(280 days)
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total hip arthroplasty.
The subject devices, Distal Centralizers, are cylindrical components designed to slide onto the distal end of a cemented femoral stem prior to insertion into the femoral canal.
The provided text describes a 510(k) premarket notification for "Distal Centralizers" (K193546). This document is primarily focused on demonstrating substantial equivalence to a predicate device, specifically regarding a change in the bioburden reduction process. It is not a study proving device performance against acceptance criteria in the typical sense of a human-AI comparative study or a standalone algorithm performance study.
Therefore, many of the requested fields cannot be answered directly from this document because it's not a study about AI or human reader performance.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Related to the change being evaluated) | Reported Device Performance (Summary) |
|---|---|
| Sterilization effectiveness is maintained after changing from Branson bioburden reduction process to REVOX technology. | Testing was completed to demonstrate that the change in bioburden reduction process using REVOX technology does not have any impact on sterilization. |
| Shelf life is maintained after changing bioburden reduction process. | Testing was completed to demonstrate that the change in bioburden reduction process using REVOX technology does not have any impact on shelf life. |
| Biocompatibility is maintained after changing bioburden reduction process. | Testing was completed to demonstrate that the change in bioburden reduction process using REVOX technology does not have any impact on biocompatibility. |
| Geometric characteristics meet established criteria (likely related to design features). | The results of the Geometric Evaluation Analyses demonstrate the subject devices met the established acceptance criterion. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not specify the sample size for the "Non-Clinical Tests" performed, nor does it provide information on data provenance. The tests are focused on the device itself (sterilization, shelf life, biocompatibility, geometry), not data from patients or users.
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 a study requiring expert interpretation of results or establishment of ground truth in a clinical sense. The "ground truth" (or rather, the reference standards) for sterilization, biocompatibility, and geometric evaluations would be established through established scientific and engineering principles and testing protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of adjudication as this is not a study involving human interpretation or subjective assessment of clinical data.
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
No. An MRMC comparative effectiveness study was not done. The device (Distal Centralizers) is a physical medical implant, not an AI or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The "standalone" performance here would refer to the physical and material performance of the centralizers themselves under the new manufacturing process, which was evaluated through non-clinical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described:
- Sterilization: Ground truth is established by validated sterilization protocols and tests (e.g., sterility testing, bioburden reduction validation) that adhere to international standards.
- Shelf life: Ground truth is established by accelerated aging or real-time shelf life studies using accepted methodologies.
- Biocompatibility: Ground truth is established by standard biocompatibility testing protocols (e.g., ISO 10993 series) against a known safe biological response.
- Geometric Evaluation: Ground truth is established by engineering specifications and design tolerances.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device that requires a training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 25, 2020
Biomet Inc. Rhonda Myer Project Manager & Regulatory Affairs Zimmer Biomet 1800 West Center Street Warsaw, Indiana 46580
Re: K193546
Trade/Device Name: Distal Centralizers Regulation Number: 888.3360 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metallic Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: JDG Dated: August 24, 2020 Received: August 26, 2020
Dear Rhonda Myer:
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,
FOR Vesa Vuniqi 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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Indications for Use
510(k) Number (if known)
Device Name Distal Centralizers
Indications for Use (Describe)
-
Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
Rheumatoid arthritis
-
Correction of functional deformity
-
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
Revision of previously failed total hip arthroplasty.
| 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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K193546 Page 1/2
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Distal Centralizer 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on September 13, 2019.
| Sponsor: | Biomet Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034 |
|---|---|
| Primary Contact Person: | Rhonda MyerRegulatory Affairs Senior Project ManagerTelephone: (574) 371-9659 |
| Secondary Contact Person: | Jason HeckamanRegulatory Affairs Associate DirectorTelephone: (574) 373-3364 |
| Date: | September 25, 2020 |
| Subject Device: | Trade Name: Distal CentralizersCommon Name: Prosthesis, Hip, Femoral Component,Cemented, MetalClassification Name: JDG ">– prosthesis, hip, femoralcomponent, cemented, metal (21 CFR 888.3360) |
| Predicate Device(s): | |
| Device | 510(k) Number |
| Integral Co-Cr Femoral Components; Including PMMA Distal Centralizers | K942479 |
| Purpose and DeviceDescription: | The purpose of this submission is to move the subject devices from Branson bioburden reduction process into a bioburden reduction process using REVOX technology. Additionally, this submission is intended to ensure modifications made since the last clearance have been reviewed by the FDA.The subject devices, Distal Centralizers, are cylindrical components designed to slide onto the distal end of a cemented femoral stem prior to insertion into the femoral canal. |
|---|---|
| ------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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Indications for Use:
Summary of Technological Characteristics:
Summary of Performance Data: (Nonclinical and/or Clinical)
Substantial Equivalence Conclusion:
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and 4. trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
-
- Revision of previously failed total hip arthroplasty
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Identical to predicate
- Indications for Use: Identical to predicate ●
- Materials: Identical to predicate ●
- Design Features: Similar to predicate
- o Sterilization: Identical to predicate
Non-Clinical Tests:
Testing was completed to demonstrate that the change in bioburden reduction process using REVOX technology does not have any impact on sterilization, shelf life, or biocompatibility of the device. Additionally, the results of the Geometric Evaluation Analyses demonstrate the subject devices met the established acceptance criterion. Collectively, these reports demonstrate the modifications being submitted at this time, since the last clearance, will perform as intended and is substantially equivalent to the predicate device(s) referenced in the submission.
Clinical Tests:
None provided
The proposed Distal Centralizers have the identical intended use and indications for use as the predicate devices. The proposed devices have similar technological characteristics to the predicates, and the information provided herein demonstrates that:
- any differences do not raise new questions of safety and effectiveness; and
- the proposed devices are at least as safe and effective as the legally marketed predicate devices.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.