(88 days)
Materialise Personalized Guides for Craniomaxillofacial Surgery are intended to guide the marking of bone and or guide surgical instruments in facial surgery.
CMF Titanium Guides are used during bone repositioning/reconstruction surgical operations for orthognathic and reconstruction (including bone harvesting) indications.
CMF Titanium Guides are intended for children, adolescents and adults.
CMF Titanium Guides are intended for single use only.
CMF Titanium Guides are to be used by a physician trained in the performance of maxillofacial surgery.
Materialise Personalized Models for Craniomaxillofacial Surgery are intended for visualization of the patient's anatomy, preparation of surgical interventions and fitting or adjustment of implants or other medical devices such as osteosynthesis plates or distractors, in mandibular and maxillofacial surgical procedures.
CMF Plastic Models are intended for infants, children, adolescents and adults.
CMF Plastic Models are intended for single use only.
CMF Plastic Models are to be used by a physician trained in the performance of maxillofacial surgery.
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery combines the use of 3D preoperative planning software with patient-matched guides and models to improve and simplify the performance of surgical interventions by transferring the pre-operative plan to surgery. Materialise Personalized Guides and Models for Craniomaxillofacial Surgery are used in the facial skeleton or in maxillofacial surgeries.
The surgical planning is based on medical images of the patient that are segmented in order to create a 3D representation of the patient's anatomy. The surgical treatment of the patient is simulated based on instructions provided by the surgeon and the patient-matched devices are tailored to the treatment and the patient's needs. The patient-matched devices are manufactured from commercially pure Titanium, polyamide, or clear acrylic by means of additive manufacturing technologies. The patient-matched devices are provided non-sterile.
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery include CMF Titanium Guides and CMF Plastic Models.
The provided text is a 510(k) summary for the device "Materialise Personalized Guides and Models for Craniomaxillofacial Surgery." It details the device's indications for use, description, comparison to predicate and reference devices, and non-clinical performance data. However, it does not include information about AI/algorithm performance, acceptance criteria for such an algorithm, or a clinical study for proving the device meets those criteria. The document lists "non-clinical testing" and states that "no guide specific mechanical testing is performed but this is covered by mechanical analysis of CMF Titanium Plates."
Therefore, I cannot extract the information required for an AI device acceptance criteria and study from this document. The document primarily focuses on the substantial equivalence of the physical, patient-matched guides and models to existing devices, covering aspects like material compatibility, mechanical properties, biocompatibility, and sterilization.
To answer your request, the ideal information would be present in a document describing an AI/ML medical device, which would typically contain details regarding the algorithm's performance metrics (acceptance criteria), the dataset used for testing, ground truth establishment, and potential MRMC studies. This document does not describe such a device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Materialise NV Polliane Carvalho Regulatory Affairs Specialist Technologielaan 15 Leuven, 3001 BELGIUM
February 21, 2025
Re: K243637
Trade/Device Name: Materialise Personalized Guides and Models for Craniomaxillofacial Surgery Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: November 25, 2024 Received: November 25, 2024
Dear Polliane Carvalho:
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.
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"
{1}------------------------------------------------
(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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
{2}------------------------------------------------
Sincerely,
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and 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}------------------------------------------------
Indications for Use
510(k) Number (if known) K243637
Device Name
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
Indications for Use (Describe)
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
Materialise Personalized Guides for Craniomaxillofacial Surgery
Materialise Personalized Guides for Craniomaxillofacial Surgery are intended to guide the marking of bone and or guide surgical instruments in facial surgery.
CMF Titanium Guides are used during bone repositioning/reconstruction surgical operations for orthognathic and reconstruction (including bone harvesting) indications.
CMF Titanium Guides are intended for children, adolescents and adults.
CMF Titanium Guides are intended for single use only.
CMF Titanium Guides are to be used by a physician trained in the performance of maxillofacial surgery.
Materialise Personalized Models for Craniomaxillofacial Surgery
Materialise Personalized Models for Craniomaxillofacial Surgery are intended for visualization of the patient's anatomy, preparation of surgical interventions and fitting or adjustment of implants or other medical devices such as osteosynthesis plates or distractors, in mandibular and maxillofacial surgical procedures.
