(121 days)
Not Found
No
The summary describes a surgical mesh made from biological and synthetic materials, intended for soft tissue repair. There is no mention of any computational or analytical functions, let alone AI/ML. The performance studies focus on material properties and biological response.
Yes.
The device is intended for implantation to reinforce soft tissues where weakness exists, such as in hernia repair, which is a therapeutic intervention.
No
The device is a surgical mesh intended for implantation to reinforce soft tissues, not to diagnose medical conditions.
No
The device description clearly states it is a resorbable surgical mesh derived from porcine tissue and a synthetic absorbable polymer, indicating it is a physical implant, 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 tissues where weakness exists in patients requiring soft tissue repair and reinforcement in plastic and reconstructive surgery." This describes a surgical implant used directly on a patient's body.
- Device Description: The description details a "resorbable surgical mesh intended to reinforce soft tissue where weakness exists." It's derived from biological and synthetic materials and is implanted.
- Lack of In Vitro Testing: The description of performance studies focuses on biocompatibility, biomechanical testing, and in vivo animal studies. There is no mention of testing biological samples (like blood, urine, or tissue) outside of the body to diagnose or monitor a condition, which is the hallmark of an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical mesh does not fit that definition.
N/A
Intended Use / Indications for Use
Meso Bilayer Surgical Mesh is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair and reinforcement in plastic and reconstructive surgery including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g. hiatal, femoral, paracolostomy, umbilical.)
Meso Bilayer Surgical Mesh is supplied sterile and for one time use.
Product codes
FTM, OXH
Device Description
Meso Bilayer Surgical Mesh is a resorbable surgical mesh intended to reinforce soft tissue where weakness exists. The implant is derived from porcine tissue and a synthetic absorbable polymer. The material is supplied sterile in double-layer packages. The implant is packaged dry and prior to use is hydrated with saline or autologous body fluids such as blood, bone marrow aspirate, or blood concentrates such as platelet rich plasma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, hernia (hiatal, femoral, paracolostomy, umbilical), muscle flap
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)
Biocompatibility testing, biomechanical bench testing, characterization testing and in vivo performance testing have been conducted to evaluate the biological safety and biomechanical performance characteristics of Meso Bilayer Surgical Mesh.
Biocompatibility testing was completed on the finished sterile device in accordance with the requirements of ISO 10993-1: 2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Testing included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Genotoxicity, Hemocompatibility, Subacute Systemic Toxicity, and Chronic Systemic Toxicity. Other safety testing included a viral inactivation study and residual chemical assessment. Results indicate that the device's biocompatibility profile is acceptable.
Biomechanical testing included tensile strength burst testing, wet tear testing, and suture retention. Testing results indicate that the device is equivalent to the predicate device and meets the requirements for its intended use.
Animal implant studies were performed to confirm the functionality and tissue response characteristics of proposed device. Results indicate a normal tissue healing response and confirm the device's remodeling capability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Image /page/0/Picture/0 description: The image shows the text "K132025 Page 1/4" at the top. Below this text is a logo for DSM, with the tagline "BRIGHT SCIENCE. BRIGHTER LIVING." The DSM logo is in bold, black letters. To the left of the DSM logo is a black and white graphic.
DSM Biomedical 735 Pennsylvania Drive Exton, PA 19341 USA
Submitted By:
Contact Person:
DSM Biomedical 735 Pennsylvania Drive Exton, PA 19341 Susan Pileggi Regulatory Specialist
510(k) SUMMARY
E: Susan. Pileggi@dsm.com P: 484-713-2100 F: 484-713-2903 May 28, 2013
Meso Bilayer Surgical Mesh
OCT 3 0 2013
Date Prepared: Device:
| Trade Name: | |
|---|---|
| Common/Usual Name: | |
| Classification Name: | |
| Classification Regulation: | |
| Device Class: | |
| Device Code: | |
| Advisory Panel: |
Surgical Mesh Mesh, Surgical 21 CFR 878.330 Class II FTM, OXH General and Plastic Surgery
Predicate:
K094061: Kensey Nash ECM Surgical Patch [Kensey Nash Corporation]
Device Description:
Meso Bilayer Surgical Mesh is a resorbable surgical mesh intended to reinforce soft tissue where weakness exists. The implant is derived from porcine tissue and a synthetic absorbable polymer. The material is supplied sterile in double-layer packages. The implant is packaged dry and prior to use is hydrated with saline or autologous body fluids such as blood, bone marrow aspirate, or blood concentrates such as platelet rich plasma.
1
Image /page/1/Picture/0 description: The image shows the DSM logo with the text "BRIGHT SCIENCE. BRIGHTER LIVING." The image also contains the text "K132025 Page 2/4" at the top. The DSM logo is a stylized image of a molecule or chemical structure. The text is in a bold, sans-serif font.
Intended Use:
Meso Bilayer Surgical Mesh is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair and reinforcement in plastic and reconstructive surgery including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g. hiatal, femoral, paracolostomy, umbilical.)
Meso Bilayer Surgical Mesh is supplied sterile and for one time use.
