The Manipuseal device is indicated for use in all laparoscopic surgical procedures where use of a uterine manipulator is appropriate and the surgeon intends to remove intraperitoneal tissue through the vagina by use of a colpotomy on culdotomy incision.

Device Description

The Manipuseal device is comprised of an occluding balloon, Manipuseal uterine manipulator and tip, and a CO2 Port. Manipulator consists of a toroidal or doughnut shaped balloon that is manufactured from silicone. The occluding balloon is designed to be inflated using a maximum of 180 ml of room air. The occluding balloon is an integral part of the Manipuseal device and is neither replaceable nor removable. The occluding balloon is filled using a commercially available 50 ml The occluding balloon occludes the vagina, while the Manipuseal syringe. manipulator is positioned in the patient and is used for manipulation. The Manipuseal is a standard uterine manipulator, which consists of a handle, body and tip made from Acrylonitrate-Butadiene-Styrene (ABS). Once the manipulator tip is positioned in the cervix, the surgeon then commences the laparoscopic portion of the procedure. By moving the Manipuseal handle outside of the patient, the tip of the device moves, therefore positioning the cervix/uterus to provide a clearer view of the surgical field. The Manipuseal provides full anteversion, retroversion, and lateral motion for greater visibility and uterine movement. The CO2 port is made up of a standard luer connection and is color coded green for easy identification. The insufflator is connected to the luer lock connector using a standard insufflator tube with an inline filter. The insufflator's maximum deliverable pressure is 14-16 mm Hg. It is also possible to produce pneumoperitoneum by connecting the insufflator to the trocar ports (a standard laparoscopic procedure).

AI/ML Overview

The provided document is a 510(k) summary for the "In Situ Systems Manipuseal," a uterine manipulator/occluder. It details the device, its intended use, predicate devices, and performance testing, among other things. However, it does not explicitly define acceptance criteria in terms of specific quantitative metrics (e.g., accuracy, sensitivity, specificity thresholds) for a device meant to be proven against such criteria.

The "studies" mentioned are limited to:

Biocompatibility testing: This indicated the device "is biocompatible." No specific acceptance criteria or detailed results are provided.
Occluder Balloon burst testing: This showed the balloon "can withstand burst testing up to 2.5 times the recommended inflation." No specific acceptance criteria (e.g., minimum burst pressure) or detailed results are provided.
Clinical study: This study "demonstrated that the Manipuseal was associated with less short term morbidity and a faster recovery rate during either abdominal or vaginal hysterectomy procedures in 358 patients." No explicit acceptance criteria or detailed results beyond this qualitative statement are provided.

Given the nature of the device (a physical surgical instrument) and the context of a 510(k) submission seeking substantial equivalence to predicate devices, the "acceptance criteria" are generally implied to be that the device performs safely and effectively for its intended use, similar to the predicate devices. The studies conducted aim to demonstrate this, rather than meet specific numerical performance thresholds typically associated with AI/software devices.

Therefore, many of the requested elements for AI/software device evaluation (like sample size for test sets, data provenance, ground truth establishment by experts, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission for a physical medical device.

However, based on the provided text, I can extract the relevant information and indicate where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Device materials are safe for human contact.	The Manipuseal is biocompatible.
Occluder Balloon Burst Strength: Balloon can withstand intended and stressed inflation pressures.	The occluding balloon can withstand burst testing up to 2.5 times the recommended inflation.
Clinical Effectiveness/Safety: Device performs its intended function safely and effectively, comparable to predicate devices.	Associated with less short term morbidity and a faster recovery rate during either abdominal or vaginal hysterectomy procedures.

Note: The acceptance criteria are "implied" as specific quantitative thresholds (e.g., "burst pressure must be > X mmHg") are not explicitly stated in the document.

2. Sample size used for the test set and the data provenance

Sample Size for the Clinical Study: 358 patients.
Data Provenance: New Zealand (retrospective or prospective status is not specified, but typically clinical studies are prospective, though the document does not confirm this.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Provided. For a physical device like a uterine manipulator, "ground truth" as conceptualized for AI/diagnostic devices (e.g., expert consensus on image findings) is not relevant. The "ground truth" here is the clinical outcomes and safety observed in patients. Clinical judgments in the study would have been made by the surgeons and medical staff involved, who are implicitly qualified by their roles.

