The ClearMedical/Aircast VenaFlow Cuffs are an accessory device to a VenaFlow System which is used for the prevention of deep vein thrombosis. The VenaFlow Cuff is designed with two inflatable bladders that fill with air to provide compression to the legs and feet. A connector tubing system attaches the Cuff to the pump system. The VenaFlow Cuffs are latex-free, made of a polyester-cotton fabric. They are The vehal low Oulls are latest nos, a proximal and distal bladder and polyethylene tubing with polypropylene luer-lock connectors.

AI/ML Overview

The provided 510(k) summary for the ClearMedical/Aircast VenaFlow Cuffs does not contain specific acceptance criteria or a detailed study proving the device meets numerically defined criteria in the way a modern AI/ML device submission would. This document is a submission from 2002 and relates to a physical medical device (reprocessed compression cuffs), not an AI/ML algorithm.

Therefore, many of the requested points for describing an AI/ML study (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.

However, I can extract the information relevant to this specific submission type:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Technological Indicators of Substantial Equivalence)	Reported Device Performance (Summary)
Infection Control (CleanMedical reprocessed cuffs are "High Level-Disinfected")	ClearMedical's infection control methods meet or exceed the CDC and APIC standards for this class of device.
Fit/Attachment	The ClearMedical/Aircast reprocessed VenaFlow Cuffs demonstrated equality in safety and performance compared to the predicate device.
Bladder Function	The ClearMedical/Aircast reprocessed VenaFlow Cuffs demonstrated equality in safety and performance compared to the predicate device, containing attached bladders that inflate with air to control circulation of a designated limb.
Velcro Adhesion	The ClearMedical/Aircast reprocessed VenaFlow Cuffs demonstrated equality in safety and performance compared to the predicate device.
Connector Function	The ClearMedical/Aircast reprocessed VenaFlow Cuffs demonstrated equality in safety and performance compared to the predicate device, utilizing tubing systems that connect to the VenaFlow pump.

Study Proving Device Meets Acceptance Criteria:

The submission refers to "bench tests and non-clinical performance data" to demonstrate substantial equivalence. These tests focused on the "Technological characteristics" listed above, comparing the reprocessed ClearMedical device to the predicate Aircast VenaFlow Cuffs. The conclusion is that "in all relevant safety and performance indicators the ClearMedical/Aircast VenaFlow Cuffs demonstrates substantial equivalence to the predicate devices."

Regarding AI/ML-specific questions:

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study. The data provenance would relate to the specific bench testing environment, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm is not relevant here. The comparison is between a reprocessed device and a new predicate device based on engineering and performance characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" equivalent in this context is the performance of the original (predicate) Aircast VenaFlow Cuffs, against which the reprocessed ClearMedical cuffs were compared via bench testing.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission for reprocessing a physical medical device relies on demonstrating "substantial equivalence" through bench testing against a predicate device across defined technological characteristics, rather than meeting specific quantitative performance metrics derived from an AI/ML algorithm's output on a dataset.

Summary

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K012601

FEB 0 6 2002

ClearMed"

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

ClearMedical/Aircast VenaFlow Cuffs (3010,

Date Summary Prepared:

August 8, 2001

Trade or Proprietary Name:

Common Name:

VenaFlow Cuffs

3012, 3015, and 3016)

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

Equivalent Device

Classification Name:

The ClearMedical/Aircast reprocessed VenaFlow Cuffs are substantially equivalent to the Aircast VenaFlow Cuffs (3010, 3012, 3015, and 3016). 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) Summary (Cont'd)

The VenaFlow Cuffs are latex-free, made of a polyester-cotton fabric. They are The vehal low Oulls are latest nos, a proximal and distal bladder and polyethylene tubing with polypropylene luer-lock connectors.

Intended Use:

The ClearMedical/Aircast VenaFlow Cuffs are intended as a single patient use The Oleannedical/Riroast VenaFlow system 30A, 30AXL, or 30AXXL pump. The accessory to an Alload Vonal 1011 cycles the incidence of deep vein thrombosis, role of the vond now of one injury and surgery, and increase arterial blood reduce pain and owoling and in conjunction with the VenaFlow pump for non-ambulatory patients in a hospital environment.

Technological Characteristics of ClearMedical and Predicate Devices:

The predicate device and the ClearMedical/Aircast VenaFlow Cuffs contain I he producte donoo with air to control circulation of a designated limb. Attached bladdolo that imate tubing systems that connect to the VenaFlow pump. In to the Salle all connection and the ClearMedical reprocessed VenaFlow Cuffs are substantially equivalent.

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

The predicate device is delivered to the customer without being labeled either "non-sterile" or "sterile" whereas the ClearMedical/Aircast VenaFlow Cuffs are delivered to the customer labeled "High Level-Disinfected." ClearMedical's infection control methods meet or exceed the CDC and APIC standards for this class of device.

Summary of ClearMedical/Aircast VenaFlow Cuff 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/Aircast VenaFlow Cuffs demonstrates substantial equivalence to the predicate devices, the Aircast VenaFlow Cuffs.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three stripes extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

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: K012601

Trade Name: ClearMedical/Aircast VenaFlow Cuffs 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 indication we nave reviewed your bocaon 310(t) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosuly) to 10gm) actment date of the Medical Device Amendments, or to connineres phor to may 20, 2017 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 I ou may, dicrorolo, marks 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 If your device 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 is 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 orth 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) I mo lotter will and my of 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) 594-4646. 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,

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

510(K) NUMBER (IF KNOWN): __

DEVICE NAME:

ClearMedical/Aircast VenaFlow Cuffs

Part Numbers: 3010, 3012, 3015, 3016

INDICATIONS FOR USE:

To reduce the incidence of deep vein thrombosis, reduce pain and swelling after injury or surgery and increase arterial blood flow.

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

Division of Cardiovascular & Respiratory Devices
510(k) Number K022601

t Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use

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).