(28 days)
No
The device description and performance studies focus on the material properties and physical performance of a wound matrix, with no mention of AI or ML technologies.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for the management of various types of wounds, which is a therapeutic purpose.
No
The device description indicates it is a wound matrix intended for management and application to wounds, not for diagnosing them.
No
The device description clearly states it is a physical, resorbable, porcine-derived extracellular matrix scaffold, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "management of wounds." This involves direct application to the wound for healing purposes.
- Device Description: The description details a "resorbable, porcine-derived, extracellular matrix (ECM) scaffold" applied to the wound. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for a health issue.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This device is applied in vivo (on the body) for therapeutic purposes.
N/A
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, 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.
Product codes
KGN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
ACell, Inc. Cytal® Wound Matrix (K152721)
Reference Device(s)
ACell, Inc. Gentrix Surgical Matrix Thick; Gentrix® Surgical Matrix Extend (K170763)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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) |
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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).