(44 days)
No
The 510(k) summary describes a bone plating system, a mechanical device, and there is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is indicated for the fixation of bone fractures, which is a therapeutic purpose aimed at treating an injury and promoting healing.
No
The device is a plating system used for fixation of small and long 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 plates (EVOS Straight Proximal Humerus 7-15 hole plates) which are hardware. The performance studies also refer to engineering analysis and bacterial endotoxin testing, which are relevant to physical devices, not software.
Based on the provided information, 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 intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a "Plating System" and "plates" used for bone fixation. This aligns with surgical implants, not diagnostic equipment or reagents.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition.
The device is a surgical implant used to stabilize bone fractures.
N/A
Intended Use / Indications for Use
The EVOS Small Fragment Plating System is indicated for adult and adolescent (greater than 12-21 years of age) 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, metatarsals, and clavicle.
Product codes
HRS
Device Description
The subject of this Traditional 510k is the EVOS Straight Proximal Humerus 7-15 hole plates (137-225mm). The EVOS Straight Proximal Humerus Plate are a line extension to the existing 3 and 5 holes EVOS Straight Proximal Humerus Plates (93-114mm). The EVOS Straight Proximal Humerus Plates were previously cleared for market via premarket notification K173293. The lengths of the subject EVOS Straight Proximal Humerus Plates are being extended to include 7-15 hole plates (137-225mm). The EVOS Straight Proximal Humerus Plates are for single use only. Similar plate lengths have been cleared on EVOS Curved Proximal Humerus 6-18 hole plates (114-246mm) via premarket notification K173293.
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 adolescent (greater than 12-21 years of age)
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)
To further support a determination of substantial equivalence, an engineering analysis was conducted on the EVOS Straight Proximal Humerus 7-15 hole plates (137-225mm). A review of the testing indicates that the EVOS Straight Proximal Humerus 7-15 hole plates (137-225mm) are substantially equivalent to predicate devices listed in the Table 6.1 above.
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
July 22, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square and the name in a sans-serif font.
Smith & Nephew, Inc. Kayla Franklin Regulatory Affairs Specialist 1 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K201527
Trade/Device Name: EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: June 5, 2020 Received: June 8, 2020
Dear Kayla Franklin:
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
1
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 devices or 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-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-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-regulatoryassistance/contact-us-division-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,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201527
Device Name
EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)
Indications for Use (Describe)
The EVOS Small Fragment Plating System is indicated for adult and adolescent (greater than 12-21 years of age) 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, metatarsals, and clavicle.
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)
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."
3
510(k) Summary
| Submitted by: | Smith & Nephew, Inc. |
|---|---|
| Advanced Surgical Devices Division | |
| 7135 Goodlett Farms Parkway | |
| Cordova, Tennessee 38016 | |
| Date of Submission: | July 22, 2020 |
| Contact Person: | Kayla Franklin, Regulatory Affairs Specialist I |
| T (901) 800-3398 | |
| M (901) 325-2471 | |
| Name of Device: | EVOS Straight Proximal Humerus 7-15 hole Plates |
| (137-225mm) | |
| Common Name: | Plate, Fixation, Bone |
| Device Classification Name | 21 CFR 888.3030 – Single/Multiple Component |
| and Reference: | Metallic Bone Fixation Appliances and Accessories |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HRS |
| Predicate Device: | EVOS Straight Proximal Humerus Plates – K173293 |
4
Device Description:
The subject of this Traditional 510k is the EVOS Straight Proximal Humerus 7-15 hole plates (137-225mm). The EVOS Straight Proximal Humerus Plate are a line extension to the existing 3 and 5 holes EVOS Straight Proximal Humerus Plates (93-114mm). The EVOS Straight Proximal Humerus Plates were previously cleared for market via premarket notification K173293. The lengths of the subject EVOS Straight Proximal Humerus Plates are being extended to include 7-15 hole plates (137-225mm). The EVOS Straight Proximal Humerus Plates are for single use only. Similar plate lengths have been cleared on EVOS Curved Proximal Humerus 6-18 hole plates (114-246mm) via premarket notification K173293.
Indications for Use
The EVOS Small Fragment Plating System is indicated for adult and adolescent (greater than 12-21 years of age) 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.
Technoloqical Characteristics
Device comparisons described in this premarket notification demonstrate that the subject device EVOS Straight Proximal Humerus 7-15 hole plates (137-225mm) are substantially equivalent to the below listed legally marketed predicate devices with regard to intended use, indications for use, design, material and performance characteristics.
Substantial Equivalence Information
The overall design, materials, and indications for the EVOS Straight Proximal Humerus 7-15 hole plates (137-225mm) are substantially equivalent to the following commercially available predicate devices.
5
Table 6.1: Predicate Devices
| Manufacturer | Description | Submission
Number | Clearance Date |
|----------------------|------------------------------------------------------------------------------------|----------------------|----------------|
| Smith & Nephew, Inc. | 72466903 EVOS
3.5mm Straight
Proximal Humerus
Plate 3H 93mm & 5H
114mm | K173293 | 01/08/2018 |
Performance Testing
To further support a determination of substantial equivalence, an engineering analysis was conducted on the EVOS Straight Proximal Humerus 7-15 hole plates (137-225mm). A review of the testing indicates that the EVOS Straight Proximal Humerus 7-15 hole plates (137-225mm) are substantially equivalent to predicate devices listed in the Table 6.1 above.
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
Conclusion
As previously noted, this 510(k) Premarket Notification is being submitted to request clearance for the EVOS Straight Proximal Humerus 7-15 hole plates (137-225mm). Based on the similarities to the predicate devices and a review of the finite element analysis testing, the subject device is substantially equivalent to the commercially available predicate devices listed above.