(49 days)
No
The device description focuses on the biological and physical properties of the extracellular matrix material and its intended use in wound management. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for the management of wounds and is composed of a resorbable, porcine-derived, extracellular matrix scaffold which functions to aid in the healing process of various types of wounds, indicating a therapeutic purpose.
No
Explanation: The document describes "Cytal® Wound Particulate" as a material intended for "management of wounds," composed of an "extracellular matrix scaffold." Its function is to be applied to a wound, either dry or pre-hydrated, to facilitate the healing process. There is no mention of it being used to identify, measure, or analyze a medical condition, disease, or its characteristics. It is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description clearly states it is a physical particulate composed of resorbable, porcine-derived extracellular matrix, packaged in a vial. This is a physical medical device, not software.
Based on the provided text, 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 applying the device directly to the wound for therapeutic purposes (promoting healing).
- Device Description: The description details a physical material (particulate) applied to the wound bed.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition, monitor a disease, or screen for health issues.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. This device is a therapeutic product applied directly to the body.
N/A
Intended Use / Indications for Use
Cytal® Wound Particulate 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 onetime use.
Product codes
KGN
Device Description
Cytal® Wound Particulate is composed of a resorbable, porcine-derived, extracellular matrix scaffold containing epithelial basement membrane, specifically known as Urinary Bladder Matrix (UBM). The devices are supplied as a dry, absorbent, white to off-white particulate sized
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 11, 2018
ACell, Inc. c/o John Smith Hogan Lovells 555 Thirteenth St., NW Washington, District of Columbia 20004
Re: K180776
Trade/Device Name: Cytal Wound Particulate Regulatory Class: Unclassified Product Code: KGN Dated: April 13, 2018 Received: April 13, 2018
Dear John Smith:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180776
Device Name Cytal® Wound Particulate
Indications for Use (Describe)
Cytal® Wound Particulate 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 onetime 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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510(k) SUMMARY ACell Inc.'s Cytal® Wound Particulate
| Submitter: | ACell, Inc.
6640 Eli Whitney Drive
Columbia, MD 21046 |
|-----------------------------------------|-----------------------------------------------------------------------------------|
| Contact Person:
Phone:
Facsimile: | Andrea Pilon Artman
410-953-8549
410-715-4511 |
| Date Prepared: | May 10, 2018 |
| Trade Name: | Cytal® Wound Particulate |
| Common Name: | Animal-Derived, Extracellular Matrix Wound Care Produc |
| Classification Name: | Dressing, Wound, Collagen |
| Regulatory Class: | Unclassified |
| Product Code: | KGN |
| Predicate Device: | ACell Inc. Cytal® Wound Matrix (K152721) |
| Reference Devices: | ACell Inc. MicroMatrix® (K172399)
Cook Biotech Inc. Cook® ECM Powder (K152033) |
Device Description
Cytal® Wound Particulate is composed of a resorbable, porcine-derived, extracellular matrix scaffold containing epithelial basement membrane, specifically known as Urinary Bladder Matrix (UBM). The devices are supplied as a dry, absorbent, white to off-white particulate sized