The Hygia Health Services Reprocessed Huntleigh Flowtron® Single Pulse DVT Sleeve is used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.

Device Description

The Hygia Health Services Reprocessed Huntleigh Flowtron® DVT sleeve is a compressible limb device that, when attached to an approved controller, provides intermittent pneumatic compression. The sleeve is constructed out of brushed nylon with a polyester foam lining. The single bladder is constructed of poly vinyl chloride (PVC), as is the inflation/deflation tube. The binding is a polyester/cotton blend, and the hook fasteners are made of polyethylene. The tube terminates in a snap lock connector. The sleeves are placed around the leg and secured with a hook and loop fastener. As the sleeves compress the leg, veins collapse, increasing the venous pressure thus ejecting the blood upward toward the heart. After compression, the sleeves 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Hygia Health Services Reprocessed Huntleigh Flowtron® DVT Compression Sleeves:

1. Table of Acceptance Criteria and Reported Device Performance

The submission is for a reprocessed medical device, and the primary "acceptance criteria" revolve around demonstrating substantial equivalence to the predicate device, the Huntleigh Flowtron® DVT Garment. This means the reprocessed device must perform functionally and safely in the same way as the original. Specific quantitative acceptance criteria (e.g., a specific pressure range with a tolerance) are not explicitly stated in the provided text as they would be for a novel device, but rather implied by the concept of "substantial equivalence."

Acceptance Criteria Category	Reported Device Performance
Functional and Operational Performance	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.
Material Integrity	The Hygia Health Services HLD protocol does not alter the device's efficacy, safety, composition, or intended use.
Intended Use	Designed to operate in the identical manner as the predicate device.

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

Sample Size: Not explicitly stated. The document mentions "Comparative bench testing" and "Clinical tests were summarized," but does not provide a specific number of units tested for either bench or clinical evaluation.
Data Provenance: Not explicitly stated. It describes "bench testing" and "clinical tests," which would typically be conducted by the manufacturer or a contracted lab. The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission for a reprocessed device, studies would likely be prospective specifically for reprocessing validation.

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

This information is not provided in the document. For device reprocessing, "ground truth" would typically relate to objective measures of device performance, material integrity, and sterility, rather than expert interpretation of images or clinical outcomes in the same way an AI diagnostic tool might require. The testing relies on established engineering and clinical measures, not expert consensus on qualitative data.

4. Adjudication Method for the Test Set

This information is not applicable/not provided in the context of this device. Adjudication methods like 2+1 or 3+1 are common in studies where expert interpretation (e.g., reading medical images) forms the ground truth and there's a need to resolve disagreements. For a reprocessed mechanical device, performance is assessed through objective measurements, not by expert consensus on interpretive data.

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

No, an MRMC comparative effectiveness study was not done. These studies are typically used for diagnostic or assistive AI tools where the performance of human readers (e.g., radiologists) with and without AI assistance is compared. This submission is for a reprocessed mechanical compression sleeve, which does not involve human "readers" interpreting data in the same way.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This question is not applicable in the context of this device. This is not an AI algorithm. Its "performance" is assessed through its mechanical function, material integrity, and ability to achieve intended physiological effects. The device itself (the reprocessed sleeve) is standalone in that it performs its compression function when connected to a controller, but "standalone" in the AI sense does not apply.

7. The Type of Ground Truth Used

The ground truth used for this type of device (a reprocessed compression sleeve) is based on objective measurements of performance characteristics and material properties compared against the specifications and performance of the original, new device. This includes:

Compression pressure profiles
Timing sequences (inflation/deflation cycles)
Material integrity after reprocessing (e.g., no degradation affecting safety or efficacy)
Safety parameters
Operational parameters
Efficacy in preventing DVT (implied by equivalence to predicate device with established efficacy).

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is a reprocessed physical medical device, not an AI model that requires a "training set."

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

This information is not applicable/not provided. As stated above, this is not an AI model.

Summary

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Image /page/0/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, and the word "HYGIA" in large, bold, black letters on the right. Below the word "HYGIA" is the phrase "HEALTH SERVICES" in smaller, thinner, black letters.

K012654

APR 1 2 2002

510(k) Summary

Summary

Substantial Equivalence Summary for the Hygia Health Services Reprocessed Huntleigh Flowtron® DVT Compression Sleeves

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: July 31, 2001

1. Contact Person

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

1. Name of Device
  Classification Name: Compressible Limb Sleeve Common or Usual Name: Intermittent Pneumatic Compressible Limb Sleeve Review Panel: Cardiovascular Class II Classification: Hygia Health Services Reprocessed Huntleigh Flowtron® Proprietary Name: DVT Sleeve.

