(100 days)
No
The device description focuses on mechanical compression and the inflation/deflation sequence is predetermined by the controller, with no mention of adaptive or learning algorithms. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is used for the "treatment of venous leg ulcers and edema" and as a "non-invasive therapeutic method for prevention of deep vein thrombosis," indicating its therapeutic purpose.
No
The device is described as a therapeutic compression device used to prevent deep vein thrombosis and treat venous leg ulcers and edema. It is not used to diagnose conditions.
No
The device description explicitly states it is a compression device consisting of sleeves/foot garments that attach to a controller, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a therapeutic method for treating conditions like venous leg ulcers, edema, and preventing deep vein thrombosis. These are all related to the physical treatment of the body, not the diagnosis of a condition through the examination of specimens derived from the human body.
- Device Description: The device description details a compression device that applies pressure to the leg/foot to improve blood flow. This is a physical intervention, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's health status.
In summary, the Hygia Health Services Reprocessed Venodyne Sleeves/Foot Cuffs are therapeutic devices used for physical treatment, not diagnostic devices used for in vitro examination of specimens.
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 predicated devices. They are designed to apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis in patients at risk. The devices are intended to be used in both the home and institutional settings on patient populations for which these devices are applicable.
The Hygia Health Services Reprocessed Venodyne Sleeves are used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency.
The Hygia Health Services Reprocessed Venodyne Sleeves are also a non-invasive therapeutic method for prevention of deep vein thrombosis.
The Hygia Health Services Reprocessed CTC VasoPress Compression Sleeves are used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.
The Hygia Health Services Reprocessed Venodyne Foot Cuffs are used in the treatment of venous leg / foot ulcers and edema which are disorders associated with venous insufficiency.
The Hygia Health Services Reprocessed Venodyne Foot Cuffs are also a non-invasive 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 that, when attached to an approved controller, provide intermittent, sequentially gradient pressure to a patient's leg/foot for the prevention of Deep Vein Thrombosis (DVT). As the sleeves/cuffs compress the legs/feet, veins 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 inflation and deflation sequence is predetermined by the product's specific controller. The pressure 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
leg/foot, lower limbs, legs/feet
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home and institutional settings
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 that the reprocessed sleeves/foot 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.
K061967, K061814, K000147, K022786, K010744, K974318, K011318, K001802, K930526
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.
K053575, K012417, K012654, K012651
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
pg 1 of 2
510(k) Summary
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
APR 2 2 2009
Date Prepared: November 26, 2008
- Contact Person
Jerome James Director, R&D Phone: (205) 314-3920 Fax: (205) 314-3959 Email: jerry.james@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 CTC and Venodyne Compression Sleeves/Foot Cuffs legally marketed under various 510(k) premarket notifications:
| K061967 | Compression Therapy Concepts |
|---|---|
| K061814 | Compression Therapy Concepts |
| K000147 | Compression Therapy Concepts |
| K022786 | Huntleigh Healthcare |
| K010744 | Huntleigh Healthcare |
| K974318 | Healthcare Services and Supply |
| K011318 | Microtek Medical, Inc. |
| K001802 | Microtek Medical, Inc. |
| K930526 | Microtek Medical, Inc. |
1
K090074
Pg 2 of 2
Previous Hygia Health Services (HHS) devices which are found to be substantially equivalent:
| HHS Reprocessed Sleeves/Foot Cuffs | K053575 |
|---|---|
| HHS Reprocessed Kendall SCD™ Sleeves | K012417 |
| HHS Reprocessed Huntleigh Flowtron® | K012654 |
| HHS Reprocessed Huntleigh Foot Cuff | K012651 |
4. Device Description
The Hygia Health Services reprocessed sleeves/foot garments are compression devices that, when attached to an approved controller, provide intermittent, sequentially gradient pressure to a patient's leg/foot for the prevention of Deep Vein Thrombosis (DVT). As the sleeves/cuffs compress the legs/feet, veins 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 inflation and deflation sequence is predetermined by the product's specific controller. The pressure of compression is determined by the controller.
5. Device Intended Use
The Hygia Health Services reprocessed sleeves/foot garments are intended to be used in the same manner as the predicated devices. They are designed to apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis in patients at risk. The devices are intended to be used in both the home and institutional settings on patient populations for which these devices are applicable.
6. Technological Characteristics
The Hygia Health Services reprocessed sleeves/foot garments are identical to the original OEM devices in reference to the technological characteristics. The overall designs, materials, energy 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 that the reprocessed sleeves/foot cuffs perform as intended and are safe and effective.
8. Conclusion
Based on the assessment of functional testing, cleaning validation, and biocompatibility testing performed, Hygia Health Services concludes that the Hygia Health Services reprocessed sleeves/foot cuffs are substantially equivalent to the predicate devices.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2009
Hygia Health Services, Inc. c/o Mr. Jerome James Director of R&D 434 Industrial Lane Birmingham, AL 35211
Re: K090074
Hygia Health Services Reprocessed Venodyne Sleeves & Foot Cuffs and CTC VasoPress Compression Sleeves Regulation Number: 21 CFR §870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II Product Code: JOW Dated: December 31, 2008 Received: January 12, 2009
Dear Mr. James:
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 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. Jerome James
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
C
Bram D. Zuckerman, M.D. Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K090074
Applicant: Hygia Health Services, Inc. 434 Industrial Lane Birmingham, AL 35211
Classification: Class II, 870.5800 Product Code: JOW Common Name: Compressible Limb Sleeve
Device Name: Hygia Health Services (HHS) Reprocessed Venodyne Sleeves Hygia Health Services (HHS) Reprocessed Venodyne Foot Cuffs Hygia Health Services (HHS) Reprocessed CTC VasoPress Compression Sleeves
| OEM Catalog # | Hygia Catalog # | Product Description | Max. #
Reprocessing
Cycles |
|---------------|-----------------|--------------------------------|----------------------------------|
| V3012 | HHS-V3012 | Venodyne Sleeve Size 12"-16" | 10 |
| V3014 | HHS-V3014 | Venodyne Sleeve Size 14"-18" | 10 |
| V3022 | HHS-V3022 | Venodyne Sleeve Size 14"-20.5" | 10 |
| V3026 | HHS-V3026 | Venodyne Sleeve Size 14"-24" | 10 |
| V6010 | HHS-V6010 | Venodyne Foot Cuff | 10 |
| VP501M | HHS-VP501M | VasoPress Calf Garment, Med. | 5 |
| VP501L | HHS-VP501L | VasoPress Calf Garment, Lg | 5 |
| VP530M | HHS-VP530M | VasoPress Thigh Garment, Med. | 5 |
| VP530L | HHS-VP530L | VasoPress Thigh Garment, Lg | 5 |
5
Indications for Use
510(k) Number (if known): _