(140 days)
Not Found
No
The description focuses on mechanical compression and does not mention any AI/ML components or capabilities.
Yes
The document states that the device is intended to "help prevent deep vein thrombosis" and "increase venous blood flow", which are therapeutic actions.
No
Explanation: The device is a compression system designed to prevent deep vein thrombosis by applying pressure, not to diagnose medical conditions.
No
The device description explicitly states it is an "electrically powered, non-invasive mechanical compression device" and mentions "Garments were tested internally," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis." This describes a therapeutic intervention applied directly to the patient's body.
- Device Description: The device is described as an "electrically powered, non-invasive mechanical compression device" that applies "intermittent, controlled pressure to the calf, thigh or foot." This is a physical therapy device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any such specimens.
Therefore, the Caremed Supply Inc. Vesoflow SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices are therapeutic devices, not IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JOW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calf, thigh or foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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)
1
K110977
pg 2 of 2
Indication for Use:
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.
Technological Characteristics and Substantial Equivalence
A. 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.
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.
2
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.
3
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
4
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:
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.
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
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