(90 days)
Not Found
Not Found
No
The device description and intended use are for a simple wound dressing, and there is no mention of AI, ML, or any computational processing.
No.
The device is a wound dressing used as a primary contact layer and does not claim any therapeutic function beyond providing a dressing for wounds.
No
The device is a wound dressing used for treating wounds, not for diagnosing them.
No
The device description clearly states it is a physical dressing made of gauze impregnated with Xeroform and petrolatum, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a wound dressing applied externally to the body for treating various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a sterile dressing made of gauze impregnated with Xeroform and petrolatum. This composition is consistent with a topical wound care product.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the body (like blood, urine, tissue, etc.) to provide information about a person's health status, disease, or condition.
- Performance Studies: The performance studies mentioned focus on biocompatibility, which is relevant for a device that comes into contact with the body, not for a diagnostic test.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to protect and aid in the healing of wounds, which falls under the category of medical devices, but not specifically IVDs.
N/A
- Intended Use / Indications for Use
The Kendall Xeroform Petrolatum Wound Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate where mild medication and deodorization are desired. - Product codes (comma separated list FDA assigned to the subject device)
FRO - Device Description
The proposed Kendall Xeroform Petrolatum Wound Dressing is a sterile, singleuse, non-adherent dressing consisting of absorbent gauze impregnated with Xeroform in a petrolatum blend. It is packaged in metalized chevron pouches and is available in 4" x 3yd roll, 1" x 8", 5" x 9", 2" x 2" and 4" x 4" sizes. - 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
171350 /
EXHIBIT #7
DEC 1 5 1997
510(k) Summary
Kendall Xeroform Petrolatum Wound Dressing
In accordance with section 513(I) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:
Kendall Healthcare Products Company 15 Hampshire Street Mansfield, MA 02048 September 3, 1997 Date Prepared:
1. Contact Person
David A. Olson Manager Regulatory Affairs (508) 261-8530
2. Name of Medical Device
Classification Name: Common or Usual Name: Unclassified Xeroform Petrolatum Wound Dressing
Identification of Legally Marketed Device ന്
The proposed Kendal! Xeroform Petrolatum Wound Dressing is substantially equivalent in intended use and composition to the Sherwood Medical Xeroform Petrolatum Dressing which was in commercial distribution before May 28, 1976.
ধ: Device Description
The proposed Kendall Xeroform Petrolatum Wound Dressing is a sterile, singleuse, non-adherent dressing consisting of absorbent gauze impregnated with Xeroform in a petrolatum blend. It is packaged in metalized chevron pouches and is available in 4" x 3yd roll, 1" x 8", 5" x 9", 2" x 2" and 4" x 4" sizes.
ട. Device Intended Use
The Kendall Xeroform Petrolatum Wound Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate where mild medication and deodorization are desired.
1
6. Product Comparison
The Kendall Xeroform Petrolatum Wound Dressing is equivalent to the referenced predicate device in that they are fabricated from similar materials, have a similar function and equivalent indications for use.
7. Nonclinical Testing
Biocompatibility testing of the Kendall Xeroform Petrolatum Wound Dressing has demonstrated that it contains no bioactive components. Testing performed on the product was based upon guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 1997
Mr. David A. Olson Manager, Regulatory Affairs Kendall Healthcare Products Company 15 Hampshisre Street Mansfield, Massachusetts 02048
Re: K973507 Kendall Xeroform Petrolatum Dressing Regulatory Class: Unclassified Product Code: FRO Dated: September 15, 1997 Received: September 16, 1997
Dear Mr. Olson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) 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 acceleratimg 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.
-
- 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). The general controls provisions of the Act include requirements for annual
3
Page 2 - Mr. David A. Olson
registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Kendall Xeroform Petrolatum Dressing
Indications For Use:
It is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate where mild medication and deodorization are desired.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K973507 |
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | _________________ |
|---|---|
| (Optional Format 1-2-96) |
(Optional Format 1-2-96)