(80 days)
LYOCELL Wound Dressing / Surgical Sponge is intended to be used for the local management of partial and full thickness wounds, including minor burns. LYOCELL is also intended to be used as a sponge for cleaning wounds and for absorbing excess body fluids or exudate. LYOCELL is also intended to be used to help control minor bleeding.
Not Found
I am sorry, but based on the provided document, I cannot describe the "acceptance criteria and the study that proves the device meets the acceptance criteria" in the requested format.
The document is a 1997 FDA 510(k) clearance letter for the "LYOCELL Wound Dressing/Surgical Sponge." This type of document does not contain detailed information about specific performance studies, acceptance criteria, or the methodology of such studies.
Instead, a 510(k) clearance states that the device is "substantially equivalent" to predicate devices already on the market. This determination is based on a review of information provided by the manufacturer, which typically includes:
- Indications for Use: What the device is intended to be used for.
- Technological Characteristics: How the device works and its materials.
- Performance Data: Often limited to bench testing or biocompatibility, and not presented with the level of detail requested for acceptance criteria and study design. Clinical trials, especially in 1997 for this type of device, would not always be required for a 510(k) unless there were new or significant safety/effectiveness concerns.
The document does not include any of the following information that you requested:
- A table of acceptance criteria and reported device performance.
- Sample size for a test set or data provenance.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for a training set.
- How ground truth for the training set was established.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
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Mr. Robert Feil President Courtaulds Fibers Inc. Highway 43, North Axis, Alabama 36505
SEP 1 9 1997
Re: K972458
Trade Name: LYOCELL Wound Dressing/Surgical Sponge Regulatory Class: Unclassified Product Code: EFQ Dated: June 30, 1997 Received: July 1, 1997
Dear Mr. Feil:
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 (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
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Page 2 - Mr. Robert Feil
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,
Cella 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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K972458
LYOCELL Wound Dressing / Surgical Sponge Device Name:
Indications For Use:
LYOCELL Wound Dressing / Surgical Sponge is intended to be used for the local management of partial and full thickness wounds, including minor burns. LYOCELL is also intended to be used as a sponge for cleaning wounds and for absorbing excess body fluids or exudate. LYOCELL is also intended to be used to help control minor bleeding.
(PLEASE DO NOT WRITE BELOW TINS 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 | 1972458 |
| Prescription Use(per 21 CFR 01.109) | X |
| OR | |
| Over-The-Counter Use |
(Optional Format 1-2-96)
N/A