The Hygia Health Services Reprocessed Huntleigh Foot Wrap is designed to enhance the circulation of blood in the veins and arterioles. It is to be used by patient's in both the home and institutional settings as a non-invasive therapeutic method to prevent:

Deep vein thrombosis
Reduce wound healing time
Treat and assist healing of venous leg ulcers
Reduce edema caused by venous insufficiency in the lower extremities
Decrease compartmental pressures

Device Description

The Hygia Health Services Reprocessed Huntleigh Foot Wrap Garment is a compressible limb device that is placed around the patient's foot and when attached to an approved controller, provides intermittent pneumatic compression. The garment is constructed out of brushed nylon with a polyester foam lining. The single bladder is constructed out of the garment itself using an internal polymer coating that provides an airtight surface. The garment does not use an inflation chamber of poly vinyl chloride (PVC). The inflation/deflation tube is however, composed of PVC. The hook fasteners are made of polyethylene. The tube terminates in a snap lock connector. The garments are placed around the foot at the area of the plantar arch and secured with a hook and loop fastener. As the garment compresses the plantar plexus, the veins collapse longitudinally, which increases the venous pressure thus ejecting the blood upward. After compression. the devices deflate allowing the veins to refill and bring oxygenated blood to the lower limbs. The controller predetermines the inflation and deflation sequence. The pressure of compression is determined by the controller and is adjusted by altering the readout on the controller.

AI/ML Overview

The provided 510(k) summary for the Hygia Health Services Reprocessed Huntleigh Foot Wrap does not contain detailed information regarding acceptance criteria, specific performance metrics with numerical results, or the methodology of a formal study with a test set, ground truth establishment, or expert involvement as described in your request.

The submission focuses on demonstrating "substantial equivalence" to a predicate device based on nonclinical comparative bench testing. This type of submission relies on showing that the reprocessed device performs similarly to the original, rather than establishing de novo performance against a set of predefined clinical acceptance criteria.

However, I can extract the available information and, where specific details are missing, state that they are not present in the provided document.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied by Substantial Equivalence Claim)	Reported Device Performance (from "Performance Data" and "Test Conclusions")
Functional and operational performance characteristics (including inflation/deflation control, timing sequence)	"All tests found that functional and operational performance characteristics including round that renotional acontrol, timing sequence... were substantially equivalent."
Safety parameters	"All tests found that... both safety... parameters used when connected to a controller were substantially equivalent."
Operational parameters	"All tests found that... operational parameters used when connected to a controller were substantially equivalent."
Efficacy (not directly tested, but implied by substantial equivalence to predicate)	"The Hygia Health Services HLD protocol does not alter the device's efficacy, safety, composition, or intended use." (A statement, not a measured performance metric)
Safety (not directly tested, but implied by substantial equivalence to predicate)	"The Hygia Health Services HLD protocol does not alter the device's efficacy, safety, composition, or intended use." (A statement, not a measured performance metric)
Composition (not directly tested, but implied by substantial equivalence to predicate)	"The Hygia Health Services HLD protocol does not alter the device's efficacy, safety, composition, or intended use." (A statement, not a measured performance metric)
Intended Use (not directly tested, but implied by substantial equivalence to predicate)	"The Hygia Health Services HLD protocol does not alter the device's efficacy, safety, composition, or intended use." (A statement, not a measured performance metric)

Note: The document only states that the reprocessed device was found "substantially equivalent" to the predicate device in these areas, without specifying numerical acceptance criteria for each characteristic or providing quantitative performance data.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not specified. The document mentions "comparative bench testing" but does not detail the number of units or test conditions used.
Data Provenance: The nature of "bench testing" implies laboratory-based data, which is neither retrospective nor prospective in the clinical sense. No country of origin for the data is mentioned, but the submitting company is based in Alabama, USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Number of Experts: Not applicable. Bench testing does not involve establishing ground truth through expert review in the way clinical studies often do. The "ground truth" for bench testing would be the measured properties of the predicate device.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, not for nonclinical bench testing as described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

MRMC Study: No. The document describes nonclinical comparative bench testing, not a clinical MRMC study.
Effect Size of Human Readers: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Standalone Performance: Not applicable. This device is a physical, reprocessed medical garment, not a software algorithm. Its performance is inherent to its physical properties and function when connected to a controller, not a standalone algorithmic output.

