(132 days)
No
The description focuses on patient-specific design based on CAD/CAM files generated from imaging data and surgeon input, without mentioning AI or ML algorithms for analysis, design, or prediction.
Yes
The device is a knee arthroplasty system intended to replace the medial tibiofemoral compartment of the knee in patients with advanced knee osteoarthritis or traumatic arthritis, which directly treats a medical condition.
No
The device is a patient-specific knee arthroplasty system intended for replacement of the medial tibiofemoral compartment of the knee in patients with advanced knee osteoarthritis; it is a prosthetic device for treatment, not diagnosis.
No
The device description clearly states it consists of physical implants (femoral and tibial components) and single-use cutting guides, which are hardware components. While software is used in the manufacturing process, the device itself is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a "patient-specific prosthesis that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee." It is a physical implant used in the body, not a test performed on samples from the body.
- Intended Use: The intended use is for "patient-specific BC Reflex Unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA)." This is a surgical procedure involving implantation, not a diagnostic test.
- Input: The input is imaging data (MRI or CT), which is used to design the physical implant, not to perform a diagnostic test on a biological sample.
Therefore, this device falls under the category of a surgical implant or prosthesis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The patient-specific BC Reflex Unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:
· joint impairment due to osteoarthritis or traumatic arthritis of the knee,
· varus deformity of the knee, and
· as an alternative to tibial osteotomy in patients with unicompartmental OA.
The patient-specific BC Reflex Uni™ components fit within an envelope of dimensions that are specific to each patient. The BC Reflex Uni™ femoral component and tibial baseplate are intended for cemented fixation.
Product codes
HSX
Device Description
The BC Reflex Uni™ Knee System is a patient-specific prosthesis that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patientspecific femoral and tibial components and single-use cutting guides are manufactured from CAD and CAM files generated from Bodycad and off the shelf software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The BC Reflex Uni™ is for cemented use only and is sterilized by gamma radiation.
The subject of this 510(k) is an updated / new design of the femoral component and instruments for implantation, relative to the femoral component described in K163700 and K181302 for the predicate BUKS.
Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (CoCrMo; ASTM F1537-11) for the femoral component, wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (Ti6A4V ELI; ASTM F136-13) for the tibial baseplate and locking pin, Ultra-High-Molecular-Weight Polyethylene (UHMWPE; F648-14) for the tibial insert.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI or CT images
Anatomical Site
knee
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
The following performance tests were performed for the BC Reflex Uni™ Knee System:
- Femoral component fatigue strength per ASTM WK51649 Standard Test Method for . Fatigue Testing of Total Knee Femoral Components under Closing Conditions.
- . Surgeon-user verification cadaver surgeries with the BC Reflex Uni™ femoral component and instruments.
The results of performance testing demonstrated substantial equivalence of the subject, predicate, and reference devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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December 5, 2019
Bodycad Laboratories, Inc. % Robert Poggie President BioVera Inc. 65 Promenade Saint Louis Notre-Dame-de-l'Ile-Perrot, j7v 7p2 CANADA
Re: K191996
Trade/Device Name: BC Reflex Uni Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX Dated: September 6, 2019 Received: September 9, 2019
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.
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
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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,
Ting Song Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
Indications for Use
510(k) Number (if known)
Device Name
BC Reflex Uni™ Knee System
Indications for Use (Describe)
The patient-specific BC Reflex Unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:
· joint impairment due to osteoarthritis or traumatic arthritis of the knee,
· varus deformity of the knee, and
· as an alternative to tibial osteotomy in patients with unicompartmental OA.
The patient-specific BC Reflex Uni™ components fit within an envelope of dimensions that are specific to each patient. The BC Reflex Uni™ femoral component and tibial baseplate are intended for cemented fixation.
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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510(k) SUMMARY
The BC Reflex Uni™ Knee System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of the BC Reflex Uni™ Knee System.
