(316 days)
PriMatrix Ag Antimicrobial is intended for the management of wounds that include:
- Partial and full thickness wounds
- Pressure, diabetic, and venous ulcers
- Second-degree burns
- Surgical wounds-donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence
- Trauma wounds-abrasions, lacerations, and skin tears
- Tunneled/undermined wounds
- Draining wounds
PriMatrix Ag Antimicrobial is an acellular dermal tissue matrix derived from fetal bovine dermis. PriMatrix Ag Antimicrobial is supplied sterile in a variety of sizes that can be trimmed by the surgeon to meet the individual patient's needs. The Ionic Silver content is intended to prevent microbial colonization of the device.
The provided text describes a 510(k) premarket notification for a medical device called PriMatrix Ag Antimicrobial Dermal Repair Scaffold. The submission focuses on establishing substantial equivalence to legally marketed predicate devices and demonstrates biocompatibility and antimicrobial effectiveness.
However, the document does not contain information related to a study that establishes acceptance criteria for its performance in the context of diagnostic accuracy, such as sensitivity, specificity, or AUC, as would be common for AI/ML-driven diagnostic devices. The device described is a dermal repair scaffold with antimicrobial properties, not an AI/ML diagnostic tool. Therefore, many of the requested categories (e.g., test set sample size, ground truth establishment, MRMC studies, standalone performance) are not applicable to the type of device being described.
Based on the provided information, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a dermal repair scaffold and not a diagnostic device, the "acceptance criteria" discussed are largely related to biocompatibility and antimicrobial effectiveness, rather than diagnostic performance metrics like sensitivity or specificity.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Demonstrated biocompatibility through independent certified laboratory testing. Tests included: cytotoxicity, hemolysis, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, implantation, and pyrogenicity. |
| Viral Inactivation | Manufacturing methods tested by an independent laboratory to assure safe levels of viral inactivation. |
| Antimicrobial Effectiveness (In Vitro) | Effective against a range of bacteria in CLSI Disc Susceptibility testing, including: Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Methicillin Resistant Staphylococcus aureus (MRSA), Enterococcus faecium, Klebsiella pneumonia, Serratia marcescens, Listeria monocytogenes, Vancomycin Resistant Enterococcus faecalis (VRE), Acinetobacter baumanni, and Streptococcis pyrogenes (Group A). |
| Antimicrobial Effectiveness (In Vivo) | In a rodent model, reduced levels of Staphylococcus aureus recovered from a contaminated wound site from ten million to no viable bacteria recovered on PriMatrix AG Antimicrobial or at the wound site within three days. |
Regarding the other requested information:
- 2. Sample size used for the test set and the data provenance: Not applicable. The studies described are laboratory and animal model tests, not human diagnostic test sets.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant here. Ground truth for antimicrobial effectiveness was established through standard microbiological and animal model assays.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is not an AI/ML-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For biocompatibility, the ground truth was established by standard toxicology and biological safety testing methods. For antimicrobial effectiveness, the ground truth was established by microbiological culture (CLSI Disc Susceptibility testing) and bacterial enumeration in an animal model.
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the K100261 submission for PriMatrix Ag Antimicrobial is for a biological wound care product with antimicrobial properties, not an AI/ML-driven diagnostic medical device. Therefore, the typical "acceptance criteria" and "study" details requested for AI/ML devices (like sensitivity, specificity, test/training sets, expert adjudication, MRMC studies) are not present in this document. The provided text details the device's biocompatibility and antimicrobial efficacy through laboratory and animal model testing to demonstrate its safety and function.