7. The Type of Ground Truth Used:

Type of Ground Truth: For the "comparative bench testing," the implicit ground truth was the established functional and operational characteristics of the predicate device (the original Huntleigh Foot Wrap Garment). The reprocessed device was compared against the original to demonstrate similarity.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. There is no mention of a "training set" as this is not an artificial intelligence or machine learning device. The "training" for the reprocessing protocol itself would be the validation studies for the "scientifically validated thermal kill pasteurization process," but details on that are not provided in terms of a "training set."

9. How the Ground Truth for the Training Set Was Established:

How Ground Truth for Training Set Was Established: Not applicable. As there is no training set in the AI/ML context, this question is not relevant to the described device. The device's "training" relates to the validation of its reprocessing method, which is stated to be a "scientifically validated thermal kill pasteurization process," but the details of this validation (including how ground truth for its effectiveness was established) are not part of this 510(k) summary.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Hygia Health Services. On the left is a black square with three white concentric circles inside. To the right of the square is the word "HYGIA" in large, bold, black letters, with the words "HEALTH SERVICES" in smaller letters underneath.

K012651

8-1

APR 1 2 2002

510(k) Summary

Summary

Substantial Equivalence Summary for the Hygia Health Services Reprocessed Huntleigh Foot Wrap.

In accordance with 21 CFR Part 807.92, this summary is submitted by:

Hygia Health Services, Inc. 2800 Milan Court Suite 259 Birmingham, Alabama 35211

Date: August 6, 2001

】. Contact Person

Geoff M. Fatzinger Director, Compliance and Regulatory Affairs (205) 943-6670

2. Name of Device

Classification Name: Compressible Limb Sleeve Common or Usual Name: Intermittent Pneumatic Compressible Limb Sleeve Review Panel: Cardiovascular Classification: Class II Proprietary Name: Hygia Health Services Reprocessed Huntleigh Foot Wrap.

HYGIA HEALTH SERVICES

M | L A N | C O U R T 2 8 0 0 2 0 5 - 9 4 3 - 6 6 7 0 V O | C E ・ 2 0 5 - 9 4 3 - 6 6 7 1 F A X

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Image /page/1/Picture/0 description: The image contains a logo for Hygia Health Services. The logo features a stylized symbol on the left, resembling interconnected circles within a square. To the right of the symbol, the word "HYGIA" is written in a bold, sans-serif font, and below it, the words "HEALTH SERVICES" are written in a smaller, lighter font.

Predicate Device 3.

Classification Name: Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sleeve Common Name: Class II Classification: Huntleigh Foot Wrap Garment Proprietary Name:

Statement of Substantial Equivalence 4.

The Hygia Health Services Reprocessed Huntleigh Foot Wrap employs no new technology other than the method used to reprocess the garment in order to allow the device to be utilized more than once. The Hygia Health Services Reprocessed Huntleigh Foot Wrap is substantially equivalent to the Huntleigh Foot Wrap Garment in that the basis of operation for both of the devices is the intermittent inflation of a single bladder, which is placed around the patient's plantar arch. The sleeves are then connected to a controller. Inflation of the device is accomplished using ambient air, and a controller cycle that functions to alternately inflate and deflate the sleeves in a predetermined manner and interval.

The Hygia Health Services Reprocessed Huntleigh Foot Wrap is substantially equivalent in function, operating parameters, and intended use to the Huntleigh Foot Wrap Garment that is currently commercially available and in distribution. The predicate device, the Huntleigh Foot Wrap, is marked for "single-patient use only". Hygia Health Services does not change the device in any way except to render the device "reusable" by placing it through a scientifically validated thermal kill pasteurization process. The Hygia Health Services HLD protocol does not alter the device's efficacy, safety, composition, or intended use.

