(56 days)
Indications for use include:
- Elbow joint destruction which significantly compromises the activities of daily living
- Post-traumatic lesions or bone loss contributing to elbow instability
- Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis
- Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain
- Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis
- Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus
- Revision arthroplasty
CAUTION: This device is intended for cemented use only.
The Zimmer Nexel Total Elbow system includes a cemented total elbow prosthesis and instrumentation. No changes are being made to the implants, but two changes to the instrumentation are being proposed in this submission.
• The Zimmer Nexel Total Elbow surgical technique is being modified to include a back table utilization of the Ulnar Bearing Assembly Tool (UBAT).
• As a result of the surgical technique change, the subject Zimmer Nexel Total Elbow Ulnar Cement Diverter is being added as an accessory instrument to the existing Zimmer Nexel Total Elbow system. The proposed cement diverter is a sterile, single-use manual orthopedic instrument manufactured from Ultra High Molecular Weight Polyethylene in conformance with ASTM F648-14. The subject component diverts excess bone cement from the articular surfaces of the existing ulnar implant component during implantation.
This document describes the Zimmer® Nexel® Total Elbow Ulnar Cement Diverter. Based on the provided text, the device is an accessory instrument to an existing total elbow replacement system, designed to divert excess bone cement during implantation. The document does not describe a clinical study in the typical sense (e.g., no patient data, no comparison of outcomes with and without the diverter). Instead, it relies on non-clinical performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the "study" (non-clinical) that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in the typical format of a clinical trial (e.g., "sensitivity must be > X%", "accuracy must be > Y%"). Instead, the acceptance is based on demonstrating the safety and effectiveness of the cement diverter and the updated surgical technique through non-clinical evaluations.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and Effectiveness of Cement Diverter and Surgical Technique | Cadaveric Evaluation: Confirmed the safety and effectiveness of the final cement diverter design and surgical technique update when used with the Nexel Total Elbow ulnar component. This implies successful cement diversion without adverse effects on implantation. |
| Compatibility with Existing Components | Functional Relationship Analysis (FRA): Confirmed compatibility requirements to ensure the cement diverter fits appropriately to all existing Nexel Total Elbow ulnar components. This indicates proper mechanical fit and function with the intended implant system. |
| No New Questions of Safety and Effectiveness | The submission states that the device does not introduce new materials, biocompatibility concerns, indications, or risks. This is a key implicit criterion for demonstrating substantial equivalence based on non-clinical data for an accessory device. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document mentions a "Cadaveric Evaluation." While the specific number of cadavers or test instances is not explicitly stated in this summary, cadaveric studies typically involve a small number of specimens.
- Data Provenance: The study is non-clinical, involving cadavers. The country of origin for the cadavers is not specified. It is inherently a prospective evaluation in the context of the device's development and regulatory submission, even though it uses post-mortem tissue.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document does not specify the number or qualifications of experts involved in the cadaveric evaluation. While such studies would ideally involve orthopedic surgeons or biomechanical engineers, this information is not provided in the 510(k) summary. The "ground truth" for these tests would likely be the direct, observable performance of the device during simulated implantation on the cadaveric specimens, assessed by the researchers and potentially expert surgeons.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe an adjudication method for the non-clinical test set. Methods like 2+1 or 3+1 are typically used in imaging studies where interpretations are subjective and require expert consensus. In a cadaveric mechanical/functional test, the assessment of "safety and effectiveness" would likely be based on direct observation and measurement, rather than a subjective interpretation requiring adjudication among multiple readers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There was no MRMC comparative effectiveness study done. This device is an orthopedic instrument, not an AI or imaging diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There was no standalone (algorithm-only) performance study done. This device is a manual orthopedic instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical evaluations was primarily direct observation and functional assessment during the cadaveric evaluation and mechanical testing (Functional Relationship Analysis). For the cadaveric study, the "ground truth" was whether the cement diverter effectively diverted cement and allowed for proper implantation without compromising the ulnar component. For the FRA, the ground truth was whether the diverter physically fit and functioned correctly with the existing components.
