(132 days)
No
The summary describes image processing and simulation but does not mention AI, ML, or related terms, nor does it provide details about training or test sets indicative of ML model development.
No.
The device is a planning system for cranial surgery, providing digital models and physical outputs, but does not directly treat or mitigate a disease or condition. It is a tool for pre-operative planning and simulation.
No
The device is a pre-operative planning and simulation tool that produces physical and digital outputs for surgical use. It does not diagnose medical conditions.
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," indicating it includes hardware components beyond just software.
Based on the provided information, the KLS Martin Individual Patient Solutions (IPS) Planning System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- IPS Planning System Function: The IPS Planning System uses medical imaging data (CT scans) as input. It processes this data to create digital models and physical outputs (anatomical models, guides, case reports) for pre-operative planning and surgical execution. It does not analyze biological specimens from the patient's body.
- Intended Use: The intended use clearly states it's for processing imaging information and providing tools for surgical planning and execution, not for analyzing biological samples for diagnostic purposes.
Therefore, the IPS Planning System falls under the category of medical devices used for surgical planning and guidance, not IVDs.
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 computerized tomography (CT) medical scan. 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, and case reports for use in the marking and cutting of cranial surgery.
The IPS Planning System is also intended as a pre-operative software tool for simulating surgical treatment options. Information provided by the software and device output is not intended to eliminate, replace, or substitute, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.
Product codes (comma separated list FDA assigned to the subject device)
PPT
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 cranial 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, and case reports for use in the marking and cutting of cranial bone in cranial surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computerized tomography (CT) medical scan
Anatomical Site
cranial bone in cranial surgery.
Indicated Patient Age Range
Pediatric & Adult
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: Performed on polyamide guides to demonstrate resistance to degradation after multiple sterilization cycles and maintaining 85% of initial tensile strength. Also provides evidence for shelf life. Tests on titanium devices demonstrated they are equivalent or better than those manufactured using traditional methods.
- Biocompatibility Testing: Evaluated in accordance with ISO 10993-1, including cytotoxicity, sensitization, irritation, chemical/material characterization, acute systemic, material-mediated pyrogenicity, and indirect (extract) hemolysis testing. All results met pre-defined acceptance criteria.
- Sterilization Testing: Steam sterilization validations performed for each output device for 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.
- Pyrogenicity Testing: LAL endotoxin testing conducted according to AAMI ANSI ST72 to ensure endotoxin levels were below USP allowed limit (
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the symbol is a blue square containing the acronym "FDA" in white letters, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
August 31, 2020
KLS-Martin L.P. Katie Rutland Regulatory Affairs Project Manager 11201 Saint Johns Industrial Parkway S Jacksonville, Florida 32246
Re: K201052
Trade/Device Name: KLS Martin Individual Patient Solutions (IPS) Planning System Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories Regulatory Class: Class II Product Code: PPT Dated: July 30, 2020 Received: July 31, 2020
Dear Katie Rutland:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
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 mediation-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,
Xiaolin Zheng, Ph.D. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201052
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 computerized tomography (CT) medical scan. 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, and case reports for use in the marking and cutting of cranial surgery.
The IPS Planning System is also intended as a pre-operative software tool for simulating surgical treatment options. Information provided by the software and device output is not intended to eliminate, replace, or substitute, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.
| 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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| | 510(k) Summary
21 CFR 807.92 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | KLS-Martin L.P.
11201 Saint Johns Industrial Pkwy S.
Jacksonville, FL 32246 |
| Contact Person: | Katie Rutland
Regulatory Affairs Project Manager
Phone: 800-625-1557
Email: katie.rutland@klsmartin.com |
| Alternate Contact: | Melissa Bachorski
RA/QMS Manager
Phone: 800-625-1557
Email: RA_QA@klsmartin.com |
| Date Prepared: | August 31, 2020 |
| 510(k) Number: | K201052 |
| Trade Name: | KLS Martin Individual Patient Solutions (IPS)
Planning System |
| Common Name: | System for the creation of patient specific anatomical
models, cutting/marking guides, and case reports |
| Classification Name: | Cranial Surgical Planning and Instrument Guides (21 CFR
882.4310) |
| Regulatory Class: | II |
| Product Code: | PPT |
| Predicate Device: | KLS Martin Individual Patient Solutions (IPS)
Planning System (K182889) |
| Reference Devices: | KLS Martin Individual Patient Solutions (IPS) Planning
System (K182789)
Stryker PEEK Customized Cranial Implant (K190229) |
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 cranial 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, and case reports for use in the marking and cutting of cranial bone in cranial surgery.
