The GelPOINT V-Path Vaginal Access System (VAS) is intended to be inserted in the vagina to allow for entry of minimally invasive instruments while maintaining insufflation for vaginal gynecological procedures.

Device Description

The GelPOINT V-Path Vaginal Access System consists of an Intravaginal Alexis retractor and two access channels that are placed vaginally to create a pathway to gynecological organs. A GelSeal cap attaches to the retractor at the opening of the vagina. The cap allows for insufflation and smoke evacuation. Sleeves inserted through the cap allow for passage of 5mm to 12mm instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.

AI/ML Overview

This document is a 510(k) summary for the GelPOINT® V-Path Vaginal Access System. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and the reported device performance:

The document describes functional testing but doesn't explicitly state quantitative acceptance criteria or provide specific numerical device performance metrics in a table format. Instead, it describes general successful outcomes.

Acceptance Criteria (Inferred from study goals)	Reported Device Performance (Summary of results)
Ability to maintain transvaginal access.	The studies confirm that the GelPOINT V-Path Vaginal Access System has the ability to establish and maintain a path of entry for minimally invasive instruments.
Ability to facilitate instrument access to the surgical site.	The studies confirm that the GelPOINT V-Path Vaginal Access System has the ability to establish and maintain a path of entry for minimally invasive instruments.
Ability to allow for device removal.	The studies confirm that the GelPOINT V-Path Vaginal Access System has the ability to allow for device removal. (Inferred from "Device removal" being an assessed function).
Ability to maintain device retention/anchoring.	The studies confirm that the GelPOINT V-Path Vaginal Access System can remain anchored in the patient while withstanding conditions under normal clinical use.
Ability to maintain insufflation.	The studies confirm that the integrity and sealing capability of the device system are adequate to maintain insufflation as a means to provide visualization of the surgical space.
Biocompatibility (non-cytotoxic, non-sensitizer, non-irritant, non-systemically toxic, non-pyrogenic).	The biocompatibility test results demonstrate the GelPOINT V-Path Vaginal Access System is biocompatible and has met the criteria to be classified as non-cytotoxic, non-sensitizer, non-irritant, non-systemically toxic, and non-pyrogenic.
Shelf-life of 3 years.	Results from testing demonstrated that the devices could maintain their specifications over the stated shelf-life duration of 3 years.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: The document mentions "bench testing" and "Functional bench testing" but does not provide specific sample sizes (e.g., number of devices tested, number of trials).
Data Provenance: The studies were internal company studies ("A protocol was developed by Applied Medical"). There is no mention of country of origin of data, and these are laboratory bench tests, not patient data, so the retrospective/prospective distinction is not applicable in the usual sense for clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The studies are described as functional bench tests, suggesting engineering or quality assurance personnel would evaluate the performance rather than clinical experts establishing a ground truth in the context of diagnostic accuracy.

4. Adjudication method for the test set:

This information is not provided. Given the nature of bench testing, it's unlikely an adjudication method like 2+1 or 3+1 (typically used for clinical imaging assessments) would be applied.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: No.
AI Assistance: The document describes a medical device for surgical access, not an AI-powered diagnostic or assistive tool. Therefore, a study on human readers improving with AI assistance is not applicable and was not conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a physical medical device, not an algorithm, so "standalone algorithm performance" is not applicable.

7. The type of ground truth used:

For the functional tests, the "ground truth" would be the successful demonstration of the device's intended functions (e.g., maintaining an open pathway, retaining its position, maintaining insufflation). For biocompatibility, the ground truth is established by meeting the pass/fail criteria outlined in the referenced ISO standards and USP <151>. For shelf-life, the ground truth is the device maintaining specifications after accelerated aging.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As above, this is not an AI/machine learning device.

In summary:

This 510(k) summary focuses on demonstrating the substantial equivalence of a physical surgical access device through functional bench testing, biocompatibility testing, and shelf-life studies. It does not involve clinical studies with patient data, expert review of images, or artificial intelligence algorithms. Therefore, many of your requested points related to AI performance, reader studies, and large-scale data sets are not relevant to this type of device submission.

Summary

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September 16, 2022

Applied Medical Resources Corporation David Yu Regulatory Affairs Specialist 22872 Avenida Empresa Rancho Santa Margarita, CA 92688

Re: K220969

Trade/Device Name: GelPOINT® V-Path Vaginal Access System Regulation Number: 21 CFR§ 884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: MOK Dated: August 17, 2022 Received: August 18, 2022

Dear David Yu:

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 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 and Part 809); 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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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,

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K220969

Device Name GelPOINT® V-Path Vaginal Access System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)> Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

GelPoint V-Path Vaginal Access System

K220969

510(K) Submitter:	Applied Medical Resources Corp.22872 Avenida EmpresaRancho Santa Margarita, CA, 92688(949) 713-8000
Contact Person:	David YuRegulatory Affairs SpecialistApplied Medical Resources Corp.David. Yu@appliedmedical.comTel: (949) 713-8023Fax: (949) 713-8205
Date of Preparation:	September 15, 2022
Trade Name:	GelPOINT® V-Path Vaginal Access System
Common Name:	Vaginal endoscopic surgery access port
Classification:	Regulation: 884.1630 ColposcopeDevice Class: Class IIProduct Code: MOK, Vaginoscope and accessories
Predicate Device:	Trade Name: KARL STORZ INFANT, BALLOONVAGINOSCOPE510(k) #: K950639Product Code: MOK
	Through FDA database search following predicate device hasbeen identified: KARL STORZ INFANT BALLOONVAGINOSCOPE manufactured by KARL STORZENDOSCOPY-AMERICA, INC (K950639). No design-relatedrecalls for these legally marketed predicate devices havebeen identified.
Indications for use:	The GelPOINT V-Path Vaginal Access System is intended to beinserted in the vagina to allow for entry of minimally invasiveinstruments while maintaining insufflation for vaginalgynecological procedures.

