Who is the manufacturer of KLS Martin Individual Patient Solutions (IPS) Planning System?

KLS-Martin L.P. filed the 510(k) submission for KLS Martin Individual Patient Solutions (IPS) Planning System (K182789).

What is the FDA product code for KLS Martin Individual Patient Solutions (IPS) Planning System?

DZJ. It is classified under 21 CFR 872.4120 as a Class 2 device in the Dental panel.

What is the regulatory pathway for KLS Martin Individual Patient Solutions (IPS) Planning System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like KLS Martin Individual Patient Solutions (IPS) Planning System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

KLS Martin Individual Patient Solutions (IPS) Planning System

K182789 · KLS-Martin L.P. · DZJ · Mar 11, 2019 · Dental

Device Facts

Record ID	K182789
Device Name	KLS Martin Individual Patient Solutions (IPS) Planning System
Applicant	KLS-Martin L.P.
Product Code	DZJ · Dental
Decision Date	Mar 11, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4120
Device Class	Class 2
Attributes	Pediatric

Indications for Use

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 scamer 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.

Device Story

System processes CT scan data to create patient-specific anatomical models, surgical guides, splints, and case reports for maxillofacial surgery. Workflow involves trained engineers using four COTS software applications to segment and manipulate images; physician provides interactive feedback during virtual planning sessions. Outputs produced via additive manufacturing (SLA, SLS, Selective Laser Melting) or traditional subtractive methods. Used in clinical settings by surgeons for pre-operative simulation and surgical guidance. System aids in reconstructive and orthognathic procedures; physical outputs are non-sterile and require end-user sterilization. Benefits include improved surgical planning accuracy and patient-specific anatomical alignment.

Clinical Evidence

No clinical data; bench testing only. Performance supported by tensile/bending tests, biocompatibility (ISO 10993-1), steam sterilization validation (ISO 17665-1), and endotoxin testing (AAMI ANSI ST72). Pediatric safety supported by risk assessment and literature review.

Technological Characteristics

Materials: Epoxy/resin, acrylic, polyamide, CP titanium, Ti-6Al-4V. Manufacturing: SLA, SLS, Selective Laser Melting, and traditional subtractive methods. Software: 4 COTS applications for DICOM to STL conversion and image manipulation. Sterilization: Steam (SAL 10^-6). Fixation: 1.5-2.7mm screws.

Indications for Use

Indicated for neonates, infants, children, adolescents, and adults requiring maxillofacial surgery planning, including anatomical modeling, surgical guide/splint creation, and pre-operative simulation. Contraindications include obvious infections, foreign body hypersensitivity, circulatory/metabolic disorders, insufficient bone tissue, secondary degenerative diseases, non-sterile surgical environments, regions with excessive weight loads, patients unable to follow post-operative instructions, bone tumors in the implant region, drug/alcohol abuse, and significant anatomical changes since the medical scan.

Regulatory Classification

Identification

A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

Predicate Devices

KLS Martin Individual Patient Solutions (IPS) Planning System (K181241)

