(36 days)
Not Found
No
The summary describes a mechanical plating system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
It is an internal fixation plating system intended for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and fragments, which are therapeutic medical procedures.
No
Explanation: The device described is a plating system (bone plates, screws, and washers) used for internal fixation of bones and fragments in surgical procedures. It is a therapeutic device, not a diagnostic one. Its intended use is for fracture fixation, arthrodesis, reconstruction, replantation, or reduction, which are all treatment-oriented actions.
No
The device description explicitly states it is comprised of "assorted implantable, small utility 'flat' locking bone plates and compatible locking and non-locking bone screws and washers," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for internal fixation of bones and fragments, which is a surgical procedure performed in vivo (within the body).
- Device Description: The device is described as an "internal fixation plating system" comprised of implantable bone plates and screws. These are physical devices implanted into the body.
- No mention of in vitro testing: The text does not mention any use of the device for testing samples (like blood, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
Therefore, this device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HTN, HWC
Device Description
The subject EVOS Mini-Fragment Plating System is a modification to a subset of the devices previously cleared Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (K132886). It is an internal fixation plating system comprised of assorted implantable, small utility "flat" locking bone plates and compatible locking and non-locking bone screws and washers to be used on various small bones and fragments. Plates consist of groups of devices with a flat cross-section where the number of holes in plates will range from 4 through 20. All described implant devices are manufactured from implant-grade 316L Stainless Steel material and will be available in a sterile or non-sterile packaged condition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones and fragments, long bones
Indicated Patient Age Range
adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults
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 (mechanical) testing was conducted.
- Finite Element Analysis (FEA) was conducted on all proposed bone plates to predict the worst-case plate to be used in subsequent non-clinical bench (mechanical) testing.
- Four-point bend fatigue testing was conducted on the worst-case bone plates identified through FEA. Results of testing concluded that, when compared to predicates tested at the same bending moment, the number of log cycles to failure met the acceptance criteria in that they were found to be non-inferior to the number of log cycles to failure achieved by the predicates.
- Four-point bend fatigue testing was also performed on the proposed 2.0mm, 2.4mm, and 2.7mm bone screws. Results of the testing concluded that, compared to the predicates and when tested at the same bending moment, the proposed bone screws met the acceptance criteria in that they were found to be non-inferior to the number of log cycles to failure achieved by the predicates.
- Torque-to-failure testing of the proposed 2.0mm, 2.4mm, and 2.7mm cortex screws and 4.0mm osteopenia screws was conducted. Results concluded that the average values for torsional strength of the proposed devices met the acceptance criteria in that they were non-inferior to the predicates and non-inferior to the minimum values cited in ASTM F543.
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.
Not Found
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
> We are smith&nephew
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | May 2, 2014 |
| Contact Person and Address: | Samantha Staubach
Regulatory Affairs Specialist I
T 901-399-6132
F 901-566-7596 |
| Name of Device: | EVOS Mini-Fragment Plating System |
| Common Name: | Bone Plates, Screws and Washers |
| Device Classification Name and
Reference: | 21 CFR 888.3030 Single/multiple component metallic bone
fixation appliances and accessories
Class II
21 CFR 888.3040 Smooth or threaded metallic bone fixation
fastener
Class II |
| Panel Code: | Orthopedics/87 |
| Product Code: | HRS/HTN/HWC |
Device Description
The subject EVOS Mini-Fragment Plating System is a modification to a subset of the devices previously cleared Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (K132886). It is an internal fixation plating system comprised of assorted implantable, small utility "flat" locking bone plates and compatible locking and non-locking bone screws and washers to be used on various small bones and fragments. Plates consist of groups of devices with a flat cross-section where the number of holes in plates will range from 4 through 20. All described implant devices are manufactured from implant-grade 316L Stainless Steel material and will be available in a sterile or non-sterile packaged condition.
Intended Use
Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and fragments and as non-load bearing stabilization and fixation of bone fragments.
Indications for Use
The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The Smith & Nephew Variable-Angle Locking Mini
1
Fragment Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and fragments. This system is also indicated for nonload bearing stabilization and reduction of bone fragments in long bones.
Components in the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are for single use only.
Technological Characteristics
Device comparisons described in this premarket notification demonstrate that the proposed bone plates and bone screws are substantially equivalent to the legally marketed predicate devices (listed below in Toble 1) with regard to intended use, indications for use, and performance characteristics.
Substantial Equivalence Information
When compared to the predicate devices listed below, substantial equivalence is based on similar function, intended use, indications for use, and overall design to the devices listed in the table below.
| Manufacturer | Description | Submission
Number | Clearance Date |
|----------------------|---------------------------------------------------------|----------------------|----------------|
| Smith & Nephew, Inc. | Variable-Angle Locking Mini-
Fragment Plating System | K132886 | 02-04-2014 |
| Smith & Nephew, Inc. | Plate and Screw Instruments | K123055 | 01-25-2013 |
| Smith & Nephew, Inc. | VLP FOOT Plating, Screw
System and Accessories | K090675 | 06-04-2009 |
Table 1: Substantially Equivalent Predicates to the EVOS Mini-Fragment Plating System
Summary of Pre-Clinical Testing
To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing was conducted to support the proposed bone plates and bone screws. Test results demonstrated that the proposed devices are substantially equivalent to one or more of the previously cleared predicate devices described above. The specific types of non-clinical testing conducted are listed below.
- . Finite Element Analysis (FEA) was conducted on all proposed bone plates to predict the worst-case plate to be used in subsequent non-clinical bench (mechanical) testing.
- Four-point bend fatigue testing was conducted on the worst-case bone plates . identified through FEA. Results of testing concluded that, when compared to
2
predicates tested at the same bending moment, the number of log cycles to failure met the acceptance criteria in that they were found to be non-inferior to the number of log cycles to failure achieved by the predicates.
- Four-point bend fatigue testing was also performed on the proposed 2.0mm, 2.4mm, . and 2.7mm bone screws. Results of the testing concluded that, compared to the predicates and when tested at the same bending moment, the proposed bone screws met the acceptance criteria in that they were found to be non-inferior to the number of log cycles to failure achieved by the predicates.
- Torque-to-failure testing of the proposed 2.0mm, 2.4mm, and 2.7mm cortex screws . and 4.0mm osteopenia screws was conducted. Results concluded that the average values for torsional strength of the proposed devices met the acceptance criteria in that they were non-inferior to the predicates and non-inferior to the minimum values cited in ASTM F543.
Conclusion
As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the EVOS Mini-Fragment Plating System. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the predicate plating systems listed above in Table 1.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, a traditional symbol of medicine, with three wavy lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 7, 2014
Smith & Nephew, Incorporated Ms. Samantha Staubach Regulatory Affairs Specialist I 1450 Brooks Road Memphis, Tennessee 38116
Re: K140814
Trade/Device Name: EVOS Mini-Fragment Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HTN, HWC Dated: April 10, 2014 Received: April 11, 2014
Dear Ms. Samantha Staubach:
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
4
Page 2 - Ms. Samantha Staubach
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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,
Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Premarket Notification Indications for Use Statement
K140814 510(k) Number (if known): _
Device Name: EVOS Mini-Fragment Plating System
Indications for Use:
The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are for single use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Casey Hanley -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K140814
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