(218 days)
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.
KLS Martin Individual Patient Solutions is comprised of patient-specific models and metallic bone plates used in conjunction with metallic bone screws for internal fixation of maxillofacial / midface and mandibular bones. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.
Implants are provided non-sterile, range in thickness from 0.3 mm - 10 mm, and are manufactured using traditional (subtractive) methods from either CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136) materials or additive methods from Ti-6Al-4V. These patient-specific devices are fixated with previously cleared KLS Martin screws.
The provided text describes the performance testing of the KLS Martin Individual Patient Solutions device, primarily focusing on non-clinical bench testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study establishing device performance against acceptance criteria in human subjects.
Therefore, many of the requested details regarding clinical study design (e.g., sample size for test set, expert adjudication, MRMC study, standalone performance, ground truth establishment for training/test sets) are not applicable as they relate to clinical studies that were explicitly stated as "not necessary for the substantial equivalence determination."
However, I can extract information related to the non-clinical performance testing and the implicit acceptance criteria derived from comparison to predicate devices and established standards.
Here's a breakdown of the available information:
Acceptance Criteria and Reported Device Performance (Non-Clinical)
The acceptance criteria are generally implied to be meeting or exceeding the performance and safety profiles of the predicate devices and relevant ASTM/ISO standards. The "reported device performance" is framed as demonstrating substantial equivalence rather than specific numerical metrics for a clinical outcome.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance (Tensile & Bending): Equivalent or superior bending resistance and fatigue life to predicate devices (specifically K944565) as per ASTM F382. | "The bending resistance and fatigue life of the subject devices was determined to be substantially equivalent to the K944565 plates." |
| Biocompatibility: Meet ISO 10993-1 standards and be equivalent to predicate (K163579) for titanium devices. | "Biocompatibility endpoints were evaluated in accordance with ISO 10993-1... The battery of cytotoxicity, chemical analysis, sensitization and irritation, and chemical/material characterization testing was leveraged from K163579 for titanium devices. The subject devices are identical to the primary predicate devices in material formulations, manufacturing methods and processes, and sterilization methods. No other chemicals have been added..." |
| Sterilization: Achieve a sterility assurance level (SAL) of 10-6 using the biological indicator (BI) overkill method as per ISO 17665-1:2006. | "Steam sterilization validations were performed... All test method acceptance criteria were met. Validations for devices manufactured from titanium were leveraged from the predicate device, KLS Martin Individual Patient Solutions (K163579). Subject titanium devices are identical in formulation, manufacturing processes, and post-processing procedures (cleaning & sterilization) as the predicate device." |
| Pyrogenicity: Contain endotoxin levels below the USP allowed limit for medical devices as per AAMI ANSI ST72. | "LAL endotoxin testing was conducted according to AAMI ANSI ST72... The results of the testing demonstrate that the subject devices contain endotoxin levels below the USP allowed limit for medical devices and meet pyrogen limit specifications. LAL endotoxin testing for titanium was leveraged from the predicate device, KLS Martin Individual Patient Solutions (K163579)." |
| Software Verification & Validation: All software requirements and specifications are implemented correctly and completely, traceable to system requirements, and conform to pre-defined specifications and acceptance criteria. | "Quality and on-site user acceptance testing provide objective evidence that all software requirements and specifications were implemented correctly and completely and are traceable to system requirements. Testing required as a result of risk analysis and impact assessments showed conformity with pre-defined specifications and acceptance criteria. Software documentation demonstrates all appropriate steps have been taken to ensure mitigation of any potential risks and performs as intended based on the user requirements and specifications." |
Study Information (Non-Clinical Focus)
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of number of unique devices for each mechanical test, but rather described as "bench testing" and "comparative performance testing." It implies sufficient samples were tested to meet standard requirements for ASTM F382 and other bench tests.
