ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM

K050411 · Zimmer, Inc. · KCY · Sep 2, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050411
• Device Name: ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
• Applicant: Zimmer, Inc.
• Product Code: KCY · General, Plastic Surgery
• Decision Date: Sep 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5910
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

The A.T.S. 3000 Automatic Tourniquet System is intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. Tourniquets have been found useful in producing a bloodless operation field in surgical procedures involving the extremities including: Reduction of certain fractures Kirschner wire removal Tumor and cyst excisions Subcutaneous fasciotomy Nerve injuries Tendon repair Bone grafts Total wrist joint replacement Replacement of joints in the fingers Knee joint replacements Amputations Replantations

Device Story

The Zimmer A.T.S. 3000 is an automatic pneumatic tourniquet system used by medical professionals in surgical settings to create a bloodless field. The system comprises a control unit connected via tubing to an inflatable cuff applied to the patient's extremity. The device features a Limb Occlusion Pressure (LOP) function to determine appropriate pressure settings. The control unit manages inflation and maintenance of the cuff pressure. By occluding blood flow, the device facilitates various orthopedic and reconstructive procedures, potentially improving surgical visibility and outcomes.

Clinical Evidence

No clinical data was required or provided for this device. Substantial equivalence was established through non-clinical performance testing, including electrical safety, hardware and software validation, environmental testing, and risk analysis, in accordance with FDA guidance and ANSI/AAMI/ISO 10993-1:1997 standards.

Technological Characteristics

Pneumatic tourniquet system consisting of a control unit and inflatable cuff. Features include automated pressure regulation and LOP determination. Complies with ANSI/AAMI/ISO 10993-1:1997 for biological evaluation. Includes hardware and software components for pressure control and monitoring.

Indications for Use

Indicated for patients undergoing surgical procedures on extremities requiring temporary blood flow occlusion to create a bloodless field. Applicable for fracture reduction, K-wire removal, tumor/cyst excision, fasciotomy, nerve/tendon repair, bone grafts, joint replacement (wrist, finger, knee), amputations, and replantations. For use by qualified medical professionals.

Regulatory Classification

Identification

A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.

Predicate Devices

• Richards Pressure Sentry Tourniquet (K840206)
• Zimmer A.T.S. 2000 Tourniquet System

Reference Devices

• Versatone D9 stethoscope (Medasonics)

Submission Summary (Full Text)

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SEP 0 2 2005

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# Summary of Safety and Effectiveness

| Submitter: | Zimmer Orthopaedic Surgical Products<br>200 West Ohio Avenue<br>P.O. Box 10<br>Dover, Ohio 44622 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Cindy J. Dickey<br>Regulatory Compliance Manager<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | February 14, 2005 |
| Trade Name: | ZIMMER A.T.S. 3000 AUTOMATIC<br>TOURNIQUET SYSTEM |
| Common Name: | Tourniquet, Pneumatic |
| Classification Name<br>and Reference: | Tourniquet, Pneumatic<br>21 CFR § 878.5910 |
| Predicate Devices: | Richards Pressure Sentry Tourniquet, manufactured<br>by Richards Medical, K840206, cleared April 25,<br>1984. |
| | Zimmer A. T.S. 2000 Tourniquet System,<br>manufactured by Zimmer Orthopaedic Surgical<br>Products, Class 1 Exempt. |
| | Versatone D9 stethoscope, manufactured by<br>Medasonics, preamendment device. |
| Device Description: | The Zimmer A. T.S. 3000 Automatic<br>Tourniquet System is a non-sterile device intended<br>to be used by qualified medical professionals to<br>temporarily occlude blood flow in a patient's<br>extremities during surgical procedures on those<br>extremities. |
| | The system consists of the A.T.S. 3000 control unit<br>that is coupled to the patient with the applied part |

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(inflatable pneumatic tourniquet cuff) via the connecting tubing. The tourniquet cuff is applied to the patient prior to the procedure beginning. The connecting tubing is attached to the inflatable tourniquet cuff and plugged into the A.T.S. 3000's connector ports.

