(452 days)
No
The document describes a mechanical orthopedic implant and its testing, with no mention of AI or ML.
Yes.
The device is an orthopedic implant (BiPolar Head) intended to replace parts of the hip joint, directly treating various bone fractures and degenerative conditions.
No
The device is an orthopedic implant (femoral head/neck and proximal femur replacement) used for treatment in hemilhip arthroplasty, not for diagnosing a condition.
No
The device description explicitly states it consists of physical components like a stainless steel outer shell and a UHMWPE insert, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "hemilhip arthroplasty," which is a surgical procedure involving the replacement of part of the hip joint. This is an in-vivo (within the living body) application, not an in-vitro (outside the living body) diagnostic test.
- Device Description: The description details the physical components of a hip implant (outer shell, insert, femoral head, femoral stem) designed for surgical implantation.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to diagnose a condition.
- Performance Studies: The performance studies described focus on mechanical properties and safety for implantation (endotoxin levels, range of motion, connection strength), not on diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat a condition, not to diagnose it.
N/A
Intended Use / Indications for Use
Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemihip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:
- · Acute femoral head or neck fracture
- · Fracture dislocation of the hip
- Avascular necrosis of the femoral head
- · Non-union of femoral neck fractures
- · Certain high subcapital and femoral neck fractures in the elderly
- · Degenerative arthritis involving only the femoral head
Product codes
KWY
Device Description
The BiPolar Head consists of a stainless steel outer shell (per ISO5832-9) and a UHMWPE insert (per ASTM F648). The outer shell is highly polished to articulate against the patient's natural acetabulum. The insert articulates against a Signature Orthopaedics 22 or 28mm cobalt-chrome femoral head (K121297). The femoral head connects to a femoral stem from Signature Orthopaedics' range to complete the hip hemiarthroplasty.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral head/neck and/or proximal femur, 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)
Bacterial endotoxin levels were evaluated on the finished form of the subject device using the LAL method. Non-clinical testing and engineering evaluations were conducted to verify that the performance of the 40-42mm BiPolar Heads are adequate for anticipated in-vivo use. Non-clinical testing included:
- Range of motion analysis
- Component connection strength and fretting corrosion testing
- . BiPolar head disclamping resistance testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K133370, K121297, K812672, K091967
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 29, 2018
Signature Orthopaedics Pty Ltd. Declan Brazil Managing Director 7 Sirius Road Lane Cove, NSW 2066 AUSTRALIA
Re: K163081 Trade/Device Name: 40-42mm BiPolar Head and 22mm Femoral Head Regulation Number: 21 CFR 888.3390 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWY Dated: January 19, 2018 Received: January 22, 2018
Dear Declan Brazil:
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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/ResourcesforYou/Industry/default.htm. 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
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.
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163081
Device Name
40-42mm BiPolar Head and 22mm Femoral Head
Indications for Use (Describe)
Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemilhip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:
- · Acute femoral head or neck fracture
- · Fracture dislocation of the hip
- Avascular necrosis of the femoral head
- · Non-union of femoral neck fractures
- · Certain high subcapital and femoral neck fractures in the elderly
- · Degenerative arthritis involving only the femoral head
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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2 510(K) SUMMARY
| Manufacturer: | Signature Orthopaedics Pty Ltd
7 Sirius Road
Lane Cove, NSW 2066
Australia |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | 40-42mm BiPolar Head and 22mm Femoral Head |
| Common Name: | Hip Prosthesis |
| Contact: | Dr. Declan Brazil
Managing Director of Signature Orthopaedics |
| Prepared By: | Signature Orthopaedics Pty Ltd
7 Sirius Road
Lane Cove, NSW 2066
Australia
Phone: +61 (2) 9428 5181
Fax: +61 (2) 8456 6065 |
| Date Prepared: | January 19th, 2018 |
| Classification: | Class II per 21 CFR 888.3390: Hip joint femoral (hemi-hip)
metal/polymer cemented or uncemented prosthesis (KWY) |
| Predicate Devices: | Primary Predicate:
• Signature Orthopaedics BiPolar Head (K133370)
• Signature Orthopaedics Femoral Head (K121297)
Secondary Predicate:
• DePuy Self-Centering Hip (K812672)
• Medacta Bipolar Heads (K091967)
Reference Predicate:
• Signature Orthopaedics UniPolar Head (K143184) |
Device Description:
The BiPolar Head consists of a stainless steel outer shell (per ISO5832-9) and a UHMWPE insert (per ASTM F648). The outer shell is highly polished to articulate against the patient's natural acetabulum. The insert articulates against a Signature Orthopaedics 22 or 28mm cobalt-chrome femoral head (K121297). The femoral head connects to a femoral stem from Signature Orthopaedics' range to complete the hip hemiarthroplasty.
Indications for Use:
Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemihip arthroplasty only, where the natural acetabulum does not require replacement. The
4
Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:
- . Acute femoral head or neck fracture
- Fracture dislocation of the hip
- . Avascular necrosis of the femoral head
- . Non-union of femoral neck fractures
- Certain high subcapital and femoral neck fractures in the elderly
- . Degenerative arthritis involving only the femoral head
Performance Testing:
Bacterial endotoxin levels were evaluated on the finished form of the subject device using the LAL method. Non-clinical testing and engineering evaluations were conducted to verify that the
performance of the 40-42mm BiPolar Heads are adequate for anticipated in-vivo use. Non-clinical testing included:
- Range of motion analysis
- Component connection strength and fretting corrosion testing
- . BiPolar head disclamping resistance testing
Substantial Equivalence:
The 40-42mm BiPolar Heads have the same intended use. indications for use, materials and design as the Signature Orthopaedics BiPolar Heads (per K133370). The 40-42mm BiPolar Heads differ from the Signature Orthopaedics BiPolar Heads (per K133370) only in the size range. The 40-42mm BiPolar Heads expand Signature Orthopaedics BiPolar Heads' size range to match the 40-42mm diameter DePuy Self Centering Hip (per K812672) and Medacta Bipolar Head (per K091967) sizes. The 22mm Femoral Head is identical to the Signature Orthopaedics Femoral Heads (per K121297) excluding the outer diameter, which has been reduced to 22mm for compatibility with the 40-42mm BiPolar Heads. Non-clinical testing results support the substantial equivalence claim.