Reference Devices

KLS Martin Individual Patient Solutions (K163579)
KLS Mini Osteosynthesis System (K943347)
KLS Martin Centre-Drive Drill-Free Screws (K971297)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. KLS-Martin L.P. Pam Martin Regulatory Affairs Supervisor 11201 Saint Johns Industrial Parkway S Jacksonville, Florida 32246 March 11, 2019 Re: K182789 Trade/Device Name: KLS Martin Individual Patient Solutions (IPS) Planning System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: February 4, 2019 Received: February 8, 2019 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Mary S. Runner - S3 For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) #### K182789 Device Name KLS Martin Individual Patient Solutions (IPS) Planning System #### Indications for Use (Describe) 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 scamer 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. Type of Use (Select one or both, as applicable) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------------------------------------------------------------| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/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. 11201 Saint Johns Industrial Pkwy S · Jacksonville, FL 32246 Phone: 904-641-7746 · 800-625-1557 · Fax: 904-641-7378 www.klsmartinnorthamerica.com | | 510(k) Summary 21 CFR 807.92 | K182789 | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Submitter: | KLS-Martin L.P. 11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 | | | Contact Person: | Pam Martin, RAC, MSc Regulatory Affairs Supervisor Phone: 800-625-1557 Email: pmartin@klsmartin.com | | | Date Prepared: | February 4, 2019 | | | Trade Name: | KLS Martin Individual Patient Solutions (IPS) Planning System | | | Common Name: | System for the creation of patient specific anatomical models, cutting/marking guides, splints, and case reports | | | Classification Name: | Bone Cutting Instruments and Accessories (21 CFR 872.4120); System, Image Processing, Radiological (21 CFR 892.2050 | | | Regulatory Class: | II | | | Product Code: | DZJ, LLZ | | | Predicate Device: | KLS Martin Individual Patient Solutions (IPS) Planning System (K181241) - Primary | | | Reference Devices: | KLS Martin Individual Patient Solutions (K163579) KLS Mini Osteosynthesis System (K943347) KLS Martin Centre-Drive Drill-Free Screws (K971297) | | #### Device Description: The KLS Martin Individual Patient Solutions (IPS) Planning System is a collection of software and associated additive manufacturing (rapid prototyping) equipment intended to provide a variety of outputs to support reconstructive and orthognathic surgeries. The system uses electronic medical images of the patients' anatomy (CT data) with input from the physician, to manipulate original patient images for planning and executing surgery. The system processes the medical images and produces a variety of patient specific physical and/or digital output devices which include anatomical models, guides, splints and case reports. #### Indications for Use: 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. {4}------------------------------------------------ Image /page/4/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/words in the logo. #### Technological Characteristics/Substantial Equivalence Discussion: The indications for use are identical for both the subject and predicate device. Further, the intended use of the subject device, KLS Martin Individual Patient Solutions (IPS) Planning System, is identical to the predicate device, the KLS Martin Individual (IPS) Patient Solutions System (K181241): The subject and primary predicate devices are 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 through the virtual planning software systems 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. These physical outputs can be anatomical models, guides, splints, templates, and case reports. All digital data and physical devices are used to aid the surgeon during maxillofacial surgeries. They are both also intended as a pre-operative software tool for simulating / evaluating surgical treatment options. #### Similarities to Predicate The KLS Martin Individual Patient Solutions (IPS) Planning System, K181241, is identical to the subject device's technological characteristics with regard to software, material composition, biocompatibility, manufacturing process, performance testing, as well as cleaning and sterilization. Both the subject and primary predicate devices use image data obtained from medical scanners, such as a CT scan. The subject device utilizes four (4) commercially off-the-shelf (COTS) software applications for image segmentation and manipulation identical to what was evaluated in the predicate device, K181241. The 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. In addition, both devices require trained employees/engineers who utilize the software applications to manipulate data and work with the physician to create the virtual planning session. