(224 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical compression.
Yes
The device is described as a "non-invasive mechanical prophylactic system that massages the feet or legs in a wavelike, milking motion that promotes blood flow and deters thrombosis" and "This therapy typically complements other prophylactic measures". Its intended use is to "increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis", indicating a direct therapeutic action to prevent a medical condition.
No
The device is described as a non-invasive mechanical prophylactic system intended to prevent deep vein thrombosis by promoting blood flow, not to diagnose a condition.
No
The device description explicitly states it is a "non-invasive mechanical prophylactic system" that "massages the feet or legs" by "inflating periodically a sleeve around the limb." This clearly indicates the presence of hardware components (sleeves, inflation mechanism) beyond just software.
Based on the provided information, the Caremed Supply Inc. VESOFLOW®PLUS SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- VESOFLOW®PLUS Function: The description clearly states that the VESOFLOW®PLUS is a "non-invasive mechanical prophylactic system" that "massages the feet or legs in a wavelike, milking motion that promotes blood flow and deters thrombosis." It works by applying external compression to the limbs.
- No Specimen Analysis: There is no mention of the device collecting or analyzing any biological specimens from the patient. Its function is purely mechanical and external.
Therefore, the VESOFLOW®PLUS falls under the category of a therapeutic or prophylactic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Caremed Supply Inc. VESOFLOW®PLUS 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
VESOFLOW®PLUS that counteracts blood stasis and coagulation changes - two of the three major factors that promote deep vein thrombosis (DVT). VESOFLOW® PLUS is a non-invasive mechanical prophylactic system that massages the feet or 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 antiembolic stockings and anticoagulants.
VESOFLOW®PLUS is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. Therefore, VESOFLOW®PLUS is identified as a compressible limb sleeve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Feet or legs / limb
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 the VESOFLOW®PLUS SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices. All the test results demonstrate VESOFLOW®PLUS SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices meet 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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection. The text is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 4, 2014
Caremed Supply, Inc. % Michael Lee President AcmeBiotechs Co., Ltd. No.45, Minsheng Rd. Danshui Town New Taipei City, 251 TW
Re: K141064
Trade/Device Name: VESOFLOW PLUS DVT Compression Devices Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: October 20, 2014 Received: October 27, 2014
Dear Michael Lee,
We have reviewed vour 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.
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
1
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 yours,
M.A. Hillebrand
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Caremed Supply Inc. 510(k) Notification
VESOFLOW®PLUS DVT Compression Device Model: IPCS/SQS
Indications for Use
510(k) Number (if known): K141064
VESOFLOW®PLUS DVT Compression Device Device Name: Model Name: IPCS/SQS
Indications for Use:
The Caremed Supply Inc. VESOFLOW®PLUS 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 ____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
3
VESOFLOW®PLUS DVT Compression Device Model: IPCS/SQS
510(k) Summary
| Type of Submission: | Traditional |
|---|---|
| Preparation Date: | 16th April 2014 |
| Submitter: | Caremed Supply Inc. |
| Address: | 7F., No. 2, Lane 235, Bao Chiao Rd., Xin |
| Tien Dist., New Taipei City 23145, | |
| Taiwan | |
| Phone: | +886-2-29179808 |
| Fax: | +886-2-29186505 |
| Contact: | Tsung-Hsuan Liu |
| (oscar(a)caremed.com.tw) | |
| Registration number: | 8022590 |
5.4 Identification of the Device:
| Proprietary/ | VESOFLOW®PLUS DVT Compression |
|---|---|
| Trade name: | Device, Model Name: IPCS/SQS |
| Classification Name: | Sleeve, Limb, Compressible |
| Device Classification: | II |
| Regulation Number: | 870.5800 |
| Panel: | Cardiovascular |
| Product Code: | JOW |
5.5 Identification of the Predicate Device:
| Predicate Device Name: | VESOFLOW |
|---|---|
| Manufacturer: | Caremed Supply Inc. |
| Regulation number: | 870.5800 |
| Product Code: | JOW |
| 510(k) Number: | K110977 |
4
5.6 Intended Use and Indications for Use of the subject device.
The Caremed Supply Inc. VESOFLOW®PLUS SOS 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.
5.7 Device Description
VESOFLOW®PLUS that counteracts blood stasis and coagulation changes - two of the three major factors that promote deep vein thrombosis (DVT). VESOFLOW® PLUS is a non-invasive mechanical prophylactic system that massages the feet or 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 antiembolic stockings and anticoagulants.
