GelPOINT Mini Advanced Access Platform

K191866 · Applied Medical · GCJ · Apr 29, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K191866
• Device Name: GelPOINT Mini Advanced Access Platform
• Applicant: Applied Medical
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Apr 29, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GelPOINT Mini Advanced Access Platform is indicated for use in general, abdominal, gynecological, and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes, extraperitoneal spaces and/or potential spaces for endoscopic instruments.

Device Story

The GelPOINT Mini Advanced Access Platform is a sterile, single-use surgical access device used in minimally invasive procedures. It consists of a flexible polyurethane sleeve-type wound retractor and a detachable gel-cap. The device is inserted through a single 15-40mm incision. The gel-cap, made of a flexible gel-like material and a polycarbonate ring, accommodates up to four access ports for laparoscopic instruments (4.8-13.2mm). The device is operated by surgeons in clinical settings. It functions by providing a sealed access channel that allows for insufflation of the surgical space while enabling instrument articulation and positioning. The flexible nature of the gel-cap allows for superior instrument movement compared to rigid ports. The cap is detachable to facilitate specimen removal. By consolidating multiple access points into a single incision, the device reduces the number of incisions required for multi-port procedures, potentially minimizing surgical trauma and improving procedural efficiency.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included biocompatibility (cytotoxicity, intracutaneous reactivity, sensitization per ISO 10993-1) and functional bench testing (resistance to detachment, system leak tests with/without instruments, seal particulation, resealing capability, and instrument drag force). All tests met acceptance criteria.

Technological Characteristics

Materials: Polyurethane (sheath/rings), polycarbonate (ring), gel-like material, stainless steel. Form factor: Sleeve-type wound retractor with detachable gel-cap. Connectivity: None. Sterilization: Gamma irradiation (27.5-40kGy). Energy: None (mechanical).

Indications for Use

Indicated for patients undergoing general, abdominal, gynecological, or thoracic minimally invasive surgical procedures requiring endoscopic access through tissue planes or extraperitoneal spaces.

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

• Applied Medical GelPort Blunt Tip Trocar System (K060629)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 29, 2020

Applied Medical Resources Corp. Mr. Frans Vandenbroek Principal Regulatory Affairs Specialist 22872 Avenida Empresa Rancho Santa Margarita, California 92688

Re: K191866

Trade/Device Name: GelPOINT Mini Advanced Access Platform Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: March 27, 2020 Received: March 31, 2020

Dear Mr. Vandenbroek:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K191866

Device Name GelPOINT Mini Advanced Access Platform

Indications for Use (Describe)

The GelPOINT Mini Advanced Access Platform is indicated for use in general, abdominal, gynecological, and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes, extraperitoneal spaces and/or potential spaces for endoscopic 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image contains the logo for Applied Medical. The logo consists of the word "Applied" stacked on top of the word "Medical" in a bold, sans-serif font. To the right of the text is a teal-colored triangular shape with three curved lines running through it.

# K191866, 510(K) Summary

| 510(K) Submitter: | Applied Medical Resources Corporation<br>22872 Avenida Empresa<br>Rancho Santa Margarita, California, 92688<br>[e-mail]<br>[phone] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Frans VandenBroek, BSME<br>Principal Regulatory Affairs Specialist<br>Applied Medical Resources<br>[e-mail]<br>Tel: [phone], Fax: [phone] |
| Date of Preparation: | April 28, 2020 |
| Trade Name: | GelPOINT Mini Advanced Access Platform |
| Common Name: | Endoscopic Access Device |
| Classification: | 21CFR876.1500, Endoscope and Accessories. |
| Product Code: | GCJ, Laparoscope, General and Plastic Surgery |
| Predicate Device: | K060629, Applied Medical GelPort Blunt Tip Trocar System |
| Device Description: | The proposed device is an iteration of Applied Medical's<br>GelPort Blunt Tip Trocar System. The predicate GelPort system<br>provides a single access port and must therefore be used in<br>combination with additional ports. Three ports is common, each<br>requiring a dedicated incision. The proposed device, in essence,<br>combines three of the single port predicates into one compact<br>construct that requires but a single incision. A fourth port is<br>included in the package as an option.<br>The proposed device is a sterile, single-use instrument intended<br>to access abdominal, thoracic and pelvic cavities in preparation<br>for endoscopic surgical procedures. It features a sleeve type<br>wound retractor and a detachable cap. The wound retractor<br>consists of a flexible polyurethane cylindrical sheath that has a<br>semi-rigid polyurethane inner ring attached at each end. The<br>detachable Gel-cap is constructed of a semi-rigid polycarbonate<br>ring and a flexible gel-like material. The Gel-cap is fastened to<br>the wound retractor with a locking attachment lever. |

{4}------------------------------------------------

The Gel-cap can accommodate up to four access ports that are inserted through the gel in a formation preferred by the user. The ports accommodate laparoscopic tools ranging from 4.8 to 13.2mm and have sealing features that allow insufflation of the surgical space. Intended Use: The GelPOINT Mini Advanced Access Platform is indicated for use in general, abdominal, gynecological, and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes, extraperitoneal spaces and/or potential spaces for endoscopic instruments.