Description of the Device న.

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Image /page/2/Picture/0 description: The image shows the logo for Hygia Health Services. The logo consists of a black square with three white concentric circles on the left, followed by the word "HYGIA" in large, bold, black letters. Below the word "HYGIA" are the words "HEALTH SERVICES" in smaller, thinner, black letters.

lower limbs. The controller predetermines the inflation and deflation sequence. The pressure of compression is determined by the controller and is adjusted by altering the readout on the controller.

Intended Use of Device 6.

The Hygia Health Services Reprocessed Huntleigh Foot Wrap operates in the identical manner as the predicate device, the Huntleigh Foot Wrap Garment. It is designed to apply compression to a patient's plantar plexus for the prevention of both deep vein thrombosis (DVT) as well as the treatment of edema secondary to venous insufficiency. The devices are used in both the home and institutional settings on patient populations for which a leg or calf compression device would not be applicable.

Technological Characteristics 7.

The technological characteristics of the Hygia Health Services Reprocessed Huntleigh Foot Wrap are identical to the original Huntleigh Foot Wrap Garment in overall design, materials, energy source, mode of operation, and performance characteristics.

Performance Data 8.

Nonclinical Tests- Comparative bench testing was utilized to assess and prove similarity of function between the Hygia Health Services Reprocessed Huntleigh Foot Wrap and the predicate device, the Huntleigh Foot Wrap Garment. All tests found that functional and operational performance characteristics including round that renotional acontrol, timing sequence, and both safety and operational parameters used when connected to a controller were substantially equivalent.

Test Conclusions- Nonclinical test results of the Hygia Health Services Reveocessed Huntleigh Foot Wrap indicated substantial equivalence in all aspects to the predicate device, the Huntleigh Foot Wrap Garment.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2002

Mr. Geoff M. Fatzinger, BS MS Director, Compliance and Regulatory Affairs c/o Hygia Health Services, Inc. 2800 Milan Court, Suite 259 Birmingham, AL 35211

K012651 Re:

Trade Name: Hygia Health Services Reprocessed Huntleigh Foot Wrap Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: February 7, 2002 Received: February 8, 2002

Dear Mr. Fatzinger:

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.

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

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Page 2 - Mr. Geoff M. Fatzinger, BS MS

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quians by some (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) I mis letter wifi anow your to FDA finding of substantial equivalence of your device to a legally prematicate 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 Compliation at (301) 29 - - t the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation onlined, "Thisoranang or esponsibilities under the Act may be obtained from the Oiner general 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 yours,

Nekatuk

onna-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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Indications For Use

Applicant: Hygia Health Services, Inc.

510(k) Number:

Device Name: Hygia Health Services Reprocessed Huntleigh Foot Wrap

Indications For Use:

The Hygia Health Services Reprocessed Huntleigh Foot Wrap is designed to enhance The Trygia Iteann Ber Hees Repressed arterioles. It is to be used by patient's in both the checation of brood in the versas a non-invasive therapeutic method to prevent:

. Deep vein thrombosis
Reduce wound healing time .
Treat and assist healing of venous leg ulcers .
Reduce edema caused by venous insufficiency in the lower extremities
Decrease compartmental pressures

PRECAUTIONS AND CONTRAINDICATIONS

Contraindications:

Wraps may not be recommended for patients with the following:

Congestive heart failure I.
Known or suspected deep vein thrombosis 2.
Severe arteriosclerosis or other ischemic vascular disease 3.
Any local leg condition in which the wrap would interfere such as 4. dermatitis, gangrene, recent skin graft, or untreated infected wounds

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Indications for Use

Precautions:

One must ensure that the wrap is applied properly. 1. .
One must ensure that the wrap is correctly connected to the pump and that 2. the connection is secure.
If numbness, tingling, or leg pain is experienced by the patient, the wrap 3. should be removed.

Division of Cardiovascular & Respiratory Devices
510(k) Number 261265/

Prescription Use
(Per 21 CFR 801.109)

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).