The Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs are used in the management of lymphedema 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.

Device Description

The Hygia Health Services reprocessed sleeves/foot garments are compression devices that, which attached to an appropriate controller, provide intermittent, sequentially graded pressure to the patient's leg/foot for the prevention of Deep Vein Thrombosis (DVT). As the sleeves/cuffs compress the legs/feet, they 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 timing and deflation of compression is determined by the controller.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Hygia Health Services Reprocessed Sleeves/Foot Cuffs. This submission focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for a new device.

Therefore, many of the requested sections (e.g., acceptance criteria, detailed device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not explicitly present in the provided document.

However, based on the information available, here's a breakdown:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating that the reprocessed devices perform as intended and are safe and effective, consistent with their predicate devices. The "acceptance" is based on functional equivalence and safety verification rather than numerical performance thresholds.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance (Summarized)
Functional Equivalence	Device operates identically to original equipment manufacturer (OEM) devices in terms of compression mechanism, pressure delivery, and cycle.	Performs "as intended," with "sources, modes of operation, and performance characteristics no different than the original devices."
Cleaning Validation	Reprocessing effectively removes contaminants and renders the device safe for reuse.	"Cleaning validation demonstrates reprocessed cuffs perform as intended and are safe and effective."
Biocompatibility	Reprocessed materials are safe for patient contact and do not induce adverse biological reactions.	"Biocompatibility testing demonstrates reprocessed cuffs perform as intended and are safe and effective."
Intended Use	Retains the same indications for use as the predicate devices (prevention of deep vein thrombosis, treatment of lymphedema and edema).	Intended to be used "in the same manner as the predicate devices."
Safety and Effectiveness	Overall, the reprocessing process does not compromise the safety or effectiveness of the device compared to the original devices.	"Functional Testing, cleaning validation, and biocompatibility testing demonstrates reprocessed cuffs perform as intended and are safe and effective."
Substantial Equivalence	Demonstrates that the reprocessed device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness.	Conclusion: "Hygia Health Services concludes that the reprocessed sleeves are substantially equivalent to the predicate devices."

Study Details

The provided document describes a 510(k) submission, which is a regulatory pathway to demonstrate substantial equivalence to a predicate device. It does not detail a clinical study in the traditional sense with test sets, ground truth, or statistical power calculations for performance metrics as might be found for a novel AI/diagnostic device.

1. Sample Sized used for the test set and the data provenance:

Sample Size (Test Set): Not specified. The performance data section vaguely mentions "Functional Testing, cleaning validation, and biocompatibility testing." These are likely laboratory tests on a sample of reprocessed devices, but the exact number of units tested is not provided.
Data Provenance: Not specified, but generally, such tests would be conducted internally by the manufacturer. The data is retrospective in the sense that the predicate devices have established performance, and the goal is to certify the reprocessed devices meet that standard.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Experts and Qualifications: Not applicable/not specified. For this type of submission, "ground truth" refers to established performance standards for the predicate devices, and the objective is to show the reprocessed devices meet those standards through various tests. It does not involve expert consensus on medical images or clinical outcomes for a "test set" in the diagnostic sense.

3. Adjudication method for the test set:

Adjudication Method: Not applicable/not specified. No human reader review or adjudication process is mentioned for evaluating the performance of the reprocessed sleeves.

4. 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:

MRMC Study: No. This is not an AI/diagnostic device. The submission is for reprocessed medical devices (compressible limb sleeves), not an AI-powered diagnostic tool. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant and not part of this submission.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Standalone Performance: Not applicable. This document pertains to a physical medical device. There is no "algorithm only" performance to evaluate.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Ground Truth Type: For this submission, the "ground truth" is the established safety and effectiveness of the legally marketed predicate devices. The reprocessed device's performance is compared against these established characteristics through functional, cleaning, and biocompatibility tests. It does not involve "expert consensus, pathology, or outcomes data" in the context of diagnostic accuracy.

7. The sample size for the training set:

Sample Size (Training Set): Not applicable. There is no AI model being trained, so no "training set" exists.

8. How the ground truth for the training set was established:

Ground Truth Establishment (Training Set): Not applicable, as there is no training set.

Summary

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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
1. Name of Device

Classification Name:	Sleeve, Limb, Compressible
Common Name:	Compressible Limb Sleeve Device
Trade orProprietary Name:	Hygia Health Services Reprocessed Sleeves/Foot Cuffs

1. Predicate Device
  Corresponding Kendall, Aircast, and Healthcare Service and Supply Sleeves/Foot Cuffs legally marketed under various 510(k) premarket notifications:

Tyco Healthcare/Kendall	K040511
Tyco Healthcare/Kendall	K040649
Healthcare Service andSupply	K974318

Aircast, Inc.	K992454

Previous Hygia Health Services (HHS) devices which are found to be substantially equivalent:

HHS Reprocessed Kendali SCD™ Sleeves K012417

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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.

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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.

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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

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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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Regulation Number and Section

§ 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).