- Data Provenance: The tests were conducted to demonstrate substantial equivalence to predicate devices (K163579, K944565), and some performance data (biocompatibility, sterilization, pyrogenicity) were "leveraged" from previous clearances of the predicate device since the materials and processes are identical. This implies the data originates from the manufacturer's internal testing or contract labs. The country of origin for the data is not specified but is presumably within the regulatory framework acceptable to the FDA. The testing is non-clinical bench testing, not retrospective or prospective human data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable. This pertains to clinical studies involving expert review of diagnostic images or outcomes. The provided text describes non-clinical bench testing and software validation.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This pertains to clinical studies involving human interpretation and ground truth establishment.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. No clinical study (MRMC or otherwise) involving human readers or AI assistance was conducted or described for this device, as "Clinical testing was not necessary for the substantial equivalence determination." This device consists of patient-specific implants and the related planning system, not an AI for image interpretation.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. While software verification and validation were performed for the planning software, it's not an "algorithm" in the sense of an AI model for diagnosis. The software is a tool for design and planning, with human input from the physician and KLS Martin engineers. Therefore, a "standalone algorithm performance" as typically defined for AI/ML devices is not relevant here.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Bench Testing: The "ground truth" for non-clinical performance testing is established by validated test methods (e.g., ASTM, ISO standards) and comparison to the known performance of the predicate devices. For software, the ground truth is its pre-defined specifications and user requirements.
- Not Applicable for clinical "ground truth" types mentioned (expert consensus, pathology, outcomes data).
-
The sample size for the training set:
- Not Applicable. This refers to machine learning models. The device involves patient-specific design based on CT scans, but not a generalizable AI model that requires a training set in the conventional sense. The software's design and functionality are established through traditional software development and validation, not machine learning training.
-
How the ground truth for the training set was established:
- Not Applicable. (See point 7).
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November 22, 2019
KLS-Martin L.P. Katie Rutland Senior Regulatory Affairs Specialist 11201 Saint Johns Industrial Parkway S Jacksonville, Florida 32246
Re: K191028
Trade/Device Name: KLS Martin Individual Patient Solutions Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: October 24, 2019 Received: October 25, 2019
Dear Katie Rutland:
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.
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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 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 (OS) 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.
for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191028
Device Name
KLS Martin Individual Patient Solutions
Indications for Use (Describe)
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.
| 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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11201 Saint Johns Industrial Pkwy S . Jacksonville, FL 32246 Phone: 904-641-7746 · 800-625-1557 · Fax: 904-641-7378 www.klsmartinnorthamerica.com
K191028
510(k) Summary 21 CFR 807.92
| Submitter: | KLS-Martin L.P.11201 Saint Johns Industrial Pkwy SJacksonville, FL 32246 |
|---|---|
| Contact Person: | Katie RutlandSenior Regulatory Affairs SpecialistPhone: 800-625-1557Email: katie.rutland(@klsmartinusa.com |
| Date Prepared: | November 21, 2019 |
| Trade Name: | KLS Martin Individual Patient Solutions |
| Common Name: | Plate, Bone |
| Classification Name: | Bone plate |
| Regulatory Class: | II |
| Product Code: | JEY |
| Regulation Number: | 21 CFR 872.4760 |
| Primary Predicate: | KLS Martin Individual Patient Solutions (K163579) |
| Reference Devices: | TruMatch CMF Titanium 3D Printed Implant (K173039)KLS Martin Micro Osteosynthesis System (K944565)KLS Martin IPS Planning System (K182789) |
Device Description:
KLS Martin Individual Patient Solutions is comprised of patient-specific models and metallic bone plates used in conjunction with metallic bone screws for internal fixation of maxillofacial / midface and mandibular bones. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.
Implants are provided non-sterile, range in thickness from 0.3 mm - 10 mm, and are manufactured using traditional (subtractive) methods from either CP Titanium (ASTM F67)
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or Ti-6Al-4V (ASTM F136) materials or additive methods from Ti-6Al-4V. These patient-specific devices are fixated with previously cleared KLS Martin screws.
- Indications for Use: 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.
Technological Characteristics & Substantial Equivalence Discussion
The intended use of the subject device. KLS Martin Individual Patient Solutions, is the same as the KLS Martin primary predicate device, KLS Martin Individual Patient Solutions (K163579), differing mainly in the skeletal region for which they are intended and technological specifications. The potential impact on substantial equivalence of each technological difference was addressed through risk analysis and verification and validation testing.
