(225 days)
METICULY Patient-specific titanium maxillofacial mesh implant is intended for bone fixation and reconstruction, restoration of bone defects and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton and midface.
The METICUL Y Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post-processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).
The METICULY Patient-specific titanium maxillofacial mesh implant underwent various performance tests to demonstrate its substantial equivalence to predicate devices.
1. Acceptance Criteria and Reported Device Performance:
The document broadly mentions compliance with various ASTM and ISO standards for material properties, manufacturing quality, biological evaluation, sterilization, and packaging. While specific quantitative acceptance criteria are not explicitly listed in a single table alongside reported values within the provided text, the conclusion states that "Verification and validation testing confirms that the product specifications have been met, demonstrating that the device will perform as intended. There were no unexpected results which indicate the suitable material used and manufacturing process compared to the standards for medical devices." This implies that the device met the requirements outlined in the referenced standards.
Here's a breakdown of the performance aspects and the reported methods/outcomes:
| Acceptance Criteria Category | Reported Device Performance/Testing Method | Implied Acceptance Criteria (based on standards compliance) |
|---|---|---|
| Material & Manufacturing | Evaluated maintained composition, particle size, flowability, density, and visual characteristics of recycled/reused powder. Density of printed samples consistently within acceptance criteria across build plate locations. Dynamic fatigue strength testing to account for worst-case print orientation. Patient-matched device form output consistently matches digital design and CT scan data inputs. | Virgin powder characteristics maintained after recycling. Consistent and acceptable density of printed implants. Sufficient dynamic fatigue strength for intended use (meets ASTM F3001-14). High fidelity between digital design, CT data, and fabricated implant (within specified tolerances). |
| Biocompatibility | Tested per ISO 10993-1, -3, -5, -6, -10, -11, -23, and USP-NF Pyrogen Test. | Non-toxic, non-sensitizing, non-irritating, non-genotoxic, no unacceptable local effects after implantation, and non-pyrogenic. |
| Sterilization | Validated using Overkill method for steam sterilization (135°C for 10 minutes) to achieve SAL of 10^-6. Tested per ANSI AAMI ST72, USP-NF <85>, <161>, <71>, ISO 17665-1, ISO 11737-1, -2. | Achieves a Sterility Assurance Level (SAL) of 10^-6. Complies with bacterial endotoxin limits and sterility verification. |
| Packaging & Transportation | Tested per ASTM F88/F88M-15, D7386-16, F1886/F1886M-16, F1929-15. | Maintains sterility and device integrity during storage and transport. Adequate seal strength, package performance, and seal integrity. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes for the various performance tests conducted (e.g., number of powder samples, printed devices for fatigue testing, implants for biocompatibility).
The data provenance is also not explicitly stated beyond the tests being conducted by the manufacturer to support the 510(k) submission. It doesn't mention country of origin for data or if it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The studies described are primarily engineering and laboratory-based performance tests for the device itself (materials, manufacturing, sterility), not clinical studies requiring expert ground truth for interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set:
This information is not applicable as the described tests are laboratory-based device performance evaluations, not clinical studies requiring expert adjudication of results.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not done or reported in this document. The submission focuses on the chemical, physical, and mechanical properties of the device and its manufacturing process, not on its diagnostic or treatment efficacy as interpreted by human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This information is not applicable. The device is a physical implant, not an algorithm or software that performs a diagnostic or treatment function on its own. While the design process involves digital input (CAD data from CT scans), the "performance" described is of the physical mesh implant, not a standalone algorithm.
7. Type of Ground Truth Used:
For the performance tests, the "ground truth" is largely established by recognized industry standards (ASTM, ISO, USP-NF). For instance:
- Material properties: Measured values compared against specified ranges in ASTM F3001-14.
- Biocompatibility: Results of biological tests (cytotoxicity, irritation, sensitization, etc.) are compared against established biological endpoints defined by ISO 10993 series and USP-NF.
- Sterilization: Achievement of a defined Sterility Assurance Level (SAL) and compliance with microbial limits as per ISO/ANSI/USP standards.
- Manufacturing accuracy: Comparison of the physical implant to the digital design and CT scan data inputs, with acceptable tolerances implied by "consistently matches."
No pathology, expert consensus on patient outcomes, or outcomes data is mentioned as ground truth for these device performance tests.
