(28 days)
No
The summary describes a mechanical plating system and modifications to its manufacturing process and components. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for fixation of bone fractures, which is a therapeutic intervention.
No
Explanation: The device is a plating system (implants and instruments) for fixing bone fractures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "Small Fragment Plating System" and describes physical components like "Straight Plates," "Locking Hole Inserts," and "Washers." It also mentions manufacturing processes and performance testing related to the physical properties of these components (e.g., bend fatigue testing). This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of small and long bone fractures." This is a surgical procedure performed in vivo (within the body) to stabilize broken bones.
- Device Description: The description talks about plates, inserts, washers, implants, and instruments used in bone fixation. These are all components used in surgical procedures, not for testing samples in vitro (outside the body).
- Performance Studies: The performance studies focus on mechanical properties like bending fatigue and bacterial endotoxin levels, which are relevant to the safety and efficacy of an implantable device used in surgery. They do not involve testing biological samples for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The EVOS Small Fragment Plating System is indicated for adult and pediatric patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acctabulum, metacarpals, metatarsals, and clavicle.
Product codes
HRS, HWC, HTN
Device Description
The subject of this special premarket notification is a modification in the manufacturing process for select EVOS Small Fragment Straight Plates that were previously cleared via K162078. Also subject to this special premarket notification is the addition of EVOS 3.5mm Locking Hole Inserts and EVOS 3.5mm Washers and Double Washers. The subject devices are intended to be used with existing Smith & Nephew implants and instruments that have been previously cleared for market for use with the EVOS Small Fragment Plating System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.
Indicated Patient Age Range
adult and pediatric patients
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
- Engineering rationales were leveraged for minor design modifications to the plates to ensure that the modifications would not have a significant influence on plate strength.
- Four point bend fatigue testing was conducted on the worst-case designs of the proposed bone plates, as previously identified through FEA. Results of the testing concluded that the bending fatigue performance achieved by the proposed bone plates manufactured from extruded material met the acceptance criteria in that they were found to be similar to the bending fatigue performance of the EVOS sculpture milled plates cleared via K162078 and additional predicate plating systems.
- Four point bend fatigue testing was conducted for an EVOS Locking plate with locking hole inserts compared to an EVOS Locking plate without locking hole inserts. Based on the results of the testing, the EVOS Locking Plates with locking hole inserts are expected to have a similar or superior (higher) bending performance as the Locking Plates without locking hole inserts.
- Bacterial endotoxin levels were evaluated using the LAL method and were shown to be under 20 EU/device
Key Metrics
Not Found
Predicate Device(s)
K162078, K993106, K061352, K100325, K000684
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & 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 image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2017
Smith & Nephew, Inc. Samantha Staubach Regulatory Affairs Specialist 1450 Brooks Road Memphis. Tennessee 38116
Re: K170887
Trade/Device Name: EVOS Small 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, HWC, HTN Dated: March 24, 2017 Received: March 27, 2017
Dear Ms. 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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" (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 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K170887
Device Name EVOS Small Fragment Plating System
Indications for Use (Describe)
The EVOS Small Fragment Plating System is indicated for adult and pediatric patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acctabulum, metacarpals, metatarsals, and clavicle.
| 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."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740
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Image /page/3/Picture/0 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange.
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------|
| Date of Summary: | April 11, 2017 |
| | Samantha Staubach
Regulatory Affairs Specialist
T 901-399-6132
F 901-566-7596 |
| Name of Device: | EVOS Small Fragment Plating System |
| Common Name: | Bone Plates, Screws, Washers |
| Device Classification Name and
Reference: | 21 CFR 888.3030 Single/multiple component metallic bone
fixation appliances and accessories |
| | 21 CFR 888.3040 Smooth or threaded metallic bone fixation
fastener |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HRS/HWC/HTN |
Predicates
| Manufacturer | Description | Submission
Number | Clearance Date |
|----------------------|-----------------------------------------------------------------------------------|----------------------|----------------------|
| Smith & Nephew, Inc. | Smith & Nephew, Inc. EVOS
Small Fragment Plating System
(primary predicate) | K162078 | November 18,
2016 |
| Smith & Nephew, Inc. | Smith & Nephew Bone Plate
System (now branded as TC-100) | K993106 | December 9, 1999 |
| Smith & Nephew, Inc. | PERI-LOC Periarticular Locked
Plating System for Upper
Extremity | K061352 | June 8, 2006 |
| Smith & Nephew, Inc. | PERI-LOC Locking Hole Inserts
and Cable Accessories | K100325 | May 4, 2010 |
| Smith & Nephew, Inc. | EVOS Mini-Fragment Plating
System (Reference Predicate) | K140814 | May 7, 2014 |
| Synthes (USA) | Synthes Small Fragment
Dynamic Compression Locking
System | K000684 | April 28, 2000 |
4
Device Description
The subject of this special premarket notification is a modification in the manufacturing process for select EVOS Small Fragment Straight Plates that were previously cleared via K162078. Also subject to this special premarket notification is the addition of EVOS 3.5mm Locking Hole Inserts and EVOS 3.5mm Washers and Double Washers. The subject devices are intended to be used with existing Smith & Nephew implants and instruments that have been previously cleared for market for use with the EVOS Small Fragment Plating System.
Indications for Use
The EVOS Small Fragment Plating System is indicated for adult and pediatric patients, as well as patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.
Technological Characteristics
The subject devices are very similar to existing Smith & Nephew Plating System implants. Compared to the Reconstruction and Compression Plates cleared via K162078, the modified plates have minor dimensional changes and are manufactured using a slightly different manufacturing process (Plates will be manufactured from extruded stock instead of being manufactured using a sculpture milled process.) No other changes were made to the subject modified plates. The 3.5mm Washers and Double Washers and Locking Hole Inserts are designed for use with the EVOS Small Plating Fragment System. These implant accessories are similar to washers and locking hole inserts provided with other Smith & Nephew Plating Systems. Device comparisons described in this premarket notification demonstrated that the proposed devices are substantially equivalent to legally marketed predicates with respect to intended use, indications, and performance characteristics.
Summary of Pre-Clinical Testing
- Engineering rationales were leveraged for minor design modifications to the plates to . ensure that the modifications would not have a significant influence on plate strength.
- Four point bend fatigue testing was conducted on the worst-case designs of the o proposed bone plates, as previously identified through FEA. Results of the testing concluded that the bending fatigue performance achieved by the proposed bone plates manufactured from extruded material met the acceptance criteria in that they were found to be similar to the bending fatigue performance of the EVOS sculpture milled plates cleared via K162078 and additional predicate plating systems.
- . Four point bend fatigue testing was conducted for an EVOS Locking plate with locking hole inserts compared to an EVOS Locking plate without locking hole inserts. Based on the results of the testing, the EVOS Locking Plates with locking hole inserts are expected to have a similar or superior (higher) bending performance as the Locking Plates without locking hole inserts.
- Bacterial endotoxin levels were evaluated using the LAL method and were shown to ● be under 20 EU/device
5
Conclusion
This Special 510(k) premarket notification is being submitted to request clearance for the EVOS Small Fragment Plating System Straight Plates and implant accessories. Based on similarities to the predicate components and a review of the mechanical testing performed, the subject devices are substantially equivalent to the predicate devices.