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the trained employee/engineer during the planning session. Both systems use additive manufacturing methods to produce physical output devices that include patient specific anatomical models, guides, and splints. In addition, the systems produce digital models and case reports for the physician to use for planning of maxillofacial surgeries or to use during surgery. Materials used in the manufacture of the subject output devices are synthetic polymers, acrylic resins, and titanium (CP titanium & Titanium Alloy) identical to what was evaluated in the predicate device, K181241. All output devices from both systems are provided non-sterile and must be sterilized by the end user prior to use. Validated sterilization studies were performed to ensure a sterility assurance level (SAL) of 10-9. In addition, the subject device uses previously cleared fixation screws that are utilized for temporary guide fixation during cutting and marking of the bone. The screws range from 1.5 mm - 2.7 mm with lengths of 4 mm - 22 mm identical to what was evaluated in the predicate device, K181241. {5}------------------------------------------------ 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 larger than the other letters in the logo. The logo is simple and modern. #### Differences to Predicate The predicate device, K181241, was cleared for the adolescent (12 to 21 years of age) and adult populations. The purpose of this submission is to expand the patient population to include the following pediatric subpopulations: - . Neonates (birth to 28 days) - Infants (29 days to < 2 years of age ● - Children (2 years of age to < 12 years of age) ● A risk assessment has been performed based on FDA guidance, "Premarket Assessment of Pediatric Medical Devices, March 24, 2014" for these subpopulations with supporting peer-reviewed clinical literature to demonstrate the safety and effectiveness of the subject device for use in the pediatric subpopulations. #### Reference Devices KLS Martin Individual Patient Solutions (K163579) has been included as a reference device to leverage performance testing with regard to material composition (material recycling process / degradation / tensile / bending), biocompatibility, manufacturing process, performance testing, as well as cleaning and sterilization for titanium guides. The KLS Martin IPS Planning System titanium guides are manufactured from identical materials (CP Titanium & Titanium Alloy), undergo the same manufacturing processes, have the same biocompatibility, demonstrate similar performance characteristics, and are cleaned and sterilized using the same validated methods as the titanium implants in the KLS Martin Individual Patients Solutions clearance (K163579). The KLS Mini Osteosynthesis System (K943347) has been included as a reference device to address the differences in screw dimensions from the reference device KLS Martin Individual Patient Solutions (K163579). In reference device K163579, screw dimensions range from 2.0 mm - 3.2 mm with lengths of 5 mm - 22 mm. The KLS Mini Osteosynthesis System has been included to cover the 1.5 mm screw dimensions and a minimum length down to 4 mm that is identical to the subject device temporary fixation screws. The KLS Martin Centre-Drive Drill-Free Screw (K971297) has been included as a reference device to address the difference in screw dimension and style from the reference device KLS Martin Individual Patient Solutions (K163579). In reference device K163579, screw dimensions ranged from 2.0 mm - 3.2 mm with lengths of 5 mm - 22 mm and a drill-free screw style. The KLS Martin Centre-Drive Drill-Free Screw has been included to cover the 1.5 mm screw dimensions with a drill-free screw style that is identical to the subject device temporary fixation screws. {6}------------------------------------------------ # KLS martın L.P. 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com | | KLS Martin IPS Planning System (Subject Device) | KLS Martin IPS Planning System K181241 (Primary Predicate) | KLS Martin Individual Patient Solutions K163579 (Reference Device) | KLS Mini Osteosynthesis System K943347 (Reference Device) | KLS Martin Centre-Drive Drill-Free Screw K971297 (Reference Device) | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | 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. | 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 implant devices are intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction. | 1) Fractures 2) Osteotomies 3) Reconstruction procedures | KLS Martin Centre-Drive Drill-Free Screws are intended for use in rigid internal fixation of the oral- maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device referenced. | | | KLS Martin IPS Planning System (Subject Device) | KLS Martin IPS Planning System K181241 (Primary Predicate) | KLS Martin Individual Patient Solutions K163579 (Reference Device) | KLS Mini Osteosynthesis System K943347 (Reference Device) | KLS Martin Centre-Drive Drill-Free Screw K971297 (Reference Device) | | Contraindications | 1. Obvious infections. 2. Hypersensitivity to foreign bodies. 3. Circulatory problems, systemic diseases, and metabolic disorders. 4. Insufficient or inadequate bone tissue. 5. Secondary diseases such as degenerative processes that may negatively influence the healing process. 6. Interventions carried out in a non-sterile environment (e.g. paranasal sinuses). 7. Regions exposed to inappropriate forces or excessive weight loads. 8. Patients unwilling or unable to follow instructions during the postoperative phase due to their mental, neurological, or physical condition. 