MTP ARTHROPUMP DISPOSABLE TUBING SET

K990911 · Mtp Medical Technical Promotion GmbH · HRX · Jun 3, 1999 · Orthopedic

Device Facts

• Record ID: K990911
• Device Name: MTP ARTHROPUMP DISPOSABLE TUBING SET
• Applicant: Mtp Medical Technical Promotion GmbH
• Product Code: HRX · Orthopedic
• Decision Date: Jun 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MTP Arthropump Disposable Tubing Set is intended to be utilized with the Karl Storz Arthropump Irrigation System for the infusion of sterile irrigant solution into joints during arthroscopic surgical procedures.

Device Story

Disposable tubing set; used with Karl Storz Arthropump Irrigation System; facilitates infusion of sterile irrigant solution into joints during arthroscopic surgery. Operated by surgeons in surgical settings. Provides fluid pathway for joint irrigation; maintains joint distension for visualization and instrumentation during procedures. Benefits patient by enabling clear surgical field.

Clinical Evidence

No clinical data.

Technological Characteristics

Materials: PVC, silicone, polyolefin, and Makrolon. Form factor: Disposable tubing set. Energy source: None (passive fluid delivery).

Indications for Use

Indicated for use by qualified surgeons for the infusion of sterile irrigant solution into joints during arthroscopic surgical procedures.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Reference Devices

• Karl Storz Arthropump Irrigation System

Submission Summary (Full Text)

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## 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 MTP's knowledge.

| Applicant: | mtp medical technical promotion gmbh<br>p.o. box 4529 • d-78510 tuttlingen<br>tel.: [phone] - 0<br>fax: [phone] - 25 |
|------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan |

[phone]

Common Name: Device Identification: Irrigation Tubing Set

> Trade Name: (optional) MTP Arthropump Disposable Tubing Set

Indication: The MTP Arthropump Disposable Tubing Set is intended for use by qualified surgeons for the infusion of sterile irrigant solution into joints during arthroscopic surgical procedures.

Device Description: The MTP Arthropump Disposable Tubing Set is intended for use by qualified surgeons for the infusion of sterile irrigant solution into joints during arthroscopic surgical procedures. The body contact materials are PVC, silicone, polyolefin, and Makrolon.

Substantial Equivalence: The MTP Arthropump Disposable Tubing Set is substantially equivalent to the predicate device since the basic features, design and intended uses are the same.

Signed:

JUN

3

Kevin Kennan

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and has a simple, clean design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1999 JUN

MTP Medical Technical Promotion GmbH c/o Mr. Kevin A. Kennan P.O. Box 1954 Culver City, California 90232

K990911 Re: Trade Name: MTP Arthropump Disposable Tubing Set Regulatory Class: II Product Code: HRX Dated: February 26, 1999 Received: March 18, 1999

## 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 (QS) 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.

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.

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Page 2 - Mr. Kevin A. Kennan

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,

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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Image /page/3/Picture/0 description: The image shows a logo for a company called MTP, which stands for Medical Technical Promotion. The logo is in black and white and features the letters "mtp" in a stylized font. The words "technical medical promotion" are written below the letters. The logo is set against a dark background.

510(k) Number (if known):

K990911

Device Name: Arthropump Disposable Tubing Set

Indications for Use: The MTP Arthropump Disposable Tubing Set is intended to be utilized with the Karl Storz Arthropump Irrigation System for the infusion of sterile irrigant solution into joints during arthroscopic surgical procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use:<br>(Per 21 CFR 801.109) | X |
|-------------------------------------------|---|
| OR Over-The-Counter Use: | |

(Optional Format 1-2-96)

(Division of)

Division Restorative Devices

| 510(k) Number | K990911 |
|---------------|---------|
|---------------|---------|

000003