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 Supra-Cervical Hysterectomy (LSH).

Device Description

The CooperSurgical Advincula Delineator™ Uterine Manipulator is a single use device, supplied sterile to the end user. It includes a cup shaped sliding colpo-pneumo occluder used to delineate the vaginal fornices, providing an anatomical marker to facilitate resection of the uterus, and a balloon to occlude the vaginal vault to maintain pneumoperitoneum during uterine resection.

AI/ML Overview

The provided document is a 510(k) summary for the CooperSurgical Advincula Delineator™ Uterine Manipulator. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study to prove a device meets those criteria from an AI/algorithm performance perspective.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable to this type of medical device submission. This document describes a physical medical device, not an AI or algorithmic device.

However, I can extract the relevant performance data and conclusions presented in the document based on the provided text.

Here's a breakdown of the information that is available in the document, formatted as requested where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner as one would for an AI algorithm (e.g., "sensitivity must be > 90%"). Instead, performance assessments were conducted to ensure the device performs comparably to its predicate and is safe and effective. The "acceptance" is implied by demonstrating substantial equivalence.

Performance Characteristic	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Vaginal Occlusion (Pneumoperitoneum)	The vagianl occluder balloon should maintain an adequate inflation capacity to create and maintain pneumoperitoneum, similar to the predicate device, and the difference in inflation capacity should not affect safety or effectiveness. The maximum inflation pressure should be the same as the predicate device. Burst volume testing should confirm safety. (Predicate: 90-120cc inflation capacity, same maximum inflation pressure, burst volume testing).	Subject Device: Occluder balloon with inflation capacity of 60-120cc. Predicate Device: Occluder balloon with inflation capacity of 90-120cc. Performance: The document states, "The primary technological difference between the subject and predicate devices is the inflation capacity of the vaginal occluder balloon. However, this minor difference does not raise different questions of safety or effectiveness as the maximum inflation pressure is the same for both the subject and predicate devices. In addition, burst volume testing was conducted to demonstrate that the difference in inflation pressure does not affect the safety and effectiveness of the subject device." The specific "burst volume" results are not detailed in this summary, but the conclusion is that the difference is acceptable.
Biocompatibility	Patient-contacting components must meet biocompatibility standards appropriate for their contact classification (external communicating, tissue/bone/dentin, ≤ 24 hours).	Components "have been evaluated for biocompatibility as appropriate for their contact classification." (Claimed as "Substantially Equivalent")
Sterilization & Shelf Life	Must achieve a Sterility Assurance Level (SAL) of 10-6 and have a confirmed shelf life.	Subject Device: Sterilized by ETO to an SAL of 10-6, with an initial shelf life of 1 year. Predicate Device: Sterilized by ETO gas to an SAL of 10-6, with a shelf life of 2 years. (Claimed as "Substantially Equivalent," implying the 1-year shelf life is acceptable).
Distal & Proximal Balloon Burst Volume	Balloons must withstand appropriate pressure/volume without bursting, comparable to the predicate.	Testing was conducted. The conclusion is that the difference in inflation capacity (which relates to burst volume) does not affect safety and effectiveness. (Details not provided in this summary, but implied satisfactory).
Distal & Proximal Balloon Leakage	Balloons must not leak when inflated.	Testing was conducted. (Details not provided in this summary, but implied satisfactory).
Distal & Proximal Balloon Fill Tube Tensile Strength	Fill tubes must have adequate tensile strength.	Testing was conducted. (Details not provided in this summary, but implied satisfactory).
Tube Bending, Compression, Tension Forces	The device tube must withstand anticipated forces during surgical use without failure.	Testing was conducted. (Details not provided in this summary, but implied satisfactory).
Security of Sliding Colpo-Pneumo Occluder	The occluder must remain securely locked once positioned.	Testing was conducted. (Details not provided in this summary, but implied satisfactory).

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: Not specified in the 510(k) summary. These would typically be engineering bench tests involving a certain number of manufactured units, not patient data.
Data Provenance: Not applicable as this relates to bench testing of a physical device, not patient data or geographical origin of data.
Retrospective/Prospective: Not applicable.

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)

Not Applicable. This is a physical device, not an AI or image-based diagnostic tool requiring expert ground truth for performance evaluation of an algorithm. "Ground truth" for this device would be established by engineering specifications and physical measurements.

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

Not Applicable. This relates to clinical interpretations, not bench testing of a physical device.

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 or diagnostic tool.

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

Not Applicable. This is not an AI or algorithmic device.

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

Not Applicable in the traditional sense. The "ground truth" for this device's performance would be derived from engineering specifications, material properties testing, and comparison to the predicate device's established performance through bench testing (e.g., measuring actual burst volume, tensile strength, confirming no leakage).

8. The sample size for the training set

Not Applicable. This is not an AI or machine learning device that requires a training set.

