Cytal® Wound Matrix 3-Layer is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs 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

Cytal® Wound Matrix 3-Layer is composed of a resorbable, porcine-derived, extracellular matrix (ECM) scaffold containing epithelial basement membrane, specifically known as urinary bladder matrix (UBM). The devices are supplied in fenestrated sheet configurations up to 16 cm x 35 cm and packaged in double peel-open pouches. The devices are terminally sterilized using electron beam irradiation. Cytal Wound Matrix 3-Layer is pre-hydrated with sterile saline and applied to the wound. The device can be cut to different sizes. The device is intended for one time use.

AI/ML Overview

The document provides information on the Cytal® Wound Matrix 3-Layer and its substantial equivalence to a predicate device. However, it does not describe acceptance criteria or a study proving that the device meets those criteria in the typical sense of a diagnostic or AI device performance study.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ACell, Inc. Cytal® Wound Matrix (K152721)) for regulatory clearance. This involves showing that the new device has "the same intended uses and similar indications, technological characteristics, and principles of operation" and that minor differences "raise no new issues of safety or effectiveness."

Therefore, many of the requested categories for a diagnostic or AI device study are not applicable or not explicitly detailed in this type of submission.

Here's a breakdown based on the provided text, addressing your questions where information is available and noting where it is not:

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

The document does not explicitly state "acceptance criteria" for clinical performance in the way one might for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the performance testing aimed to show that the device "met the clinically relevant user needs, design inputs, and specifications" and functioned "as intended," demonstrating substantial equivalence.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Suture retention strain meets design specifications	Testing performed; functioned as intended; results as expected.
Tensile strain meets design specifications	Testing performed; functioned as intended; results as expected.
Hydration uptake meets design specifications	Testing performed; functioned as intended; results as expected.
Dimensional analysis meets design specifications	Testing performed; functioned as intended; results as expected.
Packaging performance meets design specifications	Testing performed; functioned as intended; results as expected.
Clinician feedback is positive	Design validation completed via clinician feedback; functioned as intended; results as expected.
Simulated use testing is successful	Design validation completed via simulated use testing; functioned as intended; results as expected.
No new issues of safety or effectiveness	Performance data demonstrates the larger Cytal Wound Matrix 3-Layer is as safe and effective as the cleared Cytal Wound Matrix.

2. 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. The document refers to "bench testing" and "design validation testing" (clinician feedback and simulated use) but does not provide specific sample sizes for these tests.
Data provenance: Not applicable in the context of clinical data for performance; this was bench and simulated use testing.

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)

The document mentions "clinician feedback" for design validation. The number and qualifications of these clinicians are not specified.

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

None specified. The document briefly mentions "clinician feedback" but does not detail any adjudication method for potential discrepancies or consensus building.

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

No, an MRMC study was NOT done. This type of study (comparative effectiveness, human readers, AI assistance) is relevant for diagnostic AI devices. The Cytal® Wound Matrix 3-Layer is a wound dressing, not an AI or diagnostic device, so this type of study is not applicable or performed in this context.

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

Not applicable. As a wound matrix, there is no "algorithm only" performance to evaluate. The device's performance is inherent in its material properties and interaction with biological systems.

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

For the technical performance aspects (suture retention, tensile, hydration, etc.), the "ground truth" would be established by engineering and material science standards and specifications.
For "design validation" via clinician feedback and simulated use, the "ground truth" is implied to be clinician judgment regarding the device functioning as intended and meeting user needs. This is not equivalent to a clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set

Not applicable. Since this is not an AI/machine learning device, there is no "training set."

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

Not applicable. There is no training set for this type of medical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

October 25, 2019

ACell, Inc. Michelle Huettner Director. Regulatory Affairs 6640 Eli Whitney Drive Suite 200 Columbia, Maryland 21046

Re: K192725

Trade/Device Name: Cytal Wound Matrix 3-Laver Regulatory Class: Unclassified Product Code: KGN Dated: September 26, 2019 Received: September 27, 2019

Dear Michelle Huettner:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

{1}------------------------------------------------

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Cynthia J. Chang, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K192725

Device Name Cytal® Wound Matrix 3-Layer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K192725 510(k) SUMMARY Cytal® Wound Matrix 3-Layer

Submitter:	ACell, Inc.6640 Eli Whitney DriveColumbia, MD 21046
Contact Person:	Michelle Huettner
Contact Title:	Director of Regulatory AffairsACell, Inc.
Phone:	(765) 464-8198 ext 135
Facsimile:	410-715-4511
Date Prepared:	October 25, 2019
Trade Name:	Cytal® Wound Matrix 3-Layer
Common Name:	Animal-Derived, Extracellular Matrix Wound Care Product
Classification Name:	Dressing, Wound, Collagen
Regulation Number:	N/A
Regulatory Class:	Unclassified
FDA Product Code:	KGN
Predicate Device:	ACell, Inc. Cytal® Wound Matrix (K152721)
Reference Devices:	ACell, Inc. Gentrix Surgical Matrix Thick; Gentrix® Surgical Matrix Extend (K170763)

Device Description

Intended Use/Indications for Use

Cytal® Wound Matrix 3-Layer is intended for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers,

{4}------------------------------------------------

tunnel/undermined wounds, surgical wounds (donor sites/grafts, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

Summary of Technological Characteristics

The technological characteristics of the modified Cytal Wound Matrix 3-Layer (subject device) are substantially equivalent to the cleared Cytal Wound Matrix predicate. The subject and predicate devices have substantially equivalent raw materials, manufacturing processes, and sterilization requirements. More specifically, the devices are fenestrated wound dressings composed of 3-layers of a resorbable, porcine-derived, extracellular matrix scaffold containing epithelial basement membrane, known as urinary bladder matrix (UBM). The devices are manufactured using the same processes, except for utilizing the same layering configuration method cleared in ACell's reference Gentrix Surgical Matrix Thick device (K170763) to achieve the larger device size. The single use only subject and predicate devices are vacuum-pressed to dehydrate the device and terminally sterilized using electron beam irradiation to achieve a sterilization assurance level of 10°. Updated packaging has been implemented to account for the device size. The minor differences cited above for the Cytal Wound Matrix 3-Layer and the identified predicate do not raise different questions of safety or effectiveness, and performance testing demonstrates that the device has comparable performance to the predicate.

