(225 days)
No
The summary describes a patient-specific implant designed based on CT data and approved by a surgeon, manufactured using additive manufacturing. There is no mention of AI or ML being used in the design process, image analysis, or any other aspect of the device's function or manufacturing control.
No.
A therapeutic device is one that treats a disease or condition. This device is an implant for bone fixation and reconstruction, which helps to restore bone defects and provide continuity, but does not actively treat a disease.
No
This device is an implant designed for bone fixation and reconstruction, not for diagnosing medical conditions. It is a therapeutic device.
No
The device is a physical titanium mesh implant produced via additive manufacturing, not a software-only device. While software is used in the design process based on CT data, the final product is a tangible medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a "Patient-specific titanium maxillofacial mesh implant" made of titanium alloys and used with titanium screws. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT data
Anatomical Site
maxillofacial skeleton, midface, Orbital region
Indicated Patient Age Range
adults only (at least 22 years of age).
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)
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.
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.
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
§ 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.
0
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.
1
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
2
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
3
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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4
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 Lohwongwatana
Managing Director
Meticuly Co., Ltd.
924 B bldg., Rm. B116-118, B210-212
Soi Chula 7, Wang Mai, Pathum Wan Bangkok, Thailand 10330
Telephone: +6688-834-7777
Email: peeranoot@meticuly.com |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Paweena U-Thainual, PhD
MDR Solutions Co., Ltd.
1435, Kanjanapisek Rd., Bang Khae Nuea
Bang Khae, Bangkok 10160 Thailand
Email: 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 |
5
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.
6
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 | |||||
|---|---|---|---|---|---|
| Device | |||||
| comparison | Subject Device: | ||||
| METICULY | |||||
| Patient-specific | |||||
| titanium | |||||
| maxillofacial mesh | |||||
| implant | Predicate Device: | ||||
| TruMatch CMF | |||||
| Titanium 3D Printed | |||||
| Implant | Reference Device: | ||||
| LeForte System | |||||
| Bone Plate & | |||||
| Screw | Reference Device: | ||||
| METICULY | |||||
| Patient-specific | |||||
| titanium mesh | |||||
| implant | Reference Device: | ||||
| KLS Martin | |||||
| Individual Patient | |||||
| Solutions | |||||
| 510(K) number | K232889 | K173039 | K112457 | K210099 | K191028 |
| Product | |||||
| Code(s) | JEY | JEY | JEY | GXN | JEY |
| Classification | Class II | Class II | Class II | Class II | Class II |
| 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. | The TruMatch CMF | ||||
| Titanium 3D Printed | |||||
| Implant is a patient | |||||
| specific implant and | |||||
| 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, midface | |||||
| and chin. | This device is | ||||
| intended for use in | |||||
| selective trauma of | |||||
| the mid-face, | |||||
| reconstruction | |||||
| procedures and | |||||
| selective | |||||
| orthognathic | |||||
| surgery of the | |||||
| maxilla and chin. | Meticuly Patient- | ||||
| specific Titanium | |||||
| Mesh Implant is a | |||||
| device that is | |||||
| designed | |||||
| individually for each | |||||
| patient. This device | |||||
| is intended for use | |||||
| in selective trauma | |||||
| of the cranial and | |||||
| craniofacial skeleton | |||||
| (e.g., frontal bone, | |||||
| temporal bone, | |||||
| occipital bone, | |||||
| parietal bone, | |||||
| sphenoid bone, | |||||
| supraorbital process, | |||||
| vomer), cranial and | |||||
| craniofacial surgery, | |||||
| and reconstructive | |||||
| procedures. | KLS Martin | ||||
| Individual Patient | |||||
| Solutions implant | |||||
| devices are intended | |||||
| for use in the | |||||
| stabilization, | |||||
| fixation, and | |||||
| reconstruction of the | |||||
| maxillofacial / | |||||
| midface and | |||||
| mandibular skeletal | |||||
| regions. | |||||
| Material(s) | Titanium Ti-6Al-4V | ||||
| ELI (Grade23) | Commercially pure | ||||
| titanium | pure Titanium | ||||
| (ASTM F67 Grades | |||||
| 1,2, and 3) | Titanium Ti6Al4V | ||||
| ELI (Grade23) | Titanium (ASTM | ||||
| F67) or Ti-6Al-4V | |||||
| (ASTM F136) | |||||
| Technical | |||||
| Specifications | Custom-made to | ||||
| each patient using | |||||
| CT data | Custom-made to | ||||
| each patient using | |||||
| CT data | Commercially sized | Custom-made to | |||
| each patient using | |||||
| CT data | Custom-made to | ||||
| each patient using | |||||
| CT data | |||||
| Table 2: Technical Characteristics in Comparison to the Predicate and Reference Devices | |||||
| Device | |||||
| comparison | Subject Device: | ||||
| METICULY | |||||
| Patient-specific | |||||
| titanium | |||||
| maxillofacial mesh | |||||
| implant | Predicate Device: | ||||
| TruMatch CMF | |||||
| Titanium 3D Printed | |||||
| Implant | Reference Device: | ||||
