(29 days)
No
The 510(k) summary describes a mechanical implant (femoral head) with variations in size and offset. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are bench tests evaluating mechanical properties.
Yes.
Explanation: The device is a 'modified femoral head component for use in hip arthroplasty procedures' intended to address 'painful disabling joint disease', which indicates it is used for treating a medical condition and restoring function.
No
This device is a modular femoral head component used in hip arthroplasty procedures, which is a treatment, not a diagnostic tool. The performance studies focus on mechanical integrity tests, not diagnostic accuracy.
No
The device description clearly states it is a "modular femoral head component" made of "high purity alumina matrix with zirconia reinforcement," which are physical materials, not software. The performance studies are bench tests on physical properties like compression and torsion.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "single use modular femoral head component for use in hip arthroplasty procedures." This describes a surgical implant used in the body, not a device used to test samples outside the body.
- Device Description: The description details the materials, taper system, articulating surface, and size variations of a physical implant.
- Performance Studies: The performance studies listed are bench tests related to the mechanical properties and durability of the implant (compression, pull-off, torsion), not tests related to analyzing biological samples.
IVD devices are used to examine specimens such as blood, urine, or tissue to diagnose diseases or conditions. This device is a surgical implant used to replace a part of the hip joint.
N/A
Intended Use / Indications for Use
The BIOCERAM AZUL HEAD is a single use modular femoral head component for use in hip arthroplasty procedures for the following indications:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis,
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
- Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
The BIOCERAM AZUL HEAD (the modified device) is identical to the unmodified predicate device in materials, taper system, articulating surface, packaging, sterilization and shelf life, but it differs from the unmodified predicate device in size variation. Labels are different only in reference to the model number and size.
The modified device is manufactured from the same high purity alumina matrix with zirconia reinforcement, which complies with ISO 6474-2. Two additional sizes (outer diameters) will be offered: 22 mm and 26 mm. There are 2 offsets (+0, +3 mm) for the 22 mm size and 2 offsets (+0, +3.5 mm) for the 26 mm size; and the current 28 mm head will be offered in an additional offset of +7 mm. These new ODs and offsets are the same or similar to those of the Metal Heads also cleared by K160895.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip
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)
To demonstrate safety and effectiveness of modified BIOCERAM AZUL HEAD and to show substantial equivalence to the predicate device, KYOCERA Corporation conducted the following performance bench tests in accordance with internal procedures and international standards shown below. The modified device passed the testing, supporting its safety and its substantial equivalence to the predicate device.
- Static compression burst test (ISO 7206-10)
- . Post-fatigue static compression burst test (ASTM F2345 / ISO 7206-10)
- Static Pull-off test (ISO 7206-10)
- . Static torsion test (ISO 7206-13)
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
December 5, 2024
Image /page/0/Picture/1 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 text "U.S. Food & Drug Administration".
KYOCERA Corporation % Audrey Swearingen Regulatory Affairs Consultant Swearingen Regulatory Consulting, LLC 16856 Circle Hill Drive Dexter, Missouri 63841
Re: K243444
Trade/Device Name: BIOCERAM AZUL® HEAD Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO Dated: November 6, 2024 Received: November 6, 2024
Dear Audrey Swearingen:
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.
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"
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(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 OS 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 Rue"). 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-devices/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-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).
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Image /page/2/Figure/2 description: The image shows a digital signature block. It includes the name "RYAN TROMBETTA" followed by "-S". The signature indicates it is for Limin Sun, Ph.D., Assistant Director, and includes the date "2024.12.05 16:30:09 -05'00'". The block also lists DHT6A: Division of Joint Arthroplasty Devices, OHT6: Office of Orthopedic Devices, Office of Product Evaluation and Quality, and Center for Devices and Radiological Health.
