(126 days)
No
The summary describes image processing and planning software, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The focus is on physician input and standard image manipulation for creating models and guides.
No
The device is a software planning and rapid prototyping system that produces digital models or physical outputs (anatomical models, guides, splints) for use in maxillofacial surgery; it does not directly treat or diagnose a disease or condition for therapeutic purposes.
No
The device is intended for planning, simulating, and evaluating surgical treatment options, and producing physical outputs for maxillofacial surgery, not for diagnosing a disease or condition.
No
The device description explicitly states it is a "collection of software and associated additive manufacturing (rapid prototyping) equipment" and produces "patient specific physical and/or digital output devices which include anatomical models, guides, splints and case reports." The performance studies also include testing on physical components (polyamide and titanium guides). This indicates it is not solely a software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for processing imaging information, simulating/evaluating surgical treatment options, and producing physical outputs (anatomical models, guides, splints, case reports) for use in maxillofacial surgery. This is focused on surgical planning and execution, not on analyzing biological samples to diagnose or monitor a medical condition.
- Device Description: The description reinforces the use of medical images (CT data) to support reconstructive and orthognathic surgeries and produce patient-specific physical and digital outputs. Again, the focus is on surgical support, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function falls outside of that definition.
N/A
Intended Use / 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.
Product codes
DZJ, LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical scanner such as a CT based system.
Anatomical Site
maxillofacial surgery
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)
Non-Clinical Performance Data:
Tensile & Bending Testing: Tensile and bending tests 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 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. 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 10-6 using the biological indicator (BI) overkill method. All test method acceptance criteria were met. Validations for titanium were 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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VSP System (K120956)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of 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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
KLS-Martin L.P. Gary Moore Quality Management and Regulatory Affairs Manager 11201 Saint Johns Industrial Pkwy S Jacksonville, Florida 32246
September 13, 2018
Re: K181241
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: September 7, 2018 Received: September 10, 2018
Dear Gary Moore:
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 (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 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 -S
forTina 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)
K181241
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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KUS ITT CIT CIT CIIN LIP T H201 Saint John Industrial Play S • Iocksoriile, FL322
Previous Clin Clin Carpe Phone: 904-04-1378 • Fax: 904-641-737
11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 www.klsmartinnorthamerica.com
K181241 510(k) Summary 21 CFR 807.92
| Submitter: | KLS-Martin L.P.
11201 Saint Johns Industrial Pkwy S
Jacksonville, FL 32246 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary Moore
Quality Management and Regulatory Affairs Manager
Phone: 800-625-1557
Email: gmoore@klsmartin.com |
| Date Prepared: | September 13, 2018 |
| 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: | VSP System (K120956) - 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 |
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. The logo is simple and modern.
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.
Technological Characteristics/Substantial Equivalence Discussion:
The intended use of the subject device, KLS Martin Individual Patient Solutions (IPS) Planning System, is similar to the predicate device, VSP System (K120956):
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
Both the subject and primary 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.
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 output devices are similar in that both the subject and predicate devices use biocompatible polymers/acrylic resins. 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 10-6.
Output devices in both systems are temporarily fixated with screws of varying sizes and lengths to aid the surgeon in cutting and marking bone more precisely and accurately. 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.
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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 the word "martin" is in gray. The letters "L.P." are in black. The logo is simple and modern.
Differences to Predicate
The indications for use statements differ slightly in that the predicate device stipulates physical outputs to include "anatomical models, templates, and surgical guides" whereas the subject device includes "anatomical models, guides, splints, and case reports." The predicate device includes splints and case reports in the narrative description, but splints and case reports were included in the indications for use of the subject device to describe all physical outputs.
The subject device utilizes four (4) commercially off-the-shelf (COTS) software applications for image segmentation and manipulation, whereas the predicate device utilizes thirteen (13) pieces of software that is a combination of COTS and custom.
Materials used in the manufacture of the subject output devices are synthetic polymers, acrylic resins, and titanium (CP titanium & Titanium Alloy). The predicate device manufactures output devices from acrylic and polymers only and uses surgical grade stainless steel cutting and drilling inserts for use in the cutting guides.
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. The predicate device does not indicate screw diameter or length for temporary fixation of cutting guides.
