(88 days)
No
The summary describes a surgical mesh made of decellularized extracellular matrix. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI/ML. The performance studies are based on biophysical, biocompatibility, and animal testing, not data-driven model performance.
Yes.
The device is a surgical mesh used to reinforce and/or repair soft tissue where weakness exists, which is a therapeutic purpose.
No
Explanation: The device is described as a surgical mesh intended for reinforcing and/or repairing soft tissue, which is a therapeutic function, not a diagnostic one. It does not mention detecting, monitoring, or predicting a condition.
No
The device description clearly states it is a surgical mesh made of decellularized extracellular matrix and polyglycolic acid suture material, which are physical components, 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 it's a "surgical mesh to reinforce and/or repair soft tissue where weakness exists." This is a surgical implant used directly on the patient's body.
- Device Description: The description details a surgical mesh made of decellularized extracellular matrix. This is a physical material for surgical repair.
- 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 physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical tool used for physical repair within the body.
N/A
Intended Use / Indications for Use
Endoform™ Reconstructive Template is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include, but are not limited to the following procedures; hernioplasty and repair of body wall defects. The device allows reinforcement or bridging of a deficit to obtain the desired surgical outcome. Endoform™ Reconstructive Template is intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
FTM
Device Description
The Mesynthes Endoform™ Reconstructive Template (ERT) is a surgical mesh comprising either a single layer of decellularized extracellular matrix (ECM) or alternatively, multiple layers (2- to 10- layers) of ECM bonded together by dehydrothermal lamination and polyglycolic acid (PGA) suture material. The ECM component of the proposed device has received FDA clearance (K092096 and K101546) for dermal applications. The use of PGA spans a range of superficial and implantable applications including absorbable sutures (e.g. Sutrazorb® Absorbable PGA Suture, K102592) and surgical meshes (e.g. Dexon® PGA Mesh. K830889).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, body wall defects
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
Testing has been carried out to demonstrate that the product meets the performance specifications for its intended use; including biocompatibility, biophysical, viral inactivation and equivalence testing.
The following biophysical tests were performed on finished, terminally sterilized product:
- Ball burst strength
- Uniaxial strength
- Suture retention strength
The following biocompatibility tests were performed on finished sterilized product (according to ISO10993-1 standard).
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- Subacute Toxicity
- Genotoxicity (Ames, chromosomal aberration and mouse lymphoma)
- Implantation
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Animal Testing: In vivo studies have demonstrated the safety and effectiveness of the Endoform™ Reconstructive Template in a model of soft tissue reinforcement. The performance was substantially equivalent to the predicate device based on incorporation of the device into new tissue, inflammatory response and strength of the graft.
Non Clinical Performance Testing: The biophysical tests provided evidence that Endoform™ Reconstructive Template performed similarly to its predicate devices. The biocompatibility test results provided evidence that the product meets biocompatibility requirements of the ISO standard.
Clinical Performance Testing: There was no clinical testing required to support the indications for use as they are equivalent to the predicate device. The substantial equivalence of the device is supported by the nonclinical testing. The verification and validation testing was found to be comparable to predicates and supports the claims of substantial equivalence, product safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K092096, K101546, K102592, K830889
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary for Mesynthes Endoform™ Reconstructive Template 5
1. Submitter/510(k) Holder
MAY 3 1 2013
Mesynthes Ltd 69 Gracefield Road Lower Hutt Wellington New Zealand 5010
Contact Person Nancy Yopp Telephone: +64 4 931-3512 Date Prepared: 25 February 2013
2. Device Name
Proprietary Name: Endoform™ Reconstructive Template Common/Usual Name: Surgical Mesh Classification Name: FTL
3. Predicate Devices
- . SurgiSIS® 1- and 4-ply (Cook Biotech) (K980431)
- SIS Hernia Repair Device, SurgiSIS® Gold Hernia Repair Graft, 8-ply (Cook Biotech) � (K062697)
- Strattice® LTM Surgical Mesh (LifeCell) (K070560) ●
4. Device Description
The Mesynthes Endoform™ Reconstructive Template (ERT) is a surgical mesh comprising either a single layer of decellularized extracellular matrix (ECM) or alternatively, multiple layers (2- to 10- layers) of ECM bonded together by dehydrothermal lamination and polyglycolic acid (PGA) suture material. The ECM component of the proposed device has received FDA clearance (K092096 and K101546) for dermal applications. The use of PGA spans a range of superficial and implantable applications including absorbable sutures (e.g. Sutrazorb® Absorbable PGA Suture, K102592) and surgical meshes (e.g. Dexon® PGA Mesh. K830889).
