(251 days)
TiO2Mesh™ is a surgical mesh implant specifically indicated for repair of tissue defects of the abdominal wall, where a non-reabsorbable support material is required. Relevant applications include the repair of inguinal and incisional hernia in all common surgical methods. TiO2Mesh™ can be used for both laparoscopic and other open procedures.
TiO2Mesh™ is made from a monofilament polypropylene thread and has a large-pore structure with blue orientation stripes. The surgical mesh implant has a titanium dioxide coated surface. The fabric can be stretched in both directions and is highly flexible to react to body dynamics in terms of elasticity. TiO2Mesh™ is available in different shapes and sizes (product flyer TiO2Mesh™ ).
The Biocer Entwicklungs GmbH Traditional 510(k) Premarket Submission for TiO2Mesh™ does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way typically expected for an AI/ML device. This submission focuses on demonstrating substantial equivalence to predicate devices for a surgical mesh, not on the performance of a diagnostic or assistive AI system.
Here's a breakdown based on the provided text, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided document. The submission is for a physical surgical mesh and relies on comparing its technological characteristics and non-clinical testing results to predicate devices rather than setting and meeting specific performance metrics like sensitivity, specificity, or accuracy that would be relevant for an AI system.
The "Comparison Table" provided in the document compares the TiO2Mesh™ to predicate devices (TiMesh-TC and Soft Mesh) across various attributes like material, grammage, and pore size, as well as indications for use. However, these are characteristics for substantial equivalence, not acceptance criteria for performance in the context of an AI/ML device.
| Characteristic | TiO2Mesh™ (New Device) | TiMesh-TC (Predicate) | Soft Mesh (Predicate) |
|---|---|---|---|
| Manufacturer | Biocer Entwicklungs GmbH | GfE Medizintechnik GmbH | Bard |
| Trade Name | TiO2 Mesh | TiMesh-TC | Soft Mesh |
| 510(k) Number | Not Available yet | K031225 | K052155 |
| Product Code | FTL | FTL | FTL |
| Regulation Number | 878.3300 | 878.3300 | 878.3300 |
| Regulation Name | Surgical mesh. | Surgical mesh. | Surgical mesh. |
| Indications for use | Repair of tissue defects of the abdominal wall, where a non-reabsorbable support is required for inguinal and incisional hernia in all common surgical methods (laparoscopic and open procedures). | Reinforcement of tissue during surgical repair for inguinal, femoral, umbilical, and incisional hernias, rectal, vaginal, and apical prolapses, and parietal reinforcement of tissues and abdominal wall repair (laparoscopic and open surgery). | Reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects; repair of inguinal hernia defects. |
| Material | PP + Titanium | PP + Titanium | PP |
| Grammage | 43 | 65 | 44 |
| Pore size (mm) | 2.8 | 1 | 2.5 |
| Biocompatible | Yes | Yes | Yes |
| Physical Properties | Comparable (FDA Guidance used) | Comparable (FDA Guidance used) | Comparable (unknown whether FDA Guidance was used) |
2. Sample size used for the test set and the data provenance
This information is not applicable as there is no "test set" in the context of AI/ML evaluation for this device. The submission relies on non-clinical (in vitro and in vivo animal) testing and comparison to predicate devices, not on a dataset used to evaluate an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. Ground truth for an AI/ML test set is not relevant for this medical device submission. The safety and effectiveness are established through non-clinical biocompatibility and performance testing and comparison to legally marketed predicate devices, not through expert consensus on a diagnostic outcome.
4. Adjudication method for the test set
This information is not applicable. There is no test set or adjudication process for an AI/ML algorithm's output.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. A MRMC study is relevant for evaluating the impact of AI on human diagnostic performance. This device is a surgical mesh, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI algorithm.
7. The type of ground truth used
For the non-clinical testing conducted for TiO2Mesh™, the "ground truth" would be the observed biological and physical responses in the laboratory and animal studies, and the established regulatory standards and guidance documents. For example:
- Biocompatibility: Observations of cellular reactions (cytotoxicity), tissue irritation, sensitization, systemic toxicity, and local effects after implantation in animal models. The "ground truth" here is the biological response relative to established safety thresholds and standards.
- Material properties: Measured physical characteristics (grammage, pore size) compared to predicate devices and acceptable ranges for surgical meshes.
8. The sample size for the training set
This information is not applicable. There is no training set for an AI/ML algorithm.