8. Sample Size for the Training Set:
This information is not applicable as the document describes a physical medical device, not an AI/ML algorithm that requires a training set. The device design process involves patient-specific CT data, but this is an input for individual device fabrication, not a training set in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
April 30, 2024
Meticuly Co., Ltd. % Paweena U-Thainual CEO MDR Solutions Co., Ltd. 1435 Kanjanapisek Road Bang Khae Nuea, Bang Khae Bangkok, 10160 THAILAND
Re: K232889
Trade/Device Name: METICULY Patient-specific titanium maxillofacial mesh implant Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: August 21, 2023 Received: April 1, 2024
Dear Paweena U-Thainual:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and
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ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K232889
Device Name
METICULY Patient-specific titanium maxillofacial mesh implant
Indications for Use (Describe)
METICULY Patient-specific titanium maxillofacial mesh implant is intended for bone fixation and reconstruction, restoration of bone defects and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton and midface.
| 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 – K232889
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary of the METICULY Patient-specific titanium maxillofacial mesh implant:
1. Submitter Information
| Company/Applicant: | Mrs. Peeranoot LohwongwatanaManaging DirectorMeticuly Co., Ltd.924 B bldg., Rm. B116-118, B210-212Soi Chula 7, Wang Mai, Pathum Wan Bangkok, Thailand 10330Telephone: +6688-834-7777Email: peeranoot@meticuly.com |
|---|---|
| Contact: | Paweena U-Thainual, PhDMDR Solutions Co., Ltd.1435, Kanjanapisek Rd., Bang Khae NueaBang Khae, Bangkok 10160 ThailandEmail: paweena@mdrsolutions.co.th |
| Date Summary Prepared: | April 30, 2024 |
| 2. Device Name | |
| Trade Name: | METICULY Patient-specific titanium maxillofacial mesh implant |
| Common Name: | Plate, Bone |
| Classification Name: | Bone Plate |
| Review Panel: | Dental |
| Regulation: | 872.4760 |
| Class: | Class II |
| Product Code: | IFY |
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3. Predicate Device
METICULY Patient-specific titanium maxillofacial mesh implant is substantially equivalent to the following legally marketed predicate devices.
Table 1.1 Primary Predicate device
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Materialise NV | TruMatch CMF Titanium 3D Printed Implant | K173039 |
Table 1.2 Reference devices*
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| KLS-Martin L.P. | KLS Martin Individual Patient Solutions | K191028 |
| Meticuly Co., Ltd. | METICULY Patient-specific Titanium Mesh Implant | K210099 |
| Jeil Medical Corporation | LeForte System Bone Plate & Screw | K112457 |
*These devices are referred to support the similar mesh design and the use of similar material and manufacturing for the subject device.
4. Description
The METICUL Y Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post-processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).
5. Indications for Use
METICULY Patient-specific titanium maxillofacial mesh implant is intended for bone fixation and reconstruction. restoration of bone defects and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton and midface.
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6. Comparison of Technological Characteristics with the Predicate Device
The subject device is substantially equivalent to the following legally marketed predicate devices. METICUL Y Patient-specific titanium maxillofacial mesh implant and the predicate devices have the similar characteristics, for example, indication for use, intended use, sterilization method, manufacturing method, device design, and device performance. The differences of these characteristics have been addressed with the provided performance test data in this submission and do not raise different questions of safety and effectiveness.
| Table 2: Technical Characteristics in Comparison to the Predicate and Reference Devices | |||||
|---|---|---|---|---|---|
| Devicecomparison | Subject Device:METICULYPatient-specifictitaniummaxillofacial meshimplant | Predicate Device:TruMatch CMFTitanium 3D PrintedImplant | Reference Device:LeForte SystemBone Plate &Screw | Reference Device:METICULYPatient-specifictitanium meshimplant | Reference Device:KLS MartinIndividual PatientSolutions |
| 510(K) number | K232889 | K173039 | K112457 | K210099 | K191028 |
| ProductCode(s) | JEY | JEY | JEY | GXN | JEY |
| Classification | Class II | Class II | Class II | Class II | Class II |
