(74 days)
Not Found
No
The summary describes a standard mechanical tourniquet cuff and does not mention any AI or ML components or functionalities.
Yes
The device is used to restrict blood flow during surgery, which is a therapeutic intervention aimed at changing the structure or function of the body for the treatment of a condition (in this case, for surgical purposes).
No
The device description indicates that a tourniquet cuff's function is to restrict blood flow during surgery, a therapeutic action, not to diagnose a condition.
No
The device description clearly states it is composed of physical components like plastic/cloth covers, bladders, and tubes, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "restrict blood flow to a patient's limb during surgery." This is a direct intervention on the patient's body for a therapeutic purpose (facilitating surgery by creating a bloodless field).
- Device Description: The description details a physical device that applies pressure externally to a limb.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. A tourniquet cuff, while a medical device, operates on the body for a procedural purpose, not a diagnostic one.
N/A
Intended Use / Indications for Use
The intended use of a tourniquet cuff is to restrict blood flow to a patient's limb during surgery.
Product codes (comma separated list FDA assigned to the subject device)
KCY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's limb
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
MIT compared the reprocessed tourniquet cuffs to the predicate device for Physical Characteristics (Color, dimensions, damage) and Performance Characteristics (Ability to hold pressure). In all cases the reprocessed devices were substantially equivalent to the new devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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.
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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.
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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.
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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.
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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
fa
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
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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
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