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K-100261
510(k) Summarv
DEC 1 0 2010
This 510(k) summary for PriMatrix AG Antimicrobial is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitted by
TEI Biosciences Inc. 7 Elkins Street Boston, MA 02127 (617) 268-1616 (617) 268-3282 (fax)
Contact Person
Kenneth James, Ph.D. Vice President, Product Sciences and Requlatory Affairs
Date Prepared
September 3, 2010
Device Information
PriMatrix Ag Antimicrobial Dermal Repair Scaffold Proprietary name: Common name: Animal-derived, extracellular matrix wound care product Classification : Unclassified
Device Description
PriMatrix Ag Antimicrobial is an acellular dermal tissue matrix derived from fetal bovine dermis. PriMatrix Ag Antimicrobial is supplied sterile in a variety of sizes that can be trimmed by the surgeon to meet the individual patient's needs. The Ionic Silver content is intended to prevent microbial colonization of the device.
Intended Use
PriMatrix Ag Antimicrobial Dermal Repair Scaffold is intended for the management of wounds that include:
- Partial and full thickness wounds ●
- Pressure, diabetic, and venous ulcers .
- Second-degree burns ●
- Surgical wounds-donor sites/grafts, post-Mohs surgery, post-laser surgery, . podiatric, wound dehiscence
- Trauma wounds-abrasions, lacerations, and skin tears .
- Tunneled/undermined wounds .
- . Draining wounds
Legally Marketed Devices to which Equivalence is Being Claimed
PriMatrix Ag Antimicrobial is substantially equivalent in function and intended use to:
| Predicate Devices | Manufacturer | 510(k) Number |
|---|---|---|
| PriMatrix | TEI Biosciences | K083440 |
| DressSkin | TEI Biosciences | K023778 |
| ColActive Ag | Covalon Technologies | K043296 |
| Exsalt SD7 | Exciton Technologies | K083870 |
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$\mathcal{H}_{2}$
Summary of Technological Characteristics and Biocompatibility
PriMatrix Ag Antimicrobial is substantially equivalent to other wound care products with respect to its design and application.
A rigorous biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of PriMatrix Ag Antimicrobial. The tests performed included: cytotoxicity, hemolysis, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, implantation and pyrogenicity. The manufacturing methods for PriMatrix AG Antimicrobial were also tested by an independent laboratory to assure safe levels of viral inactivation.
Ionic silver is a broad spectrum antimicrobial. PriMatrix AG Antimicrobial has been shown in CLSI Disc Susceptibility testing to be effective against a range of bacteria, including: Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Methicillin Resistant Staphylococus aureus (MRSA), Enterococcus faecium, Klebsiella pneumonia, Serratia marcescens, Listeria monocytogenes, Vancomycin Resistant Enterococcus faecalis (VRE), Acinetobacter baumanni and Streptococcis pyrogenes (Group A). PriMatrix AG Antimicrobial has also been demonstrated, in a rodent model, to reduce levels of Staphylococcus aureus recovered from a contaminated wound site from ten million to no viable bacteria recovered on PriMatrix AG Antimicrobial or at the wound site within three days.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
TEI Biosciences Inc. % Kenneth James, Ph.D. 7 Elkins Street Boston, Massachusetts 02127
DEC 1 0 2010
Re: K100261
Trade/Device Name: PriMatrix Ag Antimicrobial Dermal Repair Scaffold Regulatory Class: Unclassified Product Code: FRO Dated: November 30, 2010 Received: December 01, 2010
Dear Dr. James:
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
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Page 2 - Kenneth James, Ph.D.
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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TEI BIOSCIENCES INC.
January 22, 2010
PriMatrix Ag Antimicrobial
Abbreviated 510(k) Premarket Notification
2. Indications for Use of the Device
510(k) Number (if known):
DEC 1 0 2010
Device Name: PriMatrix Ag Antimicrobial Dermal Repair Scaffold
Indications for Use:
PriMatrix Ag Antimicrobial is intended for the management of wounds that include:
- Partial and full thickness wounds .
- Pressure, diabetic, and venous ulcers .
- Second-degree burns .
- Surgical wounds-donor sites/grafts, post-Mohs surgery, post-laser . surgery, podiatric, wound dehiscence
- Trauma wounds-abrasions, lacerations, and skin tears .
- Tunneled/undermined wounds .
- Draining wounds ●
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil Odel for JKK; for nkm
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number < 10026{
N/A