DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER

• K Number: K082208
• Device Name: DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER
• Manufacturer: SCIVOLUTIONS, INC.
• Date Cleared: 2008-12-01 ( 118 days)
• Product Code: NAC
• Regulation Number: 878.4018
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K032983 , K974348 , K982892 , K973716
• Predicate For: N/A

Intended Use

The Doctors choice bandage with spray on remover is intended for prescription use in the local management of pressure sores as prescribed by a medical professional.

Device Description

The SciVolutions, Doctors Choice slow healing bandage is comprised of three products. The first is a premium gauze bandage with a non-stick net bottom side and a hydropholic breathable, waterproof polyurethane film membrane top side. The second device is a nonstick hydrocolloid bandage with the same polyurethane film membrane top side. Both of these bandage types are packaged for general use or diabetic use, with the only difference being the carton and carton labeling. The third product is the spray on remover, which may be used with both products.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Doctors Choice slow healing Bandage with Spray on Remover) and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven device.

The document states that the device is a Class 1 device, meaning it is considered low risk and falls under general controls. For these types of devices, the regulatory pathway often relies on demonstrating substantial equivalence to a predicate device rather than extensive clinical studies with detailed acceptance criteria for performance metrics common to AI/ML systems.

Therefore, many of the requested details, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to or present in this specific 510(k) submission.

Summary of what is available:

• Intended Use: The Doctors choice bandage with spray on remover is intended for prescription use in the local management of pressure sores as prescribed by a medical practitioner.
• Regulatory Clearance Basis: Substantial equivalence to predicate devices (SciVolutions Gentle Care Bandage - K032983, Algoplaque Film Extra Thin Hydrocolloid Dressing - K974348, 3M Tegasorb Thin Hydrocollide Dressing - K982892, DuoDerm Extra Thin CGF Dressing - K973716).
• Product Classification: Class 1, Product Code NAC (Dressing, Wound, Hydrophilic).

What is NOT available in the provided text (and generally not expected for this type of device and submission):

1. Table of Acceptance Criteria and Reported Device Performance: Not included, as performance is typically demonstrated by substantial equivalence to predicates for Class I devices like this.
2. Sample size used for the test set and data provenance: Not applicable/provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided.
4. Adjudication method for the test set: Not applicable/provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable/provided, as this is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
7. The type of ground truth used: Not applicable/provided.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Summary

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510(k) SUMMARY K082208

Regulatory Correspondent:

Regulatory and Marketing Services (RMS). 962 Allegro Lane Apollo Beach, FL 33572 Phone: [phone] Fax: [phone] [e-mail] DEC 0 1 2008

Submitter of 510(k):

SciVolutions 2260 Reaford Ct Gastonia, NC 28052 USA

Phone: [phone] Fax:

Contact Person:

Alan Nash

Date of Summary:

Trade/Proprietary Name:

Classification Name:

Product Code:

11/26/08

Doctors Choice slow healing Bandage with Spray on Remover

Dressing, Wound, Hydrophilic

NAC

Intended Use:

Car

The Doctors choice bandage with spray on remover is intended for prescription use in the local management of pressure sores as prescribed by a medical practitioner.

Device Description:

The SciVolutions, Doctors Choice slow healing bandage is comprised of three products. The first is a premium gauze bandage with a non-stick net bottom side and a hydropholic breathable, waterproof polyurethane film membrane top side. The second device is a nonstick hydrocolloid bandage with the same polyurethane film membrane top side. Both of these bandage types are packaged for general use or diabetic use, with the only difference being the carton and carton labeling. The third product is the spray on remover, which

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may be used with both products. Those products are in FDA classification code NAC, which is Class 1 and 510(k) exempt. Due to the product modifications and the addition of the spray on remover this 510(k) is being submitted.

166822008151

Predicate Device:

SciVolutions Gentle Care Bandage - K032983 Algoplaque Film Extra Thin Hydrocolloid Dressing - K974348 3M Tegasorb Thin Hydrocollide Dressing - K982892 DuoDerm Extra Thin CGF Dressing - K973716

Substantial Equivelance:

Substantial Equivelance.
The Scivolutions Doctors Choice Slow Healing Bandage with Spray on is a The Screations Doctors Cherce in both general purpose and diabetic dressing Class I device winen is available in over have been tested and the device is packaging. The dressing and spray on renevelicate. This device does not contain any antibacterial agent as our predicate K032983. :

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a graphic representation of an eagle or bird-like figure. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 1 2008

SciVolutions % Regulatory and Marketing Services Mr. Alan Nash 962 Allegro Lane Apollo Beach, Florida 33572

Re: K082208

Trade/Device Name: Doctors Choice slow healing Bandage with Spray on Remover Product Code: NAC Dated: November 12, 2008 Received: November 17, 2008

Dear Mr. Nash:

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.

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

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Page 2 - Mr. Alan Curtis, RAC

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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. Millman

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): K082208

Device Name: Doctors Choice slow healing Bandage with Spray on Remover

Indications for Use:

The Doctors choice bandage with spray on remover is intended for prescription use in the local management of pressure sores as prescribed by a medical professional.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Niel R.P. Onde for nixon

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

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510(k) Number K082208

Regulation Number and Section

§ 878.4018 Hydrophilic wound dressing.

(a)
Identification. A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon). This classification does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.