A. SUBMITTERS INFORMATION
| Submitter Name: | BioVera, Inc. |
|---|---|
| Submitter Address: | 65 Promenade Saint-Louis, Notre-Dame-De-L'lle-Perrot, Quebec, |
| J7V 7P2, CANADA | |
| Contact Person: | Robert A Poggie, PhD |
| Phone Number: | (514) 901-0796 |
| Fax Number: | (514) 901-0796 |
| Date of Submission: | July 25, 2019 |
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: | Guy Sevigny |
| Title: | Director, Regulatory Affairs |
| Device Trade Name: | BC Reflex Uni™ Knee System |
| Device Common Name: | Unicondylar knee device |
| Classification Name: | knee joint femorotibial metal/polymer non-constrained, cemented |
| Classification Code: | HSX - Class II |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 CFR section 888.3520 |
C1. PREDICATE DEVICE
| K163700 | Bodycad Unicompartmental Knee System (BUKS) |
|---|---|
| K181302 | Bodycad Unicompartmental Knee System (BUKS) |
| K191150 | Bodycad Unicompartmental Knee System (BUKS) |
C2. REFERENCE DEVICE
| K033363 | Zimmer Unicompartmental Knee System (ZUK) |
|---|---|
| --------- | ------------------------------------------- |
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D. DEVICE DESCRIPTION
The BC Reflex Uni™ Knee System is a patient-specific prosthesis that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patientspecific femoral and tibial components and single-use cutting guides are manufactured from CAD and CAM files generated from Bodycad and off the shelf software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The BC Reflex Uni™ is for cemented use only and is sterilized by gamma radiation.
The subject of this 510(k) is an updated / new design of the femoral component and instruments for implantation, relative to the femoral component described in K163700 and K181302 for the predicate BUKS.
Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (CoCrMo; ASTM F1537-11) for the femoral component, wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (Ti6A4V ELI; ASTM F136-13) for the tibial baseplate and locking pin, Ultra-High-Molecular-Weight Polyethylene (UHMWPE; F648-14) for the tibial insert.
E. INTENDED USE
The patient-specific BC Reflex Uni™ is indicated for unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:
- · joint impairment due to osteoarthritis or traumatic arthritis of the knee,
- · varus deformity of the knee, and
- as an alternative to tibial osteotomy in patients with unicompartmental OA.
The patient-specific BC Reflex Uni™ components fit within an envelope of dimensions that are specific to each patient. The BC Reflex Uni™ femoral component and tibial baseplate are intended for cemented fixation.
F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The BC Reflex Uni™ described in this 510(k) notification has the same intended use and general technological features as the predicate devices cleared by FDA in K163700 and K181302 (BUKS). The design modifications to the femoral component include elimination of the screw for ancillary fixation, replacing the resurfacing geometry of the bone-cement surface of the femoral component with a more traditional angular box geometry, and changes to instrumentation associated with the change in design of the femoral component. Comparison of the design features of the BC Reflex Uni™ femoral component with those of the original BUKS femoral component (K163700, K181302) and the ZUK reference device, and results of performance and simulated-surgery verification testing of the subject BC Reflex Uni™ Knee System has established substantial equivalence of the subject, predicate, and reference devices.
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G. PERFORMANCE DATA
The following performance tests were performed for the BC Reflex Uni™ Knee System:
- Femoral component fatigue strength per ASTM WK51649 Standard Test Method for . Fatigue Testing of Total Knee Femoral Components under Closing Conditions.
- . Surgeon-user verification cadaver surgeries with the BC Reflex Uni™ femoral component and instruments.
The results of performance testing demonstrated substantial equivalence of the subject, predicate, and reference devices.
H. CONCLUSION
The BC Reflex Uni™ subject components of this 510(k) notification are substantially equivalent and share the same intended use as the predicate BUKS cleared in K163700, K181302, and K191150, and the reference device (ZUK, K033363).