TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601

K020083 · Tuta Healthcare Pty Limited · HRX · Feb 12, 2002 · Orthopedic

Device Facts

• Record ID: K020083
• Device Name: TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
• Applicant: Tuta Healthcare Pty Limited
• Product Code: HRX · Orthopedic
• Decision Date: Feb 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tuta Healthcare Pty. Limited Arthroscopy Flushing set (80.601) is a gravity system for fluid management during arthroscopic procedures. During these procedures, the fluid is used to (1) distend the site, enabling good visibility and (2) flush it continuously to clear debris (loose bodies or cartilage fragments away).

Device Story

The Tuta Healthcare Arthroscopy Flushing Set is a gravity-fed irrigation system used during arthroscopic procedures. It consists of tubing and a hand pump mechanism. The device provides controlled irrigation to the joint cavity, allowing the clinician to distend the surgical site for improved visualization and continuously flush the area to remove blood, tissue debris, loose bodies, and cartilage fragments. Flow is regulated using integrated click clamps. The device is intended for use by healthcare professionals in a clinical or surgical setting.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Gravity-fed irrigation system; includes tubing, hand pump, and click clamps for flow control. Non-powered, manual operation.

Indications for Use

Indicated for fluid management during arthroscopic procedures to distend the surgical site for visibility and flush debris. Prescription use only.

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

• Irrigation Set (K883300) - Edwards Orthopedic Division, Baxter Healthcare

Submission Summary (Full Text)

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# 510 (k) Summary

## Summary of Safety and Effectiveness for Tuta's Arthroscopic Flushing Device.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### Assigned 510(k) number K 020003

| | 1. Manufacturer's Name: | Tuta Healthcare Pty. Limited |
|--|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| | Manufacturer's Address | 318-332 Burnsbay Road<br>Lane Cove , Sydney NSW 2066<br>Australia |
| | Contact Person: | Omid Souresrafil PhD |
| | Telephone Number: | + 61 2 94270300 (Switchboard)<br>+ 61 2 9429 6381 (Direct) |
| | Fax Number: | [phone] |
| | Date: | 24/12/01 |
| | 2. Device Name:<br>Trade Name:<br>Proprietary Name:<br>Classification Name: | Arthroscopy Flushing Set<br>Tuta Healthcare Arthroscopy Flushing Set 80.60<br>Arthroscope Accessory (per 21CFR 888.1100) |

#### 3. Legally Marketed Equivalent Device

#### Irrigation Set (K883300) - Edwards Orthopedic Division, Baxter Healthcare

The. Arthroscopy Flushing set in the submission is substantially equivalent to Edwards Orthopaedic Division (K883300), Baxter Healthcare Irrigation - Set

The Arthroscopy flushing set and the Edwards Orthopaedic Division devices are designed to provide irrigation, better visualization for the cleansing of surgical sights .

#### 4. Description of the intended use of the Device

The Tuta Healthcare Arthroscopy Flushing set is designed to provide controlled Irrigation to a joint during arthroscopic procedures. action of the hand pump help to remove blood, tissue debris, loose bodies and foreign matter from the joint cavity. The click clamps are used to block the flow of fluid.

- 1. Distend the arthroscopy sight enabling good visibility and
- 2. Flush the sight continuously to clear debris (loose bodies or cartilage fragments) away.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing an eagle or other national symbol. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### FEB 1 2 2002

Omid Souresrafil, Ph.D. Onlid Bouretirence and Regulatory Affairs Manager Tuta Healthcare Pty. Limited 318-332 Burns Bay Road Lane Cove NSW 2066 Australia

Re: K020083

Trade/Device Name: Arthroscopy Flushing Set Regulation Number: 881.1100 Regulation Name: Arthroscope and accessories Regulatory Class: II Product Code: HRX Dated: January 8, 2002 Received: January 10, 2002

Dear Dr. Souresrafil:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 210(x) prematics is substantially equivalent (for the indications
referenced above and have determined the device and designs marketed in inters referenced above and nave determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate device. Device Amendments for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food Drug. commerce prior to May 28, 1970, the chacultions of the Federal Food, Drug, devices that have been reculted in accordance while as proval application (PMA).
and Cosmetic Act (Act) that do not require approval assured approval applicions of the Act . and Cosmetic Act (Act) that to not require approval controls provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the generats for annual registration, listing of
general controls provisions of the Act include required it it is and includ general controls provisions of the Fectificate required in the believe against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mits existing major regulations affecting your device can
may be subject to such additional controls. Title may be subject to such additional controlis: Lincting includes be found in the Code of Poderal Regaring your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a succession of the requirements of the Act
that FDA has made a determination that your device complies with onemal that FDA has made a decertimation that your assessment of the Federal agencies. You must and listing or any Federal statutes and regulations daminding, but not limited to registration and listing (21
comply with all the Act's requirements, including, but not researces set comply with all the Act 3 requirements, mercessed in and in the requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFK Part 807); labeling (21 CFR Part 800); god analifant 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QD) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.
Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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Page 2 - Omid Souresrafil, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will anow yourse ought miling of substantial equivalence of your device to a legally premaired 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 11 you doolly 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Cr 11 cm 11 cm . 4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 59 + 10th 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 O wision 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,

Miriam C. Provost

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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# 4. STATEMENT OF INDICTIONS FOR USE

510(k) Number (if known): _ K 02008 3

Device Name: Arhtroscopy Flushing Set

Indications For Use:

The Tuta Healthcare Pty. Limited Arthroscopy Flushing set (80.601) is a gravity system Prescription Use (X), (Per 21 CFR 801.109 for fluid management during arthroscopic procedures. During these procedures, the fluid is used to (1) distend the site, enabling good visibility and (2) flush it continuously to clear debris (loose bodies or cartilage fragments away).

iriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_KO20083

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (X) (Per 21 CFR 801.109)

510 (k) Application -- Arthroscopy Flushing Set Tuta Healthcare Pty. Limited