(78 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a biological matrix for wound management, with no mention of AI or ML.
Yes.
The device is intended for the management of wounds, which are conditions that require therapeutic intervention to heal.
No
Explanation: The "Intended Use" section states that the device is "intended for the management of wounds," which indicates a therapeutic purpose rather than a diagnostic one. The "Device Description" further details its composition and form as a wound matrix, reinforcing its role in wound treatment.
No
The device description clearly states the device is composed of porcine-derived extracellular matrix scaffolds and is supplied in physical sheet configurations, indicating it is a physical medical device, 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 various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a physical matrix made from porcine tissue intended to be applied to a wound. This is a medical device used for treatment, not for testing samples from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, tissue, etc.) or to provide information for diagnosis.
- Performance Studies: The performance studies focus on biocompatibility and mechanical strength, which are relevant to a therapeutic device applied to a wound, not to the accuracy of a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cytal® Wound Matrix is applied in vivo (on the body) for wound management.
N/A
Intended Use / Indications for 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, 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 is composed of porcine-derived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied in single and multi-layer sheet configurations (1 to 8 layers) in sizes up to 10 cm x 15 cm, and can be provided with or without fenestrations in both Ivophilized and vacuum pressed configurations. The device is packaged in double peel-open pouches. The devices are terminally sterilized using electron beam irradiation. The device is intended for one time use.
The technical specifications for the Cytal" Wound Matrix are as follows, depending upon whether the device is fenestrated or unfenestrated:
- . If fenestrated: Device will be provided dry in sheet sizes up to 10 x 15 cm in double sterile barrier packaging. Device will be fenestrated appropriately according to size with parallel slits along the long axis.
- . If unfenestrated: Device will be provided dry in sheet sizes up to 10 x 15 cm in double sterile barrier packaging.
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
Biocompatibility Testing: The same material used in the Cytal" Wound Matrix underwent the following biocompatibility testing on sterilized devices per ISO-10993-1 standard: cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, pyrogenicity, subacute and subchronic toxicity and implantation, genotoxicity, and LAL endotoxin. The results of these tests provided evidence that the Cytal Wound Matrix meets biocompatibility requirements of the ISO standard.
Mechanical Testing: The same material used in the Cytal" Wound Matrix was tested for suture retention strength. The results of the mechanical testing provided evidence that the Cytal"" Wound Matrix provides adequate mechanical strength for its application.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 8, 2015
ACell Incorporated Thomas Gilbert, Ph.D. Chief Science Officer 6640 Eli Whitney Drive Columbia, Maryland 21046
Re: K152721
Trade/Device Name: Cytal "" Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: December 1, 2015 Received: December 1, 2015
Dear Dr. Gilbert:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152721
Device Name Cytal® Wound Matrix
Indications for Use (Describe)
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 (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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(K) SUMMARY
| Date Prepared: | September 21, 2015 |
|---|---|
| Manufacturer Name: | |
| Submitted by: | ACell, Inc. |
| 6640 Eli Whitney Drive | |
| Columbia, MD 21046 | |
| Contact Person: | Salman Elmi |
| Vice President, Deputy General Counsel | |
| ACell, Inc. | |
| Phone: (410) 953-8500 | |
| Email: salelmi@acell.com | |
| Fax: (240) 465-8187 |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | CytalTM Wound Matrix |
|---|---|
| Common/Usual Name: | Animal-derived, extracellular matrix wound care product |
| Regulation Name: | Collagen Wound Dressing |
| Device Class: | Unclassified |
| Product Code: | KGN |
| Reviewing Panel: | General & Plastic Surgery |
| PREDICATE DEVICE | |
| Predicate Device: | MatriStem® Wound Matrix (K112409) |
DEVICE DESCRIPTION
Cytal" Wound Matrix is composed of porcine-derived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied in single and multi-layer sheet configurations (1 to 8 layers) in sizes up to 10 cm x 15 cm, and can be provided with or without fenestrations in both Ivophilized and vacuum pressed configurations. The device is packaged in double peel-open pouches. The devices are terminally sterilized using electron beam irradiation. The device is intended for one time use.
The technical specifications for the Cytal" Wound Matrix are as follows, depending upon whether the device is fenestrated or unfenestrated:
- . If fenestrated: Device will be provided dry in sheet sizes up to 10 x 15 cm in double sterile barrier packaging. Device will be fenestrated appropriately according to size with parallel slits along the long axis.
- . If unfenestrated: Device will be provided dry in sheet sizes up to 10 x 15 cm in double sterile barrier packaging.
4
INDICATIONS FOR 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, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Cytal™ Wound Matrix has the same intended use as predicate device, which is for management of wounds. The technological characteristics of the Cytal" Wound Matrix are substantially similar to the cleared predicate, as both are comprised of animal tissue-derived, collagen extracellular matrix (ECM) scaffolds supplied in a rectangular sheet configuration that are packaged and terminally sterilized. The available sizes of the subject device (25 - 150 cm²) are consistent with the range of sizes of the predicate device (16 - 280 cm²). The subject device and the predicate device both consist of multilaminate sheets ranging from 1-8 layers. The minor difference between the Cytal Wound Matrix and the identified predicate with regard to dehydration method (lyophilized vs. vacuum pressed) does not raise different questions of safety or efficacy and performance testing demonstrates that the device has comparable performance to the predicate.
PERFORMANCE DATA
Biocompatibility Testing
The same material used in the Cytal" Wound Matrix underwent the following biocompatibility testing on sterilized devices per ISO-10993-1 standard: cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, pyrogenicity, subacute and subchronic toxicity and implantation, genotoxicity, and LAL endotoxin. The results of these tests provided evidence that the Cytal Wound Matrix meets biocompatibility requirements of the ISO standard.
Mechanical Testing
The same material used in the Cytal" Wound Matrix was tested for suture retention strength. The results of the mechanical testing provided evidence that the Cytal"" Wound Matrix provides adequate mechanical strength for its application.
CONCLUSION
Based on testing and comparison to the predicate device. Cytal" Wound Matrix does not raise different questions of safety and effectiveness and the results support a determination of substantial equivalence through this 510(k) Premarket Notification.