(61 days)
No
The document describes a biological tissue matrix for wound management and explicitly states that no AI/ML terms were found and no additional performance studies were required for this labeling correction submission.
Yes
PriMatrix is intended for the management of various wounds, which falls under the definition of a therapeutic purpose.
No
PriMatrix is intended for the management of wounds and is described as an acellular dermal tissue matrix. There is no indication that it is used to diagnose a condition.
No
The device description explicitly states that PriMatrix is an "acellular dermal tissue matrix," which is a physical material, 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 describes the management of various types of wounds. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is an acellular dermal tissue matrix, which is a material used for wound healing and tissue repair. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, PriMatrix is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PriMatrix 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-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
- Trauma wounds abrasions, lacerations and skin tears
- Tunneled/undermined wounds
- Draining wounds
Product codes
KGN
Device Description
PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surqeon to meet the individual patient's needs.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No additional verification and validation test data were required as part of this submission. This "traditional" 510(k) was submitted to clarify and correct the labeling, without changing the Intended Use of PriMatrix.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PriMatrix™ Dermal Repair Scaffold K131286
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2016
Integra LifeSciences Corp. David D. Cox, Ph.D. Vice President, Regulatory Affairs Orthopedics and Tissue Technologies Division 311 Enterprise Drive Plainsboro, NJ 08536
Re: K153690
Trade/Device Name: PriMatrix Dermal Repair Scaffold Regulatory Class: Unclassified Product Code: KGN Dated: December 21, 2015 Received: December 23, 2015
Dear Dr. Cox:
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
Page 2 - David D. Cox, Ph.D.
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
K153690 510(k) Number (if known):
PriMatrix™ Dermal Repair Scaffold Device Name:
Indications for Use:
PriMatrix is intended for the management of wounds that include:
- Partial and full thickness wounds ●
- Pressure, diabetic, and venous ulcers
- o Second-degree burns
- Surgical wounds donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, ● wound dehiscence
- Trauma wounds abrasions, lacerations and skin tears ●
- Tunneled/undermined wounds
- Draining wounds ●
V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (Part 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)
3
Image /page/3/Picture/1 description: The image shows the logo for Integra. The word "INTEGRA" is written in gray, with the words "LIMIT UNCERTAINTY" written in a smaller font below it. To the right of the word "INTEGRA" are four green squares of varying sizes, arranged in a column.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
l. Applicant Information:
| Date Prepared:
Submitter: | December 17, 2015
TEI BioSciences, Inc. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Address: | 7 Elkins Street
Boston, MA 02127 |
| Establishment
Registration No. | 3004170064 |
| Contact Person: | David D. Cox, Ph.D.
Vice President, Regulatory Affairs
Integra LifeSciences (Owner of TEI Biosciences, Inc.) |
| Telephone Number:
Fax Number: | (609) 750-2880
(609) 750-4277 |
II. Device Information:
| Trade Name: | PriMatrix™ Dermal Repair Scaffold |
|---|---|
| Common Name: | Animal-derived, dermal extracellular matrix wound care product |
| Classification Name: | Dressing, Wound, Collagen |
| Classification: | Unclassified |
| Product Code: | KGN |
| Predicate Device: | PriMatrix™ Dermal Repair Scaffold |
| 510(k) No. K131286; Product Code: KGN | |
| Device Intended Use: | |
| PriMatrix 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-Moh's surgery post-laser surgery, podiatric, wound dehiscence Trauma wounds - abrasions, lacerations and skin tears Tunneled/undermined wounds Draining wounds |
4
Image /page/4/Picture/1 description: The image shows the logo for Integra. The logo consists of the word "INTEGRA" in gray, with the tagline "LIMIT UNCERTAINTY" in a smaller, green font below it. To the right of the wordmark are four green squares of varying sizes, arranged in a descending order.
-
Device Description: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surqeon to meet the individual patient's needs.
PriMatrix is intended for the management of wounds that Intended Use: include: -
. Partial and full thickness wounds
-
o Pressure, diabetic, and venous ulcers
-
Second-degree burns ●
-
Surgical wounds donor sites/grafts, post-Moh's surgery, . post-laser surgery, podiatric, wound dehiscence
-
Trauma wounds - abrasions, lacerations and skin tears
-
Tunneled/undermined wounds ●
-
o Draining wounds
-
Contraindications: PriMatrix should not be used for patients with a known history of hypersensitivity to collagen or bovine products.
Comparison to Predicate Device(s): PriMatrix is exactly the same as the predicate in terms of materials, form, function and intended use. No changes in technology or packaging have been made to the predicate product. Only the labeling has been changed to add clarity.
- Test Data: No additional verification and validation test data were required as part of this submission. This "traditional" 510(k) was submitted to clarify and correct the labeling, without changing the Intended Use of PriMatrix.
- Summary: Based upon the technical information, intended use, in vitro, in vivo, and clinical performance information provided in previous pre-market notifications, the PriMatrix product referenced in this submission is substantially equivalent to the currently marketed predicate device, and does not raise any new questions of safety or effectiveness.