(218 days)
No
The description focuses on physician input, virtual planning with trained engineers, and verification through virtual fitting, without mentioning any automated learning or decision-making processes characteristic of AI/ML.
Yes
The device is described as a medical implant intended for the "stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions," which is a therapeutic purpose.
No.
The device is an implant for stabilization, fixation, and reconstruction of skeletal regions, and its design is based on medical imaging and physician input, but it does not perform any diagnostic function itself.
No
The device description explicitly states it is comprised of "patient-specific models and metallic bone plates used in conjunction with metallic bone screws" which are physical hardware components. While software is used in the planning and design process, the final device is a physical implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions." This describes a surgical implant used in the body, not a device used in vitro (outside the body) to examine specimens derived from the human body.
- Device Description: The description details patient-specific models and metallic bone plates and screws used for internal fixation of bones. This is consistent with a surgical implant.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JEY
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) 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
maxillofacial / midface and mandibular skeletal regions.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 10-6 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.
Performance Testing - Clinical
Clinical testing was not necessary for the substantial equivalence determination.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
KLS Martin Individual Patient Solutions (K163579)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
TruMatch CMF Titanium 3D Printed Implant (K173039), KLS Martin Micro Osteosynthesis System (K944565), KLS Martin IPS Planning System (K182789)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
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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.
1
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
2
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 S
Jacksonville, FL 32246 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Katie Rutland
Senior Regulatory Affairs Specialist
Phone: 800-625-1557
Email: 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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Image /page/4/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while "martin" is in gray. The letters "L.P." are in black. The logo is simple and modern.
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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Image /page/5/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while "martin" is in gray. The letters "L.P." are in black and are slightly smaller than the other letters in the logo.
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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Image /page/6/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while the word "martin" is in gray. The letters "L.P." are in black and are smaller than the other letters in the logo.
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.
7
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| | KLS Martin Individual
Patient Solutions | KLS Martin Individual
Patient Solutions
K163579 | TruMatch CMF
Titanium 3D Printed
Implant
K173039 | KLS Martin Micro
Osteosynthesis System
(1.5mm)
K944565 | KLS Martin IPS
Planning System
K182789 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) |
| 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. | KLS Martin Individual
Patient Solutions implant
devices are intended for
use in the stabilization and
fixation of mandibular
fractures and mandibular
reconstruction. | The TruMatch CMF
Titanium 3D Printed
Implant is a patient specific
implant and is intended for
bone fixation and
reconstruction, restoration
of bone defects and
intended to provide
continuity in regions where
the bone is missing and/or
to augment the bone by
means of an onlay device
in the maxillofacial
skeleton, midface and chin. | The KLS Martin Micro
Osteosynthesis System
(1.5mm) is used in
oral-maxillo-cranio-facial
surgery to stabilize
fractured bone structures.
The bone segments are
attached to the plate with
screws to prevent
movement of the screws. | The KLS Martin Individual
Patient Solutions (IPS)
Planning System is
intended for use as a
software system and image
segmentation system for
the transfer of imaging
information from a medical
scanner such as a CT based
system. The input data file
is processed by the IPS
Planning System and the
result is an output data file
that may then be provided
as digital models or used as
input to a rapid prototyping
portion of the system that
produces physical outputs
including anatomical
models, guides, splints, and
case reports for use in
maxillofacial surgery. The
IPS Planning System is
also intended as a
pre-operative software tool
for simulating/ evaluating
surgical treatment options. |
| | KLS Martin Individual
Patient Solutions | KLS Martin Individual
Patient Solutions
K163579 | TruMatch CMF
Titanium 3D Printed
Implant
K173039 | KLS Martin Micro
Osteosynthesis System
(1.5mm)
K944565 | KLS Martin IPS
Planning System
K182789 |
| | (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) |
| Patient-specific? | Yes. Devices are
manufactured
patient-specific, based on a
CT scan of the patient. | Yes. Devices are
manufactured
patient-specific, based on a
CT scan of the patient. | Yes. Devices are
manufactured
patient-specific, based on a
CT scan of the patient. | No. | Yes. Devices are
manufactured
patient-specific, based on a
CT 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 II
21 CFR 892.2050, Class II |
| Product Code | JEY | JEY | JEY | JEY | DZJ, LLZ |
| Material | Anatomical Models:
Epoxy/Acrylic Resins
Implants: CP Titanium or
Ti-6Al-4V | Anatomical Models:
Epoxy/Acrylic Resins
Implants: CP Titanium or
Ti-6Al-4V | Implants: CP Titanium | Implants: CP Titanium &
Ti-6Al-4V | Anatomical Models:
Epoxy/Acrylic Resins
Cutting/Marking Guides:
Polyamide, Ti-6Al-4V, CP
Titanium
Splints: acrylic/methacrylic
resins |
| Manufacturing
Method | Epoxy/Acrylic Resins:
Stereolithography (SLA)
CP Titanium: Traditional
(Subtractive)
Ti-6Al-4V: Traditional
and 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 Individual
Patient Solutions | KLS Martin Individual
Patient Solutions
K163579 | TruMatch CMF
Titanium 3D Printed
Implant
K173039 | KLS Martin Micro
Osteosynthesis System
(1.5mm)
K944565 | KLS Martin IPS
Planning System
K182789 |
| | (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-compression
Compression
Threaded | Non-compression
Compression
Threaded | Mesh-Shaped | Standard
Non-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-hole
Mandibular:
Same as predicate | Min: 7 mm
Max: 8.5 mm | Unknown | Not applicable | Not applicable |
| Length | Maxillofacial / midface:
Min: 18 mm
Max: 350 mm
Mandibular:
Same as predicate | Min: 31 mm
Max: 320 mm | Min: 10 mm
Max: 294 mm | Not applicable | Not applicable |
| Degree of curvature
(in-plane) | Maxillofacial / midface | Min: 90°
Max: 180° | Unknown | Not applicable | Not applicable |
| | KLS Martin Individual
Patient Solutions | KLS Martin Individual
Patient Solutions
K163579 | TruMatch CMF
Titanium 3D Printed
Implant
K173039 | KLS Martin Micro
Osteosynthesis System
(1.5mm)
K944565 | KLS Martin IPS
Planning System
K182789 |
| | (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 mm
Mandibular:
Same as predicate | ≥8 mm | Unknown | Not applicable | Not applicable |
| Number of Holes | Orbital & Maxillofacial /
midface:
Min: ≥ 2 per side of defect
Max: Dependent on length
& hole spacing
Mandibular:
Same as predicate | Min: 4
Max: Dependent on length
& hole spacing | Unknown | Not applicable | Not applicable |
| Screw Diameter | Orbital
1.5 mm
Maxillofacial / midface
1.5 mm - 2.3 mm
Mandibular:
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 Individual
Patient Solutions | KLS Martin Individual
Patient Solutions
K163579 | TruMatch CMF
Titanium 3D Printed
Implant
K173039 | KLS Martin Micro
Osteosynthesis System
(1.5mm)
K944565 | KLS Martin IPS
Planning System
K182789 |
| | (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) |
| | 3.5 mm – 22 mm
Mandibular:
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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kts martın L.P.
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kts martın L.P.
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kts martın L.P.
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kls martın LP.
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Image /page/12/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "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 - 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.