ANGIO-PRESS DVT Compression Device Model Name: IPCS

K143202 · Pegasus Medical Supply, Inc. · JOW · Jul 7, 2015 · Cardiovascular

Device Facts

• Record ID: K143202
• Device Name: ANGIO-PRESS DVT Compression Device Model Name: IPCS
• Applicant: Pegasus Medical Supply, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Jul 7, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pegasus Medical Supply Inc. ANGIO-PRESS IPCS Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in patients in order to help prevent deep vein thrombosis.

Device Story

Non-invasive mechanical prophylactic system; counteracts blood stasis and coagulation changes. Device inflates sleeves around limbs periodically; massages legs in wavelike, milking motion; promotes blood flow; empties pooled/static blood from femoral vein valve cusps; increases fibrinolytic activity. Used to prevent blood pooling. Complements other prophylactic measures like anti-embolic stockings and anticoagulants. Operated via AC power; no battery pack. Intended for clinical or home use (excluding outdoor/transportation settings). Healthcare providers/patients use device to reduce DVT risk; output is mechanical compression; clinical decision-making supported by prophylactic therapy.

Clinical Evidence

No clinical data. Safety and effectiveness supported by bench testing, including biocompatibility (ISO 10993), electrical safety/EMC (IEC 60601-1, IEC 60601-1-2), software (IEC 62304), and performance testing (vibration, shock, temperature).

Technological Characteristics

Compressible limb sleeve system; AC-powered pneumatic pump. Materials evaluated per ISO 10993. Software developed per IEC 62304. Dimensions: 12.6" x 4.3" x 7.7". Weight: 3.1 kg. Intermittent pneumatic compression mode. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 62366.

Indications for Use

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

• VasoPress DVT Supreme Mini, Pump Model No. VP500DM (K101915)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 7, 2015

Pegasus Medical Supply, Inc. % Michael Lee President AcmeBiotechs Co., Ltd. No. 45, Minsheng Rd. Danshui Town New Taipei City, 251 TW

Re: K143202

Trade/Device Name: ANGIO-PRESS DVT Compression Device Model Name: IPCS Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: June 4, 2015 Received: June 8, 2015

Dear Michael 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.

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

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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 (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 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. Hilleman

for

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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ANGIO-PRESS DVT Compression Device Model: IPCS

#### Indications for Use

## 510(k) Number (if known): K143202

Device Name: ANGIO-PRESS DVT Compression Device Model Name: IPCS

#### Indications for Use:

The Pegasus Medical Supply Inc. ANGIO-PRESS IPCS Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in patients in order to help prevent deep vein thrombosis.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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ANGIO-PRESS DVT Compression Device Model: IPCS

## 510(k) Summary

| 5.1 | Type of Submission: | Traditional |
|-----|------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| 5.2 | Preparation Date: | 29th October 2014 |
| 5.3 | Submitter:<br>Address: | Pegasus Medical Supply, Inc.<br>No. 27-1, Ln. 473, Sec. 2, Hezun N. Rd.,<br>Zhongli City, Taoyuan County 32060,<br>Taiwan (R.O.C.) |
| | Phone: | [phone] |
| | Fax: | [phone] |
| | Contact: | PAO-MING SHIH<br>([e-mail]) |
| | Registration number: | - |

#### 5.4 Identification of the Device:

| Proprietary/ | ANGIO-PRESS DVT Compression Device |
|------------------------|------------------------------------|
| Trade name: | Model Name: IPCS |
| 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: | VasoPress DVT Supreme Mini, Pump Model |
|------------------------|----------------------------------------|
| | No. VP500DM |
| Manufacturer: | Compression Therapy Concepts, Inc. |
| Regulation number: | 870.5800 |
| Product Code: | JOW |
| 510(k) Number: | K101915 |

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### 5.6 Intended Use and Indications for Use of the subject device.

The Pegasus Medical Supply Inc. ANGIO-PRESS IPCS Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in patients in order to help prevent deep vein thrombosis.

# 5.7 Device Description

ANGIO-PRESS DVT Compression Device that counteracts blood stasis and coagulation changes - two of the three major factors that promote deep vein thrombosis (DVT). ANGIO-PRESS DVT Compression Device 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.

