Transvaginal Access Platform

K191294 · Applied Medical Resources Corp. · HEW · Sep 6, 2019 · Obstetrics/Gynecology

Device Facts

• Record ID: K191294
• Device Name: Transvaginal Access Platform
• Applicant: Applied Medical Resources Corp.
• Product Code: HEW · Obstetrics/Gynecology
• Decision Date: Sep 6, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1640
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K191294 · Sep 6, 2019	Transvaginal Access Platform	Applied Medical Resources Corp.	iNOTES (International Natural Orifice Transluminal Endoscopic Surgery) Society Registry; Published clinical literature (Baekelandt et al., 2018)	The sponsor utilized registry data and published clinical trial results to demonstrate acceptable rates of peri- and post-operative complications, supporting the safety and clinical performance of the Transvaginal Access Platform.	Registry data; Clinical literature; vNOTES; Peri-operative complications

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Baekelandt et al. (2018); Randomized, single-center, single-blinded trial	Patients undergoing hysterectomy; Sample Size: 70; Number of Sites: 1	Total laparoscopic hysterectomy (TLH)	Peri- and post-operative complications
iNOTES Society Registry; Registry study	Patients undergoing vNOTES procedures; Sample Size: 906	Not applicable for this study	Peri- and post-operative complications

Indications for Use

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 Story

Transvaginal access platform facilitates minimally invasive gynecological surgery; device inserted transvaginally to create surgical pathway; GelSeal cap attaches at vaginal opening to maintain insufflation and allow smoke evacuation; sleeves accommodate 5mm to 12mm laparoscopic instruments; endoscope introduced through sleeve for visualization; device serves as conduit for specimen extraction; used in clinical gynecological settings by surgeons; output provides physical access and visualization for surgical intervention; benefits include enabling minimally invasive procedures, reducing need for traditional open surgery, and maintaining pneumoperitoneum/insufflation during operation.

Clinical Evidence

Clinical evidence provided via literature review: randomized, single-blinded trial (n=70) comparing vNOTES hysterectomy vs. total laparoscopic hysterectomy, and iNOTES Society Registry data (n=906). Both datasets demonstrated acceptable peri- and post-operative complication rates.

Technological Characteristics

Consists of access channel and GelSeal cap. Accommodates 5mm-12mm laparoscopic instruments. Biocompatibility per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization). Provided sterile. Mechanical testing covers access maintenance, instrument facilitation, device retention, and insufflation maintenance.

Indications for Use

Indicated for patients undergoing laparoscopic-assisted or vaginal gynecological procedures requiring transvaginal access for minimally invasive instrumentation, insufflation, and specimen extraction.

Regulatory Classification

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.

Predicate Devices

• GelPOINT Transvaginal Access Platform (K143308)

Submission Summary (Full Text)

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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.

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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary – K191294

| 510(K) Submitter: | Applied Medical Resources Corp.<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA, 92688<br>[phone] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Corinne Yestrepsky, PhD<br>Regulatory Affairs Specialist II<br>Applied Medical Resources Corp.<br>Corinne. [e-mail]<br>Tel: [phone]<br>Fax: [phone] |
| 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 & Accessories<br>Device Class: Class II<br>Product Code: HEW (culdoscope and accessories) |
| Predicate Device: | Trade Name: GelPOINT Transvaginal Access Platform<br>510(k) #: K143308<br>Product Code: HEW<br>The predicate device has not been subject to a design related recall. |
| Device Description: | The Transvaginal Access Platform consists of an access channel<br>component that is placed transvaginally to create a pathway to<br>gynecological organs in the pelvic cavity. A GelSeal cap<br>attaches to the access channel at the opening of the vagina. The<br>cap allows for insufflation and smoke evacuation. Sleeves<br>inserted through the cap allow for passage of 5mm to 12mm<br>laparoscopic instrumentation. Visualization is achieved via<br>introduction of an endoscope through a sleeve. The device is<br>provided sterile. |
| Indications for use: | The Transvaginal Access Platform is intended to be inserted<br>transvaginally to establish a path of entry for minimally invasive<br>instruments while maintaining insufflation during laparoscopic-<br>assisted and vaginal gynecological procedures. The device is<br>also 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.