(63 days)
Not Found
No
The summary describes a wound dressing and its material change, with no mention of AI or ML.
No
The device is a wound dressing used for managing surface wounds, not for treating diseases or conditions.
No
This device is a wound dressing, not a diagnostic tool. Its purpose is to manage wounds by absorbing exudate, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a "polyurethane dressing," which is a physical, hardware component, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Cutinova thin is a dressing for the management of surface wounds. This is a topical application for wound care, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The device is described as a polyurethane dressing. This aligns with a wound care product, not an in vitro diagnostic device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, antibodies, etc.)
- Providing diagnostic information about a disease or condition
Therefore, based on the information provided, Cutinova thin is a wound dressing and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cutinova thin is a polyurethane dressing that is indicated for the management of wounds with low to moderate exudate. The current modification involves a change in the material used to make the urethane from an aromatic diisocyanate to an aliphatic diisocyanate and does not affect the indications for use.
Cutinova thin is a dressing indicated for the management of surface wounds with low to moderate exudate, such as:
Minor burns
Abrasions
Cutinova thin may also be used under the direction of a health care professional for partial thickness wounds such as:
Second degree burns
Leg ulcers
Pressure ulcers
Post-op wounds
Donor sites
Cutinova thin is indicated for the management of surface wounds with low to moderate exudate, such as: First and second degree burns
Follow-up management of abrasions and donor sites
Partial thickness wounds
Leg ulcers
Stage I & II pressure ulcers
Post-operative wounds
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Cutinova thin is a polyurethane dressing that is indicated for the management of wounds with low to moderate exudate. The current modification involves a change in the material used to make the urethane from an aromatic diisocyanate to an aliphatic diisocyanate and does not affect the indications for use.
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
Over-the-Counter
under the direction of a health care professional
Prescription
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)
Biological tests were done in accordance with ISO 10993 and showed no negative effects for the modified Cutinova thin. Performance characteristics were also comparable to the currently marketed product. In addition, a very small amount of & Tocopherol was added to improve the thermal stability of the product.
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
04:45PM JOBST CHAR LEB IS . Sa
31
K984593
Summary of Safety and Effectiveness for Cutinova® thin - K984593
This 510(k) is being submitted for a modification to Cutinova thin that was originally cleared for sale in the U.S. in 1994 (K944581)
Cutinova thin is a polyurethane dressing that is indicated for the management of wounds with low to moderate exudate. The current modification involves a change in the material used to make the urethane from an aromatic diisocyanate to an aliphatic diisocyanate and does not affect the indications for use.
Biological tests were done in accordance with ISO 10993 and showed no negative effects for the modified Cutinova thin. Performance characteristics were also comparable to the currently marketed product. In addition, a very small amount of & Tocopherol was added to improve the thermal stability of the product.
Based on safety information in international data bases, biological testing and performance characteristics, it can be concluded that the modified Cutinova thin is substantially equivalent to the current legally marketed Cutinova thin.
Dated: February 9, 1999
Prepared by: Angelo Pereira Manager, Regulatory Affairs Beiersdorf-Jobst Inc. 5825 Carnegie Boulevard Charlotte, N.C. 28209
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2007
Mr. Angelo Pereira Beiersdorf-Jobst. Inc. 5825 Carnegie Boulevard Charlotte, North Carolina 28209-4633
Re: K984593 Trade Name: Cutinova Thin Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: December 23, 1998 Received: December 28, 1998
Dear Mr. Pereira:
This letter corrects our substantially equivalent letter of March 1, 1999.
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 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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act including requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration and the following limitations:
-
This device may not be labeled for use on third degree burns.
-
This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
2
Page 2 - Mr. Angelo Pereira
- This device may not be labeled as a treatment or a cure for any type of wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 continue 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.
3
Page 3 -- Mr. Angelo Pereira
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark McMillan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Page 1 of 1
...
510(k) Number:
Device name: Cutinova thin
Indications For Use:
Over-the-Counter
Cutinova thin is a dressing indicated for the management of surface wounds with low to moderate exudate, such as:
Minor burns Abrasions
Cutinova thin may also be used under the direction of a health care professional for partial thickness wounds such as:
Second degree burns Leg ulcers Pressure ulcers Post-op wounds Donor sites
(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 X
(Division Sidn-Off Division of General Restorative De 198454 510(k) Number
5
Image /page/5/Picture/1 description: The image shows a handwritten string of alphanumeric characters. The string starts with the letter 'K', followed by the numbers 9, 8, 4, 5, 9, and 3. The characters are written in a simple, slightly irregular style, typical of handwriting. The image is in black and white.
Page 1 of 1
8984593 510(k) Number.
Device name: Cutinova thin
Indications For Use:
Cutinova thin is indicated for the management of surface wounds with low to moderate exudate, such as: First and second degree burns Follow-up management of abrasions and donor sites Partial thickness wounds Leg ulcers Stage I & II pressure ulcers Post-operative wounds
Prescription
(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
P. Colly 8