(71 days)
No
The summary describes a mechanical orthopedic implant system and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is a Comprehensive Segmental Revision System intended for surgical implantation to treat various joint diseases, fractures, and deformities, which are therapeutic interventions.
No
The device, the Comprehensive Segmental Revision System, is a surgical implant designed for joint replacement and revision, not for identifying or diagnosing diseases or conditions. Its intended uses explicitly state its application in treating various joint conditions and fractures, which are therapeutic rather than diagnostic.
No
The device description clearly states it is a "Comprehensive Segmental Revision System" with physical components like "Distal Humeral Body" and "modular flange," indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a surgical implant system (Comprehensive Segmental Revision System) used to replace parts of the humerus (upper arm bone) in cases of joint disease, fractures, and bone loss. It is a physical device implanted into the body.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is mechanical replacement and stabilization within the body.
Therefore, based on the provided information, the Comprehensive Segmental Revision System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Comprehensive Segmental Revision System is intended for use in cases of:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Revision where other devices or treatments have failed.
-
- Correction of functional deformity.
-
- Oncology applications including bone loss due to tumor resection.
When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.
When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.
The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.
The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral applications.
Tissue Attachment Augments provide the option for tissue stabilization and attachment.
Product codes
JDC, KWT, KWS, MBF
Device Description
The components of the Comprehensive Segmental Revision System (SRS) components may be combined to create a proximal humeral replacement, distal humeral replacement and total humeral replacement. Previously cleared for use in conjunction with Biomet's Discovery Elbow System, the Comprehensive SRS system is being expanded to be compatible with the Zimmer Nexel Total Elbow. To accomplish this, the only component requiring modification is the Distal Humeral Body. The modified distal humeral bodies will be available in left and right configurations in three sizes 50, 60 and 70mm utilizing the same modular flange as the predicate device. The yoke geometry will match that of the humeral component in the Nexel Total Elbow System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humeral head (shoulder), humeral epicondyle (elbow), proximal shoulder, distal humeral, total humeral
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 Tests
- o None Provided Engineering analysis and MR assessment to determine that the modified components do not present a new worst case condition
- Clinical Tests .
- o None Provided
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,”
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra High Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,”
(v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 3, 2016
Biomet Manufacturing Corporation Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 Bell Drive Warsaw, Indiana 46580
Re: K153398
Trade/Device Name: Comprehensive SRS/Nexel Elbow Regulation Number: 21 CFR 888.3150 Regulation Name: Elbow joint metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: JDC, KWT, KWS, MBF Dated: December 9, 2015 Received: December 11, 2015
Dear Ms. Sandborn Beres:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
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,
Mark N. Melkerson -S
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)
Device Name Comprehensive SRS/Nexel Elbow
Indications for Use (Describe)
The Comprehensive Segmental Revision System is intended for use in cases of:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Revision where other devices or treatments have failed.
-
- Correction of functional deformity.
-
- Oncology applications including bone loss due to tumor resection.
When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.
When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.
The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.
The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral applications.
Tissue Attachment Augments provide the option for tissue stabilization and attachment.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "BIOMET" in a sans-serif font. The letters are all capitalized and appear to be in a dark gray or black color. The letters are evenly spaced and the word is horizontally oriented.
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 Comprehensive SRS/Nexel Elbow 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Patricia Sandborn Beres
Senior Regulatory Specialist
574-267-6639 |
| Date: | November 19, 2015 |
| Subject Device: | Trade Name: Comprehensive SRS / Nexel Elbow
Common Name: Shoulder, elbow and total humeral replacement
prosthesis |
| | Classification Name:
• KWT - Shoulder joint metal/polymer non-constrained cemented
prosthesis (21 CFR 888.3650)
• KWS - Shoulder joint metal/polymer semi-constrained cemented
prosthesis (21 CRFR 888.3660)
• MBF - Shoulder joint metal/polymer/metal non-constrained or
semi-constrained porous coated uncemented prosthesis (21 CFR
888.3670)
• JDC - Elbow joint metal/polymer constrained cemented prosthesis
(21 CFR 888.3150) |
Legally marketed devices to which substantial equivalence is claimed:
- o Comprehensive Segmental Revision System (SRS) - K111746
Additional reference predicate:
- Zimmer Nexel Total Elbow – K123862
Device Description
The components of the Comprehensive Segmental Revision System (SRS) components may be combined to create a proximal humeral replacement, distal humeral replacement and total humeral replacement. Previously cleared for use in conjunction with Biomet's Discovery Elbow System, the Comprehensive SRS system is being expanded to be compatible with the Zimmer Nexel Total Elbow. To accomplish this, the only component requiring modification is the Distal Humeral Body. The modified distal humeral bodies will be available in left and right configurations in three sizes 50, 60 and 70mm utilizing the same modular flange as the predicate
4
device. The yoke geometry will match that of the humeral component in the Nexel Total Elbow System.
Intended Use and Indications for Use
The Comprehensive Segmental Revision System is intended for use in cases of:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Revision where other devices or treatments have failed.
-
- Correction of functional deformity.
-
- Oncology applications including bone loss due to tumor resection.
When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.
When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.
The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.
The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral and total humeral applications.
Tissue Attachment Augments provide the option for tissue stabilization and attachment.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Identical to the predicate
- Indications for Use: Identical to the predicate
- Materials: Identical to the predicate
- Design Features: Identical to the predicate except that the geometry has been modified to mate with the Nexel Elbow
- Sterilization: Identical to the predicate
Summary of Performance Data (Nonclinical and/or Clinical)
- Non-Clinical Tests
- o None Provided Engineering analysis and MR assessment to determine that the modified components do not present a new worst case condition
- Clinical Tests .
- o None Provided
5
Image /page/5/Picture/0 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The color of the text is a dark gray, and the background is white. The overall impression is clean and professional.
Substantial Equivalence Conclusion
The proposed device has the same intended use as the predicate. The proposed device has similar technological characteristics to the predicate and the information provided herein demonstrates that:
- any differences do not raise new questions of safety and effectiveness; and .
- the proposed device is at least as safe and effective as the legally marketed predicate device. .