## Summary of Technological Characteristics:

The predicate and proposed device share these technological characteristics:

- . Both establish access ports for laparoscopic procedures executed in parts of the body ranging from the thorax to the pelvis.
- Both are inserted through incisions ranging from 1.5 4cm based on user preference. ●
- Both accommodate laparoscopic instruments ranging from 4.8 to 13.2mm.
- Both allow insufflation of the surgical space.
- Both have mechanisms for anchoring the device to the patient.

Compared to the predicate, the proposed device has these technological updates:

- . Up to four endoscopic access ports delivered in a compact construct that is placed through a single incision.
- The lower portion of the device serves as a wound protector/retractor. ●
- The upper portion accommodates up to four access ports in a cap made of a flexible gel-type material. The quantity and location of the ports is based on user preference.
- . The Gel-cap is exceptionally flexible which allows superior articulation of instruments placed through the ports.
- The Gel-cap closes the wound opening to allow insufflation of surgical spaces. ●
- The Gel-cap is detachable to accommodate removal of specimen.

## Technological Similarities, Predicate and Proposed Device

| | GelPort Blunt Tip<br>Trocar System<br>(Predicate) | GelPOINT Mini Advanced<br>Access Platform<br>(Proposed Device) |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Create an access channel for<br>placing endoscopic instruments<br>into body cavities under<br>insufflated conditions | Same |
| | GelPort Blunt Tip | GelPOINT Mini Advanced |
| | Trocar System | Access Platform |
| | (Predicate) | (Proposed Device) |
| Indications<br>for use | For use in general, abdominal,<br>gynecological, and thoracic<br>minimally invasive surgical<br>procedures to establish a path of<br>entry or to gain access through<br>tissue planes, extraperitoneal<br>spaces and/or potential spaces<br>for endoscopic instruments | Same |
| Anatomy | Area ranging from the pelvis to<br>the thorax including the breast. | Same |
| Insertion | Through an incision based on<br>surgeons experience with 12mm<br>ports. | Through an incision ranging from<br>15 to 40mm. |
| Port<br>requirement | The device delivers a single port.<br>Since most endoscopic<br>procedures require multiple<br>ports, additional ports (and<br>incisions) are required | The device provides three access<br>ports in a single construct and<br>requires but a single incision. A<br>4th port is included as an option. |
| Port size | Single port, 12mm | Three 10mm, one 12mm port |
| Anchoring | Device is secured to the patient<br>via a sliding bolster and an<br>inflatable balloon. Loops for<br>adding sutures (if desired) are<br>provided | Device is secured to the patient<br>via a sleeve type wound<br>protector/retractor |
| Insufflation | Allows insufflation | Same |
| Visualization | Standard endoscope placed<br>through access port | Same |
| Instrument<br>capability | Endoscopic instruments ranging<br>from 4.8 to 13.2mm | Same |
| Instruments<br>articulation | Articulation and positioning of<br>instruments is limited by rigidity<br>of patient tissue | Articulation and positioning of<br>instruments is superior due to<br>flexibility of gel cap |
| Specimen<br>removal | Limited. Oversize specimen<br>requires removal of port | Superior. Detaching the gel cap<br>provides a larger opening through<br>a protected wound |
| Materials | Various polymers | Polymers and stainless steel |
| Sterility | E-beam irradiation, 25-60kGy | Gamma Irradiation, 27.5-40kGy |

{5}------------------------------------------------

{6}------------------------------------------------

## Discussion of Non-clinical Performance Testing:

## Biocompatibility

A biocompatibility evaluation of the GelPOINT Mini Advanced Access Platform was conducted in accordance with the FDA's guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. " The proposed device contacts tissue for less than 24 hours and was found compatible after being subjected to these tests:

- Cytotoxicity
- Intracutaneous reactivity
- Sensitization ●

#### Functional Performance:

Side-by-side bench testing was performed on the proposed and predicate devices to demonstrate substantial equivalence. The tests focused on the functional performance of an endoscopic access device. Proposed and predicate devices were evaluated for:

- Resistance to detachment from the patient while operated as intended. ●
- System leak test with and without instruments.
- Seal particulation during instrument exchanges.
- The ability of the sealing system to reseal after removal instruments. ●
- The drag force created by inserting and removing instruments. ●

## Results and Conclusions

Predicate and proposed devices met all testing acceptance criteria. Test results demonstrate substantial equivalence between the predicate and proposed device.