CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE

K123647 · Devon Medical, Inc. · JOW · Feb 14, 2013 · Cardiovascular

Device Facts

• Record ID: K123647
• Device Name: CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE
• Applicant: Devon Medical, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The CircuFlow 5208 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 home and hospital use.

Device Story

CircuFlow 5208 is a digitally controlled sequential pneumatic compression device. Input: air pressure delivered to limb garments. Operation: pump inflates garment chambers sequentially from distal to proximal; distal chambers maintain higher pressure than proximal; pressure held constant until all chambers inflated; simultaneous release; cycle repeats. Features: programmable pressure per chamber; ability to skip chambers or decrease pressure for wounds. Usage: home and hospital; operated by physician, nurse, or patient. Output: controlled pneumatic compression. Benefit: management of edema and venous conditions via gradient compression.

Clinical Evidence

Bench testing only. Performance testing included dielectric strength, leakage current, pressure calibration, pressure gradient performance, inflation/deflation time, and treatment time performance. No clinical data provided.

Technological Characteristics

Digitally controlled sequential pneumatic compression device. Components: electrically generated compressed air source, tubing, limb sleeves. Standards: IEC 60601-1, IEC 60601-1-2, AAMI ES 60601-1, ISO 10993-5, ISO 10993-10, ISO 14971. Operation: cyclic gradient pressurization.

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)
• Lymphapress Model 201MAX (K100677)
• Proact 1 (K003909)
• CircuFlow 5100 (K100446)

Submission Summary (Full Text)

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FEB 1 4 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].930.4035 Fax:

## Common Classification & Proprietary Names:

Sequential Compression Device Common Names: Proprietary Name: CircuFlow 5208

#### Date Prepared:

July 23'd, 2012

#### Classification

The classification name, 21 CFR Part and Paragraph number, product code and classification of the CircuFlow 5208.

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

### Predicate Devices:

The CircuFlow 5208 Sequential Compression Device is substantially equivalent to the following.

| Predicate Device | Manufacturer | 510(k)# |
|--------------------------|---------------------|---------|
| CircuFlow 5200 | Devon Medical, Inc. | K101523 |
| Lymphapress Model 201MAX | Mego Afek Ltd | K100677 |
| Proact 1 | Proact Company | K003909 |
| CircuFlow 5100 | Devon Medical, Inc. | K100446 |

#### Device Description

The CircuFlow 5208 is a digitally controlled sequential pneumatic compression device designed to apply compression to a limb. The CircuFlow 5208 enables different treatment pressures and treatment times that should be used according to physician prescription. When activated, air flows into garments chambers, 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).

Page 1 of 3

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### SECTION 5

After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within each chamber can be programmed and individual chambers can be skipped or the pressure decreased in the case of a wound.

#### Intended Use:

The CircuFlow 5208 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 home and hospital use.

#### Technological Characteristics:

The manufacturer believes that the technological characteristics of the CircuFlow 5208 are substantially similar to those of the predicate devices.

The CircuFlow 5208 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 5208 are substantially similar to those of the predicate devices. The performance testing includes the following tests:

| List of Performance Tests | |
|---------------------------|------------------------------------------|
| Test 1 | Dielectric Strength Test |
| Test 2 | Leakage Current Test |
| Test 3 | Pressure Calibration for Pressure Sensor |
| Test 4 | Pressure Gradient Performance |
| Test 5 | Inflation & Deflation Time Performance |
| Test 6 | Treatment Time Performance |

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## SECTION 5

#### Standards

The CircuFlow 5208 conforms to the following standards:

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 10993-5 Biological evaluation of medical devices - Part 1: Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity

ISO 10993-10 Biological evaluation of medical devices --Part 10:Tests for irritation and delayed-type hypersensitivity

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

### Statement of Substantial Eguivalence

The CircuFlow 5208 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 5208, is substantially equivalent to the predicate devices as described herein.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

FEB 1 4 2013

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

Re: K123647

Trade/Device Name: CircuFlow 5208 Sequential Compression Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: January 31, 2013 Received: February 1, 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, 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. Mark Job

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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### SECTION 4

## INDICATIONS FOR USE STATEMENT

K1236

K12364 510(k) Number (if known):

Device Name: CircuFlow 5208 Sequential Compression Device

Indications for Use:

The CircuFlow 5208 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:

- Lymphedema 1
- Venous stasis ulcers -
- Venous insufficiency -
- * Peripheral edema

The device is intended for home and hospital use.

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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