The CooperSurgical Advincula Delineator™ Uterine Manipulator is indicated to provide delineation of the vaginal fornices and maintain pneumoperitoneum as a uterine manipulator during Total Laparoscopic Hysterectomy, Laparoscopic Assisted Vaginal Hysterectomy and/or Laparoscopic Supra-Cervical Hysterectomy.

Device Description

The Advincula Delineator Uterine Manipulator is intended for use during total laparoscopic hysterectomy (TLH), laparoscopic assisted vaginal hysterectomy (LAVH), and/or laparoscopic supracervical hysterectomy (LSH) procedures. It is single-use, disposable, and provided sterile. The device has a distal balloon built into the arched shaft, and a sliding colpotomy cup, called a Koh-Cup, that locks into place with a position lock. The handle at the proximal end allows the user to hold the device and to manipulate the uterus. When properly positioned, the outer rim of the Koh-Cup delineates the vaginal fornices and provides an anatomical landmark to facilitate uterine resection. An occluder balloon is used to maintain pneumoperitoneum during the procedure.

The Advincula Delineator Uterine Manipulator is available with Koh-Cups sized 2.5cm or 4.0cm in diameter. The Koh-Cup is made of Hytrel and the manipulator is made of stainless steel, silicone, various plastics, adhesives and inks. The subject device is intended to be used in hospitals.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Advincula Delineator™ Uterine Manipulator, which is a medical device and not an AI/ML powered device. As such, it does not involve the type of acceptance criteria and study designs typically associated with AI/ML device performance (e.g., sensitivity, specificity, MRMC studies, ground truth established by experts).

The acceptance criteria presented here are for the substantial equivalence of a modified medical device to a predicate device, focusing on material changes and packaging, rather than an AI algorithm's diagnostic or predictive performance.

Therefore, the requested information, specifically regarding AI/ML device performance, acceptance criteria, test set details, expert involvement, and ground truth methodologies, cannot be extracted from this document as it is not relevant to the described device and its review process.

Instead, the document focuses on:

Acceptance Criteria (for device modification equivalence): The "acceptance criteria" here refer to demonstrating that changes made to the device (specifically, the Koh-Cup material and packaging) do not raise new questions of safety or effectiveness compared to the predicate device.
- The criteria are met by passing a series of non-clinical performance tests.
Study Proving Acceptance Criteria Met: The study undertaken was a series of non-clinical performance tests on the modified device.

Here's a breakdown of the relevant information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test Performed	Reported Device Performance and Acceptance
Sterilization	ISO 10993-7:2008 (Ethylene oxide sterilization residuals)	Not explicitly stated "passed," but implied by "The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence."
	ISO 11135:2014 (Ethylene Oxide Sterilization Process Requirements)	Not explicitly stated "passed," but implied as above.
Shelf Life & Shipping	Shelf life demonstration up to 1 year	Demonstrated up to 1 year.
	ISO 11607-1:2006 (Packaging for Terminally Sterilized Medical Devices)	Not explicitly stated "passed," but implied as above.
	ISTA 3A:2008 (Packaged-Products for Parcel Delivery System Shipment)	Not explicitly stated "passed," but implied as above.
	ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems)	Design verification testing was performed after accelerated aging (equivalent to one year real-time aging). Devices met predetermined acceptance criteria.
Design Verification	Compression test (for Koh-Cup)	The test results show that the subject Koh-Cup met the predetermined acceptance criterion. (To verify it can withstand adequate compression force).
	Pull Off test (for Koh-Cup)	The test results show that the subject Koh-Cup met the predetermined acceptance criterion. (To verify it does not disassemble from the device when used as intended).
	Distortion test (for Koh-Cup)	The test results show that the subject Koh-Cup met the predetermined acceptance criterion. (To verify it can withstand adequate force).
	Temperature Testing (for Koh-Cup)	The test results show that the subject Koh-Cup met the predetermined acceptance criterion. (To verify it can withstand adequate temperature).
Biocompatibility	Cytotoxicity (per ISO 10993-5:2009)	Results demonstrated the new Koh-Cup was non-cytotoxic.
	Sensitization (per ISO 10993-10:2010)	Results demonstrated the new Koh-Cup was non-sensitizing.
	Irritation (per ISO 10993-10:2010)	Results demonstrated the new Koh-Cup was non-irritating.