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 computerized tomography (CT) medical scan. The input data file is processed by the IPS Planning System and the result is an output data file that
4
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, and case reports for use in the marking and cutting of cranial bone in cranial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
Information provided by the software and device output is not intended to eliminate, replace, or substitute, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.
Technological Characteristics/Substantial Equivalence Discussion:
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 (K188789):
The subject and predicate devices are intended for use 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 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, and case reports. All digital data and physical devices are used to aid the surgeon during cranial surgeries. They are both also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
The indications for use statement of the subject device is nearly identical to the predicate, K182889, differing in system outputs. The predicate, K182889, is cleared for use in the marking of bone in cranial surgery. The subject device is indicated for the marking and cutting of cranial bone in cranial surgery. The potential impact on substantial equivalence with regard to each technological difference has been addressed through risk analysis as well as verification and validation testing.
Similarities to Predicate
The subject and predicate devices share the same fundamental principle of operation - a system that processes original patient medical images (CT scan) and produces a variety of patient-specific physical and/or digital output devices for planning and executing cranial surgery.
The subject device shares identical technological characteristics as the predicate regarding software, material manufacturing process, performance testing, as well as cleaning and sterilization.
Both the subject and predicate devices use image data obtained from CT scans. The subject device utilizes two (2) commercially off-the-shelf (COTS) software applications for image segmentation and manipulation identical to what was evaluated in the predicate device, K182889. The validated commercially off-theshelf (COTS) software applications are used 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.
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Both systems use additive manufacturing methods to produce physical output devices that include patient-specific anatomical models and guides. In addition, the systems produce digital models and case reports for the physician to use for planning surgeries or to use during surgery.
Design validation activities to verify the final finished output device matches the initial input data (.STL) are identical to the predicate and reference devices, K182889
and K182789.
Materials used in the manufacture of the subject output devices are polyamide, acrylic resins, and titanium (CP titanium & Titanium Alloy) identical to what was evaluated in the predicate device, K182889.
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.
Differences from Predicate
The subject device's indications for use is nearly identical to the predicate device, differing in system outputs. The predicate, K182889, is cleared for use in the marking of bone in cranial surgery. The subject device is indicated for the marking and cutting of cranial bone in cranial surgery.
The IPS Planning System includes cutting and positioning guides, whereas the predicate only includes marking guides. Cutting and positioning guides were included as part of this device system to aid in cranial pediatric surgeries (e.g., craniosynostosis, congenital cranial deformities, etc.).
The predicate patient population includes adults only, whereas the subject device includes pediatric (neonate, infant, children, adolescents) and adult patient populations.
Risk assessments have been performed based on FDA guidance, "Premarket Assessment of Pediatric Medical Devices, March 24, 2014" for these subpopulations with supporting peer-reviewed clinical studies to demonstrate the safety and effectiveness of the subject device for use in the pediatric subpopulations.
Reference Devices
The KLS Martin Individual Patient Specific Planning System, K182789, and the Stryker PEEK Customized Cranial Implant Kit, K190229 have been included as reference devices to address differences in technological characteristics between the subject and predicate devices.
- o Target Population: The predicate device was cleared for use in the adult patient population only, whereas the subject device includes pediatric (neonate, infant, children, adolescents) and adult patient populations, which is similar to the reference devices. K182789 includes all pediatric subpopulations and adults, while K190229 includes patients 3.5 years of age and older. Risk mitigation studies for pediatric patients were completed in both reference devices along with verbiage provided in the labelling to mitigate any risks (i.e., radiation exposure).