CMF Plastic Models are intended for infants, children, adolescents and adults.
CMF Plastic Models are intended for single use only.
CMF Plastic Models are to be used by a physician trained in the performance of maxillofacial surgery.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
510(k) summary
The 510(k) summary is provided on the following page per 21 CFR 807.92(c).
510(k) summary
The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92
Submitter information
| Company name | Materialise NV |
|---|---|
| Establishment registration number | 3003998208 |
| Street Address | Technologielaan 15 |
| City | Leuven |
| Zip code | 3001 |
| Country | Belgium |
| Phone number | +32 16 74 49 56 |
| Fax number | +32 16 39 66 00 |
| Principal contact person | Polliane Carvalho |
| Contact title | Regulatory Affairs Specialist |
| Contact e-mail address | polliane.carvalho@materialise.com |
| Additional contact person | Jenny Jones |
| Contact title | Global Quality & Regulatory Manager, Medical |
| Contact e-mail address | jenny.jones@materialise.com |
Submission date
Date of the Traditional 510(k) submission is February 10, 2025
Submission information
| Trade name | Materialise Personalized Guides and Models forCraniomaxillofacial Surgery |
|---|---|
| Common or Usual name | CMF Titanium GuidesCMF Plastic Models |
| Classification name | Bone cutting instrument and accessories |
| Product code (classification regulation) | Primary product code: DZJSecondary product code: LLZ |
| Classification Panel | Dental |
| Device class | 21 CFR 872.4120, Class II |
Predicate device
{5}------------------------------------------------
The predicate device to which substantial equivalence is claimed to:
| KLS Martin Individual Patient Solutions (IPS) Planning System | ||
|---|---|---|
| Trade or proprietary or model name | KLS Martin Individual Patient Solutions (IPS) Planning | |
| System | ||
| 510(k) number | K182789 | |
| Decision date | 03/11/2019 | |
| Product code | DZJ (21 CFR 872.4120) | |
| Manufacturer | KLS Martin | |
| Review Panel | Dental |
Reference devices
| TruMatch CMF Titanium 3D Printed Implant | ||
|---|---|---|
| Trade or proprietary or model name | TruMatch CMF Titanium 3D Printed Implant | |
| 510(k) number | K173039 | |
| Decision date | 07/10/2018 | |
| Product code | JEY (21 CFR 872.4760) | |
| Manufacturer | Materialise | |
| Review Panel | Dental |
| TruMatch CMF 3D Printed Implant System | |
|---|---|
| Trade or proprietary or model name | TruMatch CMF 3D Printed Implant System |
| 510(k) number | K170272 |
| Decision date | 08/08/2017 |
| Product code | JEY (21 CFR 872.4760) |
| Manufacturer | Materialise |
| Review Panel | Dental |
| SurgiCase Guide (cranial Application) | |
|---|---|
| Trade or proprietary or model name | SurgiCase Guide |
| 510(k) number | K111558 |
| Decision date | 03/27/2012 |
| Product code | HAW (21 CFR 882.4560) |
| Manufacturer | Materialise |
| Review Panel | Neurology |
| SurgiCase Guide (mandibular and maxillofacial application) | |
|---|---|
| Trade or proprietary or model name | SurgiCase Guide (SurgiCase CMF, SurgiCase Connect, SurgiCase Guide) |
| 510(k) number | K103136 |
| Decision date | 03/18/2011 |
| Product code | JEY (21 CFR 872.4760) |
| Manufacturer | Materialise |
| Review Panel | Dental |
{6}------------------------------------------------
| KLS Martin Individual Patient Solutions | |
|---|---|
| Trade or proprietary or model name | KLS Martin Individual Patient Solutions |
| 510(k) number | K210731 |
| Decision date | 07/18/2022 |
| Product code | JEY (21 CFR 872.4760), DZJ(21 CFR 872.4120), LLZ |
| Manufacturer | KLS Martin |
| Review Panel | Dental |
Indications for use
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
Materialise Personalised Guides for Craniomaxillofacial Surgery
Materialise Personalised Guides for Craniomaxillofacial Surgery are intended to guide the marking of bone and/or guide surgical instruments in facial surgery.