Technological Characteristics:
The intended use, product design, material, and function of Meso Bilayer Surgical Mesh is substantially equivalent to the FDA cleared predicate device Kensey Nash ECM Surgical Patch (K094061).
| Characteristic | Meso Bilayer Surgical Mesh | Kensey Nash ECM Surgical Patch |
|---|---|---|
| Indications for Use | Meso Bilayer Surgical Mesh is | |
| intended for implantation to | ||
| reinforce soft tissues where | ||
| weakness exists in patients | ||
| requiring soft tissue repair | ||
| and reinforcement in plastic | ||
| and reconstructive surgery | ||
| including but not limited to | ||
| the following procedures: | ||
| reinforcement of primary | ||
| closure such as suture line | ||
| reinforcement and muscle | ||
| flap reinforcement; hernia | ||
| repair (e.g. hiatal, femoral, | ||
| paracolostomy, umbilical.) | ||
| Meso Bilayer Surgical Mesh is | ||
| supplied sterile and for one | ||
| time use. | The Kensey Nash ECM Surgical Patch is | |
| intended for implantation to reinforce soft | ||
| tissues where weakness exists in patients | ||
| requiring soft tissue repair, reinforcement | ||
| in plastic and reconstructive surgery, and in | ||
| the urological, gynecological, | ||
| gastroenterological anatomy including but | ||
| not limited to the following procedures: | ||
| reinforcement of primary closure such as | ||
| suture line reinforcement and muscle flap | ||
| reinforcement; hernia repair (e.g., hiatal, | ||
| femoral, paracolostomy, umbilical), | ||
| urethral and vaginal prolapse repair, colon | ||
| and rectal prolapse repair, reconstruction | ||
| of the pelvic floor, bladder support, and | ||
| sacrocolposuspension. | ||
| The device is supplied sterile and intended | ||
| for one time use. |
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Image /page/2/Picture/0 description: The image shows the text "K132025 Page 3/4" at the top. Below this text is a logo with a circular design on the left and the letters "DSM" in bold font on the right. Underneath the letters, the text "BRIGHT SCIENCE. BRIGHTER LIVING." is displayed. The image appears to be a page from a document or report.
| Characteristic | Meso Bilayer Surgical Mesh | Kensey Nash ECM Surgical Patch | |
|---|---|---|---|
| Origin | Porcine tissue | Porcine tissue | |
| Device | Resorbable double layer surgical | Resorbable single layer surgical mesh | |
| Characteristics | mesh | ||
| Biocompatibility Yes | Yes | ||
| Reusable | Single Use Device | Single Use Device | |
| Shelf Life | 6 months | 36 months | |
| Sterilization | Ethylene Oxide | Ethylene Oxide | |
| Method | |||
| Packaging | Double peel packages | Double peel packages |
Biocompatibility and Performance Data:
Biocompatibility testing, biomechanical bench testing, characterization testing and in vivo performance testing have been conducted to evaluate the biological safety and biomechanical performance characteristics of Meso Bilayer Surgical Mesh.
Biocompatibility testing was completed on the finished sterile device in accordance with the requirements of ISO 10993-1: 2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Testing included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Genotoxicity, Hemocompatibility, Subacute Systemic Toxicity, and Chronic Systemic Toxicity. Other safety testing included a viral inactivation study and residual chemical assessment. Results indicate that the device's biocompatibility profile is acceptable.
Biomechanical testing included tensile strength burst testing, wet tear testing, and suture retention. Testing results indicate that the device is equivalent to the predicate device and meets the requirements for its intended use.
3
Image /page/3/Picture/0 description: The image shows the logo for DSM, which includes a stylized graphic to the left and the letters "DSM" in bold font. Below the letters, the text "BRIGHT SCIENCE. BRIGHTER LIVING." is printed. The text "K132025 Page 4/4" is at the top of the image.
Animal implant studies were performed to confirm the functionality and tissue response characteristics of proposed device. Results indicate a normal tissue healing response and confirm the device's remodeling capability.
Substantial Equivalence:
Performance testing has confirmed that the Meso Bilayer Surgical Mesh is substantially equivalent to the predicate device with regard to materials, intended use, operation, and function, and technological characteristics, pursuant to section 510(k).
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 graphic of three horizontal lines that curve upwards and to the right, resembling a stylized human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Kensey Nash Corporation dba DSM Biomedical Ms. Susan Pileggi Regulatory Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19341
October 30, 2013
Re: K132025
Trade/Device Name: Meso Bilayer Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXH Dated: October 17, 2013 Received: October 18, 2013
Dear Ms. Pileggi:
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
5
Page 2 - Ms. Susan Pileggi
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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 -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications For Use Statement
510(k) Number: _K132025
Device Name: Meso Bilayer Surgical Mesh
Indications For Use:
Meso Bilayer Surgical Mesh is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair and reinforcement in plastic and reconstructive surgery including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g. hiatal, femoral, paracolostomy, umbilical.)
Meso Bilayer Surgical Mesh is supplied sterile and for one time use.
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801 Subpart D) | |
| AND/OR Over-The-Counter Use | |
| (Per 21 CFR 801 Subpart C) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K132025