(90 days)
No
The device description and performance studies focus on the material composition and physical properties of the wound dressing, with no mention of AI or ML.
Yes.
The device is indicated for the management of wounds and promotes healing by forming a moist environment, which are characteristics of a therapeutic device.
No
The device is a wound dressing designed for the management of exudating wounds by absorbing wound exudate and forming a gel to provide a moist healing environment. It does not perform any diagnostic function.
No
The device description clearly states it is a "sterile composition of maltodextrin, sodium alginate and chitosan chloride" and is available in "6 gram, 12 gram and 25 gram packets," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of exudating wounds by absorbing wound exudate and forming a gel to create a moist healing environment. This is a direct therapeutic application to the wound itself.
- Device Description: The device is a sterile composition of materials that interact with wound exudate externally. It does not involve testing or analyzing biological samples in vitro (outside the body) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no indication of providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This wound dressing does not fit that description.
N/A
Intended Use / Indications for Use
Like the predicate device, the Kendall Hydrophilic Powder Wound Dressing is indicated for the management of exudating wounds such as dermal ulcers (e.g., venous stasis, pressure, arterial, diabetic), surgical incisions, traumatic wounds (e.g., lacerations, abrasions).
Product codes
KGN
Device Description
The proposed Kendall Hydrophilic Powder Wound Dressing is a sterile composition of maltodextrin, sodium alginate and chitosan chloride. As the powder absorbs wound exudate It converts to a gel. This gel forms a moist environment at the wound interface conducive to healing The product is available in 6 gram, 12 gram and 25 gram packets.
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)
Biocompatibility testing of the Kendall Hydrophilic Powder 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.
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
Not Found
N/A
0
Ka70266
EXHIBIT #4
APR 23 1997
510(k) Summary
Kendall Hydrophilic Powder 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 Date Prepared: April 21, 1997
1.5.19.12.2014 1
ﻟﺴﻴﺴ Contact Person
11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 17
David A. Olson Manager Regulatory Affairs (508) 261-8530
- 2 Name of Medical Device
Classification Name. Unclassified Hydrophilic Powder Wound Dressing Common or Usual Name:
ﺯﻣﺎ Identification of Legally Marketed Device
The proposed Kendall Hydrophilic Powder Wound Dressing is substantially equivalent in intended use and composition to the commercially available DeRoyal Multidex® Hydrophilic Powder Wound Dressing, 510(k) No K945000.
4 Device Description
The proposed Kendall Hydrophilic Powder Wound Dressing is a sterile composition of maltodextrin, sodium alginate and chitosan chloride. As the powder absorbs wound exudate It converts to a gel. This gel forms a moist environment at the wound interface conducive to healing The product is available in 6 gram, 12 gram and 25 gram packets.
5 Device Intended Use
Like the predicate device, the Kendall Hydrophilic Powder Wound Dressing is indicated for the management of exudating wounds such as dermal ulcers (e.g., venous stasis, pressure, arterial, diabetic), surgical incisions, traumatic wounds (e.g., lacerations, abrasions).
1
Product Comparison 6
The Kendall Hydrophilic Powder 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
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
1 . UU4
14970264
7 Nonclinical Testing
Biocompatibility testing of the Kendall Hydrophilic Powder 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, each head in profile. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 200/
Mr. David A. Olson Manager, Regulatory Affairs Kendall Healthcare Products Company 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K970266 Kendall Hydrophilic Powder Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: January 22, 1997 Received: January 23, 1997
Dear Mr. Williams:
This letter corrects our substantially equivalent letter of April 23, 1997.
We have reviewed your Section 510(k) premarket notification of intent to market the wc nave reviewed your bootion be (--)----------------------------------------------------------------------------------------------------------------------------------------ucvice referenced about and it closure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device m interstate commerce proble to maj 20, 2017 reclassified in accordance with the provisions of Amendinents of to area, and Cosmetic Act (Act) that do not require approval of a the Federal Pood, Drug, and Costient Hev (100), market the device, subject to the general promatics approvisions of the Act. The general controls provisions of the Act include controls providents of an annual registration, listing of devices, good manufacturing practice, requirements for anifall registrations 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.
3
Page 2 – Mr. David A. Olson
- 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 (1 vice 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 I carrier agencies: "Four 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 Fins letter will and in your of substantial equivalence of your device 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.
4
Page 3 - Mr. David A. Olson
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 N. N son Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health