(217 days)
KLS Martin Internal Distraction – Sterile (K161470)
No
The device description focuses on patient-specific design based on CT scans and virtual planning with physician input, which is a form of computer-aided design and manufacturing, not AI/ML. There is no mention of AI, DNN, or ML in the document.
Yes.
The device is intended as a bone stabilizer and lengthening device for the correction of congenital deficiencies or post-traumatic defects, which directly addresses a medical condition or abnormality.
No
Explanation: The device is intended for bone stabilization and lengthening, not for diagnosing medical conditions. It is a surgical implant system.
No
The device description explicitly states it is comprised of patient-specific models, guides, and distraction footplates, which are physical components manufactured from titanium. While software is used in the planning and design process, the final device is a physical implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a bone stabilizer and lengthening/transport device for correcting bone deficiencies and defects. This is a therapeutic and reconstructive purpose, not a diagnostic one.
- Device Description: The description details the physical components (models, guides, footplates, screws) and their manufacturing process based on patient anatomy. It focuses on the physical interaction with the patient's bone for structural support and manipulation.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide information about a patient's health status or disease. The image processing is used for planning and designing the physical device, not for diagnostic interpretation of the images themselves.
- Performance Studies: The performance studies focus on mechanical properties, biocompatibility, sterilization, and clinical performance related to bone distraction and fixation. These are typical evaluations for implantable medical devices, not IVDs.
IVDs are devices intended to be used in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
KLS Martin IPS Distraction includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, alveolar ridge, palate, and symphysis) and mid-face bones that require gradual distraction in adults, adolescents, children and infants weighing more than 2.5 kg.
Product codes (comma separated list FDA assigned to the subject device)
MQN
Device Description
KLS Martin IPS Distraction System is comprised of patient-specific models, guides and distraction footplates used in conjunction with previously cleared distractor bodies and metallic bone screws for internal fixation and reconstruction of maxillofacial / midface and mandibular bones. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization 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 personnel 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 sterile or non-sterile, range in thickness from 0.6 - 10 mm, and are manufactured using additive or traditional (subtractive) methods from either CP Titanium (ASTM F67) or Ti-6A1-4V (ASTM F136) materials. These patient-specific devices are fixated with previously cleared KLS Martin screws.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical imaging (CT scan)
Anatomical Site
mandible (including ramus, body, alveolar ridge, palate, and symphysis) and mid-face bones, maxillofacial / midface and mandibular bones
Indicated Patient Age Range
adults, adolescents, children and infants weighing more than 2.5 kg.
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)
Performance Testing - Non-clinical:
- A direct comparison weld strength test was performed to address the difference in material combinations (titanium alloy/titanium alloy connection vs. CP titanium/titanium alloy connection) used for the subject versus predicate/reference devices. The titanium alloy/titanium alloy material combination was able to withstand a greater tensile load than the CP titanium alloy material combination.
- Additional performance testing presented in K191028 and equally relevant to the subject device, was conducted in accordance with the device testing considerations outlined in Technical Considerations for Additive Manufactured Medical Devices, issued December 5, 2017.
- Biocompatibility endpoints were evaluated in accordance with ISO 10993. The battery of cytotoxicity, chemical analysis, sensitization, and chemical/material characterization testing was leveraged from K191028 for titanium devices.
- Steam sterilization validations were performed using the dynamic-air-removal cycle in accordance with ISO 17665-1:2006 to a sterility assurance level (SAL) of 10-9 using the biological indicator (BI) overkill method. Validations for devices manufactured from titanium were leveraged from the reference device, KLS Martin Individual Patient Solutions (K191028).
- As part of the sterilization, LAL endotoxin testing was conducted according to AAMI ANSI ST72:2019 to address the presence of bacterial endotoxins and ensure the devices meet pyrogen limit specifications. Results demonstrated that the devices contain endotoxin levels below the USP allowed limit and meet pyrogen limit specifications. LAL endotoxin testing for titanium was leveraged from K191028.
- 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 required resulting from risk analysis and impact assessments showed conformity with pre-defined specifications and acceptance criteria.
Performance Testing - Clinical:
- Risk mitigation assessments have been completed based on FDA guidance, "Premarket Assessment of Pediatric Medical Devices," issued March 24, 2014, to demonstrate the safety and effectiveness for use of the IPS output devices in the pediatric population. These risk assessments evaluated age, size, growth and development, body habitus, developmental milestones, pathophysiology, behavioral factors, psychosocial factors, surgical factors, and cumulative effects from repeat or unplanned radiation exposure (i.e., CT scan).
