(79 days)
Not Found
Not Found
No
The description focuses on the material properties and physical function of the wound dressing, with no mention of AI or ML.
Yes
The device is used for the management of wounds and creates a moist environment at the wound interface, which aids in healing, thus providing a therapeutic effect.
No
The device is a wound dressing designed to absorb exudate and provide a moist healing environment, not to diagnose medical conditions.
No
The device description clearly states it is a physical wound dressing made of alginate fibers, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the device is a wound dressing used for managing wound exudate and creating a moist wound environment. It is applied directly to the wound surface.
- Lack of Diagnostic Function: The device does not analyze biological samples to provide diagnostic information about a patient's health status. Its function is purely therapeutic and supportive in wound healing.
Therefore, the Kendall CURASORB® Zn+Mg Alginate Wound Dressing falls under the category of a medical device, specifically a wound care product, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Kendall CURASORB® Zn+Mg Alginate Wound Dressings are external wound dressings designed to help protect the wound, provide a moist environment for wound healing, and absorb wound exudate. CURASORB® Zn+Mg Dressings are indicated for use on wounds which present moderate to heavy wound exudate such as dermal ulcers, traumatic wounds, donor sites and seconddegree burns.
Product codes
KMF
Device Description
The Kendall CURASORB® Zn+Mg Alginate Wound Dressings are sterile, single-use, nonwoven, absorptive dressings. The off-white alginate fibers are composed of calcium, sodium, zinc and magnesium. As the dressing absorbs wound exudate it converts to a firm gel/fiber mat. This gel cushions the wound and forms a moist environment at the wound interface. The product is available in 2" x 2", 4" x 4", and 4" x 8" , 6" x 10", 12" x 24" pads, as well as 12", 24" and 36" long wound packing rope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (dermal ulcers, traumatic wounds, donor sites, second-degree burns)
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
Nonclinical Testing: "Biocompatibility testing of the Kendall CURASORB® Zn+Mg Alginate 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 I, with the FDA modified matrix presented in memorandum G95-1."
Key Metrics
Not Found
Predicate Device(s)
Kendall CURASORB® Calcium Alginate Dressing, Kendall CURASORB® Zn Alginate Wound Dressing
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
Exhibit 9
DEC - 4 1997
510(k) Summary
In accordance with section 513(i)(3) of the SMDA and as described 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: September 4, 1997
Contact Person 1.
Jan L. Efflandt, Regulatory Affairs Telephone: (508) 261-8037
-
- Name of Device
| Classification Name: | Unclassified |
|---|---|
| Common or Usual Name: | Calcium Zinc and Magnesium Alginate |
| Dressing | |
| Proprietary Name: | CURASORB® Zn+Mg Alginate Wound |
| Dressing |
3. Statement of Substantial Equivalence
The Kendall CURASORB® Zn+Mg Alginate Wound Dressing is substantially equivalent in composition, form, function and intended use to the commercially available Kendall CURASORB® Calcium Alginate Dressing and Kendall CURASORB® Zn Alginate Wound Dressing.
Device Description 4.
The Kendall CURASORB® Zn+Mg Alginate Wound Dressings are sterile, single-use, nonwoven, absorptive dressings. The off-white alginate fibers are composed of calcium, sodium, zinc and magnesium. As the dressing absorbs wound exudate it converts to a firm gel/fiber mat. This gel cushions the wound and forms a moist environment at the wound interface. The product is available in 2" x 2", 4" x 4", and 4" x 8" , 6" x 10", 12" x 24" pads, as well as 12", 24" and 36" long wound packing rope.
ട്. Device Intended Use
Like predicate devices, the Kendall CURASORB® Zn+Mg Alginate Wound Dressings are external wound dressings designed to help protect the wound, provide a moist environment for wound healing, and absorb wound exudate. CURASORB® Zn+Mg Dressings are indicated for use on wounds which present moderate to heavy wound exudate
1
such as dermal ulcers, traumatic wounds, donor sites and seconddegree burns.
Product Comparison .
The Kendall CURASORB® Zn+Mg Alginate Wound Dressings are equivalent to the referenced predicate devices 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 CURASORB® Zn+Mg Alginate 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 I, with the FDA modified matrix presented in memorandum G95-1.
2
Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & IAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, depicted in a minimalist, flowing design. The seal appears to be a formal emblem, possibly representing a government agency or organization related to health and services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 1997
Ms. Jan L. Efflandt 'Regulatory Affairs Administrator Kendall Healthcare Products Company 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K973509 Kendall CURASORB® Zn+Mg Alginate Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: September 15, 1997 Received: September 16, 1997
Dear Ms. Efflandt:
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 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.
-
- 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 - Ms. Jan L. Efflandt
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,
[signature]
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):
973509
Device Name: CURASORB Zn+Mg Alginate Wound Dressing
Indications For Use:
The proposed device is for use in the management of wounds which present moderate to heavy wound exudate such as dermal ulcers (i.e., venous stasis, pressure, arterial, diabetic); traumatic wounds (i.e., lacerations, punctures, abrasions or incisions); donor sites; 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)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative | |
| 510(k) Number | IC973509 |
| Prescription Use
| (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------------------------------ | ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)