MANIPUSEAL

K051160 · Insitu Systems · HEW · Sep 2, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K051160
• Device Name: MANIPUSEAL
• Applicant: Insitu Systems
• Product Code: HEW · Obstetrics/Gynecology
• Decision Date: Sep 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Manipuseal is a uterine manipulator/occluder used during laparoscopic surgery. Device consists of a handle, body, and tip made of ABS, with an integral silicone toroidal occluding balloon. Surgeon positions tip in cervix; manipulates handle externally to antevert, retrovert, or laterally move uterus for improved surgical field visibility. Occluding balloon is inflated with up to 180 ml of room air to seal the vagina. Device includes a green-coded CO2 port for connection to an insufflator (max pressure 14-16 mm Hg) to maintain pneumoperitoneum. Used in clinical settings by surgeons to facilitate tissue removal through colpotomy or culdotomy incisions, potentially reducing morbidity and recovery time.

Clinical Evidence

Clinical study of 358 patients in New Zealand undergoing abdominal or vaginal hysterectomy procedures. Results indicated the device was associated with less short-term morbidity and a faster recovery rate compared to standard procedures. Bench testing included biocompatibility and balloon burst testing (withstood 2.5x recommended inflation).

Technological Characteristics

Materials: ABS (handle, body, tip), silicone (occluding balloon). Principle: Mechanical uterine manipulation and pneumatic vaginal occlusion. Energy: Manual operation; pneumatic (CO2 insufflation). Connectivity: Standard luer connection for insufflator. Form factor: Handheld surgical instrument with integrated balloon.

Indications for Use

Indicated for patients undergoing laparoscopic surgical procedures requiring uterine manipulation and removal of intraperitoneal tissue via colpotomy or culdotomy incision.

Regulatory Classification

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.

Predicate Devices

• A & A Medical Uterine Manipulator (K010056)
• Koh Colpotomizer System Manipulator/Occluder (K954311)

Submission Summary (Full Text)

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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.

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.

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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.

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 or culdotomy incision.

#### 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 [phone] or [phone] 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:

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.

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_