(85 days)
BENCOX Delta Option Heads of BENCOX Total Hip System is intended for Cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:
a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques
d. Patients with failed previous surgery where pain, deformity, or dysfunction persists
e. Revision of previously failed total hip arthroplasty
The BENCOX Delta Option Head consists of a delta ball head and a titanium sleeve (Ti6Al4V). The ball heads are made of the BIOLOX® delta ceramic material, which is a high-purity alumina composite material according to ISO 6474-2 Type X, and come in various outer diameters.
The ceramic BIOLOX® delta ball head is assembled with the corresponding titanium sleeve and is then placed over the titanium alloy tapers of an in-situ hip stem prosthesis. The titanium sleeve has an inner taper which fits the dimensions of a metallic hip stem prosthesis, and the BIOLOX® delta ball head has a taper which fits to the dimensions of the outer diameter of the titanium sleeve.
This document is a 510(k) premarket notification for a medical device (BENCOX Delta Option Heads, a hip joint prosthesis component). It is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device.
Crucially, this document is NOT a study describing the performance of an AI/ML medical device. It details the engineering and material properties of a physical orthopedic implant. Therefore, the questions related to AI/ML device performance, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable to this document.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical (bench) testing performed to demonstrate the device's safety and effectiveness compared to predicate devices, rather than clinical performance or AI/ML algorithm validation.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific acceptance criteria values and the device's reported performance against those criteria. It lists the types of non-clinical tests performed to demonstrate substantial equivalence. These tests are implicitly conducted against established engineering and material standards for orthopedic implants.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance | Demonstrated substantial equivalence to predicate devices. Specific tests include: |
| Burst Testing | Performed |
| Fatigue Testing | Performed |
| Post-fatigue Burst Testing | Performed |
| Pull-off Testing | Performed |
| Torque-out Testing | Performed |
| Biocompatibility/Safety | Demonstrated substantial equivalence to predicate devices. Specific tests include: |
| Range of Motion | Performed |
| Corrosion Testing and Assessment | Performed |
| Pyrogen Testing (USP<161>, ANSI/AAMI ST72) | Conducted, met recommended limits per FDA guidance, Endotoxin limit of < 20EU/Device for Bacterial endotoxin testing (BET). |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample sizes (number of units tested) for each non-clinical test (Burst, Fatigue, etc.). These are typically described in detailed test reports not included in this summary.
- Data Provenance: The tests were performed by Corentec Co., Ltd. (manufacturer) based in the Republic of Korea. The data is non-clinical/bench testing data, not human subject data, so "retrospective or prospective" doesn't apply in the same way.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is not an AI/ML device and the "ground truth" for mechanical testing is based on engineering specifications, material science, and well-established test methods (e.g., ISO standards, ASTM standards), not expert interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device where image adjudication would be relevant. Mechanical testing results are objective measurements.
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
Not applicable. This is a physical orthopedic implant, not an AI/ML medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical orthopedic implant, not an AI/ML medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance relies on engineering specifications, material properties, and established international standards (e.g., ISO 6474-2 Type X for ceramic material, USP<161>, ANSI/AAMI ST72 for pyrogenicity) for mechanical and biocompatibility testing of hip prostheses. Equivalence is demonstrated to legally marketed predicate devices which conform to these standards.
8. The sample size for the training set
Not applicable. This is a physical orthopedic implant, not an AI/ML medical device.
9. How the ground truth for the training set was established
Not applicable. This is a physical orthopedic implant, not an AI/ML medical device.
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March 16, 2023
Corentec Co., Ltd. Yoorim Bae RA Specialist 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu Cheonan-si, Chungcheongnam-do 31056 Republic of Korea
Re: K223828
Trade/Device Name: BENCOX Delta Option Heads 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, KWY Dated: December 12, 2022 Received: December 21, 2022
Dear Yoorim Bae:
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.