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

Not Applicable. This is not an AI or machine learning device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 21, 2015

Cooper Surgical Inc. % Tim Lohnes Senior Regulatory Consultant Orchid Design 80 Shelton Technology Center Shelton. CT 06484

Re: K143650

Trade/Device Name: CooperSurgical Advincula Delineator™ Uterine Manipulator Regulation Number: 21 CFR 884.1640 Regulation Name: Culdoscope and accessories Regulatory Class: Class II Product Code: HEW Dated: June 16, 2015 Received: June 18, 2015

Dear Mr. Lohnes,

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. 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 (reporting of medical device

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin Fisher, PhD. 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) K143650

Device Name

CooperSurgical 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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Goper Surgical

07. 510(K) SUMMARY:

510(k) Summary of Safety and Effectiveness, (21 CFR 807.92):
Submitter:	Cooper Surgical Inc.,
	95 Corporate Drive,
	Trumbull, CT 06611
Contact Person:	Tim M. Lohnes
	Senior Regulatory Consultant,
	Orchid Design
	Phone: (203) 922 0105
	Fax: (203) 922 0130
	tim.lohnes@orchid-ortho.com
Date Prepared:	December 15, 2014
Name of Device::	CooperSurgical Advincula Delineator™Uterine Manipulator
Common/Usual Name:	Cannula, manipulator/injector, uterine
Classification Name:	884.1640, Culdoscope and accessories
Device Class:	Class II
Product Code:	HEW
Predicate Device(s):	Cooper Surgical Koh ColpotomizerSystem, K954311
Device Description;

Intended 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 (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH) and/or Laparoscopic Supra-Cervical Hysterectomy (LSH).

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Comparison of Technological Characteristics to the Predicate Device:

Attribute	Cooper SurgicalAdvinculaDelineator™ UterineManipulator(subject)	Cooper SurgicalKoh ColpotomizerSystem, K954311	Determination
Body Contact Type	Externalcommunicating, tissue, ≤24 hours	Externalcommunicating, tissue, ≤24 hours	SubstantiallyEquivalent
Material(s)	Stainless steel, silicone,various plastics,adhesives and inks.	Stainless steel,silicone, variousplastics, adhesives andinks.	SubstantiallyEquivalent
Environment	Operating room	Operating room	SubstantiallyEquivalent
Vaginal Occlusion(Pneumoperitoneum)	Occluder balloon withinflation capacity of 60-120cc	Occluder balloon withinflation capacity of 90-120cc	Different
Indications for Use	The CooperSurgicalAdvincula Delineator™Uterine Manipulator isindicated to providedelineation of thevaginal fornices andmaintainpneumoperitoneum as auterine manipulatorduring TotalLaparoscopicHysterectomy (TLH),Laparoscopic AssistedVaginal Hysterectomy(LAVH) and/orLaparoscopic SupraCervical Hysterectomy(LAH).	The Koh ColpotomizerSystem is indicated foruse in all laparoscopicprocedures where the useof a uterine manipulatoris appropriate and thesurgeon intends toremove or accessintraperitoneal tissuethrough the vagina byuse of a colpotomy orculdotomy incision.	SubstantiallyEquivalent
Biocompatibility	The patient contactingcomponents of theAdvincula Delineator™Uterine Manipulatorhave been evaluated forbiocompatibility asappropriate for theircontact classification(ext. communicating,tissue/bone/dentin, ≤ 24hours	The patient contactingcomponents of theKoh ColpotomizerSystem have beenevaluated forbiocompatibility asappropriate for theircontact classification(ext. communicating,tissue/bone/dentin, ≤24 hours	SubstantiallyEquivalent

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Cooper Surgical Inc. Advincula Delineator

Packaging	The AdvinculaDelineator™ UterineManipulatoris packaged in a 16 MilFlexible Blister pouchwith a heat-sealed1073B Tyvek lid,packed 3 to a carton.	The Koh-Efficientdevice is packaged in a.035" PETG Blister;heat-sealed 1073Tyvek lid, packaged 6to a chipboard carton.	SubstantiallyEquivalent
Stability/Shelf Life	The AdvinculaDelineator™ UterineManipulator issterilized by ETO to aAssurance Level (SAL)of 10-6, with an initialshelf life of 1 year.	The sterile componentsof the Koh-EffecentSystem device aresterilized by ETO gasto a Assurance Level(SAL) of 10-6, with ashelf life of 2 years.	SubstantiallyEquivalent

The basis of substantial equivalence of the CooperSurgical Advincula Delineator™ Uterine Manipulator is the similarities in materials, design, function, performance, sterilization, and indications for use in comparison to the predicate device. The primary technological difference between the subject and predicate devices is the inflation capacity of the vaginal occluder balloon. However, this minor difference does not raise different questions of safety or effectiveness as the maximum inflation pressure is the same for both the subject and predicate devices. In addition, burst volume testing was conducted to demonstrate that the difference in inflation pressure does not affect the safety and effectiveness of the subject device.

Performance Data:

The Cooper Surgical Advincula Delineator™ Uterine Manipulator was tested in comparison to the predicate Cooper Surgical Koh Colpotomizer System K954311, with regards to;

1. Distal & proximal balloon burst volume
1. Distal & proximal balloon leakage
1. Distal & proximal balloon fill tube tensile strength

The Cooper Surgical Advincula Delineator™ Uterine Manipulator was also tested in regards to bending, compression, and tension forces applied to the tube, as well as the security of the sliding colpo-pneumo occluder when locked.

Clinical testing was not required to support the conclusion of substantial equivalence.

Conclusion:

The substantial equivalence of the CooperSurgical Advincula Delineator™ Uterine Manipulator has been established by demonstrating the similarities in design, materials, function, performance, and Intended Use are equivalent to the previously cleared Cooper Surgical Koh Colpotomizer System, K954311.

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.