HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR

K020688 · Hydrocision, Inc. · HRX · Apr 3, 2002 · Orthopedic

Device Facts

• Record ID: K020688
• Device Name: HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR
• Applicant: Hydrocision, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Apr 3, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HydroCision ArthroJet System with Cautery and TurboBurr is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation and shaping of soft tissue, and drilling, reaming, decorticating and smoothing of bone, cartilage and other bone related tissue in a variety of surgical procedures including open and arthroscopic spinal surgeries and small and large joint arthroscopic procedures.

Device Story

System uses fluidjet technology for orthopedic surgery; consists of reusable power control unit, sterile disposable pump cartridge/tubing, and sterile disposable handpieces. Handpieces feature rotating burr driven by fluidjet-powered rotor. Surgeon operates device in OR during open or arthroscopic spinal and joint procedures. Fluidjet performs tissue resection/ablation; rotating burr performs bone drilling/smoothing. Quick-disconnect handpieces allow tip geometry selection for optimized access. Direct-drive turbine mechanism provides higher rotational speed and lower torque compared to previous gear-driven designs. Output allows precise tissue/bone removal and hemostasis, aiding surgical access and procedural efficiency.

Clinical Evidence

Bench and cadaver testing conducted to determine device functionality and conformance to design input requirements. No clinical data provided.

Technological Characteristics

Reusable power console; fluidjet-driven rotor; sterile disposable pump cartridge and tubing; handpieces with high-pressure fluid conduit/nozzle and low-pressure collection tube. Turbine drive mechanism uses direct drive. Tip geometries vary by handpiece. System is non-implantable, arthroscopic accessory.

Indications for Use

Indicated for orthopedic surgical procedures requiring soft tissue cutting/removal/shaping and hard tissue/bone ablation/drilling/reaming/decorticating/smoothing, including bleeding control. Applicable to open and arthroscopic spinal surgeries and small/large joint arthroscopic 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

• HydroCision ArthroJet System with Cautery and Burr (K002764)
• Anspach eMax Drill (K011444)

Submission Summary (Full Text)

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

K020688 1/2

# APR 0 3 2002

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

# 510K Summary of Safety and Effectiveness February 27, 2002 HydroCision ArthroJet System with Cautery and TurboBurr A Modification to the HydroCision ArthroJet System with Cautery and Burr

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

#### 2. Device Name

Proprietary Name: HydroCision ArthroJet System with Cautery and TurboBurr Common/Usual Name: Arthroscope and Accessories Classification name: Arthroscope and Accessories

- 3. Identification of Legally Marketed Device
The modified HydroCision ArthroJet System with Cautery and TurboBurr is substantially equivalent in intended use to the HydroCision ArthroJet System with Cautery and Burr (K002764) and the Anspach eMax Drill (K011444).

#### 4. Device Description

The HydroCision ArthroJet System with Cautery and TurboBurr consists of the reusable power control unit; a sterile, disposable pump cartridge and tubing assembly; and sterile, disposable handpieces. It provides the same functions as the predicate upon which it is based. The handpiece includes the rotating burr, which is driven by a fluidjet driven rotor.

- ડ. Intended Use
The HydroCision ArthroJet System with Cautery and TurboBurr is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting,

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

K020688 2/2

ablation and shaping of soft tissue, and drilling, reaming, decorticating and smoothing of bone, cartilage and other bone related tissue in a variety of surgical procedures including open and arthroscopic spinal surgeries and small and large joint arthroscopic procedures.

- Comparison of Technological Characteristics 6. Both the current and modified devices:
- Have the same indicated use A. Both are intended for resection of tissue and bone in open and arthroscopic spinal surgeries and small and large joint arthroscopic procedures.
- Use the same fundamental scientific technology B.
- a reusable power console unit .
- fluid jet technology .
- a sterile, disposable pump cartridge and tubing assembly, and . handpiece assemblies comprised of two principal components:
- a high pressure fluid conduit with integral fluidjet . nozzle
- a low pressure collection tube. .
- The differences between the proposed HydroCision ArthroJet System with C. Cautery and TurboBurr and the current HydroCision ArthroJet System with Cautery and Burr (K002764) are:
- Direct fluidjet functions have been separated from the rotational o functions into a variety of handpieces with slightly different tip configurations. This allows the handpieces of the modified device to be smaller than the current device, which combines direct fluidjet and rotational functions. It also allows the surgeon to select from a variety of different tip geometries to optimize access to the target tissue.
- The attachment of the handpiece to the pump cartridge and tubing o assembly has been changed from a permanently affixed attachment to a quick disconnect. This allows the surgeon to easily change handpieces for different functions and optimized access to target tissue.
- The turbine drive mechanism for the burr is being modified from o gear driven to direct drive, resulting in higher rotational speed of the tip and lower torque.
- 7. Performance Testing

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

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized depiction of an eagle or bird-like figure with three wing-like lines extending upwards and to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR 0 3 2002

Re: K020688

Trade/Device Name: HydroCision ArthroJet System with Cautery and TurboBurr Regulation Number: 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: February 27, 2002 Received: March 4, 2002

Dear Ms. Iampietro:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass sured in the encrease 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

### Page 2 - Ms. Debbie Iampietro

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

for 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

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

5 10(k) Number (if known):

K020658

Device Name:

HydroCision ArthroJet System with Cautery and TurboBurr

Indications For Use:

The HydroCision ArthroJet System with Cautery and TurboBurr is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation and shaping of soft tissue, and drilling, reaming, decorticating and smoothing of bone, cartilage and other bone related tissue in a variety of surgical procedures including open and arthroscopic spinal surgeries and small and large joint arthroscopic procedures.

(PLEASE 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

Muriam C. Provost

eral Restorative and Neurological D

510(k) Number K020658