The Caremed Supply Inc. Vesoflow SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

Device Description

The Caremed Vesoflow® SQS and IPCS Deep Vein Thrombosis (DVT) Compression Systems are electrically powered, non-invasive mechanical compression devices designed for use by patients for whom external compression therapy is indicated. Their intended function and use is to increase venous blood flow and help prevent Deep Vein Thrombosis (DVT), by applying intermittent, controlled pressure to the calf, thigh or foot.

The Vesoflow product will be available in two (2) models. These are the Vesoflow SQS and the Vesoflow IPCS. They differ in that the SQS delivers sequential compression therapy while the Vesoflow IPCS delivers intermittent compression therapy.

AI/ML Overview

The provided 510(k) summary for the Caremed Supply Vesoflow SQS and IPCS Deep Vein Thrombosis Device does not contain detailed information about acceptance criteria and a specific study proving the device meets those criteria in the way typically seen for AI/ML-based medical devices.

Instead, the submission focuses on:

Substantial Equivalence: The primary method for FDA clearance for this type of device (compression therapy) is by demonstrating substantial equivalence to predicate devices (Huntleigh Healthcare Universal Flowtron (K010744) and Tyco/Kendall SCD Express (K040511)). This means demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
Performance Data (Safety Standards): The only "performance data" mentioned is compliance with the IEC 60601-1 Standard for Medical electrical equipment, Part 1: General requirements for safety. This is a general electrical safety standard, not a clinical performance or diagnostic accuracy study.
Internal Garment Testing: It states that "Garments were tested internally by Caremed and met their specified requirements." This is vague and does not provide details of the requirements, test methods, or results.

Therefore, many of the requested sections below cannot be populated from the provided text because a clinical performance study with acceptance criteria, ground truth, expert readers, and statistical analysis (as typically done for diagnostic AI/ML products) was not included or required for this type of device submission.

Here is an attempt to address your request based only on the provided text, with many N/A or "Not Provided" entries due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated for Clinical Performance)	Reported Device Performance (Based on provided text)
*Implied from Substantial Equivalence and Safety Standards*
Safety: Device meets applicable electrical safety standards.	Device has been tested to and meets IEC 60601-1 Standard for Medical electrical equipment, Part 1: General requirements for safety.
Functional Performance: Garments meet specified requirements.	Garments were tested internally by Caremed and met their specified requirements. (Specific requirements, test methods, and results are not provided).
Effectiveness: Similar effectiveness to predicate devices in increasing venous blood flow and helping prevent DVT.	Demonstrated substantial equivalence to Huntleigh Healthcare Universal Flowtron (K010744) and Tyco/Kendall SCD Express (K040511) for the intended use and technological characteristics.

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

Test Set Sample Size: Not applicable (N/A) – No clinical performance test set or study detailed for efficacy. The primary "test" was for electrical safety (IEC 60601-1) and internal garment testing, for which sample sizes are not specified.
Data Provenance: Not applicable (N/A) – No clinical data is described. The IEC 60601-1 testing is a laboratory-based safety standard, not a clinical study with patient data. Internal garment testing details are not provided.

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

Not applicable (N/A) – No clinical performance study requiring expert ground truth for a test set is described.

4. Adjudication Method for the Test Set

Not applicable (N/A) – No clinical performance study requiring adjudication is described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described. This type of study focuses on diagnostic performance compared to human readers, which is not relevant for this mechanical compression therapy device.

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

Not applicable (N/A) – This is a mechanical compression device, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

Not applicable (N/A) – No clinical performance study requiring a specific type of ground truth (like expert consensus, pathology, or outcomes data) is described. The "ground truth" for the device's substantial equivalence relates to its functional characteristics and safety compliance compared to existing devices and standards.

8. The Sample Size for the Training Set

Not applicable (N/A) – This is not an AI/ML device; therefore, there is no "training set."

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

Not applicable (N/A) – This is not an AI/ML device; therefore, there is no "training set" or associated ground truth establishment.

Summary

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K110977
pg 1 of 2

AUG 25 2011

510(k) SUMMARY Caremed Supply Vesoflow SQS and IPCS Deep Vein Thrombosis Device

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

Caremed Supply, Inc. C/O Spectre Solutions, Inc. 5905 Fawn Lane Cleveland, Ohio 44141

Contact Person: Edward A. Kroll President and Representative Consultant for Caremed Supply, Inc. Phone: (440) 546-9810 Fax: (440) 546-9124

Date Prepared: February 2, 2011

Name of Device and Name/Address of Sponsor:

Caremed Supply, Inc. 7f, no.2, lane 235, bao chiao rd, xin tien city taipei xen, China 231 Phone: 886-2-29179808 Fax: 886-2-29186505

Common or Usual Name:

Compression Therapy Device

Classification Name

Sleeve, Limb, Compression

Predicate Devices

Huntleigh Healthcare Universal Flowtron (K010744) Tyco/Kendall SCD Express (K040511)

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K110977
pg 2 of 2

Indication for Use:

Technological Characteristics and Substantial Equivalence

A. Device Description

B. Substantial Equivalence

Products which are substantially equivalent to the Vesoflow are the Tyco/Kendall SCD Express (K040511) and the Huntleigh Healthcare Flowtron Universal (K010744).

Performance Data

The Vesoflow SQS and IPCS compression therapy devices have been tested to and meet IEC 60601-1 Standard for Medical electrical equipment, Part 1: General requirements for safety. Garments were tested internally by Caremed and met their specified requirements.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Caremed Supply, Inc. c/o Mr. Edward A. Kroll President Spectre Solutions, Inc. 7F, No. 2, Lane 235 Baoqiao Road Xindian City 231 Taipei 231, Taiwan China

AUG 25 2011

Re: K110977

Vesoflow® SQS and IPCS Deep Vein Thrombosis (DVT) Compression Therapy System (Vesoflow®) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II

Product Code: JOW Dated: July 23, 2011

Received: July 27, 2011

Dear Mr. Kroll:

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 10 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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Page 2 - Mr. Edward A. Kroll

If your device is classified (see above) into either class II (Special Controls) or classion on be If your device is classined (Sec above) mo enner eightions affecting your device can be
may be subject to additional controls. Existing major regulations affective (FDA mov may be subject to additional comrolor "Entraling and to 898. In addition, FDA may found in the Code of I occrain regeration your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuated of a babenian and other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a delemination administered by other Federal agencies. You must of ally Federal statutes and regulations annualites but not limited to: registration and listing (21 comply with an the Act 3 requirements more and device reporting (reporting of medical CFK Fall 807); adeinig (21 CFR 803); good manufacturing practice requirements as set a device-related adverse events) (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice tor your do riters CDRH/CDRHOffices/ucm115809.html for go to mtp.//www.ida.gov/rtoouri DTGCHealth's (CDRH's) Office of Compliance. Also, please me Chich for Devices and Radionogreams by reference to premarket notification" (21CFR Patience) note the regulation childed, "Misolunding of totorely of adverse events under the MDR regulation (21 CFR Part 803), please go to

CFK Fall 803), picase go to of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the I ou may offan of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely 40

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

Enclosure

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K110977

Indications for Use

510(k) Number (if known): TBD

Device Name: Vesoflow SQS and IPCS Deep Vein Thrombosis (DVT) Compression System

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division/Sign. Off

(Division Sign-Off) Division of Cardiovascu ir Devices 510(k) Number

Page 1 of 1

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).