(60 days)
The SALGINA 2.5mm Distal Radius System is indicated for
- · Intra-articular fractures of the Distal Radius.
- · Extra-articular fractures of the Distal Radius
The CASCELLA 3.5mm Superior Clavicle System is indicated for:
- fixation of fractures of the clavicle shaft
- fixation of fractures of the lateral clavicle
- malunions of the clavicle
- · non-unions of the clavicle
The LEPORELLO 3.5mm Olecranon System is indicated for
- · fractures
- osteotomies
- nonunions
of the olecranon and proximal ulna.
The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture.
Plates and screws are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F139) or pure titanium (ASTM F67 or ISO 5832-2). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899. ISO 7153-1. ISO 5832-1. and ASTM F138/139). medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Non-clinical testing has demonstrated the devices are MR Conditional.
The provided text describes a 510(k) premarket notification for the Bonebridge Osteosynthesis Plating System. The focus of the submission is on demonstrating substantial equivalence to predicate devices through non-clinical testing. This document does NOT describe a study that proves a device meets acceptance criteria for an AI/software-as-a-medical-device (SaMD) product, nor does it provide information relevant to a multi-reader, multi-case (MRMC) study or the establishment of ground truth by expert consensus for an AI model.
The information provided pertains to the mechanical, material, and labeling aspects of a physical bone fixation system, not a diagnostic AI device. Therefore, I cannot extract the requested information regarding AI device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or MRMC study details from this document.
The document only states that:
- Clinical investigations were not required due to a clinical evaluation including a literature review and verification/validation activities.
- Usability evaluation was successfully completed in accordance with IEC 62366-1, with no significant usability issues identified.
The non-clinical tests summarized are related to the physical properties and safety of the implantable device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present acceptance criteria in a table format with specific quantitative metrics for the "acceptance criteria" and "reported device performance" in the context of an AI device. Instead, it lists various non-clinical tests performed on the physical implant and states whether they "Pass" or "Fail" against their respective standards. These are not performance metrics for an AI algorithm.
| Non-Clinical Test | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Minimal dose of 25kGy validated using VDmax25 method (ISO 11137-2) for SAL of 10-6. Cleaning and sterilization procedures validated (ISO 17664, ISO 17665-1) at 132°C for 4 minutes with 20 min drying time. | Pass |
| Packaging Validation | Validation of sterile packaging in accordance with ISO 11607 1/2 and ASTM F1980. Transport simulation (ISTA 2A) followed by Dye-Penetration (ASTM F1929), Visual inspection (ASTM F1886/1886M), Seal strength (ASTM F88/F88M), and Microbial barrier testing (DIN 58953-6, Chapter 2.14). | Pass |
| Biocompatibility | Biological Evaluation and toxicological risk assessment for biological safety according to ISO 10993-series and FDA guidance. | Pass |
| Mechanical Testing | Static and dynamic comparative testing demonstrating substantial equivalence of each subject plate variant to corresponding predicate devices with respect to maximum force (static) and maximum force for a given number of cycles (dynamic). Predefined acceptance criteria for mechanical performance successfully met. Design verification successfully completed for compatibility, anatomical shape, and appearance. | Pass |
| MRI Safety | Assessment of displacement force and torque effects in the main static magnetic field at 3Tesla (ASTM F2052-21, ASTM F2213-17). Assessment of heating effects due to RF-field during MR scans at 1.5Tesla and 3Tesla (ASTM F2182-19). Assessment of image artifacts at 3Tesla (ASTM F3110-24). The tested implant and associated product family can be claimed as MR conditional. | Pass |
2. Sample size used for the test set and data provenance:
Not applicable. This is for a physical device, and no AI test set is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for an AI algorithm is not established in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was done or mentioned, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable.
8. The sample size for the training set:
Not applicable.
9. How the ground truth for the training set was established:
Not applicable.