- To demonstrate clinical performance of KLS Martin IPS implants in the pediatric subpopulations of infants (weighing more than 2.5 kg), children, and adolescents (29 days through 21 years of age), 5 clinical studies including patients 26 days of age through 21 years of age, were analyzed:
- Doscher, et al (2014): Patient age 26 days, Patient Population Neonate, Treatment CT-based patient-specific surgical planning for mandibular distraction osteogenesis (DO)
- Gray, et al (2017): Patient age 3 – 17 years, Patient Population Children & Adolescents, Treatment Virtual Surgical Planning (VSP) using CT scans and CAD/CAM technology in craniofacial reconstructive surgeries
- Steinbacher (2015): Patient age
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
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KLS Martin L.P. Susan Leander Regulatory Affairs Project Manager 11201 Saint Johns Industrial Parkway S Jacksonville, Florida 32246
8/11/22
Re: K220050
Trade/Device Name: KLS Martin IPS Distraction Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: MQN Dated: June 30, 2022 Received: July 12, 2022
Dear Susan Leander:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220050
Device Name KLS Martin IPS Distraction
Indications for Use (Describe)
KLS Martin IPS Distraction includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, alveolar ridge, palate, and symphysis) and mid-face bones that require gradual distraction in adults, adolescents, children and infants weighing more than 2.5 kg.
| 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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11201 Saint Johns Industrial Pkwy S · Jacksonville, FL 32246 Phone: 904-641-7746 · 800-625-1557 · Fax: 904-641-7378 www.klsmartinnorthamerica.com
K220050
510(k) Summary 21 CFR 807.92
| Submitter: | KLS-Martin L.P.
11201 Saint Johns Industrial Pkwy S
Jacksonville, FL 32246 |
|----------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Susan Leander
Regulatory Affairs Project Manager
Phone: 800-625-1557
Email: susan.leander@klsmartin.com |
| Date Prepared: | August 11, 2022 |
| Trade Name: | KLS Martin IPS Distraction |
| Common Name: | Plate, Bone |
| Classification Name: | Bone Plate |
| Regulatory Class: | II |
| Product Code: | MQN |
| Primary Predicate: | KLS Martin Internal Distraction – Sterile (K161470) |
| Reference Devices: | KLS Martin Individual Patient Solutions (K191028)
KLS Martin Zurich Distraction System (K010139) |
Device Description
KLS Martin IPS Distraction System is comprised of patient-specific models, guides and distraction footplates used in conjunction with previously cleared distractor bodies and metallic bone screws for internal fixation and reconstruction of maxillofacial / midface and mandibular bones. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization 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 personnel 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 sterile or non-sterile, range in thickness from 0.6 - 10 mm, and are manufactured using additive or traditional (subtractive) methods from either CP Titanium (ASTM F67) or Ti-6A1-4V (ASTM F136) materials. These patient-specific devices are fixated with previously cleared KLS Martin screws.
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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 the word "martin" is in gray. The letters "L.P." are in black. The logo is simple and modern.
Indications for Use
KLS Martin IPS Distraction includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, alveolar ridge, palate, and symphysis) and mid-face bones that require gradual distraction in adults, adolescents, children, and infants weighing more than 2.5 kg.
Technological Characteristics & Substantial Equivalence Discussion
The intended use and technological characteristics of the subject device, KLS Martin IPS Distraction are the same as those of the predicate device. KLS Martin Internal Sterile Distraction, cleared under K161470. Both are distraction devices made of titanium. Both use standard distractors with attached footplates. The potential impact on substantial equivalence of each technological difference was addressed through risk analysis and verification and validation testing.
Similarities to Predicate and Reference Devices
The primary predicate device, KLS Martin Internal Sterile Distraction, K161470, and the subject device, KLS Martin IPS Distraction are intended for gradual distraction in the facial skeleton and share the same fundamental principle of operation - metallic bone plates used in conjunction with metallic bone screws for bone stabilization and lengthening of bones. The indications for use for the subject device are the same as the predicate device. The skeletal regions for the subject and predicate devices are similar.
Both the primary predicate device and the KLS Martin Zurich Distraction System reference device, cleared under K010139, present evidence of substantially equivalent use of similar devices. The method to attach the patient-specific footplates to the distraction bodies is the same for the subject, predicate and reference devices.
The KLS Martin IPS Distraction devices are provided sterile (same as K161470) or non-sterile (same as K010139 and K191028). The non-sterile devices require the end-user to process them using validated cleaning and sterilization methods prior to use as recommended in the labeling.
The KLS Martin Individual Patient Solutions is included as a reference device to support the use of patient-specific metallic implants. Both the subject and the KLS Martin Individual Patient Solutions (K191028) reference devices use image data obtained from medical scanners, such as a CT scan. They both use validated commercial-off-the-shelf (COTS) software applications to transfer patient imaging from a DICOM format to an .STL format and manipulate the images to produce a final design file.
The manufacturing materials used for the implants in the subject device are similar to those cleared in their own prior clearance. K191028. The design and dimensions of the plates will be based on patientspecific data. using similar methods described in K191028. made from either CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136) using traditional (subtractive) or additive manufacturing methods. The bone plates are similar in final finished form to those presented in the K191028 reference device, and therefore performance and biocompatibility are adequately addressed.
IPS Distractor bone plates will be attached to maxillofacial, midface or mandibular bones and to distractor bodies for distraction osteogenesis. Bone plates in the subject device may be implanted permanently in skeletally mature patients or they may be removed on completion of the procedure, as is common for K161470 and K010139 predicate and reference devices. Permanent implants are not recommended for use in skeletally immature patients (16 years of age or younger).
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Differences from Predicate and Reference Devices
The indications for use statements for the subject device and predicate devices are the same, except the subject device statement specifically lists the following targeted patient populations:
- · Infants that weigh more than 2.5 kg (29 days to