| LeForte System | |||||
| Bone Plate & | |||||
| Screw | Reference Device: | ||||
| METICULY | |||||
| Patient-specific | |||||
| titanium mesh | |||||
| implant | Reference Device: | ||||
| KLS Martin | |||||
| Individual Patient | |||||
| Solutions | |||||
| Manufacturing | |||||
| Method | 3D printed using | ||||
| laser powder bed | |||||
| fusion additive | |||||
| manufacturing | Additive | ||||
| manufacturing, | |||||
| Selective Laser | |||||
| Melting | Machined and | ||||
| surface treated by | |||||
| anodization | 3D printed using | ||||
| laser powder bed | |||||
| fusion additive | |||||
| manufacturing | Epoxy/ Acrylic | ||||
| Resins: | |||||
| Stereolithography | |||||
| (SLA) | |||||
| CP Titanium: | |||||
| Traditional(Subtract | |||||
| ive) | |||||
| Ti-6A1-4V: | |||||
| Traditional and 3D | |||||
| (Additive; Selective | |||||
| Laser Melting) | |||||
| Fixation | |||||
| Method | Commercially | ||||
| available titanium | |||||
| screws systems | Commercially | ||||
| available titanium | |||||
| screws system | |||||
| (Synthes) | Own plate and | ||||
| screw system | Commercially | ||||
| available titanium | |||||
| screws systems | Own plate and | ||||
| screw system | |||||
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Plate | |||||
| Dimension | OrbiMesh | ||||
| Length: 10-100 mm | |||||
| Width: 10-90 mm | |||||
| Height: 0.4-125 mm | |||||
| FaciMesh | |||||
| Length: 10-120 mm | |||||
| Width: 10-100 mm | |||||
| Height: 0.4-125 mm | Length: 10-294mm | ||||
| Width: Unknown | |||||
| Height: Unknown | Length: 5.2-223.5 | ||||
| mm | |||||
| Width: Unknown | |||||
| Height: 4.2 - 46.8 | |||||
| mm | Length: 20 - 105 | ||||
| mm | |||||
| Width: 20 - 105 mm | |||||
| Height: 0.4 - 125 | |||||
| mm | Length: 18-350 mm | ||||
| Width: | |||||
| Min: $\geq$ 4.5 mm | |||||
| (around | |||||
| screw holes) | |||||
| Min: $\geq$ 3 mm | |||||
| (not around | |||||
| screw hole) | |||||
| Max: Dependent on | |||||
| screw-hole | |||||
| Height: Unknown | |||||
| Overall | |||||
| Thickness | OrbiMesh | ||||
| 0.4 – 0.9 mm | |||||
| FaciMesh | |||||
| 0.4 - 0.9 mm | 0.4—10 mm | 0.2-2.5 mm | 0.4-0.9 mm | Orbital: | |
| 0.3-1.0 mm | |||||
| Maxillofacial / | |||||
| Midface: | |||||
| 0.6-10.0 mm | |||||
| Internal angle | |||||
| at edge | |||||
| boundary | 45-180 deg | 0-12 deg/mm length | Unknown | 45-180 deg | In Plane: |
| 30-180 deg | |||||
| Out of Plane: | |||||
| 15-180 deg | |||||
| Plate Holes | Non-locking | Unknown | Non-locking | Non-locking | Locking threads |
| optional | |||||
| Screw | |||||
| Diameter | 1.5-2.3 mm | Unknown | 0.7-1.6 mm | 1.4-1.8 mm | 1.5-2.3 mm |
| Device | |||||
| comparison | Subject Device: | ||||
| METICULY | |||||
| Patient-specific | |||||
| titanium | |||||
| maxillofacial mesh | |||||
| implant | Predicate Device: | ||||
| TruMatch CMF | |||||
| Titanium 3D Printed | |||||
| Implant | Reference Device: | ||||
| LeForte System | |||||
| Bone Plate & | |||||
| Screw | Reference Device: | ||||
| METICULY | |||||
| Patient-specific | |||||
| titanium mesh | |||||
| implant | Reference Device: | ||||
| KLS Martin | |||||
| Individual Patient | |||||
| Solutions | |||||
| Screw Length | 4.0-7.0 mm | Unknown | 4.0-18.0 mm | 3.0-4.0 mm | 3.5-22 mm |
7
8
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 Manufacturing | |
| Titanium-6 Aluminum-4 Vanadium ELI (Extra Low | |
| Interstitial) 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 process | |
| ISO 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:Tests | |
| for genotoxicity carcinogenicity and reproductive | |
| toxicity | |
| ISO 10993-5 Third edition 2009-06-01 (2-245) | |
| Biological evaluation of medical devices - Part 5:Tests | |
| for 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:Tests | |
| for 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:Tests | |
| for irritation | |
| USP-NF M98900_01_01 (2-295) | |
| Pyrogen Test (USP Rabbit Test) | |
| Sterilization process control and validation | ANSI AAMI ST72:2019 (14-541) |
| Bacterial endotoxins - Test methods routine | |
| monitoring and alternatives to batch testing | |
| USP-NF M98830_02_01 Bacterial | |
| Endotoxins Test (14-570) | |
| USP-NF M98910_01_01 Medical Devices- | |
| Bacterial Endotoxin and Pyrogen Tests (14-564) | |
| USP-NF M98810_01_01 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 routine | |
| control 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 - Microbiological | |
| methods - Part 1: Determination of a population of | |
| microorganisms on product | |
| ISO 11737-2 Third edition 2019-12 (14-540) | |
| Sterilization of medical devices - Microbiological | |
| methods - Part 2: Tests of sterility performed in the | |
| definition validation and maintenance of a sterilization | |
| Process | |
| ISO 19227 First edition 2018-03 (11-348) | |
| Implants for surgery - Cleanliness of orthopedic implants |
- General requirements |
| Packaging and transportation control and
validation | ASTM F88/F88M-15 (14-482)
Standard Test Method for Seal Strength of Flexible
Barrier Materials |
| | ASTM D7386-16 (5-113)
Standard Practice for Performance Testing of Packages
for Single Delivery Systems |
| | F1886/F1886M-16 (14-501)
Standard Test Method for Determining Integrity of Seals
for Flexible Packaging by Visual Inspection |
| | F1929-15 (14-484)
Standard Test Method for Detecting Seal Leaks in
Porous Medical Packaging by Dye Penetration |
9
10
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.