(494 days)
No
The description focuses on image processing for virtual planning and additive manufacturing, with physician input and manual verification steps. There is no mention of AI or ML algorithms being used for image analysis, planning, or design.
Yes
The device produces physical outputs including implants, anatomical models, guides, splints, and case reports for use in maxillofacial, midface, & mandibular surgery, which are used to stabilize, fix, and reconstruct skeletal regions.
No
The IPS software is a pre-operative tool for simulating/evaluating surgical treatment options and generating output data for manufacturing physical devices like implants and anatomical models. It does not provide a diagnosis of a patient's condition.
No
The device description explicitly states it is comprised of "a collection of software and associated additive manufacturing equipment" and produces "patient-specific physical and/or digital output devices which include implants, anatomical models, guides, splints, and case reports." It also details the manufacturing methods and materials for physical implants and includes non-clinical testing for physical properties (tensile & bending), biocompatibility, sterilization, and pyrogenicity of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "pre-operative software tool for simulating / evaluating surgical treatment options" and a system for producing physical outputs like implants, anatomical models, guides, and splints for use in surgery. It is focused on surgical planning and providing tools for surgical procedures.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
- Lack of In Vitro Testing: The description of the device and its intended use does not involve any testing of specimens derived from the human body outside of the body. The input is medical imaging (CT scans), which is used for planning and manufacturing, not for analyzing biological samples.
- Focus on Surgical Planning and Implants: The core function of the system is to process imaging data for surgical planning and to produce patient-specific surgical tools and implants. This is a surgical device system, not a diagnostic one.
While the system uses medical imaging and processes data, its purpose is to support surgical intervention, not to diagnose a condition or provide information about a physiological state through in vitro testing.
N/A
Intended Use / Indications for Use
KLS Martin Individual Patient Solutions (IPS) is intended as a pre-operative software tool for simulating / evaluating surgical treatment options as a software and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the IPS software and the result is an output data file that may then be provided as digital models or used as input in an additive manufacturing portion of the system that produces physical outputs including implants, anatomical models, guides, splints, and case reports for use in maxillofacial, midface, & mandibular surgery.
KLS Martin Individual Patient Solutions (IPS) implant devices are intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in children (2 years of age), adolescents (12 years of age - 21 years of age), and adults.
Product codes (comma separated list FDA assigned to the subject device)
JEY, DZJ, LLZ
Device Description
KLS Martin Individual Patient Solutions (IPS) is comprised of a collection of software and associated additive manufacturing equipment intended to produce various outputs to support reconstructive and orthognathic surgeries. The system processes the medical images to produce various patient-specific physical and/or digital output devices which include implants, anatomical models, guides, splints, and case reports.
Patient-specific metallic bone plates are 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 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 output device over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.
Implants are provided non-sterile and are manufactured using traditional (subtractive) or additive manufacturing methods from either CP Titanium (ASTM F67) or Ti-6AI-4V (ASTM F136). 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 based system (CT scan)
Anatomical Site
Maxillofacial / Midface & Mandible
Indicated Patient Age Range
children (2 years of age to
§ 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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KLS-Martin L.P. Pam Martin Regulatory Affairs Project Management 11201 Saint Johns Industrial PKWY S Jacksonville, Florida 32246
7/18/2022
Re: K210731
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, DZJ, LLZ Dated: June 27, 2022 Received: June 28, 2022
Dear Pam Martin:
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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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
2
Indications for Use
510(k) Number (if known) K210731
Device Name
KLS Martin Individual Patient Solutions
Indications for Use (Describe)
KLS Martin Individual Patient Solutions (IPS) is intended as a pre-operative software tool for simulating / evaluating surgical treatment options as a software and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the IPS software and the result is an output data file that may then be provided as digital models or used as input in an additive manufacturing portion of the system that produces physical outputs including implants, anatomical models, guides, splints, and case reports for use in maxillofacial, midface, & mandibular surgery.
KLS Martin Individual Patient Solutions (IPS) implant devices are intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in children (2 years of age), adolescents (12 years of age - 21 years of age), and adults.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for KLS Martin Group. The letters "KLS" are in red, while "martin" and "GROUP" are in gray. A registered trademark symbol is located to the right of the word "martin".
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KLS-Martin L.P. Mail: P.O. Box 16369 • Jacksonville, FL 32245-6369 Physical: 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246-7652 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com
K210731 510(k) Summary 21 CFR 807.92
| Submitter: | KLS-Martin L.P.
