(160 days)
The device is intended to be used in the management of segmental diaphyseal bone loss of the femur in oncology patients secondary to radical bone loss and/or resection due to tumors. The intramedullary rods can be fixed with interlocking screws without or with bone cement.
The OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System is a series of modular intramedullary rod segments that may be used as either proximal or distal segments. The segments are designed to be attached together to form a complete intramedullary rod using semicircular hollow attachment shells that are clamped together with multiple screws to create a complete intramedullary rod. The complete unit is designed to accept interlocking bone screws for additional rotational stability. The implants from this submission are an extension of the OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System (K051965/K113303). The components from this submission can be used in combination with the rod segments from the OsteoBridge™ IDSF diameter 10 to 16 mm (K051965) as well as with the dia. 5 mm interlocking screws. In addition sterile intramedullary rod segments are available in diameters of 18 mm and 20 mm in lengths of 90 mm and 110 mm. The hollow central attachment shell for use in the femur has a diameter of 34 mm and is available in four lengths 40 mm, 50 mm, 60 mm and 70 mm with reducing bushings to allow the use of different diameter rods proximally and distally to better fit the medullary canal. If the defect size is larger than 70 mm, two attachment shells can be connected by a spacer connector. All components of the OsteoBridge™ IDSF system are manufactured from Ti-6Al-4V titanium alloy conforming to ASTM F 136-13.
This section describes the acceptance criteria and study proving the device meets said criteria for the OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System.
The provided document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo study with explicit acceptance criteria for performance against a specific clinical outcome. Therefore, the "acceptance criteria" here refer to the mechanical performance standards necessary to be "as safe and effective as" the predicate device, as determined by recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Test Performed | Predicate Device Performance / Standard Requirement | OsteoBridge™ IDSF System Performance |
|---|---|---|---|
| Mechanical Properties for Intramedullary Rods (ASTM F-1264-03) | Mechanical and Functional Testing (specific tests not detailed in this summary, but implied by standard) | Assumed to meet or establish the benchmark for the standard. The predicate devices (K051965, K113303) also met these standards. | "All products have successfully passed all tests." "The OsteoBridge™ IDSF system has hereby been proven to be mechanically safe." Performance is stated to be "as well as or better than the predicate device." |
| Worst-Case Scenario Loading | Worst case scenario for the strength of the system was tested. (Specific loading conditions not detailed) | Implied to be adequately withstood by the predicate devices. | Successfully passed. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical trials. The testing refers to mechanical and functional testing of device components. This typically involves a certain number of manufactured units or material samples to ensure consistency and meet statistical requirements for mechanical testing. However, the exact number is not provided in this summary.
- Data Provenance: The "Non-Clinical Performance Data" was generated by Merete Medical, the manufacturer. The location of the testing facilities is not specified, but the applicant (Merete Medical GmbH) is based in Berlin, Germany. The data is retrospective in the sense that the testing was performed to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This section is not applicable as the "test set" in this context refers to physical device components undergoing mechanical testing, not human-interpreted data requiring expert consensus or ground truth from medical professionals. The "ground truth" here is metallurgical and mechanical performance meeting a defined ASTM standard.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as above. Mechanical tests are typically evaluated against predefined pass/fail criteria from a standard, not through adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (intramedullary rod system) and concerns mechanical performance, not an AI or imaging diagnostic algorithm that would typically involve MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical implant, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance data is adherence to the ASTM F-1264-03 standard for intramedullary fixation rods. This standard specifies test methods and performance requirements for the mechanical properties of such devices. The ground truth refers to whether the device's mechanical properties (e.g., strength, fatigue resistance) meet the requirements set forth in this recognized standard.
