(79 days)
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.
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.
This submission for K973509 is a 510(k) for a wound dressing, which typically relies on demonstrating substantial equivalence to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria in the same way a diagnostic or therapeutic device might. Therefore, the requested information in the prompt, particularly points 1, 5, 6, and details about sample sizes, experts, and ground truth for training/test sets, is not included in the provided 510(k) summary.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the 510(k) summary. For wound dressings in a 510(k), acceptance criteria are typically met by demonstrating substantial equivalence in composition, function, and intended use to a predicate device, along with biocompatibility and other regulatory requirements. Specific quantitative performance metrics (e.g., absorption rate, healing time improvement) against pre-defined acceptance criteria are generally not part of a 510(k) for this type of device unless specific claims are being made that necessitate such testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No specific test set or data provenance details are provided as this is not a study presenting clinical performance data from human subjects or a diagnostic algorithm. The "testing" mentioned refers to biocompatibility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is not a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving expert adjudication of a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a wound dressing, not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a medical device (wound dressing), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No ground truth in this context is relevant for a wound dressing 510(k) submission.
8. The sample size for the training set:
Not applicable. There is no training set for a wound dressing.
9. How the ground truth for the training set was established:
Not applicable. There is no training set or ground truth in this context.
Summary of what is provided in the K973509 510(k) for the Kendall CURASORB® Zn+Mg Alginate Wound Dressing:
The device's acceptability is based on substantial equivalence to existing predicate devices (Kendall CURASORB® Calcium Alginate Dressing and Kendall CURASORB® Zn Alginate Wound Dressing).
Study/Evidence that proves the device meets the acceptance criteria (substantial equivalence):
- Product Comparison: The submission states that the Kendall CURASORB® Zn+Mg Alginate Wound Dressings are equivalent to the referenced predicate devices because "they are fabricated from similar materials, have a similar function and equivalent indications for use."
- Biocompatibility 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." This demonstrates that the materials used are safe for their intended purpose in contact with the body.
The FDA's letter concurs with the finding of substantial equivalence, allowing the device to be marketed, with specific limitations on labeling claims related to third-degree burns, accelerated healing, long-term use, or explicit claims of treatment/cure.
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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 AlginateDressing |
| Proprietary Name: | CURASORB® Zn+Mg Alginate WoundDressing |
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
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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.
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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.
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- 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
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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
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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)
§ 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.