VESOFLOW®PLUS is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. Therefore, VESOFLOW®PLUS is identified as a compressible limb sleeve.
5.8 Non-clinical Testing
A series of safety tests were performed to assess the safety and effectiveness of the VESOFLOW®PLUS SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices.
| Testing Item | Standard and regulations applied |
|---|---|
| Biocompatibility | ISO 10993-1:2009/Cor. 1:2010(E) Biological evaluation of |
| medical devices – Part 1: Evaluation and testing with a risk | |
| management process. | |
| ISO 10993-5:2009 (E) Biological evaluation of medical devices | |
| – Part 5: Tests for in vitro cytotoxicity. | |
| ISO 10993-10:2010(E) Biological evaluation of medical devices | |
| - Part 10: Tests for Tests for irritation and skin sensitization. | |
| ISO 10993-12 Biological Evaluation Of Medical Devices -- Part | |
| 12: Sample Preparation And Reference Materials. | |
| (Biocompatibility) | |
| ISO/IEC 17025:2005 General Requirements for the Competence | |
| of Testing and Calibration Laboratories. | |
| USP 35 Biological reactivity tests, in vitro | |
| Software | IEC 62304 First Edition 2006-05, Medical Device Software - |
| Software Life Cycle Processes. (Software/Informatics) | |
| Electromagnetic | |
| Compatibility & | |
| Electrical Safety | EN 60601-1-2 : 2007/AC:2010 Medical electrical equipment - |
| Part 1-2: General requirements for basic safety and essential | |
| performance - Collateral standard: Electromagnetic compatibility |
- Requirements and tests. |
| IEC 60601-1-2 : 2007 Medical Electrical Equipment - Part 1-2:
General Requirements For Basic Safety And Essential
Performance - Collateral Standard: Electromagnetic
Compatibility - Requirements And Tests. (General I (QS/RM)) | |
| IEC 61000-3-2 : 2005+A1:2008+A2:2009 Electromagnetic
compatibility (EMC) - Part 3-2: Limits - Limits for harmonic
current emissions (equipment input current ≤16 A per phase). | |
| IEC 61000-3-3 : 2008 Electromagnetic compatibility (EMC) -
Part 3-3: Limits - Limitation of voltage changes, voltage
fluctuations and flicker in public low-voltage supply systems, for
equipment with rated current ≤16 A per phase and not subject to
conditional connection. | |
| IEC 61000-4-2 : 2008 Electromagnetic compatibility (EMC) -
Part 4-2: Testing and measurement techniques - Electrostatic
discharge immunity test. | |
| IEC 61000-4-3 : 2006+A1:2007+A2:2010 Electromagnetic
compatibility (EMC) - Part 4-3: Testing and measurement
techniques - Radiated, radio-frequency, electromagnetic field
immunity test | |
| | |
| | IEC 61000-4-4 : 2012 Electromagnetic compatibility (EMC) -
Part 4-4: Testing and measurement techniques - Electrical fast
transient/burst immunity test. |
| | IEC 61000-4-5 : 2005+corr.October:2009 Electromagnetic
compatibility (EMC) - Part 4-5: Testing and measurement
techniques - Surge immunity test. |
| | IEC 61000-4-6 : 2008 Electromagnetic compatibility (EMC) -
Part 4-6: Testing and measurement techniques - Immunity to
conducted disturbances, induced by radio-frequency fields. |
| | IEC 61000-4-8 : 2009 Electromagnetic compatibility (EMC) -
Part 4-8: Testing and measurement techniques - Power frequency
magnetic field immunity test. |
| | IEC 61000-4-11 : 2004 Electromagnetic compatibility (EMC) -
Part 4-11: Testing and measurement techniques - Voltage dips,
short interruptions and voltage variations immunity tests. |
| | CISPR 11 : 2009+A1:2010 Industrial, scientific and medical
equipment - Radio-frequency disturbance characteristics - Limits
and methods of measurement. |
| Performance | IEC 60068-2-14: 2009 Environmental testing - Part 2-14: Tests -
Test N: Change of temperature.
ISTA 2A Standard |
| Risk Management | ISO14971 Medical Devices - Application Of Risk Management
To Medical Devices. (General I (QS/RM))
IEC 60812 Analysis Techniques For System Reliability -
Procedure For Failure Mode And Effects Analysis (Fmea).