9. How the ground truth for the training set was established
This information is not applicable. There is no training set for an AI/ML algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per 510(k) for a physical device):
The submission demonstrates substantial equivalence through a combination of:
- Comparison of Technological Characteristics: A detailed comparison table (Section 8) outlines the similarities and differences between TiO2Mesh™ and two predicate devices (TiMesh-TC and Soft Mesh) across key attributes like material, grammage, pore size, and biocompatibility. The claim is that the characteristics are comparable, especially to TiMesh-TC which also uses PP+Titanium.
- Non-Clinical Testing (Section 9):
- Biocompatibility Studies: A series of in vitro and in vivo tests were conducted on TiO2Mesh™ extracts or the device itself to assess:
- Cytotoxicity (Cell Growth Analysis via BCA-Staining)
- Irritation (Intracutaneous Reactivity)
- Sensitization (Local Lymph Node Assay LLNA)
- Acute Systemic Toxicity (in the Mouse)
- Local Effects after Implantation (7-day and 90-day periods)
- Investigation of Extractable Organic Substances (GC/MS Fingerprint)
- Bacterial Endotoxins (LAL-Test Kinetic Turbidimetric Assay)
- Inhibition or enhancement of LAL-Test (KTA)
- Physical and Sterilization Validation:
- Transport simulation and packaging validation report.
- ETO Sterilization validation report.
- Biocompatibility Studies: A series of in vitro and in vivo tests were conducted on TiO2Mesh™ extracts or the device itself to assess:
Conclusion stated in the document (Section 11): The non-clinical testing results and the comparative analysis of technological characteristics led to the conclusion that TiO2Mesh™ is "substantially equivalent" to the referenced predicate devices, meaning it has the same intended use and either identical technological characteristics, or different characteristics that do not raise new questions of safety or effectiveness. No clinical testing was required or performed for this 510(k) submission to demonstrate "acceptance criteria" or "device performance" in a clinical setting, as the substantial equivalence argument was based entirely on non-clinical data and comparison to existing devices.
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JUL 1 7 2012
Biocer Entwicklungs GmbH Traditional 510(k) Premarket Submission TiO2Mesh'"
Section 5 – 510(k) Summary for TiO2Mesh™
1. Submission Sponsor
Biocer Entwicklungs GmbH Address: Ludwig-Thomas Strasse 36c, Bayreuth COUNTRY: Germany Phone: 49 0 921-78-77-70-0 Fax: 49 0 921-78-77-70-79 Contact: Martina Feldmann Ph.D., Product Manager.
2. Submission Correspondent
Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701 Cell Phone: Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Cheryl Fisher, Sr. QA/RA Consultant Email: project.management@emergogroup.com
Date Prepared ന്
17 July 2012
4. Device Name
Trade/Proprietary Name: TiO2Mesh™ Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh Polymeric Classification Regulation: 878.3300 Surgical Mesh Classification Panel: 878 General and Plastic Surgery Product Code: OXJ, Mesh, Surgical, non-absorbable, large Abdominal Wall defects FTL, Mesh, Surgical, polymeric
Device Class: 2
FDA Establishment Registration #: Not available yet.
5. Predicate Devices
GfE Medizintechnik GmbH ; TiMeshTC Bard; SoftMesh
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Biocer Entwicklungs GmbH Traditional 510(k) Premarket Submission TiO2Mesh™
6. Device Description
TiO2Mesh™ is made from a monofilament polypropylene thread and has a large-pore structure with blue orientation stripes. The surgical mesh implant has a titanium dioxide coated surface. The fabric can be stretched in both directions and is highly flexible to react to body dynamics in terms of elasticity. TiO2Mesh™ is available in different shapes and sizes (product flyer TiO2Mesh™ ).
7. Intended Use
TiO₂Mesh™ is a surgical mesh implant specifically indicated for repair of tissue defects of the abdominal wall, where a non-reabsorbable support material is required. Relevant applications include the repair of inguinal and incisional hernia in all common surgical methods. TiO2Mesh™ can be used for both laparoscopic and other open procedures.
