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).

Device Description

The Advincula Delineator is a uterine manipulator that 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 is available with Koh-Cups sized 2.5cm, 3.5cm or 4.0cm in diameter. There are flexible plastic and Ultem plastic Koh-Cups available for use in electrocautery procedures, and a version with a stainless-steel outer rim for use in harmonic scalpel or laser procedures.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Device: Advincula Delineator™ Uterine Manipulator (K180429)

Type of Device: Uterine Manipulator, Class II

This device is not an AI/ML powered device, so all the acceptance criteria and study information is related to mechanical and material performance, not algorithmic performance. Therefore, sections pertaining to expert review, MRMC studies, standalone performance, and training/test set details for AI/ML will be marked as "Not Applicable (N/A)".

1. Table of Acceptance Criteria and Reported Device Performance

This device is a physical medical device, not a software or AI/ML product. The acceptance criteria focus on mechanical performance and biocompatibility.

Acceptance Criterion (Test Performed)	Reported Device Performance
Design Verification Testing
Pull-Off Test	Met predetermined acceptance criterion.
Compression Test	Met predetermined acceptance criterion.
Design Validation Testing
Cadaveric Model Evaluation	Performed as intended and met user needs.
Biocompatibility Testing (ISO 10993)
Cytotoxicity (ISO 10993-5:2009)	Non-cytotoxic.
Sensitization (ISO 10993-10:2010)	Non-sensitizing.
Irritation (ISO 10993-10:2010)	Non-irritating.
Shelf Life Testing (ASTM F1980-07)
After 1 year of accelerated aging	Met predetermined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for each test (e.g., number of devices tested in the pull-off or compression tests). However, it implies testing was performed on a sufficient number of devices to demonstrate the device meets acceptance criteria.

Data Provenance: The tests are explicitly non-clinical performance and design validation tests on the physical device itself. The "cadaveric model" implies testing was performed using human cadavers.
- Country of Origin of the Data: Not specified, but likely performed by or for CooperSurgical, Inc. in the US.
- Retrospective or Prospective: These are prospective tests performed specifically for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. This is a physical device, not an AI/ML system requiring expert interpretation or ground truth establishment in a diagnostic context. The "ground truth" here is the physical performance of the device against engineering specifications.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are relevant for subjective interpretations (e.g., in medical image reading). For objective engineering tests (pull-off, compression, biocompatibility), the results are typically quantitative and directly measured against a specification.

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

No. An MRMC study is not applicable to a uterine manipulator. These studies are typically performed to assess the impact of AI on human reader performance for diagnostic tasks.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No. This a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, material science principles, and established biocompatibility standards (e.g., ISO 10993). For the design validation, the "ground truth" was the device "performs as intended and meets user needs" in a cadaveric model, which would be an outcome-based assessment in a simulated use environment.

8. The Sample Size for the Training Set

N/A. This term is applicable to AI/ML models. For a physical device, the concept of a "training set" is not relevant in the same way. The design and manufacturing processes are iterative, but there's no defined "training set" as in machine learning.

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

N/A. As above, this concept doesn't apply to this kind of device.

Summary

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March 14, 2018

CooperSurgical, Inc. Roaida Johnson Director, RA New Product Development 95 Corporate Drive Trumbull, CT 06611

Re: K180429

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: February 14, 2018 Received: February 16, 2018

Dear Roaida Johnson:

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. 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180429

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)

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K180429 Advincula Delineator™ Uterine Manipulator Special 510(k) Summary

Submitter Information

Company Name:	CooperSurgical Inc.
Company Address:	95 Corporate DriveTrumbull, CT 06611Telephone: 203-601-5200 Ext. 3325Fax: 203-601-9870
Contact Person:	Roaida Johnson

March 13, 2018 Date Prepared:

Device Information

Trade Names:	Advincula Delineator™ Uterine Manipulator
Common Name:	Uterine Manipulator
Classification:	Class II per 21 CFR 884.1640
Classification Name:	Culdoscope and Accessories
Product Code:	HEW - Culdoscope (And Accessories)

Predicate Device Information

The Advincula Delineator uterine manipulator is substantially equivalent to the following predicates:

Predicate: CooperSurgical Advincula Delineator Uterine Manipulator (K143650)

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

Device Description

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Indications for Use

Substantial Equivalence Discussion

Table 1 provides a comparison of the subject and predicate device. Table 1: Comparison of the Subject Advincula Delineator to the Predicate Devices

Attribute	Subject Advincula Delineator	Predicate AdvinculaDelineator
510(k) Number	K180429	K143650
Manufacturer	CooperSurgical	Same
Indications for Use	The CooperSurgical Advincula Delineator UterineManipulator is indicated to provide delineation ofthe vaginal fornices and maintainpneumoperitoneum as a uterine manipulator duringTotal Laparoscopic Hysterectomy (TLH),Laparoscopic Assisted Vaginal Hysterectomy(LAVH) and/or Laparoscopic SupracervicalHysterectomy (LSH).	Same
FundamentalScientificTechnology	The device has a distal balloon built into the archedshaft, and a sliding colpotomy cup, called a Koh-Cup, that locks into place. The handle at theproximal end allows the user to hold the device andmanipulate the uterus, and the Koh-Cup delineatesthe vaginal fornices. An occluder balloon is used tomaintain pneumoperitoneum.	Same
ManipulatorMaterial(s)	Stainless steel, silicone, various plastics, adhesivesand inks	Same
Koh-Cup Materials	Stainless steel, plastic (soft and hard)	Different; this devicedoes not include a softplastic cup
Vaginal Occlusion(pneumoperitoneum)	Occluder balloon with inflation capacity of 60-120cc	Same
Environment of use	Operating room	Same
Patient Contact	External communicating device, limited (<24)	Same
Sterilization Method	Ethylene Oxide	Same
Number of Uses	Single-Use, Disposable	Same
Packaging	Individually packaged in a flexible blister pouchwith a Tyvek lid, and three (3) pouches in an SBSbox	Same
Shelf Life	1 Year	3 Years

The subject and predicate devices have indications for use and the same fundamental scientific technology. The only difference between the predicate and subject device is the material from which the

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Koh-Cup component is made. This difference does not raise different questions of safety and effectiveness as compared to the predicate.

Non-Clinical Performance Testing

As part of demonstrating substantial equivalence to the predicate, the following tests were performed to evaluate the new Koh-cup for safety and performance:

● Design Verification Testing

Pull-Off Test: To verify that the modified Koh-Cup does not disassemble from the device о when used as intended. The test results show that the subject Koh-Cup met the predetermined acceptance criterion.
Compression Test: 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.

Design Validation Testing .

This test, which evaluated the use of the new Koh-Cup in a cadaveric model, validated that o the Advincula Delineator with the modified Koh-Cup performs as intended and meets user needs.
. Biocompatibility Testing per ISO 10993-1:2009
- Cytotoxicity per ISO 10993-5:2009; results demonstrated the new Koh-Cup was non-O cytotoxic
- 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 non-O irritating

Shelf Life Testing per ASTM F1980-07 (Reapproved 2011) ●

Design verification testing was performed after 1 year of accelerated aging. Devices met O predetermined acceptance criteria.

Conclusion

The Advincula Delineator Uterine Manipulator has the same intended use as the predicate device. The addition of 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.