The ColpoWave Colpotomizer and CerviGrip Uterine Manipulator is indicated for use by a surgeon in laparoscopic procedures where uterine manipulation of the position of the vaginal fornices for colpotomy incisions is required, and for maintaining pneumoperitoneum during vaginal vault closure.

Device Description

The Surgitools Pty Ltd. ColpoWave Colpotomizer and CerviGrip Uterine Manipulator consists of the ColpoWave™ Colpotomizer, CerviGrip™ Uterine Manipulator, and the ColpoWave™ Balloon accessory. All parts are made without natural latex rubber and supplied sterile to be disposed of after use.

The single-use CerviGrip™ Uterine Manipulator is designed with an integrated cervical screw, a sliding uterine tip, tail screw that can lock the uterine tip in place, and a screw to hold the colpotomizer in place. The CerviGrip™ Uterine Manipulator is manufactured with ABS polymer and 304 Stainless Steel.

The ColpoWave™ Colpotomizer is non-fenestrated and has incorporated two different sizes due to the double-ended colpotomizer design (30mm or 40mm diameter). Cup shape with one partial circumferential raised lip at each end and a second partial raised circumferential lip 20mm from each end providing the surgeon with a known distance to help gauge pelvic distances during dissection. The ColpoWave™ Colpotomizer is manufactured with green ABS polymer to provide better visualization (greater contrast than white against tissue).

The ColpoWave™ Balloon is an optional accessory, which is inflated to fit various vaginas.

AI/ML Overview

The provided FDA 510(k) summary for the ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of clinical performance or diagnostic accuracy. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing, biocompatibility, sterilization validation, and shelf-life testing).

Therefore, I cannot provide the requested information regarding acceptance criteria and clinical study details (sample size, data provenance, expert ground truth establishment, adjudication, MRMC studies, standalone performance, or training set details) from the provided text.

However, I can extract the non-clinical performance data that was used to demonstrate the device's safety and effectiveness.

Non-Clinical Performance Data

The device's safety and effectiveness and substantial equivalence were demonstrated through the following non-clinical tests:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance:

Since explicit acceptance criteria values are not provided, I will list the type of performance testing and the outcome, implying that the device met the internal requirements, and national/international standards for these tests.

Acceptance Criteria Category	Reported Device Performance
Performance Testing	The device successfully passed bench testing to evaluate mechanical and functional properties. It was shown to be robust to withstand forces that exceed expected in-use forces, including tensile tests, manipulation, and balloon strength and stability. (Implied: Met internal requirements, national, and international standards for mechanical and functional properties.) A specific acceptance value is not provided.
Biocompatibility Testing	Test Performed: Cytotoxicity, Intracutaneous Reactivity, Sensitization, and Acute Systemic Toxicity testing per ISO 10993-1, ISO 10993-10, and ISO 10993-11. Tests were conducted on finished, packaged, and sterilized devices. Reported Performance: All patient-contacting device components passed biocompatibility testing required by ISO 10993-1 and FDA General Program Memorandum G95-1. (Implied: Met specified limits for these tests.)
Sterilization Validation	Standard: ISO 11135-1. Reported Performance: Validation results met the acceptance criteria defined in the standard. Demonstrated ability of the process to deliver a Sterility Assurance Level (SAL) of $10^{-6}$. EtO Residuals: Conducted in accordance with ISO 10993-7. Validated a minimum release period of 7 days. (Implied: Residuals were within acceptable limits.)
Shelf Life Testing	Method: Accelerated aging post-sterilization. Reported Performance: Demonstrated no degradation in strength or functionality over the anticipated shelf life period of three (3) years. (Implied: Maintained specified strength and functionality after accelerated aging.)

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

Not applicable. The document explicitly states: "There was no human clinical testing required to support the substantial equivalence of the subject device." The tests performed were laboratory-based (bench testing, biocompatibility, sterilization, shelf-life).

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

Not applicable. No clinical test set with corresponding expert ground truth was utilized.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set or adjudication method was used.

