(108 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies focus on mechanical and material properties, not computational analysis or learning.
Yes
Explanation: The device is an elbow arthroplasty system intended for total elbow replacement to relieve severe pain or disability and correct functional deformities, which categorizes it as a therapeutic device.
No
The device described is a total elbow prosthesis intended for surgical replacement of the elbow joint, not for diagnosing medical conditions.
No
The device description clearly states it is a "total elbow prosthesis consisting of a humeral, an ulnar, and an optional radial implant," which are physical hardware components. The performance studies also focus on testing these physical components.
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 for diagnosis, monitoring, or screening.
- Device Description: The Latitude EV™ Total Elbow Arthroplasty system is a prosthetic implant designed to replace the elbow joint. It is surgically implanted into the body.
- Intended Use: The intended use is for total elbow arthroplasty, which is a surgical procedure to replace a damaged elbow joint with an artificial one. This is a treatment, not a diagnostic test performed on a specimen outside the body.
The provided information clearly describes a surgically implanted medical device, not a device used for testing biological samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The Latitude EVTM Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.
The Latitude EVTM Total Elbow Arthroplasty system is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JDB, JDC
Device Description
The Latitude EVTM Total Elbow Arthroplasty system is a total elbow prosthesis consisting of a humeral, an ulnar, and an optional radial implant. The Latitude EV system is designed to facilitate the reproduction of the natural flexion/extension axis and kinematics of the prosthesis is a semi-constrained prosthesis when it is implanted in an unlinked configuration and becomes a constrained prosthesis when the ulnar cap is used to link the humeral and ulnar implant assemblies. All components are intended for cemented use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Elbow
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 bench testing and process validations were performed to demonstrate substantial equivalence to the predicate device.
- Radial stem fatigue and pull-out testing
- Radial assembly disassociation testing
- Radial head poly bearing analysis
- Plasma-sprayed coating characterization and testing to ASTM F1854-15, ASTM F1160-14, ASTM F1044-05, ASTM F1147-05, ASTM F1978-17
- CT analysis of radial canals
- Tolerance analysis and cadaver lab
- Biocompatibility evaluations to ISO 10993-1:2009
- Cleaning evaluations to ISO 11737-1:2006, AAMI ST72:2011, ISO 10993-5:2009, and ASTM F750-87 for implants and AAMI TIR30:2011 for instruments
- Endotoxin testing to AAMI ST72:2011
- Packaging and distribution evaluations to ISO 11607-1:2006. ISO 11607-2:2006, ISTA Procedure 2A (2011), ASTM D4332-14, ASTM D4169-16, ASTM F2096-11
- Sterilization evaluations to ISO 11137-1:2006 and ISO 11137-2:2006 for implants and ISO 17665-1:2006 for instruments
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
§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow 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 includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
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December 27, 2018
Tornier Inc. Renee Stoffel Sr. Regulatory Affairs Specialist 10801 Nesbitt Ave South Bloomington, Minnesota 55437
Re: K182461
Trade/Device Name: LATITUDE EV Total Elbow Arthroplasty Regulation Number: 21 CFR 888.3160 Regulation Name: Elbow Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDB, JDC Dated: December 18, 2018 Received: December 20, 2018
Dear Renee Stoffel:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
Digitally signed
by Vesa Vuniqi -S
Date: 2018.12.27
15:19:29 -05'00'
Mark N. Melkerson For: Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K182461
Device Name LATITUDE EVTM
Indications for Use (Describe)
The Latitude EV™ Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.
The Latitude EV™ Total Elbow Arthroplasty system 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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Image /page/3/Picture/1 description: The image shows the word "TORNIER" in a blue serif font. To the right of the word is a blue hexagon containing a stylized letter "T". The letter "T" is also in a blue serif font and has a smaller hexagon inside of it.
