(182 days)
No
The device description and performance studies focus on mechanical properties and material, with no mention of AI/ML or related concepts.
Yes
The device is described as a system for long-term stabilization of major bone defects due to tumors, which addresses a medical condition, fitting the definition of a therapeutic device.
No
The device description indicates it is an implantable system for stabilizing bone defects, not a device for diagnosis.
No
The device description clearly outlines physical components made of titanium alloy (spacers, intramedullary nails, screws, connector), indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The OsteoBridge™ IDSF System is a surgical implant designed to physically stabilize bone defects. It is made of titanium and is implanted directly into the bone.
- Intended Use: The intended use is to provide "long-term stabilization of major bone defects." This is a structural and mechanical function within the body, not an analysis of biological specimens.
The description clearly indicates a device used in vivo (within the body) for structural support, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Long-term stabilization of major bone defects resulting from
o Radical bone loss due to tumors and/or metastases
o Bone resections following tumors and/or metastases - For use only in the diaphyseal region of humerus, tibia and femur
Product codes
HSB
Device Description
The OsteoBridge™ IDSF System is intended to be used in the management of segmental diaphyseal bone loss secondary to radical bone loss and/or resection due to tumors in either humerus, tibia or femur in oncology patients. The modular system includes a spacer made of two cylindrical half-shells that clamp over the ends of two intramedullary nails with eight screws. Spacers and intramedullary nails of different sizes can be selected to accommodate varying intramedullary canal diameters and different bone defect sizes. If the defect size is larger than 70 mm, two spacers may be connected with a spacer connector. The nails can be used non-cemented. All components of the OsteoBridge™ IDSF System are manufactured from Ti6Al4V ELI titanium alloy according to ASTM F 136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus, tibia, femur
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)
The change of the delivery form from non-sterile is performed according to the validated sterilization processes. The packaging for the sterile implants has been chosen according to the packaging validation test per DIN EN 22248:1993-02 to verify robustness of package containing the worst-case device showed that the packaging and device remained undamaged after the test. The trial implants are delivered in a tray, anodized blue and lasered with "DO NOT IMPLANT", so they cannot be mismatched with the sterile implants. The improvement in the connector mechanism and the surface of the devices has been tested in a dynamic bending test per ASTM F1264-16 as well as in a static torsion test. Both tests showed equivalent fatique limits and torsional strength.
Merete has conducted mechanical analysis and functional worst case tests to demonstrate that the OsteoBridge™ IDSF System has the mechanical properties necessary to perform as well or better than the predicate device. These tests have been performed in accordance with ASTM F1264-16 "Standard Specification and Test Methods for Intramedullary Fixation Devices". The OsteoBridge™ IDSF System have successfully passed all tests within the mechanical verification and have been proven to be mechanically as good as or better than the predicate device.
Clinical Data was not needed for these devices to show substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
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October 17, 2018
Merete GmbH Paul Münch Head of Regulatory Affairs Alt-Lankwitz 102 12247 Berlin Germany
Re: K181026
Trade/Device Name: OsteoBridge™ IDSF System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: September 14, 2018 Received: September 17, 2018
Dear Mr. Münch:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about 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,
Digitally signed Vesa by Vesa Vuniqi -S Vuniqi -S Date: 2018.10.17
Mark N. Melkerson For: Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181026
Device Name OsteoBridge IDSF System
Indications for Use (Describe)
- Long-term stabilization of major bone defects resulting from
o Radical bone loss due to tumors and/or metastases
o Bone resections following tumors and/or metastases
- For use only in the diaphyseal region of humerus, tibia and femur
| 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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Image /page/3/Picture/0 description: The image shows the logo for Merete. The logo consists of two interlocking circles on the left, followed by the word "merete" in a dark blue font. Above the logo, the text "K181026 - Page 1 of 3" is visible.