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 device is a surgical instrument, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a surgical instrument.

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

Not applicable. As no human clinical testing was performed, no clinical ground truth (expert consensus, pathology, outcomes data) was established for the device. The "ground truth" for the non-clinical tests would have been the established performance specifications and regulatory standards for mechanical properties, biocompatibility, sterilization, and shelf life.

8. The sample size for the training set:

Not applicable. This device is a surgical instrument, not a machine learning or AI model that requires a training set.

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

Not applicable. As no training set was used, no ground truth for a training set was established.

Summary

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

October 27, 2016

Surgitools Pty Ltd. % Elizabeth Pugh Regulatory Affairs Consultant Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, Texas 78701

Re: K161065

Trade/Device Name: ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator Regulation Number: 21 CFR 884.1640 Regulation Name: Culdoscope and accessories Regulatory Class: Class II Product Code: HEW Dated: September 28, 2016 Received: September 28, 2016

Dear Elizabeth Pugh:

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

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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-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,

For Division

Douglas Silverstein -S 2016.10.27 15:26:25 -04'00' 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) K161065

Device Name

ColpoWave™ Colpotomizer and CerviGrip™ 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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510(k) Summary

K161065

1. Submission Sponsor

Surgitools Pty Ltd. 231 Timberlane Dr. Woodvale Western Australia 6026, Australia Phone number: 61-08-93093222 Contact: Jai Singh Title: Director: Global Sales & Marketing

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Rd, Suite 300 Austin, TX 78746 Office Phone: (512) 327.9997 Contact: Elizabeth Pugh, Consultant, RA Email: project.management@emergogroup.com

3. Date Prepared

October 14, 2016

4. Device Identification

Trade/Proprietary Name:	ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator
Common/Usual Name:	Uterine Manipulator and Colpotomizer
Classification Name:	Culdoscope and accessories
Regulation Number:	884.1640
Product Code:	HEW, Culdoscope and accessoriesLKF, Cannula, manipulator/injector, uterine
Device Class:	Class II
Classification Panel:	Obstetrics/Gynecology

5. Legally Marketed Predicate Device(s)

K110819, Singh Colpotomizer System, Surgitools Pty Ltd.

6. Device Description

The Surgitools Pty Ltd. ColpoWave Colpotomizer and CerviGrip Uterine Manipulator consists of the ColpoWave™ Colpotomizer, CerviGrip™ Uterine Manipulator, and the ColpoWave™ Balloon

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accessory. All parts are made without natural latex rubber and supplied sterile to be disposed of after use.

The ColpoWave™ Balloon is an optional accessory, which is inflated to fit various vaginas.

7. Indications for Use Statement

The ColpoWave Colpotomizer and CerviGrip Uterine Manipulator is indicated for use by a surgeon in laparoscopic procedures where uterine manipulation and visualization of the position of the vaginal fornices for colpotomy incisions is required, and for maintaining pneumoperitoneum during vaginal vault closure.

8. Predicate Comparison

The following table compares the Surgitools Colpotomizer and CerviGrip Uterine Manipulator to the predicate device with respect to indications for use, technological characteristics, and materials:

Trade Name	Singh Colpotomizer SystemK110819 (Surgitools Pty Ltd.)	ColpoWave Colpotomizer and CerviGripUterine ManipulatorK161065 (Surgitools Pty Ltd.)
Indications for use	The Singh Colpotomizer System isindicated for use by a surgeon inlaparoscopic procedures requiringuterine manipulation and thevisualization of the position of thevaginal fornices for colpotomy incisionsinto the vaginal vault. The surgeonmakes the colpotomy incisions to accessor remove intraperitoneal tissue fromthe pelvic cavity.	The ColpoWave Colpotomizer andCerviGrip Uterine Manipulator isindicated for use by a surgeon inlaparoscopic procedures where uterinemanipulation and visualization of theposition of the vaginal fornices forcolpotomy incisions is required, and formaintaining pneumoperitoneum duringvaginal vault closure.

