HYDROCISION DEBDRIDEMENT SYSTEM

K991383 · Hydrocision, Inc. · FQH · Mar 31, 2000 · General Hospital

Device Facts

• Record ID: K991383
• Device Name: HYDROCISION DEBDRIDEMENT SYSTEM
• Applicant: Hydrocision, Inc.
• Product Code: FQH · General Hospital
• Decision Date: Mar 31, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5475
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HydroCision, Inc. Debridement System is intended for wound debridement, soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgement, would require the use of a pulse lavage device with sharp debridement. This device is not intended to be used on burns.

Device Story

HydroCision Debridement System uses pressurized sterile saline streams to lavage and clean wounds; simultaneously washes tissue surface and vacuums away foreign material, contamination, and necrotic tissue. System comprises reusable power console and sterile, disposable pump cartridge, handpiece, and tubing assembly. Used in clinical/surgical settings by physicians. Output is a clean wound site; facilitates removal of debris and infected tissue. Benefits patient by providing effective debridement and cleansing of surgical or wound sites.

Clinical Evidence

Bench testing conducted for functionality. Porcine study compared HydroCision device to Zimmer Puls-A-Vac II. Results showed both techniques equally effective in clearing bacterial and particulate contamination from wounds, as measured by quantitative bacteriology and radiographic analysis.

Technological Characteristics

System utilizes pressurized saline streams for lavage and vacuum-assisted debris removal. Components include reusable power console and sterile, disposable pump cartridge, handpiece, and tubing assembly. Operates via fluid dynamics; no electronic sensing or software-based control algorithms described.

Indications for Use

Indicated for wound and soft tissue debridement and surgical site cleansing where pulse lavage with sharp debridement is clinically required. Contraindicated for use on burns.

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

• Stryker Corporation Interpulse Pulse Lavage System (K972069)
• Zimmer Pulsavac Wound Debridement System
• ArthroJet System (K982266)

Reference Devices

• Zimmer Puls-A-Vac II pulsatile lavage device

Submission Summary (Full Text)

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K991383

# MAR 3 1 2000

HYDROCISION, INC. 100 Burtt Rd, Suite G01 Andover, MA 01810

## 510K Summary HydroCision, Inc. Debridement System

Sponsor Name 1. HydroCision, Inc 100 Burtt Road, Suite GO1 Andover, MA 01810 Telephone: [phone] Contact Individual: Debbie Iampietro

#### 2. Device Name

Proprietary Name: HydroCision Debridement System Common/Usual Name: pulse lavage with sharp debridement Classification Name: unclassified

- 3. Identification of Legally Marketed Device
The HydroCision, Inc Debridement System is substantially equivalent in intended use to the Stryker Corporation Interpulse Pulse Lavage System (K972069) in combination with sharp debridement. The intended use is also the same as the Zimmer Pulsavac Wound Debridement System in combination with sharp debridement.

It is also substantially equivalent in design, materials and construction to its own ArthroJet System cleared under K982266.

- 4. Device Description
The HydroCision Debridement System uses pressurized streams of sterile saline to lavage and clean wounds. The streams of saline simultaneously wash the tissue surface and vacuum away foreign material, including contamination and infected and necrotic tissue from the wound. The system employs two basic system components to achieve this purpose:

- the reusable power console unit t
- t the sterile, disposable pump cartridge, handpiece and tubing assembly

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### Intended Use

The HydroCision, Inc. Debridement System is intended for wound debridement, soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgement, would require the use of a pulse lavage device with sharp debridement. This device is not intended to be used on burns.

#### 6 Comparison of Technological Characteristics

The HydroCision. Inc Debridement System is substantially equivalent in intended use to the Stryker Corporation Interpulse Pulse Lavage System (K972069) in combination with sharp debridement. This device is intended for wound debridement, soft tissue debridement, and cleansing of the surgical or medical clinical site. The device helps to remove blood, tissue debris and foreign matter from the operative or wound site. The intended use is also the same as the Zimmer Pulsavac Wound Debridement System in combination with sharp debridement. It is also substantially equivalent in design, materials and construction to its own ArthroJet System cleared under K982266.

The devices have similar flow rates and power requirements. The components of each system are similar in that they each contain: a reusable power console unit, a sterile. disposable pump cartridge, a handpiece assembly, and a tubing set

### 6. Performance Testing

Bench testing was conducted to determine device functionality. In addition, a porcine study compared the HydroCision device to the Zimmer Puls-A-Vac II pulsatile lavage device in combination with sharp debridement. The results of this evaluation found both techniques were equally effective in clearing bacterial and particulate contamination from the wounds as examined by quantitative bacteriology and radiographic analysis.

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# MAR 3 1 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Debbie Iampietro Regulatory Affairs Hydrocision, Inc. 100 Burtt Road, Suite G01 Andover, Massachusetts 01810

Re: K991383 Trade Name: HydroCision Inc. Debridement System Regulatory Class: II Product Code: FQH Dated: January 7, 2000 Received: January 10, 2000

Dear Ms. Iampietro:

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 (OS) 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 - Ms. Debbie Iampietro

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,

Stypt Rhodes

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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Attachment b

510(k) Number K991383

HydroCision Inc. Debridement System Device Name:

Indications For Use:

The HydroCision, Inc. Debridement System is intended for wound debridement, soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgement, would require the use of a pulse lavage device with sharp debridement. This device is not intended to be used on burns.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Styph Edwards

(Division Sigh-Off) Division of General Restorative Devices K991383 510(k) Number _

Prescription Use

OR

Over-The-Counter Use