(139 days)
The JAWS Nitinol Staple System implants are indicated for use in osteotomy, arthrodesis and fragment fixation of the bones and joints of the foot including fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement) located in the long bones of the lower extremities such as the fibula and tibia.
The JAWS Nitinol Staple System includes three styles of bone staples having various sizes to accommodate a variety of small bone applications. The implants and instruments are sold sterile.
The provided text describes a 510(k) premarket notification for the JAWS Nitinol Staple System, focusing on substantial equivalence to a predicate device and MRI safety and compatibility testing. It does not describe an AI/ML powered device, and therefore does not contain information on acceptance criteria for an AI model, a study proving an AI model meets acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The "Performance Testing" section states that "MR Safety and Compatibility Testing has been completed and presented in the submission as recommended in the FDA Guidance 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment' issued May 20, 2021, including FDA-recognized standards tests for the following potential hazards."
Therefore, I cannot fulfill your request for an AI/ML-specific acceptance criteria and study description based on the provided document. The document describes a physical medical device (bone staples) and its testing for safety and compatibility in an MRI environment.
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February 16, 2023
Paragon 28, Inc. Haylie Hertz Sr. Regulatory Affairs Specialist 14445 Grasslands Dr. Englewood, Colorado 80112
Re: K223056
Trade/Device Name: JAWS Nitinol Staple System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: January 20, 2023 Received: January 20, 2023
Dear Haylie Hertz:
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 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,
Limin Sun -S
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K223056
Device Name JAWS Nitinol Staple System
Indications for Use (Describe)
The JAWS Nitinol Staple System implants are indicated for use in osteotomy, arthrodesis and fragment fixation of the bones and joints of the foot including fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement) located in the long bones of the lower extremities such as the fibula and tibia.
| 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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510(K) SUMMARY
| 510(k) Number: | K223056 |
|---|---|
| Manufacturer: | Paragon 28, Inc.14445 Grasslands Dr.Englewood, CO 80112 |
| Contact: | Haylie HertzSr. Regulatory Affairs SpecialistParagon 28, Inc.14445 Grasslands Dr.Englewood, CO 80112Phone: 303-720-0017hhertz@paragon28.com |
| Date Prepared: | January 20, 2023 |
| Device Trade Name: | JAWS Nitinol Staple System |
| Device Class: | Class II |
| Predicate Device: | JAWS Nitinol Staple System (K170923) |
| Device Description: | The JAWS Nitinol Staple System includes three styles of bonestaples having various sizes to accommodate a variety of small boneapplications. The implants and instruments are sold sterile. |
| Classification andProduct Code: | 21 CFR 888.3030; Staple, fixation, bone, JDR |
| Indications for Use: | The JAWS Nitinol Staple System implants are indicated for use inosteotomy, arthrodesis and fragment fixation of bones and joint ofthe foot including fixation of small bone fragments (i.e., smallfragments of bone which are not comminuted to the extent topreclude staple placement) located in the long bones of the lowerextremities such as the fibula and tibia. |
| SubstantialEquivalence: | The intended use, principle of operation and fundamental scientifictechnology of the modified device are identical to the predicatedevice. The MR safety and compatibility performance and labelingmodifications were accomplished via testing in the MRIenvironment and updated labeling per the FDA Guidance “Testingand Labeling Medical Devices for Safety in the MagneticResonance (MR) Environment” issued May 20, 2021. The data |
| PerformanceTesting: | MR Safety and Compatibility Testing has been completed andpresented in the submission as recommended in the FDA Guidance"Testing and Labeling Medical Devices for Safety in the MagneticResonance (MR) Environment" issued May 20, 2021, includingFDA-recognized standards tests for the following potential hazards:Image Artifact per ASTM F2119 Test Method forEvaluation of MR Image Artifacts from Passive Implants Magnetically Induced Displacement Force per ASTMF2052 Test Method for Measurement of MagneticallyInduced Displacement Force on Medical Devices in theMagnetic Resonance Environment Magnetically Induced Torque per ASTM F2213 TestMethod for Measurement of Magnetically Induced Torqueon Medical Devices in the Magnetic ResonanceEnvironment Radiofrequency (RF) Induced Heating per ASTM F2182Test Method for Measurement of Radio Frequency InducedHeating On or Near Passive Implants during MagneticResonance Imaging Computational Modeling and Simulation ofRadiofrequency Induced Heating in the MagneticResonance Environment |
| Based on the results, the JAWS Nitinol Staples will be labeled as"MR Conditional" with MRI Safety Information in the instructionsfor use as described in ASTM F2503 Standard Practice forMarking Medical Devices and Other Items for Safety in theMagnetic Resonance Environment. | |
| Conclusion: | The proposed device modifications do not raise new issues of safetyor effectiveness and has been fully evaluated. The subject devicesare substantially equivalent to the legally marketed, predicatedevice. |
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demonstrate substantial equivalence and the subject modifications do not raise new issues of safety or effectiveness.
§ 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.