(29 days)
Not Found
No
The summary describes a biological tissue matrix and its mechanical and biological performance testing. There is no mention of AI or ML technology.
Yes.
The device is intended for implantation to reinforce and repair soft tissue where weakness or damage exists, which directly addresses a medical condition or weakness in the body, qualifying it as therapeutic.
No.
SurgiMend® Meshed is a surgical implant designed to reinforce and repair soft tissue. Its function is reconstructive and reparative, not diagnostic. It does not analyze patient data or provide information about a medical condition.
No
The device description clearly states that SurgiMend Meshed is a meshed acellular dermal tissue matrix derived from bovine dermis, which is a physical material intended for implantation. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for implantation to reinforce and repair soft tissue in the body. IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: The device is a tissue matrix for implantation, not a reagent, instrument, or system used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
The device is clearly intended for surgical implantation and repair, which falls under the category of a medical device used in vivo.
N/A
Intended Use / Indications for Use
SurgiMend® Meshed is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend® Meshed is specifically indicated for plastic and reconstructive surgery.
Product codes
OXH, FTM
Device Description
SurgiMend Meshed is a meshed acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in various sizes and designed to expand at a 2:1 ratio when hydrated with 0.9% saline.
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
Performance testing for the modified device includes mechanical tests (burst strength, suture pull-out), conformability and differential scanning calorimetry (DSC) were conducted to be 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 modified device was characterized in a pre-clinical, acute/subacute animal model to evaluate the effect of meshing on the host biologic response after implantation. The study also evaluated implanted material histologically for revascularization and resorption/ remodeling of meshed (test) and solid (control) configurations. Gross, sub-gross and histological evaluation of explanted materials and surrounding tissues indicated no significant change in biological response with both materials exhibiting a bioreactivity score of Non-irritant in a modified ISO 10993-6 scoring system. The results of this study demonstrated that there were no significant differences between the predicate and modified device with respect to host biologic response and implant characteristics.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2017
TEI Biosciences, Inc c/o Ms. Kavita Amin Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K171357
Trade/Device Name: SurgiMend PRS Meshed, Revize-X Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OXH, FTM Dated: May 8, 2017 Received: May 9, 2017
Dear Ms. Amin:
This letter corrects our substantially equivalent letter of June 7, 2017.
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
forth in the quality systems (OS) 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/ResourcesforYou/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
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
2
Page 3 – Ms. Kavita Amin
Change Control Table, Change History
Change Control Table
| Version | Document Author | Document Approver | Date Approved |
|---|---|---|---|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |
Complete Change Control Table (all versions) retained in SWIFT Docs.
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Indications for Use
510(k) Number (if known) K171357
Device Name
SurgiMend® Meshed Collagen Matrix for Soft Tissue Reconstruction
Indications for Use (Describe)
Indications For Use: SurgiMend® Meshed is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend® Meshed is specifically indicated for plastic and reconstructive surgery.
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
SurgiMend® Meshed 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: 609-373-7109
Date the Summary was prepared:
June 1, 2017 Name of the device:
| Trade name: | SurgiMend® PRS Meshed / Revize™-X Collagen Matrix for Soft
Tissue Reconstruction |
|----------------------|-------------------------------------------------------------------------------------|
| Common Name: | Surgical Mesh |
| Classification Name: | Mesh, Surgical (21 CFR 878.3300) |
| Product Code: | OXH, FTM |
Predicate Device:
SurgiMend Meshed is substantially equivalent in function and intended use to its predicate device as detailed in Table 1.
| 510(k)
Number | Product
Code | Trade Name | Manufacturer |
|------------------|-----------------|-------------------------------------------------------------|----------------------|
| K083898 | FTM | SurgiMend Collagen Matrix for
Soft Tissue Reconstruction | TEI Biosciences Inc. |
Table 1: Predicate Device
Device Description:
SurgiMend Meshed is a meshed acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in various sizes and designed to expand at a 2:1 ratio when hydrated with 0.9% saline.
Indication for Use:
SurgiMend Meshed is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend Meshed is specifically indicated for plastic and reconstructive surgery.
Substantial Equivalence Comparison:
The modified device, SurgiMend Meshed, has the same manufacturing process as the predicate device, SurgiMend (K083898), with the addition of meshing, prior to packaging
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and sterilization. The modified device, SurgiMend Meshed, is manufactured with the same material, material specification, processing steps and chemical composition as the predicate device, SurgiMend (K083898). The modified device adds a 2:1 fenestration pattern to the design of the predicate device, through a meshing process prior to packaging. The addition of a defined mesh in this new configuration allows the device to expand approximately 2-fold in area and to be more conformable during application.
Testing and Test Results:
The modified device, SurgiMend Meshed, is comprised of the same materials, processed, packaged and is sterilized by the same method as the predicate device (K083898). The biocompatibility testing conducted on the predicate device serves to confirm biocompatibility of the modified device, SurgiMend Meshed.
Performance testing for the modified device includes mechanical tests (burst strength, suture pull-out), conformability and differential scanning calorimetry (DSC) were conducted to be 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 modified device was characterized in a pre-clinical, acute/subacute animal model to evaluate the effect of meshing on the host biologic response after implantation. The study also evaluated implanted material histologically for revascularization and resorption/ remodeling of meshed (test) and solid (control) configurations. Gross, sub-gross and histological evaluation of explanted materials and surrounding tissues indicated no significant change in biological response with both materials exhibiting a bioreactivity score of Non-irritant in a modified ISO 10993-6 scoring system. The results of this study demonstrated that there were no significant differences between the predicate and modified device with respect to host biologic response and implant characteristics.
Conclusion:
The modified device, SurgiMend Meshed, 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. The modified device is as safe and as effective as the predicate device.