ANGIO-PRESS DVT Compression Device is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. Therefore, ANGIO-PRESS DVT Compression Device 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 ANGIO-PRESS DVT Compression Device.

| Testing Item | Standard and regulations applied |
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | ISO 10993-1:2009/Cor. 1:2010(E) Biological evaluation of medical<br>devices - Part 1: Evaluation and testing with a risk management<br>process. |
| | ISO 10993-5:2009 (E) Biological evaluation of medical devices –<br>Part 5: Tests for <i>in vitro</i> cytotoxicity. |
| | ISO 10993-10:2010 (E) Biological evaluation of medical devices – |
| Part 10: Tests for Tests for irritation and skin sensitization. | |
| ISO 10993-12: 2012 (E) Biological evaluation of medical devices – | |
| Part 12: Sample Preparation And Reference Materials. | |
| ISO/IEC 17025:2005 General Requirements for the Competence of<br>Testing and Calibration Laboratories. | |
| USP 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 - Part<br>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 Performance<br>- Collateral Standard: Electromagnetic Compatibility –<br>Requirements And Tests. (General I (QS/RM)) |
| | IEC 60601-1 Medical Electrical Equipment – Part 1:General<br>requirements for basic safety and essential performance |
| Performance | IEC 60068-2-6 Environmental testing - Part 2-6: Tests - Test Fc:<br>Vibration (sinusoidal) |
| | IEC 60068-2-27 Environmental testing - Part 2-27: Tests - Test Ea<br>and guidance: Shock |
| | ISTA 2A Standard |
| | IEC 60068-2-14: 2009 Environmental testing - Part 2-14: Tests -<br>Test N: Change of temperature. |
| Risk Management | ISO 14971 Medical Devices - Application Of Risk Management<br>To Medical Devices. |
| | IEC 60812 Analysis Techniques For System Reliability –<br>Procedure For Failure Mode And Effects Analysis (Fmea). |
| Usability | IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical Equipment<br>- Part 1-6: General Requirements For Basic Safety And Essential<br>Performance - Collateral Standard: Usability. |
| IEC 62366 Edition 1.1 2014-01, Medical Devices - Application Of | |
| Usability Engineering To Medical Devices. | |

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All the test results demonstrate ANGIO-PRESS DVT Compression Device meet the requirements of its pre-defined acceptance criteria and intended uses.

# 5.9 Clinical Testing

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

# 5.10 Substantial Equivalence Determination

The ANGIO-PRESS DVT Compression Device is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared VasoPress DVT Supreme Mini, Pump Model No. VP500DM (K101915). Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

| Item | ANGIO-PRESS DVT<br>Compression Device | VasoPress DVT Supreme<br>Mini, Pump Model No.<br>VP500DM (K101915) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number | 870.5800 | 870.5800 |
| Classification | Class II | Class II |
| Product Code | JOW | JOW |
| Prescription Use | Yes | Yes |
| Indications for Use | The Pegasus Medical<br>Supply Inc. ANGIO-PRESS<br>IPCS Deep Vein<br>Thrombosis (DVT)<br>Compression Devices are<br>intended to increase venous<br>blood flow in patients in<br>order to help prevent deep<br>vein thrombosis. | The VasoPress Pump (Model<br>VP500DM) is an external<br>pneumatic compression device<br>for use with VasoPress DVT<br>garments, and is intended to<br>lower the risk of deep vein<br>thrombosis (DVT) in patients<br>who may be at risk. |

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| Model | IPCS | VP500DM |
|----------------------------------|---------------------|---------------------------|
| Dimension | 12.6" x 4.3" x 7.7" | 9.45" x 4.53" x 6.1" |
| Weight | 3.1 kg | 2 kg (without Power Cord) |
| Fuse Rating | 1A/250V | 1A or T1AH 250V |
| Pressure Range | Same | 40 and 80 mmHg |
| Input Rating | Same | AC 100-240V, 50/60Hz |
| Operating Humidity | Same | 30 - 75% |
| Operation Temperature | Same | 15°C - 35°C |
| Applied Part | Same | Garment and Air Hose |
| Applied Mode of<br>Pressure | Same | Intermittent |
| Number of Chambers in<br>Garment | Same | No |
| Inflation time per<br>chamber | Same | 12 seconds |
| Deflation time per<br>chamber | Same | 48 seconds |
| Pressure Range<br>Calf/Thigh | Same | 40 mmHg |
| Pressure Range Foot | Same | 80 mmHg |
| Battery Pack | No | Yes |

### 5.11 Similarity and difference

The difference between the proposed device and the predicate device is the battery pack. For predicate device, VasoPress DVT Supreme Mini, Pump Model No. VP500DM (K101915), the original intention to include battery pack function was to offer user a power solution when device was being used outdoor or during transportation. The system will automatically shift to battery power when the device which has been installed with the battery pack be disconnected from AC power source. Battery pack is an optional feature to VasoPress DVT and AC power source is the main power source.

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The main power source of the proposed device, ANGIO-PRESS DVT Compression Device is AC power, same with the predicate device. ANGIO-PRESS DVT Compression Device design does not include battery pack function, so it can't offer an outdoor or transpiration power solution as VasoPress DVT. But ANGIO-PRESS DVT Compression Device can offer the same function as VasoPress DVT which has not been installed with the battery pack. Also, ANGIO-PRESS DVT Compression Device will not change or affect the patient population who is intended to use this device. Therefore, the only difference of the proposed device without the battery pack to the predicate device is that the proposed device is not intended to be used outdoor or on transportation.

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 ANGIO-PRESS DVT Compression Device is substantially equivalent to the predicate device.