(55 days)
No
The description focuses on mechanical compression and mentions the timing and deflation are determined by a controller, with no indication of AI/ML being used for decision-making or analysis.
Yes
The device is used for the "management of lymphedema and edema" and for the "prevention of deep vein thrombosis," which are therapeutic applications.
No
The device is described as a therapeutic compression device for managing lymphedema, edema, and preventing deep vein thrombosis, not for diagnosing conditions.
No
The device description clearly states it is a compression device consisting of sleeves/foot garments that attach to a controller, indicating a physical hardware component. The summary of performance studies also mentions functional testing, cleaning validation, and biocompatibility testing, which are typical for physical medical devices, not software-only devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for the management of lymphedema and edema, and the prevention of deep vein thrombosis. These are therapeutic and preventative applications, not diagnostic ones.
- Device Description: The device description details a mechanical compression system that applies pressure to the legs/feet to aid blood flow. This is a physical intervention, not a test performed on biological samples to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Hygia Health Services reprocessed sleeves/foot garments are intended to be used in the same manner as the predicate devices. They are designed to apply intermittent pneumatte compression to the lower limbs to help prevent deep vein thrombosis in patients at risk. There are no contraindications where the applicable.
The Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs are used in the treatment of chronic venous stasis ulcers and edema which are disorders associated with venous insufficiency.
The Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The Hygia Health Services reprocessed sleeves/foot garments are compression devices, which attached to an appro [sic] re's [sic] controller, provide intermittent, sequentially graduated pressure to e [sic] re's [sic] leg/foot for the prevention of Deep veins vem Thromoosis [sic] (DVT). As the sleeves/cuffs compress the legs/feet, collapse, forcing the blood to move upward towards the heart. After compression, the sleeves/cuffs deflate which allows the veins to reopen and bring oxygenated blood to the region. The mination [sic] and deliation [sic] of compression is determined by the controller.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs, leg/foot
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)
Functional Testing, cleaning validation, and biocompatibility testing demonstrates r [sic] unctional Testing, creating [sic] var cuffs perform as intended and are safe and effective.
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.
K040511, K040649, K974318, K992454
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.
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
FEB 1 5 2006
510(k) Summary
K 053575
In accordance with 21 CFR Part 807.92, this summary is submitted by:
Hygia Health Services, Inc. 434 Industrial Lane Birmingham, Alabama 35211 Phone: (205) 314-3920 Fax: (205) 314-3959
Date Prepared: December 19, 2005
-
Contact Person 1 .
Mr. Kyle Ferguson R&D Director Phone: (205) 314-3920 Fax: (205) 314-3959 Email: kyle ferguson@hygia.net -
- Name of Device
| Classification Name: | Sleeve, Limb, Compressible |
|---|---|
| Common Name: | Compressible Limb Sleeve Device |
| Trade or | |
| Proprietary Name: | Hygia Health Services Reprocessed Sleeves/Foot Cuffs |
-
- Predicate Device
Corresponding Kendall, Aircast, and Healthcare Service and Supply Sleeves/Foot Cuffs legally marketed under various 510(k) premarket notifications:
- Predicate Device
| Tyco Healthcare/Kendall | K040511 |
|---|---|
| Tyco Healthcare/Kendall | K040649 |
| Healthcare Service and | |
| Supply | K974318 |
| Aircast, Inc. | K992454 |
Previous Hygia Health Services (HHS) devices which are found to be substantially equivalent:
HHS Reprocessed Kendali SCD™ Sleeves K012417
1
| HHS Reprocessed Huntleigh Flowtron® | K012654 |
|---|---|
| HHS Reprocessed Novamedix Impad® | K021509 |
Device Description 4.
The Hygia Health Services reprocessed sleeves/foot garments are compression The Hygia Ficann Scriveds reproved controller, provide intermittent, devices that, which attactica to an appro re's leg/foot for the prevention of Deep sequentially gradion prossare to e sleeves/cuffs compress the legs/feet, veins vem Thromoosis (DVT). As the slectrosreations ords the heart. After compression,
collapse, forcing the blood to move upward towards the heart. After compression, conapse, forcing the blood to move ap-has to reopen and bring oxygenated
the sleeves/cuffs deflate which allows the veins to reopen and bring wines by a the sleeves/curls deflate whilen and deflation sequence is predetermined by the blood to the region. The mination and deliation of compression is determined by the controller.
5. Device Intended Use
The Hygia Health Services reprocessed sleeves/foot garments are intended to be The Frygia Health Del rioco reprevedicated devices. They are designed to apply used in the Same mainer as the predication to the lower limbs to help prevent deep vein
the same micrinttein pilculiare compressee are intended to be used in both the thrombosis in patients at fish - There - The applicable.
Technological Characteristics 6.
The Hygia Health Services reprocessed sleeves/foot garments are identical to the The Trygin Freann Des in reference to the technological characteristics. The original OLM devices in references sources, modes of operation, and performance characteristics are no different than the original devices.
7. Performance Data
Functional Testing, cleaning validation, and biocompatibility testing demonstrates r unctional Testing, creating var cuffs perform as intended and are safe and effective.
Conclusion 8.
Based on the assessment of functional testing, cleaning validation, and Dasca on the ussessment or farmed, Hygia Health Services concludes that the blocompatibility tobility tobally and and the to the predicate devices.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2006
Hygia Health Services c/o Mr. Kyle Ferguson 434 Industrial Lane Birmingham, Alabama 35211
Re: K053575
K03375
Hygia Health Services Reprocessed Sleeves/Foot Cuffs Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (Two) Product Code: JOW Dated: December 19, 2005 Received: December 23, 2005
Dear Mr. Ferguson:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 710(x) prematice is substantially equivalent (for the indications
referenced above and have determined the device marketed in interstate referenced and nave decemined the arrived the devices marketed in interstate for use stated in the enclosure) to regally mancede prouver and Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food Drug commerce prior to May 28, 1970, the charge with the provisions of the Federal Food, Drug, devices that have been reciassince in accordance while approval approval applications (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, listing of You may, therefore, market the device, subject to tire generat michrending and general controls provisions of the Fet merator required in the magainst 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) mio exist case in cregulations affecting your device can
may be subject to such additional controls. Existing major regulations affe may be subject to such additional controlis. Extremgion of 898 In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Pederal Regarders in the Federal Register.
3
Page 2 - Mr. Kyle Ferguson
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 or any I 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 OFF Part 807), its ensigned (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 premance medicate 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/indcx.html.
Sincerely yours,
R. Z. A., M.D.
Bram D Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_K053575
Device Name: Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs
Indications For Use:
The Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs are used in the The Trygia Health Octvlood Reprosessor and edema which are disorders associated with venous insufficiency.
The Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K053575 |
|---|---|
| --------------- | --------- |
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