9. Bone tumors located in the implant base region. | 1. Obvious infections. 2. Hypersensitivity to foreign bodies. 3. Circulatory problems, systemic diseases, and metabolic disorders. 4. Insufficient or inadequate bone tissue. 5. Secondary diseases such as degenerative processes that may negatively influence the healing process. 6. Interventions carried out in a non-sterile environment (e.g. paranasal sinuses). 7. Regions exposed to inappropriate forces or excessive weight loads. 8. Patients unwilling or unable to follow instructions during the postoperative phase due to their mental, neurological, or physical condition. 9. Bone tumors located in the implant base region. | 1. Obvious infections. 2. Hypersensitivity to foreign bodies. 3. Suspected sensitivity to the implant material. 4. Circulatory problems, systemic diseases and metabolic disorders. 5. Insufficient or inadequate bone tissue. 6. Secondary diseases such as degenerative processes that may negatively influence the healing process. 7. Interventions carried out in a non-sterile environment (e.g. paranasal sinuses). 8. Regions exposed to inappropriate forces or excessive weight loads. 9. Patients unwilling or unable to follow instructions during the postoperative phase due to their mental, neurological or physical condition. 10. Osteoporosis or osteomalacia or other | 1. Active infection. 2. Patient conditions including: blood supply limitations, insufficient quantity or quality of bone or latent infections. 3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. 4. Foreign body sensitivity. Where material sensitivity is suspected, tests are to be made prior to implantation. | 1. Active infection. 2. Patient conditions including: blood supply limitations, insufficient quantity or quality of bone or latent infections. 3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. 4. Foreign body sensitivity. Where material sensitivity is suspected, tests are to be made prior to implantation. | | | KLS Martin IPS Planning System (Subject Device) | KLS Martin IPS Planning System K181241 (Primary Predicate) | KLS Martin Individual Patient Solutions K163579 (Reference Device) | KLS Mini Osteosynthesis System K943347 (Reference Device) | KLS Martin Centre-Drive Drill-Free Screw K971297 (Reference Device) | | | 10. Obvious drug or alcohol abuse. 11. Significant changes to the patient's anatomy has occurred since the medical scan used for planning purposes was obtained. | 10. Obvious drug or alcohol abuse. 11. Significant changes to the patient's anatomy has occurred since the medical scan used for planning purposes was obtained. | structural bone damage preventing the stable fixation of implant components. 11. Bone tumors located in the implant base region. 12. Obvious drug or alcohol abuse. | | | | Classification | 21 CFR 872.4120, Class II 21 CFR 892.2050, Class II | 21 CFR 872.4120, Class II 21 CFR 892.2050, Class II | 21 CFR 872.4760, Class II | 21 CFR 872.4760, Class II | 21 CFR 888.3040, Class II | | Product Code | DZJ, LLZ | DZJ, LLZ | JEY | JEY | HRS | | Target Population | Pediatric & Adults | Adolescent & Adult | Not applicable | Not applicable | Not applicable | | Material | Anatomical Models: Epoxy/Resin, Acrylic Cutting/Marking Guides: Polyamide, Titanium Alloy (Ti-6Al-4V), CP Titanium Splints: methacrylate | Anatomical Models: Epoxy/Resin, Acrylic Cutting/Marking Guides: Polyamide, Titanium Alloy (Ti-6Al-4V), CP Titanium Splints: methacrylate | Anatomical Models: Epoxy/Resin, Acrylic Implants: CP Titanium & Titanium Alloy (Ti-6Al-4V) | Implants: CP Titanium & Titanium Alloy (Ti-6Al-4V) | Screws: Titanium Alloy (Ti-6Al-4V) | | Manufacturing Method | Epoxy/Resin, Acrylic: Stereolithography (SLA) CP Titanium: Traditional (Subtractive) Ti-6Al-4V: 3D (Additive; Selective Laser Melting) Polyamide: 3D (Additive; Selective Laser Sintering) | Epoxy/Resin, Acrylic: Stereolithography (SLA) CP Titanium: Traditional (Subtractive) Ti-6Al-4V: 3D (Additive; Selective Laser Melting) Polyamide: 3D (Additive; Selective Laser Sintering) | Epoxy/Resin, Acrylic: Stereolithography (SLA) CP Titanium: Traditional (Subtractive) Ti-6Al-4V: 3D (Additive; Selective Laser Melting) | CP Titanium & Titanium Alloy (Ti-6Al-4V): Traditional (Subtractive) | Titanium Alloy (Ti-6Al-4V): Traditional (Subtractive) | | | KLS Martin IPS Planning System (Subject Device) | KLS Martin IPS Planning System K181241 (Primary Predicate) | KLS Martin Individual Patient Solutions K163579 (Reference Device) | KLS Mini Osteosynthesis System K943347 (Reference Device) | KLS Martin Centre-Drive Drill-Free Screw K971297 (Reference Device) | | Sterilization | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | | Temporary/Permanent Screw Diameter | Temporary: 1.5 mm – 2.7 mm | Temporary: 1.5 mm – 2.7 mm | Permanent: 2.0 mm - 3.2 mm | Permanent: 1.5 mm - 2.0 mm | Permanent: 1.0 mm - 2.0 mm | | Temporary/Permanent Screw Length | Temporary: 4 mm - 22 mm | Temporary: 4 mm - 22 mm | Permanent: 5 mm - 22 mm | Permanent: 4 mm - 19 mm | Permanent: 2 mm - 9 mm | | Temporary/Permanent Screw Style | maxDrive & crossDrive (Drill-Free, locking [ThreadLock Taper Screw - TLTS]) | maxDrive & crossDrive (Drill-Free, locking [ThreadLock Taper Screw - TLTS]) | maxDrive & crossDrive (Drill-Free, locking [ThreadLock Taper Screw - TLTS]) | maxDrive & crossDrive | Centre-Drive & crossDrive (Drill-Free) | {7}------------------------------------------------ ## KLS martın L.P. 