8. Technological Characteristics and Substantial Equivalence
The following table compares the TiO2MeshTM to the TiMesh-TC with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Manufacturer | Biocer EntwicklungsGmbH | GfE MedizintechnikGmbH | Bard |
|---|---|---|---|
| Trade Name | TiO2 Mesh | TiMesh-TC | Soft Mesh |
| 510(k) Number | Not Available yet | KO31225 | KO52155 |
| Product Code | FTL | FTL | FTL |
| RegulationNumber | 878.3300 | 878.3300 | 878.3300 |
| RegulationName | Surgical mesh. | Surgical mesh.The TiMESH also | Surgical mesh.Bard® Large Pore |
| Indications foruse: | TiO2Mesh™ is asurgical meshimplant specificallyindicated for repairof tissue defectsof the abdominalwall, where a non-reabsorbablesupport isrequired. Relevantapplicationsinclude the repair | known as TiMESH-TC,along with EthiconInc. Prolene SoftMesh, U.S.S.C.'s NonAbsorbablePolypropyleneSurgical Mesh areintended to be usedfor thereinforcement oftissue during surgicalrepair. Thus, theTiMESH also knownas TiMESH-TC meshand all the predicates | Soft Mesh isindicated for use inthe reconstructionof soft tissuedeficiencies, suchas for the repair ofhernias and chestwall defects. BardLargePore Soft MeshPre-Shaped isindicated for therepair of inguinalhernia defects |
| TiO2Mesh™Manufacturer | Biocer EntwicklungsGmbH | GfE MedizintechnikGmbH | Bard |
| Trade Name | TiO2 Mesh | TiMesh-TC | Soft Mesh |
| of inguinal andincisional hernia inall commonsurgical methods.TiO2Mesh™ canbe used for bothlaparoscopic andother openprocedures. | have the sameintended use. TheTiMESH is specificallyindicated forlaparoscopic andopen surgery for therepair of direct orindirect inguinal,femoral, umbilical,and incisionalhernias; rectal,vaginal, and apicalprolapses; andparietalreinforcement oftissues andabdominal wallrepair. The TiMESHhas the sameindications for use asa combination of thepredicated devicesTIMESH is aperscriptive deviceand should only beused by a licensedphysician. | ||
| Material | PP + Titanium | PP + Titanium | PP |
| Grammage | 43 | 65 | 44 |
| Pore size {mm} | 2.8 | 1 | 2.5 |
| Biocompatible | Yes | Yes | Yes |
| PhysicalProperties | ComparableFDA Guidanceused | ComparableFDA Guidance used | Comparable(unknown whetherFDA Guidance wasused) |
Comparison Table
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Biocer Entwicklungs GmbH Traditional 510(k) Premarket Submission TiO2Mesh™
9. Non-Clinical Testing
- a. In vitro Cytotoxicity Assay: Cell Growth Analysis via BCA-Staining with an Extract of TiO2Mesh™
- ف Irritation Test (Intracutaneous Reactivity) with TiO2Mesh™
- Test for Sensitisation (Local Lymph Node Assya LLNA) TiO2Mesh™ C.
·
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Biocer Entwicklungs GmbH Traditional 510(k) Premarket Submission TiO2Mesh™
- Acute Systemic Toxicity in the Mouse with 4 Extracts of TiO2Mesh™ di
- Test for the Local Effects after Implantation (7 days period) with TiO2Mesh™ e.
- f. Test for the Local Effects after Implantation (90 days period) with TiO2Mesh™
- g. Investigation of Extractable Organic Substances (GC/MS Fingerprint) after Liquid
- Extraction of a Surgical Mesh Implant h.
- Test for Bacterial Endotoxins using Limulus-Amoebocyte-Lysate (LAL-Test) Kinetic i.
- j. Turbidimetric Assay (KTA): Test for inhibition or enhancement with TiO2Mesh™
- k. Transport simulation and packaging of TiO2Mesh™ - Validation Report
-
- ETO Sterilization TiO2Mesh™ - Validation report
10. Clinical Testing
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing. The verification and validation testing of the device was found to be acceptable and supports the claims of substantial equivalence and product safety and effectiveness assuming substantially equivalent technical characteristics are the basis for the safety and effectiveness of the device.
11. Conclusion
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
The TiO2Mesh™, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 7 2012
Biocentw % Emergo Group Ms. Cheryl Fisher Senior QA/RA, Consultant 611 West 5th Street, 3rd Floor Austin, Texas 78701
Re: K113311
Trade/Device Name: Ti02Mesh™ Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL, OXJ Dated: June 01, 2011 Received: June 04, 2011
Dear Ms. Fisher:
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
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Page 2 - Ms. Cheryl Fisher
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 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/Resourcesfor You/Industry/default.htm
Sincerely yours,
Mark N. Melkers
Division of Surgical, Orthopedic
and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Director
Enclosure
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Biocer Entwicklungs GmbH Traditional 510(k) Premarket Submission TiO2Mesh™
Section 4 - Indications for Use Statement
510(k) Number (if known): K113311
Device Name: TiO2Mesh™
Indications for Use:
TiO Mesh™ is a surgical mesh implant specifically indicated for repair of tissue defects of the abdominal wall, where a non-reabsorbable support material is required. Relevant applications include the repair of inguinal and incisional hernia in all common surgical methods. TiO9Mesh™ can be used for both laparoscopic and other open procedures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use ____________ (21 CFR 801 Subpart C)
510(k) Num
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Knaebel MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
§ 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.