(General I (OS/RM)) |
5
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All the test results demonstrate VESOFLOW®PLUS SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices meet the requirements of its pre-defined acceptance criteria and intended uses.
7
5.9 Clinical Testing
No clinical test data was used to support the decision of safety and effectiveness.
5.10 Substantial Equivalence Determination
The VESOFLOW®PLUS SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices have similar intended use, materials, safety and similar technological characteristics with the predicate device. Information described above can demonstrate the VESOFLOW®PLUS SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices are substantial equivalent to the predicate device.
| Model Name | VESOFLOW®PLUS SQS | VESOFLOW SQS |
|---|---|---|
| Dimension | 7.54"x 5.12"x7.95" | 9.8" x 8.9" x 8.1" |
| Weight | 2.8kg | 2.5kg |
| Pressure Range | Calf/Thigh : 45, 40 and 30mmHg | |
| Foot: 130mmHg | Calf/Thigh : 45, 40 and 30mmHg | |
| Foot: 130mmHg | ||
| Input Rating | AC 100-240V, 50/60Hz | AC 100-240V, 50/60Hz |
| Fuse Rating | 1A/250V | 1A/250V |
| Operating Humidity | 30-75% | 30-75% |
| Operation | ||
| Temperature | 15°C- 35°C | 15°C- 35°C |
| Applied Part | Garment and Air Hose | Garment and Air Hose |
| Applied Mode of | ||
| Pressure | Sequential | Sequential |
| Number of | ||
| Chambers in | ||
| Garment | 3 | 3 |
| Inflation time per | ||
| chamber | 12 seconds | 12 seconds |
| Deflation time per | ||
| chamber | 48 seconds | 48 seconds |
| Pressure sequence | 45, 40 and 30 mmHg | 45, 40 and 30 mmHg |
8
| calf/thigh | ||
|---|---|---|
| Pressure Range | ||
| Calf/Thigh | 45, 40 and 30 mmHg | 45, 40 and 30 mmHg |
| Pressure Range Foot | 130 mmHg | 130 mmHg |
| Pre-Programmed | ||
| Controls | Yes | Yes |
| Battery Pack | Yes | Yes |
| Model Name | VESOFLOW®PLUS IPCS | VESOFLOW IPCS |
|---|---|---|
| Dimension | 7.54"x 5.12"x7.95" | 9.8" x 8.9" x 8.1" |
| Weight | 2.8kg | 2.5kg |
| Pressure Range | 40 and 130mmHg | 40 and 130mmHg |
| Input Rating | AC 100-240V, 50/60Hz | AC 100-240V, 50/60Hz |
| Fuse Rating | 1A/250V | 1A/250V |
| Operating Humidity | 30-75% | 30-75% |
| Operation | ||
| Temperature | 15°C - 35°C | 15°C - 35°C |
| Applied Part | Garment and Air Hose | Garment and Air Hose |
| Applied Mode of | ||
| Pressure | Intermittent | Intermittent |
| Number of | ||
| Chambers in | ||
| Garment | No | No |
| Inflation time per | ||
| chamber | ||
| (Calf/Thigh) | 12 seconds | 12 seconds |
| Deflation time per | ||
| chamber | ||
| (Calf/Thigh) | 48 seconds | 48 seconds |
9
| Inflation time per
| chamber (Foot) | 3 seconds | 3 seconds |
|---|---|---|
| Deflation time per | ||
| chamber (Foot) | 30 seconds | 30 seconds |
| Pressure Range | ||
| Calf/Thigh | 40 mmHg | 40 mmHg |
| Pressure Range Foot | 130 mmHg | 130 mmHg |
| Pre-Programmed | ||
| Controls | Yes | Yes |
| Battery Pack | Yes | Yes |
5.11 Similarity and difference
The difference between the proposed device and the predicate device is software driven. The proposed device has tested on safety and performance tests and the results were complied with the test requests. Therefore, the difference of proposed device and predicate device did not raise any problems of safety or effectiveness. The proposed device is substantially equivalent to the predicate device in intended use, design, and performance claims.
5.12 Conclusion
After analyzing bench tests, safety testing data, it can be concluded that VESOFLOW®PLUS SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices are as safe and effective as the predicate device.