| Indications foruse | METICULYPatient-specifictitaniummaxillofacial meshimplant is intendedfor bone fixation andreconstruction,restoration of bonedefects and intendedto provide continuityin regions where thebone is missingand/or to augmentthe bone by meansof an onlay device inthe maxillofacialskeleton andmidface. | The TruMatch CMFTitanium 3D PrintedImplant is a patientspecific implant andis intended for bonefixation andreconstruction,restoration of bonedefects and intendedto provide continuityin regions where thebone is missingand/orto augment the boneby means of an onlaydevice in themaxillofacialskeleton, midfaceand chin. | This device isintended for use inselective trauma ofthe mid-face,reconstructionprocedures andselectiveorthognathicsurgery of themaxilla and chin. | Meticuly Patient-specific TitaniumMesh Implant is adevice that isdesignedindividually for eachpatient. This deviceis intended for usein selective traumaof the cranial andcraniofacial skeleton(e.g., frontal bone,temporal bone,occipital bone,parietal bone,sphenoid bone,supraorbital process,vomer), cranial andcraniofacial surgery,and reconstructiveprocedures. | KLS MartinIndividual PatientSolutions implantdevices are intendedfor use in thestabilization,fixation, andreconstruction of themaxillofacial /midface andmandibular skeletalregions. |
| Material(s) | Titanium Ti-6Al-4VELI (Grade23) | Commercially puretitanium | pure Titanium(ASTM F67 Grades1,2, and 3) | Titanium Ti6Al4VELI (Grade23) | Titanium (ASTMF67) or Ti-6Al-4V(ASTM F136) |
| TechnicalSpecifications | Custom-made toeach patient usingCT data | Custom-made toeach patient usingCT data | Commercially sized | Custom-made toeach patient usingCT data | Custom-made toeach patient usingCT data |
| Table 2: Technical Characteristics in Comparison to the Predicate and Reference Devices | |||||
| Devicecomparison | Subject Device:METICULYPatient-specifictitaniummaxillofacial meshimplant | Predicate Device:TruMatch CMFTitanium 3D PrintedImplant | Reference Device:LeForte SystemBone Plate &Screw | Reference Device:METICULYPatient-specifictitanium meshimplant | Reference Device:KLS MartinIndividual PatientSolutions |
| ManufacturingMethod | 3D printed usinglaser powder bedfusion additivemanufacturing | Additivemanufacturing,Selective LaserMelting | Machined andsurface treated byanodization | 3D printed usinglaser powder bedfusion additivemanufacturing | Epoxy/ AcrylicResins:Stereolithography(SLA)CP Titanium:Traditional(Subtractive)Ti-6A1-4V:Traditional and 3D(Additive; SelectiveLaser Melting) |
| FixationMethod | Commerciallyavailable titaniumscrews systems | Commerciallyavailable titaniumscrews system(Synthes) | Own plate andscrew system | Commerciallyavailable titaniumscrews systems | Own plate andscrew system |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| PlateDimension | OrbiMeshLength: 10-100 mmWidth: 10-90 mmHeight: 0.4-125 mmFaciMeshLength: 10-120 mmWidth: 10-100 mmHeight: 0.4-125 mm | Length: 10-294mmWidth: UnknownHeight: Unknown | Length: 5.2-223.5mmWidth: UnknownHeight: 4.2 - 46.8mm | Length: 20 - 105mmWidth: 20 - 105 mmHeight: 0.4 - 125mm | Length: 18-350 mmWidth:Min: $\geq$ 4.5 mm(aroundscrew holes)Min: $\geq$ 3 mm(not aroundscrew hole)Max: Dependent onscrew-holeHeight: Unknown |
| OverallThickness | OrbiMesh0.4 – 0.9 mmFaciMesh0.4 - 0.9 mm | 0.4—10 mm | 0.2-2.5 mm | 0.4-0.9 mm | Orbital:0.3-1.0 mmMaxillofacial /Midface:0.6-10.0 mm |
| Internal angleat edgeboundary | 45-180 deg | 0-12 deg/mm length | Unknown | 45-180 deg | In Plane:30-180 degOut of Plane:15-180 deg |
| Plate Holes | Non-locking | Unknown | Non-locking | Non-locking | Locking threadsoptional |
| ScrewDiameter | 1.5-2.3 mm | Unknown | 0.7-1.6 mm | 1.4-1.8 mm | 1.5-2.3 mm |
| Devicecomparison | Subject Device:METICULYPatient-specifictitaniummaxillofacial meshimplant | Predicate Device:TruMatch CMFTitanium 3D PrintedImplant | Reference Device:LeForte SystemBone Plate &Screw | Reference Device:METICULYPatient-specifictitanium meshimplant | Reference Device:KLS MartinIndividual PatientSolutions |
| Screw Length | 4.0-7.0 mm | Unknown | 4.0-18.0 mm | 3.0-4.0 mm | 3.5-22 mm |
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7. Performance Tests
The submission provided validation information to support the use of the leftover powder material recycling/reuse between print runs based on representative testing that evaluated maintained composition, particle size, flowability, density, and visual characteristics within the same acceptance criteria ranges as virgin powder. Testing has been provided to show that the density of printed samples representative of the subject devices is consistently within the same acceptance criteria throughout a comprehensive array of build plate locations. Dynamic fatigue strength testing of the subject device to account for the worst-case consideration of print orientation. Validation testing was provided to demonstrate the printed patient-matched device form output consistently matches the digital design and CT scan data inputs under the representative manufacturing conditions across a repeatable process. According to the results, the METICULY Patient-specific titanium maxillofacial mesh implant is considered substantially equivalent to the predicate device.
