ANGIO-PRESS LITE DVT Compression Device

K173012 · Pegasus Medical Supply, Inc. · JOW · May 10, 2018 · Cardiovascular

Device Facts

• Record ID: K173012
• Device Name: ANGIO-PRESS LITE DVT Compression Device
• Applicant: Pegasus Medical Supply, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: May 10, 2018
• 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 LITE DVT Compression Device is intended to increase venous blood flow in patients in order to help prevent deep vein thrombosis.

Device Story

Non-invasive intermittent pneumatic compression system; consists of pump and single-patient-use leg/foot garments. Pump delivers pre-set inflation pressure (40mmHg calf/thigh; 80mmHg foot) to garments; pressure transfers to extremities to augment venous blood flow and reduce stasis. Used in clinical settings; operated by healthcare providers. Output is mechanical compression; aids in DVT prevention. System operates on continuous cycle (12s inflation/48s deflation per chamber).

Clinical Evidence

No clinical test data was used to support the decision of substantial equivalence. Bench testing only.

Technological Characteristics

Intermittent pneumatic compression system. Pump-driven inflation of soft, pliable garments. Pressure: 40mmHg (calf/thigh), 80mmHg (foot). Airflow: ≥ 6.0 L/min. Cycle: 12s inflation, 48s deflation. Electrical: AC 110-120V, 60Hz. Class II, Type BF. Ingress protection: IP21. Operating environment: 15°C-40°C, 30-75% humidity. Software: Embedded control logic for inflation/deflation cycles.

Indications for Use

Indicated for patients requiring increased venous blood flow to help prevent deep vein thrombosis.

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

• ANGIO-PRESS DVT Compression Device Model Name: IPCS (K143202)

Submission Summary (Full Text)

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May 10, 2018

Pegasus Medical Supply, Inc. Pao-Ming Shih General Manager No. 27-1, Ln. 473, Sec. 2, Hezun N. Rd., Zhongli City Taoyuan County, 32060 Tw

Re: K173012

Trade/Device Name: ANGIO-PRESS LITE DVT Compression Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: April 17, 2018 Received: April 18, 2018

Dear Pao-Ming Shih:

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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

### Nicole G. Ibrahim -S

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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### Indications for Use

510(k) Number (if known)

K173012

Device Name ANGIO-PRESS LITE DVT Compression Device

Indications for Use (Describe)

The Pegasus Medical Supply Inc. ANGIO-PRESS LITE DVT Compression Device is intended to increase venous blood flow in patients in order to help prevent deep vein thrombosis.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | × |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |

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Pegasus Medical Supply, Inc. ANGIO-PRESS LITE DVT Compression Device Traditional 510(k), K173012/S003 Section 5 - 510(k) Summary

#### 510(k) SUMMARY

| 5.1 | Type of Submission: | Traditional |
|-----|------------------------|---------------------------------------------------------------------------------|
| 5.2 | Date of Summary: | May 9, 2018 |
| 5.3 | Submitter:<br>Address: | Pegasus Medical Supply, Inc.<br>No.27-1, Ln. 473, Sec. 2, Hezun N. Rd., Zhongli |
| | | City, Taoyuan County 32060, Taiwan (R.O.C.) |
| | Phone: | [phone] |
| | Fax: | [phone] |
| | Contact: | PAO-MING SHIH |
| | | (borisshih(@pegasus-pms.com) |

#### 5.4 Identification of the Device:

| Proprietary/Trade name: | ANGIO-PRESS LITE DVT | |
|------------------------------|--------------------------|--|
| | Compression Device | |
| Classification Product Code: | JOW | |
| Regulation Number: | 870.5800 | |
| Regulation Description: | Compressible limb sleeve | |
| Review Panel: | Cardiovascular | |
| Device Class: | II | |

#### Identification of the Predicate Device: 5.5

| Predicate Device Name: | ANGIO-PRESS DVT Compression |
|------------------------------|------------------------------|
| | Device Model Name: IPCS |
| Manufacturer: | Pegasus Medical Supply, Inc. |
| Classification Product Code: | JOW |
| Regulation number: | 870.5800 |
| Device Class: | II |
| 510(k) Number: | K143202 |

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#### 5.6 Intended Use/ Indications for Use of the Device

The Pegasus Medical Supply Inc. ANGIO-PRESS LITE DVT Compression Device is intended to increase venous blood flow in patients in order to help prevent deep vein thrombosis.

#### 5.7 Device Description

The ANGIO-PRESS LITE DVT Compression Device is a non-invasive intermittent pneumatic compression system that aids in prevention and reduction in incidence of deep vein thrombosis (DVT).

The system consists of a pump and soft pliable compression single patient use garments for leg or foot compression. The pump supplies compression on a pre-set inflation pressure of 40mmHg for calf and thigh compression, and 80mmHg for foot compression. Pressure in the garments is transferred to the extremities, augmenting venous blood flow, thus reducing stasis.

#### 5.8 Non-clinical Testing

A series of safety and performance tests were conducted on the subject device, ANGIO-PRESS LITE DVT Compression Device.

- . Biocompatibility
- Software Validation
- . Electromagnetic compatibility and electrical safety
- Reliability
- . Performance
- . Usability

All the test results demonstrate ANGIO-PRESS LITE DVT Compression Device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.

