(76 days)
No
The device description and performance studies focus on the mechanical properties and materials of a hip replacement component, with no mention of AI or ML.
Yes.
The device is used for hip replacements to treat various medical conditions, including degenerative joint disease, arthritis, and fractures.
No
The device description and intended use clearly state that this is a prosthetic implant system for hip replacement (hemi-arthroplasty), used to replace parts of the femur. It is a treatment device, not a diagnostic one.
No
The device description clearly states the device is a physical implantable system made of CoCrMo and UHMWPE, used for hip replacements. It is a hardware device, not software.
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, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that the ic-Bipolar Heads is a component of a hip replacement system. It is an implantable device used to replace parts of the hip joint.
- Intended Use: The intended use describes surgical procedures for replacing the proximal femur and hip joint components. This is a surgical intervention, not a diagnostic test performed on a sample.
- Lack of Diagnostic Language: The document does not mention any diagnostic tests, analysis of biological samples, or providing information about a patient's health status based on laboratory results.
Therefore, the ic-Bipolar Heads is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ic-Bipolar Heads is for uncemented use in conjunction with the MUTARS® Proximal Femoral Replacement System for the following indications:
- Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.
- Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.
Use of this prosthesis is generally only indicated in skeletally mature patients.
The ic-Bipolar Heads is for uncemented use in conjunction with the EcoFit® Hip System for the following indications:
- Non-inflammatory 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.
Product codes
KWY
Device Description
The ic-Bipolar Head System consists of a bipolar liner, retaining ring, and femoral head. The system is used for hip replacements in which the femur requires replacement but the acetabulum does not (i.e. hemi-arthroplasty) The ic-Bipolar Head System articulates directly with the natural (non-replaced) acetabulum on the outer side and with a femoral head on the inner side. The ic-Bipolar Head System is manufactured of CoCrMo and UHMWPE. The ic-Bipolar Head System is used in conjunction with the EcoFit® Hip System (K163577) and MUTARS® Proximal Femur Replacement System (K181778).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal femur, hip
Indicated Patient Age Range
skeletally mature patients
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)
All necessary testing has been performed for the worst-case configuration of the ic-Bipolar Head System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of finished devices. The performance of the ic-Bipolar Head System was characterized through the following tests:
- UHMWPE Characterization
- Taper Disassemblv
- Modular Disassembly
- Range of Motion
- Endotoxin Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Aesculap Bipolar Acetabular Cup (K060707)
Reference Device(s)
MUTARS® Proximal Femur Replacement System (K181778), Ecofit Hip System (K163577)
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.
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.
August 28, 2019
Implantcast, GmbH % Dave Mcgurl Director, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K191569
Trade/Device Name: Implantcast ic-Bipolar Head System 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: June 13, 2019 Received: June 13, 2019
Dear Dave Mcgurl:
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 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
1
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 mediation-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.
Vesa Vuniqi, Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191569
Device Name ic-Bipolar Head System
Indications for Use (Describe)
The ic-Bipolar Heads is for uncemented use in conjunction with the MUTARS® Proximal Femoral Replacement System for the following indications:
-
Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.
-
Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.
Use of this prosthesis is generally only indicated in skeletally mature patients.
The ic-Bipolar Heads is for uncemented use in conjunction with the EcoFit® Hip System for the following indications:
-
Non-inflammatory 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.
| 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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1. 510(K) SUMMARY
| Device Trade Name: | ic-Bipolar Head System |
|---|---|
| Manufacturer: | implantcast GmbH |
| Lueneburger Schanze 26 | |
| 21614 Buxtehude | |
| Germany | |
| Contact: | Ms. Juliane Höppner |
| Phone: +49 4161 744-135 | |
| Fax: +49 4161 744-200 | |
| j.hoeppner@implantcast.de | |
| Prepared by: | Mr. Dave McGurl |
| Director, Regulatory Affairs | |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| Phone: 202.552.5797 | |
| Fax: 202.552.5798 | |
| dmcgurl@mcra.com | |
| Date Prepared: | August 14, 2019 |
| Classification: | 21 CFR §888.3390 |
| Class: | II |
| Product Codes: | KWY |
| Primary Predicate Device: | Aesculap Bipolar Acetabular Cup (K060707) |
| Common Name: | Bipolar Hip |
| Reference Devices: | MUTARS® Proximal Femur Replacement System (K181778) |
| Ecofit Hip System (K163577) |
4
Indications for Use:
The ic-Bipolar Heads is for uncemented use in conjunction with the MUTARS® Proximal Femoral Replacement System for the following indications:
- Proximal femur replacement in oncology cases where radical resection and replacement । of bone is required.
- Limb salvage procedures including surgical intervention for severe trauma, failed । previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.
Use of this prosthesis is generally only indicated in skeletally mature patients.
The ic-Bipolar Heads is for uncemented use in conjunction with the EcoFit® Hip System for the following indications:
- । Non-inflammatory 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.
Device Description:
The ic-Bipolar Head System consists of a bipolar liner, retaining ring, and femoral head. The system is used for hip replacements in which the femur requires replacement but the acetabulum does not (i.e. hemi-arthroplasty) The ic-Bipolar Head System articulates directly with the natural (non-replaced) acetabulum on the outer side and with a femoral head on the inner side. The ic-Bipolar Head System is manufactured of CoCrMo and UHMWPE. The ic-Bipolar Head System is used in conjunction with the EcoFit® Hip System (K163577) and MUTARS® Proximal Femur Replacement System (K181778).
Performance Testing:
All necessary testing has been performed for the worst-case configuration of the ic-Bipolar Head System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of finished devices. The performance of the ic-Bipolar Head System was characterized through the following tests:
- UHMWPE Characterization ●
- o Taper Disassemblv
- Modular Disassembly
- Range of Motion
- Endotoxin Testing
Substantial Equivalence:
Like the ic-Bipolar Head System, the Aesculap BiPolar Acetabular Cup predicate incorporates nearly identical geometry, similar or identical sizes (28mm), and corresponding indications for use. Like the ic-Bipolar Head System, the predicate is also manufactured from medical grade
5
CoCrMo Alloy and UHMWPE. Both components are intended to be used with a hip stem and articulate against the natural acetabulum. The ic-Bipolar Head System is substantially equivalent with respect to materials, indications, function and performance to Aesculap Bipolar Acetabular Cup (K060707).