(197 days)
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 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. 3000 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. 3000's connector ports.
The Zimmer A.T.S. 3000 Automatic Tourniquet System is a non-sterile device designed to temporarily occlude blood flow in a patient's extremities during surgical procedures. The device was found to be substantially equivalent to other legally marketed tourniquet systems (Richards Pressure Sentry Tourniquet and Zimmer A.T.S. 2000 Tourniquet System), and its LOP feature was found substantially equivalent to the Medasonics Versatone D9 stethoscope.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Predicate Equivalence | Substantially equivalent to existing devices in design, materials, and indications for use. | The device is substantially equivalent to the Richards Pressure Sentry Tourniquet and the Zimmer A.T.S. 2000 Tourniquet System. The LOP feature is substantially equivalent to the Medasonics Versatone D9 stethoscope. |
| Applicable Standards | Meets applicable sections of "Guidance for FDA Reviewers and Industry," May 29, 1998. | The device meets applicable sections of this guidance document. |
| Meets ANSI/AAMI/ISO 10993-1:1997, "Biological evaluation of Medical Devices." | The device meets this standard. | |
| Performance Testing | Electrical safety | Testing completed. |
| Hardware and Software | Testing completed. | |
| Software validation | Validation completed. | |
| Environmental testing | Testing completed. | |
| Performance testing | Testing completed. | |
| Risk Analysis | Risk analysis conducted. | Risk analysis completed. |
| Clinical Performance | Clinical data requirements | Clinical data and conclusions were not needed for this device due to its substantial equivalence to established predicate devices and the nature of the device (temporary occlusion of blood flow, well-understood mechanism). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly mention a "test set" in the context of clinical data for performance evaluation because it states that clinical data and conclusions were not needed for this device.
The performance assessment was based on non-clinical testing and comparison to predicate devices. Therefore, details like sample size, provenance, retrospection/prospection are not applicable for a traditional clinical "test set" in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as clinical data and a "test set" requiring expert ground truth were not used for device acceptance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as clinical data and a "test set" requiring adjudication were not used for device acceptance.
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 device is a pneumatic tourniquet system, not an AI-assisted diagnostic or interpretative tool that would involve multi-reader multi-case studies or AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to a physical medical device like a pneumatic tourniquet system. There is no "algorithm only" performance to evaluate in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance, the "ground truth" was established by compliance with recognized standards and guidance documents (e.g., "Guidance for FDA Reviewers and Industry," ANSI/AAMI/ISO 10993-1:1997), and through established engineering and safety testing protocols. The substantial equivalence to predicate devices also serves as a baseline for expected performance and safety, derived from their long-standing use and acceptance in the medical field.
8. The sample size for the training set
Not applicable. This device is a physical medical device and does not involve AI or machine learning models that would require a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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SEP 0 2 2005
1
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string begins with a capital letter 'K', followed by the numbers '050411'. The numbers are written in a clear and legible manner. The handwriting appears to be casual and the characters are spaced evenly.
Summary of Safety and Effectiveness
| Submitter: | Zimmer Orthopaedic Surgical Products200 West Ohio AvenueP.O. Box 10Dover, Ohio 44622 |
|---|---|
| Contact Person: | Cindy J. DickeyRegulatory Compliance ManagerTelephone: (330) 364-9493Fax: (330) 364-9490 |
| Date: | February 14, 2005 |
| Trade Name: | ZIMMER A.T.S. 3000 AUTOMATICTOURNIQUET SYSTEM |
| Common Name: | Tourniquet, Pneumatic |
| Classification Nameand Reference: | Tourniquet, Pneumatic21 CFR § 878.5910 |
| Predicate Devices: | Richards Pressure Sentry Tourniquet, manufacturedby Richards Medical, K840206, cleared April 25,1984. |
| Zimmer A. T.S. 2000 Tourniquet System,manufactured by Zimmer Orthopaedic SurgicalProducts, Class 1 Exempt. | |
| Versatone D9 stethoscope, manufactured byMedasonics, preamendment device. | |
| Device Description: | The Zimmer A. T.S. 3000 AutomaticTourniquet System is a non-sterile device intendedto be used by qualified medical professionals totemporarily occlude blood flow in a patient'sextremities during surgical procedures on thoseextremities. |
| The system consists of the A.T.S. 3000 control unitthat 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 (240) 217-0115. 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 (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free anain html Manufacturers, International and Collisation Assistance and Consults.
(301) 443-6597 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
§ 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.