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 ● 800-625-1557 ● Fax: 904-641-7378 www.klsmartinnorthamerica.com {8}------------------------------------------------ # KLS martın L.P. 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com {9}------------------------------------------------ ### KLS martın LP. 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while the words "martin L.P." are in gray. The logo is simple and modern, and it is likely used to represent the company in a variety of contexts. #### Non-Clinical Performance Data: #### Tensile & Bending Testing Tensile and bending tests leveraged from the primary predicate (K181241) were performed on the subject polyamide guides to demonstrate the subject devices made from polyamide can withstand multiple sterilization cycles without degradation and can maintain 85% of its initial tensile strength. This testing also provides evidence of shelf life for the subject polyamide guides in that the material will not degrade or the performance of the device will not be affected within the shelf life period. Shelf life period of the device is 6 months. Tensile and bending tests for titanium were performed as outlined in the reference device, KLS Martin Individual Patient Solutions (K163579). Results of the testing demonstrate additively manufactured titanium devices are equivalent to, or better than, titanium devices manufactured using traditional (subtractive) methods. The subject titanium devices are identical in formulation, manufacturing processes, and post-processing procedures (cleaning & sterilization) as the reference device, K163579. #### Biocompatibility Testing Biocompatibility endpoints were evaluated in accordance with ISO 10993-1. The battery of cytotoxicity, sensitization, irritation, and chemical/material characterization testing conducted on the subject devices manufactured from polyamide are within the pre-defined acceptance criteria, leveraged from the primary predicate KLS Martin Individual Patient Solutions (IPS) Planning System, K181241. The above biocompatibility tests were also conducted for titanium and are within the pre-defined acceptance criteria, as outlined in the reference device KLS Martin Individual Patient Solutions (K163579). The results of the testing adequately address biocompatibility for the output devices and their intended use. #### Sterilization Testing Steam sterilization validations were performed for each output device for 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 polyamide and titanium were leveraged from the predicate and reference devices, K181241 and K163579, respectively. Subject titanium devices are identical in formulation, manufacturing processes, and post-processing procedures (cleaning & sterilization) as the reference device, K163579. #### Pyrogenicity Testing LAL endotoxin testing was conducted according to AAMI ANSI ST72 on the subject devices to address the presence of bacterial endotoxins and ensure they meet pyrogen limit specifications. The results of the testing demonstrate that the KLS Martin IPS Planning System 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 reference device, KLS Martin Individual Patient Solutions (K163579). Subject titanium devices are identical in formulation, manufacturing processes, and post-processing procedures (cleaning & sterilization) as the reference device, K163579. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for KLS Martin L.P. The text "KLS" is in red, while the text "martin L.P." is in gray. The font is sans-serif and bolded. #### 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. #### Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence. #### Conclusion: The KLS Martin IPS Planning System shares identical technological characteristics and has the same intended use as the predicate device. A risk assessment has been performed based on FDA guidance, "Premarket Assessment of Pediatric Medical Devices, March 24, 2014" with supporting peer-reviewed clinical literature to demonstrate the safety and effectiveness of the subject device for use in the pediatric subpopulations. Based on this risk assessment, expanding the patient population from adolescents and adults to include neonates, infants, and children does not identify new issues of safety or effectiveness, and concludes the subject device is substantially equivalent to the predicate device. {12}------------------------------------------------ 11201 Saint Johns Industrial Pkwy S · Jacksonville, FL 32246 Phone: 904-641-7746 · 800-625-1557 · Fax: 904-641-7378 www.klsmartinnorthamerica.com #### 510(k) Summary 21 CFR 807.92 | Submitter: | KLS-Martin L.P. 11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Pam Martin, RAC, MSc Regulatory Affairs Supervisor Phone: 800-625-1557 Email: pmartin@klsmartin.com | | Date Prepared: | January 2, 2019 | | Trade Name: | KLS Martin Individual Patient Solutions (IPS) Planning System | | Common Name: | System for the creation of patient specific anatomical models, cutting/marking guides, splints, and case reports | | Classification Name: | Bone Cutting Instruments and Accessories (21 CFR 872.4120); System, Image Processing, Radiological (21 CFR 892.2050…

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