CMF Titanium Guides are used during bone repositioning/reconstruction surgical operations for orthognathic and reconstruction (including bone harvesting) indications.
CMF Titanium Guides are intended for children, adolescents and adults.
CMF Titanium Guides are intended for single use only.
CMF Titanium Guides are to be used by a physician trained in the performance of maxillofacial surgery.
Materialise Personalized Models for Craniomaxillofacial Surgery
Materialise Personalized Models for Craniomaxillofacial Surgery are intended for visualization of the patient's anatomy, preparation of surgical interventions and fitting or adjustment of implants or other medical devices such as osteosynthesis plates or distractors, in mandibular and maxillofacial surgical procedures.
CMF Plastic Models are intended for infants, children, adolescents and adults.
CMF Plastic Models are intended for single use only.
CMF Plastic Models are to be used by a physician trained in the performance of maxillofacial surgery.
Device Description
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery combines the use of 3D preoperative planning software with patient-matched guides and models to improve and simplify the performance of surgical interventions by transferring the pre-operative plan to surgery. Materialise Personalized Guides and Models for Craniomaxillofacial Surgery are used in the facial skeleton or in maxillofacial surgeries.
The surgical planning is based on medical images of the patient that are segmented in order to create a 3D representation of the patient's anatomy. The surgical treatment of the patient is simulated based on instructions provided by the surgeon and the patient-matched devices are tailored to the treatment and the patient's needs. The patient-matched devices are manufactured from commercially pure Titanium, polyamide, or clear acrylic by means of additive manufacturing technologies. The patient-matched devices are provided non-sterile.
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery include CMF Titanium Guides and CMF Plastic Models.
{7}------------------------------------------------
| Manufacturing | Additive manufacturing - Selective Laser Melting |
|---|---|
| Material | Commercially pure Titanium |
| Sterilization | Pre-vacuum steam sterilization at the hospital |
| Style | Mesh-shaped, contoured to patient's anatomy |
| Thickness | 0.8 mm |
| Maximal guide length | 94.2 mm for guides with solid-pattern links104.2 mm for guides with mesh-pattern links400 mm for bone graft harvesting guides |
| Minimal number of teeth used for support | 4 teeth (2 on each side) for full arch2 teeth for partial arch |
| Pre-drilling barrels | Guidance of drill- Min height is 3.0 mm- Inner diameter equals drill diameter + 0.05mmGuidance of drill sleeve (DePuy Synthes ref 03.503.045)- Min height is 5.0 mm- Inner diameter is 3.57 mm |
| Fixation holes | Inner diameter- 2.2 or 2.7 mm for MatrixMANDIBLE screw- 2.1 mm for MatrixORTHOGNATHIC screw- 1.9 mm for MatrixMIDFACE screwCountersink diameter- 4.0 mm for MatrixMANDIBLE screw- 3.5 mm for MatrixORTHOGNATHIC & MatrixMIDFACE screw |
| Features | - Marking cylinders- Flanges- Cutting slot- Handle- Label |
The main parameters for the CMF Titanium Guides are summarized below.
The main parameters for the CMF Plastic Models are summarized below.
| Manufacturing | Additive manufacturing – Selective Laser Sintering (SLS) orStereolithography (SLA) |
|---|---|
| Material | Polyamide or Clear acrylic |
{8}------------------------------------------------
| Sterilization | Pre-vacuum steam sterilization at the hospital |
|---|---|
| Style | Solid or hollow |
Substantial Equivalence Comparison Indications for Use
Similarities to Predicate & Reference Devices
The subject device (K243637), the predicate (K182789), and reference devices K173039, K170272, K111558, K103136, K210731) are intended to be used in the facial skeleton or maxillofacial surgeries. subject and predicate devices are patient specific devices used during The bone repositioning/reconstruction surgical operations for orthognathic and reconstruction indications. The subject device CMF Titanium Guides are included in predicate (K182789) and reference devices (K173039, K170272, and K210731). The subject device CMF Plastic Models is included in the predicate (K182789) and reference device (K210731).
