(59 days)
Not Found
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
This device is a plate system used for surgical fixation of clavicle fractures and dislocations, which is a structural support device, not a therapeutic device designed to cure or heal a condition.
No
The device is a system of plates and templates designed for the fixation of fractures and dislocations, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it consists of physical plates and templates, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of bone fractures and joint dislocations (lateral clavicle fractures and acromioclavicular joint dislocations). This is a surgical implant used directly on the patient's body.
- Device Description: The device is a system of plates and screws designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System consists of the plate types Long, Short and Button which can be used to treat simple and complex clavicle fractures including malunions, non-unions and isolated ligamentous injuries of the AC joint. The subject plates are available in three hook depths, in left- and right-side versions, in both sterile and non-sterile configurations and are available in stainless steel and titanium. The system also consists of non-implantable templates that correspond to the implants. Templates are intended for implant size selection and are available non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lateral clavicle, acromioclavicular joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons within a health care facility.
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)
Mechanical performance testing of constructs has been performed to compare the subject DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates to the predicate DePuy Synthes 3.5mm LCP Clavicle Hook Plates. This data supports that the mechanical performance of the subject devices is at least equivalent to that of the predicate devices.
A magnetic resonance compatibility assessment has been performed to establish MR Conditional parameters for the subject DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates.
Endotoxin testing has been performed according to the LAL test method to establish that the sterile subject DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates meet the specified endotoxin requirement of 20EU/device.
Biocompatibility evaluation and testing has been performed in accordance with ISO 10993-1 and it is concluded that the subject DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates are biologically safe when used as intended.
Clinical testing was not necessary for the determination of substantial equivalence.
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.
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September 11, 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 and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
DePuy Synthes % Georgina Mueller Regulatory Affairs Specialist II Synthes GmbH Luzernstrasse 21 Zuchwil. SO 4528 Switzerland
Re: K201959
Trade/Device Name: DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate 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 Dated: July 7, 2020 Received: July 14, 2020
Dear Georgina Mueller:
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,
for - 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K201959
Device Name DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
Indications for Use (Describe)
The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
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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5 510(k) Summary
| Sponsor | DePuy Synthes
Georgina Mueller
1301 Goshen Parkway
West Chester, PA 19380
Phone: +41 61 965 63 14 | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | September 3, 2020 | |
| Proprietary Name | DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System | |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories | |
| Classification | Class II
Regulation Number: 21 CFR 888.3030
Product Code: HRS | |
| Predicate device | Synthes 3.5mm LCP Clavicle Hook Plates (Synthes USA Clavicle Hook Plate;
K061753) | |
| Device Description | The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System consists of the plate
types Long, Short and Button which can be used to treat simple and complex clavicle
fractures including malunions, non-unions and isolated ligamentous injuries of the AC
joint. The subject plates are available in three hook depths, in left- and right-side versions,
in both sterile and non-sterile configurations and are available in stainless steel and
titanium. The system also consists of non-implantable templates that correspond to the
implants. Templates are intended for implant size selection and are available non-sterile. | |
| Indications for use | The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is indicated for fixation
of lateral clavicle fractures and dislocations of the acromioclavicular joint. | |
| Technological
Characteristics | The design, features, and specifications of the subject and predicate devices are compared
below.
The range of plate lengths, thickness and hook depths of the subject devices are
similar to those offered in the predicate devices. The subject plate hooks are
angulated, whereas the predicate plate hooks are not. The materials of both the subject and predicate devices are the same with plates
offered in stainless steel and titanium (i.e. 316L and commercially pure titanium). The subject and predicate plates have varying screw holes; in number, type and
diameter. Subject and predicate plates feature Locking and Compression Technology
(LCP) and subject plates additionally feature Variable Angle (VA) technology to
allow insertion of screws up to 15° angulation in addition to nominal angulation,
whereas the predicate plates feature Locking Technology (LCP) only at nominal
angulation. The subject plates have Variable Angle locking and Combi holes whereas the
predicate plates have Locking holes and Combi holes. The subject plate screw
holes are 2.7mm diameter whereas the predicate plate screw holes are 3.5mm
diameter. All plates are compatible with Cortex Screws to ensure axial and plate-to-bone
compression and with screws using locking technology to ensure angular stable
fixation. Additional compatible screw types vary for subject (VA Locking,
Metaphyseal) and predicate (Locking, Cancellous) plates, as do the screw
diameters for subject plates (2.7mm) and predicate plates (3.5mm and 4.0mm). | |
| | | Subject plates feature Suture / K-wire holes, whereas these are not featured in the
•
predicate plates. |
| | | Both subject and predicate plates are pre-contoured to accommodate for anatomical
differences, are available as mirrored plates dedicated for the left and right clavicle
and are designed to allow intra-operative contouring. |
| | | Plates have a rounded shaft-profile to reduce prominence and feature tapered tips
•
(edges) to facilitate plate insertion. Subject plates (long version only) feature notches
to facilitate plate bending, whereas the predicate plates do not feature notches. |
| Non-clinical
Performance Data | | Mechanical performance testing of constructs has been performed to compare the subject
DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates to the predicate DePuy Synthes
3.5mm LCP Clavicle Hook Plates. This data supports that the mechanical performance of
the subject devices is at least equivalent to that of the predicate devices. |
| | | A magnetic resonance compatibility assessment has been performed to establish MR
Conditional parameters for the subject DePuy Synthes 2.7mm VA LCP Clavicle Hook
Plates. |
| | | Endotoxin testing has been performed according to the LAL test method to establish that
the sterile subject DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates meet the specified
endotoxin requirement of 20EU/device. |
| | | Biocompatibility evaluation and testing has been performed in accordance with ISO
10993-1 and it is concluded that the subject DePuy Synthes 2.7mm VA LCP Clavicle
Hook Plates are biologically safe when used as intended. |
| Clinical
Performance Data | | Clinical testing was not necessary for the determination of substantial equivalence. |
| Substantial
Equivalence | | Both the subject and the predicate devices are intended for use in fixation of the clavicle
and the acromioclavicular joint during open reduction internal fixation (ORIF)
performed by surgeons within a health care facility. Subject plates are available sterile
and nonsterile, whereas the predicate plates are available sterile only. Sterile plates for
both subject and predicate are sterilized by gamma irradiation. |
| | | The subject devices have the same indications as the predicate 3.5mm LCP Clavicle
Hook Plates (K061753). |
| | | The non-clinical performance data as well as the comparison of design features included
in this premarket notification demonstrate that any differences in technological
characteristics of the subject devices compared to the predicate devices do not raise any
new issues of safety and effectiveness. |
| | | It is concluded that the information provided herein supports substantial equivalence of
the subject devices. |
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