In summary, the provided FDA 510(k) clearance letter and associated summary pertain to the substantial equivalence of a physical bone fixation system with existing predicate devices based on non-clinical engineering and material properties testing. It does not contain any information about acceptance criteria or studies related to AI or software-as-a-medical-device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 20, 2024
Bonebridge AG Michelle Gumpelmayer Head of QM&RA Bahnhofstrasse 11 Zug, Zug 6300 Switzerland
Re: K243308
Trade/Device Name: Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: October 21, 2024
Dear Michelle Gumpelmayer:
Received: October 21, 2024
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
Thomas Mcnamara -S
For: Christopher Ferreira, MS Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)
Indications for Use (Describe)
The SALGINA 2.5mm Distal Radius System is indicated for
- · Intra-articular fractures of the Distal Radius.
- · Extra-articular fractures of the Distal Radius
The CASCELLA 3.5mm Superior Clavicle System is indicated for:
- · fixation of fractures of the clavicle shaft
- · fixation of fractures of the lateral clavicle
- · malunions of the clavicle
- · non-unions of the clavicle
The LEPORELLO 3.5mm Olecranon System is indicated for
- · fractures
- · osteotomies
- · nonunions
of the olecranon and proximal ulna.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
In accordance with 21 CFR 807.92 the following information is provided for the Bonebridge Osteosynthesis Plating System.
ADMINISTRATIVE INFORMATION
| Date prepared | October 21, 2024 |
|---|---|
| Submission type: | Traditional 510(k) |
| Purpose of 510(k): | Modification of currently cleared device K240318:Line extensions of the cleared SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System and LEPORELLO 3.5mm Olecranon SystemAnnouncement of minor modifications to the device since the last clearance (K240318) |
| Submitter | Bonebridge AGBahnhofstrasse 116300 ZugSwitzerland |
| Official Contact | Michelle GumpelmayerHead of QM&RA, Bonebridge AGPhone: +41 76 731 07 32Email michelle.gumpelmayer@bonebridge.ch |
| Alternative Contact | Alexander HäuslerCOO, Bonebridge AGPhone: +41 79 660 81 42Email alexander.haeusler@bonebridge.ch |
| US agent | Richard Robel, confinis corporationEmail: usagent@confinis.com |
| Trade name: | Bonebridge Osteosynthesis Plating System |
|---|---|
| Variants, types: | TRIFT 3.5mm 1/3 Tubular SystemSALGINA 2.5mm Distal Radius SystemCASCELLA 3.5mm Superior Clavicle SystemTAMINA 3.5mm Proximal Humerus SystemPOYA 3.5mm Lateral Proximal Tibia SystemPOYA 3.5mm Posteromedial Tibia SystemDALVAZZA 2.5mm Distal Ulna SystemLEPORELLO 3.5mm Olecranon SystemLORRAINE 3.5mm Distal Humerus System |
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| SITTER 3.5mm Versatile System | ||
|---|---|---|
| ------------------------------- | -- | -- |
Common name: Plate, Fixation, Bone
Regulation number: 21 CFR 888.3030
Classification name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory class: Class II
Product Code: HRS
PREDICATE DEVICES
| Primary predicate device: | Bonebridge Osteosynthesis Plating System (K240318) |
|---|---|
| SALGINA 2.5mm Distal Radius System |
Additional predicate devices:
| SALGINA 2.5mm Distal Radius System(line extension) | K142906 APTUS Wrist 2.5 System(volar plates) |
|---|---|
| K191848 APTUS Wrist 2.5 System(wrist spanning plate) | |
| K082807 Synthes (USA) 3.5mmLocking Compression Plate (LCP)System with Expanded Indications | |
| K102694 2.4mm Variable Angle LCPDorsal Distal Radius System | |
| CASCELLA 3.5mm Superior ClavicleSystem (line extension) | K073186 Synthes 3.5mm LCPClavicle Plate System |
| K000684 Synthes Small FragmentDynamic Compression Locking (DCL)System | |
| LEPORELLO 3.5mm OlecranonSystem (line extension) | K120070 Synthes Variable Angle LCPElbow System / Olecranon Plates |
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INDICATIONS FOR USE
The SALGINA 2.5mm Distal Radius System is indicated for
- · Intra-articular fractures of the Distal Radius.
- · Extra-articular fractures of the Distal Radius
The CASCELLA 3.5mm Superior Clavicle System is indicated for:
- fixation of fractures of the clavicle shaft
- fixation of fractures of the lateral clavicle
- malunions of the clavicle
- · non-unions of the clavicle
The LEPORELLO 3.5mm Olecranon System is indicated for
- · fractures
- osteotomies
- nonunions
of the olecranon and proximal ulna.