Limin Sun -S
Limin Sun, Ph.D. 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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Indications for Use
510(k) Number (if known) K223828
Device Name BENCOX Delta Option Heads
Indications for Use (Describe)
BENCOX Delta Option Heads of BENCOX Total Hip System is intended for Cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:
a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques
d. Patients with failed previous surgery where pain, deformity, or dysfunction persists
e. Revision of previously failed total hip arthroplasty
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
(As required by 21 CFR 807.92)
Date: March 15, 2023
ADMINISTRATIVE INFORMATION
| Manufacturer: | Corentec Co., Ltd.12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-GuCheonan-si, Chungchongnam-do, Rep. of Korea -31056Telephone: +82-41-585-7114; Fax: +82-41-585-7113 |
|---|---|
| Official Contact: | Yoorim BaeRA Specialist12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-GuCheonan-si, Chungchongnam-do, Rep. of Korea -31056Ph: +82-41-410-7116 (Direct) ; Fax: +82-41-585-7113 |
Email: yoorim.bae@corentec.com
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | BENCOX Delta Option Heads |
|---|---|
| Common Name: | Femoral Head Prosthesis |
| Regulation and Classification Name: | 21 CFR 888.3353Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis |
| Regulatory Class: | Class II |
| Product Codes: | LZO, KWY |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |
Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed:
| Primary Devices Supporting Substantial Equivalence: | ||
|---|---|---|
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
| K192416 | BIOLOX Delta Ceramic Femoral Heads,BIOLOX Option Ceramic Femoral Head System | Zimmer GmbH |
| Reference Devices Supporting Substantial Equivalence: | ||
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
| K121665 | BENCOX Forte & BENCOX Delta | Corentec Co., Ltd. |
| K173776 | BIOLOX delta Option and Extra-long Heads | MicroPortOrthopedics Inc. |
| K103012 | Exactech BIOLOX®Delta Femoral Heads andBIOLOX® Option Femoral Heads and Adapters | Exactech, Inc. |
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Indications For Use
BENCOX Delta Option Heads of BENCOX Total Hip System is intended for Cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:
a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
- d. Patients with failed previous surgery where pain, deformity, or dysfunction persists
- e. Revision of previously failed total hip arthroplasty
Purpose and Device Description
The BENCOX Delta Option Head consists of a delta ball head and a titanium sleeve (Ti6Al4V). The ball heads are made of the BIOLOX® delta ceramic material, which is a high-purity alumina composite material according to ISO 6474-2 Type X, and come in various outer diameters.
The ceramic BIOLOX® delta ball head is assembled with the corresponding titanium sleeve and is then placed over the titanium alloy tapers of an in-situ hip stem prosthesis. The titanium sleeve has an inner taper which fits the dimensions of a metallic hip stem prosthesis, and the BIOLOX® delta ball head has a taper which fits to the dimensions of the outer diameter of the titanium sleeve.
The design features and materials of the subject device, BENCOX Delta Option head are substantially equivalent to BIOLOX® delta Option devices cleared under K192683 and K173776 since the subject device is supplied by CeramTec.
Summary of Technological Characteristics
Device Comparisons and performance testing indicate that the BENCOX Delta Option Heads are substantially equivalent to the predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles.
Non-Clinical Studies
The following tests were performed on the BENCOX Delta Option Heads to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
- . Burst Testing
- . Fatigue Testing
- · Post-fatigue Burst Testing
- . Pull-off Testing
- . Torque-out Testing
- . Range of Motion
- . Corrosion Testing and Assessment
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Pyrogen testing was conducted in accordance with USP<161>, and ANSI/AAMI ST72 to ensure the proposed BENCOX Delta Option Heads meet recommended limits per FDA's Guidance Document submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile.
Bacterial endotoxin testing (BET) as specified in ANSVAAMI ST72:2011 was used for pyrogenicity testing to achieve an Endotoxin limit of < 20EU/Device.
Clinical Testing: Clinical testing was not required
Substantial Equivalence Conclusion
Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, the BENCOX Delta Option Heads are substantially equivalent to the predicate devices identified in this premarket notification.
§ 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.