Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System

K151189 · Devon Medical Products · JOW · Sep 18, 2015 · Cardiovascular

Device Facts

• Record ID: K151189
• Device Name: Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System
• Applicant: Devon Medical Products
• Product Code: JOW · Cardiovascular
• Decision Date: Sep 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cirona 6300 disposable deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used in the home or clinical settings to: - Aid in the prevention of DVT - Enhance blood circulation - Diminish post-operative pain and swelling - Reduce wound healing time - Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs - As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

Device Story

Portable pneumatic compression system; consists of pump and sleeve assemblies. Operates by noninvasively inflating/deflating garment to simulate muscle contractions and stimulate blood flow in extremities. Provides 50mmHg pressure followed by 50-second deflation cycle. Used in home or clinical settings; operated by patient or clinician. Output is mechanical compression; assists in DVT prevention, circulation, and edema reduction. Benefits patient by reducing DVT risk and promoting healing.

Clinical Evidence

No clinical data or animal studies were conducted. Evidence consists of bench testing, including pressure accuracy, pressure switch, cycle time, alarm function, battery life, and garment burst testing. Biocompatibility testing (cytotoxicity, sensitization, irritation) performed per GLP.

Technological Characteristics

Pneumatic compression system. Components: pump and sleeve assemblies. Pressure: 50mmHg. Cycle: 50s deflation. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366, IEC 60601-1-11. Biocompatibility: Cytotoxicity, sensitization, irritation testing performed.

Indications for Use

Indicated for patients requiring DVT prophylaxis, enhancement of blood circulation, reduction of post-operative pain/swelling, wound healing, or treatment of venous/arterial/diabetic ulcers, stasis dermatitis, chronic venous insufficiency, and lower limb edema. Suitable for patients expecting long periods of immobility. Prescription required.

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

• Vena Pro (K133274)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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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

Devon Medical Products Steve Xu Regulatory Affairs Specialist 1100 First Avenue, Suite 202 King Of Prussia, Pennsylvania 19406

Re: K151189

> Trade/Device Name: Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: August 7, 2015 Received: August 10, 2015

Dear Steve Xu,

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. 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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# Indications for Use

510(k) Number (if known) K151189

Device Name

Cirona 6300 Disposable Deep Vein Thrombosis Prevention System

Indications for Use (Describe)

The Cirona 6300 disposable deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

This device can be used in the home or clinical settings to:

- Aid in the prevention of DVT ●
- . Enhance blood circulation
- Diminish post-operative pain and swelling .
- Reduce wound healing time .
- Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs
- As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# Section 5

#### 510K Summary

#### Submitter:

Devon Medical Products

1100 First Avenue, Suite 202

King of Prussia, PA 19406

Phone: [phone]

610.930.4035 Fax:

Contact Person: John Siegel, COO

Date Prepared: September 18, 2015

## Device:

Common Names: Intermittent Pneumatic Compression Device

Cirona™ 6300 Disposable Deep Vein Thrombosis Prevention System Proprietary Name:

Regulatory Class II

Product Code: JOW

### Predicate Devices:

The Cirona 6300 Deep Vein Thrombosis Prevention System is equivalent to the following:

| Predicate Device | Manufacturer | 510(k)# |
|------------------|----------------------|---------|
| Vena Pro | Innovamed Health LLC | K133274 |

### Device Description

Premarket notification device:

Cirona 6300 Disposable Deep Vein Thrombosis Prevention System

The Cirona™ 6300 disposable deep vein thrombosis prevention system (refer as Cirona 6300 below) is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by simulating blood flow in the extremities (simulating muscle contractions). The Cirona 6300 system consists of a pair of pump and sleeve assemblies.

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# Section 5

The device will alternatively inflate and deflate the garment (sleeve) to stimulate blood flow in the extremities (muscle contraction). The device provides a 50mmHg pressure and followed by 50 seconds of deflation period once it reaches the desired pressure.

# Intended Use:

The Cirona 6300 disposable deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

This device can be used in the home or clinical settings to:

- . Aid in the prevention of DVT
- Enhance blood circulation
- . Diminish post-operative pain and swelling
- Reduce wound healing time

Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg . ulcers, chronic venous insufficiency and reduction of edema in the lower limbs

- As a prophylaxis for DVT by persons expecting to be stationary for long periods of time .
# Technological Characteristics:

Below is a table of comparison for the technological characteristics against the predicate device:

| Predicate | Innovamed Vena Pro |
|------------------------|--------------------|
| Indication for Use | S |
| Components | S |
| Material | SE |
| Biocompatibility | SE |
| Principle of Operation | SE |
| Pressure | S |
| User Interface | S |

*SE - Substantial Equivalent *S - Same

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# Section 5

The manufacturer believes that the technological characteristics of the Cirona 6300 Disposable Deep Vein Thrombosis Prevention System are substantially similar to those of the predicate device. Cirona 6300 has very similar components to its predicate devices and very similar principles of operation.

# Performance Tests

To verify that the device design met its function and performance requirements, samples of the device underwent function and mechanical testing.

The following tests were conducted:

| Function Performance Tests | |
|----------------------------|------------------------------------------|
| TR36.0001 | Pressure Accuracy Test Report |
| TR36.0002 | Pressure Switch Test Report |
| TR36.0003 | Cirona 6300 Cycle Time Test Report |
| TR36.0004 | Alarm Function Test Report |
| TR36.0005 | Battery Life Test Report |
| TR36.0010 | Cirona 6300 Garment Burst Testing Report |

The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is substantially equivalent to the predicate.

### Biocompatibility

Biocompatibility test evaluation for Cirona 6300 is done in according to the FDA Good Laboratory Practice. The following tests were done:

- . Cytotoxicity
- . Sensitization
- Irritation

# Sterilization and Shelf Life

Sterilization and shelf life is not applicable to Cirona 6300.

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# Electrical Safety and Electromagnetic Compatibility (EMC)

EMC tests were conducted according to the following standards:

- IEC 60601-1: 2005+C1:2006+C2:2007 Medical electrical equipment Part 1: General . requirements for basic safety and essential performance
- IEC 60601-1-2: 2007 Medical electrical equipment Part 1-2: General requirements for basic ● safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for safety -Collateral Standard: Usability including IEC 62366: Application of usability engineering to medical devices
- IEC 60601-1-11: 2010 Medical electrical equipment Part 1-11: General requirements for . basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

## Software Verification and Validation

Software verification and validation was conducted and documentation is provided. The software was considered as a "moderate" level of concern, since a failure or latent flaw in the software could directly result in serious injury to the patient or operator.

### Animal Study and Clinical Study

No animal study or clinical study was conducted.

### Statement of Substantial Equivalence

The Cirona 6300 Disposable Deep Vein Thrombosis Prevention System is substantially equivalent in technology, function, operating parameters, and intended use to predicate devices that are currently commercially available and in distribution, and does not raise any new questions of safety or effectiveness.