(35 days)
Non-woven Compress is indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers.
Non-woven Compress is a sterile wound dressing indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers. Non-woven Compress absorbs wound exudate. The absorbent material, on hydration, forms a gel which immobilizes absorbed fluid exudate and helps prevent migration. The wound contact layer is designed to facilitate easy removal from both wet and dry wounds.
The provided document is a 510(k) Premarket Notification for a Non-woven Compress wound dressing. It focuses on demonstrating substantial equivalence to a predicate device, not on clinical performance acceptance criteria based on specific metrics like sensitivity or specificity. Therefore, many of the requested items (e.g., expert ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|
| Intended Use Equivalence: | Both products are equivalent in intended use for managing acute and chronic wounds. |
| Design and Function Equivalence: | Both products are equivalent in design and function. |
| Bench Testing Equivalence: | Comparative bench testing conducted shows the two products (Non-woven Compress and Mirasorb Sponges) to be equivalent. Specific metrics of this bench testing are not detailed in this summary. |
| Biocompatibility: | Non-sensitizing, non-cytotoxic, non-hemolytic, and a negligible irritant. |
| Compliance with Good Laboratory Practices (GLP): | All biocompatibility tests were conducted in accordance with GLP. |
| Compliance with ISO 10993 Part I: | Biocompatibility testing utilized ISO 10993 Part I with FDA modified matrix. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The comparative bench testing and biocompatibility testing were performed, but details on the number of samples or specimens are not disclosed in this summary.
- Data Provenance: Not specified for the bench testing. Biocompatibility testing was conducted in accordance with ISO 10993 Part I and GLP, implying controlled laboratory settings. The document is a submission to the US FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This type of medical device (wound dressing) submission relies on bench testing and biocompatibility rather than expert clinical assessment of diagnostic accuracy. There is no "ground truth" in the sense of expert consensus on images or clinical outcomes for performance evaluation in this context.
4. Adjudication Method for the Test Set
- Not Applicable. As there are no expert assessments for ground truth, no adjudication method is relevant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No. An MRMC study is not relevant for this type of device. The comparison is between the new device and a predicate device through bench tests and biocompatibility, not on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical wound dressing, not a software algorithm or AI device.
7. The Type of Ground Truth Used
- For Bench Testing: The "ground truth" for bench testing would be the performance characteristics of the predicate device (Mirasorb Sponges) and predefined engineering specifications or performance standards for wound dressings. The document states "Test results show the two products to be equivalent," implying that the Non-woven Compress's performance characteristics matched those of the predicate device.
- For Biocompatibility: The "ground truth" is established by the pass/fail criteria defined in the ISO 10993 Part I standard and FDA guidance for biological evaluation.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of a physical wound dressing and its regulatory submission. This concept applies to machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. There is no training set for this device.
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510(k) Premarket Notification Non-woven Compress
MAR 97
1
ITEM 10: SUMMARY OF SAFETY AND EFFECTIVENESS
ConvaTec, A Division of E.R. Squibb and Sons, Inc Applicant: 100 Headquarters Park Drive, Skillman, NJ 08558 Adrienne McNally, Senior Manager, Regulatory Affairs Contact: (908) 281-2630
Device:
Nonwoven Compress
Substantially Mirasorb Sponges Equivalent Device:
Non-woven Compress is a sterile wound dressing indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers. Non-woven Compress absorbs wound exudate. The absorbent material, on hydration, forms a gel which immobilizes absorbed fluid exudate and helps prevent migration. The wound contact layer is designed to facilitate easy removal from both wet and dry wounds.
Non-woven Compress is contraindicated for use on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components.
Non-woven Compress is substantially equivalent to Johnson and Johnson's Mirasorb Sponges. 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. The absorbent material in the Non-woven Compress forms a gel which helps retain fluid and exudate.
Comparative bench testing was conducted on Non-woven Compress and Mirasorb Sponges. Test results show the two products to be equivalent.
Non-woven Compress 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 Non-woven Compress is considered to be nonsensitizing, non-cytotoxic, non-hemolytic and a negligible irritant. 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 stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 1998
Ms. Adrienne McNally Senior Manager, Regulatory Affairs Convatec Division of E. R. Squibb & Son 100 Headquarters Park Drive Skillman, New Jersey 08558
Re: K980382 Trade Name: Non Woven Compress Regulatory Class: Unclassified Product Code: KMF Dated: January 28,1998 Received: February 2, 1998
Dear Ms. McNally:
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 2. wound healing or epithelization.
- This device may not be labeled as a long-term, permanent, or no-change dressing, or 3. as an artificial (synthetic)-sking-anders ....................................................................................................................................
-
- 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 - Ms. McNally
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
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ITEM 3.10: INDICATIONS FOR USE STATEMENT
K980382 510(k) Number (if known): Not Known
Device Name: Non-woven Compress
Indications for Use:
Non-woven Compress is indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers.
(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 | K980382 |
|---|---|
| --------------- | --------- |
Prescription Use (Per 21 CFR 801.109) OR
Over the Counter Use √
(Optimal Format 1-2-96)
ﺴﺴ
§ 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.