(28 days)
Fine Osteotomy™ is a system intended for open- and closed-wedge osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.
Fine Osteotomy™ disposable instrumentation is intended to assist in pre-operative planning and/or the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.
Fine OsteotomyTM is a patient-specific device.
Fine Osteotomy™ is a system for planning and performing osteotomies of the distal femur and proximal tibia and for stabilizing the bone with bone screws and a patientspecific bone plate that fits the patient's anatomy. Fine Osteotomy™ consists of patientspecific surgical planning and instrument guides designed from images of the patient's bones, a patient-specific bone plate designed from the patient's images, compression and/or locking bone screws, and class 1 reusable manual instruments. The bone plate is a patient-specific, single-use implant; the surgical planning and instrument guides are patient-specific, single-use. Fine Osteotomy™ is offered in three configurations: 1) as a system of patient specific implants and single use instruments for performing osteotomies and implanting hardware to stabilize the resection, 2) as patient specific single use instruments alone for performing osteotomies, and 3) as a patient specific bone plate and screws for stabilizing a bone resection or fracture.
When used as a system, Fine Osteotomy™ enables the surgeon to perform an osteotomy and stabilize the bone around the knee that matches the pre-surgical plan using the patient-specific cutting guides and bone plate. When the planning guides and resection instruments are used alone, Fine Osteotomy™ enables the surgeon to perform an osteotomy around the knee that matches the pre-surgical plan using the patientspecific cutting guides designed from the patient's CT images. When the bone plate and screws are used alone, Fine Osteotomy™ enables the surgeon to stabilize fractured or resected bone per the pre-surgical plan using the patient's CT images in design of the Bodycad plate and use of the bone models intra operatively to guide placement of the implants and alignment of bone. Fine Osteotomy is provided clean, non-sterile.
The purpose of this Special 510(k) Device Modification is to notify the FDA of changes and additions to the single use instruments and added software option for segmentation of images and creation of STL files of the bone models.
Materials: Wrought Titanium-6Aluminum-4Vanadium ELI Alloy (Ti6Al4V ELI: ASTM F136-13) for the bone plates and screws, additively manufactured Nylon-12 for patient specific, single use resection guides and models.
The provided text does not contain detailed information about specific acceptance criteria, a study that proves the device meets those criteria, or the performance of the device in relation to such criteria. The document is a 510(k) summary for a medical device (Fine Osteotomy™) being submitted to the FDA, asserting substantial equivalence to a previously cleared predicate device.
Here's what can be extracted and what information is missing based on your request:
Missing Information:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications used to establish ground truth for the test set.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, the effect size of human reader improvement with AI assistance.
- Whether a standalone (algorithm only) performance study was done.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
Information provided in the document related to performance/validation:
The document mentions "Verification and validation (V&V) activities" but details are limited.
G. PERFORMANCE DATA
Verification and validation (V&V) activities included the following:
- Engineering analyses of updated and new single-use instruments demonstrating "no new risks and no new worst case." (This is a safety assessment, not a performance metric against acceptance criteria).
- Surgeon user evaluations demonstrating the new and updated instruments "to work as intended." (This is a qualitative statement, lacking specific metrics or criteria).
- Validation of the new software option for segmentation of patient image files and creation of STL files and virtual models "with similar resolution as previously 510(k) cleared Bodycad segmentation software." (This hints at a comparative resolution study, but no specific acceptance criteria or quantitative performance data are provided).
In summary, the provided FDA 510(k) summary focuses on establishing substantial equivalence for device modifications rather than detailing a comprehensive clinical or performance study with defined acceptance criteria and quantitative results, which would typically be included in a more extensive study report.
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June 2, 2023
BodyCad Laboratories, Inc. % Robert Poggie President BioVera, Inc. 65 Promenade Saint Louis Notre Dame de L'Ile Perrot, OC J7W 3J6 Canada
Re: K231314
Trade/Device Name: Fine OsteotomyTM Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC, PBF Dated: May 5, 2023 Received: May 5, 2023
Dear Robert Poggie:
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 mediation-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.
Shumaya Ali-S
Shumaya Ali, M.P.H. 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
510(k) Number (if known) K231314
Device Name
Fine OsteotomyTM
Indications for Use (Describe)
Fine Osteotomy™ is a system intended for open- and closed-wedge osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.
Fine Osteotomy™ disposable instrumentation is intended to assist in pre-operative planning and/or the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.
Fine OsteotomyTM is a patient-specific device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K231314 SPECIAL 510(k) SUMMARY for Fine Osteotomy™
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of Fine Osteotomy™.
