ARTISAN PULSE LAVAGE SYSTEM

K972551 · Howmedica Corp. · FQH · Oct 29, 1997 · General Hospital

Device Facts

• Record ID: K972551
• Device Name: ARTISAN PULSE LAVAGE SYSTEM
• Applicant: Howmedica Corp.
• Product Code: FQH · General Hospital
• Decision Date: Oct 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5475
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Artisan Pulse Lavage System is intended to be used in the preparation of the intramedullary canal and/or bone surfaces in orthopedic procedures, including primary and/or revision total joint arthroplasty. This device may also be used to provide lavage for wound/burn irrigation/debridement in trauma situations, or any other situation where irrigation may be indicated. The pulsatile action of the pump helps to remove blood, tissue debris and foreign matter from the operative/wound site. When connected to a suction source the device can be used to aspirate material/fluids from the operative/wound site.

Device Story

Artisan Pulse Lavage System is a handheld, pneumatic-powered device for orthopedic and wound irrigation. It utilizes a resterilizable handpiece and sterile disposable pump cartridge with various tubing configurations. The system delivers pulsatile fluid flow to remove blood, tissue debris, and foreign matter from operative or wound sites. When connected to an external suction source, the device simultaneously aspirates fluids and debris. Operated by clinicians in surgical or clinical settings, the device facilitates site preparation and debridement, potentially improving surgical outcomes by ensuring clean bone surfaces or wound beds.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Handheld, pneumatic-powered lavage system. Components include resterilizable handpiece, resterilizable air hose, and sterile disposable pump cartridge. Features pulsatile pump action and optional suction adapter. No electronic or software components.

Indications for Use

Indicated for preparation of intramedullary canal and bone surfaces during orthopedic procedures (primary/revision joint arthroplasty) and for wound/burn irrigation/debridement in trauma or other clinical situations requiring irrigation.

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.

Predicate Devices

• Exeter Lavage System - Howmedica (K790811)
• Surgi-Lav 66 System Stryker Corporation
• Pulsed Irrigation/Suction System - Stryker Corporation (K873466)
• Pulsed Irrigation/Suction System - Stryker Corporation (K951666)
• Davol Simpulse Lavage System Bard (K870915)
• Davol Simpulse SOLO Pulsed Lavage System - Bard

Submission Summary (Full Text)

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K972551

## 510(k) Summary

OCT 2 9 1997

## Device:

The Artisan Pulse Lavage System is intended to be used in the preparation of the intramedullary canal and/or bone surfaces in orthopedic procedures, including primary and/or revision total joint arthroplasty. This device may also be used to provide lavage for wound/burn irrigation/debridement in trauma situations, or any other situation where irrigation may be indicated. The pulsatile action of the pump helps to remove blood, tissue debris and foreign matter from the operative/wound site. When connected to a suction source the device can be used to aspirate material/fluids from the operative/wound site.

The Artisan Pulse Lavage System is a hand held pneumatic powered lavage system which utilizes a resterilizable handpiece, and sterile disposable pump cartridge with a choice of tubing configurations for intramedullary or soft tissue debridement. The system can also provide suction via the use of a pump cartridge with suction adapter. The system is connected to the power source by a resterilizable air hose.

The Artisan Pulse Lavage System is substantially equivalent to several other legally marketed devices. Examples of these are:

- 1. Exeter Lavage System - Howmedica (K790811)
- Surgi-Lav 66 System Stryker Corporation (Preamendment) 2.
- 3. Pulsed Irrigation/Suction System - Stryker Corporation (K873466 and K951666)
- Davol Simpulse Lavage System Bard (K870915) 4.
- ട. Davol Simpulse SOLO Pulsed Lavage System - Bard

For information contact:

Margaret F. Crowe Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 [phone] Fax No.: [phone]

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Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Margaret F. Crowe Manager, Regulatory Affairs Howmedica Incorporated 359 Veterans Boulevard Rutherford, New Jersey 07070

OCT 29 1997

K972551 Re : Artisan Pulse Lavage System Trade Name: Regulatory Class: II Product Code: FQH Dated: October 6, 1997 Received: October 7, 1997

Dear Ms. Crowe:

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 The general controls provisions of the Act 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 Requlations, 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 In addition, FDA may publish further announcements action. 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

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Page 2 - Ms. Crowe

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to beqin 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,

Us Alatrust

Timot Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

, Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Artisan Pulse Lavage System

Indications for Use:

י

The Artisan Pulse Lavage System is intended to be used in the preparation of the intramedullary canal and/or bone surfaces in orthopedic procedures, including primary and/or revision total joint arthroplasty. This device may also be used to provide lavage for wound/burn irrigation/debridement in trauma situations, or any other situation where irrigation may be indicated. The pulsatile action of the pump helps to remeve blood, --tissue debris and foreign matter from the operative/wound site. When connected to a suction source the device can be used to aspirate material/fluids from the operative/wound site.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------------|--------------------------|
| (Division Sign-Off) | Patricia Accosta |
| Division of Dental, Infection Control, and General Hospital Devices | 1972551 |
| | |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use |
| | (Optional Format 1-2-96) |

**Prescription Use**
**(Per 21 CFR 801.109)**