(118 days)
No
The document describes a physical medical device (a hip replacement liner) and its materials and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is used for total hip replacement to treat conditions like osteoarthritis and femoral neck fracture, which are therapeutic interventions.
No
The device is an implantable component for total hip replacement, used for treatment rather than diagnosis.
No
The device description clearly states it is made of cross-linked Ultra-High-Molecular-Weight Polyethylene and is a physical component (liner) for an acetabular cup, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Cl../..X liner is a component of a total hip replacement system. It's a physical implant designed to be placed within the body.
- Intended Use: The intended use is for surgical implantation in the hip joint to treat various conditions like osteoarthritis and fractures. This is a therapeutic and structural function, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, performing tests on bodily fluids, or providing diagnostic information about a patient's condition based on laboratory analysis.
Therefore, the Cl../..X liner for NOVAE® Dual Mobility Acetabular Cup is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes:
- Osteoarthritis
- Femoral neck fracture
- Dislocation risk
- Osteonecrosis of the femoral head
- Revision procedures where other treatments or devices have failed and if bone reconstruction so permits
SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use.
Product codes
LZO, MEH
Device Description
The Cl../..X liner for NOVAE® Dual Mobility Acetabular Cup is made of cross-linked Ultra-High-Molecular-Weight Polyethylene which meet the strength requirements of the ASTM F648 and the testing listed in the ASTM F2565. The liner is mobile (free) in the NOVAE® metallic shell (clearance K111572) and retained on the prosthetic femoral head. Liners can be used with Ø22.2 or 28 mm prosthetic femoral heads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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)
Non-clinical Test Summary: The following tests were conducted:
- Dimensional analysis
- Head insertion force
- Head lever out force
- Wear analysis
Acceptance criteria were met for each test above.
Clinical Test Summary: No clinical studies were performed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, representing the department's focus on health and human well-being. The profiles are depicted in a simple, abstract manner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2015
Gloster Biomedical International Ms. Catherine Gloster Founder and Principal Consultant 577 North Hope Avenue Santa Barbara, California 93110
Re: K142675 Trade/Device Name: CI../..X liner for NOVAE® Dual Mobility Acetabular Cup 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, MEH Dated: October 20, 2014 Received: October 21, 2014
Dear Ms. Gloster:
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. 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 requirements, including, but not limited to: registration and listing
1
Page 2 - Ms. Catherine Gloster
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 4
Indications for Use Statement
510(k) Number (if known): K142675
Device Name: Cl../..X liner for NOVAE® Dual Mobility Acetabular Cup
Indications For Use:
NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes:
- Osteoarthritis
- Femoral neck fracture
- Dislocation risk
- Osteonecrosis of the femoral head
- Revision procedures where other treatments or devices have failed and if bone reconstruction so permits
SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Section 5
510(k) Summary
Date: January 15th, 2015
| Company name and address: | SERF
85 avenue des Bruyères
69153 Décines Cedex
FRANCE
Phone: +33 4 72 05 60 10
Fax: +33 4 72 02 19 18 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact person: | Jean-Luc AURELLE
General Manager / Industrial Manager |
| Date prepared: | July 25th, 2014 |
| Trade name: | CI../..X liner for NOVAE® Dual Mobility Acetabular Cup |
| Common name: | Total hip prosthesis – Acetabular component |
Classification name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353, Product Code LZO/MEH)
Device description
The Cl../..X liner for NOVAE® Dual Mobility Acetabular Cup is made of cross-linked Ultra-High-Molecular-Weight Polyethylene which meet the strength requirements of the ASTM F648 and the testing listed in the ASTM F2565. The liner is mobile (free) in the NOVAE® metallic shell (clearance K111572) and retained on the prosthetic femoral head. Liners can be used with Ø22.2 or 28 mm prosthetic femoral heads.
Substantial equivalence claimed to predicate devices
The Cl../..X liner for NOVAE® Dual Mobility Acetabular Cup is substantially equivalent to the Cl../..E liner for NOVAE® Dual Mobility Acetabular Cup (K111572, SERF) in terms of intended use, design, range of sizes, mechanical safety and performances.
The Cl../..X liner for NOVAE® Dual Mobility Acetabular Cup is substantially equivalent to ApeX-LNK Poly™ Acetabular Cup Liner (K100555, OMNIlife science) in terms of intended use, material and manufacturing and sterilization processes.
4
| Device | CI../..X liner for NOVAE®
Dual Mobility Acetabular
Cup | NOVAE® Dual Mobility
Acetabular Cup | ApeX-LNK PolyTM
Acetabular Cup Liners |
|----------------------------------|--------------------------------------------------------------|----------------------------------------|------------------------------------------|
| 510(k) number | / | K111572 | K100555 |
| Intended use | | | |
| Total hip
replacement | Yes | Yes | Yes |
| Cementless/
cemented | Yes/Yes | Yes/Yes | Unknown |
| Primary/
Revision | Yes/Yes | Yes/Yes | Yes/Yes |
| Design | | | |
| Dual mobility | Yes | Yes | No |
| Liner is retained
on the head | Yes | Yes | No |
| Materials | | | |
| Liner | Cross-linked UHMWPE | UHMWPE | Cross-linked UHMWPE |
Intended use
Cl../..X liner for NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes:
- . Osteoarthritis
- . Femoral neck fracture
- Dislocation risk ●
- Osteonecrosis of the femoral head
- . Revision procedures where other treatments or devices have failed and if bone reconstruction so permits
SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use
Non-clinical Test Summary
The following tests were conducted:
- . Dimensional analysis
- . Head insertion force
- Head lever out force .
- . Wear analysis
Acceptance criteria were met for each test above.
Clinical Test Summary
No clinical studies were performed
Conclusions Nonclinical and Clinical
Cl../..X liner for NOVAE® Dual mobility Acetabular Cup is substantially equivalent to the predicate devices in terms of indications for use, design, material, function and performances.