(123 days)
Not Found
No
The description details a process of patient-specific device design based on CT scans and physician input, with verification performed by virtually fitting models. There is no mention of AI or ML algorithms being used in the design or manufacturing process. The process described is based on traditional engineering and design principles guided by medical imaging and physician feedback.
Yes
The device is used for the "stabilization and fixation of mandibular fractures and mandibular reconstruction," which directly addresses and treats a medical condition, qualifying it as a therapeutic device.
No
This device is for the stabilization and fixation of mandibular fractures and reconstruction, and includes patient-specific implants and surgical guides. It does not perform diagnostic functions.
No
The device description explicitly lists physical components such as "patient-specific models, metallic fibula and mandible surgical guides, and metallic bone plates" and describes their manufacturing and materials. While software is used in the planning process, the final device includes hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "stabilization and fixation of mandibular fractures and mandibular reconstruction." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device components are implants (plates and screws) and surgical guides, all used in a surgical setting.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) outside of the body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed for testing biological samples in vitro (in a lab setting) to provide diagnostic information. This device is an implantable surgical device used in vivo (within the living body).
N/A
Intended Use / Indications for Use
KLS Martin Individual Patient Solutions implant devices are in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
KLS Martin Individual Patient Solutions is comprised of patient-specific models, metallic fibula and mandible surgical guides, and metallic bone plates. Metallic bone plates are used in conjunction with metallic bone screws for internal fixation of mandibular bone. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated device model over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.
Implants are provided non-sterile, range in thickness from 1.0 – 3.0 mm, and are manufactured using traditional (subtractive) or rapid prototyping (additive) methods from either CP Titanium (ASFM F67) or Ti-6Al-4V (ASTM F136) materials. These patient-specific devices are fixated with previously cleared KLS Martin screws.
KLS Martin Individual Patient Solutions consists of the following components:
• Plates
Screws KLS Martin Individual Patient Solutions consists of the following accessories:
Instrumentation
Metallic fibula and mandible surgical guides
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
Mandible
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 was performed and submitted with the KLS Martin Individual Patient Solutions Traditional 510(k) (K163579). KLS Martin Individual Patient Solutions is manufactured in accordance with the requirements of the current Good Manufacturing Practices for Medical Devices and follows 21 CFR Subpart C "Design Controls." All verification and validation activities identified by the risk analysis were performed to demonstrate continued conformance with applicable conformance standards which included:
ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 17665-2 Sterilization of health care products – Moist heat - Part 2: Guidance on the application of ISO 17665-1
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K163579 KLS Martin Individual Patient Solutions, K032442 KLS Martin Mandibular Reconstruction System II
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
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August 13, 2018
KLS-Martin L.P. Jennifer Register Director Regulatory Affairs Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K180962
Trade/Device Name: KLS Martin Individual Patient Solutions Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, Dated: June 16, 2018 Received: June 13, 2018
Dear Jennifer Register:
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
1
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 mediation-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
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
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Indications for Use
510(k) Number (if known) K180962
Device Name
KLS Martin Individual Patient Solutions
Indications for Use (Describe)
KLS Martin Individual Patient Solutions implant devices are in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
| 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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Kıs martın LP.
510(k) Summary K180962
In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) summary for KLS Martin Individual Patient Solutions is provided below.
| Date Summary
| Prepared | August 10, 2018 |
|---|---|
| Submitter | KLS-Martin L.P. |
| 11201 Saint Johns Industrial Pkwy S | |
| Jacksonville, FL 32246 | |
| Phone 800-625-1557 | |
| Fax 904-641-7378 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Jennifer Register | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 | |
| jregister@SecureBME.com | |
| Trade Name | KLS Martin Individual Patient Solutions |
| Common Name | Plates, Bones |
| Code -Classification | JEY |
| 21 CFR 872.4760.: Class II | |
| Primary Predicate | K163579 KLS Martin Individual Patient Solutions |
| Other Predicates | K032442 KLS Martin Mandibular Reconstruction System II |
| Device Description | KLS Martin Individual Patient Solutions is comprised of patient-specific models, |
| metallic fibula and mandible surgical guides, and metallic bone plates. Metallic | |
| bone plates are used in conjunction with metallic bone screws for internal fixation | |
| of mandibular bone. The devices are manufactured based on medical imaging | |
| (CT scan) of the patient's anatomy with input from the physician during virtual | |
| planning and prior to finalization and production of the device. The physician | |
| only provides input for model manipulation and interactive feedback by viewing | |
| digital models of planned outputs that are modified by trained KLS Martin | |
| engineers during the planning session. For each design iteration, verification is | |
| performed by virtually fitting the generated device model over a 3D model of the | |
| patient's anatomy to ensure its dimensional properties allow an adequate fit. |
Implants are provided non-sterile, range in thickness from 1.0 – 3.0 mm, and are
manufactured using traditional (subtractive) or rapid prototyping (additive)
methods from either CP Titanium (ASFM F67) or Ti-6Al-4V (ASTM F136)
materials. These patient-specific devices are fixated with previously cleared KLS
Martin screws.