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| Device Comparison Table | ||||
|---|---|---|---|---|
| KLS Martin IPS Planning System | ||||
| (Subject Device) | KLS Martin IPS Planning System | |||
| K182889 | ||||
| (Primary Predicate) | KLS Martin IPS Planning System | |||
| K182789 | ||||
| (Reference) | Stryker PEEK Customized | |||
| Cranial Implant Kit | ||||
| K190229 | ||||
| (Reference) | ||||
| 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 computerized tomography | ||||
| (CT) medical scan. 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, and case reports | ||||
| for use in the marking and cutting | ||||
| of cranial bone in cranial surgery. | ||||
| The IPS Planning System is also | ||||
| intended as a pre-operative | ||||
| software tool for simulating / | ||||
| evaluating surgical treatment | ||||
| options. Information | ||||
| provided by the software | ||||
| and device output is not intended | ||||
| to eliminate, replace, or | ||||
| substitute, in whole or in part, the | ||||
| healthcare provider's judgment and | ||||
| analysis of the patient's condition. | 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 computerized | ||||
| tomography (CT) medical scan. 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 and case | ||||
| reports for use in the marking of | ||||
| cranial bone in cranial 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. | The PEEK Customized Cranial | |||
| Implant Kit is indicated for the | ||||
| augmentation and/or restoration of | ||||
| bony and/or soft tissue deformities | ||||
| in the cranial and craniofacial | ||||
| skeleton (orbital rim, zygoma, and | ||||
| adjacent bone); including but not | ||||
| limited to, the correction and | ||||
| prevention of persistent temporal | ||||
| hollowing (PTH) in patients 3.5 | ||||
| years of age and older. | ||||
| Device Comparison Table | ||||
| KLS Martin IPS Planning System | ||||
| (Subject Device) | KLS Martin IPS Planning System | |||
| K182889 | ||||
| (Primary Predicate) | KLS Martin IPS Planning System | |||
| K182789 | ||||
| (Reference) | Stryker PEEK Customized | |||
| Cranial Implant Kit | ||||
| K190229 | ||||
| (Reference) | ||||
| 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 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. | 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 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. | 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 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. | Unknown |
| Device Comparison Table | | | | |
| | KLS Martin IPS Planning System
(Subject Device) | KLS Martin IPS Planning System
K182889
(Primary Predicate) | KLS Martin IPS Planning System
K182789
(Reference) | Stryker PEEK Customized
Cranial Implant Kit
K190229
(Reference) |
| Classification | 21 CFR 882.4310, Class II | 21 CFR 882.4310, Class II | 21 CFR 872.4120, Class II
21 CFR 892.2050, Class II | 21 CFR 882.5320, Class II |
| Product Code | PPT | PPT | DZJ, LLZ | GWO |
| Material | Anatomical Models: Epoxy/Resin,
Acrylic
Cutting/Marking Guides:
Polyamide, Ti-6Al-4V, CP
Titanium | Anatomical Models: Epoxy/Resin,
Acrylic
Cutting/Marking Guides:
Polyamide, Ti-6Al-4V, CP
Titanium | Anatomical Models: Epoxy/Resin,
Acrylic
Cutting/Marking Guides: PA, Ti
6Al-4V, CP Titanium
Splints: methacrylate | Polyether ether ketone (PEEK) |
| Manufacturing
Method | Epoxy/Resin, Acrylic: 3D (SLA)
CP Titanium: Traditional
(Subtractive)
Ti-6Al-4V: 3D (Additive: SLM)
Polyamide: 3D (Additive; SLS) | Epoxy/Resin, Acrylic: 3D (SLA)
CP Titanium: Traditional
(Subtractive)
Ti-6Al-4V: 3D (Additive; SLM)
Polyamide: 3D (Additive; SLS) | Epoxy/Resin, Acrylic: 3D (SLA)
CP Titanium: Traditional
(Subtractive)
Ti-6Al-4V: 3D (Additive: SLM)
Polyamide: 3D (Additive; SLS) | Unknown |
