The Hygia Health Services Reprocessed NuTech® Foot Wrap is designed to enhance the circulation of blood in the venules and artise 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 NuTech® 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 polyester foam backing. The single bladder is constructed out of poly vinyl chloride (PVC), which is RF welded at the seams. The inflation/deflation tube is also 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, veins collapse longitudinally, increasing 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 text describes a 510(k) summary for a reprocessed medical device, specifically the Hygia Health Services Reprocessed NuTech® Foot Wrap. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics in the way one might for a novel diagnostic AI or complex therapeutic device.

Here's an analysis based on the provided text, addressing your points where possible:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list numerical acceptance criteria. Instead, the "acceptance criteria" are implicitly defined by the demonstration of "substantial equivalence" to the predicate device, the NuTech® PlexiPulse Foot Wrap Garment.

Table of Acceptance Criteria (Implicit) and Reported Device Performance:

Acceptance Criteria (Implicit)	Reported Device Performance
Functional Equivalence: Compression, pressure control, timing sequence.	Nonclinical bench testing found "functional and operational performance characteristics including compression, pressure control, timing sequence... were substantially equivalent" to the predicate device.
Safety Parameters: Ensures safe operation.	Nonclinical bench testing found "safety and operational parameters used when connected to a controller were substantially equivalent" to the predicate device. The reprocessing HLD (High-Level Disinfection) protocol does not alter the device's "safety".
Operational Parameters: Ensures correct operation when connected to a controller.	Nonclinical bench testing found "safety and operational parameters used when connected to a controller were substantially equivalent" to the predicate device.
Efficacy: Maintains intended therapeutic effect (prevention of DVT, treatment of edema, etc.).	Clinical tests were summarized. "Clinical test results... indicated substantial equivalence in all aspects to the predicate device." The reprocessing HLD protocol does not alter the device's "efficacy". The device "operates in the identical manner as the predicate device" for its intended use (enhance circulation, prevent DVT, reduce wound healing time, treat venous leg ulcers, reduce edema, decrease compartmental pressures).
Material/Design Equivalence: Overall design, materials, energy source, mode of operation.	"The technological characteristics... are identical to the original NuTech® PlexiPulse Foot Wrap Garment in overall design, materials, energy source, mode of operation, and performance characteristics." The reprocessed device employs "no new technology other than the method used to reprocess the garment." The HLD protocol does not alter the device's "composition."
Intended Use: Identical intended use as the predicate.	"Operates in the identical manner as the predicate device... It is designed to apply compression to a patient's plantar plexus for the prevention of deep vein thrombosis (DVT) as well as the treatment of edema secondary to venous insufficiency. The device may be used in both the home and institutional settings on patient populations for which a leg or calf compression device would not be applicable."

Detailed Responses to Specific Questions:

A table of acceptance criteria and the reported device performance:
- See the table above. The acceptance criteria are "substantial equivalence" across various functional, safety, operational, material, and efficacy domains compared to the predicate device. The reported device performance is that nonclinical (bench) and clinical tests "indicated substantial equivalence in all aspects" to the predicate device.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify the sample size for nonclinical (bench) tests nor for the "clinical tests."
- The document does not specify the data provenance (country of origin, retrospective/prospective). It simply states nonclinical and clinical test results were "summarized." Given the context of a 510(k) for a reprocessed device, these tests would likely be focused on verifying the reprocessing method's impact and the device's maintained functionality rather than extensive de novo clinical trials.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided as the submission focuses on substantial equivalence based on physical and functional characteristics, not on diagnostic accuracy requiring expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided and is not applicable to this type of device submission.
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:
- An MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices, which this reprocessed foot wrap is not.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A standalone performance study of an algorithm was not done. This device is a mechanical medical device, not an AI or software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The concept of "ground truth" in the diagnostic sense is not directly applicable here. For the nonclinical tests, the "ground truth" was likely defined by established engineering parameters and performance specifications of the predicate device. For the "clinical tests," the "ground truth" would implicitly be the clinical outcomes or functional measures compared to known performance of the predicate device, although specific details are not provided.
The sample size for the training set:
- This device does not involve a "training set" in the context of machine learning or AI.
How the ground truth for the training set was established:
- This question is not applicable as there is no training set for this type of medical device.

