(77 days)
Not Found
Not Found
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The Global Bipolar System is indicated for treating various conditions such as degenerative joint disease, rheumatoid arthritis, and fractures, which aligns with the definition of a therapeutic device designed to cure, mitigate, treat, or prevent disease.
No
Explanation: The device is an orthopedic implant for joint replacement and repair, not a tool for diagnosing medical conditions. Its indications for use describe treatment of specific orthopedic conditions rather than diagnosis.
No
The device description explicitly states that the system consists of physical components: a bipolar liner, full lock ring liner, and a metal retaining ring. This indicates it is a hardware medical device, not software-only.
No, 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 and Intended Use: The provided information clearly describes a device intended for surgical implantation to treat conditions affecting the hip joint. It is a physical implant used within the body, not a device used to analyze samples outside the body.
The Global Bipolar System is a surgical implant used in orthopedic procedures.
N/A
Intended Use / Indications for Use
The Global Bipolar System is indicated for the following:
- Non-inflammatory degenerative joint disease including osteoarthritis, 1. osteonecrosis, avascular necrosis and post traumatic arthritis;
-
- rheumatoid arthritis;
- arthritis secondary to a variety of diseases and anomalies and correction of 3. functional deformity such as congenital hip dysplasia or ankylosing spondylitis;
- revision procedures where other treatment or devices have failed; and ధ:
- treatment of proximal femoral non-union, femoral neck fracture, and trochanteric న. fractures of the proximal femur with head involvement.
Product codes (comma separated list FDA assigned to the subject device)
KWY
Device Description
The Global Bipolar System consists of a bipolar liner, full lock ring liner, and a metal retaining ring. The system is to be used with existing femoral heads distributed by Smith & Nephew.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Hip joint / proximal femur
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A review of the mechanical test data indicated that the Global Bipolar System is equivalent to devices currently on the market and are capable of withstanding expected in vivo loading without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Smith & Nephew Bipolar System, Centrax Bipolar System, Multipolar Bipolar System, Self-Centering Bipolar System, Ringloc Bipolar System
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).
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§ 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.
0
K02 3743
Smith & Nephew, Inc. Summary of Safety and Effectiveness :Global Bipolar System
Contact Person and Address
Date of Summary: November 6, 2002
Janet Akil Director, Clinical and Regulatory Affairs Smith & Nephew, Inc., Orthopaedics Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-5153
JAN 2 3 2003
Name of Device: Global Bipolar System Common Name: Bipolar System
Device Classification Name
21 CFR 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis
Substantial Equivalence Information
The Global Bipolar System is substantially equivalent to the following: Smith & Nephew Bipolar System, Centrax Bipolar System; Multipolar Bipolar System; Self-Centering Bipolar System; and the Ringloc Bipolar System.
Device Description
The Global Bipolar System consists of a bipolar liner, full lock ring liner, and a metal retaining ring. The system is to be used with existing femoral heads distributed by Smith & Nephew.
Indications for Use
The Global Bipolar System is indicated for the following:
- Non-inflammatory degenerative joint disease including osteoarthritis, 1. osteonecrosis, avascular necrosis and post traumatic arthritis;
-
- rheumatoid arthritis;
- arthritis secondary to a variety of diseases and anomalies and correction of 3. functional deformity such as congenital hip dysplasia or ankylosing spondylitis;
- revision procedures where other treatment or devices have failed; and ধ:
- treatment of proximal femoral non-union, femoral neck fracture, and trochanteric న. fractures of the proximal femur with head involvement.
Technological & Performance Characteristics:
The Global Bipolar System is similar to currently marketed bipolar systems. The components share the same intended use, material, and design features of one or more of the above mentioned predicates. A review of the mechanical test data indicated that the Global Bipolar System is equivalent to devices currently on the market and are capable of withstanding expected in vivo loading without failure.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a bird or abstract human figure, composed of curved lines, within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2003
Ms. Janet J. Akil Director, Regulatory Affairs Orthopaedic Division Smith & Nephew, Inc. 1450 Brooks Road. Memphis. Tennessee 38116
Re: K023743
Trade Name: Global Bipolar System Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: II Product Code: KWY Dated: November 6, 2002 Received: November 7, 2002
Dear Ms. Akil:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 – Ms. Janet J. Akil
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
sincerely yours,
Mark A. Milkerss
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
2374/3
Global Bipolar System Indications Statement
The Global Bipolar System is indicated for the following:
-
- Non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis;
-
- rheumatoid arthritis;
- arthritis secondary to a variety of diseases and anomalies and correction 3. of functional deformity such as congenital hip dysplasia or ankylosing spondylitis;
- revision procedures where other treatment or devices have failed; and 4.
- న్. treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.
****************************************************************************************************************************************************************************** Concurrence of CDRH, Office of Device Evaluation Prescription Use OR Over-The Counter Use (Per 21 CFR 801.109) Division Sign-Off) Division of General, Restorative and Neurological Devices (023743 10(k) Number -