ACELL UBM LYOPHILIZED WOUND DRESSING by ACELL, INC

The ACell UBM Lyophilized Wound Dressing is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

Device Description

The ACell UBM Lyophilized Wound Dressing is primarily composed of porcine collagen and is supplied sterile in single sheet sizes ranging from 2 x 4 cm to 14 x 20 cm.

AI/ML Overview

The provided text describes the 510(k) summary for the ACell UBM Lyophilized Wound Dressing. It indicates that the device was subjected to various tests to assess its biocompatibility and performance. However, it does not provide specific acceptance criteria in a table format with reported device performance metrics. Instead, it makes a general statement about passing "all tests."

Here's an attempt to answer the questions based on the available information, noting where information is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	Passed requirements
Performance	Passed requirements
Safety	Shown to be safe
Effectiveness	Shown to be effective

Note: The document states, "The ACell UBM Lyophilized Wound Dressing was subjected to a number of tests to assess the biocompatibility and the performance of the material. It passed the requirements of all tests and was shown to be safe and effective as a wound dressing." However, it does not detail the specific parameters or thresholds for these "requirements" or provide quantitative data for the device's performance against them.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The filing describes the type of tests conducted (biocompatibility, performance) but does not specify the sample sizes used for these tests, the origin of any data, or whether it was retrospective or prospective.

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)

This information is not provided in the document. The document describes testing of the material itself rather than a diagnostic or interpretive device that would require expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. As the tests appear to be primarily laboratory or material-based rather than involving human interpretation, an adjudication method in the typical sense for medical imaging or similar devices would not be applicable.

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

An MRMC comparative effectiveness study was not conducted, and this device is not an AI diagnostic device. The product is a wound dressing.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable as the device is a physical wound dressing and not an algorithm or software. Its performance is inherent to its material properties and biological interaction, not through an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device would be established through laboratory testing standards and in-vivo/in-vitro biocompatibility assessments, rather than expert consensus on diagnostic images or pathology. The document generally states "passed the requirements of all tests," implying adherence to established testing protocols for safety and performance of medical devices.

8. The sample size for the training set

This information is not provided and is not applicable as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

This information is not provided and is not applicable as this is not an AI/ML device that requires a training set.

Summary

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DEC 1 9 2002

021637 と 510(k) SUMMARY—ACell UBM Lyophilized Wound Dressing

Submitter Name:	ACell, Incorporated
Submitter Address:	10555 Guilford RoadSuite 113Jessup, Maryland 20790
Contact Person:	James R. DeFranciscoChief Executive Officer
Phone Number:	410-715-1700
Fax Number:	301-317-0776
Date Prepared:	May 17, 2002
Device Trade Name:	ACell UBM Lyophilized Wound Dressing
Device Common Name:	Topical Wound Dressing
Classification Name:	Bandage, Liquid (79KMF)
Predicate Devices:	K993948, Cook Biotech, Inc., SIS Wound Dressing IIK001738, DePuy, Inc., Restore® Orthobiologic Soft TissueImplant
Device Description:	The ACell UBM Lyophilized Wound Dressing is primarilycomposed of porcine collagen and is supplied sterile in singlesheet sizes ranging from 2 x 4 cm to 14 x 20 cm.
Intended Use:	The ACell UBM Lyophilized Wound Dressing is intended for themanagement of wounds including: partial and full-thicknesswounds, pressure ulcers, venous ulcers, diabetic ulcers, chronicvascular ulcers, tunneled/undermined wounds, surgical wounds(donor sites/grafts, post-Moh's surgery, post-laser surgery,podiatric, wound dehiscence), trauma wounds (abrasions,lacerations, second-degree burns, and skin tears), and drainingwounds. The device is intended for one-time use.

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14021637

Discussion of tests andtest results:	The ACell UBM Lyophilized Wound Dressing was subjected to anumber of tests to assess the biocompatibility and theperformance of the material. It passed the requirements of alltests and was shown to be safe and effective as a wounddressing.
Conclusion:	This device, with respect to material composition, devicecharacteristics and intended use, is substantially equivalent to thepredicate devices

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ACell, Inc. c/o Ms. Patsy J. Trisler, J.D. RAC PharmaNet, Inc. : . 815 Connecticut Avenue, NW Suite 610 Washington, DC 20006

Re: K021637

Trade/Device Name: ACell UBM Lyophilized Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: November 22, 2002 Received: November 25, 2002

Dear Ms. Trisler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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.

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Page 2 - Ms. Patsy J. Trisler, J.D. RAC

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

uriam C. Provost

ftx Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K 021637

Device Name:

ACell UBM Lyophilized Wound Dressing

Indications for Use:

The ACell UBM Lyophilized Wound Dressing is intended for the management of wounds including; partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, , lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

(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)	X
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Over-The-Counter Use
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Miriam C. Provost

(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number	K021637
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(Optional Format 1-2-96)

000019

Section 4.0

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Regulation Number and Section

N/A