Similarities to Predicate
The subject and primary predicate devices are both intended for reconstructive surgery in the facial skeleton and share the same fundamental principles of operation - patient-specific metallic bone plates used in conjunction with metallic bone screws for facial reconstructive surgery.
Both the subject and predicate devices use image data obtained from medical scanners, such as a CT scan. They both use validated commercially off-the-shelf (COTS) software applications to transfer patient imaging from a DICOM format to a .STL format and manipulate the images to produce a final design file.
The manufacturing materials used in the subject device are identical to those cleared in KLS Martin Individual Patient Solutions (K163579). The design and dimensions of the plates are based on patient-specific data, using identical methods described in K163579, manufactured from either CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136) using traditional (subtractive) or additive manufacturing (Selective Laser Melting (SLM)) methods.
The specifications for the subject, primary predicate, and reference devices are similar with respect to plate style, width, length, degree of curvature, fixation hole spacing, and number of fixation holes. Mechanical bench testing performed on both a worst-case midface and orbital plate design, demonstrate that the design expansion to include orbital and maxillofacial / midface implants does not impact substantial equivalence.
All subject and predicate 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 labeling.
Differences from Predicate
The indications for use statement for the subject device of this submission differs from the primary predicate in the addition of the maxillofacial / midface skeletal regions. The skeleton region for which the predicate device was cleared includes only the mandibular region. The subject device expands the indications for use by including the maxillofacial / midface skeletal region and add these devices to the KLS Martin Individual Patient Solutions implant devices. The change in skeletal region presented in the indications for use statement of the subject device compared to the primary predicate device does not impact the substantial
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equivalence of the subject device. This difference in skeletal region is mitigated by previously cleared reference devices that are intended for the maxillofacial / midface regions.
The subject and primary predicate devices use the same validated commercially off-the-shelf (COTS) software applications to transfer patient imaging from a DICOM format to a .STL format, Materialise Mimics and Geomagic® Freeform Plus™. However, the subject device utilizes an additional COTS software for designing orthognathic implants, IPS CaseDesigner. IPS CaseDesigner was cleared under K161634. This software was also utilized and reviewed in the reference device, K182789, in the creation of orthognathic splints.
Previously cleared specifications for the predicate plate thicknesses range from 1.0 mm -3.0 mm and are fixated with previously cleared KLS Martin titanium screws ranging in diameter from 2.0 mm - 3.2 mm in lengths from 5 mm - 22 mm. The subject device plates range in thickness from 0.3 mm - 10 mm and are fixated with previously cleared KLS Martin titanium screws ranging in diameter from 1.5 mm - 3.2 mm in lengths from 3.5 mm - 22 mm. The subject device dimensions differ by offering additional device sizes to accommodate cases in orbital and maxillofacial / midface reconstruction. Subject device implants with thicknesses ranging from 0.6 mm - 10 mm will be used in maxillofacial reconstructive surgeries involving volumetric defects. Responsible clinical conditions for volumetric defects include, but are not limited to, bone resection due to tumors or disease, blunt force trauma, facial defects, bone atrophy, and aesthetic augmentation for facial symmetry. The differences in plate thickness between the subject and predicate devices are addressed with performance data and previously cleared reference devices with plate dimensions that align with the subject device specifications.
Reference Devices
TruMatch CMF Titanium 3D Printed Implant (K173039) has been included as a reference device to address the technological differences between the primary predicate and subject device. The subject device is expanding the primary predicate anatomical regions from the mandible to the orbital and maxillofacial / midface skeletal regions. Both the reference and subject devices offer volumetric implants that augment and contour in the midface skeletal region to allow facial aesthetics and symmetry reconstruction. The reference device is included for the maxillofacial / midface plate design specifications that fall outside of the primary predicate specifications for volumetric implants in the subject device to aid in facial aesthetics and the creations of symmetry in reconstructive surgeries. TruMatch devices are cleared for orbital plate thicknesses ranging from 0.4 mm - 1.5 mm and midface plate thicknesses ranging from 0.8 mm - 10 mm.
