(121 days)
No
The device description and performance studies focus on mechanical properties and sterility, with no mention of AI/ML, image processing, or data analysis.
Yes
The device is a bone plate system designed to treat femoral neck fractures, which is a therapeutic intervention.
No
Explanation: The device description indicates it is comprised of bone plates and screws for treating femoral neck fractures, which are surgical implants rather than diagnostic tools.
No
The device description explicitly states it is comprised of contoured locking bone plates and compatible locking and non-locking bone screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating bone fractures (intracapsular femoral neck fractures). This is a surgical intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is comprised of bone plates and screws, which are implants used to stabilize bone. This is a therapeutic device, not a diagnostic one.
- Lack of IVD characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Smith & Nephew CONQUEST FN is a surgical implant used for the treatment of a physical injury.
N/A
Intended Use / Indications for Use
The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.
Product codes (comma separated list FDA assigned to the subject device)
JDO, KTT
Device Description
The CONQUEST FN system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. The subject premarket notification describes additional sizes of the bone plates to the Smith & Nephew CONQUEST FN system. The subject devices are manufactured from the same implant-grade stainless steel (316L) and designed for singleuse. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral neck
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)
- Construct Fatigue Testing was conducted on the CONQUEST FN 3 Hole Small Stature. Plate. Results of the test concluded that the CONQUEST FN 3 Hole Small Stature Plate met the acceptance criteria and is expected to have similar construct stability during bending fatigue as compared to the predicate.
- Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxin Testing: Questions and Answers," and ANSI/AAMI ST72.
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
§ 888.3030 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
February 28, 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.
K193029 Smith & Nephew, Inc. 1450 E Brooks Rd, Memphis, TN 38116 US Trade/Device Name: CONQUEST FN Contact Name: Thomas Fearnley Senior Regulatory Affairs Specialist
Re: K193029
Trade/Device Name: CONQUEST FN Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDO, KTT Dated: January 24, 2020 Received: January 27, 2020
Dear Thomas Fearnley:
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 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
1
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 mediation-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.
Vesa Vuniqi, MS 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) K193029
Device Name CONQUEST FN
Indications for Use (Describe)
The Smith & Nephew CONQUEST FN is indicated for displaced intracapsular femoral neck fractures.
| 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)
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3
Image /page/3/Picture/2 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" in black and orange. The words "We are" are in black, while "smith&nephew" is in orange.
| Submitted by: | Smith & Nephew, Inc.
Advance Surgical Devices Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Date of Summary: | October 29, 2019 |
| Contact Person and Address: | Thomas Fearnley
Senior Regulatory Affairs Specialist
T (901) 399-1224
F (901) 566-7022 |
| Name of Device: | CONQUEST FN |
| Common Name: | Internal Fracture Fixation Device |
| Device Classification Name and
Reference: | 21 CFR 888.3030 Single/multiple component metallic bone
fixation appliances and accessories
Class II |
| Panel Code: | Orthopedics/87 |
| Product Code: | JDO,KTT |
Device Description
The CONQUEST FN system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. The subject premarket notification describes additional sizes of the bone plates to the Smith & Nephew CONQUEST FN system. The subject devices are manufactured from the same implant-grade stainless steel (316L) and designed for singleuse. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.
Intended Use
The Smith & Nephew CONQUEST FN is intended for use in internal fixation of femoral neck fractures.
Indications for Use
The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.
Comparison to Technological Characteristics with Predicate Device
Device comparisons described in this premarket notification demonstrated that the proposed CONQUEST FN bone plates are substantially equivalent to the legally marketed predicate devices listed below with regard to intended use, indications for use, and performance characteristics.
The subject bone plates feature characteristics very similar to the CONQUEST FN system bone plates cleared via K152686, with the primary differences being the elimination of the plate shaft and distal screw holes. All other design aspects, indications for use, intended use, material and fundamental scientific technology remain the same as those in K152686.
4
Substantial Equivalence Information
The substantial equivalence of the CONQUEST FN 3 Hole Small Stature Plate is based on its similarities in indications for use, design features, sterilization methods, and materials to the predicate systems listed in the following table.
| Manufacturer | Description | Submission
Number | Clearance
Date |
|----------------|-------------------------------------------------|----------------------|-------------------|
| Smith & Nephew | CONQUEST FN (Primary Predicate) | K152686 | 3/17/2016 |
| Smith & Nephew | Smith & Nephew Cannulated Screws and
Washers | K111994 | 10/11/2011 |
Table 5.1: Substantially Equivalent Predicates to CONQUEST FN 3 Hole Small Stature Plate
5
A comparison of the subject device to the predicate device is described in the following table. Table 5.2 Summary of Comparison to Predicate Devices
| Design Aspect
Reviewed | CONQUEST FN 3
Hole Small Stature
Plate | CONQUEST FN
(primary predicate) | Cannulated Screws and
Washers |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Type | N/A | Primary | Reference |
| 510(k) Number | Subject 510(k) | K152686 | K111994 |
| Same intended
use | Yes | Yes | Yes |
| Same
Indications for
Use | The Smith & Nephew
CONQUEST FN is
indicated for
displaced and
undisplaced
intracapsular femoral
neck fractures | The Smith & Nephew
CONQUEST FN is
indicated for
displaced and
undisplaced
intracapsular femoral
neck fractures | The Smith & Nephew
Cannulated Screws and
Washers are used for
adult and pediatric
patients as indicated for
pelvic, small, and long
bone fracture fixation. |
| Similar
Operating
Principle | Yes | Yes | No |
| Raw material
type | 316L Stainless Steel | 316L Stainless Steel | 316L Stainless Steel |
| Similar design
features.
function and
intended use | Yes | Yes | No |
| Anatomically
based Femoral
Locking Plate | Yes | Yes | No |
| Screws | 7.5 and 8.5mm
Locking Screws
(based on POGO
Screw design
K080649, up to 3) | 7.5 and 8.5mm
Locking Screws
(based on POGO
Screw design
K080649, up to 3)
4.5mm locking and
non-locking screws | 4.0mm, 5.5mm,
6.5mm, 7.0mm and
8.0mm Cannulated
Screws |
Summary of Pre-Clinical Testing
- Construct Fatigue Testing was conducted on the CONQUEST FN 3 Hole Small Stature . Plate. Results of the test concluded that the CONQUEST FN 3 Hole Small Stature Plate met the acceptance criteria and is expected to have similar construct stability during bending fatigue as compared to the predicate.
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification
6
(510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxin Testing: Questions and Answers," and ANSI/AAMI ST72.
Conclusion
The proposed additional sizes of CONQUEST FN plates are substantially equivalent to the previously cleared CONQUEST FN plates cleared with the CONQUEST FN system in K152686 in that the indications for use and fundamental scientific technology for the subject devices are identical.