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

Not Applicable / Not Provided. This concept is specific to studies where multiple readers interpret data and reconcile disagreements. For a clinical study observing patient outcomes with a physical device, this type of adjudication is not typically performed or relevant.

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

No. This is a physical medical device, not an AI or diagnostic imaging device. An MRMC study is not relevant.

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

No. This question is not applicable to a physical medical device.

7. The type of ground truth used

Clinical Outcomes/Safety Data: The "ground truth" effectively derived from patient outcomes (morbidity, recovery rate) as observed in the clinical study.

8. The sample size for the training set

Not Applicable / Not Provided. This question is for AI/machine learning models. For a physical device, there is no "training set." The device is designed, manufactured, and then tested.

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

Not Applicable / Not Provided. As there is no training set for a physical device, this question is not relevant.

Summary

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SEP - 2 2005

K 051160

510(k) Summary

for

In Situ Systems Manipuseal

1. SPONSOR
  Insitu Systems 26 Dakota Cres, Sockburn Christchurch 8004 New Zealand Contact Person: Paul Morrison 64-3-348-0203 Telephone:

Date Prepared: May 4, 2005

2. DEVICE NAME

Proprietary Name:	Manipuseal
Common/Usual Name:	Uterine Manipulator/Occluder
Classification Name:	Uterine Manipulator/Injector and Accessories

PREDICATE DEVICES 3.

K010056 A & A Medical Uterine Manipulator RUMI Koh Colpotomizer System Manipulator/Occluder K954311

DEVICE DESCRIPTION 4.

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The Manipuseal is a standard uterine manipulator, which consists of a handle, body and tip made from Acrylonitrate-Butadiene-Styrene (ABS). Once the manipulator tip is positioned in the cervix, the surgeon then commences the laparoscopic portion of the procedure. By moving the Manipuseal handle outside of the patient, the tip of the device moves, therefore positioning the cervix/uterus to provide a clearer view of the surgical field. The Manipuseal provides full anteversion, retroversion, and lateral motion for greater visibility and uterine movement

The CO2 port is made up of a standard luer connection and is color coded green for easy identification. The insufflator is connected to the luer lock connector using a standard insufflator tube with an inline filter. The insufflator's maximum deliverable pressure is 14-16 mm Hg. It is also possible to produce pneumoperitoneum by connecting the insufflator to the trocar ports (a standard laparoscopic procedure).

INTENDED USE 5.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The overall design of the Manipuseal Manipulator/Occluder is similar to the design of the A & A Uterine Manipulator and the Koh Colpotomizer System. All of these devices consist of a uterine manipulator and an occluding balloon. The technological characteristics are similar in that the occluding balloons of both the proposed and predicate devices are filled with either water or room air in order to occlude the vagina. The only difference between the proposed and predicate devices is that the Manipuseal does not include a dye injector port, whereas the A & A device and the Koh Colpotomizer system offer a dye port. This minor difference does not affect safety or effectiveness since the main function of the proposed and predicate devices are the same in that they manipulate the uterus and provide an occluding balloon.

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PERFORMANCE TESTING 7.

Biocompatibility testing and Occluder Balloon burst testing was completed. This testing showed that the Manipuseal is biocompatible and the occluding balloon can withstand burst testing up to 2.5 times the recommended inflation.

A clinical study was performed in New Zealand which demonstrated that the Manipuseal was associated with less short term morbidity and a faster recovery rate during either abdominal or vaginal hysterectomy procedures in 358 patients.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

SEP - 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

InSitu Systems % Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

Re: K051160 Trade/Device Name: Manipuseal Regulation Number: 21 CFR 884.1640 Regulation Name: Culdoscope and accessories Regulatory Class: II Product Code: HEW Dated: August 15, 2005 Received: August 16, 2005

Dear Ms. McNamara-Cullinane:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval}, it may be subject to such 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and in your of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you don't office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 0 5 11 (k) 0

Device Name: Manipuseal

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Byrom

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number_

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.