HYGIA HEALTH SERVICES

MILAN COURT · · SUITE · 259 · · BIRMINGHAM , AL 35211 28000 2 0 5 - 9 4 3 - 6 6 7 0 - V O 1 C E

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Image /page/1/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, and the word "HYGIA" in large, bold, black letters on the right. Below the word "HYGIA" are the words "HEALTH SERVICES" in smaller, thinner, black letters.

3. Predicate Device

Classification Name: Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sleeve Common Name: Classification: Class II Huntleigh Flowtron® DVT Garment Proprietary Name:

Statement of Substantial Equivalence 4.

The Hygia Health Services Reprocessed Huntleigh Flowtron® DVT Sleeve employs no new technology other than the method used to reprocess the sleeve in order to allow the device to be utilized more than once. The Hygia Health Services Reprocessed Huntleigh Flowtron® DVT Sleeve is substantially equivalent to the Huntleigh Flowtron® DVT 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 lower limbs. The sleeves are then connected to a controller via a set of connecting tubes that range from 60-inches in length to 120-inches in length. Inflation of the sleeve 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 Flowtron® DVT Sleeve is substantially equivalent in function, operating parameters, and intended use to the Huntleigh Flowtron® DVT sleeve that is currently commercially available and in distribution. There is no significant change in the device, the predicate Huntleigh Flowtron® DVT sleeve is marked for "single-patient use" only. Hygia Health Services reprocess the sleeve via thermal high-level disinfection (HLD) so as to make the sleeve able to be reused. The Hygia Health Services HLD protocol does not alter the device's efficacy, safety, composition, or intended use.

5. Description of the Device

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Image /page/2/Picture/0 description: The image shows the logo for Hygia Health Services. The logo consists of a stylized symbol on the left, resembling three concentric circles within a square. To the right of the symbol, the word "HYGIA" is written in large, bold, sans-serif font. Below "HYGIA", the words "HEALTH SERVICES" are written in a smaller font.

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 Flowtron® DVT Sleeve is designed to operate in the identical manner as the predicate device, the Huntleigh Flowtron® DVT. It is designed to apply compression to a patient's lower limbs for the prevention of deep vein thrombosis (DVT) as well as the treatment of edema secondary to venous insufficiency. The device is used in both the home and institutional settings on patient populations for which this device applicable.

7. Technological Characteristics

The technological characteristics of the Hygia Health Services Reprocessed Huntleigh Flowtron® DVT sleeve are identical to the original Huntleigh Flowtron® DVT 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 Flowtron® DVT sleeve and the predicate device, the Huntleigh Flowtron® DVT. 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.

Clinical Tests- Clinical tests were summarized in support of the premarket notification submission.

Test Conclusions- Clinical and nonclinical test results of the Hygia Health Services Reprocessed Huntleigh Flowtron® DVT Sleeve indicated substantial equivalence in all aspects to the predicate device, the Huntleigh Flowtron® DVT Garment.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

K012654 Re:

Trade Name: Hygia Health Services Reprocessed Huntleigh Flowtron® DVT Sleeve 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 vours.

Donna-Bea Tillmah, 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: K012654

Device Name: Hygia Health Services Reprocessed Huntleigh Flowtron ® Single

Pulse DVT Sleeve

Indications For Use:

PRECAUTIONS AND CONTRAINDICATIONS

Contraindications:

Sleeves may not be recommended for patients with the following:

Any local leg condition in which sleeves would interfere such as 1. dermatitis, gangrene, recent skin graft, untreated infected wounds, or vein ligation (immediate postoperative).
Congestive heart failure. 2.
Severe arteriosclerosis or other ischemic vascular disease 3.
Pulmonary edema 4.
Known or suspected deep vein thrombosis or phlebitis న్.
Deformity of the leg 6.

Precautions:

One must ensure that the sleeve is applied properly. 1.
1. One must ensure that the sleeve is correctly connected to the pump

and that the connection is secure.

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Image /page/6/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, and the word "HYGIA" in large, bold, black letters on the right. Below the word "HYGIA" are the words "HEALTH SERVICES" in smaller, black letters.

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If numbness, tingling, or leg pain is experienced by the patient, the sleeve should be removed.

Prescription Use
(Per 21 CFR 801.109)

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Division of Cardiovascular & Respiratory Devices
510(k) Number K012654

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).