VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS

K122873 · Caremed Supply, Inc. · JOW · Jan 15, 2013 · Cardiovascular

Device Facts

• Record ID: K122873
• Device Name: VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS
• Applicant: Caremed Supply, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Jan 15, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

VASOPOUSE® is a non-invasive mechanical prophylactic system for DVT prevention; operates by periodically inflating a sleeve around a limb to massage legs in a wavelike, milking motion. This motion counteracts blood stasis and coagulation changes; promotes blood flow; helps empty pooled or static blood from femoral vein valve cusps; increases fibrinolytic activity by stimulating plasminogen activator release. Device is used in clinical settings; operated by healthcare providers to complement other prophylactic measures like anti-embolic stockings and anticoagulants. Output is mechanical compression of the limb. Benefits include reduced risk of DVT and associated pulmonary embolism.

Clinical Evidence

Bench testing only. Safety and performance testing conducted per EN/IEC60601-1-2:2007, ISO10993-1:2009, ISO10993-5:2009, ISO10993-10:2002/AMD.1:2006(E), IEC60068-2-06, IEC60068-2-27, and ISO14971:2007. Testing included function, vibration, shock, free fall drop, and life tests. Results demonstrated compliance with pre-defined acceptance criteria.

Technological Characteristics

Mechanical compression limb sleeve system. Operates via periodic pneumatic inflation. Pressure range 40/45 and 130 mmHg. No battery backup. Complies with IEC60601-1, EN/IEC60601-1-2, IEC60068-2-06, IEC60068-2-27, ISO14971, ISO10993-1, ISO10993-5, and ISO10993-10 standards. Class II device.

Indications for Use

Indicated for at-risk patients requiring increased venous blood flow to 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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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<br>Taipei City 23145, Taiwan, R.O.C. |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | TSUNG-HSUAN LIU |
| Establishment Registration Number: | 8022590 |

#### Identification of the Device: 5.5

| Proprietary/Trade name: | VASOPOUSE® Deep Vein Thrombosis Compression<br>Device<br> |
|-------------------------|-----------------------------------------------------------|
| | 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 |

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# 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

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#### 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.<br>VASOPOUSE® SQS and IPCS<br>Deep Vein Thrombosis (DVT)<br>Compression Devices are intended<br>to increase venous blood flow in at<br>risk patients in order to help prevent<br>deep vein thrombosis. | The Caremed Supply Inc. Vesoflow<br>SQS and IPCS Deep Vein<br>Thrombosis (DVT) Compression<br>Devices are intended to increase<br>venous blood flow in at risk patients<br>in order to help prevent deep vein<br>thrombosis. |
| Model | SQS/IPCS | SQS/IPCS |
| Pressure Range | Same | 40/45 and 130 mmHg |
| Sterilization | N/A | N/A |
| Referenced | Same | IEC60601-1:<br>1988+A1:1991+A2:1995<br>EN/IEC60601-1-2:2007<br>EN/IEC60601-1-4 |
| Standards | | |

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| Caremed Supply Inc.<br>510(k) Notification | | VASOPOUSE® DVT Compression Device<br>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.

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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.

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# 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 [phone] or [phone] 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

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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

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510(k) Number K122873

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