Date Prepared: December 18, 2018
Administrative Information
| Name: | Tornier, Inc. |
|---|---|
| Address: | 10801 Nesbitt Avenue South |
| Bloomington, MN 55437 | |
| United States of America | |
| Contact Person: | Renee Stoffel |
| Title: | Principal Regulatory Affairs Specialist |
| Phone: | 952-683-7471 |
| Fax: | 952-426-7601 |
Device Information
| Name of Device: | LATITUDE EV™ Total Elbow Arthroplasty |
|---|---|
| Common Name (s): | Elbow Prosthesis |
| Regulatory Class: | II |
| Regulation: | 21 CFR 888.3160, elbow joint metal/polymer semi-constrained cemented prosthesis. |
| 21 CFR 888.3150, elbow joint metal/polymer constrained cemented prosthesis. | |
| Product Codes: | JDB |
| JDC |
Predicate Device Information
| Predicate: | LATITUDE EVTM Total Elbow Arthroplasty (LATITUDE™ Elbow Prosthesis) |
|---|---|
| 510(k) Number: | K100562, K171010 |
| Reference Device: | RHS |
| 510(k) Number: | K060438 |
Device Description
The Latitude EV™ Total Elbow Arthroplasty system is a total elbow prosthesis consisting of a humeral, an ulnar, and an optional radial implant. The Latitude EV system is designed to facilitate the reproduction of the natural flexion/extension axis and kinematics of the prosthesis is a semi-constrained prosthesis when it is implanted in an unlinked configuration and becomes a constrained prosthesis when the ulnar cap is used to link the humeral and ulnar implant assemblies. All components are intended for cemented use only.
Indications for Use
The LATITUDE EVTM Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of
4
Image /page/4/Picture/1 description: The image shows the word "TORNIER" in a serif font, with each letter in blue. To the right of the word is a blue hexagon containing a stylized letter "T" inside of it. The letter "T" is also blue and has a smaller hexagon inside of it.
functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.
The LATITUDE EV™ Total Elbow Arthroplasty system is intended for cemented use only.
Comparison of Technological Characteristics with the Predicate Device
Modified radial head and radial stem components will be offered in additional sizes for primary and revision surgery. The new radial stems feature a TI plasma-sprayed coating and the radial head-stem locking mechanism was modified. The new radial components are compatible with existing ulnar and humeral components. The design differences do not raise new issues of safety or effectiveness and are supported by performance testing and process validations.
Non-clinical Performance Testing
Non-clinical bench testing and process validations were performed to demonstrate substantial equivalence to the predicate device.
- . Radial stem fatigue and pull-out testing
- . Radial assembly disassociation testing
- . Radial head poly bearing analysis
- Plasma-sprayed coating characterization and testing to ASTM F1854-15, ASTM F1160-14, . ASTM F1044-05, ASTM F1147-05, ASTM F1978-17
- CT analysis of radial canals
- . Tolerance analysis and cadaver lab
- . Biocompatibility evaluations to ISO 10993-1:2009
- . Cleaning evaluations to ISO 11737-1:2006, AAMI ST72:2011, ISO 10993-5:2009, and ASTM F750-87 for implants and AAMI TIR30:2011 for instruments
- . Endotoxin testing to AAMI ST72:2011
- . Packaging and distribution evaluations to ISO 11607-1:2006. ISO 11607-2:2006, ISTA Procedure 2A (2011), ASTM D4332-14, ASTM D4169-16, ASTM F2096-11
- Sterilization evaluations to ISO 11137-1:2006 and ISO 11137-2:2006 for implants and ISO . 17665-1:2006 for instruments
Clinical Testing
No clinical studies were performed.
Conclusions
The LATITUDE EVIM Total Elbow Arthroplasty system does not raise new questions of safety or effectiveness. Differences in technological characteristics have been addressed with performance testing. The results of performance testing for the modified LATITUDE EV™ radial components support substantial equivalence to the current LATITUDE EV™ system (K100562, K171010).
Tornier, Inc. LATITUDE EVTM