The KLS-Martin Mini Osteosynthesis System (K944565) has been included as a reference device to address the technological differences between the primary predicate and subject device. The subject device includes implants for the orbital region with a minimum thickness of 0.3 mm, and implants for the midface region with a minimum thickness of 0.6 mm. Because the primary predicate only includes devices for the mandible region with a minimum thickness of 1.0 mm, and the TruMatch CMF Titanium 3D Printed Implant reference device only includes implants with minimum thicknesses of 0.4 mm and 0.8 mm for the orbital and midface regions, respectively, K944565 reference devices have been included to address the subject device minimum plate thicknesses of 0.3 mm -0.6 mm. The K944565 reference device includes traditionally manufactured (subtractive, milled) titanium plates of various sizes and shapes that range in thickness from 0.3 - 0.6 mm and are intended
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for the stabilization of bone in oral-maxillo-craniofacial surgery. Comparative performance testing and additional bench analysis has addressed any minor differences between the subject, primary predicate, and reference devices.
The KLS Martin IPS Planning System (K182789) has been included as a reference device to support compatibility with the subject device.
A device comparison table of the subject, predicate, and reference devices is provided below.
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| KLS Martin IndividualPatient Solutions | KLS Martin IndividualPatient SolutionsK163579 | TruMatch CMFTitanium 3D PrintedImplantK173039 | KLS Martin MicroOsteosynthesis System(1.5mm)K944565 | KLS Martin IPSPlanning SystemK182789 | |
|---|---|---|---|---|---|
| (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) | |
| Indications for Use | KLS Martin IndividualPatient Solutions implantdevices are intended foruse in the stabilization,fixation, and reconstructionof the maxillofacial /midface and mandibularskeletal regions. | KLS Martin IndividualPatient Solutions implantdevices are intended foruse in the stabilization andfixation of mandibularfractures and mandibularreconstruction. | The TruMatch CMFTitanium 3D PrintedImplant is a patient specificimplant and is intended forbone fixation andreconstruction, restorationof bone defects andintended to providecontinuity in regions wherethe bone is missing and/orto augment the bone bymeans of an onlay devicein the maxillofacialskeleton, midface and chin. | The KLS Martin MicroOsteosynthesis System(1.5mm) is used inoral-maxillo-cranio-facialsurgery to stabilizefractured bone structures.The bone segments areattached to the plate withscrews to preventmovement of the screws. | The KLS Martin IndividualPatient Solutions (IPS)Planning System isintended for use as asoftware system and imagesegmentation system forthe transfer of imaginginformation from a medicalscanner such as a CT basedsystem. The input data fileis processed by the IPSPlanning System and theresult is an output data filethat may then be providedas digital models or used asinput to a rapid prototypingportion of the system thatproduces physical outputsincluding anatomicalmodels, guides, splints, andcase reports for use inmaxillofacial surgery. TheIPS Planning System isalso intended as apre-operative software toolfor simulating/ evaluatingsurgical treatment options. |
| KLS Martin IndividualPatient Solutions | KLS Martin IndividualPatient SolutionsK163579 | TruMatch CMFTitanium 3D PrintedImplantK173039 | KLS Martin MicroOsteosynthesis System(1.5mm)K944565 | KLS Martin IPSPlanning SystemK182789 | |
| (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) | |
| Patient-specific? | Yes. Devices aremanufacturedpatient-specific, based on aCT scan of the patient. | Yes. Devices aremanufacturedpatient-specific, based on aCT scan of the patient. | Yes. Devices aremanufacturedpatient-specific, based on aCT scan of the patient. | No. | Yes. Devices aremanufacturedpatient-specific, based on aCT scan of the patient. |
| Classification | 21 CFR 872.4760.Class II | 21 CFR 872.4760.Class II | 21 CFR 872.4760.Class II | 21 CFR 872.4760,Class II | 21 CFR 872.4120, Class II21 CFR 892.2050, Class II |