5. Intended Use
Endoform™ Reconstructive Template is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include, but are not limited to the following procedures; hernioplasty and repair of body wall defects. The device
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K130547 Page 2/3
allows reinforcement or bridging of a deficit to obtain the desired surgical outcome. Endoform™ Reconstructive Template is intended for single use only.
6. Technological Characteristics and Substantial Equivalence
Endoform™ Reconstructive Template and predicate devices are all primarily composed of mammalian collagens and are used for soft tissue reinforcement. They share similar indications for use, physical properties and biochemical composition. The technological characteristics of Endoform™ Reconstructive Template are substantially equivalent to other legally marketed predicate devices in terms of intended uses and indications, biological and physical performance data. Table 1 compares the ERT device and its predicates.
| Manufacturer | Mesynthes | Cook Biotech | Cook Biotech | LifeCell |
|---|---|---|---|---|
| 510K Number | proposed | K980431 | K062697 | K070560 |
| Device name | Endoform™ Reconstructive | |||
| Template | SurgiSIS® 1- and 4-ply | SurgiSIS® 8-ply (SIS | ||
| Hernia Repair Device, | ||||
| SurgiSIS® Gold Hernia | ||||
| Repair Graft) | LTM Surgical Mesh (Strattice®) | |||
| Classification | Surgical mesh (FTL) | |||
| 21 CFR 878.3300 | ||||
| Class II | Surgical Mesh (FTM) | |||
| 21 CFR 878.3300 | ||||
| Class II | Surgical mesh (FTL) | |||
| 21 CFR 878.3300 | ||||
| Class II | FTM | |||
| Intended use | Endoform™ Reconstructive | |||
| Template is intended for use as a | ||||
| surgical mesh to reinforce and/or | ||||
| repair soft tissue where weakness | ||||
| exists. Indications for use include, | ||||
| but are not limited to the following | ||||
| procedures; hernioplasty and repair | ||||
| of body wall defects. The device | ||||
| allows reinforcement or bridging of | ||||
| a deficit to obtain the desired | ||||
| surgical outcome. Endoform™ | ||||
| Reconstructive Template is | ||||
| intended for single use only. | SurgiSIS® is intended to be | |||
| used for implantation to | ||||
| reinforce soft tissue. It is | ||||
| intended for one-time use. | The SIS Hernia Repair | |||
| Device is intended to be | ||||
| implanted to reinforce | ||||
| soft tissue where | ||||
| weakness exists. | ||||
| Indications for use | ||||
| include the repair of a | ||||
| hernia and body wall | ||||
| defect. The device is | ||||
| intended for one-time | ||||
| use. | LTM Surgical Mesh (LTM) is | |||
| intended for use as a soft tissue | ||||
| patch to reinforce soft tissue | ||||
| where weakness exists and for the | ||||
| surgical repair of damaged or | ||||
| ruptured soft tissue membranes. | ||||
| Indications for use include the | ||||
| repair of hernias and /or body | ||||
| wall defects which require the use | ||||
| of reinforcing or bridging material | ||||
| to obtain the desired surgical | ||||
| outcome. LTM is intended for | ||||
| single patient use only. | ||||
| Animal origin | Ovine | Porcine | Porcine | Porcine |
| Tissue type | Forestomach | Small intestine | Small intestine | Dermal |
| Nominal sizes | Variety of shapes and sizes, up to | |||
| 200 cm² | Variety of shapes and sizes, | |||
| up to 400 cm² | Variety of shapes and | |||
| sizes, up to 400 cm² | 5 x 16 cm - 20 x 25 cm | |||
| Thickness | Approx. 0.15 - 1.2 mm (1-, 2-, 4-, | |||
| 6-, 8- and 10-ply) | Approx. 0.1 - 0.4 mm (1- | |||
| and 4-ply) | Approx. 0.8 mm (8-ply) | Approx. 1.4 mm | ||
| Presentation | Sterile, lyophilized sheets in peel | |||
| pouch | Sterile lyophilized sheets in | |||
| peel pouch | Sterile lyophilized sheets | |||
| in peel pouch | Sterile hydrated sheets packaged | |||
