(254 days)
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implantable prosthetic system designed to relieve severe pain and significant disability, correct functional deformities, and treat fractures, all of which fall under the definition of a therapeutic device.
No
Explanation: This device is an arthroplasty system intended for the replacement of the elbow joint. Its purpose is to repair or replace damaged anatomical structures within the elbow, not to diagnose a condition or disease.
No
The device description clearly states it is a total elbow prosthesis consisting of physical implants (humeral, ulnar, and optional radial). The performance studies also focus on physical properties like fatigue testing, coating characterization, and biocompatibility, which are relevant to hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The LATITUDE EV™ Total Elbow Arthroplasty system is a prosthetic implant designed to replace the elbow joint. It is a physical device implanted into the body during surgery.
- Intended Use: The intended use is for total elbow arthroplasty, which is a surgical procedure to replace the elbow joint.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes.
Therefore, based on the provided information, the LATITUDE EV™ Total Elbow Arthroplasty system is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
JDB, JDC
Device Description
The LATITUDE EVI™ 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 semiconstrained 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
Prescription Use
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 testing was performed to demonstrate substantial equivalence to the predicate device.
- Humeral and ulnar stem fatigue testing
- Plasma-sprayed coating characterization and testing to ASTM F1854-15, ASTM F1160-14, . ASTM F1044-05, ASTM F1147-05, ASTM F1978-17
- Biocompatibility evaluation to ISO 10993-1:2018
- . Packaging and shelf life evaluations to ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1980-16
- Distribution testing to ISTA Procedure 3A (2011), ASTM D4169-16, ASTM F2096-11 .
- Sterilization evaluation to ISO 11137-1:2006 and ISO 11137-2:2006 .
- . Endotoxin testing to AAMI ST72:2011
No clinical studies were performed.
The results of performance testing for the modified LATITUDE EV™ humeral and ulnar components support substantial equivalence to the current LATITUDE EV™ system (K182461).
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
August 5, 2020
Image /page/0/Picture/1 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Tornier Inc. Renee Stoffel Principal Regulatory Affairs Specialist 10801 Nesbitt Ave South Bloomington, Minnesota 55347
Re: K193247
Trade/Device Name: LATITUDE EV™ Total Elbow Arthroplasty system 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: July 8, 2020 Received: July 10, 2020
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 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 (reporting of medical device-related adverse events) (21 CFR 803) for devices or
1
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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/trainingand-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-regulatory-assistance/contact-usdivision-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,
For Michael Owens 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)
Device Name LATITUDE EV™ Total Elbow Arthroplasty
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 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.
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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Image /page/3/Picture/1 description: The image shows the word "TORNIER" in a large, sans-serif, blue font. To the right of the word is a blue hexagon containing a stylized letter "T" inside. The letter "T" is also blue and has a unique design.
Date Prepared: July 8, 2020
Administrative Information
| Name:
Address: | Tornier, Inc.
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
| Primary Predicate: | K182461, LATITUDE EV™ Total Elbow Arthroplasty |
|---|---|
| Additional Predicate: | K171010, LATITUDE EV™ Total Elbow Arthroplasty |
| Reference Devices: | K070787, LATITUDE™ Elbow Prosthesis |
| K053189, COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES |
Device Description
The LATITUDE EVI™ 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 semiconstrained 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.
4
Image /page/4/Picture/0 description: The image shows the word "TORNIER" in a large, bold, blue font. To the right of the word is a blue hexagon containing a stylized letter "T". The letter "T" is also blue and is made up of two smaller hexagons.
Indications for Use
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 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 to Predicate Device
The initial manufacturing process for the LATITUDE EV humeral and ulnar stems was changed from forging to casting for a subset of the stem sizes and lengths. Additional modifications for the subject components include sterile packaging materials, labeled shelf life, dimensional specifications, and material specifications. These manufacturing and 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 testing was performed to demonstrate substantial equivalence to the predicate device.
- Humeral and ulnar stem fatigue testing ●
- Plasma-sprayed coating characterization and testing to ASTM F1854-15, ASTM F1160-14, . ASTM F1044-05, ASTM F1147-05, ASTM F1978-17
- Biocompatibility evaluation to ISO 10993-1:2018 ●
- . Packaging and shelf life evaluations to ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1980-16
- Distribution testing to ISTA Procedure 3A (2011), ASTM D4169-16, ASTM F2096-11 .
- Sterilization evaluation to ISO 11137-1:2006 and ISO 11137-2:2006 .
- . Endotoxin testing to AAMI ST72:2011
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™ humeral and ulnar components support substantial equivalence to the current LATITUDE EV™ system (K182461).