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of mechanical device testing or a 510(k) submission for a physical implant. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reasons as above.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2015
Merete Medical GmbH % Mr. Rüdiger Hilken Merete Medical, Incorporated 4 Crotty Lane, Suite 118, New York International Plaza New Windsor, New York 12553
Re: K142451
Trade/Device Name: OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System
Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: January 6, 2015 Received: January 13, 2015
Dear Mr. Hilken:
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. 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
{1}------------------------------------------------
Page 2 - Mr. Rüdiger Hilken
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
1. Indications for Use Statement
Indications for Use
510(k) Number (if known): K142451
Device Name: OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System
Indications for Use:
The device is intended to be used in the management of segmental diaphyseal bone loss of the femur in oncology patients secondary to radical bone loss and/or resection due to tumors. The intramedullary rods can be fixed with interlocking screws without or with bone cement.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
{3}------------------------------------------------
2. 510(k) Summary of Safety and Effectiveness Information
| Date Prepared: | August 2014 |
|---|---|
| Submitted by: | Merete Medical GmbHAlt-Lankwitz 10212247 Berlin, Germany |
| FDA Registration Number: | 3002949614 |
| Contact Person: | Rüdiger HilkenMerete Medical, Inc.4 Crotty Lane – Suite 118New York International PlazaNew Windsor, NY 12553Phone: 914 967 1532 |
| Device Name: | OsteoBridge™ IDSF - Intramedullary Diaphyseal SegmentalDefect Fixation Rod System |
| Common Name: | Intramedullary Fixation System |
| Classification Names: | Intramedullary fixation rod(21 CFR 888.3020) |
| Product Code: | HSB |
| Proposed Regulatory Class: | Class II |
| Predicate Devices: | K051965 – OsteoBridge™ IDSF Intramedullary DiaphysealSegmental Defect Fixation SystemK113303 - OsteoBridge™ IDSF Intramedullary DiaphysealSegmental Defect Fixation System |
Device Description:
The OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System is a series of modular intramedullary rod segments that may be used as either proximal or distal segments. The segments are designed to be attached together to form a complete intramedullary rod using semicircular hollow attachment shells that are clamped together with multiple screws to create a complete intramedullary rod. The complete unit is designed to accept interlocking bone screws for additional rotational stability.
The implants from this submission are an extension of the OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System (K051965/K113303). The components from this submission can be used in combination with the rod segments from the OsteoBridge™ IDSF diameter 10 to 16 mm (K051965) as well as with the dia. 5 mm interlocking screws. In addition sterile intramedullary rod segments are available in diameters of 18 mm
{4}------------------------------------------------
and 20 mm in lengths of 90 mm and 110 mm. The hollow central attachment shell for use in the femur has a diameter of 34 mm and is available in four lengths 40 mm, 50 mm, 60 mm and 70 mm with reducing bushings to allow the use of different diameter rods proximally and distally to better fit the medullary canal. If the defect size is larger than 70 mm, two attachment shells can be connected by a spacer connector.
All components of the OsteoBridge™ IDSF system are manufactured from Ti-6Al-4V titanium alloy conforming to ASTM F 136-13.
Indications for Use
The device is intended to be used in the management of segmental diaphyseal bone loss of the femur in oncology patients secondary to radical bone loss and/or resection due to tumors. The intramedullary rods can be fixed with interlocking screws without or with bone cement.
Substantial Equivalence:
The OsteoBridge™ IDSF System is technologically equivalent to the predicate devices.
Legally marketed Devices to which substantial Equivalence is claimed
K051965 - OsteoBridge™ IDSF Intramedullary Diaphyseal Segmental Defect Fixation System
K113303 - OsteoBridge™ IDSF Intramedullary Diaphyseal Segmental Defect Fixation System
Non-Clinical Performance Data:
In order to demonstrate that the OsteoBridge™ IDSF has the mechanical properties necessary to perform its intended use, and that the device performs as well as or better than the predicate device. Merete has conducted mechanical and functional testing (according to ASTM F-1264-03). The tests represent the worst case scenario for the strength of the system. All products have successfully passed all tests. The OsteoBridge™ IDSF system has hereby been proven to be mechanically safe.
§ 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.