DEVICE DESCRIPTION
The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture.
Plates and screws are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F139) or pure titanium (ASTM F67 or ISO 5832-2). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899. ISO 7153-1. ISO 5832-1. and ASTM F138/139). medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Non-clinical testing has demonstrated the devices are MR Conditional.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE
The subject device and the predicate devices have intended use, similar indications for use, and have the same technological characteristics. The subject and predicate devices are all fabricated from the same or similar materials and share similar design characteristics, including plate screw holes to accommodate locking and nonlocking screws. The subject and predicate devices encompass the same range of physical dimensions, and the subject device is compatible with screws from the predicate devices. The subject and predicate devices are sterilized by the standard methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy.
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SUMMARY OF NON-CLINICAL TESTS
| Sterilizationvalidation: | Gamma irradiation: The minimal dose of 25kGy is validatedusing VDmax25 method as described in ISO 11137-2 andconfirmed a Sterility Assurance Level SAL of 10-6.Steam sterilization: Cleaning and sterilization procedureshave been successfully validated in accordance with ISO17664 and ISO 17665-1 at 132°C (270F) for 4 minutes and20 min drying time. | Pass |
|---|---|---|
| Packagingvalidation: | Validation of the sterile packaging has been successfullyperformed in accordance with ISO 11607 1/2 and ASTMF1980. Furthermore, a transport simulation was conductedaccording ISTA 2A followed by these packaging verificationtests:• Dye-Penetration, ASTM F1929• Visual inspection, ASTM F1886/1886M• Seal strength, ASTM F88/F88M• Microbial barrier testing, DIN 58953-6, Chapter 2.14 | Pass |
| Biocompatibility: | Biological Evaluation and toxicological risk assessment toevaluate the device's biological safety for the intended use,in accordance with ISO 10993-series and FDA guidance. | Pass |
| Mechanicaltesting: | Static and dynamic comparative testing was performed foreach subject plate variant, including statistical analysis andcomparison to the respective predicate devices. Substantialequivalence of each Bonebridge subject plate variant to thecorresponding predicate devices (K240318, K142906,K191848, K082807, K102694, K120070, K073186, andK000684) was demonstrated with respect to maximum force(static test) and maximum force for a given number of cycles(dynamic test). All predefined acceptance criteria weresuccessfully met, demonstrating that the mechanicalperformance of each subject plate variant is substantiallyequivalent to the corresponding predicate devices.Design verification was successfully completed for eachsubject plate variant, including compatibility verification ofimplants and instruments as well as assessment ofanatomical shape and appearance. | Pass |
| MRI safety: | The Bonebridge Osteosynthesis Plating System is MRconditional considering local SAR based on the followingtests• Assessment of displacement force and torque effects inthe main static magnetic field at 3Tesla. Additionally,the expected magnetic force in a stronger magneticfield gradient of 30T/m was extrapolated. (According toASTM F2052-21 and ASTM F2213-17)• Assessment of heating effects due to the RF-fieldduring MR scans at 1.5Tesla and 3Tesla according toASTM F2182-19• Assessment of image artifacts at 3Tesla according toASTM F3110-24 | Pass |
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The tested implant and associated product family can be claimed as MR conditional.
SUMMARY OF CLINICAL AND USABILITY TESTS
Based on a clinical evaluation, including a literature review and the results of verification and validation activities, it was concluded that clinical investigations were not required. The results of the summative usability evaluation, conducted in accordance with IEC 62366-1, confirm that no significant usability issues were identified with the use of the Bonebridge Osteosynthesis Plating System. Following the line extensions and updates to the Usability Risk Assessment, the originally established acceptance criteria remain applicable. Therefore, the summative usability evaluation studies for the Bonebridge Osteosynthesis Plating System are considered successful.
CONCLUSION
The subject Bonebridge Osteosynthesis Plating System has similar indications, intended use, target populations, technological characteristics, and materials as the predicate devices. Non-clinical testing demonstrated that the performance of the proposed devices is substantially equivalent to the predicate devices.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.