(89 days)
To assist in the management of venous stasis ulcers by applying pressure.
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.
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.
The PFAB will be offered in three sizes (Small, Medium, and Large).
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.
The provided document K070457 describes the submission of a 510(k) for the "Leg Compressor & PFAB" device. However, it explicitly states that performance data consists solely of biocompatibility testing. The submission concludes that the device is "as safe and effective as the predicate device" based on minor changes and material identity to a predicate.
Therefore, the document does not contain any information regarding a study demonstrating the device's clinical performance, acceptance criteria, sample sizes, ground truth establishment, or expert involvement. The device was classified as "Unclassified" and later as "Elastic Bandage" (Product Code FRO N.HW / MHW), which typically implies a lower regulatory burden and often does not require extensive clinical performance studies for 510(k) clearance if substantial equivalence to existing devices can be proven through other means (e.g., material equivalence, intended use equivalence).
Here's a breakdown of why many of your requested items cannot be fulfilled from this document:
- Table of acceptance criteria and reported device performance: Not available. The document does not define specific performance metrics or acceptance criteria for clinical effectiveness.
- Sample size for test set and data provenance: No clinical test set or study is mentioned beyond biocompatibility.
- Number of experts and qualifications for ground truth: Not applicable, as no clinical ground truth was established for performance.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not done.
- Standalone performance study: No standalone clinical performance study is described. The "Performance Data" section only mentions biocompatibility.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable, as this is not an AI/ML device, and no training set for an algorithm is mentioned.
- How the ground truth for the training set was established: Not applicable.
Summary from the provided document:
The only "performance data" mentioned is:
"The materials that make contact with the patient are biocompatible and are identical to the materials used in one of the predicate devices."
And the conclusion:
"We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device."
This indicates that the clearance was based on demonstrating substantial equivalence through material safety and comparison to existing predicate devices, rather than a new clinical performance study.
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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 (203) 944-9320 or fax at (203) 944-9317.
Regulatory Consultant
Joseph Azary Azary Technologies LLC 543 Long Hill Avenue Shelton, CT 06484
Tel: (203) 944-9320 Email: info@azarytech.com Fax: (203) 944-9317
Manufacturer / Sponsor
Sun Scientific LLC 88 Ashford Avenue Dobbs Ferry, NY 10522
Tel: (914) 591-8400
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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K070457 Page 2/3
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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K070457 Page 3/3
| Size | Dimensions(Length x Width) | Flanges | Tape(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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
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 (240) 276-0115 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 (800) 638-2041 or (240) 276-3150 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
Page 1 of 1
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
510(k) Number
§ 880.5075 Elastic bandage.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.