(369 days)
Not Found
No
The device description and intended use are for a standard antibacterial adhesive bandage, and there is no mention of AI or ML in the provided text.
No
The device, an antibacterial adhesive bandage, is intended to provide an antibacterial barrier for minor cuts and scrapes, which is a protective and preventative function rather than actively treating, diagnosing, or curing a specific disease or condition. While it aids in wound care, its primary action is not therapeutic in the sense of directly alleviating or curing a medical ailment.
No
Explanation: The device is an antibacterial adhesive bandage used for minor cuts and scrapes, providing a barrier. Its purpose is therapeutic/protective, not to diagnose a condition or disease.
No
The device description clearly states it is an antibacterial adhesive bandage, which is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for topical application to the skin to provide an antibacterial barrier for minor cuts and scrapes. This is a direct application to the body surface, not a test performed on a sample taken from the body.
- Device Description: The description focuses on the physical form (bandages) and the active ingredient (benzalkonium chloride) for topical application.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
Antibacterial Adhesive Bandages are to be applied to the skin for topical application. The bandages help provide an antibacterial barrier for minor cuts and scrapes.
Product codes (comma separated list FDA assigned to the subject device)
FRO, MXE
Device Description
Antibacterial adhesive bandages are similar to many pre-amendment and already cleared products with benzalkonium chloride. They are provided in various sizes in a box for over the counter purchase. The benzalkonium chloride concentration is 1%.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
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
N/A
0
November 15, 2021
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The logos are placed side-by-side.
Scivolutions, Inc Art Ward Medical Device Consultant 962 Allegro Ln. Apollo Beach, Florida 33572
Re: K020318 Trade/Device Name: Scivolutions Various Antibacterial Bandages Regulatory Class: Unclassified Product Code: FRO
Dear Art Ward:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 3, 2003. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code FRO.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, Ph.D., OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a family or group of people.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 3 2003
SciVolutions, Inc. Alan Nash 268 Tosca Drive Stoughton, Massachusetts 02072
Re: K020318 Trade/Device Name: SciVolutions Antibacterial Bandages Regulatory Class: Unclassified Product Code: MXE: Medical Adhesive Tape and Bandage with Disinfectant Dated: December 19, 2002 Received: December 24, 2002
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
2
Page 2 – Mr. Alan Nash
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 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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
fel Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Kozo38
| 510(k) Number (if known): | K020318 |
|---|---|
| --------------------------- | --------- |
SciVolutions, Inc. Antibacterial Adhesive Bandages Device Name:
Indications For Use:
Antibacterial Adhesive Bandages are to be applied to the skin for topical application. The bandages help provide an antibacterial barrier for minor cuts and scrapes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Miriam C Provost
Vision Restorative
4
510(K) SUMMARY K020318 (as required by 807.92(c))
SciVolutions. Inc. Submitter of 510(k): 268 Tosca Dr. Stoughton, MA 02072 781-344-3211 Phone: Fax: 781-344-9203 Alan Nash Contact Person: November 4, 2002 Date of Summary : SciVolutions Antibacterial Bandages Trade Name: Classification Name: Tape and bandage, Adhesive (with disinfectant) Predicate Device:
William Feinstein and Associates, Inc. Anti-Bacterial Adhesive K992817 Bandage
Intended Use:
Antibacterial Adhesive Bandages are to be applied to the skin for topical application. The bandages help provide an antibacterial barrier for minor cuts and scrapes.
Product Description:
Antibacterial adhesive bandages are similar to many pre-amendment and already cleared products with benzalkonium chloride. They are provided in various sizes in a box for over the counter purchase. The benzalkonium chloride concentration is 1%.