KLS Martin Individual Patient Solutions consists of the following components:
• Plates |
| Screws KLS Martin Individual Patient Solutions consists of the following accessories: Instrumentation Metallic fibula and mandible surgical guides | |
| Intended Use | KLS Martin Individual Patient Solutions implant devices are intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
The purpose of this submission is to add optional metallic fibula and mandible surgical guide accessories to be used by the surgeon in bone graft harvesting and resection procedures. |
| Technological
Characteristics | KLS Martin Individual Patient Solutions is similar to the predicate devices in that it: has the same indications for use does not have any labeling changes that affect the intended use of the device does not alter the fundamental scientific technology relies on the same materials, fabrication technology and operating principles Based on the comparisons described above to the predicate devices and the comparison table below, KLS Martin Individual Patient Solutions does not raise any new issues of safety and effectiveness. |
| Non-Clinical
Performance Testing
Conclusion | Non-clinical performance data was performed and submitted with the KLS Martin Individual Patient Solutions Traditional 510(k) (K163579). KLS Martin Individual Patient Solutions is manufactured in accordance with the requirements of the current Good Manufacturing Practices for Medical Devices and follows 21 CFR Subpart C "Design Controls." All verification and validation activities identified by the risk analysis were performed to demonstrate continued conformance with applicable conformance standards which included: ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices ISO 17665-2 Sterilization of health care products – Moist heat - Part 2: Guidance on the application of ISO 17665-1 |
| Substantial
Equivalence
Summary
(Conclusion) | The proposed device has the same intended use as the predicate device. The performance testing included in the submission demonstrates that the differences in technological characteristics do not raise new questions of safety or effectiveness. The information submitted supports substantial equivalence. |
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Image /page/4/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while "martin" is in gray. The letters "L.P." are in black and are larger than the other letters in the logo.
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| Device Comparison Table | |||
|---|---|---|---|
| Individual Patient | |||
| Solutions | |||
| (Subject Device) | KLS Martin Individual | ||
| Patient Solutions | |||
| K163579 | |||
| (Primary Predicate) | KLS Martin Mandibular | ||
| Reconstruction System II | |||
| K032442 | |||
| (Predicate) | |||
| Indications for | |||
| Use | KLS Martin Individual | ||
| Patient Solutions implant | |||
| devices are intended for | |||
| us in the stabilization and | |||
| fixation of mandibular | |||
| fractures and mandibular | |||
| reconstruction. | KLS Martin Individual Patient | ||
| Solutions implant devices are | |||
| intended for use in the | |||
| stabilization and fixation of | |||
| mandibular fractures and | |||
| mandibular reconstruction. | The KLS Martin Mandibular | ||
| Reconstruction System II is | |||
| intended for us in the | |||
| stabilization and fixation of | |||
| mandibular fractures and | |||
| mandibular reconstruction. | |||
| Patient-specific | |||
| configuration? | Yes. Devices are | ||
| manufactured patient- | |||
| specific, based on a CT | |||
| scan of the patient. | Yes. Devices are | ||
| manufactured patient-specific, | |||
| based on a CT scan of the | |||
| patient. | No. Devices are provided in a | ||
| standard shape and matched | |||
| to the patient's anatomy | |||
| intraoperatively. | |||
| Classification | 21 CFR 872.4760, Class | ||
| II | 21 CFR 872.4760, Class II | 21 CFR 872.4760, | |
| Class II | |||
| Product Code | |||
| Material | JEY | ||
| CP Titanium or Ti-6A1- | |||
| 4V | JEY | ||
| CP Titanium or Ti-6A1-4V | MQN | ||
| CP Titanium or Ti-6A1-4V | |||
| Manufacturing | |||
| Method | Traditional (Subtractive) | ||
| 3D (Additive) | Traditional (Subtractive) 3D | ||
| (Additive) | Traditional (Subtractive) | ||
| Sterilization | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) |
| Anatomical Sites | Mandible | Mandible | Mandible |