(263 days)
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
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.
The provided text describes a medical device, the Zimmer A.T.S. 4000TS Tourniquet System, and its regulatory submission. However, it does not contain the specific information requested about acceptance criteria for device performance and a study proving the device meets those criteria, particularly in the context of an AI/algorithm-based device.
The document states that the device 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". It is a pneumatic tourniquet.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
- Missing. The document mentions "predetermined acceptance criteria" were met for various tests (Electrical safety, Environmental, Software, Usability, Hardware, and Software validation), but it does not specify what those criteria were or detail the reported performance against them. This is a pneumatic tourniquet, not an AI/algorithm-based diagnostic device, so typical metrics like sensitivity, specificity, or AUC are not applicable here.
2. Sample size used for the test set and the data provenance:
- Not applicable. This device is a pneumatic tourniquet system, not a diagnostic or AI-based device that would typically involve test sets of patient data. The "testing" referred to in the document is for hardware, software, electrical safety, usability, etc., not for analyzing patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. See point 2.
4. Adjudication method for the test set:
- Not applicable. See point 2.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware and software system for controlling a pneumatic tourniquet, not a standalone AI algorithm for diagnosis or interpretation.
7. The type of ground truth used:
- Not applicable for performance validation in the AI/data sense. The "ground truth" for this device would relate to the accuracy and reliability of its mechanical and software functions (e.g., pressure regulation, alarm functionality). These are typically validated through engineering tests and simulations, not patient data ground truth.
8. The sample size for the training set:
- Not applicable. The device's software and hardware undergo development and testing, not "training" in the machine learning sense.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
Summary of what the document does state about performance and testing:
- Non-Clinical Performance and Conclusions:
- During development, 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 conducted in accordance with IEC 62304:2006 and AAMI/ANSI HE-75:2009.
- Device Usability testing conducted in accordance with IEC 60601-1-6 and IEC 62366:2007.
- Hardware and Software testing, including validation.
- Conclusion: "All tests passed according to predetermined acceptance criteria." (Specific criteria and performance details are not provided).
- During development, the following testing was completed:
- Clinical Performance and Conclusions:
- "Clinical data and conclusions were not needed for this device." This statement is crucial and indicates that no human clinical study was conducted to demonstrate safety or effectiveness for this 510(k) submission, likely because it was deemed substantially equivalent to a predicate device based on its design and non-clinical performance.
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200 West Ohio Avenue Dover, OH 44622 (330) 364-0981
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: (317) 569-9500 x106 (317) 569-9520 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 |
§ 878.5910 Pneumatic tourniquet.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.