| Product Code | JEY | JEY | JEY | JEY | DZJ, LLZ |
| Material | Anatomical Models:Epoxy/Acrylic ResinsImplants: CP Titanium orTi-6Al-4V | Anatomical Models:Epoxy/Acrylic ResinsImplants: CP Titanium orTi-6Al-4V | Implants: CP Titanium | Implants: CP Titanium &Ti-6Al-4V | Anatomical Models:Epoxy/Acrylic ResinsCutting/Marking Guides:Polyamide, Ti-6Al-4V, CPTitaniumSplints: acrylic/methacrylicresins |
| ManufacturingMethod | Epoxy/Acrylic Resins:Stereolithography (SLA)CP Titanium: Traditional(Subtractive)Ti-6Al-4V: Traditionaland 3D (Additive;Selective Laser Melting) | Epoxy/Acrylic Resins:Stereolithography (SLA)CP Titanium: Traditional(Subtractive)Ti-6Al-4V: 3D (Additive:Selective Laser Melting) | CP Titanium: 3D Additive | Subtractive (traditional) -Milling | Epoxy/Acrylic Resins:Stereolithography (SLA)CP Titanium: Traditional(Subtractive)Ti-6Al-4V: 3D (Additive;Selective Laser Melting)Polyamide: 3D (Additive;Selective Laser Sintering) |
| Sterilization | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) |
| Anatomical Sites | Maxillofacial / Midface &Mandible | Mandible | Maxillofacial / Midface &Chin | Craniomaxillofacial | Maxillofacial / Mandible |
| KLS Martin IndividualPatient Solutions | KLS Martin IndividualPatient SolutionsK163579 | TruMatch CMFTitanium 3D PrintedImplantK173039 | KLS Martin MicroOsteosynthesis System(1.5mm)K944565 | KLS Martin IPSPlanning SystemK182789 | |
| (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) | |
| Plate Specifications | |||||
| Thickness | • Orbital: 0.3 mm – 1.0 mm• Maxillofacial / midface reconstruction:o 0.6 mm – 10 mm• Mandibular reconstruction: 1.0 mm – 3.0 mm | Mandibular reconstruction:1.0 mm – 3.0 mm | • Orbital: 0.4 mm – 1.5 mm• Midface reconstruction:o 0.8 mm – 10 mm• Mandibular reconstruction: 1.2 mm – 10 mm | 0.3 mm – 0.6 mm | Not applicable |
| Style | Non-compressionCompressionThreaded | Non-compressionCompressionThreaded | Mesh-Shaped | StandardNon-locking | Not applicable |
| Width(screw-hole dependent) | Maxillofacial / midface:Min: ≥ 4.5 mm (around screw holes)Min: ≥ 3 mm (not around screw hole)Max: Dependent on screw-holeMandibular:Same as predicate | Min: 7 mmMax: 8.5 mm | Unknown | Not applicable | Not applicable |
| Length | Maxillofacial / midface:Min: 18 mmMax: 350 mmMandibular:Same as predicate | Min: 31 mmMax: 320 mm | Min: 10 mmMax: 294 mm | Not applicable | Not applicable |
| Degree of curvature(in-plane) | Maxillofacial / midface | Min: 90°Max: 180° | Unknown | Not applicable | Not applicable |
| KLS Martin IndividualPatient Solutions | KLS Martin IndividualPatient SolutionsK163579 | TruMatch CMFTitanium 3D PrintedImplantK173039 | KLS Martin MicroOsteosynthesis System(1.5mm)K944565 | KLS Martin IPSPlanning SystemK182789 | |
| (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) | |
| Min: 30°Max: 180°Mandibular:Same as predicate | |||||
| Degree of curvature(out-of- plane) | Maxillofacial / midface:Min: 15°Max: 180°Mandibular:Same as predicate | Min: 60°Max: 180° | Unknown | Not applicable | Not applicable |
| Hole spacing | Orbital & Maxillofacial /midface:≥4.5 mmMandibular:Same as predicate | ≥8 mm | Unknown | Not applicable | Not applicable |
| Number of Holes | Orbital & Maxillofacial /midface:Min: ≥ 2 per side of defectMax: Dependent on length& hole spacingMandibular:Same as predicate | Min: 4Max: Dependent on length& hole spacing | Unknown | Not applicable | Not applicable |
| Screw Diameter | Orbital1.5 mmMaxillofacial / midface1.5 mm - 2.3 mmMandibular:Same as predicate | 2.0 mm - 3.2 mm | Unknown | 1.5 mm - 1.8 mm | 1.5 mm - 2.7 mm |
| Screw Length | Orbital & Maxillofacial /midface | 5 mm - 22 mm | Unknown | 3.5 mm - 15 mm | 4 mm - 22 mm |
| KLS Martin IndividualPatient Solutions | KLS Martin IndividualPatient SolutionsK163579 | TruMatch CMFTitanium 3D PrintedImplantK173039 | KLS Martin MicroOsteosynthesis System(1.5mm)K944565 | KLS Martin IPSPlanning SystemK182789 | |
| (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) | |
| 3.5 mm – 22 mmMandibular:Same as predicate | |||||
| Screw Style | maxDrive & crossDrive(Drill-Free, locking[ThreadLock Taper Screw-TLTS], standard) | maxDrive & crossDrive(Drill-Free, locking[ThreadLock Taper Screw-TLTS], standard) | Unknown | Centre-Drive | maxDrive & crossDrive(Drill-Free, locking[ThreadLock Taper Screw-TLTS]) |