11201 Saint Johns Industrial Pkwy S.
Jacksonville, FL 32246 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Pam Martin, MSc, RAC
Regulatory Affairs Project Manager
Phone: 800-625-1557
Email: pmartin@klsmartin.com |
| Alternate Contact: | Melissa Bachorski
Director of RA/QMS North America
Phone: 800-625-1557
Email: melissa.bachorski@klsmartin.com |
| Date Prepared: | July 15, 2022 |
| Trade Name: | KLS Martin Individual Patient Solutions |
| Common Name: | System used to plan & fabricate patient-specific bone plates,
anatomical models, cutting/marking guides, splints, and case
reports |
| Regulation Numbers: | 21 CFR 872.4760 |
| Regulatory Class: | II |
| Primary ProCode: | JEY |
| Subsequent ProCodes: | DZJ, LLZ |
| Primary Predicate: | KLS Martin Individual Patient Solutions (K191028) |
| Reference Devices: | KLS Martin Mini Osteosynthesis System (K943347)
TruMatch CMF Titanium 3D Printed Implant (K170272)
KLS Martin IPS Planning System (K182789) |
Device Description:
KLS Martin Individual Patient Solutions (IPS) is comprised of a collection of software and associated additive manufacturing equipment intended to produce various outputs to support reconstructive and orthognathic surgeries. The system processes the medical images to produce various patient-specific physical and/or digital output devices which include implants, anatomical models, guides, splints, and case reports.
Patient-specific metallic bone plates are 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 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
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Image /page/4/Picture/0 description: The image shows the logo for KLS Martin Group. The letters "KLS" are in red, while "martin" and "GROUP" are in gray. There is a registered trademark symbol next to the word "martin".
KLS-Martin L.P. Mail: P.O. Box 16369 · Jacksonville, FL 32245-6369 Physical: 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246-7652 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com
the generated output device over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.
Implants are provided non-sterile and are manufactured using traditional (subtractive) or additive manufacturing methods from either CP Titanium (ASTM F67) or Ti-6AI-4V (ASTM F136). These patient-specific devices are fixated with previously cleared KLS Martin screws.
Indications for Use:
KLS Martin Individual Patient Solutions (IPS) is intended as a pre-operative software tool for simulating / evaluating surgical treatment options as a software 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 software and the result is an output data file that may then be provided as digital models or used as input in an additive manufacturing portion of the system that produces physical outputs including implants, anatomical models, guides, splints, and case reports for use in maxillofacial, midface, & mandibular surgery.
KLS Martin Individual Patient Solutions (IPS) implant devices are intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in children (2 years of age to =3.5 mm
Maxillofacial / midface:
=4.5 mm
Mandibular:
=4.5 mm
(non-continuity defect)
=6.4 mm (continuity defect) | Orbital & Maxillofacial / midface:
=4.5 mm
Mandibular:
=8 mm | Not applicable | Not applicable | Unknown |
| | KLS Martin Individual Patient
Solutions | KLS Martin Individual Patient
Solutions
K191028 | KLS Martin IPS Planning System
K182789 | KLS Martin Mini Osteosynthesis
System (2.0mm)
K943347 | TruMatch CMF Titanium 3D
Printed Implant System
K170272 |
| | (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) |
| Number of Holes | Orbital, Mandibular, Maxillofacial /
Midface: ≥2 per side of defect | Orbital & Maxillofacial / midface:
Min: ≥ 2 per side of defect
Max: Dependent on length & design
Mandibular:
Min: 4
Max: Dependent on length & design | Not applicable | Not applicable | Unknown |
| Screw Diameter | Orbital:
1.5 mm
Maxillofacial / midface:
1.5 mm – 2.3 mm
Mandibular:
2.0 mm – 3.2 mm | Orbital:
1.5 mm
Maxillofacial / midface:
1.5 mm – 2.3 mm
Mandibular:
2.0 mm – 3.2 mm | 1.5 mm - 2.7 mm | 1.5 mm - 2.3 mm | Unknown |
| Screw Length | Orbital & Maxillofacial / midface:
3.5 mm – 22 mm
Mandibular:
5 mm - 22 mm | Orbital & Maxillofacial / midface:
3.5 mm – 22 mm
Mandibular:
5 mm - 22 mm | 4 mm – 22 mm | 4 mm – 19 mm | Unknown |
| Screw Style | Head style:
• maxDrive
• crossDrive
Design features:
• Drill-Free
• Locking
• ThreadLock TaperScrew – TLTS
• Standard | Head style:
• maxDrive
• crossDrive
Design features:
• Drill-Free
• Locking
• ThreadLock TaperScrew – TLTS
• Standard | Head style:
• maxDrive
• crossDrive
Design features:
• Drill-Free
• Locking
• ThreadLock TaperScrew – TLTS
• Standard | Head style:
• Centre-Drive
• maxDrive
• crossDrive | Unknown |
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Image /page/11/Picture/0 description: The image shows the logo for KLS Martin Group. The text "KLS" is in red, while "martin" and "GROUP" are in gray. A registered trademark symbol is next to the word "martin".
