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 Description

The proposed device is an iteration of Applied Medical's GelPort Blunt Tip Trocar System. The predicate GelPort system provides a single access port and must therefore be used in combination with additional ports. Three ports is common, each requiring a dedicated incision. The proposed device, in essence, combines three of the single port predicates into one compact construct that requires but a single incision. A fourth port is included in the package as an option.
The proposed device is a sterile, single-use instrument intended to access abdominal, thoracic and pelvic cavities in preparation for endoscopic surgical procedures. It features a sleeve type wound retractor and a detachable cap. The wound retractor consists of a flexible polyurethane cylindrical sheath that has a semi-rigid polyurethane inner ring attached at each end. The detachable Gel-cap is constructed of a semi-rigid polycarbonate ring and a flexible gel-like material. The Gel-cap is fastened to the wound retractor with a locking attachment lever. 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.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device (GelPOINT Mini Advanced Access Platform) and outlines the testing conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain the specific information typically found in a study proving a device meets acceptance criteria for an AI/ML-driven medical device, such as performance metrics (accuracy, sensitivity, specificity), details on test set data (sample size, provenance), expert ground truth establishment, or multi-reader studies.

The document focuses on non-clinical performance testing for a physical medical device (an endoscopic access platform), not a software or AI-based device. Therefore, many of the requested categories (e.g., number of experts, adjudication method, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device and study.

Below, I will extract the information that is present in the document relevant to non-clinical performance testing and note where the requested information is not applicable or not provided.

Study Proving Device Meets Acceptance Criteria for GelPOINT Mini Advanced Access Platform

This document describes the non-clinical performance testing used to demonstrate substantial equivalence of the GelPOINT Mini Advanced Access Platform to its predicate device, the GelPort Blunt Tip Trocar System. The testing primarily focused on the physical and functional aspects of the access platform.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Predicate and proposed devices met all testing acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria or the specific numerical results for each test. Instead, it describes the types of functional tests performed.

Test Category	Acceptance Criteria (Descriptions from Document)	Reported Device Performance
Biocompatibility	In accordance with FDA guidance ISO 10993-1 for devices contacting tissue for less than 24 hours. Compatible in: Cytotoxicity, Intracutaneous reactivity, Sensitization.	"The proposed device ... was found compatible after being subjected to these tests." (Implies acceptance criteria were met for these tests).
Functional Performance	Implicit: Demonstrate substantial equivalence by performing comparably to the predicate device and maintaining functional integrity. Quantitative thresholds not specified.	"Predicate and proposed devices met all testing acceptance criteria." (Specific numerical results are not provided, but it's stated they passed).
Resistance to Detachment	(Not explicitly defined beyond "while operated as intended")	Met acceptance criteria.
System Leak Test	(Not explicitly defined beyond "with and without instruments")	Met acceptance criteria.
Seal Particulation	(Not explicitly defined beyond "during instrument exchanges")	Met acceptance criteria.
Seal Resealing Ability	(Not explicitly defined beyond "after removal instruments")	Met acceptance criteria.
Instrument Drag Force	(Not explicitly defined beyond "created by inserting and removing instruments")	Met acceptance criteria.

2. Sample Size and Data Provenance

Sample Size for Test Set: Not explicitly stated for each test, but implied to be sufficient for "side-by-side bench testing" of the proposed and predicate devices.
Data Provenance: This is not applicable in the context of clinical data for an AI/ML device. The testing was bench testing (laboratory-based, physical performance testing) rather than involving human subject data or retrospective/prospective patient data. The manufacturer is "Applied Medical Resources Corporation" based in California, USA, where the testing presumably took place.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable: This type of testing (functional performance of a physical surgical access device) does not involve medical image interpretation or clinical decision-making that would require expert-established ground truth. The ground truth refers to the physical functionality and safety parameters measured in the lab.

