(50 days)
The ConvaTec Nonwoven Pad is intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions and excisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology.
Nonwoven Pad is a sterile, absorbent pad dressing intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor abrasions, minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers of mixed aetiology. Nonwoven Pad absorbs wound exudate. The hydrophobic layer minimizes strike through of exudate and ensures distribution of the fluid throughout the dressing.
The provided text describes basic conformity testing for a medical device (Nonwoven Pad) for a 510(k) submission, not a study involving AI or complex statistical analysis for performance metrics as you've outlined in your request. Therefore, most of the information required for your output (like acceptance criteria for AI, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is not present in the given document.
However, I can extract the relevant information that is available regarding acceptance criteria and the "study" that proves the device meets them, keeping in mind the limitations of the input text.
Here's a summary of what's available and an explanation of why other requested fields cannot be filled:
- A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device: Intended use, design, and function | "Test results show the two products to be equivalent." |
| Biocompatibility: Non-toxic | "results of this testing demonstrate that Nonwoven Pad is considered to be non-toxic. All tests were conducted in accordance with Good Laboratory Practices." |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified, but implied to be from laboratory bench testing.
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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 device does not involve expert interpretation or AI. The tests are physical/chemical.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This device does not involve expert interpretation.
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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
- No. This is not an AI device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the comparative bench testing was likely the performance of the predicate device (TENDERSORB® WET PRUF® Abd Pad) for characteristics like absorbency and preventing strike-through.
- The "ground truth" for biocompatibility was established through ISO 10993 Part I "Biological Evaluation of Medical Devices" standards.
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The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning.
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How the ground truth for the training set was established
- Not applicable. This device does not involve a "training set."
Summary of the Study (as described in the text):
The "study" refers to a series of tests conducted to demonstrate the safety and effectiveness of the Nonwoven Pad, primarily through substantial equivalence to a predicate device.
- Bench Testing: Comparative bench testing was performed between the Nonwoven Pad and the predicate device, TENDERSORB® WET PRUF® Abd Pad. The purpose was to show equivalence in intended use, design, and function. The results indicated that "the two products to be equivalent." Specific metrics like absorbency or strike-through minimization are mentioned as functions of the device, implying these were likely part of the bench tests, though no specific numerical results or methodologies beyond a general statement of equivalence are provided.
- Biocompatibility Testing: The device underwent biocompatibility testing according to ISO 10993 Part I "Biological Evaluation of Medical Devices" with an FDA modified matrix. The results "demonstrate that Nonwoven Pad is considered to be non-toxic," and these tests were conducted under Good Laboratory Practices (GLP).
Conclusion on Meeting Acceptance Criteria:
Based on the provided text, the device met its acceptance criteria by demonstrating:
- Substantial Equivalence to a legally marketed predicate device (Kendall's TENDERSORB® WET PRUF® Abd Pad) through comparative bench testing for intended use, design, and function.
- Biocompatibility by passing tests conducted under ISO 10993 Part I and being deemed non-toxic.
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APR 1 5 1998
ITEM 8: SUMMARY OF SAFETY AND EFFECTIVENESS
| Applicant: | ConvaTec, A Division of E.R. Squibb and Sons, Inc100 Headquarters Park Drive, Skillman, NJ 08558 |
|---|---|
| Contact: | Ameer Ally, Director,Regulatory Affairs(908) 904-2543 |
| Device: | Nonwoven Pad |
| SubstantiallyEquivalent Device: | TENDERSORB® WET PRUF® Abd Pad(Kendall Healthcare Products Company) |
Nonwoven Pad is a sterile, absorbent pad dressing intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor abrasions, minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers of mixed aetiology. Nonwoven Pad absorbs wound exudate. The hydrophobic layer minimizes strike through of exudate and ensures distribution of the fluid throughout the dressing.
Nonwoven Pad is contraindicated for use on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components.
Nonwoven Pad is substantially equivalent to Kendall's TENDERSORB® WET PRUF® Abd Pad . Both products are equivalent in intended use, design and function. They are considered general use wound care dressings which can be used in the management of acute and chronic wounds.
Comparative bench testing was conducted on Nonwoven Pad versus TENDERSORB® WET PRUF® Abd Pad. Test results show the two products to be equivalent.
Nonwoven Pad has been subjected to biocompatibility testing utilizing the ISO 10993 Part I "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995). The results of this testing demonstrate that Nonwoven Pad is considered to be non-toxic. All tests were conducted in accordance with Good Laboratory Practices.
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Image /page/1/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of several curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 1998
Mr. Ameer Ally Director, Regulatory Affairs ConvaTec P.O. Box 5254 Princeton, New Jersey 08558
K980720 Re: Trade Name: ConvaTec Nonwoven Pad Regulatory Class: Unclassified Product Code: KMF Dated: February 23, 1998 Received: February 24, 1998
Dear Mr. Ally:
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. 1.
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- 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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- 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 registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
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Page 2 - Mr. Ally
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,
Mark n Mullein
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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ITEM 1J: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Not Known
Device Name: Nonwoven Pad
Indications for Use:
The ConvaTec Nonwoven Pad is intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions and excisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109) OR
Over-the-Counter Use
(Optimal Format 1-2-96)
Mark N-Milke
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(Division Sign-Off)
- Division of General Restorative Devices
510(k) Number. K980720
§ 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.