(115 days)
No
The summary describes a biological tissue-based implant and does not mention any computational or algorithmic components, let alone AI/ML.
No
This device is intended for implantation to reinforce and repair soft tissues, not to treat a disease or condition in a therapeutic manner.
No
SurgiMend is an implantable device used to reinforce soft tissue and repair damaged membranes. Its intended uses, such as hernia repair and muscle flap reinforcement, describe therapeutic or reconstructive interventions, not diagnostic processes.
No
The device description clearly states that SurgiMend is an acellular dermal tissue derived from bovine dermis, which is a physical material intended for implantation. It does not describe any software component.
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 SurgiMend is for implantation to reinforce and repair soft tissue. This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as an acellular dermal tissue derived from bovine dermis, available in various configurations and sizes for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while SurgiMend is a surgical implant used to repair and reinforce tissue within the body.
N/A
Intended Use / Indications for Use
SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes.
SurgiMend is specifically indicated for:
- · Plastic and reconstructive surgery
- · Muscle flap reinforcement
- · Hernia repair including abdominal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.
Product codes
FTM
Device Description
SurgiMend is an acellular dermal tissue derived from bovine dermis. The device is available in solid, fenestrated, and perforated configurations. The device is supplied sterile in a variety of sizes, shapes, and thicknesses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, muscle flap, abdominal, femoral, diaphragmatic, scrotal, umbilical, incisional hernias.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 modified device, SurgiMend MP, is comprised of the same materials, processed, packaged and sterilized by the same method as the predicate device (K083898). The biocompatibility testing conducted on SurgiMend Collagen Matrix for Soft Tissue Reconstruction (K083898) product confirms the biological safety of the SurgiMend MP.
Performance testing for SurgiMend MP is the same as the predicate device. Mechanical testing, including tensile strength, suture pull-out, tear resistance, and ball burst were conducted in compliance with FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, March 2, 1999. All test results were acceptable.
The implantation studies were conducted in three different animal models (12 week rat hernia repair study, 4 week rat intra-abdominal, 2 week rat intra-muscle implant model) with the primary endpoint of mechanical strength to support soft tissue reinforcement. The studies also also characterized secondary endpoints of revascularization and tissue integration of perforated test and non-perforated control configurations. These studies demonstrate the basic properties of the subject device after implantation remain unchanged from the predicate. The result demonstrates the subject device is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 16, 2017
Integra LifeSciences Corporation c/o Ms. Kavita Amin Specialist, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K162965
Trade/Device Name: SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: January 13, 2017 Received: January 17, 2017
Dear Ms. Amin:
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 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,
Jennifer R. Stevenson -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) K162965
Device Name
SurgiMend® MP Collagen Matrix for Soft Tissue Reconstruction
Indications for Use (Describe)
SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes.
SurgiMend is specifically indicated for:
- · Plastic and reconstructive surgery
- · Muscle flap reinforcement
- · Hernia repair including abdominal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction
Submitter's name and address:
TEI Biosciences Inc. 7 Elkins Street Boston, MA 02127 USA
Contact person and telephone number:
Kavita Amin Specialist, Regulatory Affairs Telephone: 609-750-7827
Date the Summary was prepared: 13 January 2017
Name of the device:
| Trade name: | SurgiMend® MP Collagen Matrix for Soft Tissue
Reconstruction |
|----------------------|-----------------------------------------------------------------|
| Common Name: | Surgical Mesh |
| Classification Name: | Mesh, Surgical (21 CFR 878.3300) |
| Product Code: | FTM |
Predicate Device:
SurgiMend® MP is substantially equivalent in function and intended use to its predicate device as detailed in Table 1.
Table 1: Predicate Device
| 510(k)
Number | Product
Code | Trade Name | Manufacturer |
|------------------|-----------------|--------------------------------------------------------------|-------------------------|
| K083898 | FTM | SurgiMend® Collagen Matrix for
Soft Tissue Reconstruction | TEI Biosciences
Inc. |
Device Description:
SurgiMend is an acellular dermal tissue derived from bovine dermis. The device is available in solid, fenestrated, and perforated configurations. The device is supplied sterile in a variety of sizes, shapes, and thicknesses.
Indication for Use:
SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes:
SurgiMend is specifically indicated for:
- Plastic and reconstructive surgery ●
- Muscle flap reinforcement ●
- Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, ● umbilical, and incisional hernias.
4
Substantial Equivalence Comparison:
The modified device, SurgiMend MP, utilizes the same design, material, manufacturing process, packaging and sterilization parameters as the predicate device (K083898). The proposed device, SurgiMend MP, is offered in perforated configuration with holes of 2-3 mm in diameter in a staggered array. The addition of defined holes in this new configuration allows for better fluid flow through the device upon implantation.
Testing and Test Results:
The modified device, SurgiMend MP, is comprised of the same materials, processed, packaged and sterilized by the same method as the predicate device (K083898). The biocompatibility testing conducted on SurgiMend Collagen Matrix for Soft Tissue Reconstruction (K083898) product confirms the biological safety of the SurgiMend MP.
Performance testing for SurgiMend MP is the same as the predicate device. Mechanical testing, including tensile strength, suture pull-out, tear resistance, and ball burst were conducted in compliance with FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, March 2, 1999. All test results were acceptable.
The implantation studies were conducted in three different animal models (12 week rat hernia repair study, 4 week rat intra-abdominal, 2 week rat intra-muscle implant model) with the primary endpoint of mechanical strength to support soft tissue reinforcement. The studies also also characterized secondary endpoints of revascularization and tissue integration of perforated test and non-perforated control configurations. These studies demonstrate the basic properties of the subject device after implantation remain unchanged from the predicate. The result demonstrates the subject device is substantially equivalent to the predicate device.
Conclusion:
The modified device, SurgiMend MP, is substantially equivalent to the commercially available marketed device. SurgiMend. The modifications expressed in this 510(k) Premarket Notification do not change the intended use, nor alter the fundamental scientific technology of the device, and do not raise any new issues of safety and effectiveness.