Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a patient-specific implant designed based on CT/MRI data and manufactured using additive manufacturing. While it involves processing patient imaging data to create a custom design, there is no mention of AI or ML being used in the design process, image analysis, or any other function of the device. The performance studies focus on material properties, mechanical testing, and finite element analysis, not on the performance of an AI/ML algorithm.

Therapeutic

No

This device is designed to replace bony voids in the craniofacial skeleton and is intended for reconstructive procedures, not for treating a disease or condition in a therapeutic manner. It is a structural implant.

Diagnostic

No

Explanation: This device is an implant designed to replace bony voids in the craniofacial skeleton, which is a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device is a physical titanium mesh implant produced via additive manufacturing, not a software-only device. While software is likely used in the design process based on CT/MRI data, the final product is a hardware implant.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is a patient-specific titanium mesh implant for use in surgical procedures on the craniofacial skeleton. This is a surgical implant, not a diagnostic test performed in vitro (outside the body).
Device Description: The description details a physical implant made of titanium alloy, designed to replace bony voids. This is consistent with a surgical device.
Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze biological samples (like blood, urine, or tissue), or provide information about a patient's health status through in vitro testing.
Performance Studies: The performance studies focus on the physical and mechanical properties of the implant, its manufacturing process, and its equivalence to predicate surgical devices. These are typical evaluations for a surgical implant, not an IVD.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer), cranial and craniofacial surgery, and reconstructive procedures.

Product codes

GXN

Device Description

Meticuly's Patient-specific Titanium Mesh Implant is a device designed individually to replace each patient's bony voids in the cranial and/or craniofacial skeleton comprises of frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer. This patient-specific device is intended to be used with titanium screws. The subject device has been validated and tested with titanium screws with the diameter of 1.4 mm - 1.8 mm (K141452 : Jeil Medical's LeForte Neuro system screws). The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion). The surgeon approves the design of the mesh implant prior to fabrication of the implant device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Custom-made to each patient using CT data

Anatomical Site

craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

The Meticuly Patient-specific Titanium Mesh Implant was mechanically tested for tensile and elastic strength, with test results similar to those of predicates. The performance of the subject device was assessed through three comparative tests. According to the Meticuly Patient-specific Titanium Mesh Implant is considered substantially equivalent to the predicate device.

Test: Comparative device modeling with Finite Element Analysis (FEA)
Test method summary: Computational simulation was performed with a compression load in the normal direction on the center of the mesh implant. The load was applied on the surface of the implant. This static loading represents a simulation of a relaxed person resting on a pillow.
Results: The FEA consideration is based on maximum equivalent stress, safety factor and maximum deformation. The result of the comparative test shows that the subject device is substantially equivalent to the predicate device.

Test: Comparative mechanical testing with modified compression test
Test method summary:

The subject device and the predicate device were designed or shaped into a similar design. Both subject device and predicate device were fixated onto the plastic anatomic model that represented the skull with screws.
Compression test was performed under the displacement control to maximum displacement in the normal direction on the center of the mesh implant.
Results: The mechanical consideration is based on the stiffness and energy absorption. The result of the comparative test shows that the subject device is substantially equivalent to the predicate device.

Test: Comparative roughness testing via non-contact method
Test method summary: The surface roughness evaluation was performed following the ISO 4288 and ISO 25178.
Results: The result of the comparative test shows that the subject device is substantially equivalent to the predicate device.

Test: Device fidelity and validation of device dimensional fit
Test method summary: Confirm the design qualification and fidelity of the device with the quality instruments.
Results: The results show the fidelity of the device and the traceability between the CT scan data and the final product.

Key Metrics

Not Found

Predicate Device(s)

K141452

Reference Device(s)

K151692

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).

Summary

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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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 21, 2021

Meticuly Co., Ltd. Peeranoot Lohwongwatana Managing Director 32/77, Soi Samakkee 58/20, Samakkee rd., Tasai Muang Nonthaburi, Nonthaburi 11000, Thailand

Re: K210099

Trade/Device Name: Meticuly Patient-Specific Titanium Mesh Implant Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN Dated: November 17, 2021 Received: November 22, 2021

Dear Peeranoot Lohwongwatana:

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. 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 located 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.

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 803) for

1

devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210099

Device Name

Meticuly Patient-specific Titanium Mesh Implant

Indications for Use (Describe)

Meticuly patient-specific tianium mesh implant is a device that is designed individually for each patient. This device is intended for use in selective trauma of the craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer), cranial and craniofacial surgery, and reconstructive procedures.

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K210099

The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary of the K210099 Meticuly Patient-Specific Titanium 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
	Telephone: +662-804-2101
	Email: paweena@mdrsolutions.co.th
Date Summary Prepared:	December 13, 2021
2. Device Name
Trade Name:	Meticuly Patient-Specific Titanium Mesh
Common Name:	Implant Preformed Nonalterable Cranioplasty
Classification Name:	Plate Neurology
Review Panel:	Neurology (NE)
Regulation:	882.5330
Class:	Class II
Product Code:	GXN

3. Predicate Device

Meticuly Patient-specific Titanium Mesh Implant is substantially equivalent to the following legally marketed predicate device:

4

Applicant	Device Name	510(k) Number
Jeil Medical
Corporation	LaForte Neuro System Bone Plate and Screw	K141452

Table 1.1 Primary Predicate device

Table 1.2 Reference device*

Applicant	Device Name	510(k) Number
BioArchitects USA, LLC.	BioArchitects Patient Specific
Cranial/Craniofacial Plate	K151692

*This device is referred to support the use of a similar material and manufacturing for the subject device

4. Description

Meticuly's Patient-specific Titanium Mesh Implant is a device designed individually to replace each patient's bony voids in the cranial and/or craniofacial skeleton comprises of frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer. This patient-specific device is intended to be used with titanium screws. The subject device has been validated and tested with titanium screws with the diameter of 1.4 mm - 1.8 mm (K141452 : Jeil Medical's LeForte Neuro system screws). The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion). The surgeon approves the design of the mesh implant prior to fabrication of the implant device.