A. SUBMITTERS INFORMATION
| Submitter Name: | BioVera, Inc. |
|---|---|
| Submitter Address: | 65 Promenade Saint-Louis,Notre-Dame-De-L'Ile-Perrot, QC, J7W 3J6, CANADA |
| Contact Person: | Robert A Poggie, PhD |
| Phone & Fax Number: | (514) 901-0796 |
| Date of Submission: | June 1, 2023 |
B. DEVICE IDENTIFICATION & MANUFACTURER
| Manufacturer Name: | Bodycad Laboratories Inc. |
|---|---|
| Manufacturer Address: | 2035 rue du Haut-Bord, Quebec, Quebec, G1N 4R7, Canada |
| Registration Number: | 3012086398 |
| Contact Name: | Nadine Adia |
| Title: | Regulatory Affairs Director |
| Device Trade Name: | Fine Osteotomy™ |
| Device Common Name: | Orthopaedic Surgical Planning and Instrument Guides |
| Classification Name: | Plate, Fixation, Bone; Screw, Fixation Bone; Single/multiplecomponent metallic bone fixation appliances and accessories |
| Classification Codes: | Primary code, PBF.Additional codes, HWC and HRS. |
| Classification Panel: | Orthopedic |
| Regulation Numbers: | Primary regulation, 21 CFR 888.3030.Additional regulation, 21 CFR 888.3040. |
C. PRIMARY PREDICATE DEVICE
| K211646 | Fine OsteotomyTM |
|---|---|
| REFERENCE DEVICE | |
| K183105 | Mimics Medical |
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D. DEVICE DESCRIPTION
Fine Osteotomy™ is a system for planning and performing osteotomies of the distal femur and proximal tibia and for stabilizing the bone with bone screws and a patientspecific bone plate that fits the patient's anatomy. Fine Osteotomy™ consists of patientspecific surgical planning and instrument guides designed from images of the patient's bones, a patient-specific bone plate designed from the patient's images, compression and/or locking bone screws, and class 1 reusable manual instruments. The bone plate is a patient-specific, single-use implant; the surgical planning and instrument guides are patient-specific, single-use. Fine Osteotomy™ is offered in three configurations: 1) as a system of patient specific implants and single use instruments for performing osteotomies and implanting hardware to stabilize the resection, 2) as patient specific single use instruments alone for performing osteotomies, and 3) as a patient specific bone plate and screws for stabilizing a bone resection or fracture.
When used as a system, Fine Osteotomy™ enables the surgeon to perform an osteotomy and stabilize the bone around the knee that matches the pre-surgical plan using the patient-specific cutting guides and bone plate. When the planning guides and resection instruments are used alone, Fine Osteotomy™ enables the surgeon to perform an osteotomy around the knee that matches the pre-surgical plan using the patientspecific cutting guides designed from the patient's CT images. When the bone plate and screws are used alone, Fine Osteotomy™ enables the surgeon to stabilize fractured or resected bone per the pre-surgical plan using the patient's CT images in design of the Bodycad plate and use of the bone models intra operatively to guide placement of the implants and alignment of bone. Fine Osteotomy is provided clean, non-sterile.
The purpose of this Special 510(k) Device Modification is to notify the FDA of changes and additions to the single use instruments and added software option for segmentation of images and creation of STL files of the bone models.
Materials: Wrought Titanium-6Aluminum-4Vanadium ELI Alloy (Ti6Al4V ELI: ASTM F136-13) for the bone plates and screws, additively manufactured Nylon-12 for patient specific, single use resection guides and models.
E. INDICATIONS FOR USE
Fine Osteotomy™ is a system intended for open- and closed-wedge osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.
Fine Osteotomy™ disposable instrumentation is intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.
Fine Osteotomy™ is a patient-specific device.
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F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The subject device, Fine Osteotomy™, has the same intended use, has the same indications for use, is manufactured with the same materials and processes, and has the same technological features as the primary predicate device which is Fine Osteotomy™ cleared in K211646. Except for updates and additions to single use instrumentation and an added software option for segmentation of patient images, the technological characteristics of the subject and primary predicate devices are identical. Comparison of the technological characteristics and indicated use of the subject and primary predicate devices demonstrate that the subject device is substantially equivalent to the primary predicate device, both of which are Bodycad's Fine Osteotomy™
G. PERFORMANCE DATA
Verification and validation (V&V) activities included the following:
- · Engineering analyses of updated and new single use instruments demonstrated no new risks and no new worst case.
- · Surgeon user evaluations demonstrated the new and updated instruments to work as intended, and
- · Validation of the new software option for segmentation of patient image files and creation of STL files and virtual models with similar resolution as previously 510(k) cleared Bodycad segmentation software.
H. CONCLUSION
The information presented in this Special 510(k) device modification show the Bodycad Fine Osteotomy™ to be substantially equivalent to the legally marketed primary predicate device, Bodycad Fine Osteotomy™. It has the same technological characteristics, materials, sizes, manufacturing processes, and principles of operation as the primary predicate device.
§ 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.