(280 days)
Not Found
No
The device description and performance studies focus on mechanical components and sterilization processes, with no mention of AI/ML or related concepts.
No.
The device is a distal centralizer, which is an accessory used during implantation of a femoral stem in hip replacement surgery. While the surgery itself is therapeutic, the centralizer is a mechanical component facilitating the surgical procedure rather than directly treating a condition itself.
No
The device, Distal Centralizers, is a cylindrical component designed to aid in the insertion of a femoral stem during hip arthroplasty (a surgical procedure), not to diagnose a condition. Its intended uses are corrections, treatments, and revisions of joint and bone issues.
No
The device description clearly states the device is a "cylindrical component designed to slide onto the distal end of a cemented femoral stem," indicating it is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are related to treating joint diseases and fractures through surgical implantation. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a physical component (distal centralizer) designed to be implanted during surgery. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- No mention of analyzing biological specimens: The description and intended use do not involve the analysis of blood, urine, tissue, or any other biological sample.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- 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.
Product codes (comma separated list FDA assigned to the subject device)
JDG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral canal
proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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
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.
Not Found
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
§ 888.3360 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.
0
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Rhonda Myer
Regulatory Affairs Senior Project Manager
Telephone: (574) 371-9659 |
| Secondary Contact Person: | Jason Heckaman
Regulatory Affairs Associate Director
Telephone: (574) 373-3364 |
| Date: | September 25, 2020 |
| Subject Device: | Trade Name: Distal Centralizers
Common Name: Prosthesis, Hip, Femoral Component,
Cemented, Metal
Classification Name: JDG ">– prosthesis, hip, femoral
component, 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 Device
Description: | 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. |
| ------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
4
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.