VESOFLOW PLUS DVT COMPRESSION DEVICE

K141064 · Caremed Supply, Inc. · JOW · Dec 4, 2014 · Cardiovascular

Device Facts

• Record ID: K141064
• Device Name: VESOFLOW PLUS DVT COMPRESSION DEVICE
• Applicant: Caremed Supply, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Dec 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

VESOFLOW®PLUS is a non-invasive mechanical prophylactic system for DVT prevention; counteracts blood stasis and coagulation changes. Device uses inflatable sleeves around feet or legs; applies wavelike, milking motion to empty pooled/static blood from femoral vein valve cusps; increases fibrinolytic activity via plasminogen activator release. System operates via periodic inflation/deflation cycles. Used in clinical settings to complement other prophylaxis like antiembolic stockings or anticoagulants. Healthcare providers use the device to manage patient risk of DVT; therapy benefits patients by reducing blood pooling and thrombosis risk.

Clinical Evidence

No clinical test data was used to support the decision of safety and effectiveness. Bench testing only.

Technological Characteristics

Compressible limb sleeve system; sequential or intermittent pneumatic compression. Materials: Garment and air hose (applied parts). Power: AC 100-240V, 50/60Hz; includes battery pack. Dimensions: 7.54" x 5.12" x 7.95". Software: IEC 62304 compliant. Safety/EMC: IEC 60601-1-2, IEC 61000 series, CISPR 11. Biocompatibility: ISO 10993-1, -5, -10, -12. Risk Management: ISO 14971, IEC 60812.

Indications for Use

Indicated for at-risk patients to increase venous blood flow and help prevent deep vein thrombosis (DVT).

Regulatory Classification

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.

Predicate Devices

• VESOFLOW (K110977)

Submission Summary (Full Text)

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Public Health Service

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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 ____________________________________________________________________________________________________________________________________________________________________

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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: | [phone] |
| Fax: | [phone] |
| 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 |

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# 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<br>medical devices – Part 1: Evaluation and testing with a risk<br>management process. |
| | ISO 10993-5:2009 (E) Biological evaluation of medical devices<br>– 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<br>12: Sample Preparation And Reference Materials.<br>(Biocompatibility) | |
| ISO/IEC 17025:2005 General Requirements for the Competence<br>of Testing and Calibration Laboratories. | |
| USP 35 Biological reactivity tests, in vitro | |
| Software | IEC 62304 First Edition 2006-05, Medical Device Software -<br>Software Life Cycle Processes. (Software/Informatics) |
| Electromagnetic<br>Compatibility &<br>Electrical Safety | EN 60601-1-2 : 2007/AC:2010 Medical electrical equipment -<br>Part 1-2: General requirements for basic safety and essential<br>performance - Collateral standard: Electromagnetic compatibility<br>- Requirements and tests. |
| IEC 60601-1-2 : 2007 Medical Electrical Equipment - Part 1-2:<br>General Requirements For Basic Safety And Essential<br>Performance - Collateral Standard: Electromagnetic<br>Compatibility - Requirements And Tests. (General I (QS/RM)) | |
| IEC 61000-3-2 : 2005+A1:2008+A2:2009 Electromagnetic<br>compatibility (EMC) - Part 3-2: Limits - Limits for harmonic<br>current emissions (equipment input current ≤16 A per phase). | |
| IEC 61000-3-3 : 2008 Electromagnetic compatibility (EMC) -<br>Part 3-3: Limits - Limitation of voltage changes, voltage<br>fluctuations and flicker in public low-voltage supply systems, for<br>equipment with rated current ≤16 A per phase and not subject to<br>conditional connection. | |
| IEC 61000-4-2 : 2008 Electromagnetic compatibility (EMC) -<br>Part 4-2: Testing and measurement techniques - Electrostatic<br>discharge immunity test. | |
| IEC 61000-4-3 : 2006+A1:2007+A2:2010 Electromagnetic<br>compatibility (EMC) - Part 4-3: Testing and measurement<br>techniques - Radiated, radio-frequency, electromagnetic field<br>immunity test | |
| | |
| | IEC 61000-4-4 : 2012 Electromagnetic compatibility (EMC) -<br>Part 4-4: Testing and measurement techniques - Electrical fast<br>transient/burst immunity test. |
| | IEC 61000-4-5 : 2005+corr.October:2009 Electromagnetic<br>compatibility (EMC) - Part 4-5: Testing and measurement<br>techniques - Surge immunity test. |
| | IEC 61000-4-6 : 2008 Electromagnetic compatibility (EMC) -<br>Part 4-6: Testing and measurement techniques - Immunity to<br>conducted disturbances, induced by radio-frequency fields. |
| | IEC 61000-4-8 : 2009 Electromagnetic compatibility (EMC) -<br>Part 4-8: Testing and measurement techniques - Power frequency<br>magnetic field immunity test. |
| | IEC 61000-4-11 : 2004 Electromagnetic compatibility (EMC) -<br>Part 4-11: Testing and measurement techniques - Voltage dips,<br>short interruptions and voltage variations immunity tests. |
| | CISPR 11 : 2009+A1:2010 Industrial, scientific and medical<br>equipment - Radio-frequency disturbance characteristics - Limits<br>and methods of measurement. |
| Performance | IEC 60068-2-14: 2009 Environmental testing - Part 2-14: Tests -<br>Test N: Change of temperature.<br>ISTA 2A Standard |
| Risk Management | ISO14971 Medical Devices - Application Of Risk Management<br>To Medical Devices. (General I (QS/RM))<br>IEC 60812 Analysis Techniques For System Reliability -<br>Procedure For Failure Mode And Effects Analysis (Fmea).<br>(General I (OS/RM)) |

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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.

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# 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<br>Foot: 130mmHg | Calf/Thigh : 45, 40 and 30mmHg<br>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<br>Temperature | 15°C- 35°C | 15°C- 35°C |
| Applied Part | Garment and Air Hose | Garment and Air Hose |
| Applied Mode of<br>Pressure | Sequential | Sequential |
| Number of<br>Chambers in<br>Garment | 3 | 3 |
| Inflation time per<br>chamber | 12 seconds | 12 seconds |
| Deflation time per<br>chamber | 48 seconds | 48 seconds |
| Pressure sequence | 45, 40 and 30 mmHg | 45, 40 and 30 mmHg |

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| calf/thigh | | |
|------------------------------|--------------------|--------------------|
| Pressure Range<br>Calf/Thigh | 45, 40 and 30 mmHg | 45, 40 and 30 mmHg |
| Pressure Range Foot | 130 mmHg | 130 mmHg |
| Pre-Programmed<br>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<br>Temperature | 15°C - 35°C | 15°C - 35°C |
| Applied Part | Garment and Air Hose | Garment and Air Hose |
| Applied Mode of<br>Pressure | Intermittent | Intermittent |
| Number of<br>Chambers in<br>Garment | No | No |
| Inflation time per<br>chamber<br>(Calf/Thigh) | 12 seconds | 12 seconds |
| Deflation time per<br>chamber<br>(Calf/Thigh) | 48 seconds | 48 seconds |

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| Inflation time per<br>chamber (Foot) | 3 seconds | 3 seconds |
|--------------------------------------|------------|------------|
| Deflation time per<br>chamber (Foot) | 30 seconds | 30 seconds |
| Pressure Range<br>Calf/Thigh | 40 mmHg | 40 mmHg |
| Pressure Range Foot | 130 mmHg | 130 mmHg |
| Pre-Programmed<br>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.