(63 days)
Not Found
No
The summary describes a wound dressing and a material change, with no mention of AI/ML, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is a medical dressing indicated for the management of various types of wounds, including ulcers and burns, which aligns with the definition of a therapeutic device.
No
The device description indicates Cutinova hydro is a "polyurethane dressing that is indicated for the management of moderately to highly exudating wounds." Its purpose is to manage wounds, not to diagnose conditions or diseases.
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 the device is for the "management of surface, moderately to highly secreting wounds." This describes a therapeutic or wound care application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a "polyurethane dressing" used for managing exudating wounds. This is consistent with a wound care product, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, based on the provided information, Cutinova hydro is a wound dressing and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cutinova hydro may be used under the direction of a health care professional for the management of surface, moderately to highly exudating wounds such as: Leg ulcers Pressure ulcers Second degree burns
Cutinova hydro is indicated for the management of surface, moderately to highly secreting wounds such as:
Leg ulcers Stage I-IV pressure ulcers First and second degree burns
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Cutinova hydro is a polyurethane dressing that is indicated for the management of moderately to highly exudating wounds. The current modification involves a change in the material used to make the urethane from an aromatic diisocyanate to an aliphatic disocyanate and does not affect the indications for use.
In addition, a very small amount of to Tocopherol was added to improve the thermal stability of the product.
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
health care professional
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 hydro. Performance characteristics were also comparable to the currently marketed 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
04:46PM JOBST CHAR FEB 15 "99
3
984595
P.6
Summary of Safety and Effectiveness for Cutinova® hydro - K984595
This 510(k) is being submitted for a modification to Cutinova hydro that was originally cleared for sale in the U.S. in 1991 (K905688)
Cutinova hydro is a polyurethane dressing that is indicated for the management of moderately to highly exudating wounds. The current modification involves a change in the material used to make the urethane from an aromatic diisocyanate to an aliphatic disocyanate 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 hydro. Performance characteristics were also comparable to the currently marketed product. In addition, a very small amount of to 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 hydro is substantially equivalent to the current legally marketed Cutinova hydro.
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 design of three human profiles facing right, arranged in a staggered formation. The profiles are connected by a flowing line that forms the shape of a wing or a stylized representation of movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the top half of the design.
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: K984595 Trade Name: Cutinova Hydro 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 We have reviewed your Section 910(ts) premation with the device is substantially equivalent to device referenced above and have decembined the sessate commerce prior to May 28, 1976,
legally marketed predicate devices marketed in interstate daying that have been legally marketed predical Device Amendments or to devices that have been
the enactment date of the Medical Device Americal Food. Drug, and Cosme the enactment date of the Medical Device Finalisms of the Federal Food, Drug, and Cosmetic Act
reclassified in accordance with the provisions of the Federal (DMAA) . You may, reclassified in accordance with the proval (PMA). You may, therefore,
(Act) that do not require approval of a premarket approval (PMA). The general (Act) that do not require approval or a premisions of the Act. The general
market the device, subject to the general controls provisions of the Active market the device, subject to the general controls for annual registration, listing of
controls provisions of the Act including requirements for any provinst mishranding a controls provisions of the Act fileting requirements of the most of the 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 Eederal 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.
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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 A. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1
.
. --
Device name: Cutinova hydro
Indications For Use:
510(k) Number:
Over the Counter
Cutinova hydro may be used under the direction of a health care professional for the management of surface, moderately to highly exudating wounds such as: Leg ulcers Pressure ulcers
Second degree burns
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over The Counter Use (Per 21 CFR 801.109)
(Division Sigh-Off) Division of General Restorative Device KSB4595 510(k) Number .
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Image /page/5/Picture/1 description: The image shows a handwritten alphanumeric string. The string is "K984595". The characters are written in a cursive style with thick, dark lines, making them easily readable against the white background.
Page 1 of 1
510(k) Number (if known): _
Device name: Cutinova hydro
Indications For Use:
.
Cutinova hydro is indicated for the management of surface, moderately to highly secreting wounds such as:
Leg ulcers Stage I-IV pressure ulcers First and second degree burns
(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 of General Restorative Devices
510(k) Number K984595
Concurrence of CDRH, Office of Device Evaluation (ODE)