	Subject Device	Predicate Device	Reference Device
ACell, Inc.	Cytal® Wound Matrix3-Layer	Cytal® Wound Matrix	Gentrix® Surgical MatrixThick; Gentrix® SurgicalMatrix Extend
510(k) No.	K192725	K152721	K170763
Device Class	Unclassified	Unclassified	Class II
Product Code	KGN	KGN	FTM, OXH, OXK
Classification	Dressing, Wound, Collagen	Dressing, Wound, Collagen	Surgical Mesh
Indications for Use/Intended Use	Cytal Wound Matrix 3-Layer is intended for themanagement of woundsincluding: partial and fullthickness wounds, pressureulcers, venous ulcers,diabetic ulcers, chronicvascular ulcers,tunnel/undermined wounds,surgical wounds (donorsites/grafts, post-Mohssurgery, post-laser surgery,podiatric, wounddehiscence), trauma wounds(abrasions, lacerations,second-degree burns, andskin tears), and drainingwounds. The device isintended for one-time use.	Cytal Wound Matrix isintended for themanagement of woundsincluding: partial and fullthickness wounds, pressureulcers, venous ulcers,diabetic ulcers, chronicvascular ulcers,tunnel/undermined wounds,surgical wounds (donorsites/grafts, post-Mohssurgery, post-laser surgery,podiatric, wounddehiscence), trauma wounds(abrasions, lacerations,second-degree burns, andskin tears), and drainingwounds. The device isintended for one-time use.	Gentrix Surgical MatrixThick and Gentrix SurgicalMatrix Extend are intendedfor implantation to reinforcesoft tissue where weaknessexists in patients requiringgastroenterological or plastic& reconstructive surgery.Reinforcement of soft tissuewithin gastroenterologicaland plastic & reconstructivesurgery includes, but is notlimited to, the followingprocedures: hernia and bodywall repair, colon and rectalprolapse repair, tissue repair,and esophageal repair.

A table comparing the key features of the subject and predicate devices is provided below.

{5}------------------------------------------------

ACell, Inc.	Subject Device	Predicate Device	Reference Device
	Cytal® Wound Matrix3-Layer	Cytal® Wound Matrix	Gentrix® Surgical MatrixThick; Gentrix® SurgicalMatrix Extend
Material Source	Porcine Urinary BladderMatrix (UBM)	Porcine Urinary BladderMatrix (UBM)	Porcine Urinary BladderMatrix (UBM)
Material Type	Collagen,Extracellular Matrix	Collagen,Extracellular Matrix	Collagen,Extracellular Matrix
Resorbable	Yes	Yes	Yes
Number of Layers	3-Layers	2-,3-,6-,8-Layers	8- Layers
Clinically RelevantSizes (Nominal)	16 cm x 25 cm &16 cm x 35 cm	3 cm x 3.5 cm to 10 cm x15 cm	Up to 30 cm x 40 cm
For Single Use	Yes	Yes	Yes
Sterilization	Electron-beam Irradiation	Electron-beam Irradiation	Electron-beam Irradiation
Packaging	Dual Foil:PETSterile Barrier System	Dual Tyvek:PETSterile Barrier System	Dual Foil:PETSterile Barrier System
Storage & HandlingConditions on Labeling	Store in a clean, dryenvironment at roomtemperature	15 - 35°C	Store in a clean, dryenvironment at roomtemperature

Performance Data

The following bench testing was performed to ensure that the additional Cytal Wound Matrix 3-Layer device sizes met the clinically relevant user needs, design inputs, and specifications to demonstrate substantial equivalence to the predicate device:

Suture retention strain ●
Tensile strain
Hydration uptake ●
Dimensional analysis ●
Packaging performance ●

In addition, design validation testing was completed via clinician feedback and simulated use testing. In all instances, Cytal Wound Matrix 3-Layer functioned as intended and the results of the testing were as expected. The results of the design verification bench testing and design validation testing demonstrate that the device is substantially equivalent to the predicate device. There were no pre-clinical animal studies or clinical studies conducted to support the substantial equivalence of the subject device to the predicate device.

Conclusions

The subject larger size (16 cm x 25 cm & 16 cm x 35 cm) Cytal Wound Matrix 3-Layer is as safe and effective as the Cytal Wound Matrix 2-, 3-, 6-, 8-Layers currently offered in sizes 3 cm x 3.5 cm to 10 cm x 15 cm. Cytal Wound Matrix 3-Layer has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. In addition, the minor technological differences between the larger Cytal Wound Matrix 3-Layer and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrates that the larger Cytal Wound Matrix 3-Layer is as safe and effective as the cleared Cytal Wound Matrix. Thus, the modified Cytal Wound Matrix is substantially equivalent to the cleared Cytal Wound Matrix (K152721).

Regulation Number and Section

N/A