(27 days)
No
The 510(k) summary describes minor design modifications to existing bone screws and does not mention any AI or ML capabilities. The performance studies focus on mechanical properties like insertion torque and stripping torque.
No
The device is a plating system indicated for fixation of bone fractures, not for therapeutic treatment.
No
Explanation: The device is a plating system intended for fixation of bone fractures, not for diagnosing medical conditions. Its purpose is to treat, not to diagnose.
No
The device description explicitly states that the subject of the submission are "minor modifications to the 3.5mm nonlocking cortex screws and 4.7mm non-locking osteopenia screws," which are physical hardware components (screws). The performance studies also focus on the physical properties of these screws (insertion testing, stripping torque testing).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "fixation of small and long bone fractures." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "non-locking cortex screws and non-locking osteopenia screws," which are implants used in orthopedic surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a disease or condition.
IVD devices are used to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used to treat bone fractures.
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
Device Description
The subject of this special premarket notification are minor modifications to the 3.5mm nonlocking cortex screws and 4.7mm non-locking osteopenia screws (fully and partially threaded) previously cleared for market via Traditional 510(k), K162078. Design modifications described in this submission include minor updates to the tip of the cortex screw design and an increase in the screw head diameter for both the cortex and osteopenia screws.
The subject EVOS Small Fragment non-locking screws 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, acctabulum, 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
- Screw insertion testing: Insertion testing was conducted for the cortex screws with modified tips and was compared to the existing EVOS design. Results of the testing demonstrated that screws manufactured with the modified tip performed similar or superior to the existing EVOS screw design.
- Maximum stripping torque testing: EVOS screws with modified screw head diameters were compared against the existing EVOS screw design. Results of the testing demonstrated that the proposed head design modification met the acceptance criteria in that they were significantly different compared to the current EVOS screw design (increase in maximum stripping torque).
- Engineering rationale: Pyrogen testing was previously conducted for EVOS screws to support clearance of K162078. Existing results for the EVOS implants, as well as other implants cleaned using the same cleaning system that are considered more worstcase in terms of features, were reviewed and it was determined that the subject devices do not represent a new worst-case device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 23, 2017
Smith & Nephew, Inc. Ms. Samantha Staubach Regulatory Affairs Specialist 1450 East Brooks Road Memphis, TN 38116
Re: K172262
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 Dated: July 26, 2017 Received: July 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 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 (DICE) 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 (DICE) 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, Katherine D. Kavlock
-5
for 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)
K172262
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740
3
Image /page/3/Picture/1 description: The image contains the Smith & Nephew logo. The logo features a stylized orange flower-like symbol on the left. To the right of the symbol, the text "We are smith&nephew" is displayed, with "We are" in gray and "smith&nephew" in orange.
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | August 18, 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 Screws |
| Device Classification Name and
Reference: | 21CFR 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 |
Predicates
| Manufacturer | Description | Submission
Number | Clearance Date |
|----------------------|------------------------------------------------------------|----------------------|----------------------|
| Smith & Nephew, Inc. | Smith & Nephew, Inc. EVOS
Small Fragment Plating System | K162078 | November 18,
2016 |
Device Description
The subject of this special premarket notification are minor modifications to the 3.5mm nonlocking cortex screws and 4.7mm non-locking osteopenia screws (fully and partially threaded) previously cleared for market via Traditional 510(k), K162078. Design modifications described in this submission include minor updates to the tip of the cortex screw design and an increase in the screw head diameter for both the cortex and osteopenia screws.
The subject EVOS Small Fragment non-locking screws 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.
4
Technological Characteristics
The subject devices are very similar to existing Smith & Nephew Plating System 3.5mm nonlocking cortex screws and 4.7mm non-locking osteopenia screws cleared via K162078. The minor modifications to the tip of the cortex screw and the head of the cortex and osteopenia screws are not expected to impact device safety or effectiveness, as demonstrated through mechanical testing. Device comparisons described in this premarket notification demonstrated that the proposed devices are identical to the predicate EVOS Small Fragment Plating System non-locking screws with respect to intended use, indications, materials, methods of manufacture, sterility, and packaging.
Summary of Pre-Clinical Testing
- Screw insertion testing Insertion testing was conducted for the cortex screws with . modified tips and was compared to the existing EVOS design. Results of the testing demonstrated that screws manufactured with the modified tip performed similar or superior to the existing EVOS screw design.
- Maximum stripping torque testing EVOS screws with modified screw head . diameters were compared against the existing EVOS screw design. Results of the testing demonstrated that the proposed head design modification met the acceptance criteria in that they were significantly different compared to the current EVOS screw design (increase in maximum stripping torque).
- Engineering rationale Pyrogen testing was previously conducted for EVOS screws to ● support clearance of K162078. Existing results for the EVOS implants, as well as other implants cleaned using the same cleaning system that are considered more worstcase in terms of features, were reviewed and it was determined that the subject devices do not represent a new worst-case device.
Conclusion
This Special 510(k) premarket notification is being submitted to request clearance for the modified non-locking screws intended to be used with the EVOS Small Fragment Plating System. Based on similarities to the predicate components and a review of the mechanical testing performed, the subject modified screws are substantially equivalent to the predicate screws cleared via K162078.