ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM

K123553 · Zimmer, Inc. · KCY · Aug 9, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K123553
• Device Name: ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
• Applicant: Zimmer, Inc.
• Product Code: KCY · General, Plastic Surgery
• Decision Date: Aug 9, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5910
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

The A.T.S. 4000TS 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. 4000TS is a 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 pneumatic cuff applied to a patient's limb. The device regulates pneumatic pressure to temporarily occlude blood flow. It includes an LOP (Limb Occlusion Pressure) feature to manage pressure settings. The system is operated by qualified medical professionals; output is a pressurized cuff state. Clinical benefit is the facilitation of surgical procedures by minimizing bleeding in the operative field.

Clinical Evidence

No clinical data was required or provided for this device. Substantial equivalence was established through non-clinical performance testing, including electrical safety (IEC 60601-1, 60601-1-2, 60601-1-8), software validation (IEC 62304), and usability testing (IEC 60601-1-6, IEC 62366).

Technological Characteristics

Pneumatic tourniquet system; consists of control unit and inflatable cuff. Complies with IEC 60601-1, 60601-1-2, 60601-1-8 for electrical safety and environmental conditions. Software developed per IEC 62304:2006 and AAMI/ANSI HE-75:2009. Usability testing per IEC 60601-1-6 and IEC 62366:2007.

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, and joint replacements/amputations. 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

• Zimmer® A.T.S.® 3000 Automatic Tourniquet System (K050411)

Submission Summary (Full Text)

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K123553

Page 1 of 2

200 West Ohio Avenue Dover, OH 44622 [phone]

9 2013

AUG

Image /page/0/Picture/4 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" enclosed in a circle. Below the circle, the word "zimmer" is written in a bold, sans-serif font, with all letters in lowercase.

### Summary of Safety and Effectiveness

Sponsor:

Contact Person:

Date:

Trade Name:

Product Code / Device:

Regulation Number / Description:

Predicate Device:

Device Description:

Zimmer Surgical, Inc. 200 West Ohio Avenue Dover, OH 44622

Allison Scott, RAC Regulatory Affairs Consultant Telephone: [phone] x106 [phone] Fax:

November 16, 2012

Zimmer® A.T.S. ® 4000TS Tourniquet System

KCY - Pneumatic tourniquet

21 CFR § 878.5910 - Pneumatic tourniquet

Zimmer® A.T.S.® 3000 Automatic Tourniquet System, K050411, cleared 09/02/2005

The Zimmer A.T.S. 4000TS Tourniquet System is a non-sterile device intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.

The system consists of the A.T.S. 4000TS control unit that is coupled to the patient with the applied part (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. 4000TS's connector ports.

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## Intended Use:

The A.T.S. 4000TS 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. 4000TS Automatic Tourniquet System is substantially equivalent to other legally marketed tourniquet systems, specifically the Zimmer A.T.S. 3000 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. 4000TS Automatic Tourniquet System is substantially equivalent to the Zimmer A.T.S. 3000 Tourniquet System.

Non-Clinical Performance and Conclusions:

During the development process of the AT.S. 4000TS, the following testing was completed: Electrical safety and Environmental testing in accordance with IEC 60601-1, 60601-1-2, 60601-1-8: Software and device development was conducted in accordance with requirements of IEC 62304:2006 and AAMI/ANSI HE-75:2009; Device Usability testing was conducted in accordance with requirements of IEC 60601-1-6 and IEC 62366:2007, and Hardware and Software testing, including validation. All tests passed according to predetermined acceptance criteria.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

# Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an abstract symbol, resembling a person embracing or supporting another figure. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hompshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

August 9, 2013

Allison Scott, RAC Regulatory, Affairs Consultant Zimmer Incorporated 9001 Wesleyan Road, Suite 200 Indianapolis, Indiana 46268

Re: K123553

Trade Device Name: Zimmer® A.T.S.® 4000TS Automatic Tourniquet System Regulation Number: 21 CFR 878.5910 Regulation Name: Pneumatic tourniquet Regulation Class: Class I Product Code: KCY Dated: June 27, 2013 Received: July 3, 2012

Dear Ms. Scott:

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 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) 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Allison Scott, RAC

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

## 510(k) Number (if known):

### Device Name:

Zimmer® A.T.S. ® 4000TS Tourniquet System

### Indications for Use:

The A.T.S. 4000TS 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 AND/OR Prescription Use _X_ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| DSD-DIVISION SIGN-OFF | Joshua C. Nipper | Page 15 of 3780 |
|------------------------------|------------------|-----------------|
| Division of Surgical Devices | -S | |
| 510(k) Number: | K123553 | |