MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM

K011612 · Hydrocision, Inc. · FQH · Jun 22, 2001 · General Hospital

Device Facts

• Record ID: K011612
• Device Name: MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM
• Applicant: Hydrocision, Inc.
• Product Code: FQH · General Hospital
• Decision Date: Jun 22, 2001
• Decision: SESE
• Submission Type: Special
• 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 stream 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. Operated by clinicians in surgical or wound care settings. Output is physical removal of debris/tissue; assists physician in wound management and site preparation. Benefits include effective cleaning of operative or wound sites.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System consists of reusable power console and sterile, disposable pump cartridge, handpiece, and tubing assembly. Operates via pressurized saline stream for lavage and vacuum suction. No software or electronic algorithm described.

Indications for Use

Indicated for wound debridement, 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

• HydroCision, Inc. Debridement System (K991383)

Submission Summary (Full Text)

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# JUN 2 2 2001

HydroCision 100 Burtt Rd. Suite G01 Andover, MA 01810 Tel: [phone] Fax: [phone]

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## 510K Summary of Safety and Effectiveness Modification to the HydroCision, Inc. Debridement System

- 1 . Sponsor Name
HvdroCision, Inc 100 Burtt Rd. Suite G01 Andover, MA 01810 Tel: [phone] Contact Individual: Debbie lampietro

#### .). Device Name

Proprietary Name: HydroCision DebridementSystem Common/Usual Name: Pulse lavage with sharp debridement Classification Name: Unclassified Class II - General Surgery Devices

#### .3. Identification of Legally Marketed Device

The modified HydroCision, Inc Debridement System is substantially equivalent in intended use to the HydroCision, Inc Debridement System (K991383).

#### Device Description 4.

The HydroCision Debridement System uses a pressurized stream of sterile saline to lavage and clean wounds. The stream of saline simultaneously washes the tissue surface and vacuums away foreign material, including contamination and infected and necrotic tissue from the wound. The svstem employs two basic system components to achieve this purpose

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

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#### バ Intended Use

The HydroCision. Inc. Debridement System is intended for wound debridement, soft The Truttonsholishout ne. Beausing of the surgical site in applications in which, in the nissue deoridement, would require the use of a pulse lavage device with sharp debridement. This device is not intended to be used on burns.

### Comparison of Technological Characteristics 6

The modified HydroCision. Inc Debridement System is substantially equivalent in intended use and design to the currently marketed HydroCision, Inc Debridement System (K991383). This device is intended for wound debridement, soft tissue debridement, and cleansing of the surgical site. The device helps to remove blood, tissue debris and foreign matter from the operative or wound site

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. The only difference between the two devices is in the maximum pressure and the tip configuration. These differences do not raise new questions of safety and effectiveness. Bench data demonstrates this

#### Performance Testing 6.

Bench testing was conducted to determine device functionality and conformance to design input requirements.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 2001

HydroCision, Inc. c/o Ms. Debbie Iampietro QRC Consulting 7 Tiffany Trail Hopkinton, Massachusetts 01748

Re: K011612

Trade/Device Name: HydroCision Debridement System Regulation Number: 880.5475 Regulatory Class: II Product Code: FQH Dated: May 25, 2001 Received: May 25, 2001

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 legally marketed predicate 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 (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 nredicate 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Mark N Milkman

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

Enclosure

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## KD11612 510(k) Number (if known)

HydroCision Debridement System Device Name

Indications For Use

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

IPLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _______

KO11612

Mali N. Mckissm

eral. Restorative and Neurological Devices

000010

510(k) Number_