4. Adjudication Method for the Test Set

Not Applicable: No adjudication of expert opinions was necessary as the study was non-clinical bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No: This was not an MRMC study. MRMC studies are typically performed for imaging diagnostics or AI-assisted interpretation, where human reader performance is evaluated. This document describes the testing of a physical surgical access device.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

Not Applicable: This is a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant. The device functionality was tested standalone in a bench setting.

7. The Type of Ground Truth Used

Bench Test Measurements/Physical Properties: The "ground truth" for this study was based on objective measurements of physical and functional properties during bench testing (e.g., resistance to detachment, leak rates, particulation, resealing ability, drag force) and biological compatibility.

8. The Sample Size for the Training Set

Not Applicable: This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not Applicable: As above, no training set was involved.

Summary

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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

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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Indications for Use

510(k) Number (if known) K191866

Device Name GelPOINT Mini Advanced Access Platform

Indications for Use (Describe)

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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K191866, 510(K) Summary

510(K) Submitter:	Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, California, 92688contact@appliedmedical.com(949) 713-8000
Contact Person:	Mr. Frans VandenBroek, BSMEPrincipal Regulatory Affairs SpecialistApplied Medical Resourcesfvandenbroek@appliedmedical.comTel: (949) 713-8369, Fax: (949) 713-8205
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'sGelPort Blunt Tip Trocar System. The predicate GelPort systemprovides a single access port and must therefore be used incombination with additional ports. Three ports is common, eachrequiring a dedicated incision. The proposed device, in essence,combines three of the single port predicates into one compactconstruct that requires but a single incision. A fourth port isincluded in the package as an option.The proposed device is a sterile, single-use instrument intendedto access abdominal, thoracic and pelvic cavities in preparationfor endoscopic surgical procedures. It features a sleeve typewound retractor and a detachable cap. The wound retractorconsists of a flexible polyurethane cylindrical sheath that has asemi-rigid polyurethane inner ring attached at each end. Thedetachable Gel-cap is constructed of a semi-rigid polycarbonatering and a flexible gel-like material. The Gel-cap is fastened tothe wound retractor with a locking attachment lever.

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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 TipTrocar System(Predicate)	GelPOINT Mini AdvancedAccess Platform(Proposed Device)
Intended use	Create an access channel forplacing endoscopic instrumentsinto body cavities underinsufflated conditions	Same
	GelPort Blunt Tip	GelPOINT Mini Advanced
	Trocar System	Access Platform
	(Predicate)	(Proposed Device)
Indicationsfor use	For use in general, abdominal,gynecological, and thoracicminimally invasive surgicalprocedures to establish a path ofentry or to gain access throughtissue planes, extraperitonealspaces and/or potential spacesfor endoscopic instruments	Same
Anatomy	Area ranging from the pelvis tothe thorax including the breast.	Same
Insertion	Through an incision based onsurgeons experience with 12mmports.	Through an incision ranging from15 to 40mm.
Portrequirement	The device delivers a single port.Since most endoscopicprocedures require multipleports, additional ports (andincisions) are required	The device provides three accessports in a single construct andrequires but a single incision. A4th port is included as an option.
Port size	Single port, 12mm	Three 10mm, one 12mm port
Anchoring	Device is secured to the patientvia a sliding bolster and aninflatable balloon. Loops foradding sutures (if desired) areprovided	Device is secured to the patientvia a sleeve type woundprotector/retractor
Insufflation	Allows insufflation	Same
Visualization	Standard endoscope placedthrough access port	Same
Instrumentcapability	Endoscopic instruments rangingfrom 4.8 to 13.2mm	Same
Instrumentsarticulation	Articulation and positioning ofinstruments is limited by rigidityof patient tissue	Articulation and positioning ofinstruments is superior due toflexibility of gel cap
Specimenremoval	Limited. Oversize specimenrequires removal of port	Superior. Detaching the gel capprovides a larger opening througha protected wound
Materials	Various polymers	Polymers and stainless steel
Sterility	E-beam irradiation, 25-60kGy	Gamma Irradiation, 27.5-40kGy

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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.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.