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 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 and the sterile, disposable pump cartridge, handpiece and tubing assembly.

AI/ML Overview

The HydroCision, Inc. Debridement System, a pulse lavage device with sharp debridement, was reviewed for K991383. The study relied on bench testing and a comparative animal study against a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functionality (Bench Testing)	Bench testing was conducted to determine device functionality. The summary implies the device met its functional requirements, although specific metrics or thresholds for "functionality" are not provided in this document.
Equivalence in wound cleaning (Porcine Study)	The HydroCision device and the predicate device (Zimmer Puls-A-Vac II) were found to be "equally effective in clearing bacterial and particulate contamination from the wounds as examined by quantitative bacteriology and radiographic analysis." This indicates the device met the criteria for comparable wound debridement effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Porcine Study (Test Set): While a specific number for the porcine subjects is not explicitly stated in the provided text, the study involved a comparison between the HydroCision device and the Zimmer Puls-A-Vac II device.
Data Provenance: The porcine study was conducted as a prospective, in-vivo animal study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given text. For the porcine study, it's possible that veterinary pathologists or microbiologists were involved in assessing bacterial and particulate contamination, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the given text. For the porcine study, it's unknown if multiple assessors were used and how discrepancies were resolved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve With AI vs. Without AI Assistance

This section is not applicable as the device is not an AI-powered diagnostic tool, but rather a surgical debridement system. The study was a comparison of device effectiveness, not human reader performance with or without AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable as the device is not an algorithm. The "standalone" performance refers to the device's functional and cleaning capabilities demonstrated through bench and animal testing.

7. The Type of Ground Truth Used

Bench Testing: The ground truth for functionality would have been engineering specifications and predetermined performance parameters for flow rates, power, etc.
Porcine Study: The ground truth for wound cleaning effectiveness was established through:
- Quantitative Bacteriology: Direct measurement of bacterial load.
- Radiographic Analysis: Assessment of particulate contamination removal using imaging.

8. The Sample Size for the Training Set

This section is not applicable as there is no "training set" in the context of this device. The device is not a machine learning algorithm that requires training data. The development and validation relied on engineering design and performance testing.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable as there is no training set.

Summary

{0}------------------------------------------------

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: 978 474-9300 Contact Individual: Debbie Iampietro

2. Device Name

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

1. 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.

1. 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

{1}------------------------------------------------

Intended Use

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.

રે.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above two wavy lines.

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.

{3}------------------------------------------------

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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

{4}------------------------------------------------

Attachment b

510(k) Number K991383

HydroCision Inc. Debridement System Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Styph Edwards

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

Prescription Use

Over-The-Counter Use

Regulation Number and Section

§ 880.5475 Jet lavage.

(a)
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.(b)
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.