Reference Devices
The KLS Martin Individual Patient Solutions (K163579) has been included as a reference device to address differences in technological characteristics between the KLS Martin IPS Planning System and the predicate device with regard to material composition, 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 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
kıs martın ı.p.
11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com
| Device Comparison Table | |||||
|---|---|---|---|---|---|
| KLS Martin IPS Planning | |||||
| System | |||||
| (Subject Device) | Medical Modeling VSP® | ||||
| System | |||||
| K120956 | |||||
| (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 VSP® 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 VSP® | |||||
| 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, | |||||
| templates, and surgical | |||||
| guides for use in | |||||
| maxillofacial surgery. The | |||||
| VSP® 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 |
- Osteotomies
- 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. |
| Device Comparison Table | | | | | |
| | KLS Martin IPS Planning
System
(Subject Device) | Medical Modeling VSP®
System
K120956
(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.
- Hypersensitivity to foreign bodies.
- Circulatory problems, systemic diseases, and metabolic disorders.
- Insufficient or inadequate bone tissue.
- Secondary diseases such as degenerative processes that may negatively influence the healing process.
- Interventions carried out in a non-sterile environment (e.g. paranasal sinuses).
- Regions exposed to inappropriate forces or excessive weight loads.
- Patients unwilling or unable to follow instructions during the postoperative phase due to their mental, neurological, or physical condition.
- Bone tumors located | The models, templates and guides from the VSP System and the associated case report should not be used if any of the following occur:
- Patient has an active infection.
- Significant changes to patient's anatomy have occurred since the medical scan used for product definition was obtained. | 1. Obvious infections.
- Hypersensitivity to foreign bodies.
- Suspected sensitivity to the implant material.
- Circulatory problems, systemic diseases and metabolic disorders.
- Insufficient or inadequate bone tissue.
- Secondary diseases such as degenerative processes that may negatively influence the healing process.
- Interventions carried out in a non-sterile environment (e.g. paranasal sinuses).
- Regions exposed to inappropriate forces or excessive weight loads.
- Patients unwilling or unable to follow instructions during the postoperative phase due to their mental, neurological or physical condition.
- Osteoporosis or | 1. Active infection.
- Patient conditions including: blood supply limitations, insufficient quantity or quality of bone or latent infections.
- Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
- Foreign body sensitivity. Where material sensitivity is suspected, tests are to be made prior to implantation. | 1. Active infection.
- Patient conditions including: blood supply limitations, insufficient quantity or quality of bone or latent infections.
- Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
- Foreign body sensitivity. Where material sensitivity is suspected, tests are to be made prior to implantation. |
| Device Comparison Table | | | | | |
| | KLS Martin IPS Planning
System
(Subject Device) | Medical Modeling VSP®
System
K120956
(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) |
| | in the implant base
region. - Obvious drug or
alcohol abuse. - Significant changes to
the patient's anatomy
has occurred since the
medical scan used for
planning purposes
was obtained. | | osteomalacia or other
structural bone damage
preventing the stable
fixation of implant
components. - Bone tumors located in
the implant base region. - 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, LLC | JEY | JEY | HWC |
| Material | Anatomical Models:
Epoxy/Resin, Acrylic
Cutting/Marking Guides:
Polyamide, Titanium Alloy
(Ti-6Al-4V), CP Titanium
Splints: methacrylate | Acrylic and epoxy
photopolymers, surgical
instrument grade stainless
steel | 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) | 3D (Additive) | 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) |
| Device Comparison Table | | | | | |
| | KLS Martin IPS Planning
System
(Subject Device) | Medical Modeling VSP®
System
K120956
(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: Unknown | 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: Unknown | 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]) | Unknown | maxDrive & crossDrive
(Drill-Free, locking
[ThreadLock Taper Screw -
TLTS]) | maxDrive & crossDrive | Centre-Drive & crossDrive
(Drill - Free) |
7
kıs 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
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kıs martın ı.p.
11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com
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kıs 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
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Image /page/10/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.
Non-Clinical Performance Data:
Tensile & Bending Testing
Tensile and bending tests 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 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. 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 titanium were 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.
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.
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Image /page/11/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 stacked on top of each other.
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 has the same intended use and similar technological characteristics as the predicate and reference devices. Technological differences have been assessed with performance testing presented in this submission. Testing has demonstrated that any differences in technological characteristics do not identify new issues of safety or effectiveness, and concludes the subject device is substantially equivalent to the predicate device.