The subject devices (CMF Titanium Guides) and the reference device (K170272) are both indicated for adolescents and adult populations. The subject devices (CMF Titanium Guides and CMF Plastic Models) and the predicate (K182789) and reference devices (K210731 CMF Titanium Guides and CMF Models) are both indicated for children, adolescents, and adult populations.
Differences to Predicate & Reference Devices
The subject device (CMF Titanium Guides) expands the target population to include children from the reference devices (K173039 and K170272) which were cleared for adolescents and adult populations.
The subject device (CMF Plastic Models) expands the target population from reference device (K210731) to include infants.
To demonstrate the safety and effectiveness of the subject device in the pediatric population, a risk mitigation assessment has been performed based on FDA guidance, "Premarket Assessment of Pediatric Medical Devices, March 24, 2014" for the target pediations. This risk assessment, in combination with the peer-reviewed clinical data on the subject devices, supports the safe and effective use of the subject device in pediatric patients. The potential impact on the substantial equivalence of each technological difference was addressed through risk analysis and verification and validation testing.
Substantial Equivalence Comparison Technological Characteristics
Similarities to Predicate & Reference Devices
The subject devices (K243637) and the predicate (K182789), and reference devices (K173039, K170272, K111558, K103136, K210731) share the same principles of operation where software is used to convert individual patient medical images to virtual models for surgical planning and design and fabrication of patient-specific devices for use in craniomaxillofacial surgery.
{9}------------------------------------------------
The subject devices (K243637) and the predicate (K182789), and reference devices (K173039, K170272, K111558, K103136, K210731) use additive manufacturing methods to produce physical output devices. The subject device (CMF Titanium Guides), predicate device (K182789) and reference devices (K173039, K170272 and K210731) are produced with the additive manufacturing technology Selective Laser Melting (SLM).
The subject device (CMF Titanium Guides) and the predicate device (K182789) can both be made of commercially pure Titanium as material.
The subject device (CMF Plastic Models), the predicate device (K182789) and reference device (K210731) are produced with the additive manufacturing technology Stereolithography (SLA) using Acrylic Resin. The subject device (CMF Plastic Models) and the predicate device are also produced with an additional additive manufacturing technology Selective Laser sintering with Polyamide.
The subject devices are manufactured using identical methods to those cleared in the primary predicate (K182789) and reference devices (K173039, K170272, K111558, K103136).
The subject, predicate, and reference devices are provided non-sterile and require the end-user to process the devices using validated cleaning and sterilization methods prior to use as recommended in the device instructions for use.
Differences to Predicate & Reference Devices:
The subject device is limited to the use of 3D pre-operative planning software with patient-matched guides and models, while the predicate and reference devices collectively combine the use of 3D pre-operative planning software with patient-matched implants, plates, models and splints to improve and simplify the performance of surgical interventions by transferring the pre-operative plan to surgery.
Any differences in specifications between the subject and predicate devices have been covered by worst case design tests performed to demonstrate that the design expansion does not raise new or different questions for the determination for substantial equivalence.
The subject device (CMF Titanium guides) is not produced through traditional (subtractive) manufacturing as is the case for the Cutting/Marking Guides in CP Titanium of the predicate device (K182789). The subject device (CMF Plastic Models) is also produced with an additive manufacturing technology Selective Laser Sintering with Polyamide whereas for the reference devices (K111558, K103136, K210731) CMF Guides are produced with this technology/material.
A device comparison table of the subject, predicate, and reference devices is provided below.