510(k) Summary of Safety and Effectiveness
Information as required by 21 CFR 807.92
| Date Prepared: | 09th October 2018 |
|---|---|
| Submitted by: | Merete GmbH |
| Alt-Lankwitz 102 | |
| 12247 Berlin, Germany | |
| Contact Person: | Merete GmbH |
| Paul Münch (Head of Regulatory Affairs) | |
| Alt-Lankwitz 102 | |
| 12247 Berlin, Germany | |
| Phone: +49-30 779980-181 | |
| Fax: +49-30 779980-177 | |
| Trade Name: | OsteoBridge™™ IDSF System |
| Common Device Name: | Intramedullary Fixation System |
| Classification Names: | Intramedullary fixation rod (21 CFR 888.3020) |
| Device Product Code: | HSB |
| Proposed Regulatory Class: | Class II |
Legally marketed Devices to which substantial Equivalence is claimed:
| Predicate Devices: | K142451 OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect
Fixation Rod System |
|--------------------|-----------------------------------------------------------------------------------------------|
| Reference Devices: | K101939 OSTEOBRIDGE™ IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD
FIXATION SYSTEM |
Device Description:
The OsteoBridge™ IDSF System is intended to be used in the management of segmental diaphyseal bone loss secondary to radical bone loss and/or resection due to tumors in either humerus, tibia or femur in oncology patients. The modular system includes a spacer made of two cylindrical half-shells that clamp over the ends of two intramedullary nails with eight screws. Spacers and intramedullary nails of different sizes can be selected to accommodate varying intramedullary canal diameters and different bone defect sizes. If the defect size is larger than 70 mm, two spacers may be connected with a spacer connector. The nails can be used non-cemented. All components of the OsteoBridge™ IDSF System are manufactured from Ti6Al4V ELI titanium alloy according to ASTM F 136.
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Indications for Use:
Image /page/4/Picture/1 description: The image shows the logo for Merete. The logo consists of two interlocking circles on the left, followed by the word "merete" in a stylized font. Above the logo, the text "K181026 - Page 2 of 3" is visible.
- Long-term stabilization of major bone defects resulting from o
- Radical bone loss due to tumors and/or metastases O
- o Bone resections following tumors and/or metastases
- For use only in the diaphyseal region of humerus, tibia and femur ●
Comparison of technological characteristics with the predicate devices:
All implants of the OsteoBridge™ IDSF System are delivered sterile now. Some implants of the predicate device had to be sterilized by the operator prior to use. The change of the delivery form of the implants results in the launch of reuseable trial components, which are offered in individual trays for each bone application (humerus, tibia and femur). The reducing bushings of the predicate device have been removed in the new system. The connector mechanism of the intramedullary rods has been adapted to the inner geometry and diameter of the matching spacer. All connecting mechanism surfaces are smooth instead of blasted.
Clinical and non-clinical data:
The change of the delivery form from non-sterile is performed according to the validated sterilization processes. The packaging for the sterile implants has been chosen according to the packaging validation test per DIN EN 22248:1993-02 to verify robustness of package containing the worst-case device showed that the packaging and device remained undamaged after the test. The trial implants are delivered in a tray, anodized blue and lasered with "DO NOT IMPLANT", so they cannot be mismatched with the sterile implants. The improvement in the connector mechanism and the surface of the devices has been tested in a dynamic bending test per ASTM F1264-16 as well as in a static torsion test. Both tests showed equivalent fatique limits and torsional strength.
Merete has conducted mechanical analysis and functional worst case tests to demonstrate that the OsteoBridge™ IDSF System has the mechanical properties necessary to perform as well or better than the predicate device. These tests have been performed in accordance with ASTM F1264-16 "Standard Specification and Test Methods for Intramedullary Fixation Devices". The OsteoBridge™ IDSF System have successfully passed all tests within the mechanical verification and have been proven to be mechanically as good as or better than the predicate device.
Clinical Data was not needed for these devices to show substantial equivalence.
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Substantial Equivalence:
The wording of the Indications for Use has been changed, but the modifications neither change the intended use of the subject device nor affect the safety and effectiveness of the device when used as labeled. The content remained the same - respectively the subject device is used for 3 bone applications in the event of bone loss due to tumors in oncology patients. The OsteoBridge™ IDSF System has passed all defined criteria, has performed as well or better than the predicate device and is therefore considered substantially equivalent to the cleared predicate device.