5. Indications for Use

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.

6. Comparison of Technological Characteristics with the Predicate Device

The subject device is substantially equivalent to the following legally marketed predicate devices. Meticuly Patient-specific Titanium 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 raised 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 Mesh Implant	Predicate Device: LeForte
Neuro System
Bone Plate and Screw	Reference Device:
BioArchitects Patient
Specific Cranial/Craniofacial
Plate
510(K) number	K210099	K141452	K151692
Product Code(s)	GXN	GWO, GXR, HBW	GXN

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510(k) Summary

Table 2: Technical Characteristics in Comparison to the Predicate and Reference Devices
Device
comparison	Subject Device:
Meticuly Patient-specific
Titanium Mesh Implant	Predicate Device: LeForte
Neuro System
Bone Plate and Screw	Reference Device:
BioArchitects Patient
Specific Cranial/Craniofacial
Plate
Classification	Class II	Class II	Class II
Indications for
Use	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.	This device is intended for
use in selective trauma of the
cranial skeleton, cranial
surgery and reconstructive
procedures.	The BioArchitects Patient
Specific Cranial/Craniofacial
Plate implant device is
intended to replace bony
voids in the cranial and/or
craniofacial skeleton (e.g.,
frontal bone, temporal bone,
occipital bone, nasal bone,
parietal bone, supraorbital
process, lacrimal bone,
zygomatic bone, sphenoid
bone, ethmoid process,
vomer). It is a patient
specific device.
Material(s)	Titanium Ti-6Al-4V ELI
(Grade23)	Commercially pure Titanium	Titanium alloy (Ti-6Al-4V
ELI)
Technical
Specifications	Custom-made to each patient
using CT data	Custom sized to each patient	Custom-made to each patient
using CT or MRI data
Manufacturing
Method	3D printed using laser
powder bed fusion additive
manufacturing	Machined and surface treated
by anodization	3D printed using electron
beam melting additive
manufacturing
Fixation
Method	Commercially available
titanium screws systems	Own plate and screw system	Commercially available
titanium screws systems
Sterilization	Non-sterile	Non-sterile	Non-sterile

7. Performance Tests

Materials and manufacturing method quality of Meticuly Patient-specific Titanium 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, and sterilization 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.

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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	ASTM F756-17 Standard Practice for Assessment of
Hemolytic Properties of Materials

ISO 10993-1 Fourth edition 2009-10-15 (2-220)
Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process
[Including: Technical Corrigendum 1 (2010)]

ISO 10993-3 Third edition 2014-10-1 (2-228)
Biological evaluation of medical devices - Part 3:Tests
for genotoxicity carcinogenicity and reproductive
toxicity

ISO 10993-4:2017 Biological evaluation of medical
devices - Part 4: Selection of tests for interactions with
blood

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 (20247)
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 |
| Table 3: Testing and compliance standards summary table | |
| Test | Standard (FDA recognition number) |
| Sterilization process control and validation | ANSI AAMI ST72:2011/(R)2016 (14-360)
Bacterial endotoxins - Test methods routine
monitoring and alternatives to batch testing |
| | USP 42-NF37:2019 Bacterial Endotoxins Test
(14-533) |
| | USP 42-NF37:2019 Medical Devices-Bacterial
Endotoxin and Pyrogen Tests (14-534) |
| | 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 |
| | 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 |
| 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 |

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8. Pre-clinical performance test

The Meticuly Patient-specific Titanium Mesh Implant was mechanically tested for tensile and elastic strength, with test results similar to those of predicates. The performance of the subject device was assessed through three comparative tests. According to the Meticuly Patient-specific Titanium Mesh Implant is considered substantially equivalent to the predicate device.

8

Table 4: Performance testing summary table
Test	Test method summary	Results
Comparative device modeling
with Finite Element Analysis
(FEA)	Computational simulation was
performed with a compression load
in the normal direction on the
center of the mesh implant. The
load was applied on the surface of
the implant. This static loading
represents a simulation of a relaxed
person resting on a pillow.	The FEA consideration is based on
maximum equivalent stress, safety
factor and maximum deformation.
The result of the comparative test
shows that the subject device is
substantially equivalent to the
predicate device.
Comparative mechanical
testing with modified
compression test	- The subject device and the
predicate device were designed or
shaped into a similar design. Both
subject device and predicate
device were fixated onto the
plastic anatomic model that
represented the skull with screws.

Compression test was performed
under the displacement control to
maximum displacement in the
normal direction on the center of
the mesh implant. | The mechanical consideration is
based on the stiffness and energy
absorption. The result of the
comparative test shows that the
subject device is substantially
equivalent to the predicate device. |
| Comparative roughness testing
via non-contact method | The surface roughness evaluation
was performed following the ISO
4288 and ISO 25178. | The result of the comparative test
shows that the subject device is
substantially equivalent to the
predicate device. |
| Device fidelity and validation
of device dimensional fit | Confirm the design qualification
and fidelity of the device with the
quality instruments. | The results show the fidelity of the
device and the traceability between
the CT scan data and the final
product. |

9. 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. The device performs as intended and does not raise new questions of safety or effectiveness; Thus, the subject device is concluded to be substantially equivalent to the legally commercialized predicate devices for the purposes of this 510(k) submission.