{10}------------------------------------------------
| Characterist | Subject device | Predicate device | Reference device | Reference device | Reference devices | Reference device |
|---|---|---|---|---|---|---|
| ic | Materialise | KLS Martin IPS | TruMatch CMF | TruMatch CMF 3D | - SurgiCase Guide | KLS Martin Individual |
| Personalized Guides | Planning System | Titanium 3D Printed | Printed Implant | (K111558) | Patient Solutions | |
| and Models for | (K182789) | Implant (K173039) | System (K170272) | - SurgiCase Guide | (K210731) | |
| Craniomaxillofacial | (SurgiCase CMF, | |||||
| Surgery | SurgiCase Connect, | |||||
| SurgiCase Guide) | ||||||
| (K103136) | ||||||
| Product | DZJ, LLZ | DZJ, LLZ | JEY | JEY | HAW | JEY, DZJ, LLZ |
| code | ||||||
| Classificatio | 21 CFR 872 4120, Class II | 21 CFR 872 4120, Class II | 21 CFR 872 4760, Class II | 21 CFR 872 4760, Class II | 21 CFR 882.4560, Class II | 21 CFR 872 4760, Class II |
| n | ||||||
| Indications | Materialise Personalized | The KLS Martin Individual | TruMatchTheCMF | TheTruMatchCMF | SurgiCaseGuidesare | KLSIndividual |
| for Use | Guides and Models for | Patient Solutions (IPS) | 3DPrintedTitanium | PrintedTitanium3D | intended to be used as | Patient Solutions (IPS) is |
| Craniomaxillofacial | Systemાં રPlanning | Implant isaPatient | SystemાટImplant | surgical tools to transfer | intendedas a pre- | |
| Surgery | for use as aintended | Specific Implant and is | forboneintended | a pre-operative plan to | operative software tool | |
| system andsoftware | forintendedbone | repositioning,fixation | the surgery. The devices | simulatingtor | ||
| Materialise Personalized | segmentationımage | reconstruction, | and reconstruction of the | are intended to guide the | evaluatingsurgical | |
| GuidestorCraniomaxillofacial | system for the transfer ofimaginginformation | restorationofbonevolumetricdefects and | maxillofacialskeleton,midface, mandible and | marking of bone and/orguidesurgical | treatment options as asoftwareandimage | |
| Surgery | from a medical scanner | ofincreasethe | chininadolescents | instrumentsduring | segmentation system for | |
| Materialise Personalized | such as a CT based | mandibularandfacial | (greater than 12 to 21 | craniofacial osteotomies. | the transfer of imaging | |
| Guidestor | system. The input data | bones. The TruMatch | years of age) and adults. | The principal difference | informationtroma | |
| Craniomaxillofacial | file is processed by the | CMF Titanium 3D printed | Specific indications for | between the subject and | medical scanner such as a | |
| Surgery are intended to | IPS Planning System and | implant is indicated for | use: | predicate device is with | CT based system. The | |
| guide the marking of | the result is an output | non-loadbearing | - Orthognathic Surgery | respect to the anatomical | filedataાંટinput | |
| and/orguidebone | data file that may then be | applications. | - Reconstructive | region where the guides | ાંખરprocessed by the | |
| surgical instruments in | provideddigitalવર | mandibleand | bewillapplied | software and the result is | ||
| facial surgery. | models or used as input | maxillofacial surgery | craniofacialtorthe | an output data file that | ||
| CMF Titanium Guides are | to a rapid prototyping | Mandibleand | subject guides versus | may then be provided as | ||
| duringusedbone | portion of the system | maxillofacialtrauma | mandibular and maxillary | digital models or used as | ||
| repositioning/reconstruc | that produces physical | surgery | for the predicate guides. | input in an additive | ||
| tion surgical operationsfor orthognathic and | outputsincluding | SurgiCase Guides areintended for single use | manufacturing portion of | |||
| reconstruction (including | anatomicalmodels,guides, splints, and case | only. | the system that producesphysicaloutputs | |||
| boneharvesting) | reportstorusein | includingimplants, | ||||
| indications. | maxillofacial surgery. The | anatomicalmodels, | ||||
| IPS Planning System is | guides, splints, and case | |||||
| also intended as a pre- | inforreportsuse |
{11}------------------------------------------------
| CMF Titanium Guides are | operative software tool | maxillofacial, midface, & | |
|---|---|---|---|
| intended for children, | simulating/for | mandibular surgery. | |