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SystemComponents	Uterine manipulator with cervicalscrew attachment; Sliding uterine tip (inner rod); Sliding and rotating funnels(available in two sizes) with a lipacting as a colpotomizer; O-ring and screw to hold thefunnel in place; and Vaginal occluder (plasticvaginal plug)	Uterine manipulator with cervicalscrew attachment Sliding uterine tip Sliding and rotating colpotomizer(incorporating two sizes) ColpoLock and screw to hold thecolpotomizer in place; Pneumatic plug (PneumoBloc); and Vaginal occluder (ColpoWave Balloon
Uterine Tips	Single length inner rod	Single length inner rod
Vaginal Plug	OD 43mmLength 50mm	ColpoWave Balloon is inflated to fitvarious vaginas
DesignColpotomizer	Two colpotomizers of differentsizes. 35mm and 40mm Cup shape with partialcircumferential raised lip at its end. White. Non-fenestrated.	One colpotomizer incorporating twodifferent sizes. One side diameter30mm and one of diameter 40mm Cup shape with one partialcircumferential raised lip at each endand a second partial raisedcircumferential lip 20mm from eachend. Green. Non-fenestrated.
Uterinemanipulator	Uterine manipulator with cervicalscrew attachment; Sliding uterine tip (inner rod); Tail screw with hydrotubation port;and O-ring and screw to hold the funnelin place	Uterine manipulator with integratedcervical screw and hydrotubationport; Sliding uterine tip; Tail screw that can lock the uterinetip in place; and ColpoLock and screw to holdcolpotomizer in place.
Materials	Stainless steel and polymer	Stainless steel and polymer
Single use or reusable	Reusable	Single use
Biocompatible materials	Yes	Yes

The Surgitools ColpoWave Colpotomizer and CerviGrip Uterine Manipulator has the same intended use but different technological characteristics compared to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness.

9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of the ColpoWave Colpotomizer and CerviGrip Uterine Manipulator and in showing substantial equivalence to the predicate device, Surgitools Pty Ltd. completed a number of tests and validations. The ColpoWave Colpotomizer and CerviGrip Uterine Manipulator meets all the requirements for overall design, sterilization, and biocompatibility confirming that the design output meets the design inputs and specifications for the device.

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The ColpoWave Colpotomizer and CerviGrip Uterine Manipulator passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

Performance Testing
The device successfully passed bench testing to evaluate mechanical and functional properties to ensure the device is robust to withstand forces that exceed the expected forces during use, including tensile tests, manipulation, and balloon strength and stability.
Biocompatibility testing per ISO 10993-1, ISO 10993-10 and ISO 10993-10 and ISO 10993-11
The subject device is an external communicating device that contacts tissue for less than 24 hours. Cytotoxicity, Intracutaneous Reactivity, Sensitization, and Acute Systemic Toxicity Testing were performed. All tests were conducted on the finished device after manufacturing, packaging, and sterilization had been completed to reflect the actual state of the device when exposed to the patient. All patient-contacting device components passed biocompatibility testing required by ISO 10993-1 and FDA General Program Memorandum G95-1.
. Sterilization Validation
The sterility of the Surgitools Uterine Manipulator and Colpotomizer system is assured by using a validated sterilization method qualified in accordance with ISO 11135-1. The validation results met the acceptance criteria defined in the standard and demonstrates the ability of the process to deliver SAL of 10 °. Examination of the EtO residuals has been conducted in accordance with ISO 10993-7, which has validated a minimum release period of 7 days.
Shelf Life Testing
After the sterilization cycle was complete, the products were accelerated aged and tested to demonstrate no degradation in strength or functionality over the anticipated shelf life period of three (3) years.

10. Clinical Performance Data

There was no human clinical testing required to support the substantial equivalence of the subject device.

11. Conclusion

Based on the comparison and analysis above, the Surgitools ColpoWave Colpotomizer and CerviGrip Uterine Manipulator is substantially equivalent to the referenced 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.