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Device Description

Manufacturer	Applied Medical Resources Corp	KARL STORZENDOSCOPY-AMERICA,INC
Trade Name	GelPOINT V-Path VaginalAccess SystemK220969	KARL STORZ INFANTBALLOONVAGINOSCOPEK950639
General DeviceCharacteristics
Device Design	The Vaginal Access Systemconsists of similarly designedintravaginal Alexis retractor and avaginal access channelthat acts as the anchor for theintravaginal Alexis retractor.Intended to be insertedtransvaginally, to allow passage ofminimally invasive instruments forthe purpose of visualizinggynecological organs, and to allowfor diagnostic and operativegynecological procedures includingthe extraction of specimens	The device consists of avaginoscopes, balloonvaginoscopes, vaginoscopesheaths, fiber optic lightcarrier and adjustablemagnifiers.Designed to be used forendoscopic diagnostic andsurgical procedures involvingthe infant vagina and cervix.
Anatomical Sites	Vagina	Vagina
Placement	Transvaginal	Transvaginal

Comparison of Technological Characteristics with the Predicate Device

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VisualizationCapability	Visualization is achieved viaintroduction of an endoscopethrough an access port.	N/A
Expansion ofSurgical Space	Utilizes CO2 insufflation via aninsufflator (not included withdevice) connected to insufflationport on the device.	N/A
DeviceRemovals	The intravaginal Alexis retractordoes not include a tether becausethe retractor is only placed at thevaginal introitus and can beremoved after unrolling the outerring. The access channel is alsoplaced at the introitus and isremoved manually by the user.	N/A
Materials	Polyether polyurethane,thermoplastic elastomer	N/A
Sterilization	Ethylene Oxide, SterilityAssurance Level of 10-6Single use device; device isdiscarded after use	N/A

The subject and predicate device have the same intended use, namely:

To be inserted vaginally. ●
To allow passage of minimally invasive instruments for the purpose of . visualizing gynecological organs.
To allow for diagnostic and operative gynecological procedures including the . extraction of specimens.

The differences in device design, presence of imaging capability, and material do not constitute a new intended use. Additionally, there are no different questions of safety and effectiveness that arise from the differences in technology. The technological differences between GelPOINT V-Path Vaginal Access System and the predicate device can be evaluated through performance testing and do not alter the intended use of the GelPOINT V-Path Vaginal Access System.

Discussion of Performance Data

The subject device and predicate device share the same ability to achieve vaginal access to the vaginal canal. Therefore, bench testing for the subject device was conducted to demonstrate the clinically relevant functionality to provide access to the vaginal canal.

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There are no existing performance standards to evaluate the functions of the GelPOINT V-Path Vaginal Access System. A protocol was developed by Applied Medical to evaluate the ability of the subject device to provide access to the vaginal canal and remain anchored following deployment. Maintenance of insufflation and device removal were also assessed.

Function Testing

Functional bench testing was performed to demonstrate the adequate functionality of the Vaginal Access System, as follows:

Maintenance of transvaginal access ●
Facilitation of instrument access to surgical site ●
Device removal
Device retention ●
Maintenance of insufflation

The studies confirm that the GelPOINT V-Path Vaginal Access System has the ability to establish and maintain a path of entry for minimally invasive instruments and can remain anchored in the patient while withstanding conditions under normal clinical use. The studies also confirm that the integrity and sealing capability of the device system are adequate to maintain insufflation as a means to provide visualization of the surgical space.

Biocompatibility

Biocompatibility studies were performed in accordance with the 2020 FDA guidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and "testing" as follows:

Cytotoxicity: ISO 10993-5:2009 ●
Sensitization: ISO 10993-10:2010 .
Irritation: ISO 10993-10:2010 ●
Acute Systemic Toxicity: ISO 10993-11:2017
Pvrogenicity Potential: USP <151>. ISO 10993-11:2017 .

The biocompatibility test results demonstrate the GelPOINT V-Path Vaginal Access System is biocompatible. The results show the subject device has met the criteria to be classified as a non-cytotoxic, non-sensitizer, non-irritant device that shows no sign of being systemically toxic or pyrogenic. The information provided for biocompatibility testing indicate the subject device is acceptable to demonstrate substantial equivalence from a biocompatibility standpoint.

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Shelf-Life

The GelPOINT V-Path Vaginal Access System has a shelf life of 3 years when packaged in Tyvek and nylon film pouches, in accordance with the results of accelerated aged stability studies. Results from testing demonstrated that the devices could maintain their specifications over the stated shelf-life duration.

Clinical Performance Data

Clinical data are not needed to support substantial equivalence for the subject device.

Conclusion

The GelPOINT V-Path Vaginal Access System has the same intended use as the predicate device. The GelPOINT V-Path Vaginal Access System has different technological characteristics from the predicate device, but these differences do not raise different questions of safety and effectiveness. Performance testing, as described above, demonstrates that the GelPOINT V-Path Vaginal Access System is as safe and effective as the predicate. Therefore, the GelPOINT V-Path Vaginal Access System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 884.1630 Colposcope.

(a)
Identification. A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.(b)
Classification. Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.