| adolescents and adults. | evaluatingsurgical | KLS Martin Individual | |
| CMF Titanium Guides are | treatment options. | Patient Solutions (IPS) | |
| intended for single use | implantdevicesare | ||
| only. | intended for use in the | ||
| CMF Titanium Guides are | stabilization,fixation, | ||
| to be used by a physician | and reconstruction of the | ||
| inthetrained | maxillofacial / midface | ||
| ofperformance | and mandibular skeletal | ||
| maxillofacial surgery. | regions in children (2 | ||
| years of age to < 12 years | |||
| Materialise Personalized | of age), adolescents (12 | ||
| Modelsfor | years of age - 21 years of | ||
| Craniomaxillofacial | age), and adults. | ||
| Surgery | |||
| Materialise Personalized | |||
| ModelsforCraniomaxillofacial | |||
| Surgery are intended for | |||
| visualizationofthe | |||
| patient'sanatomy,preparation of surgical | |||
| interventions and fitting | |||
| adjustmentofor or | |||
| implants or other medical | |||
| devicessuchવર | |||
| osteosynthesis plates or | |||
| indistractors, | |||
| mandibularand | |||
| maxillofacialsurgical | |||
| procedures. | |||
| CMF Plastic Models are | |||
| intended for infants, | |||
| children, adolescents and | |||
| adults. | |||
| CMF Plastic Models are | |||
| intended for single use | |||
| only. | |||
| CMF Plastic Models are | |||
| to be used by a physician | |||
| trainedinthe |
{12}------------------------------------------------
| performanceofmaxillofacial surgery. | ||||||
|---|---|---|---|---|---|---|
| Devices | CMF Titanium Guides andCMF Plastic Models | Anatomical ModelsCutting/Marking GuidesSplints | CMF Implants, Guides | CMF Plates, Guides | CMF Guides | CMF Implants, Guides,Models, Splints |
| TargetPopulation | • Infant (CMF Modelsonly)• Children• Adolescents• Adults | Pediatric and Adults | Adults | Adolescents and adults | Adults | Children, adolescentsand adults. |
| Principles ofOperation | Medical images used toplan surgery and designpatient matched devices | Medical images used toplan surgery and designpatient matched devices | Medical images used toplan surgery and designpatient matched devices | Medical images used toplan surgery and designpatient matched devices | Medical images used toplan surgery and designpatient matched devices | Medical images used toplan surgery and designpatient matched devices |
| Manufacturing | Additive manufacturing | Traditional and Additivemanufacturing• Epoxy/Resin, Acrylic:Stereolithography (SLA)• CP Titanium:Traditional(Subtractive)• Ti-6Al-4V: 3D (Additive;Selective Laser Melting)• Polyamide: 3D(Additive; SelectiveLaser Sintering) | Additive manufacturing | Additive manufacturing | Additive manufacturing | • Epoxy/Acrylic Resins:Additive;Stereolithography (SLA)• CP Titanium:Traditional(Subtractive)• Ti-6Al-4V: Additive;Selective Laser Melting(SLM) & Traditional(Subtractive)• Acrylic/methacrylicresins (DLP)• Photopolymer resins(cDLM) |
| Material(s) | CMF Titanium Guides:Commercially PureCMF Plastic Models:Acrylic resin, Polyamide | • Anatomical Models:Epoxy/Acrylic Resins• Cutting/MarkingGuides: Polyamide,Titanium alloy (Ti-6Al-4V), CP Titanium• Splints: methacrylate | Commercially PureTitanium | Commercially PureTitanium | Polyamide | • Anatomical Models:Epoxy/Acrylic Resins• Cutting/MarkingGuides: Polyamide, Ti-6Al-4V, CP Titanium |
| Sterilization | Non-sterile (Pre-vacuumsteam Sterilization) | Non-sterile (Steam) | Non-sterile (Pre-vacuumsteam Sterilization) | Non-sterile (Moist heat) | Non-sterile (Moist heat) | Non-sterile (Steam) |
{13}------------------------------------------------
Substantial Equivalence Comparison Performance Data
The following non-clinical testing was conducted as a basis for the determination of substantial equivalence:
| Device | Name | Test method | Conclusion |
|---|---|---|---|
| CMFTitaniumGuides | Compatibility testing | Bench test with surgeons to verifycompatibility of CMF TitaniumGuides with Synthes Matrix screwsand Materialise Standard+ Solutionsscrews and instrumentation | The CMF Titanium devices arecompatible with the DePuy SynthesMatrixNEURO,MatrixMIDFACE,MatrixORTHOGNATHIC,MatrixMANDIBLE systems andMaterialise Standard+ Solutions screwsand instrumentation. |
