(72 days)
The DePuy Synthes 2.4mm LCP Straight Wrist Plate is intended for Colles' and distal radius fractures with dorsal angulation of the distal fragment.
The 2.4mm LCP Straight Wrist Plate is designed for distal radius fractures with severe comminution requiring prolonged fixation, as an alternative to external fixation. Applied to the dorsal aspect of the wrist, the plate restores length and neutralizes loads on the consolidating fracture fragments.
The provided text describes a 510(k) premarket notification for a medical device, specifically the DePuy Synthes 2.4mm LCP Straight Wrist Plate. However, this document is a letter from the FDA regarding the substantial equivalence of a new version of an existing device (a sterile-packaged version) to an already cleared predicate device.
Crucially, this document states that "Clinical data was not necessary for the determination of substantial equivalence." This means that there was no clinical study, algorithm performance evaluation, or human reader study performed for this specific submission to demonstrate the device's efficacy or safety. The acceptance criteria and performance data typically requested for AI/ML-based medical devices or devices requiring clinical evidence are therefore not present in this document.
The "acceptance criteria" here refers to the FDA's regulatory criteria for determining substantial equivalence, not performance metrics of a device in a study. The "study that proves the device meets the acceptance criteria" in this context is the non-clinical performance testing that verifies the sterile packaging does not affect safety or performance, and the comparison to the predicate device.
Therefore, I cannot provide the detailed information requested in your prompt as it pertains to clinical performance and AI/ML model evaluation. The document specifically indicates that such data was not required for this particular submission.
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November 7, 2019
Synthes (USA) Products LLC Thomas Shea Manager, Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K192327
Trade/Device Name: DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile 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: October 7, 2019 Received: October 8, 2019
Dear Thomas Shea:
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
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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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Indications for Use
510(k) Number (if known) K192327
Device Name
DePuy Synthes 2.4mm LCP Straight Wrist Plate
Indications for Use (Describe)
The DePuy Synthes 2.4mm LCP Straight Wrist Plate is intended for Colles' and distal radius fractures with dorsal angulation of the distal fragment.
| 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)
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510(k) Summary
| Sponsor | DePuy SynthesThomas Shea1301 Goshen ParkwayWest Chester, PA USAPhone: 610-719-5679 |
|---|---|
| Date Prepared | August 22, 2019 |
| Proprietary Name | DePuy Synthes 2.4mm LCP Straight Wrist Plate |
| 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 2.4mm LCP Wrist Plate (K040588) |
| Reason for Submission | To introduce a sterile packaged version of the 2.4mm LCP Straight Wrist Plate. |
| Device Description | The 2.4mm LCP Straight Wrist Plate is designed for distal radius fractures with severe comminution requiring prolonged fixation, as an alternative to external fixation. Applied to the dorsal aspect of the wrist, the plate restores length and neutralizes loads on the consolidating fracture fragments. |
| Indications for use | The DePuy Synthes 2.4mm LCP Straight Wrist Plate is intended for Colles' and distal radius fractures with dorsal angulation of the distal fragment. |
| Contraindications | N/A |
| Comparison to Predicate | The subject device has the same indications for use, design, dimensions and material of manufacture as the predicate device. |
| Non-clinical Performance Testing | Verification activities support that the introduction of a sterile packaged version of the 2.4mm LCP Straight Wrist Plate will not affect the safety or performance. |
| Clinical Performance Data | Clinical data was not necessary for the determination of substantial equivalence. |
| Substantial Equivalence | The subject device has the same indications for use, design,dimensions and material of manufacture as the predicate device. |
| The summary of verification and validation activities included in thissubmission supports that the addition of a sterile version of the2.4mm LCP Straight Wrist Plate does not raise any issues regardingsafety and effectiveness. | |
| It is concluded that the information provided in this submissionsupports substantial equivalence. |
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§ 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.