HYDROCISION ARTHROJET SYSTEM

K982266 · Hydrocision, Inc. · HRX · Sep 25, 1998 · Orthopedic

Device Facts

• Record ID: K982266
• Device Name: HYDROCISION ARTHROJET SYSTEM
• Applicant: Hydrocision, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Sep 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrojet system is intended to resect damaged tissue and remove extraneous matter found in articular body cavities. The system may be used open or arthroscopically to resect tears and other defects, remove loose fragments, shave away debris and perform appropriate synovectomy procedures.

Device Story

The HydroCision ArthroJet is an electrically powered surgical system used for tissue resection and ablation in articular body cavities. The system comprises a console, pump cartridge, tubing, and handpiece. Operation involves an electric motor driving a cam-actuated piston within a disposable cartridge to pressurize saline. This pressurized saline is delivered through a handpiece as a high-velocity waterjet stream, which cuts and ablates tissue. The system is intended for use by surgeons in open or arthroscopic procedures to remove damaged tissue, loose fragments, and debris. The waterjet mechanism provides an alternative to mechanical rotating cutters, facilitating tissue removal from the surgical site. Clinical benefits include effective resection of articular defects and synovectomy.

Clinical Evidence

Bench testing and animal studies provided. Porcine knee evaluation demonstrated the ability to resect and ablate various tissue types. In-vivo testing in rabbits confirmed efficacy in resecting menisci compared to the predicate device. Handpiece bending strength was evaluated for arthroscopic application suitability.

Technological Characteristics

Electrically powered console with cam-driven piston pump; disposable saline cartridge; handpiece for waterjet delivery. System operates via high-pressure fluid dynamics rather than mechanical rotation. No software or electronic control algorithms described.

Indications for Use

Indicated for patients requiring resection of damaged tissue or removal of extraneous matter in articular body cavities, including synovectomy and removal of loose fragments or debris, via open or arthroscopic surgical procedures.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Dyonics Articular Shaver System (K982266)

Submission Summary (Full Text)

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### SEP 2 5 1998

#### 510(K) SUMMARY

# 大982266

#### 1. SUBMITTER:

SEP 2 5 1998

HydroCision, Inc. 220 Ballardvale Street Wilmington, MA 01887 Telephone: [phone]

Contact: Don Freeman, President Date Prepared: June 17, 1998

#### 2. DEVICE:

Arthroscopic Cutting System Classification Name: Arthroscope and Accessories Trade Name: HydroCision ArthroJet

#### 3. PREDICATE DEVICE:

The predicate device used to determine substantial equivalence for the HydroCision ArthroJet was the Dyonics Articular Shaver System, marketed by Smith & Nephew Dyonics, Andover, MA

#### 4. DEVICE DESCRIPTION:

The HydroCision ArthroJet system consists of an electric motor used to power a drive train inside a console. The drive train converts the rotational motion of a cam to a transverse motion of a plunger which in turn drives a piston contained in a disposable cartridge. The repeated motion of the piston pressurizes saline in the cartridge which is then carried through tubing to a handpiece. The handpiece delivers the high pressure saline to the joint, resulting in the cutting action of the waterjet. The result is a thin waterjet stream capable of cutting and ablating tissue which is then removed from the surgical site.

#### 5. INTENDED USE:

The Arthrojet system is intended to resect damaged tissue and remove extraneous matter found in articular body cavities. The system may be used open or arthroscopically to resect tears and other defects, remove loose fragments, shave away debris and perform appropriate synovectomy procedures.

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#### 6. COMPARISON OF CHARACTERISTICS:

The HydroCision ArthroJet system is electrically powered and consists of a console unit, pump cartridge, tubing and handpiece. It uses a drive train to pressurize saline in a pump cartridge which is delivered to a hand piece resulting in a thin high pressure waterjet stream capable of cutting and ablating tissue, which is then removed from the site.

The Dyonics shaver is also an electrically powered unit which is used to power a hand held motor. The motor is used to exert rotational force to a disposable cutter. The cutter resects tissue by rotating at high rates of speed resulting in the tissue being cut and removed from the area.

The indications for use of the two devices are identical.

#### 7. PERFORMANCE DATA:

The following performance data is provided in support of the substantial equivalence determination:

- 1. Porcine Evaluation: The ability of the ArthroJet to resect and ablate variuos types of tissue was demonstrated in a porcine knee.
- 2. In-Vivo Testing: The testing demonstrated the efficacy of the HydroCision ArthroJet in resecting rabbit menisci when compared to the predicate device. The testing confirmed that the device functions adequately to meet its intended use.
- 3. Bending Strength: The bending strength of the handpiece was evaluated for its ability to withstand arthroscopic applications.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

P 25 1998

D.C. Freeman, Jr. Ph.D. President HydroCision, Inc. 220 Ballardvale Street Wilmington, Massachusetts 01887

Re: K982266 Trade Name: HydroCision Arthrojet System Regulatory Class: II Product Code: HRX Dated: June 25, 1998 Received: June 29, 1998

Dear Dr. Freeman:

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, Druq, 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. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 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 - Dr. Freeman, Jr.

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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982266

## INDICATION FOR USE

The ArthroJet system is intended to resect damaged tissue and remove extraneous matter found in articular body cavities. The system may be used open or arthroscopically to resect tears and other defects, remove loose fragments, shave away debris and perform appropriate synovectomy procedures.

Prescription Use
(Per 21 CFR 801.109)

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