Materials and manufacturing method quality of METICULY Patient-specific titanium maxillofacial mesh implant were assessed through physical properties and mechanical properties. The device testing was designed to validate the manufacturing process and to ensure that the subject device complicable voluntary consensus standards for biocompatibility, packaging, transportation. The device was validated using the Overkill method for steam sterilization with moist heat at 135°C for 10 minutes to achieve a SAL of 10-6.
Verification and validation testing confirms that the product specifications have been met, demonstrating that the device will perform as intended. There were no unexpected results which indicate the suitable material used and manufacturing process compared to the standards for medical devices.
| Table 3: Testing and compliance standards summary table | |
|---|---|
| Test | Standard (FDA recognition number) |
| Materials and manufacturing method | ASTM F3001-14 (8-439)Standard Specification for Additive ManufacturingTitanium-6 Aluminum-4 Vanadium ELI (Extra LowInterstitial) with Powder Bed Fusion |
| Biological evaluation and Biocompatibility | ISO 10993-1 Fifth edition 2018-08 (2-258)Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management processISO 10993-3 Third edition 2014-10-1 (2-228) |
| Table 3: Testing and compliance standards summary table | |
| Test | Standard (FDA recognition number) |
| Biological evaluation of medical devices - Part 3:Testsfor genotoxicity carcinogenicity and reproductivetoxicity | |
| ISO 10993-5 Third edition 2009-06-01 (2-245)Biological evaluation of medical devices - Part 5:Testsfor in vitro cytotoxicity | |
| ISO 10993-6 Third edition 2016-12-01 (2-247)Biological evaluation of medical devices -- Part 6:Tests for local effects after implantation | |
| ISO 10993-10 Third Edition 2010-08-01 (2-174)Biological evaluation of medical devices - Part 10:Testsfor irritation and skin sensitization | |
| ISO 10993-11 Third edition 2017-09 (2-255)Biological evaluation of medical devices - Part 11:Tests for systemic toxicity | |
| ISO 10993-23 First Edition 2021-01 (2-291)Biological evaluation of medical devices - Part 10:Testsfor irritation | |
| USP-NF M98900_01_01 (2-295)<151> Pyrogen Test (USP Rabbit Test) | |
| Sterilization process control and validation | ANSI AAMI ST72:2019 (14-541)Bacterial endotoxins - Test methods routinemonitoring and alternatives to batch testing |
| USP-NF M98830_02_01 <85> BacterialEndotoxins Test (14-570) | |
| USP-NF M98910_01_01 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests (14-564) | |
| USP-NF M98810_01_01 <71> Sterility Tests (14-569) | |
| ISO 17665-1 First edition 2006-08-15 (14-333)Sterilization of health care products - Moist heat - Part1:Requirements for the development validation and routinecontrol of a sterilization process for medical devices | |
| Table 3: Testing and compliance standards summary table | |
| Test | Standard (FDA recognition number) |
| ISO 11737-1 Third edition 2018-01 (14-514)Sterilization of health care products - Microbiologicalmethods - Part 1: Determination of a population ofmicroorganisms on product | |
| ISO 11737-2 Third edition 2019-12 (14-540)Sterilization of medical devices - Microbiologicalmethods - Part 2: Tests of sterility performed in thedefinition validation and maintenance of a sterilizationProcess | |
| ISO 19227 First edition 2018-03 (11-348)Implants for surgery - Cleanliness of orthopedic implants- General requirements | |
| Packaging and transportation control andvalidation | ASTM F88/F88M-15 (14-482)Standard Test Method for Seal Strength of FlexibleBarrier Materials |
| ASTM D7386-16 (5-113)Standard Practice for Performance Testing of Packagesfor Single Delivery Systems | |
| F1886/F1886M-16 (14-501)Standard Test Method for Determining Integrity of Sealsfor Flexible Packaging by Visual Inspection | |
| F1929-15 (14-484)Standard Test Method for Detecting Seal Leaks inPorous Medical Packaging by Dye Penetration |
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8. Conclusion
Based upon testing and comparison to the predicate device, the METICULY Patient-specific titanium mesh implant has the same intended use and similar technological characteristics. Thus, the subject device is concluded to be substantially equivalent to the legally commercialized predicate devices for the purposes of this 510(k) submission.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.