and a detachable, airtight gel cap. The cap allows for insufflation of the surgical site and accommodates multiple sleeves/ports for the passage of a laparoscope and laparoscopic instruments without loss of insufflation. The device is inserted using an introducer and affixed to the patient via sutures. It is used by surgeons in a clinical/surgical setting. The platform facilitates minimally invasive procedures by maintaining a working space through insufflation, allowing the surgeon to visualize and manipulate tissue using standard laparoscopic tools. The current modification introduces a shorter access channel (3.5cm) to better accommodate patients with shorter anal canals.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing and performance data previously established in K110792 and K133393, which remain applicable to the modified access channel length.

Technological Characteristics

Disposable transanal access port constructed of polymers. Features an access channel (3.5cm to 15cm length) and a gel-based airtight cap for insufflation. Includes multiple sleeves/ports for instrument and laparoscope passage. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring transanal access for diagnostic or therapeutic procedures using multiple 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

• GelPOINT® Path Transanal Access Platform (K133393)
• GelPOINT® Path Transanal Access Platform (K110792)

Submission Summary (Full Text)

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

July 20, 2017

Applied Medical Resources Corp. Corinne Weisheit, Ph.D. Regulatory Affairs Specialist I 22872 Avenida Empresa Rancho Santa Margarita, CA 92688

Re: K171701

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: June 6, 2017 Received: June 8, 2017

Dear Corinne Weisheit:

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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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Charles Viviano -S

For

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) K171701

Device Name GelPOINT® Path Transanal Access Platform

Indications for Use (Describe)

The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary

| 510(K) Submitter: | Applied Medical Resources Corp.<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA, 92688<br>[phone] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Corinne Weisheit, PhD<br>Regulatory Affairs Specialist I<br>Applied Medical Resources Corp.<br>[e-mail]<br>Tel: [phone]<br>Fax: [phone] |
| Date of Preparation: | June 6, 2017 |
| Trade Name: | GelPOINT® Path Transanal Access Platform |
| Common Name: | Transanal endoscopic surgery access port |
| Classification: | Regulation: 21 CFR 876.1500, Endoscope & Accessories<br>Device Class: Class II<br>Product Code: FER |
| Predicate Device: | Applied Medical's GelPOINT® Path Transanal Access Platform<br>510(k)#: K133393 and K110792<br>Product Code: FER |
| Device Description: | GelPOINT Path is inserted into the anal canal to establish access<br>to the rectum and lower sigmoid colon in preparation for<br>transanal endoscopic surgery. The access channel lumen may be<br>closed off with an airtight cap. The cap allows for insufflation of<br>the surgical site. The cap is constructed of a gel material through<br>which multiple sleeves may be placed. These sleeves establish<br>ports that allow passage of a laparoscope and laparoscopic<br>instruments without loss of insufflation.<br>GelPOINT Path was previously cleared in access channel lengths<br>ranging from 4.5cm to 15cm. The proposed clearance for the<br>access channel length is 3.5cm to 15cm. |

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Indications for use: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

### Comparison of Technological Characteristics with the Predicate Device

The subject device is a line extension to the GelPOINT Path Transanal Access Platform device family cleared in K110792 and K133393. Similarities to the predicate GelPOINT Path devices include:

- All dilate the anus to allow access to the surgical site. ●
- All are inserted using an introducer ●
- All are affixed to the patient via sutures
- All allow insertion of instruments including endoscopes ●
- All are made of polymers ●
- All are disposable ●
- All are capable of insufflation ●
- All have a detachable airtight cap that facilitates insufflation and removal of ● specimens

The predicate devices were cleared for access channel lengths ranging from 4.5cm to 15cm. The proposed device access channel will measure as short as 3.5cm. The shorter access channel better accommodates patients with shorter anal canals.

### Discussion of Performance Testing

Safety and effectiveness for GelPOINT Path Transanal Access Platform was established in K110792 and K133393. Performance testing described in K110792 applies to the proposed clearance due to the fact that the access channel length does not impact the performance specifications required for the device's intended use.

### Conclusion

The GelPOINT Path Transanal Access Platform with an access channel that is 3.5cm in length is substantially equivalent to the previously cleared range described in K110792 and K133393.