(118 days)
Not Found
No
The description focuses on mechanical compression and does not mention any AI/ML components or capabilities.
Yes
The device is used to prevent deep vein thrombosis and promote blood flow, which are therapeutic actions.
No
The device description clearly states its purpose is to "increase venous blood flow" and act as a "non-invasive mechanical prophylactic system that massages the legs... to promote blood flow and deter thrombosis." It is designed to prevent DVT, not to diagnose it.
No
The device description explicitly mentions "non-invasive mechanical prophylactic system" and "massages the legs in a wavelike, milking motion," indicating a physical device with mechanical components, not solely software. The performance studies also include tests like "Vibration Test," "Shock Test," and "Free Fall Drop," which are relevant to hardware, not software-only devices.
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 physical intervention on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a "non-invasive mechanical prophylactic system that massages the legs in a wavelike, milking motion." This is a mechanical device for external use, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples from the body to provide information for diagnosis, monitoring, or screening. The VASOPOUSE® device is a therapeutic/prophylactic device that physically interacts with the body to prevent a condition.
N/A
Intended Use / Indications for Use
The Caremed Supply Inc. VASOPOUSE® 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
VASOPOUSE® that counteracts blood stasis and coagulation changes - two of the three major factors that promote deep vein thrombosis (DVT) - a potentially life threatening condition which can lead to pulmonary embolism. VASOPOUSE® is a non-invasive mechanical prophylactic system that massages the legs in a wavelike, milking motion that promotes blood flow and deters thrombosis, helping to empty pooled or static blood from the valve cusps of the femoral vein. Fibrinolytic activity is increased, stimulating the release of a plasminogen activator. This therapy typically complements other prophylactic measures, such as ant embolic stockings and anticoagulants.
VASOPOUSE® is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. Therefore, VASOPOUSE® is identified as a compressible limb sleve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
legs (implied by "massages the legs")
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)
A series of safety tests were performed to assess the safety and effectiveness of VASOPOUSE. The safety tests were conducted in accordance with EN/IEC60601-1-2:2007, ISO10993-1:2009, ISO10993-5:2009, and ISO10993-10:2002/AMD.1:2006(E). The performance testing conducted on subject device and predicate device are listed below:
- Function Test
- Vibration Test
- Shock Test
- Free Fall Drop
- Life Test
All the test results demonstrate VASOPOUSE® meets the requirements of its pre-defined acceptance criteria and intended uses.
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
122873
Caremed Supply Inc. 510(k) Notification
VASOPOUSE® DVT Compression Device Model: IPCS/SQS
JAN 1 5 2013
510(k) Summary
- 5.1 Type of Submission: Traditional/Special/Abbreviated
- Preparation Date: Sep 11, 2012 5.2
- 5.3 Revised Date:
| 5.4 Submitter: | Caremed Supply Inc. |
|---|---|
| Address: | 7F., No. 2, Lane 235, Bao Chiao Rd., Xin Tien Dist., New |
| Taipei City 23145, Taiwan, R.O.C. | |
| Phone: | +886-2-29179808 |
| Fax: | +886-2-29186505 |
| Contact: | TSUNG-HSUAN LIU |
| Establishment Registration Number: | 8022590 |
Identification of the Device: 5.5
| Proprietary/Trade name: | VASOPOUSE® Deep Vein Thrombosis Compression
Device
|
|-------------------------|-----------------------------------------------------------|
| | Model Name: IPCS/SQS |
| | Model No.: M6-9/M6-5 |
| Common Name: | Compression Therapy Device |
| Classification Name: | Sleeve, Limb, Compression |
| Device Classification: | Class II |
| Regulation Number: | 870.5800 |
| Panel: | Cardiovascular |
| Product Code: | JOW |
5.6 Identification of the Predicate Device:
| Predicate Device Name: | VESOFLOW |
|---|---|
| Manufacturer: | CAREMED SUPPLY INC. |
| Product Code: | JOW |
| 510(k) Number: | K110977 |
1
5.7 Intended Use and Indications for Use of the subject device
The Caremed Supply Inc. VASOPOUSE® SQS and IPCS Decp Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.
