(60 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on CAD/CAM file generation from imaging and surgeon input, not AI/ML algorithms.
Yes
The device is a unicompartmental knee arthroplasty system intended to treat advanced knee osteoarthritis and traumatic arthritis, which are medical conditions, thereby providing a therapeutic benefit by replacing the affected joint components.
No
Explanation: The device is a patient-specific knee arthroplasty system intended for the replacement of the medial tibiofemoral compartment of the knee in patients with advanced knee osteoarthritis. Its purpose is therapeutic (replacement) rather than diagnostic.
No
The device description explicitly states that the system consists of "femoral and tibial implants" and "single-use instruments," which are physical hardware components. While software is used to generate CAD/CAM files for manufacturing, the device itself is a physical implant system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The BC Reflex Uni™ Knee System is a surgical implant used to replace a portion of the knee joint. It is a physical device implanted into the patient's body.
- Intended Use: The intended use clearly states it's for "patient-specific BC Reflex Unicompartmental knee arthroplasty," which is a surgical procedure.
- Device Description: The description details the components of the implant (femoral and tibial implants) and the process of creating them based on imaging, not on analyzing biological specimens.
- Performance Studies: The performance studies focus on sterilization, shelf life, biocompatibility, and cleaning/sterilization of the implant and instruments, not on the accuracy or performance of a diagnostic test.
The device uses imaging data (MRI or CT) to create a patient-specific implant, but it does not analyze biological specimens for diagnostic purposes. It is a medical device used in a surgical procedure.
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 (comma separated list FDA assigned to the subject device)
HSX
Device Description
The BC Reflex Uni™ Knee System is a patient-specific unicompartmental knee system that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial implants and single-use instruments are manufactured from CAD and CAM files generated from Bodycad software that are based on MRI or CT images of the patient's knee and surgeon input.
The main purpose of this traditional 510(k) Notification is to advise the FDA of Bodycad's use of low temperature hydrogen peroxide sterilization (VH2O2) for terminal sterilization of BC Reflex Uni patient kits. Secondary purposes of this 510(k) notification are validation of cleaning and steam sterilization of BC Reflex Uni Knee System components in case of breach of sterile packaging in transit or handling, and minor design updates to single use instrumentation and software. BC Reflex Uni components are supplied sterile (SAL of 10-6 via gamma radiation or VH2O2).
Materials: Femoral component: ASTM F1537-11 wrought CoCrMo. Tibial baseplate and locking pin: ASTM F136 titanium alloy (ELI). Tibial insert: F648-14 UHMWPE.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following verification and validation (V&V) activities were performed:
- . Validation of terminal sterilization with SAL of 10-6 for worst-case BC Reflex Uni kits using the STERIS V-PRO maX (K102330) per the applicable clauses of ISO 14937.
- Validations of shelf life, biocompatibility per ISO 10993-1, packaging per AAMI/ANSI/ISO . 11607, and verification of acceptable levels of residual hydrogen peroxide per ISO 10993-17.
- . Validation that BC Reflex Uni components meets pyrogen limit specifications (e.g., bacterial endotoxins test (BET), also known as the Limulus amebocyte lysate (LAL) test).
- . Validation of point of use cleaning and steam sterilization applicable to BC Reflex Uni components using the partial cycle validation approach outlined in ANSI/AAMI/ISO 17665-1:2006/(R)2013, Annex D, and the validation approach outlined in ANSI/AAMI/ISO 14937:2009/(R)2013, Annex D (Approach 3).
