(261 days)
Not Found
Not Found
No
The description focuses on mechanical compression and pressure adjustment, with no mention of AI/ML terms or functionalities.
Yes
The device is intended to aid in blood circulation, prevent deep vein thrombosis, and pulmonary embolism, which are therapeutic interventions for bed-confined patients.
No
Explanation: The device, a compression sleeve, is described as aiding in blood circulation and preventing deep vein thrombosis and pulmonary embolism by physically compressing limbs. Its function is to provide therapy (compression) rather than to diagnose medical conditions by collecting or analyzing data about the patient's state.
No
The device description explicitly mentions physical components like plastic/cloth covers, plastic/rubber bladders, plastic tubes, and a compressor, indicating it is a hardware device with potential software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid in blood circulation and prevent deep vein thrombosis and pulmonary embolism in bed-confined patients. This is a therapeutic and preventative function performed directly on the patient's body.
- Device Description: The device description details a mechanical system involving compression sleeves, bladders, tubes, and a compressor. This is a physical device that applies external pressure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on biological samples outside of the body to provide diagnostic or other health-related information. This compression sleeve operates on the body for a therapeutic and preventative purpose.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg, foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
bed confined patients
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)
Testing by MIT has shown that the reprocessed devices are substantially equivalent to the predicate in performance.
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.
MIT compared the reprocessed compression devices to the predicate devices (for the parameters above) and in all cases the devices were substantially equivalent.
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.
Kendall Sequential Compression Device
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
§ 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).
0
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.
1
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.
2
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.
3
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
4
| 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)