(38 days)
No
The summary describes a biological matrix device for tissue reinforcement and includes standard biocompatibility and mechanical testing, with no mention of AI/ML, image processing, or data-driven performance metrics.
Yes
The device is intended for implantation to reinforce soft tissue where weakness exists in patients requiring surgery, which classifies it as a therapeutic device aimed at treating a medical condition.
No
The device is described as a surgical matrix intended for implantation to reinforce soft tissue, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the device is composed of "porcine-derived extracellular matrix scaffolds" and is supplied in "multi-layer sheet configurations," indicating it is a physical implantable 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 states that the device is for "implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a "porcine-derived extracellular matrix scaffold" supplied in "multi-layer sheet configurations." This is a physical material intended for surgical placement.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The device itself is the treatment/reinforcement.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Gentrix™ Surgical Matrix 2-layer are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, and esophageal repair.
Gentrix™ Surgical Matrix 6-layer and 8-Layer are intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, and esophageal repair.
Product codes
FTM, OXH
Device Description
Gentrix™ Surgical Matrix 2-Layer, 6-Layer, 8-Layer devices are composed of porcinederived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied in multi-layer sheet configurations in sizes up to 10 cm x 15 cm, and packaged in double peel-open foil pouches. The devices are terminally sterilized using electron beam irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, urological, gastroenterological, plastic & reconstructive surgery (including hernia and body wall, colon and rectal, and esophageal).
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
Biocompatibility Testing: Gentrix™ Surgical Matrix 2-Layer, 3-Layer, 8-Layer underwent the following biocompatibility testing on sterilized devices per FDA's extent of recognition of ISO-10993-1 standard for a permanently implanted device: cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, pyrogenicity, subacute and subchronic toxicity and implantation, genotoxicity, hemocompatibility, and LAL endotoxin. The results of these tests provided evidence that the Gentrix™ Surgical Matrix is substantially equivalent to the predicate and reference devices and meets biocompatibility requirements of the ISO standard.
Mechanical Testing: Gentrix™ Surgical Matrix 2-Layer, 6-Layer, 8-Layer material was tested for the following: tensile strength, suture retention strength, ball burst strength, delamination strength, tear strength, and stiffness test. The results of the mechanical testing provided evidence that the Gentrix™ Surgical Matrix is substantially equivalent to the predicate and reference devices and provides adequate mechanical strength for its application throughout its labeled shelf life.
Material Characterization: Gentrix™ Surgical Matrix 2-Layer, 3-Layer, 8-Layer material was tested for the following: moisture content, hydration uptake, and hydrated onset temperature. The results of the material characterization testing provided evidence that the Gentrix is substantially equivalent to the predicate and reference devices and provides adequate performance for its application throughout its labeled shelf life.
Key Metrics
Not Found
Predicate Device(s)
MatriStem® Surgical Matrix RS, PSM, PSMX (K141084)
Reference Device(s)
ACell Surgical Mesh ML, MLPlus (K041140)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2016
ACell Incorporated % John Smith, M.D., J.D. Hogan Lovells US LLP 555 Thirteenth Street Northwest Washington, District of Columbia 20004
Re: K162554
Trade/Device Name: Gentrix™ Surgical Matrix 2-Layer, 3-Layer, 6-Layer, 8 Layer Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM, OXH Dated: October 19, 2016 Received: October 19, 2016
Dear Dr. 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 (reporting of medical devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. 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.
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.
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) K162554
Device Name
GentrixTM Surgical Matrix 2-Layer, 3-Layer, 6-Layer, 8-Layer
Indications for Use (Describe)
Gentrix™ Surgical Matrix 2-layer are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, and esophageal repair.
