STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK

K972069 · Stryker Instruments · FQH · Jul 29, 1997 · General Hospital

Device Facts

• Record ID: K972069
• Device Name: STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK
• Applicant: Stryker Instruments
• Product Code: FQH · General Hospital
• Decision Date: Jul 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5475
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker InterPulse Lavage System is intended for wound debridement, soft tissue debridement and cleansing of a medical, clinical, or surgical site. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin on burn wounds, and cleansing wounds incurred from trauma

Device Story

Stryker InterPulse Lavage System is a single-patient-use, sterile, disposable pulsed lavage device for wound and surgical site debridement/cleansing. System components include irrigation handpiece, tubing, irrigation/suction tips, and splash shields. Handpiece is battery-operated (internal or external pack). User controls irrigation flow (100-1500 ml/min) via trigger displacement. Specific tips provide variable flow rates and patterns; tips for wound/soft tissue debridement are limited to 15 psi. A protective plug enables handpiece reuse on the same patient for chronic wound hydrodebridement. An optional lighted tip provides site illumination via internal batteries. Device is used by clinicians in surgical or clinical settings to remove debris and cleanse tissue, potentially improving wound healing outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pulsed lavage system; battery-powered handpiece; variable flow rate (100-1500 ml/min); pressure-limited to 15 psi for wound/soft tissue tips; includes irrigation/suction tubing and splash shields; optional battery-powered illumination tip; single-patient-use, sterile, disposable.

Indications for Use

Indicated for wound debridement, soft tissue debridement, and cleansing of surgical, medical, or clinical sites, including bone cleansing, chronic wound hydrodebridement, burn wound debridement, and trauma wound cleansing.

Regulatory Classification

Identification

A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Reference Devices

• Davol (unspecified)
• Davis+Geck (unspecified)

Submission Summary (Full Text)

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K972069

Stryker

INSTRUMENTS

mazoo MI 4 6) 323-7700 [phone]

## JUL 29 1997

## Device Name:

Regulatory Class:

| Classification Name: | Jet Lavage: 21CFR 880.5475, Class II |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Pulsed Lavage |
| Proprietary Name: | Stryker InterPulse Lavage System |
| Device Sponsor: | Stryker Corporation<br>Instruments Division<br>4100 E. Milham<br>Kalamazoo, MI 49001<br>Registration No: 1811755 |

Class II

## Summary of Safety and Effectiveness:

The Stryker InterPulse Lavage System is a pulsed lavage system intended for wound debridement, soft tissue debridement, and cleansing of the surgical or medical/clinical site.

The Stryker InterPulse System is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields.

The Stryker InterPulse Handpiece is operated by batteries which are either located and sealed within the handpiece housing or in an external battery pack. The flow of irrigation is variable between approximately 100ml/min and 1500ml/min depending on which irrigation tip is attached to the handpiece as well as the amount of displacement of the handpiece trigger.

The InterPulse system includes an assortment of tips which provide a variation in irrigant flow rate and irrigation flow pattern. Tips that are indicated for wound and soft

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tissue debridement do not exceed a pressure of 15 psi at the wound site. A Protective Plug allows the user to reuse the InterPulse handpiece on the same patient for subsequent hydrodebridement of chronic wounds. A lighted irrigation tip provides illumination of the irrigating site. This tip has a bulb that is illuminated by batteries located within the tip.

The Stryker InterPulse Lavage System is equivalent to existing marketed products by companies such as Davol and Davis+Geck. Power modality, intended use, and safety risks are all substantially equivalent.

The Stryker InterPulse System does not raise any new safety and efficacy concerns when compared to similar legally marketed devices.

Therefore, the Stryker InterPulse System is substantially equivalent to these existing devices.

Tammy Lounds Associate Manager, Regulatory Affairs Stryker Instruments

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tammy Lounds Associate Manager, Regulatory Affairs Stryker® Instruments …………………… 4100 East Milham Avenue Kalamazoo, Michigan 49001-6197

JUL 2 9 1997

K972069 Re: Trade Name: Stryker InterPulse System Regulatory Class: II Product Code: FQH Dated: May 29, 1997 Received: June 3, 1997

Dear Ms. Lounds:

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 requirements , 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

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Page 2 - Ms. Tammy Lounds

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.

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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|--|--|

K972069 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: InterPulse System

Indications For Use:

The Stryker InterPulse Lavage System is intended for wound debridement, soft tissue I he birgher meets and cleansing of a medical, clinical, or surgical site. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin on burn wounds, and cleansing wounds incurred from trauma

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Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The- Counter Use _ Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)