Regarding the AI/ML specific questions (2-9), this document does not contain that information as the device is not an AI/ML product.

2. Sample size used for the test set and the data provenance: Not applicable. Testing was performed on physical device samples, not data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not relevant here. Device performance was assessed against engineering and biocompatibility standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" here refers to the pre-established engineering and biocompatibility specifications and standards the physical device needed to meet.
8. The sample size for the training set: Not applicable. There is no training data set for this physical medical device.
9. How the ground truth for the training set was established: Not applicable.

In summary, the document details the testing performed to demonstrate that a physical medical device with material and packaging changes is substantially equivalent to a previously cleared predicate device, rather than the performance of an AI/ML algorithm.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 21, 2020

CooperSurgical, Inc. Kyle Hooper Regulatory Affairs Associate 95 Corporate Drive Trumbull, CT 06611

K201086 Re: Trade/Device Name: Advincula Delineator™ Uterine Manipulator Regulation Number: 21 CFR 884.1640 Regulation Name: Culdoscope and Accessories Regulatory Class: II Product Code: HEW Dated: April 22, 2020 Received: April 23, 2020

Dear Kyle Hooper:

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

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

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

Jason R. Roberts, Ph.D. Acting 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

Enclosure

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

Indications for Use

510(k) Number (if known) K201086

Device Name

Advincula Delineator™ Uterine Manipulator

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)

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."

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

510(k) SUMMARY

510(k) Submitter

Company Name:	CooperSurgical Inc.
Company Address:	95 Corporate Drive
	Trumbull, CT 06611

CONTACT

Name:	Kyle Hooper
Telephone:	203-601-5200 Ext. 3230
Fax:	203-601-9870
Email:	Kyle.Hooper@coopersurgical.com

Date Prepared: May 20, 2020

DEVICE IDENTIFICATION

Trade Name:	Advincula Delineator™ Uterine Manipulator
Common Name:	Uterine Manipulator
Regulation Number:	21 CFR 884.1640
Regulation Name:	Culdoscope and Accessories
Regulatory Class:	Class II
Product Code:	HEW
Product Code Name:	Culdoscope (and Accessories)

Predicate Device Information

Advincula Delineator™ Uterine Manipulator (K180429).

The predicate device has not been subject to a design-related recall.

DEVICE DESCRIPTION

Indications for Use

The CooperSurgical Advincula Delineator™ Uterine Manipulator is indicated to provide delineation of the vaginal fornices and maintain pneumoperitoneum as a uterine manipulator during Total

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

Laparoscopic Hysterectomy, Laparoscopic Assisted Vaginal Hysterectomy and/or Laparoscopic Supra-Cervical Hysterectomy.

Table 1: Subject and Predicate Device Comparison
Attribute	Subject Advincula Delineator™ Uterine Manipulator	Predicate (K180429) Advincula Delineator™ Uterine Manipulator	Discussion
Manufacturer	CooperSurgical, Inc.	CooperSurgical, Inc.	Same
Indications for Use	The CooperSurgical Advincula Delineator™ Uterine Manipulator is indicated to provide delineation of the vaginal fornices and maintain pneumoperitoneum as a uterine manipulator during Total Laparoscopic Hysterectomy, Laparoscopic Assisted Vaginal Hysterectomy and/or Laparoscopic Supra-Cervical Hysterectomy.	The CooperSurgical Advincula Delineator Uterine Manipulator is indicated to provide delineation of the vaginal fornices and maintain pneumoperitoneum as a uterine manipulator during Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH) and/or Laparoscopic Supracervical Hysterectomy (LSH).	Same
Fundamental Scientific Technology	The device has a distal balloon built into the arched shaft, and a sliding colpotomy cup, called a Koh-Cup, that locks into place. The handle at the proximal end allows the user to hold the device and manipulate the uterus, and the Koh-Cup delineates the vaginal fornices. An occluder balloon is used to maintain pneumoperitoneum.	The device has a distal balloon built into the arched shaft, and a sliding colpotomy cup, called a Koh-Cup, that locks into place. The handle at the proximal end allows the user to hold the device and manipulate the uterus, and the Koh-Cup delineates the vaginal fornices. An occluder balloon is used to maintain pneumoperitoneum.	Same
Manipulator Material(s)	Stainless steel, silicone, various plastics, adhesives and inks	Stainless steel, silicone, various plastics, adhesives and inks	Same
Koh-Cup Materials	Hytrel	Isothane	Different
Vaginal Occlusion (Pneumoperitoneum)	Occluder balloon with inflation capacity of 60-120cc	Occluder balloon with inflation capacity of 60-120cc	Same
Environment of Use	Operating Room	Operating Room	Same

