(251 days)
No
The device description focuses on material composition and physical characteristics, with no mention of AI or ML.
No.
The device is a bandage for topical application on minor cuts and scrapes, which is a supportive and protective function rather than directly therapeutic. It does not exert therapeutic effect through pharmacological, immunological, or metabolic means.
No
The device is described as a bandage for minor cuts and scrapes, which is a therapeutic rather than diagnostic function. It does not mention any capabilities for identifying, examining, or monitoring health conditions or diseases.
No
The device description clearly outlines physical components like a backing, central pad, and wrapper, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "topical application for minor cuts and scrapes." This is a direct application to the body for a therapeutic purpose (wound care), not for testing a sample taken from the body to diagnose a condition.
- Device Description: The description details a bandage with an antibacterial pad. This is a physical device applied externally.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This bandage does not fit that description.
N/A
Intended Use / Indications for Use
SciVolutions Antibacterial Gentle Care Bandages are to be applied to the skin for topical application for minor cuts and scrapes.
Product codes
FRO
Device Description
The Antibacterial Gentle Care Bandages uses the identical BZC antibacterial pad as on The Antibactional Gentre Garden ander K020318. Only the backing (non-woven) our providually clours providing a higher water vapor permeability and soft feel.
Antibacterial Gentle Care Bandages
Non-woven skin color treated hydrophobic backing (Latex Free)
Central pad: High absorption capacity, covered with an anti adherent polyethylene veil, Ochtral pad. Figh abound, impregnated with 1% benzalkonium chloride solution.
Encased in Latex Free Kraft Paper Cold Sealed to make a envelope wrapper
Sizes: .75" x 3" / 1" x 3"
Uses: Gentle Care 25
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Page 1 of 2
JUN - 1 2004
K032983 510(K) SUMMARY (as required by 807.92(c))
| Submitter of 510(k): | SciVolutions, Inc.
268 Tosca Dr.
Stoughton, MA 02072
Phone: 781-344-3211
Fax: 781-344-9203 |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Contact Person: | Alan Nash |
| Date of Summary: | May 14, 2004 |
| Trade Name: | SciVolutions Antibacterial Gentle Care Bandages |
| Classification Name: | Tape and bandage, Adhesive (with disinfectant) |
Predicate Device:
SciVolutions Various Antibacterial Bandages K020318
Indications for Use:
SciVolutions Antibacterial Gentle Care Bandages are to be applied to the skin for topical application for minor cuts and scrapes.
1
Page 2 of 2 510(k) Summary
Device Description
The Antibacterial Gentle Care Bandages uses the identical BZC antibacterial pad as on The Antibactional Gentre Garden ander K020318. Only the backing (non-woven) our providually clours providing a higher water vapor permeability and soft feel.
Antibacterial Gentle Care Bandages
Non-woven skin color treated hydrophobic backing (Latex Free)
Central pad: High absorption capacity, covered with an anti adherent polyethylene veil, Ochtral pad. Figh abound, impregnated with 1% benzalkonium chloride solution.
Encased in Latex Free Kraft Paper Cold Sealed to make a envelope wrapper
Sizes: .75" x 3" / 1" x 3"
Uses: Gentle Care 25
| In mm-inch | Backing (mm-Inch) | Pad in mm |
|---|---|---|
| 20x72 - 0.75x3 | 20x72 - 0.75x3 | 10.8x25 |
| 25x72 - 1x3 | 25x72 - 1x3 | 13.6x25 |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a three-tiered wave-like design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2004
SciVolutions, Inc. c/o Mr. Arthur J. Ward RMS. Inc. 962 Allegro Lane Apollo Beach, Florida 33572
Re: K032983
Trade/Device Name: SciVolutions, Inc. Antibacterial Gentle Care Bandages Regulatory Class: Unclassified Product Code: FRO Dated: April 15, 2004 Received: April 26, 2004
Dear Mr. Ward:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatinent date of the Medical Device Amendments, or 10 conninered pror to that 20, 2017) in accordance with the provisions of the Federal Food, Drug, de rices that have been resuire approval of a premarket approval application (PMA). and Cosmetic Act (110) that de nevice, subject to the general controls provisions of the Act. The Tou may, therefore, mailes 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 If your de vice is enashined (soral controls. Existing major regulations affecting your device can may be subject to sach added a legulations, 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 I loast of advised that I Drivieran that your device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any it cach stututed and regulations .
comply with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Hot 010 cm . 10 cm (01); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality of evelsions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Arthur J. Ward
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). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Miriam C. Provost
(accelia 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
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: SciVolutions, Inc. Antibacterial Gentle Care Bandages
Indications For Use:
SciVolutions Antibacterial Gentle Care Bandages are to be applied to the skin for topical application for minor cuts and scrapes.
Prescription Use (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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_103298