5.8 Device Description
VASOPOUSE® that counteracts blood stasis and coagulation changes - two of the three major factors that promote deep vein thrombosis (DVT) - a potentially life threatening condition which can lead to pulmonary embolism. VASOPOUSE® is a non-invasive mechanical prophylactic system that massages the legs in a wavelike, milking motion that promotes blood flow and deters thrombosis, helping to empty pooled or static blood from the valve cusps of the femoral vein. Fibrinolytic activity is increased, stimulating the release of a plasminogen activator. This therapy typically complements other prophylactic measures, such as ant embolic stockings and anticoagulants.
VASOPOUSE® is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. Therefore, VASOPOUSE® is identified as a compressible limb sleve.
5.9 Statement of Substantial Equivalence
The VASOPOUSE® SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices are substantially equivalent in all aspects, e.g., technological characteristics, modes of operation, performance characteristics, intended use, etc., to the commercially available VESOFLOW SQS and IPCS DVT Compression Devices. The changes between the two systems include the exclusion of battery back up and the dimension of the pump.
5.10Non-clinical Testing
A series of safety tests were performed to assess the safety and effectiveness of VASOPOUSE . The safety tests were conducted in accordance with EN/IEC60601-1-2:2007, ISO10993-1:2009, ISO10993-5:2009, and ISO10993-10:2002/AMD.1:2006(E). The performance testing conducted on subject device and predicate device are listed below:
- · Function Test
- · Vibration Test
2
Caremed Supply Inc. 510(k) Notification
VASOPOUSE® DVT Compression Device Model: IPCS/SQS
- Shock Test
- Free Fall Drop
- Life Test
All the test results demonstrate VASOPOUSE® meets the requirements of its pre-defined acceptance criteria and intended uses.
5.11Substantial Equivalence Determination
The VASOPOUSE® submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared VESOFLOW (K110977). Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
| Item | VESOPOUSE® | VESOFLOW (K110977) |
|---|---|---|
| Similarities | ||
| Regulation Number | 870.5800 | 870.5800 |
| Classification | Class II | Class II |
| Product Code | JOW | JOW |
| Prescription Use | Yes | Yes |
| Indications for Use | The Caremed Supply Inc. | |
| VASOPOUSE® 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. | 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. | ||
| Model | SQS/IPCS | SQS/IPCS |
| Pressure Range | Same | 40/45 and 130 mmHg |
| Sterilization | N/A | N/A |
| Referenced | Same | IEC60601-1: |
| 1988+A1:1991+A2:1995 | ||
| EN/IEC60601-1-2:2007 | ||
| EN/IEC60601-1-4 | ||
| Standards |
3
| Caremed Supply Inc.
510(k) Notification | | VASOPOUSE® DVT Compression Device
Model: IPCS/SQS | |
|--------------------------------------------|----|------------------------------------------------------|--|
| | | IEC60068-2-06 | |
| | | IEC60068-2-27 | |
| | | ISO14971:2007 | |
| | | ISO10993-1:2009 | |
| | | ISO10993-5:2009 | |
| | | ISO10993-10:2002/AMD.1:2006(E) | |
| Differences | | | |
| Battery Pack | No | Yes | |
5.12Conclusion
After analyzing bench tests, safety testing data, it can be concluded that VASOPOUSE® IPCS and SQS DVT Compression Device are substantially equivalent to the predicate device.
4
Image /page/4/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
JAN 1 5 2013
Caremed Supply Inc. c/o Mr. Michael Lee Consultant 7F., No. 2, LANE 235, BAO CHIAO RD. NEW TAIPEI CITY, XIN TIEN DIST. TAIWAN, R.O.C, 23145
Re: K122873
Trade/Device Names: VASOPOUSE® Deep Vein Thrombosis Compression Device Regulatory Number: 21 CFR 870.5800 Regulation Name: Sleeve, Limb, Compression Regulatory Class: Class II Product Code: JOW Dated: September 11, 2012 Received: September 19, 2012
Dear Mr. Lee:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
Page 2 - Mr. Michael Lee
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Matthew G. Hillebrenner
for
· Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Caremed Supply Inc. 510(k) Notification
VASOPOUSE® DVT Compression Device Model: IPCS/SQS
Indications for Use
877 122 510(k) Number (if known):
Device Name: VASOPOUSE® IPCS/SQS Deep Vein Thrombosis Compression Device
Indications for Use:
The Caremed Supply Inc. VASOPOUSE® 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ovascular Devices
M.A. Hillel
Page 1 of
510(k) Number K122873
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