(27 days)
No
The document describes a mechanical implant and associated instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a femoral stem used in hip arthroplasty to treat various joint diseases and fractures, aiming to reduce pain and restore joint function. This directly aligns with the definition of a therapeutic device designed to cure, mitigate, treat, or prevent disease.
No
Explanation: The device is a femoral stem, which is an implant used in hip replacement surgery to treat various joint conditions and fractures. Its purpose is therapeutic and restorative, not to diagnose a medical condition.
No
The device description clearly indicates it is a physical femoral stem made of Ti-6Al-4V with a porous coating, and includes reusable implant specific instruments made of stainless steel. This 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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is a femoral stem, which is an implant used in hip replacement surgery. Its intended uses are to treat various conditions affecting the hip joint and proximal femur.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples or provide diagnostic information. It is a physical implant designed to restore function and reduce pain.
Therefore, this device falls under the category of a surgical implant rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- 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.
- Revision of previously failed total hip arthroplasty.
Porous coated components are intended for uncemented, biological fixation.
Product codes (comma separated list FDA assigned to the subject device)
LPH, KWL, LZO, LWJ, KWZ, KWY, JDI, OQG, OQH, OQI, PBI
Device Description
The Echo Bi-Metric Microplasty Femoral Stem is a monolithic, collarless, straight stem designed to reduce hip pain for patients and restore joint biomechanics and stability. The femoral stem is designed to fit patient femoral anatomies for primary or revision hip arthroplasties. The stems are manufactured from Ti-6Al-4V per ASTM F136/ASTM F620 and feature a proximal circumferential porous plasma spray (PPS) coating for biological fixation per ASTM F1580.
Patient contacting, reusable implant specific instruments are manufactured from stainless steel and include an aluminum titanium nitride (AlTiN) PVD or titanium nitride (TiN) PVD coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Results from mechanical tests demonstrate that the proposed Echo Bi-Metric Microplasty Femoral Stems are substantially equivalent to the predicate femoral stems. A description of the tests performed on the proposed device is as follows:
- Proximal Fatigue Testing - ISO 7206-6
- Distal Fatigue Testing - ISO 7206-4
- Range of Motion Analysis — ISO 21535
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.
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2015
Biomet, Incorporated Ms. Amy Walriven Manager, Regulatory Affairs 56 East Bell Drive Warsaw, Indiana 46581
Re: K150503 Trade/Device Name: Echo Bi-Metric Microplasty Line Extension Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, KWL, LZO, LWJ, KWZ, KWY, JDI, OQG, OQH, OQI, PBI Dated: February 25, 2015 Received: February 26, 2015
Dear Ms. Amy Walriven:
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
(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/ResourcesforYou/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,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Echo Bi-Metric Microplasty Line Extension
Indications for Use (Describe)
-
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.
-
Revision of previously failed total hip arthroplasty.
Porous coated components are intended for uncemented, biological fixation.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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 Echo Bi-Metric Microplasty Line Extension 510(k) premarket notification.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Amy L Walriven
Manager, Regulatory Affairs
Phone: (574) 372-6660
Fax: (574) 372-1683 |
| Date: | March 13, 2015 |
| Subject Device: | Trade Name: Echo Bi-Metric Microplasty Hip System
Common Name: Hip Prosthesis
Product Code(s): LPH, LZO, KWZ, JDI, KWL, LWJ, KWY, OQG, OQH, OQI, PBI
Regulation/Description:
• 21 CFR 888.3358 - Hip joint metal/polymer/metal semi-
constrained porous-coated uncemented prosthesis
• 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-
constrained cemented or nonporous uncemented prosthesis
• 21 CFR 888.3310 - Hip joint metal/polymer constrained
cemented or uncemented prosthesis
• 21 CFR 888.3350 - Hip joint metal/polymer semi-constrained
cemented prosthesis
• 21 CFR 888.3360 – Hip joint femoral (hemi-hip) metallic cemented
or uncemented prosthesis
• 21 CFR 888.3390 – Hip joint femoral (hemi-hip) metal/polymer
cemented or uncemented prosthesis |
Legally marketed devices to which substantial equivalence is claimed:
- Echo Bi-Metric Microplasty Hip System (K143009) ●
- Balance Microplasty Hip System (K050251) - Reference
Device Description
The Echo Bi-Metric Microplasty Femoral Stem is a monolithic, collarless, straight stem designed to reduce hip pain for patients and restore joint biomechanics and stability. The femoral stem is designed to fit patient femoral anatomies for primary or revision hip arthroplasties. The stems
4
are manufactured from Ti-6Al-4V per ASTM F136/ASTM F620 and feature a proximal circumferential porous plasma spray (PPS) coating for biological fixation per ASTM F1580.
Patient contacting, reusable implant specific instruments are manufactured from stainless steel and include an aluminum titanium nitride (AlTiN) PVD or titanium nitride (TiN) PVD coating.
Intended Use and Indications for Use
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis. 2)
- Correction of functional deformity. 3)
-
- 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. 5)
Porous coated components are intended for uncemented, biological fixation.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
- . Intended Use: The proposed and predicate Echo Bi-Metric Microplasty Femoral Stem devices have the identical intended use.
- Indications for Use: The proposed and predicate Echo Bi-Metric Microplasty Femoral Stem devices have identical indications for use.
- . Materials: The proposed and predicate Echo Bi-Metric Microplasty Femoral Stem devices are manufactured from Ti-6Al-4V per ASTM F136 and ASTM F620 and feature a porous plasma spray (PPS) coating per ASTM F1580.
- Design Features: The proposed and predicate Echo Bi-Metric Microplasty Femoral Stem devices incorporate the same design features.
- Sterilization: The proposed and predicate Echo Bi-Metric Microplasty Femoral Stem devices are provided sterile via the same sterilization methods for single-use.
Summary of Performance Data
Results from mechanical tests demonstrate that the proposed Echo Bi-Metric Microplasty Femoral Stems are substantially equivalent to the predicate femoral stems. A description of the tests performed on the proposed device is as follows:
- . Proximal Fatigue Testing - ISO 7206-6
- . Distal Fatigue Testing - ISO 7206-4
- Range of Motion Analysis — ISO 21535
Substantial Equivalence Conclusion
The proposed Echo Bi-Metric Microplasty Femoral Stems have the same intended use and indications for use as the predicate devices. Performance test data demonstrates the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.