In summary: The provided 510(k) summary is for a reprocessed intermittent pneumatic compression foot wrap. The regulatory pathway is based on demonstrating "substantial equivalence" to a legally marketed predicate device. The supporting evidence provided consists of nonclinical (bench) tests and summarized clinical test results, all asserting that the reprocessed device performs identically and safely compared to the original. The details regarding specific sample sizes, expert involvement, or AI-related metrics (like MRMC studies, training sets, or ground truth establishment for AI) are not included because they are not relevant to this type of medical device submission.

Summary

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APR 1 2 2002

K012650

510(k) Summary

Summary

Substantial Equivalence Summary for the Hygia Health Services Reprocessed NuTech® 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

1. Contact Person

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

Name of Device 2.

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

HYGIA HEALTH SERVICES

2 8 0 0 0 m | L A N | C O U R T | ● | S U | T E | 2 5 9 | 3 5 2 1 1 BIRMINGHAM . 2 0 5 - 9 4 3 - 6 6 7 0 V O I 205-943-6671 �

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Image /page/1/Picture/0 description: The image contains a logo for Hygia Health Services. The logo features a black square with three white concentric circles on the left. To the right of the square, the word "HYGIA" is written in large, bold, black letters. Below "HYGIA", the words "HEALTH SERVICES" are written in smaller letters.

Predicate Device 3.

Classification Name: Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sleeve Common Name: Classification: Class II NuTech® PlexiPulse Foot Wrap Garment Proprietary Name:

Statement of Substantial Equivalence 4.

The Hygia Health Services Reprocessed NuTech® 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 NuTech® Foot Wrap is substantially equivalent to the NuTech® PlexiPulse Foot Wrap 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 garments 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 NuTech® Foot Wrap is substantially equivalent in function, operating parameters, and intended use to the NuTech® PlexiPulse Foot Wrap that is currently commercially available and in distribution. The predicate device, the NuTech® PlexiPulse Foot Wrap, is marked for "singlepatient 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 5.

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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, lighter letters.

Intended Use of Device 6.

The Hygia Health Services Reprocessed NuTech® Foot Wrap operates in the identical manner as the predicate device, the NuTech® PlexiPulse Foot Wrap Garment. It is designed to apply compression to a patient's plantar plexus for the prevention of deep vein thrombosis (DVT) as well as the treatment of edema secondary to venous insufficiency. The device may be 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 NuTech® Foot Wrap are identical to the original NuTech® PlexiPulse Foot Wrap Garment in overall design, materials, energy source. mode of operation, and performance characteristics.

8. Performance Data

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

9. Clinical Data

Clinical tests were summarized in support of this pre-market notification submission.

Test Conclusions- Nonclinical and clinical test results of the Hygia Health Services Reprocessed NuTech® Foot Wrap indicated substantial equivalence in all aspects to the predicate device, the NuTech® PlexiPulse Foot Wrap Garment.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of what appears to be an abstract caduceus symbol, featuring three curved lines that resemble a bird or a flowing design.

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

K012650 Re:

Trade Name: Hygia Health Services Reprocessed NuTech® 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 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 yours,

onna-Bea Tillman 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

Indications For Use

Applicant: Hygia Health Services, Inc.

510(k) Number: · ·

Device Name: Hygia Health Services Reprocessed NuTech® Foot Wrap

01265()

Indications For Use:

The Hygia Health Services Reprocessed NuTech® Foot Wrap is designed to enhance The Hygla Tieann Scivices Reprocessou Aux costs. It to be used by patient's in both the circulation of blood in the venules and artise 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 1.
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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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 2012650

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).