| Software | Materialise Mimics (K073468)
Geomagic® Freeform PlusTM | Materialise Mimics (K073468)
Geomagic® Freeform PlusTM | Materialise Mimics (K073468)
Geomagic® Freeform PlusTM
IPS CaseDesigner (K161634)
MathWorks® MATLAB | Unknown |
| Target Population | Pediatric & Adult | Pediatric & Adult | Pediatric & Adult | Pediatric & Adult |
| Sterilization | Non-sterile (steam) | Non-sterile (steam) | Non-sterile (steam) | Non-sterile (steam) |
| Anatomical Sites | Cranial | Cranial | Mandibular and Maxillofacial | Cranial |
| Thickness | Cutting/Marking Guide
Min: 1.0 mm
Max: 5 mm | Cutting/Marking Guide
Min: 1.0 mm
Max: 5 mm | Cutting/Marking Guide
Min: 1.0 mm
Max: 5.0 mm | Not applicable |
| Device Comparison Table | | | | |
| | KLS Martin IPS Planning System
(Subject Device) | KLS Martin IPS Planning System
K182889
(Primary Predicate) | KLS Martin IPS Planning System
K182789
(Reference) | Stryker PEEK Customized
Cranial Implant Kit
K190229
(Reference) |
| Width | Cutting/Marking Guide
Min: 7 mm
Max: 200 mm | Cutting/Marking Guide
Min: 7 mm
Max: 200 mm | Cutting/Marking Guide
Min: 7 mm
Max: 200 mm | Not applicable |
| Length | Cutting/Marking Guide
Min: 15 mm
Max: 350 mm | Cutting/Marking Guide
Min: 15 mm
Max: 350 mm | Cutting/Marking Guide
Min: 15 mm
Max: 350 mm | Not applicable |
| Degree of curvature
(in-plane) | Cutting/Marking Guide
Min: 90°
Max: 180° | Cutting/Marking Guide
Min: 90°
Max: 180° | Cutting/Marking Guide
Min: 90°
Max: 180° | Not applicable |
| Degree of curvature
(out-of-plane) | Cutting/Marking Guide
Min: 60°
Max: 180° | Cutting/Marking Guide
Min: 60°
Max: 180° | Cutting/Marking Guide
Min: 60°
Max: 180° | Not applicable |
| Screw hole spacing | Cutting/Marking Guide
Min: ≥4.5 mm
Max: No Max | Cutting/Marking Guide
Min: ≥4.5 mm
Max: No Max | Cutting/Marking Guide
Min: ≥4.5 mm
Max: No Max | Not applicable |
| No. of holes | Cutting/Marking Guide
Min: 2
Max: Depends on length and hole
spacing | Cutting/Marking Guide
Min: 2
Max: Depends on length and hole
spacing | Cutting/Marking Guide
Min: 2
Max: Depends on length and hole
spacing | Not applicable |
| Screw Diameter | Temporary: 1.0 mm - 2.7 mm | Temporary: 1.0 mm - 2.7 mm | Temporary: 1.5 mm - 2.7 mm | Not applicable |
| Screw Length | Temporary: 2 mm - 11 mm | Temporary: 2 mm - 11 mm | Temporary: 4 mm - 22 mm | Not applicable |
| Screw Style | maxDrive & crossDrive (Drill-Free,
non-locking) | maxDrive & crossDrive (Drill-Free, locking [ThreadLock
Taper Screw -TLTS]) | maxDrive & crossDrive (Drill-Free, non-locking, locking, TLTS | Not applicable |
7
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Non-Clinical Performance Data
Tensile & Bending Testing
Tensile and bending tests 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. This testing is identical to the predicate device and is leveraged from K182889.
Tensile and bending tests for titanium were performed as outlined in the predicate device. K182889. 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 predicate device and is leveraged from K182889.
Biocompatibility Testing
Biocompatibility endpoints were evaluated in accordance with ISO 10993-1. The battery of cytotoxicity, sensitization, irritation, chemical/material characterization, acute systemic, material-mediated pyrogenicity, and indirect (extract) hemolysis testing conducted on the subject devices were within the pre-defined acceptance criteria, and therefore, adequately addresses biocompatibility for the output devices and their intended use. Biocompatibility testing is identical to the predicate device and is leveraged from K182889.
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. Sterilization testing is identical to the predicate device and is leveraged from K182889.
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 that have contact with cerebrospinal fluid (