| in a double peel pouch | ||||
| configuration | ||||
| Components | Ovine derived collagen and | |||
| associated ECM components | ||||
| -collagen I | ||||
| -collagen III | ||||
| -polyglycolic acid (PGA) suture | ||||
| material | Porcine derived collagen and | |||
| associated ECM components | ||||
| -collagen I | ||||
| -collagen III | Porcine derived collagen | |||
| and associated ECM | ||||
| components | ||||
| -collagen I | ||||
| -collagen III | Porcine derived collagen and | |||
| associated ECM components | ||||
| -collagen I | ||||
| -collagen III |
TABLE 5-1. Substantial Equivalence Comparison
7. Non Clinical Performance Testing
Testing has been carried out to demonstrate that the product meets the performance specifications for its intended use; including biocompatibility, biophysical, viral inactivation and equivalence testing.
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K130547 Page 3/3
The following biophysical tests were performed on finished, terminally sterilized product:
- . Ball burst strength
- Uniaxial strength .
- Suture retention strength ●
These tests provided evidence that Endoform™ Reconstructive Template performed similarly to its predicate devices.
The following biocompatibility tests were performed on finished sterilized product (according to ISO10993-1 standard).
- . Cytotoxicity
- . Sensitization
- Irritation .
- Systemic Toxicity .
- Subacute Toxicity ◆
- Genotoxicity (Ames, chromosomal aberration and mouse lymphoma)
- Implantation .
The results of these tests provided evidence that the product meets biocompatibility requirements of the ISO standard.
8. Animal Testing
In vivo studies have demonstrated the safety and effectiveness of the Endoform™ Reconstructive Template in a model of soft tissue reinforcement. The performance was substantially equivalent to the predicate device based on incorporation of the device into new tissue, inflammatory response and strength of the graft.
9. Clinical Performance Testing
There was no clinical testing required to support the indications for use as they are equivalent to the predicate device. The substantial equivalence of the device is supported by the nonclinical testing. The verification and validation testing was found to be comparable to predicates and supports the claims of substantial equivalence, product safety and effectiveness.
10. Conclusions Drawn
Based on the testing completed and the comparisons with predicate devices, Endoform™ Reconstructive Template does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
3
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
May 31, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Mesynthe, Ltd. % Aptiv Solutions Mr. Ronald Warren 11440 West Bernardo Court, Suite 300 San Diego, California 92127
Re: K130547
Trade/Device Name: Endoform™ Reconstructive Template Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: February 25, 2013 Received: March 04, 2013
Dear Mr. Warren:
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
4
Page 2 - Mr. Ronald Warren
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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, For
Peter D. Rumm-S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement 4
510(k) Number (if known): K130547
Endoform™ Reconstructive Template Device Name:
Endoform™ Reconstructive Template is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include, but are not limited to the following procedures; hernioplasty and repair of body wall defects. The device allows reinforcement or bridging of a deficit to obtain the desired surgical outcome. Endoform™ Reconstructive Template is intended for single use only.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130547 ·
Mesynthes Limited, Traditional 510(k) Endoform Reconstructive Template™