Substantial Equivalence Discussion Table 1: Subject and Predicate Device Comparison

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

Patient Contact	External communicatingdevice, limited (<24)	External communicatingdevice, limited (<24)	Same
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Same
Number of Uses	Single-Use, Disposable	Single-Use, Disposable	Same
Packaging	Individually packaged intray with Tyvek lid, andthree (3) trays in an SBSbox	Individually packaged in aflexible blister pouchwith a Tyvek lid, and three(3) pouches in an SBSbox	Different
Shelf Life	1-year	1-year	Same

The subject and predicate devices have the same indications for use and the same fundamental scientific technology. The differences between the predicate and subject device is the material of the Koh-Cup component and packaging material. These differences do not raise different questions of safety and effectiveness as compared to the predicate.

Non-Clinical Performance

As part of demonstrating substantial equivalence to the predicate, a risk analysis was completed to identify the risks associated with the Advincula Delineator™ Uterine Manipulator material changes. Verification testing were conducted to evaluate the modifications. The following tests associated with the device modifications were performed on the subject device according to methods and acceptance criteria outlined in the predicate device (K180429). The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device.

● Sterilization

ISO 10993-7:2008 Biological Evaluation of Medical devices Part 7: Ethylene oxide o sterilization residuals
ISO 11135:2014 Sterilization of Health-care Product Ethylene Oxide Requirements o for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
Shelf Life and Shipping
- O Shelf life was demonstrated up to 1 year
- O ISO 11607-1: 2006, Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems.
- ISTA 3A: 2008, Packaged-Products for Parcel Delivery System Shipment 150 lb. or Less. O
- ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for O Medical Devices
- O Design verification testing was performed after accelerated aging equivalent to one year of real-time aging. Devices met predetermined acceptance criteria.

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

● Design Verification Testing

Compression: To verify that the modified Koh-Cup can withstand adequate O compression force. The test results show that the subject Koh-Cup met the predetermined acceptance criterion
Pull Off: To verify that the modified Koh-Cup does not disassemble from the device O
when used as intended. The test results show that the subject Koh-Cup met the o predetermined acceptance criterion.
O Distortion: To verify that the modified Koh-Cup can withstand adequate force. The test results show that the subject Koh-Cup met the predetermined acceptance criterion
Temperature Testing: To verify that the modified Koh-Cup can withstand adequate o temperature. The test results show that the subject Koh-Cup met the predetermined acceptance criterion.
. Biocompatibility Testing (Cytotoxicity, Sensitization, Irritation)
- O Cytotoxicity per ISO 10993-5:2009; results demonstrated the new Koh-Cup was noncytotoxic
- Sensitization per ISO 10993-10:2010; results demonstrated the new Koh-Cup was non o sensitizing
- Irritation per ISO 10993-10:2010; results demonstrated the new Koh-Cup was nono irritating

CONCLUSION

The Advincula Delineator Uterine Manipulator has the same intended use as the predicate device. The new Koh-Cup material does not raise different questions of safety and effectiveness, and the results of the testing described above demonstrate that the subject device with the modified Koh-cup is as safe and effective as the predicate. Therefore, the subject device is substantially equivalent to the predicate.

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.