(174 days)
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.
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.
The provided text is a 510(k) summary for the ProgenaMatrix™ device, a wound dressing. This document confirms the device's substantial equivalence to predicate devices based on non-clinical and biocompatibility testing, rather than a clinical study evaluating its performance in relation to acceptance criteria for diagnostic efficacy. Therefore, it does not contain the information required to populate most of the requested fields.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or device performance measurements in the context of diagnostic accuracy, as it is not a diagnostic device. It lists mechanical properties, biocompatibility tests, and clinical tests (patch and prick tests) that were conducted to demonstrate substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes non-clinical and biocompatibility testing, not a clinical study with a "test set" in the diagnostic sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth establishment by experts is not described for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of diagnostic findings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a wound dressing, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here refers to established scientific methods for evaluating material properties, biocompatibility, and safety, not diagnostic categories.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device.
9. How the ground truth for the training set was established
Not applicable.
Summary of available information (based on the provided text):
The document indicates that the ProgenaMatrix™ device underwent Non-Clinical Testing and Biocompatibility Testing to demonstrate substantial equivalence to its predicate device. This testing focused on material properties and safety.
Non-Clinical Testing evaluated:
- Tensile Strength
- Moisture Vapor Transmission Rate
- Water Transmission Rate
- Degradation Potential
- Manufacturing Residuals
- Viral Inactivation
- Protein Characterization
- Removal of Contaminants
Biocompatibility Testing included:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Toxicity
- Subacute & Subchronic Toxicity (Implantation Endpoint Assessment)
- Endotoxin Testing
- Pyrogenicity
- Toxicological Risk Assessment
- Chronic Toxicity
- Genotoxicity
- Carcinogenicity
Clinical Testing (mentioned in the non-clinical testing section, which is unusual phrasing) involved:
- Repeat Insult Patch Test
- Skin Prick Test
The conclusions state that the device "has the same intended use, principles of operation and substantially equivalent technological characteristics as Keratec Wound Dressing... 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." It concludes the device 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."
However, specific quantitative acceptance criteria or detailed results for these tests are not provided in the summary. The document focuses on the types of tests performed to establish equivalence for regulatory clearance, not detailed performance metrics against specific acceptance thresholds in the way a diagnostic study would.
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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
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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
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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, LLC2275 Northwest Pkwy SE, Suite 170Marietta, GA 30067Phone : 770-627-2547 |
| 510(k) Contact | Secure BioMed EvaluationsElizabeth O'Keeffe, Ph.D.7828 Hickory Flat Highway Suite 120Woodstock, GA 30188770-837-2681 (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 toassist wound healing by facilitating a moist wound healing environment. It ispackaged in a sterile, moisture-proof, peel-open pouch containing water andpropylene glycol. |
| Intended Use | ProgenaMatrix™ is indicated for dry and exuding partial and full thicknesswounds such as: pressure (stage I-IV) and venous stasis ulcers, ulcers caused bymixed vascular etiologies, diabetic ulcers, donor sites and grafts, first andsecond degree burns, superficial injuries, cuts, abrasions and surgical wounds.ProgenaMatrix™ is not intended to be used on third degree burns. |
| TechnologicalCharacteristics | The subject device has substantially equivalent technological characteristics asthe predicate device and/or the reference device in terms of principles ofoperation, intended use, material performance, and biocompatibility. |
| Non-ClinicalTesting | 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 | |
| BiocompatibilityTesting | • 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. |
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N/A