(26 days)
No
The summary describes a topical fabric for scar management and does not mention any computational or data-driven components indicative of AI/ML.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that Oleeva Fabric is "indicated for the management of hypertrophic scars and keloids" and can "reduce hypertrophic scaring and keloid formation," which are therapeutic actions.
No.
The device is indicated for the management and prevention of scars, which is a therapeutic rather than diagnostic function. It does not identify or detect a disease or condition.
No
The device description clearly states "Oleeva Fabric is used topically" and refers to "Consistent use of Oleeva may minimize scars," indicating a physical material applied to the skin, not a software application.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Oleeva Fabric's Function: The description clearly states that Oleeva Fabric is used topically on the skin to manage and prevent scars. It does not involve the analysis of specimens taken from the body.
Therefore, Oleeva Fabric falls under the category of a topical medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Oleeva Fabric is indicated for the management of hypertrophic scars and keloids. Consistent use of Oleeva Fabric can reduce hypertrophic scaring and keloid formation resulting from surgical or traumatic injury of the skin. Oleeva Fabric may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.
Product codes
MDA
Device Description
Oleeva Fabric is used topically to reduce hypertrophic scars and keloids. Consistent use of Oleeva may minimize scars resulting from traumatic or surgical injuries. Oleeva can reduce existing scars, and may be used after traumatic or surgical injury to aid in the prevention of new scars.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 878.4025 Silicone sheeting.
(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(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 § 878.9.
0
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1111 Hamilton Street ♦ Allentown. PA 18101 Phone: (610) 432-8220 FAX: (610) 432-8240 Toll Free in U.S.: 1-800)-25-SILON (1-800-257-4566) http://www.silon.com
Attachment 4
510 (k) Summary of Safety and Efficacy Oleeva® Fabric
IDENTIFICATION
Device Name: Oleeva Fabric Common or Usual Name: Elastomer, Silicone, for Scar Management
CLASSIFICATION
Class:
Previous silicone scar management products had been unclassified. Classification Panel: Previous silicone scar management products have been subject to the General & Plastic Surgery classification panel - Medical Specialty Code SU. Product Code: MDA
PRODUCT DESCRIPTION
Oleeva Fabric is used topically to reduce hypertrophic scars and keloids. Consistent use of Oleeva may minimize scars resulting from traumatic or surgical injuries. Oleeva can reduce existing scars, and may be used after traumatic or surgical injury to aid in the prevention of new scars.
INDICATIONS FOR USE
Oleeva Fabric is indicated for the management of hypertrophic scars and keloids. Consistent use of Oleeva Fabric can reduce hypertrophic scaring and keloid formation resulting from surgical or traumatic injury of the skin. Oleeva Fabric may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.
SUBSTANTIAL EQUIVALENCE
The new device is substantially equivalent to the existing Oleeva Fabric product (K982036), Oleeva Foam (K002109), as well as the other silicone sheeting products manufactured by Bio Med Sciences, Inc.
BIOCOMPATIBILTY SUMMARY
Oleeva Fabric passes the following test protocols which were conducted in conformity to EN/ISO 10993 guidelines.
- . Kligman Maximization
- Primary Dermal Irritation
- Agarose Diffusion Cytotoxicity .
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2002
Bio Med Sciences, Inc. Mark E. Dillon President 1111 Hamilton Street Allentown, Pennsylvania 18101
Re: K023136
Trade/Device Name: Oleeva® Fabric Regulation Name: Silicone sheeting for scar management Regulatory Class: Unclassified Product Code: MDA Dated: September 19, 2002 Received: September 20, 2002
Dear Mr. Dillon:
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.
2
Page 2 -- Mr. Mark E. Dillon
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Stupt Rlveda
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
Attachment 2
Indications for Use Statement
| 510(k)
Number
| (if known) | Oleeva Fabric, 510(k) K982036, |
|---|---|
| Device Name | Oleeva Fabric |
| Indications | |
| for Use | Oleeva Fabric is indicated for the management of hypertrophic scars and keloids. Consistent use of Oleeva Fabric can reduce hypertrophic scaring and keloid formation resulting from surgical or traumatic injury of the skin. |
Oleeva Fabric may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.
[As with the Predicate Device, we request OTC clearance for the modified device.] |
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 |
|---|---|---|
| ------------------------------------------- | ---- | ---------------------- |
Division Sign Off
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________