Tourniquet cuffs are composed of either a plastic or cloth cover, over one or more plastic or rubber bladders. There are one or more plastic tubes leading from the bladder to a connector that attaches to a compressor. All work on the same principal, a compressor inflates the bladder(s) with air to restrict the blood flow in the limb during surgery.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for Medical Instruments Technology, Inc.'s reprocessed tourniquet cuffs:

Acceptance Criteria and Device Performance Study for Reprocessed Tourniquet Cuffs

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Physical Characteristics:	Reprocessed devices were "substantially equivalent" to new devices.
- Color	(Implicitly met, as "substantially equivalent")
- Dimensions	(Implicitly met, as "substantially equivalent")
- Damage	(Implicitly met, as "substantially equivalent")
Performance Characteristics:	Reprocessed devices were "substantially equivalent" to new devices.
- Ability to hold pressure	(Implicitly met, as "substantially equivalent")
Bio-compatibility & Cleanliness:	Met.
- Freedom from residual bioburden	Achieved through washing procedure utilizing chosen cleaning agents.
- Freedom from residual cleansers	Achieved through rinsing after washing.
- Continued cleanliness	Achieved by packaging in an environmentally controlled room.
Sterilization & ETO Residuals:	Met.
- Sterilization system validation	ETO sterilization system validated.
- Acceptable residual ETO levels	Residual ETO testing performed and reduced to an acceptable level.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set. It broadly refers to "reprocessed tourniquet cuffs" and "the predicate device" during comparisons.

The data provenance is internal to Medical Instruments Technology, Inc. and is retrospective, as the testing was performed on their reprocessed devices and compared against an existing predicate device (Instrumed, Color Cuff K890014).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for the test set in the traditional sense of clinical or diagnostic evaluation. The assessments seem to be engineering and performance-based comparisons conducted by MIT.

4. Adjudication Method

The document does not describe an adjudication method for the test set, as there is no indication of multiple reviewers or differing interpretations of results requiring resolution. The evaluation appears to be a direct comparison against pre-defined parameters by MIT staff.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically relevant for diagnostic imaging or interpretation tasks where human readers make assessments. The device in question is a reprocessed medical instrument, and the evaluation focuses on its physical and performance characteristics, not human reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The entire evaluation described is a standalone assessment of the reprocessed device's physical and performance characteristics, comparing it directly to the predicate device without human-in-the-loop performance being a factor. The "algorithm" here is the reprocessing procedure and subsequent quality checks, which are evaluated on their own merits.

7. Type of Ground Truth Used

The "ground truth" for the test set was essentially the characteristics and performance of the new predicate device (Instrumed Color Cuff K890014). The reprocessed cuffs were evaluated for "substantial equivalence" against this established benchmark.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of device evaluation. This concept is typically associated with machine learning or AI models. The evaluation here is for a physical medical device, not a software algorithm that would require training data.

9. How the Ground Truth for the Training Set Was Established

As there is no training set mentioned or implied, the method for establishing its ground truth is not applicable.

Summary

{0}------------------------------------------------

Medical Instruments Technology, Inc's Reprocessed Tourniquet Cuffs Premarket Notification

Medical Instruments Technologyme

Quality Reprocessing and Surgical Cost Containment Systems

Section 12: 510k Summary

l, Name of Submitter

Medical Instruments Technology, Inc. 385 North 3050 East Saint George, UT 84790 Tel: (435) 674-4010 Fax: (435) 674-9819

Contact persons: Tom Haueter, RA/QA Manager Crystal Batcabe, Assistant RA/QA Manager

Summary Prepared August 10, 2001

Device name and Classification: II.

Common Name: Tourniquet cuff, Sleeve, Limb, Compressible Classification: Class II per 21 CFR 878.5910

III. Predicate Device:

MIT's reprocessed compressions cuffs are substantially equivalent to: Instrumed, Color Cuff (K890014)

IV. Description of Device

{1}------------------------------------------------

V. Intended Use:

The intended use of a tourniquet cuff is to restrict blood flow to a patient's limb during surgery.

VI. Technological Characteristics:

MIT's reprocessed tourniquet cuffs have the same technological characteristics as the Instrumed Color Cuffs (K890014). The materials used in the manufacture of the garments are not changed during the reprocessing process. Additionally, MIT does not change any part of the cuff that might affect its function.

Testing by MIT has shown that the reprocessed devices are substantially equivalent to the predicate in performance.

VII. Bio-Compatibility:

Because MIT does not change any of the materials in reprocessing, the biocompatibility of MIT's reprocessed tourniquet cuffs is equivalent to the original manufacturers'. MIT does wash the tourniquet cuffs to ensure that they are free of residual bioburden. The washing procedure utilizes cleaning agents, which have been chosen for their safety and effectiveness. MIT rinses all of the tourniquet cuffs after washing to ensure that no residual cleansers remain. Additionally, MIT packages the devices in an environmentally controlled room to ensure continued cleanliness of the devices.

MIT has validated the ETO sterilization system used. Additionally, MIT has performed residual ETO testing to ensure that residual ETO has been reduced to an acceptable level.

{2}------------------------------------------------

Medical Instruments Technology, Inc's Reprocessed Tourniquet Cuffs Premarket Notification

Substantial Equivalence: VIII.

Physical Characteristics: Color, dimensions, damage

MIT compared the reprocessed tourniquet cuffs to the predicate device for the parameters above. In all cases the reprocessed devices were substantially equivalent to the new devices.

Performance Characteristics: Ability to hold pressure

MIT compared the reprocessed tourniquet cuffs to the predicate devices (for the parameters above) and in all cases the devices were substantially equivalent.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol resembling an eagle or bird with three stylized wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 2001

Mr. Jack Speer President Medical Instruments Technology, Inc. 385 North 3050 East St. George. Utah 84790

Re: K012632

Trade/Device Name: Reprocessed Pneumatic Tourniquet Cuffs Regulation Number: 878.5910 Regulation Name: Pneumatic tourniquet Regulatory Class: I Product Code: KCY Dated: August 10, 2001 Received: August 13, 2001

Dear Mr. Speer :

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

{4}------------------------------------------------

Page 2 - Mr. Jack Speer

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis leter will and in your e FDA finding of substantial equivalence of your device to a legally promated predicated 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 additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 27 - 4 the Office of Compliance at (301) 594-4639. 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 Outler general misticales, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susa Web

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

{5}------------------------------------------------

KD12632 Medical Instruments Technology, Inc's Reprocessed Tourniquet Cuffs Premarket Notification Section 14:

Indications for Use Statement

The intended use of a tourniquet cuff is to restrict blood flow to a patient's limb during surgery.

I certify that, in my capacity as PRESIDENT of MEDICAL INSTRUMENTS TECHNOLOGY, INC., the indications for use stated above are accurate and that the device will not be marketed for any other indications for use.

Jack Jones
(Signature)

Jack Speer, President MIT, Inc. (Typed Name)

8-10-01
(Date)

Date)

Division Sign Off

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

510(k) Number K012632

Regulation Number and Section

§ 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.