(174 days)
No
The summary describes a biological wound dressing and its performance testing, with no mention of AI or ML.
Yes
The device is indicated for various types of wounds, including ulcers and burns, and is designed to assist wound healing, which aligns with the definition of a therapeutic device.
No
Explanation: The device description and intended use focus on wound healing by facilitating a moist wound healing environment, not on diagnosing medical conditions. The performance studies also focus on physical and biological properties relevant to wound dressings, not diagnostic capabilities.
No
The device description clearly states that ProgenaMatrix™ is a "clear keratin matrix derived from human hair," which is a physical material, not software. The performance studies also focus on the physical and biological properties of this material.
Based on the provided information, ProgenaMatrix™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that ProgenaMatrix™ is indicated for the treatment of various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a wound dressing designed to facilitate healing by providing a moist environment. This aligns with a therapeutic device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide diagnostic information. The performance studies focus on mechanical properties, biocompatibility, and skin reactions, which are relevant to a therapeutic wound dressing.
Therefore, ProgenaMatrix™ is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ProgenaMatrix™ is indicated for dry and exuding partial and full thickness wounds such as: pressure (stage I-IV) and venous stasis ulcers caused by mixed vascular etiologies, diabetic ulcers, donor sites and grafts, first and second degree burns, superficial injuries, cuts, abrasions and surgical wounds.
ProgenaMatrix™ is not intended to be used on third degree burns.
Product codes
KGN
Device Description
ProgenaMatrix™ is a clear keratin matrix derived from human hair designed to assist wound healing by facilitating a moist wound healing environment. It is packaged in a sterile, moisture-proof, peel-open pouch containing water and propylene glycol.
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 subject device has mechanical properties substantially equivalent to the predicate device with the same intended use. The following characteristics were evaluated:
• Tensile Strength
• Moisture Vapor Transmission Rate
• Water Transmission Rate
• Degradation Potential
• Manufacturing Residuals
• Viral Inactivation
• Protein Characterization
• Removal of Contaminants
Biocompatibility Testing:
• Cytotoxicity
• Sensitization
• Irritation
• Acute Toxicity
• Subacute & Subchronic Toxicity (Implantation Endpoint Assessment)
• Endotoxin Testing
• Pyrogenicity
• Toxicological Risk Assessment
• Chronic Toxicity
• Genotoxicity
• Carcinogenicity
Clinical Testing:
• Repeat Insult Patch Test
• Skin Prick Test
Key Metrics
Not Found
Predicate Device(s)
K080949 Keratec Wound Dressings (a/k/a Keraderm, now known as Keramatrix®)
Reference Device(s)
K073251 Hyalomatrix®
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 17, 2019
Cell Constructs I, LLC % Elizabeth O'Keefe Regulatory Affairs Director Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K182010
Trade/Device Name: ProgenaMatrix™ Regulatory Class: Unclassified Product Code: KGN Dated: December 18, 2018 Received: December 18, 2018
Dear Elizabeth O'Keefe:
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
1
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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
Anjana Jain -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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
510(k) Number (if known) K182010 Device Name
ProgenaMatrix™
Indications for Use (Describe)
ProgenaMatrix™ is indicated for dry and exuding partial and full thickness wounds such as: pressure (stage I-IV) and venous stasis ulcers caused by mixed vascular etiologies, diabetic ulcers, donor sites and grafts, first and second degree burns, superficial injuries, cuts, abrasions and surgical wounds.
ProgenaMatrix™ is not intended to be used on third degree burns.
Type of Use (Select one or both, as applicable) 区 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."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301)443.6740 EF
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510(k) Summary of Safety and Effectiveness
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the Cell Constructs I, LLC ProgenaMatrix™ is provided below.
| Date | 01/16/2019 |
|---|---|
| Submitted by | Cell Constructs I, LLC |
| 2275 Northwest Pkwy SE, Suite 170 | |
| Marietta, GA 30067 | |
| Phone : 770-627-2547 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Elizabeth O'Keeffe, Ph.D. | |
| 7828 Hickory Flat Highway Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 (direct) | |
| Regulatory@SecureBME.com | |
| Trade Name | ProgenaMatrix™ |
| Common Name | Dressing, Wound, Collagen |
| Code -Classification | KGN: Unclassified |
| Primary Predicate | K080949 Keratec Wound Dressings (a/k/a Keraderm, now known as Keramatrix®) |
| Reference Devices | K073251 Hyalomatrix® |
| Device Description | ProgenaMatrix™ is a clear keratin matrix derived from human hair designed to |
| assist wound healing by facilitating a moist wound healing environment. It is | |
| packaged in a sterile, moisture-proof, peel-open pouch containing water and | |
| propylene glycol. | |
| Intended Use | ProgenaMatrix™ is indicated for dry and exuding partial and full thickness |
| wounds such as: pressure (stage I-IV) and venous stasis ulcers, ulcers caused by | |
| mixed vascular etiologies, diabetic ulcers, donor sites and grafts, first and | |
| second degree burns, superficial injuries, cuts, abrasions and surgical wounds. | |
| ProgenaMatrix™ is not intended to be used on third degree burns. | |
| Technological | |
| Characteristics | The subject device has substantially equivalent technological characteristics as |
| the predicate device and/or the reference device in terms of principles of | |
| operation, intended use, material performance, and biocompatibility. | |
| Non-Clinical | |
| Testing | The subject device has mechanical properties substantially equivalent to the |
| predicate device with the same intended use. The following characteristics were | |
| evaluated: | |
| • Tensile Strength | |
| • Moisture Vapor Transmission Rate | |
| • Water Transmission Rate | |
| • Degradation Potential | |
| • Manufacturing Residuals | |
| • Viral Inactivation | |
| • Protein Characterization | |
| • Removal of Contaminants | |
| Biocompatibility | |
| Testing | • Cytotoxicity |
| • Sensitization | |
| • Irritation | |
| • Acute Toxicity | |
| • Subacute & Subchronic Toxicity (Implantation Endpoint Assessment) | |
| • Endotoxin Testing | |
| • Pyrogenicity | |
| • Toxicological Risk Assessment | |
| • Chronic Toxicity | |
| • Genotoxicity | |
| • Carcinogenicity | |
| Clinical Testing | • Repeat Insult Patch Test |
| • Skin Prick Test | |
| Conclusions | ProgenaMatrix™ has the same intended use, principles of operation and |
| substantially equivalent technological characteristics as Keratec Wound Dressing | |
| (a/k/a Keraderm, now known as Keramatrix®). While ProgenaMatrix™ differs | |
| from the predicate device in the source of keratin protein (human vs. sheep), | |
| both devices share the same mode of action in that they assist in providing a | |
| moist wound healing environment. ProgenaMatrix™ is substantially equivalent | |
| with respect to safety and effectiveness to the predicate and reference devices | |
| and does not raise different questions of safety and effectiveness. |
4