(261 days)
The intended use of a compression sleeve is to aid in blood circulation in bed confined patients, to prevent deep vein thrombosis and pulmonary embolism.
The intended use of a compression sleeve is to increase venous blood flow in bed-confined patients, to prevent deep vein thrombosis and pulmonary embolism.
Compression sleeves come in 3 adjustable sizes for the leg, one size for the knee and various sizes for the foot. They 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 squeeze the blood out of the foot or leg and deflates to allow the blood to flow back into the foot or leg. On many of the machines, air pressure can be adjusted to allow for the length and thickness of the leg.
Acceptance Criteria and Device Performance Study for Reprocessed Compression Sleeves
The provided document describes the 510(k) premarket notification for Medical Instruments Technology, Inc.'s reprocessed compression sleeves, seeking substantial equivalence to the Kendall Sequential Compression Device. The study focuses on demonstrating that the reprocessed devices maintain the same functional and technological characteristics as new devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Characteristics: | |
| - Color | Reprocessed devices were substantially equivalent to new devices. |
| - Dimensions | Reprocessed devices were substantially equivalent to new devices. |
| - Damage | Reprocessed devices were substantially equivalent to new devices. |
| Performance Characteristics: | |
| - Ability to hold pressure | Reprocessed devices were substantially equivalent to the predicate device. |
| - Ability to release pressure | Reprocessed devices were substantially equivalent to the predicate device. |
| Biocompatibility: | No biocompatibility concerns exist with sequential compression devices reprocessed using MIT's procedures. |
| Technological Characteristics: | Same technological characteristics as the Kendall SCDs. Materials used in manufacture are not changed. No part affecting function is changed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the "test set" or the number of reprocessed devices subjected to detailed evaluation. It mentions "Testing by MIT has shown that the reprocessed devices are substantially equivalent..." and "MIT compared the reprocessed compression devices to the predicate device...".
The data provenance is retrospective, as the devices are reprocessed versions of existing products. The country of origin of the data is United States, as Medical Instruments Technology, Inc. is based in Saint George, UT, and the submission is to the U.S. FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. The evaluation seems to have been conducted by MIT's internal team.
4. Adjudication Method for the Test Set
The document does not describe any explicit adjudication method (e.g., 2+1, 3+1). The comparisons were made by MIT directly, implying an internal assessment rather than a formal expert panel adjudication process for discrepancies.
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
No, an MRMC comparative effectiveness study was not performed. This submission is for reprocessed medical devices, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm-only) performance study was not done. The "device" in question is a physical reprocessed medical sleeve, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for performance comparison was primarily comparison to the new, predicate device. This involved:
- Direct observation and measurement for physical characteristics (color, dimensions, damage).
- Functional testing to assess pressure holding and release capabilities, likely against manufacturer specifications or observed performance of new devices.
Essentially, the "ground truth" was defined by the characteristics and performance of the original, new devices.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here, as this is not a machine learning or AI-based device. The reprocessed devices are compared against the predicate device to demonstrate functional equivalence, not to train an algorithm.
9. How the Ground Truth for the Training Set Was Established
As the concept of a training set is not applicable, the establishment of ground truth for a training set is also not relevant to this submission.
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MAY 0-1 2002 Medical Instruments Technology, Inc's Reprocessed Compression Sleeve Premarket Notification
Medical Instruments TechnologyInc.
Quality Reprocessing and Surgical Cost Containment Systems
Section 12: 510k Summary
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.
Proprietary Name: N/A Common Name: Compression Sleeve, Sleeve, Limb, Compressible Classification: Class II per 21 CFR 870 5800 JOW
lli. Predicate Device:
MIT's reprocessed compressions sleeves are substantially equivalent to:
Kendall Sequential Compression Device, Tyco Healthcare Group LP, Mansfield, MA 02048
Description of Device IV.
Compression sleeves come in 3 adjustable sizes for the leg, one size for the knee and various sizes for the foot. They 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 squeeze the blood out of the foot or leg
385 North 3050 East St. George, Utah 86790 tust 888-673-4010 or 435-674-4010 fax: 635-676-9819
ISO 9002 ceptified. FDA registered.
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Medical Instruments Technology, Inc's Reprocessed Compression Sleeve Premarket Notification
and deflates to allow the blood to flow back into the foot or leg. On many of the machines, air pressure can be adjusted to allow for the length and thickness of the leg. Below is a list of the brand names and models that MIT reprocesses. Although different manufacturers originally make the devices, the intended use of the devices is identical.
V. Intended Use:
The intended use of a compression sleeve is to aid in blood circulation in bed confined patients, to prevent deep vein thrombosis and pulmonary embolism.
VI. Technological Characteristics:
MIT's reprocessed compression sleeves have the same technological characteristics as the Kendall SCD's. 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 SCD that might affect its function.
Testing by MIT has shown that the reprocessed devices are substantially equivalent to the predicate in performance.
VII. Blo-Compatibility:
MIT, Inc. has provided appropriate test data to demonstrate that no biocompatibility concerns exist with sequential compression devices reprocessed using MIT's procedures.
Substantial Equivalence: VIII.
Physical Characteristics: Color, dimensions, damage
MIT compared the reprocessed compression devices 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, ability to release pressure
MIT compared the reprocessed compression devices to the predicate devices (for the parameters above) and in all cases the devices were substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 1 2002
Mr. John P. Batcabe R & D Manager Medical Instruments Technology, Inc. 385 North 3050 East St. George, UT 84790
Re: K012614
Device Name: Reprocessed Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: January 29, 2002 Received: January 30, 2002
Dear Mr. Batcabe:
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.
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Page 2 - Mr. John P. Batcabe
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact 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 Division of Small Manufacturers, 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 vours,
J. D. Tulek
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K012614 |
|---|---|
| Device Name: | Reprocessed Compression Sleeves |
Indications For Use:
Medical Instruments Technology, Inc's Reprocessed Compression Sleeve Premarket Notification
Appendix 14: Indications for Use Statement
The intended use of a compression sleeve is to increase venous blood flow in bed-confined patients, to prevent deep vein thrombosis and pulmonary embolism.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012614
Prescription Use
X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
Pagc
(Optional Format 1-2-96)
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).