CIRCUFLOW 5150

K123959 · Devon Medical, Inc. · JOW · Feb 28, 2013 · Cardiovascular

Device Facts

• Record ID: K123959
• Device Name: CIRCUFLOW 5150
• Applicant: Devon Medical, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The CircuFlow™ 5150 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions: - Lymphedema - Venous stasis ulcers - Venous insufficiency - Peripheral edema The device is intended for both home and hospital use.

Device Story

CircuFlow 5150 is a digitally controlled sequential pneumatic compression device; applies gradient pressure to limbs via garment chambers. Input: physician-prescribed pressure and treatment time settings. Operation: pump inflates garment chambers sequentially from distal to proximal; distal chambers maintain higher pressure than proximal (7% pressure reduction per successive chamber); holds pressure until all chambers inflated; releases simultaneously; cycle repeats. Used in home or hospital; operated by clinician or patient. Output: mechanical compression to limb. Benefit: treatment of lymphedema, venous stasis ulcers, venous insufficiency, and peripheral edema.

Clinical Evidence

Bench testing only. Performance testing included pressure accuracy, cycle time, reverse pressure, treat time performance, pressure sensor calibration, and sleeve integrity tests to ensure specifications are met.

Technological Characteristics

Digitally controlled pneumatic pump; electrically generated compressed air; tubing; limb sleeves. Conforms to IEC 60601-1, IEC 60601-1-2, AAMI ES 60601-1, ISO 10993-1, and ISO 14971. Sequential inflation logic with 7% pressure gradient between chambers.

Indications for Use

Indicated for patients requiring treatment for lymphedema, venous stasis ulcers, venous insufficiency, or peripheral edema. Intended for use in home and hospital settings.

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

• CircuFlow™ 5200 (K101523)
• CircuFlow™ 5100 (K100446)

Submission Summary (Full Text)

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K123959

## SECTION 5

FEB 2 8 2013

## 510(K) SUMMARY

#### Submitter:

Devon Medical Products, Inc.

#### Contact Person:

Ruth Wu, COO 1100 First Avenue, Suite 202 King of Prussia, PA 19406 Phone: [phone] Fax: [phone]

#### Common Classification & Proprietary Names:

Sequential Compression Device Common Names: CircuFlow™ 5150 Proprietary Name:

#### Date Prepared:

October 31rd, 2012

#### Classification

The classification name, 21 CFR Part and Paragraph number, product code and classification of the CircuFlow 10 5150.

| Classification Name | 21 CFR<br>Section | Product<br>Code | Class |
|-----------------------------|-------------------|-----------------|-------|
| Compressible Limb<br>Sleeve | 870.5800 | JOW | II |

#### Predicate Devices:

The CircuFlow™ 5150 Sequential Compression Device is substantially equivalent to the following.

| Predicate Device | Manufacturer | 510(k)# |
|------------------|---------------------|---------|
| CircuFlow™ 5200 | Devon Medical, Inc. | K101523 |
| CircuFlow™ 5100 | Devon Medical, Inc. | K100446 |

## Device Description

The CircuFlow™ 5150 is a digitally controlled sequential pneumatic compression device designed to apply compression to a limb. The CircuFlow™ 5150 enables different treatment pressures and treatment times that should be used according to physician prescription. When activated, air flows into the garment chambers, and the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones).

After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to

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## SECTION 5

prevent reverse gradient flow. Once all chambers are inflated, they are then all released

simultaneously, and the cycle repeats. Pressure within in the first chamber can be programmed, with each successive chamber having its pressure be 7% less than the previous chamber.

#### Intended Use:

The CircuFlow™ 5150 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:

- Lymphedema -
- Venous stasis ulcers -
- Venous insufficiency -
- Peripheral edema -

The device is intended for both home and hospital use.

#### Technological Characteristics:

The manufacturer believes that the technological characteristics of the CircuFlow™ 5150 are substantially equivalent to those of the predicate devices.

The CircuFlow™ 5150 has very similar components to its predicate devices and has very similar principles of operation. The device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve, like the predicates, pressure is applied cyclically for a specified period of time, according to the physician's prescription.

#### Performance Testing

Bench and laboratory testing was performed and assures that the product meets its specifications. The manufacturer believes that the technological characteristics of the CircuFlow™ 5150 are substantially similar to those of the predicate devices. The performance testing includes the following tests:

| List of Performance Tests | |
|---------------------------|----------------------------------|
| Test 1 | Pressure Accuracy Test |
| Test 2 | Cycle Time Test |
| Test 3 | Reverse Pressure Test |
| Test 4 | Treat Time Performance |
| Test 5 | Pressure Sensor Calibration Test |
| Test 6 | Sleeve Integrity Test |
| Test 7 | Treat Time Test |

#### Standards

The CircuFlow™ 5150 conforms to the following standards:

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IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard:

AAMI ES 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ISO 14971 Medical devices - Application of risk management to medical devices

#### Statement of Substantial Equivalence

The CircuFlow™ 5150 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.

#### Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Devon Medical Products believes that the CircuFlow™ 5150 is substantially equivalent to the predicate devices as described herein.

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Image /page/3/Picture/0 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" around the perimeter. Inside the circle is a stylized symbol of three human figures connected by flowing lines, representing health and well-being.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

February 28, 2013

Devon Medical Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street. NW Buffalo, MN 55313

Re: K123959

Trade/Device Name: CircuFlow 5150 Sequential Compression Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: February 15, 2013 Received: February 19, 2013

Dear Mr. Job:

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. Iisting 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

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Page 2 - Mr. Mark Job

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

## Matthew Gillillebrenner

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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## SECTION 4

## INDICATIONS FOR USE STATEMENT

K123959 510(k) Number (if known):

Device Name: CircuFlow™ 5150 Sequential Compression Device

Indications for Use:

The CircuFlow™ 5150 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:

- Lymphedema -
- Venous stasis ulcers -
- -Venous insufficiency
- -Peripheral edema

The device is intended for both home and hospital use.

Prescription Use ____________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Matthew G. Hillebrenner