(118 days)
Not Found
No
The device description and other sections do not mention any AI or ML components or capabilities. The device is a bandage and spray remover.
Yes
The device is intended for the "local management of pressure sores," which indicates a therapeutic purpose.
No
The device is described as a bandage with a spray-on remover for the local management of pressure sores, which is a treatment rather than a diagnostic function.
No
The device description clearly outlines physical components: gauze bandages, hydrocolloid bandages, and a spray-on remover. There is no mention of software as a component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "local management of pressure sores." This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a bandage and a spray-on remover. These are physical products applied externally to the body for wound care. They do not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, or analysis of biological fluids or tissues.
Therefore, the Doctors choice bandage with spray on remover falls under the category of a medical device for wound management, not an in vitro diagnostic device.
N/A
Intended Use / 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 practitioner.
Product codes (comma separated list FDA assigned to the subject device)
NAC
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SciVolutions Gentle Care Bandage - K032983, Algoplaque Film Extra Thin Hydrocolloid Dressing - K974348, 3M Tegasorb Thin Hydrocollide Dressing - K982892, DuoDerm Extra Thin CGF Dressing - K973716
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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510(k) SUMMARY K082208
Regulatory Correspondent:
Regulatory and Marketing Services (RMS). 962 Allegro Lane Apollo Beach, FL 33572 Phone: (813) 645-2855 Fax: (813) 645-2856 awconsitng@aol.com DEC 0 1 2008
Submitter of 510(k):
SciVolutions 2260 Reaford Ct Gastonia, NC 28052 USA
Phone: 704-853-0100 704-853-0400 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
1
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. :
2
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
3
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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
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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