| CMFTitaniumGuides | Shape specification | The necessary geometrical accuracyof a CMF Titanium Guide for asurgeon to be comfortable withimplanting a manually bent bonefixation plate | Bench tests with surgeons successfullydemonstrated the necessarygeometrical accuracy. |
| CMFTitaniumGuides | Mechanical verification | The CMF Titanium Guides should beresistant to stresses applied duringsurgery. No guide specificmechanical testing is performed butthis is covered by mechanicalanalysis of CMF Titanium Plates.Note: CMF Titanium Plates areleveraged devices for informationpurposes only and not subject to thisK243637 submission. | Analysis and testing demonstrated themechanical performance of the CMFTitanium Guides. |
| CMFTitaniumGuides | Pediatric fit testing &useful life determination | The useful life of the CMF TitaniumGuides was verified | The useful life of the CMF devices isfound to be mainly exceeding 6 months |
| Device | Name | Test method | Conclusion |
|---|---|---|---|
| CMF Polyamideand ClearAcrylic Models | Resistancetohandling forcesduring surgery | Use during validation activities | There are no expected handling forcesexerted onto the models during use.Where models were available duringthe various Sawbones and cadavericvalidationactivities,nonewerereported to have deformed or brokenduring use. |
{14}------------------------------------------------
Biocompatibility:
| Device | Test method | Conclusion |
|---|---|---|
| CMF TitaniumGuides | Cytotoxicity:●ISO 10993-5: Tests for in-vitro cytotoxicity - L929 Neutralred uptake Cytotoxicity | The result showed non-cytotoxicity. |
| ●Sensitization:ISO 10993-10: Tests for irritation and delayed-typehypersensitivity - Kligman Maximization test | The result showed non-sensitizer | |
| Intra-cutaneous reactivity:●ISO 10993-10: Tests for irritation and delayed-typehypersensitivity - Intra-cutaneous Injection Test | The result showed non-irritant. | |
| Chemical characterization:●ISO10993-18: Biological Evaluation of Medical Devices -Part 18: Chemical Characterization of Materials (2005) | The risk of toxicity isconsidered to be low. | |
| Assessment of allowable limits for leachable substances:●ISO 10993-17 (2009) "Biological evaluation of medicaldevices — Part 17: Establishment of allowable limits forleachable substances" | No toxicological concernremains further biologicaltesting are considered notjustified. | |
| PyrogenicityISO 10993-11: 2006 | According to EP: The resultshowed no-pyrogenicityAccording to USP: The resultshowed non-pyrogenicity. |
| Device | Test method | Conclusion |
|---|---|---|
| CMF PlasticModels | Biocompatibility assessment per ISO 10993 | The CMF Plastic Models areevaluated and safe for usewith respect tobiocompatibility. |
The sterilization testing is similar for all devices.
| Device | Test method | Conclusion |
|---|---|---|
| CMF Titanium | Steam sterilization validation | The results of the steam sterilization validation show that the CMF |
| Guides | according to ISO 17665- | Titanium Guides can be sterilized to a SAL of 10th using the |
| 1:2006, | recommended steam sterilization instructions | |
| CMF Plastic | Steam sterilization validation | The results of the steam sterilization validation show that the CMF |
| Models | according to ISO 17665- | Plastic Models can be sterilized to a SAL of 10° using the |
| 1:2006, | recommended steam sterilization instructions |
Performance Data Clinical
To demonstrate the safety and effectiveness of the subject device in the pediatric population, a risk mitigation assessment has been performed based on FDA guidance, "Premarket Assessment of Pediatric Medical Devices, March 24, 2014" for the target pediatric populations. This risk assessment in combination with the peer-reviewed clinical data on the subject device and similar devices, support the safe and effective use of the subject device in pediatric patients.
{15}------------------------------------------------
Substantial Equivalence Performance Conclusion
The non-clinical performance testing indicates that the subject device is substantially equivalent to the predicate device and reference devices.
- Mechanical testing was performed using standard laboratory test methods and compared to the . reference devices.
- . Compatibility with screw system was demonstrated.
- . Biocompatibility was demonstrated as per standards.
- . Sterilization validation was conducted.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.