KSEA UNIMAT 45

K981703 · Karl Storz Endoscopy · BTA · Aug 12, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981703
• Device Name: KSEA UNIMAT 45
• Applicant: Karl Storz Endoscopy
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Aug 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These instruments are intended for use by qualified surgeons and provide aspiration of fluid and tissue from the surgical site during laparoscopic surgical procedures, and general and endoscopic plastic, reconstructive and aesthetic surgical procedures.

Device Story

Karl Storz Unimat 45 is an aspiration pump system used to remove fluid and tissue from surgical sites. Operated by qualified surgeons in clinical settings (laparoscopic, plastic, reconstructive, aesthetic surgery), the device provides user-adjustable suction underpressure. It functions as a mechanical suction source to assist in maintaining a clear surgical field. The device benefits patients by facilitating site clearance during procedures. It is not intended for liposuction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Aspiration pump system with user-adjustable suction underpressure. Electromechanical device. Standalone unit.

Indications for Use

Indicated for aspiration of fluid and tissue from surgical sites during laparoscopic, general, endoscopic plastic, reconstructive, and aesthetic surgical procedures performed by qualified surgeons. Contraindicated for liposuction procedures.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is white and the background is black. The logo is made up of the words "STORZ" and "Karl Storz Endoscopy".

5981723

## AUG 12 1998

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

| Applicant: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan<br>Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:<br>Suction Pump |

Trade Name: (optional) Karl Storz Unimat 45

The Karl Storz Unimat 45 system is designed to provide aspiration of the surgical site Indication: during laparoscopic and aesthetic surgical procedures.

Device Description: The Karl Storz Unimat 45 and accessories are a aspiration pump with user adjustable aspiration suction underpressure.

The Karl Storz Unimat 45 system is substantially equivalent to the Substantial Equivalence: predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Unimat 45 and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

Signed:

:
Kevin Kennan

Senior Regulatory Affairs Specialist

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines representing the wings and two curved lines representing the body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 1998

Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600

K981703 Re: Trade Name: KSEA Unimat 45 Regulatory Class: II Product Code: GCJ Dated: July 23, 1998 Received: July 24, 1998

## Dear Mr. Kennan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Kennan

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone].

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Hunell Payne

on Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K981703

Device Name: Unimat 45

Indications for Use: These instruments are intended for use by qualified surgeons and provide aspiration of fluid and tissue from the surgical site during laparoscopic surgical procedures, and general and endoscopic plastic, reconstructive and aesthetic surgical procedures.

ContraIndications for Use: These instruments are contraindicated for liposuction procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div> <img alt="Signature" src="signature.png"/> </div> |
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| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K981703 |

| Prescription Use:<br>(Per 21 CFR 801.109) | X | OR Over-The-Counter Use:<br>(Optional Format 1-2-96) |
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