Gentrix™ Surgical Matrix 6-layer and 8-Layer are intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, and esophageal repair.
| 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
This summary of 510(k) safety and effectiveness is being submitterd in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
October 19, 2016 Date Prepared:
Manufacturer Name:
Submitted by:
ACell, Inc. 6640 Eli Whitney Drive Columbia, MD 21046
Contact Person:
Salman Elmi Vice President, Deputy General Counsel ACell, Inc. Phone: (410) 953-8500 Email: salelmi@acell.com Fax: (240) 465-8187
DEVICE NAME AND CLASSIFICATION
| 510(k) Number: | K162554 |
|---|---|
| Trade/Proprietary Name: | Gentrix™ Surgical Matrix 2-Layer, 3-Layer, 6-Layer, 8-Layer |
| Common/Usual Name: | Surgical Mesh, ECM, Surgical Scaffold |
| Regulation Name: | Surgical Mesh |
| Device Class: | Class II, 21 CFR 878.3300 |
| Product Code: | FTM, OXH |
| Reviewing Panel: | General & Plastic Surgery |
| Predicate Devices: | MatriStem® Surgical Matrix RS, PSM, PSMX (K141084) |
| Reference Devices: | ACell Surgical Mesh ML, MLPlus (K041140) |
DEVICE DESCRIPTION
Gentrix™ Surgical Matrix 2-Layer, 6-Layer, 8-Layer devices are composed of porcinederived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied in multi-layer sheet configurations in sizes up to 10 cm x 15 cm, and packaged in double peel-open foil pouches. The devices are terminally sterilized using electron beam irradiation.
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INDICATIONS FOR USE
Gentrix™ Surgical Matrix 2-layer and 3-layer are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following procedures; hernia and body wall repair, colon and rectal prolapse repair, and esophageal repair.
Gentrix™ Surgical Matrix 6-layer and 8-Laver are intended for implantation to reinforce soft tissue where weakness exists in - patients requiring - gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.
EQUIVALENCE TO MARKETED DEVICES
Gentrix™ Surgical Matrix 2-Layer, 3-Layer, 6-Layer have the same intended use as the predicate and reference surgical meshes, which is to reinforce soft tissue where weakness exists. The technological characteristics of the Gentrix™ Surgical Matrix 2-Layer, 6-Laver, and 8-Laver are substantially similar to the cleared predicate and reference devices, as all are identical in materials and manufacturing to the predicate and reference devices. Gentrix™ Surgical Matrix, the predicate device, and the reference device are comprised of animal tissue-derived, collagen extracellular matrix (ECM) scaffolds supplied in a multilaminate rectangular sheet configuration that are packaged and terminally sterilized. The available sizes of the subject device (8 – 150 cm²) are identical with the range of sizes of the predicate device, and within the range of the cleared reference device (8 – 280 cm²). The packaging system for Gentrix™ Surgical Matrix 2-Layer, 3-Layer, 8-Layer was validated per ANSI/AAMI/ISO 11607-1 and -2. and is substantially similar to the packaging system used for the cleared predicate and reference devices. The minor differences between the Gentrix™ Surgical Matrix 2-Layer, 3-Layer, 6-Layer and the predicate and reference devices do not raise different questions of safety or efficacy and performance testing demonstrates that the device has comparable performance to the predicates.
PERFORMANCE DATA
Biocompatibility Testing
Gentrix™ Surgical Matrix 2-Layer, 3-Layer, 8-Layer underwent the following biocompatibility testing on sterilized devices per FDA's extent of recognition of ISO-10993-1 standard for a permanently implanted device: cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, pyrogenicity, subacute and subchronic toxicity and implantation, genotoxicity, hemocompatibility, and LAL endotoxin. The results of these tests provided evidence that the Gentrix™ Surgical Matrix is substantially equivalent to the predicate and reference devices and meets biocompatibility requirements of the ISO standard.
5
Mechanical Testinq
Gentrix™ Surgical Matrix 2-Layer, 6-Layer, 8-Layer material was tested for the following: tensile strength, suture retention strength, ball burst strength, delamination strength, tear strength, and stiffness test. The results of the mechanical testing provided evidence that the Gentrix™ Surgical Matrix is substantially equivalent to the predicate and reference devices and provides adequate mechanical strength for its application throughout its labeled shelf life.
Material Characterization
Gentrix™ Surgical Matrix 2-Layer, 3-Layer, 8-Layer material was tested for the following: moisture content, hydration uptake, and hydrated onset temperature. The results of the material characterization testing provided evidence that the Gentrix is substantially equivalent to the predicate and reference devices and provides adequate performance for its application throughout its labeled shelf life
CONCLUSION
Based on direct testing and comparison to predicate and reference devices, Gentrix™ Surgical Matrix 2-Layer, 3-Layer, 6-Layer do not raise different questions of safety and effectiveness and the results support a determination of substantial equivalence through this 510(k) Premarket Notification.