The Transvaginal Access Platform is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments while maintaining insufflation during laparoscopic-assisted and vaginal gynecological procedures. The device is also a conduit for the extraction of specimens.

Device Description

The Transvaginal Access Platform consists of an access channel component that is placed transvaginally to create a pathway to gynecological organs in the pelvic cavity. A GelSeal cap attaches to the access channel 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 laparoscopic instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.

AI/ML Overview

The Acceptance Criteria and supporting study information are derived from the "Discussion of Performance Data" and "Comparison with the Predicate Device" sections of the provided text.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Sterilization: Device must be sterile.	Sterilization validation was provided to support substantial equivalence.
Shelf Life: Device must maintain integrity and functionality over its specified shelf life, including transportation.	Shelf life testing including transportation simulation, package integrity, and device functionality testing was provided.
Biocompatibility: Device materials must be biocompatible (non-cytotoxic, non-irritating, non-sensitizing).	Biocompatibility testing including cytotoxicity per ISO 10993-5 and irritation and sensitization testing per ISO 10993-10 was provided.
Mechanical Performance:
- Maintenance of Transvaginal Access: Device must effectively maintain transvaginal access.	Assessment of maintenance of transvaginal access was performed.
- Facilitation of Instrument Access: Device must facilitate instrument access to the surgical site.	Assessment of facilitation of instrument access to surgical site was performed.
- Device Removal: Device must be easily removable.	Assessment of device removal was performed.
- Device Retention: Device must remain securely in place during procedures.	Assessment of device retention was performed.
- Maintenance of Insufflation: Device must maintain insufflation (or pneumoperitoneum).	Assessment of maintenance of insufflation was performed.
Clinical Performance (Safety): Acceptable rates of peri- and post-operative complications.	Both clinical datasets (Baekelandt et al. (2018) and iNOTESs Society Registry) demonstrated acceptable rates of peri- and post-operative complications following use of the subject device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size:
- Baekelandt et al. (2018) study: n=70
- iNOTESs Society Registry data: n=906
Data Provenance: The document does not specify the country of origin for either dataset.
- Baekelandt et al. (2018): Randomized, single-center, single-blinded trial (Prospective).
- iNOTESs Society Registry data: Registry data (Likely prospective, though details aren't fully specified).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The studies report "acceptable rates of peri- and post-operative complications," implying clinical assessment, but the number or qualifications of experts involved in determining these outcomes are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

No MRMC study was done that involved AI vs. human readers. The studies described (Baekelandt et al. and iNOTESs Registry) are clinical performance studies of a medical device (Transvaginal Access Platform), not an AI diagnostic tool. They compare different surgical approaches or document outcomes with the device.

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

Not applicable. The device is a physical surgical access platform, not an algorithm. Therefore, no standalone algorithm performance study was performed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the clinical performance criteria ("acceptable rates of peri- and post-operative complications") appears to be clinical outcomes data, likely assessed by healthcare professionals involved in the care of the patients. This would include direct observation, patient follow-up, and review of medical records for complications.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

Summary

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September 6, 2019

Applied Medical Resources Corp. Corinne Yestrepsky Regulatory Affairs Specialist II 22872 Avenida Empresa Rancho Santa Margarita, CA 92688

Re: K191294 Trade/Device Name: Transvaginal Access Platform Regulation Number: 21 CFR 884.1640 Regulation Name: Culdoscope And Accessories Regulatory Class: II Product Code: HEW Dated: August 2, 2019 Received: August 7, 2019

Dear Corinne Yestrepsky:

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. 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

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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,

for Sharon M. Andrews Acting 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

Enclosure

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Indications for Use

510(k) Number (if known) K191294

Device Name Transvaginal Access Platform

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 – K191294

510(K) Submitter:	Applied Medical Resources Corp.22872 Avenida EmpresaRancho Santa Margarita, CA, 92688(949) 713-8000
Contact Person:	Corinne Yestrepsky, PhDRegulatory Affairs Specialist IIApplied Medical Resources Corp.Corinne. Yestrepsky@appliedmedical.comTel: (949) 713-8176Fax: (949) 713-8205
Date of Preparation:	September 6, 2019
Trade Name:	Transvaginal Access Platform
Common Name:	Transvaginal endoscopic surgery access port
Classification:	Regulation: 21 CFR 884.1640, Culdoscope & AccessoriesDevice Class: Class IIProduct Code: HEW (culdoscope and accessories)
Predicate Device:	Trade Name: GelPOINT Transvaginal Access Platform510(k) #: K143308Product Code: HEWThe predicate device has not been subject to a design related recall.
Device Description:	The Transvaginal Access Platform consists of an access channelcomponent that is placed transvaginally to create a pathway togynecological organs in the pelvic cavity. A GelSeal capattaches to the access channel at the opening of the vagina. Thecap allows for insufflation and smoke evacuation. Sleevesinserted through the cap allow for passage of 5mm to 12mmlaparoscopic instrumentation. Visualization is achieved viaintroduction of an endoscope through a sleeve. The device isprovided sterile.
Indications for use:	The Transvaginal Access Platform is intended to be insertedtransvaginally to establish a path of entry for minimally invasiveinstruments while maintaining insufflation during laparoscopic-assisted and vaginal gynecological procedures. The device isalso a conduit for the extraction of specimens.

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Comparison with the Predicate Device

The subject and predicate device have different indications for use statements. The predicate device is indicated only for laparoscopic hysterectomy, while the subject device is indicated for laparoscopic assisted and vaginal gynecologic procedures. The key difference is that the subject device can be used during a procedure that only relies on vaginal access (i.e., no laparoscopic access), as well as laparoscopic-assisted gynecologic procedures other than hysterectomy. In addition, the subject device indication uses the term "maintaining insufflation" versus the "maintaining pneumoperitoneum" term used in the predicate device indication. This change in terminology is to account for insufflation of the vaginal canal when the subject device is in use.

The subject and predicate device have the same intended use - establishing a path of entry for instruments, maintaining insufflation, and serving as a conduit for extraction of specimens during minimally invasive gynecologic procedures.

The subject and predicate device have different technological characteristics, including device retention, instrument compatibility, specimen removal method and size, device removal, and device materials. These differences in technological characteristics do not raise different questions of safety or effectiveness.

Discussion of Performance Data

The following performance testing was provided to support a substantial equivalence determination:

Sterilization validation
. Shelf life testing including transportation simulation, package integrity, and device functionality testing
Biocompatibility including cytotoxicity per ISO 10993-5 and irritation and ● sensitization testing per ISO 10993-10
Mechanical performance testing including assessments of the following:
- Maintenance of transvaginal access o
- Facilitation of instrument access to surgical site o
- Device removal O
- o Device retention
- Maintenance of insufflation o
Clinical performance data
- o Baekelandt et al (2018) - randomized, single-center, single-blinded trial to compare hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) versus total laparoscopic hysterectomy (TLH) (n=70)
- Orifice -International Natural Transluminal Endoscopic Surgerv o (iNOTESs) Society Registry data (n=906)
- Both data sets demonstrated acceptable rates of peri- and post-operative o

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complications following use of the subject device.

Conclusion

Based on the intended use, technological characteristics, and performance testing results, the subject Transvaginal Access Platform device is considered substantially equivalent to the predicate device.

Regulation Number and Section

§ 884.1640 Culdoscope and accessories.

(a)
Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.