Enclosure
3
Indications for Use
510(k) Number (if known) K243444
Device Name BIOCERAM AZUL® HEAD
Indications for Use (Describe)
The BIOCERAM AZUL HEAD is a single use modular femoral head component for use in hip arthroplasty procedures for the following indications:
-
Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis,
-
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
-
Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
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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510(k) Summary
BIOCERAM AZUL® HEAD
1. Submission Sponsor
KYOCERA Corporation 6 Takeda Tobadono-cho, Fushimi-ku, Kyoto 612-8501 Japan Contact: Ms. Yoshimi Amano Title: Senior Manager of Regulatory Affairs Section, Medical Division
2. Submission Correspondent
Swearingen Regulatory Consulting, LLC Office Phone: (512) 818-3811 Email: Audrey@swearingenregconsulting.com Contact: Audrey Swearingen Title: Regulatory Consultant
3. Date Prepared
December 4, 2024
4. Device Identification
| Trade/Proprietary Name: | BIOCERAM AZUL® HEAD |
|---|---|
| Regulation Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous |
| uncemented prosthesis. | |
| Regulation Number(s): | 888.3353 |
| Product Code: | LZO |
| Class: | 2 |
| Classification Panel: | Orthopedic |
5. Legally Marketed Predicate Device(s)
| Device name: | Initia Total Hip System & BIOCERAM AZUL® HEAD |
|---|---|
| 510(k) number: | K160895 |
| Manufacturer: | KYOCERA Medical Corporation |
KYOCERA Corporation is also using the Metal Head cleared in K160895 as a reference device, as the new BIOCERAM AZUL HEAD sizes are shared by the Metal Head.
5
6. Device Description
The BIOCERAM AZUL HEAD (the modified device) is identical to the unmodified predicate device in materials, taper system, articulating surface, packaging, sterilization and shelf life, but it differs from the unmodified predicate device in size variation. Labels are different only in reference to the model number and size.
The modified device is manufactured from the same high purity alumina matrix with zirconia reinforcement, which complies with ISO 6474-2. Two additional sizes (outer diameters) will be offered: 22 mm and 26 mm. There are 2 offsets (+0, +3 mm) for the 22 mm size and 2 offsets (+0, +3.5 mm) for the 26 mm size; and the current 28 mm head will be offered in an additional offset of +7 mm. These new ODs and offsets are the same or similar to those of the Metal Heads also cleared by K160895.
7. Indication for Use Statement
The BIOCERAM AZUL HEAD is a single use modular femoral head component for use in hip arthroplasty procedures for the following indications:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late-stage avascular necrosis,
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
8. Substantial Equivalence Discussion
The new BIOCERAM AZUL Head has the same intended use as the predicate BIOCERAM AZUL Head. The new BIOCERAM AZUL Head has the same technological characteristics as the BIOCERAM AZUL Head of the predicate device, with respect to materials and design, except for these aspects:
- Size 22 mm OD now offered in +0 and +3 mm offsets;
- Size 26 mm OD now offered in +0 and +3.5 mm offsets;
- Size 28 mm OD now offered in +7 mm offset
However, these new sizes and offsets are the same or very close to those of the metal heads also cleared in K160895. The worst-case design was tested to demonstrate equivalency to the predicate device. The minor differences of the subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.
9. Non-Clinical Performance Data
To demonstrate safety and effectiveness of modified BIOCERAM AZUL HEAD and to show substantial equivalence to the predicate device, KYOCERA Corporation conducted the following performance bench tests in accordance with internal procedures and international standards shown below. The modified
6
device passed the testing, supporting its safety and its substantial equivalence to the predicate device.
- Static compression burst test (ISO 7206-10)
- . Post-fatigue static compression burst test (ASTM F2345 / ISO 7206-10)
- Static Pull-off test (ISO 7206-10)
- . Static torsion test (ISO 7206-13)
10. Statement of Substantial Equivalence
The modified BIOCERAM AZUL HEAD has the same intended use and the same or similar technological characteristics as the predicate device. The new sizes represented by the subject device were successfully evaluated through appropriate safety and performance testing, demonstrating that the subject device does not raise any new questions of safety and effectiveness when compared to the predicate device, and is at least as safe and effective as the predicate device. Therefore, the modified BIOCERAM AZUL HEAD is substantially equivalent to the predicate BIOCERAM AZUL HEAD.