8. The sample size for the training set
There is no training set sample size because this is a mechanical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2015
Zimmer. Incorporated Ms. Caroline Bloemker Regulatory Affairs Associate P.O. Box 708 Warsaw, Indiana 46580
Re: K150501
Trade/Device Name: Zimmer® Nexel® Total Elbow Ulnar Cement Diverter Regulation Number: 21 CFR 888.3150 Regulation Name: Elbow joint metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: JDC Dated: February 24, 2015 Received: February 26, 2015
Dear Ms. Caroline Bloemker:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Caroline Bloemker
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/Resourcesfor You/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 vours.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150501
Device Name
Zimmer® Nexel® Total Elbow Ulnar Cement Diverter
Indications for Use (Describe)
Indications for use include:
-
Elbow joint destruction which significantly compromises the activities of daily living
-
Post-traumatic lesions or bone loss contributing to elbow instability
-
Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis
-
Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain
-
Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis
-
Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus
-
Revision arthroplasty
CAUTION: This device is intended for cemented use only.
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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510(k) Summary
| Sponsor: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Caroline BloemkerAssociate, Regulatory AffairsTelephone: (574) 371-1980Fax: (574) 372-4605 |
| Date: | February 24, 2015 |
| Trade Name: | Zimmer® Nexel® Total Elbow Ulnar Cement Diverter |
| Common Name: | Cement Diverter |
| Classification andProduct Code: | Class II Accessory21 CFR § 888.3150 Elbow joint metal/polymerconstrained cemented prosthesis (JDC) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Zimmer® Nexel® Total Elbow, manufactured by ZimmerInc., K123862, cleared March 12, 2013. |
| Purpose and Device Description: | The Zimmer Nexel Total Elbow system includes acemented total elbow prosthesis and instrumentation. Nochanges are being made to the implants, but two changesto the instrumentation are being proposed in thissubmission.• The Zimmer Nexel Total Elbow surgical technique isbeing modified to include a back table utilization ofthe Ulnar Bearing Assembly Tool (UBAT).• As a result of the surgical technique change, thesubject Zimmer Nexel Total Elbow Ulnar CementDiverter is being added as an accessory instrument tothe existing Zimmer Nexel Total Elbow system. Theproposed cement diverter is a sterile, single-usemanual orthopedic instrument manufactured fromUltra High Molecular Weight Polyethylene inconformance with ASTM F648-14. The subjectcomponent diverts excess bone cement from the |
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articular surfaces of the existing ulnar implant component during implantation.
| Intended Use: | Since the subject component is a Class II accessory to theNexel Total Elbow, it will assume the below Nexel TotalElbow indications. |
|---|---|
| Indications for use include:- Elbow joint destruction which significantlycompromises the activities of daily living- Post-traumatic lesions or bone loss contributing toelbow instability- Ankylosed joints, especially in cases of bilateralankylosis from causes other than active sepsis- Advanced rheumatoid, post-traumatic, or degenerativearthritis with incapacitating pain- Instability or loss of motion when the degree of jointor soft tissue damage precludes reliable osteosynthesis- Acute comminuted articular fracture of the elbow jointsurfaces that precludes less radical procedures,including 13-C3 fractures of the distal humerus- Revision arthroplastyCaution: This device is intended for cemented use only. | |
| Comparison to Predicate Device: | The proposed surgical technique change does not have aneffect on the intended use or technological characteristicsof the predicate device.The cement diverter is being introduced due to the changein the surgical technique. Since the cement diverter isunique to the Nexel Total Elbow system, it is being addedas a Class II accessory to the Nexel Total Elbow systemand assumes the same classification.The proposed device is identical in intended use to thepredicate device. The materials, sterility, performancecharacteristics, and technological characteristics arecomparable to the existing Nexel Total Elbow system anddo not introduce new questions of safety andeffectiveness. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions:The results of non-clinical testing demonstrate that theproposed surgical technique and cement diverter are safeand effective when utilized with the predicate, Nexel TotalElbow system, for their intended use. Testing/analysisperformed included: |
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- -Cadaveric Evaluation confirmed the safety and effectiveness of the final cement diverter design and surgical technique update when used with the Nexel Total Elbow ulnar component.
- Functional Relationship Analysis (FRA) confirmed compatibility requirements to ensure the cement diverter fits appropriately to all existing Nexel Total Elbow ulnar components.
Clinical Performance and Conclusions:
In this case, clinical data and conclusions were not needed to demonstrate substantial equivalence.
Substantial Equivalence Zimmer considers the proposed cement diverter to be a Conclusions unique instrument to the Nexel Total Elbow system; therefore, it will assume the intended use of the predicate device. It does not introduce new materials, biocompatibility concerns, indications or risks, and therefore Zimmer considers the new surgical technique and cement diverter substantially equivalent to the predicate submission.
§ 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.”