Mail: P.O. Box 16369 • Jacksonville, FL 32245-6369 Physical: 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246-7652 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com
Surgical Innovation is Our Passion
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Image /page/12/Picture/0 description: The image shows the logo for KLS Martin Group. The text "KLS" is in red, and the text "martin" and "GROUP" are in gray. A registered trademark symbol is located to the right of the word "martin".
KLS-Martin L.P.
Mail: P.O. Box 16369 • Jacksonville, FL 32245-6369 Physical: 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246-7652 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com
Performance Data - Non-clinical
Tensile & Bending Testing
Bench testing was used to demonstrate that any dimensional or design differences between the subject, primary predicate, and reference devices do not raise new or different questions to determine 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 the reference device K943347. The bending resistance and fatigue life of the subject devices was determined to be substantially equivalent to the K943347 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 K191028 for titanium devices. The battery of cytotoxicity, sensitization and irritation, and chemical/material characterization testing was leveraged from K182789 for devices made from previously evaluated synthetic polymers and acrylic resins.
The subject device also includes splints additively manufactured from a light-cured photopolymer resin material composed of acrylate/methacrylate polymers. The battery of cytotoxicity, sensitization and irritation, and material mediated pyrogenicity testing provided in this submission adequately addresses the necessary biocompatibility endpoints per ISO 10993.
The subject device's manufacturing methods and processes are similar to the predicate device. No other chemicals have been added (e.g., fillers, 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 additively manufactured from titanium were leveraged from the primary predicate device, K191028. Validations for devices manufactured from previously evaluated synthetic polymers and acrylic resins were leveraged from reference device K182789.
The subject device also includes splints additively manufactured from a new light-cured resin photopolymer material. The photopolymer resin is composed of acrylate/methacrylate polymers and is manufactured using cDLM methods. The proposed splints are similar in material composition and utilize similar manufacturing methods as the acrylic/methacrylic resins used to fabricate splints via DLP methods previously evaluated under reference device K182789.
Subject devices undergo similar manufacturing processes and identical post-processing procedures (cleaning & sterilization) as the primary predicate and reference device, K182789.
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Image /page/13/Picture/0 description: The image shows the logo for KLS Martin Group. The text "KLS" is in red, and the text "martin" is in gray. The word "GROUP" is in gray and is located below the other text.
KLS-Martin L.P.
Mail: P.O. Box 16369 • Jacksonville, FL 32245-6369 Physical: 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246-7652 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com
Pyrogenicity Testing
LAL endotoxin testing was conducted according to AAMI ANSI ST72 to address the presence of bacterial endotoxins. 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 (K191028). 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 outputs utilizing 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 demonstrate 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 Data - Clinical
Risk mitigation assessments have been completed based on FDA guidance, "Premarket Assessment of Pediatric Medical Devices, " issued March 24, 2014, to demonstrate the safety and effectiveness for use of the IPS output devices in the pediatric population. These risk assessments evaluated the following risk factors for pediatric patients: age, size, growth and development, body habitus, developmental milestones, pathophysiology, behavioral factors, psychosocial factors, human factors, surgical factors, and cumulative effects from repeat or unplanned radiation exposure (i.e., CT scan).
The short-term and long-term mitigations for both children and adolescents are similar with regard to implantation. The patient's anatomy and the approving medical practitioner will dictate the size of the implant. Assuming no physes are violated when placing the implant, there are no short-term concerns when placing the patient-specific implant. The most challenging long-term impact for both subpopulations is use of permanent implants in a growing patient. There is a possibility that an implant may restrict growth and development when implanted into a maturing individual. The surgeon performing the procedure will determine whether the implant needs to be removed long-term.
Unplanned or repeat radiation exposure prior to or following the pediatric patient's initial surgery is a risk that is mitigated by device labeling to include special considerations for pediatric populations to minimize ionizing radiation by using low-dose and child-size CT scan protocols when deemed appropriate based on patient size, weight, height, and clinical needs.
To demonstrate clinical performance of KLS Martin IPS implants in the pediatric subpopulations of children (2 years of age to