(72 days)
Not Found
Not Found
No
The provided text describes a wound dressing and does not mention any AI or ML capabilities, image processing, or performance metrics typically associated with AI/ML devices.
No
The device is described as a wound dressing, which is generally considered a medical device for wound management rather than a therapeutic device in the sense of delivering therapy or treatment beyond basic wound care. Its indications for use are focused on dressing wounds, not treating underlying conditions.
No
The device is described as a wound dressing, intended for managing various types of wounds, burns, and surgical sites. Its function is to cover and protect wounds, not to diagnose medical conditions through analysis or measurement.
No
The device description and intended use clearly describe a physical wound dressing, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are all related to wound care and dressing, which are applied externally to the body. IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: While the description is "Not Found," the intended use clearly points to a physical dressing.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD.
Therefore, this device falls under the category of a wound dressing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use is as a wound dressing layer for skin graft recipient sites, newly sutured wounds, abrasions, lacerations and minor or partial thickness burns. These dressings may also be used as an initial layer for wounds with light exudates where deodorization is desired.
These dressings are intended for use as a primary layer for donor sites, skin graft recipient sites and minor burns. These dressings may also be used as an initial layer for surgical incision sites and as a seal around tubes and drains exiting the body.
These dressings are intended for use as a primary dressing in the management of light to medium draining wounds such as minor burns, abrasions and lacerations. These dressings may also be used under the care of a health care professional for heavy draining wounds such as surgical incisions, skin grafts and dermal ulcers.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Not Found
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
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a stylized graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. To the right of the text is a graphic that resembles a stylized human figure or a bird in flight, composed of curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JAN - 7 2010 .
Medline Industries, Inc. % Mr. Matt Clausen Regulatory Affairs One Medline Place Mundelein, Illinois 60060-4486
Re: K093349
Trade/Device Name: Medline Curad Oil Emulsion Dressing Medline Curad Xeroform Petrolatum Dressing Medline Curad Petrolatum Gauze Dressing
Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: FRO Dated: December 22, 2009 Received: December 23, 2009
Dear Mr. Clausen:
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 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
1
Page 2 – Mr. Matt Clausen
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): KOG 3 349
Device Name:
Medline Curad Xeroform Petrolatum Dressing
Indications for Use:
The intended use is as a wound dressing layer for skin graft recipient sites, newly sutured wounds, abrasions, lacerations and minor or partial thickness burns. These dressings may also be used as an initial layer for wounds with light exudates where deodorization is desired.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(6)
David Krane
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093349
3
Indications for Use
510(k) Number (if known): KOG 3 349
Device Name:
Medline Curad Petrolatum Gauze Dressing
Indications for Use:
These dressings are intended for use as a primary layer for donor sites, skin graft recipient sites and minor burus. These dressings may also be used as an initial layer for surgical incision sites and as a seal around tubes and drains exiting the body.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keane
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093349
(7)
4
Indications for Use
510(k) Number (if known): KOG 3 349
Device Name:
Medline Curad Oil Emulsion Dressing
Indications for Use:
These dressings are intended for use as a primary dressing in the management of light to medium draining wounds such as minor burns, abrasions and lacerations. These dressings may also be used under the care of a health care professional for heavy draining wounds such as surgical incisions, skin grafts and dermal ulcers.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keane
(Division Sign-Off)
(8)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093349