#### The A. T.S. 3000 Automatic Tourniquet System is intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. Tourniquets have been found useful in producing a bloodless operation field in surgical procedures involving the extremities including:

Reduction of certain fractures Kirschner wire removal Tumor and cyst excisions Subcutaneous fasciotomy Nerve injuries Tendon repair Bone grafts Total wrist joint replacement Replacement of joints in the fingers Knee joint replacements Amputations Replantations

The Zimmer A.T.S. 3000 Automatic Tourniquet System is substantially equivalent to other legally marketed tourniquet systems, specifically the Richards Pressure Sentry Tourniquet and the Zimmer A.T.S. 2000 Tourniquet System in that the devices are similar in design, materials, and indications for use. Additionally, the LOP feature of the Zimmer A. T.S. 3000 Automatic Tourniquet System is substantially equivalent to the Medasonics Versatone D9 stethoscope in the determination of patient LOP.

#### Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

This device has been tested and does meet the

#### Indications for Use:

Comparison to Predicate Device:

**Performance Data (Nonclinical**

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applicable sections of the Guidance document "Guidance for FDA Reviewers and Industry, " May 29, 1998, as well as, ANSI/AAMI/ ISO 10993-1:1997, "Biological evaluation of Medical Devices."

During the development process of the AT.S. 3000, the following testing was completed:

Electrical safety testing Hardware and Software testing Software validation Environmental testing Performance testing Risk analysis

Test protocols and summaries are included within the submission.

#### Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular fashion around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 2 2005

Ms. Cindy J. Dickey Regulatory Compliance Manager Zimmer Orthopaedic Surgical Products 200 West Ohio Avenue P.O. Box 10 Dover, Ohio 44622

Re: K050411

K030411
Trade/Device Name: Zimmer A.T.S. 3000 Automatic Tourniquet System Regulation Number: 21 CFR 878.5910 Regulation Name: Pneumatic tourniquet Regulatory Class: I Product Code: KCY Dated: June 29, 2005 Received: July 8, 2005

Dear Ms. Dickey:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 710(x) premainer is substantially equivalent (for the indications referenced above and nave determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate device Amendments for use stated in the enclosure) to regally mancede producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderel Food. Drug commerce prior in May 20, 1970, the charge and the provisions of the Federal Food, Drug, devices that have been reciassified in acceraanse while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act . The and Cosmetic Act (Act) that do not require approvine of the general controls of the Act. The You may, therefore, market the device, sucject to the ments for annual registration, listing of
general controls provisions of the Act include requirements for annual registr general controls provisions of the Act mendo requirements of the management 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) into exist of the major regulations affecting your device can
may be subject to such additional controls. Existing major regulation may be subject to such additional controller "Extrong computer of the 21, In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, In add be found in the Code of Peachar Regerning 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 issualice of a backers complies with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a delectimation that your as reast by other Federal agencies. You must as and ligit or any Federal statutes and regulations administres by Jun not limited to: registration and listing (21 l comply with all the Act 3 requirements) (1) ; good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2- Ms. Cindy J. Dickey

This letter will allow you to begin marketing your device as described in your Section 510(k)
The same of the support of allers of selection as a legal This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equipales of your premarket notification. 116 FDA imaling of substanted by 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), please
rs (11) in 11 (11) (11) (115) 1115 - Alge, please note the regulation enti If you desire specific advice for your de vice of our ... Also, please note the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note 170 contact the Office of Compliatice at (240) 270 - 197 Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21) - 1 the Division of Small "Misbranding by reference to prematicilities under the Act from the Division of Small
other general information on your responsibilities under the Act from the Division of Sm other general intormation on your responsibilities and are and or [phone] or
Manufacturers, International and Consumer Assistance at its toll-free anain html Manufacturers, International and Collisation Assistance and Consults.
[phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Barbara Buchund
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): K 05041)

Device Name:

Zimmer A.T.S. 3000 Automatic Tourniquet System

### Indications for Use:

The A.T.S. 3000 Automatic Tourniquet System is intended to be used by qualified medical The A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . procedures on those extremities. Tourniquets have been found useful in producing a procedures on those extremities. Tourinquous na recomment of the extremities including:

Reduction of certain fractures Kirschner wire removal Tumor and cyst excisions Subcutaneous fasciotomy Nerve injuries Tendon repair Bone grafts Total wrist joint replacement Replacement of joints in the fingers Knee joint replacements Amputations Replantations Over-The-Counter Use AND/OR Prescription Use _ X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (Please do not write below this line - Continue on another page if needed) ODE MAM Concurring The Page 1 of 1 Division of General, Restorative, and Neurological Devices

510(k) Number

000040