The results of V&V testing and engineering review, risk analysis, and design control activities demonstrated no new issues affecting safety or effectiveness resulting from the new methods of cleaning and sterilization of the BC Reflex Uni Knee System and the two minor updates to the single use instruments and update to software.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
August 20, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Bodycad Laboratories, Inc. % Robert Poggie President BioVera, Inc. 65 Promenade Saint Louis Notre Dame de L'Ile Perrot, QC J7V 7P2 CANADA
Re: K211895
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: June 16, 2021 Received: June 21, 2021
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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,
Ting Song, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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'Ile-Perrot, |
| Province of Quebec, J7V7P2, CANADA | |
| Contact Person: | Robert A Poggie, PhD |
| Phone & Fax Number: | (514) 901-0796 |
| Date of Submission: | June 16, 2021 |
B. DEVICE IDENTIFICATION & MANUFACTURER
| Manufacturer Name: | Bodycad Laboratories Inc. |
|---|---|
| Manufacturer Address: | 2035 rue du Haut-Bord, Quebec, QC, G1N 4R7, Canada |
| Registration Number: | 3012086398 |
| Contact Name: | Nadine Adia |
| Title: | Specialist, 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. PRIMARY PREDICATE DEVICE
| K203697 | BC Reflex Uni™ Knee System (primary predicate device) |
|---|---|
| C2. REFERENCE DEVICES | |
| K210252 | ConforMIS iTotal iDentity CR and PS Knee Systems |
K102330 STERIS V-PRO maX
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D. DEVICE DESCRIPTION
The BC Reflex Uni™ Knee System is a patient-specific unicompartmental knee system that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial implants and single-use instruments are manufactured from CAD and CAM files generated from Bodycad software that are based on MRI or CT images of the patient's knee and surgeon input.
The main purpose of this traditional 510(k) Notification is to advise the FDA of Bodycad's use of low temperature hydrogen peroxide sterilization (VH2O2) for terminal sterilization of BC Reflex Uni patient kits. Secondary purposes of this 510(k) notification are validation of cleaning and steam sterilization of BC Reflex Uni Knee System components in case of breach of sterile packaging in transit or handling, and minor design updates to single use instrumentation and software. BC Reflex Uni components are supplied sterile (SAL of 10-6 via gamma radiation or VH2O2).
Materials: Femoral component: ASTM F1537-11 wrought CoCrMo. Tibial baseplate and locking pin: ASTM F136 titanium alloy (ELI). Tibial insert: F648-14 UHMWPE.
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. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The BC Reflex Uni Knee System described in this 510(k) notification is essentially the same as the primary predicate device cleared by FDA in K203697. Commonalities shared by both the subject and primary predicate devices include:
- Patient specific knee implants and instruments designed and manufactured from MRI or CT images of the patient's knee.
- · Patient specific components including CoCr femoral and Ti allov locking pin and tibial baseplate, polyethylene inserts, and single use Nylon-12 bone models and guides.
- · The clinical indications for use and intended use are identical.
- · The CoCrMo, titanium alloy, UHWMPE, and Nylon-12 materials are identical.
- · The manufacturing processes are identical.
- · Single use, patient specific kit provided sterile with SAL of 10-6.
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The differences between the subject and primary predicate devices are:
- Addition of a second option for terminal sterilization of BC Reflex Uni patient kits using low temperature vapor hydrogen peroxide sterilization (VH2O2) using the STERIS V-PRO maX (K102330).
- · Addition of ability to perform one-time, point of use cleaning and steam sterilization of BC Reflex Uni components in case of breach of sterile packaging in transit or handling.
- Two minor updates to the single use instruments and two minor updates to the software to better facilitate surgical procedure and patient specific design.
G. PERFORMANCE DATA
The followinq verification and validation (V&V) activities were performed:
- . Validation of terminal sterilization with SAL of 10-6 for worst-case BC Reflex Uni kits using the STERIS V-PRO maX (K102330) per the applicable clauses of ISO 14937.
- Validations of shelf life, biocompatibility per ISO 10993-1, packaging per AAMI/ANSI/ISO . 11607, and verification of acceptable levels of residual hydrogen peroxide per ISO 10993-17.
- . Validation that BC Reflex Uni components meets pyrogen limit specifications (e.g., bacterial endotoxins test (BET), also known as the Limulus amebocyte lysate (LAL) test).
- . Validation of point of use cleaning and steam sterilization applicable to BC Reflex Uni components using the partial cycle validation approach outlined in ANSI/AAMI/ISO 17665-1:2006/(R)2013, Annex D, and the validation approach outlined in ANSI/AAMI/ISO 14937:2009/(R)2013, Annex D (Approach 3).
The results of V&V testing and engineering review, risk analysis, and design control activities demonstrated no new issues affecting safety or effectiveness resulting from the new methods of cleaning and sterilization of the BC Reflex Uni Knee System and the two minor updates to the single use instruments and update to software.
H. CONCLUSION
The results of V&V testing and engineering review, risk analysis, and design control activities demonstrated substantial equivalence of the subject BC Reflex Uni Knee System sterilized by low temperature hydrogen peroxide vapor to the primary predicate device, the BC Reflex Uni Knee System sterilized by gamma radiation.