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#### 5.9 Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

#### 5.10 Substantial Equivalence Determination

The ANGIO-PRESS LITE DVT Compression Device submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared ANGIO-PRESS DVT Compression Device Model Name: IPCS (K143202). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

| Item | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Proprietary Name | ANGIO-PRESS LITE DVT<br>Compression Device | ANGIO-PRESS DVT Compression<br>Device | N/A |
| Model Name | ANGIO-PRESS LITE | IPCS | |
| 510(k) No. | (to be assigned) | K143202 | |
| Intended Use | The Pegasus Medical Supply Inc.<br>ANGIO-PRESS LITE DVT<br>Compression Device is intended to<br>increase venous blood flow in<br>patients in order to help prevent<br>deep vein thrombosis. | The Pegasus Medical Supply Inc.<br>ANGIO-PRESS IPCS Deep Vein<br>Thrombosis (DVT) Compression<br>Devices is intended to increase<br>venous blood flow in patients in<br>order to help prevent deep vein<br>thrombosis. | Same |
| Type of use | Prescription Use | Prescription Use | Same |
| For Control Unit (Pump) | | | |
| Size (L x W x H) | 26 x 10.5 x 16 cm | 31.5 x 11 x 19.5 cm<br>(12.6" x 4.3" x 7.7") | Different but does<br>not impact safety<br>and effectiveness<br>of subject device |
| Weight | 2.5 Kg | 3.1 Kg | Different but does |
| | | | not impact safety<br>and effectiveness<br>of subject device |
| Pressure Range | Calf/Thigh: 40 mmHg<br>Foot: 80 mmHg | Calf/Thigh: 40 mmHg<br>Foot: 80 mmHg | Same |
| Input Rating | AC 110-120V, 60Hz | AC 100-240V, 50/60Hz | Different but does<br>not impact safety<br>and effectiveness<br>of subject device |
| Fuse Rating | T1AL 250V | 1A/250V | Different but does<br>not impact safety<br>and effectiveness<br>of subject device |
| IEC Classification | Class II, Type BF<br>Not AP or AGP type | Class I Type BF<br>Not AP or APG type | Different but does<br>not impact safety<br>and effectiveness<br>of subject device |
| Ingress of Water<br>Protection | IP21 | N/A | Different but does<br>not impact safety<br>and effectiveness<br>of subject device |
| Operation Humidity | 30% to 75% non-condensing | 30 - 75% | Same |
| Operation<br>Temperature | 15°C - 40°C | 15°C - 35°C | Different but does<br>not impact safety<br>and effectiveness<br>of subject device |
| Operation<br>Atmospheric<br>Pressure Range | 700 hPa to 1060 hPa | 700 hPa to 1060 hPa | Same |
| Mode of Operation | Continuous | Continuous | Same |
| Applied Part | Garment and Air Tubing | Garment and Air Hose | Same |
| Applied Mode of | Intermittent | Intermittent | Same |

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# Pegasus Medical Supply, Inc.
ANGIO-PRESS LITE DVT Compression Device

# Traditional 510(k), K173012/S003

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# Pegasus Medical Supply, Inc.
ANGIO-PRESS LITE DVT Compression Device

# Traditional 510(k), K173012/S003

| Pressure | | | | | |
|------------------------------------------------------------------------------------------------|----------------------------------|------------------------|-------------------------------------------------|----------------|----------------------------------------|
| Inflation time | 12 seconds | | 12 seconds | | Same |
| per chamber | | | | | |
| Deflation time | 48 seconds | | 48 seconds | | Same |
| per chamber | | | | | |
| Airflow | ≧ 6.0 L/min | | ≧ 6.0 L/min | | Same |
| Software | | | | | Different but does |
| | w/o Timer and Pressure display | | w/ Timer and Pressure display | | not impact safety |
| Control Panel | w/o Reset Timer function | | w/ Reset Timer function | | and effectiveness |
| | | | | | of subject device |
| For Applied Part | | | | | |
| Calf Garments<br>(For calf<br>circumference)<br>Thigh Garments<br>(For thigh<br>circumference) | Small | Up to 14" | Extra Small | 35 cm | |
| | | | (XS) | | |
| | Medium<br>Large | Up to 18"<br>Up to 24" | Small | 43 cm | Different but does |
| | | | (名) | | not impact safety |
| | | | Medium<br>(M) | 48 cm | and effectiveness<br>of subject device |
| | Bariatric<br>Medium | Up to 32"<br>Up to 29" | Bariatric | 81 cm<br>71 cm | |
| | | | (B) | | |
| | | | Medium | | Different but does |
| | | | (M) | | not impact safety |
| | Large | Up to 36" | Large | 89 cm | and effectiveness |
| | Bariatric | Up to 42" | (L) | | of subject device |
| Foot Garments<br>(For US men's size) | Standard | Up to 13 | Regular | Size 7 - 9 | Different but does |
| | | | (U) | | not impact safety |
| | Large | Over 13 | Large | Size 9 - 11 | and effectiveness |
| | | | (L) | | of subject device |
| Air Tubing /<br>Air Hose | Replacement tubing, 60" and 120" | | Air hose extension of<br>1.5, 3, and 4.5 metres | | Different but does |
| | | | | | not impact safety |
| | | | | | and effectiveness |
| | | | | | of subject device |

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#### 5.11 Similarity and Difference

The ANGIO-PRESS LITE DVT Compression Device has been compared with "ANGIO-PRESS DVT Compression Device Model Name: IPCS". The subject device has same intended use, principle of operation and similar technological characteristics as the predicate device. Although there are some specifications that are different between two devices, the performance test has been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device. The subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore, the difference between the subject device and the predicate device did not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device in intended use, safety and performance claims.

### 5.12 Conclusion

After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the ANGIO-PRESS LITE DVT Compression Device is substantially equivalent to the predicate device.