SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB

K070457 · Sun Scientific, LLC · MHW · May 16, 2007 · General Hospital

Device Facts

• Record ID: K070457
• Device Name: SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB
• Applicant: Sun Scientific, LLC
• Product Code: MHW · General Hospital
• Decision Date: May 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5075
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

To assist in the management of venous stasis ulcers by applying pressure.

Device Story

Device consists of a Pre-Filled Air Bladder (PFAB) and a Leg Compressor. PFAB is an oval polyurethane bladder with hydrophilic foam base for exudate absorption and adhesive flanges for skin attachment. Leg Compressor is a nylon-covered urethane air chamber worn over the PFAB to hold it in place and apply additional pressure. Includes a self-adjusting, color-coded manometer for reference pressure monitoring and a safety release valve. Device is used to redistribute and apply pressure to venous leg ulcers to facilitate healing. Operated by clinician or patient; used in clinical or home settings. Manometer provides visual feedback to avoid over-inflation (red zone starts at ~30 mm Hg). Output is mechanical compression; assists in wound management by maintaining clean, covered, pressurized environment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on biocompatibility of materials and similarity to legally marketed predicate devices.

Technological Characteristics

Materials: Polyurethane film, hydrophilic foam, nylon fabric. Sensing: Mechanical self-adjusting manometer for reference pressure monitoring. Energy: Manual inflation. Form factor: Three sizes (Small, Medium, Large). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for the management of venous stasis ulcers in patients requiring compression therapy.

Regulatory Classification

Identification

An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.

Predicate Devices

• Unna Boot Dressing by Graham Field (K883224)
• Unna Sleeve by ACI Medical (K903532)
• Unna Flex Elastic Unna Boot by Convatec (Exempt)
• Hydrasorb Sterile Dressing by Avitar (K973260)
• C-Boot (K041659)

Submission Summary (Full Text)

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K070457

# SUN SCIENTIFIC LLC

MAY 16 2007

# 510 (k) Summary

Date Prepared [21 CFR 807.92(a)(1)]

5/11/07

#### Submitter's Information [21 CFR 807.92(a)(1)]

This 510(k) is being submitted by Joseph Azary (consultant) on behalf of Sun Scientific LLC Joseph Azary can be contacted by telephone at [phone] or fax at [phone].

#### Regulatory Consultant

Joseph Azary Azary Technologies LLC 543 Long Hill Avenue Shelton, CT 06484

Tel: [phone] Email: [e-mail] Fax: [phone]

#### Manufacturer / Sponsor

Sun Scientific LLC 88 Ashford Avenue Dobbs Ferry, NY 10522

Tel: [phone]

FDA Establishment Registration is pending.

NOTE: Please have the FDA Substantial Equivalence letter reflect this device is a product of Sun Scientific LLC

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#### Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)|

Device Trade Name: Leg Compressor & PFAB, Leg Compressor & Pre-Filled Air Bladder Device Common, Usual, or Classification Names: Compression Legging, Bandage

# Classification: Unclassified, Product Code FRO N.HW

#### Predicate Device [21 CFR 807.92(a)(3)]

The subject device is most similar to the following types of devices: Unna Boot Dressing by Graham Field - K883224 Unna Sleeve by ACI Medical - K903532 Unna Flex Elastic Unna Boot by Convatec - Exempt from 510(k), classified as "FQM" Hydrasorb Sterile Dressing by Avitar - K973260 C-Boot - K041659

#### Description of the Device [21 CFR 807.92(a)(4)]

The device includes a Leg Compressor and a Pre-Filled Air Bladder (PFAB).

The PFAB does not apply pressure, but when it is used in conjunction with a compression bandage, it will exert local pressure (because of the air pocket). Compression bandages exert pressure, therefore the pre-filled air bladder will redistribute the pressure that the bandage would already by supplying.

Overall the device is meant to redistribute and apply pressure to the venous ulcer. It has been found over the years that compression bandages or stockings healed more venous leg ulcers than no compression.1

1 Nelson, E, Cullum, N, and Jones, J, "Venous Leg Ulcers" published in American Family Physician, April 2005.

If the venous ulcer is kept covered and clean with applied pressure the healing process is more effective. The concept behind this device is to keep the wound covered and apply pressure on the wound.

#### PFAB (Pre-Filled Air Bladder)

The PFAB is an oval shaped polyurethane pre-filled air bladder with four flanges. The tips of the flanges have medical adhesive, which adheres to the skin. The bottom of the PFAB has medical grade hydrophilic foam, which will cover the ulcer and is used to absorb the exudates.

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| Size | Dimensions<br>(Length x Width) | Flanges | Tape<br>(thickness) |
|--------|--------------------------------|---------|---------------------|
| Small | 2" x 1.5" | 1.5" | 0.75" |
| Medium | 4.5" x 2.5" | 1.5" | 0.75" |
| Large | 6" x 4" | 1.5" | 0.75" |

The PFAB will be offered in three sizes (Small, Medium, and Large). The dimensions are as follows:

#### Leg Compressor

The leg compressor is used to hold the PBAB in place and apply additional pressure. The leg compressor contains an air chamber that is made of 2 layers of urethane film. The outer black fabric is Nylon. The leg compressor also has a self adjusting manometer attached to the outside to measure the pressure within the air bladder, which will be situated along the Great Saphenous Vein.

The manometer is used for reference only and is not meant to be used for accurate measurements of pressure.

The Leg Compressor includes a safety release valve to deflate the compressor. In addition, the manometer is color coded. As a precaution the user should not inflate the compressor in the red zone.

The pressure at the beginning of the red zone is approximately 30 mm Hg, which is similar to the pressure from a typical Umma Boot or compression bandage.

#### Intended Use [21 CFR 807.92(a)(5)]

To assist in the management of venous stasis ulcers by applying pressure.

### Technological Characteristics [21 CFR 807.92(a)(6)|

Sun Scientific LLC believes that the subject device is substantially equivalent to the predicate devices.

#### Performance Data [21 CFR 807.92(b)(1)]

The materials that make contact with the patient are biocompatible and are identical to the materials used in one of the predicate devices.

#### Conclusion [21 CFR 807.92(b)(3)]

We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAY 16 2007

Sun Scientific, LLC % Azary Technologies, LLC Mr. Joseph M. Azary 543 Long Hill Avenue Shelton, Connecticut 06484

Re: K070457

Trade/Device Name: Sun Scientific LLC - Leg Compressor and PFAB Regulation Number: 21 CFR 880.5075 Regulation Name: Elastic bandage Regulatory Class: I Product Code: MHW Dated: February 12, 2007 Received: February 20, 2007

Dear Mr. Azary:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Joseph M. Azary

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milkersen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K070457

Device Name: Sun Scientific LLC - Leg Compressor and PFAB

Indications For Use:

To assist in the management of venous stasis ulcers by applying pressure.

Prescription Use X (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)

Mach

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(Division Sign-Off) (Division of General, Restorative, and Neurological Devices

510(k) Number