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Performance Testing - Non-clinical
Tensile & Bending Testing
Bench testing was used to demonstrate that any differences between the subject, primary predicate, and reference devices do not negatively impact substantial equivalence. Mechanical testing was conducted in accordance with ASTM F382 to compare the bending properties of the subject plates against plates previously cleared in reference device K944565. The bending resistance and fatigue life of the subject devices was determined to be substantially equivalent to the K944565 plates.
Biocompatibility Testing
Biocompatibility endpoints were evaluated in accordance with ISO 10993-1. The battery of cytotoxicity, chemical analysis, sensitization and irritation, and chemical/material characterization testing was leveraged from K163579 for titanium devices. The subject devices are identical to the primary predicate devices in material formulations, manufacturing methods and processes, and sterilization methods. No other chemicals have been added (e.g., fillers, additives, cleaning agents). Therefore, this adequately addresses biocompatibility for the subject device system.
Sterilization Testing
Steam sterilization validations were performed using the dynamic-air-removal cycle in accordance with ISO 17665-1:2006 to a sterility assurance level (SAL) of 106 using the biological indicator (BI) overkill method. All test method acceptance criteria were met. Validations for devices manufactured from titanium were leveraged from the predicate device, KLS Martin Individual Patient Solutions (K163579). Subject titanium devices are identical in formulation, manufacturing processes, and post-processing procedures (cleaning & sterilization) as the predicate device.
Pyrogenicity Testing
LAL endotoxin testing was conducted according to AAMI ANSI ST72 to address the presence of bacterial endotoxins and ensure they meet pyrogen limit specifications. The results of the testing demonstrate that the subject devices contain endotoxin levels below the USP allowed limit for medical devices and meet pyrogen limit specifications. LAL endotoxin testing for titanium was leveraged from the predicate device, KLS Martin Individual Patient Solutions (K163579). Subject titanium devices are identical in formulation, manufacturing processes, and post-processing procedures (cleaning & sterilization) as the predicate device.
Software Verification and Validation
Software verification and validation was performed on each individual software application that is used in the planning and design of the patient's images (CT). Quality and on-site user acceptance testing provide objective evidence that all software requirements and specifications were implemented correctly and completely and are traceable to system requirements. Testing required as a result of risk analysis and impact assessments showed conformity with pre-defined specifications and acceptance criteria. Software documentation demonstrates all appropriate steps have been taken to ensure mitigation of any potential risks and performs as intended based on the user requirements and specifications.
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Image /page/13/Picture/0 description: The image shows the logo for KLS Martin L.P. The words "KLS" are in red, while "martin" is in gray. The letters "L.P." are in black and are larger than the other letters in the logo.
Performance Testing - Clinical
Clinical testing was not necessary for the substantial equivalence determination.
Substantial Equivalence Conclusion
KLS Martin Individual Patient Solutions has the same intended use and similar technological characteristics as the primary predicate device. Technological differences have been assessed through performance testing and inclusion of reference devices presented in this submission. Testing and the incorporation of reference devices with similar technological characteristics as the subject device have demonstrated that any differences in technological characteristics between the subject device and primary predicate device do not impact substantial equivalence.
§ 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.