Who is the manufacturer of Cytal Wound Matrix 3-Layer?

Acell, Inc. filed the 510(k) submission for Cytal Wound Matrix 3-Layer (K192725).

What is the FDA product code for Cytal Wound Matrix 3-Layer?

KGN. as a Class U device in the SU panel.

What is the regulatory pathway for Cytal Wound Matrix 3-Layer?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Cytal Wound Matrix 3-Layer?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Cytal Wound Matrix 3-Layer

Q: What are the predicate devices for Cytal Wound Matrix 3-Layer?

Cytal® Wound Matrix (K152721).

K192725 · Acell, Inc. · KGN · Oct 25, 2019 · SU

Device Facts

Record ID	K192725
Device Name	Cytal Wound Matrix 3-Layer
Applicant	Acell, Inc.
Product Code	KGN · SU
Decision Date	Oct 25, 2019
Decision	SESE
Submission Type	Special
Device Class	Class U
Attributes	Therapeutic

Intended Use

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 Story

Cytal Wound Matrix 3-Layer is a resorbable, porcine-derived extracellular matrix (ECM) scaffold composed of urinary bladder matrix (UBM). Supplied as fenestrated sheets in sizes up to 16 cm x 35 cm, the device is pre-hydrated with sterile saline and applied directly to the wound by a clinician. It acts as a wound dressing to support the management of various acute and chronic wounds. The device is for single-use only and is terminally sterilized via electron beam irradiation. It functions as a scaffold for tissue repair; it is not an active device and does not involve electronic processing or software.

Clinical Evidence

No clinical studies or pre-clinical animal studies were conducted. Substantial equivalence is supported by bench testing, including suture retention strain, tensile strain, hydration uptake, dimensional analysis, and packaging performance, alongside clinician feedback and simulated use testing.

Technological Characteristics

Resorbable porcine-derived urinary bladder matrix (UBM) scaffold; 3-layer configuration; fenestrated sheet form factor (up to 16 cm x 35 cm); terminally sterilized via electron beam irradiation (SAL 10^-6); vacuum-pressed; pre-hydrated with sterile saline; non-electronic; no software.

Indications for Use

Indicated for management of partial/full-thickness wounds, pressure/venous/diabetic/chronic vascular ulcers, tunnel/undermined wounds, surgical wounds (donor sites, grafts, post-Mohs/laser/podiatric, dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds in patients requiring wound care.

Predicate Devices

Cytal® Wound Matrix (K152721)

Reference Devices

Gentrix Surgical Matrix Thick (K170763)
Gentrix® Surgical Matrix Extend (K170763)

Related Devices

K152721 — Cytal Wound Matrix · Acell, Inc. · Dec 8, 2015
K213607 — Geistlich Wound Matrix PLUS · Geistlich Pharma AG · Apr 28, 2022
K153754 — MicroMatrix · Acell, Inc. · Mar 14, 2016
K180776 — Cytal Wound Particulate · Acell, Inc. · May 11, 2018
K242828 — Corplex P/ Theracor P/ Allacor P · Stimlabs, LLC · Oct 18, 2024

Submission Summary (Full Text)

{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) 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. | 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 Drive Columbia, MD 21046 | |----------------------|--------------------------------------------------------------------------------------| | Contact Person: | Michelle Huettner | | Contact Title: | Director of Regulatory Affairs ACell, 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 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. ## 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 Matrix 3-Layer | Cytal® Wound Matrix | Gentrix® Surgical Matrix Thick; Gentrix® Surgical Matrix 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 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. | Cytal Wound Matrix 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. | Gentrix Surgical Matrix Thick and Gentrix Surgical Matrix Extend are intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse 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 Matrix 3-Layer | Cytal® Wound Matrix | Gentrix® Surgical Matrix Thick; Gentrix® Surgical Matrix Extend | | Material Source | Porcine Urinary Bladder Matrix (UBM) | Porcine Urinary Bladder Matrix (UBM) | Porcine Urinary Bladder Matrix (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 Relevant Sizes (Nominal) | 16 cm x 25 cm & 16 cm x 35 cm | 3 cm x 3.5 cm to 10 cm x 15 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:PET Sterile Barrier System | Dual Tyvek:PET Sterile Barrier System | Dual Foil:PET Sterile Barrier System | | Storage & Handling Conditions on Labeling | Store in a clean, dry environment at room temperature | 15 - 35°C | Store in a clean, dry environment at room temperature | ## 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).