Prevention of deep vein thrombosis. Enhancement of venous and arterial circulation. Prevention of venous stasis. Assist in healing of cutaneous ulcers, including venous stasis ulcers. Reduction of acute and chronic edema. Reduction of lower limb pain due to trauma or surgery. Reduction of compartmental pressures.

Device Description

The ClearMedical/Huntleigh Foot Garments are an accessory device to a Foot Garment System which is used for the prevention of deep vein thrombosis. The Foot Garment is designed with an inflatable bladder that fills with air to provide compression to the feet. A connector tubing system attaches the Foot Garment to the pump system. The Foot Garments are latex-free, made of a polyester-cotton fabric. They are designed with velcro hook straps, a vented bladder and molded polyethylene tubing with a polypropylene colder snap-lock connector.

AI/ML Overview

The provided text describes a 510(k) summary for ClearMedical/Huntleigh Foot Garments, which were deemed substantially equivalent to predicate devices. However, the document does not contain specific acceptance criteria for performance or detailed study results beyond a general statement that "bench tests and non-clinical performance data" were assessed to establish substantial equivalence.

Therefore, many of the requested details about acceptance criteria, study sample sizes, ground truth establishment, expert qualifications, and specific performance metrics are not available in the provided text. The document focuses on regulatory equivalence rather than a detailed clinical performance study with defined acceptance criteria.

Based on the available information, here is what can be extracted and what is not present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Not explicitly stated as numerical targets)	Reported Device Performance
Methods of infection control: Meets/exceeds CDC and APIC standards	ClearMedical's infection control methods meet or exceed the CDC and APIC standards for this class of device. The device is labeled "High Level-Disinfected."
Fit/attachment: Substantial equivalence to predicate	Demonstrated equality in safety and performance to predicate device.
Bladder function: Substantial equivalence to predicate	Demonstrated equality in safety and performance to predicate device.
Velcro adhesion: Substantial equivalence to predicate	Demonstrated equality in safety and performance to predicate device.
Connector function: Substantial equivalence to predicate	Demonstrated equality in safety and performance to predicate device.
Safety and performance (general): Substantial equivalence to predicate	In all relevant safety and performance indicators, the ClearMedical/Huntleigh Foot Garments demonstrate substantial equivalence to the predicate devices.

2. Sample sized used for the test set and the data provenance

Sample Size: Not specified. The document only mentions "bench tests and non-clinical performance data."
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

Not applicable/Not specified. The assessment was based on "bench tests and non-clinical performance data" against a predicate device, not on diagnostic accuracy requiring expert ground truth in a clinical setting.

4. Adjudication method for the test set

Not applicable/Not specified. The assessment was based on comparison to a predicate device via bench testing.

5. 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

No. This is not an AI-assisted diagnostic device.

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

No. This is a medical device (Foot Garments) for DVT prevention, not a standalone algorithm.

7. The type of ground truth used

Reference standard/Comparison: The predicate device (Huntleigh Foot Garments) was used as the basis for comparison to demonstrate substantial equivalence. The "ground truth" was largely established through technical and functional equivalence to this legally marketed device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for ClearMed. The logo consists of the word "ClearMed" in a bold, sans-serif font, with the letters slightly spaced apart. To the right of the word "ClearMed" is the trademark symbol. Above the word "ClearMed" is a graphic of a water droplet inside of a diamond shape.

510(k) Summary

Submitter's name and Address:

ClearMedical, Inc. 1776 - 136th Place NE Bellevue, WA 98005 Ph (425) 401-1414 Fax (425) 401-1515

FDA Registration Number:

3017110

Contact Person:

Richard Radford Director of Research and Product Development

Date Summary Prepared:

August 8, 2001

Trade or Proprietary Name:

Common Name:

Foot Garments

Classification Name:

Sleeve, Limb, Compressible (per 21 CFR section 870.5800)/JOW

ClearMedical/Huntleigh Foot Garments

Equivalent Device

The ClearMedical/Huntleigh reprocessed Foot Garments are substantially equivalent to the following Huntleigh Foot Garments (FG200-LRG, FG200-STD, FG100-SM. FG100-R). This determination has been reached based on an evaluation and analysis of the predicate device's technical and promotional labeling and specific bench testing. For all established indicators of substantial equivalence, the ClearMedical devices demonstrated equality in safety and performance.

Device Description:

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510(k) Summarv (Cont'd)

compression to the feet. A connector tubing system attaches the Foot Garment to the pump system.

The Foot Garments are latex-free, made of a polyester-cotton fabric. They are designed with velcro hook straps, a vented bladder and molded polyethylene tubing with a polypropylene colder snap-lock connector.

Intended Use:

The ClearMedical/Huntleigh Foot Garments are intended as a single patient use accessory to a Huntleigh FP 5000 pump. The role of the Foot Garment is to reduce the incidence of deep vein thrombosis, reduce pain and swelling after injury and surgery, and increase arterial blood flow. The Foot Garment is used in conjunction with the FP 5000 pump for non-ambulatory patients in a hospital environment.

Technological Characteristics of ClearMedical and Predicate Devices:

The predicate device and the ClearMedical/Huntleigh Foot Garments contain bladders that inflate with air to control circulation of a limb. Attached to the Garment is a connector tubing system that connects to the FP 5000 pump. In form, the predicate device and the ClearMedical reprocessed Foot Garments are substantially equivalent.

Technological indicators of substantial equivalence were identified and included methods of infection control, fit/attachment, bladder function, velcro adhesion and connector function.

The predicate device is delivered to the customer labeled 'non-sterile' whereas the ClearMedical/Huntleigh Foot Garments are delivered to the customer labeled "High Level-Disinfected." ClearMedical's infection control methods meet or exceed the CDC and APIC standards ("Guideline for Handwashing and Hospital Environmental Control", 1985, "APIC Guideline for Selection and Use of Disinfectants") for this class of device.

Summary of ClearMedical/Huntleigh Foot Garment Performance:

Based on an assessment of bench tests and non-clinical performance data, we believe that in all relevant safety and performance indicators the ClearMedical/ Huntleigh Foot Garments demonstrates substantial equivalence to the predicate devices, the Huntleigh Foot Garments.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 6 2002

Mr. Richard Radford Director of Research and Product Development ClearMedical, Inc. 1776 136th Place NE Belluvue, WA 98005-2328

Re: K012616

Trade Name: ClearMedical/Huntleigh Foot Garments Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: January 16, 2002 Received: January 17, 2002

Dear Mr. Radford:

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.

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Page 2 - Mr. Richard Radford

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be actived a determination that your device complies with other requirements of the Act that I Drines Internations and regulations administered by other Federal agencies. You must or any I catales and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fat 6077; accems (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic rordlict 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) rms letter notification. The FDA finding of substantial equivalence of your device to a legally premium to modicate 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) 594-4646. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-4639 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 O wision 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,

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

KO12616 510(K) NUMBER (IF KNOWN):

ClearMedical/Huntleigh Foot Garments (without pump) DEVICE NAME:

INDICATIONS FOR USE:

Prevention of deep vein thrombosis.

Enhancement of venous and arterial circulation.

Prevention of venous stasis.

Assist in healing of cutaneous ulcers, including venous stasis ulcers.

Reduction of acute and chronic edema.

Reduction of lower limb pain due to trauma or surgery.

Reduction of compartmental pressures.

(Please do not write below this line-continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ (Per 21 CFR 801.109)

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

Division of Cardiovascular & Respiratory Devices
510(k) Number K012616

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).