(72 days)
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No
The document describes a mechanical bone staple system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a system of bone staples used for fixation in osteotomy, arthrodesis, and fragment fixation of bones and joints, which are therapeutic medical procedures.
No
Explanation: The device is described as an implantable staple system for bone fixation. Its intended use is for osteotomy, arthrodesis, and fragment fixation, which are surgical procedures, not diagnostic ones. There is no mention of it being used to identify or analyze medical conditions.
No
The device description explicitly states it is a "bone staple system" consisting of "bone staples of various sizes" and "instruments," which are physical 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 surgical procedures (osteotomy, arthrodesis, fragment fixation) involving bones and joints. This is a therapeutic and structural function, not a diagnostic one performed on in vitro samples.
- Device Description: The device is a bone staple, which is an implantable medical device used to fix bone fragments. This is a physical intervention, not a test performed on biological samples.
- No mention of in vitro testing: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing any diagnostic tests outside of the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
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.
Product codes
JDR
Device Description
The JAWS® Nitinol Staple System are bone staples of various sizes to accommodate a variety of small bone applications. The implants and instruments are sold sterile.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
bones and joints of the foot, long bones of the lower extremities such as the fibula and tibia
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering analysis is presented to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices. Testing on MR compatibility and corrosion was also conducted. The results of this analysis and testing demonstrated the modified designs are substantially equivalent to the predicate devices. All performance testing conducted for the JAWS® Nitinol Staple System met the predetermined acceptance criteria or were otherwise considered acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
May 11, 2023
Paragon 28 Inc Haylie Hertz Senior Regulatory Affairs Specialist 14445 Grasslands Drive Englewood, Colorado 80112
Re: K230550
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: March 15, 2023 Received: March 15, 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K230550
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: | K230550 |
|---|---|
| Manufacturer: | Paragon 28, Inc. |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Contact: | Haylie Hertz |
| Associate Regulatory Affairs Specialist | |
| Paragon 28, Inc. | |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Phone: 303-720-0017 | |
| hhertz@paragon28.com | |
| Date Prepared: | May 11, 2023 |
| Device Trade Name: | JAWS® Nitinol Staple System |
| Device Class and | |
| Common Name: | |
| Classification: | Class II, staple, fixation, bone |
| 21 CFR 888.3030: Single/multiple component metallic bone | |
| fixation appliances and accessories | |
| Product Codes: | JDR |
| Indications for Use: | The JAWS® Nitinol Staple System implants are indicated |
| for use in osteotomy, arthrodesis and fragment fixation of | |
| bones and joint 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. | |
| Device Description: | The JAWS® Nitinol Staple System are bone staples of |
| various sizes to accommodate a variety of small bone | |
| applications. The implants and instruments are sold sterile. | |
| Predicate Device: | JAWS® Nitinol Staple System (K223056) |
| Substantial | |
| Equivalence: | The proposed JAWS® Nitinol Staple System is substantially |
| equivalent to the predicate JAWS® Nitinol Staple System | |
| (K223056) with respect to indications, design, material and | |
| function. | |
| Performance Testing: | Engineering analysis is presented to provide evidence that the |
| original testing and subsequent performance is not adversely | |
| affected by the modifications to the subject devices. Testing | |
| on MR compatibility and corrosion was also conducted. The | |
| results of this analysis and testing demonstrated the modified | |
| designs are substantially equivalent to the predicate devices. | |
| Conclusions: | The JAWS® Nitinol Staple System subject to this submission |
| possesses the same intended use and technological | |
| characteristics as the predicate device system components. | |
| All performance testing conducted for the JAWS® Nitinol | |
| Staple System met the predetermined acceptance criteria or | |
| were otherwise considered acceptable. As such, the JAWS® | |
| Nitinol Staple System components are substantially | |
| equivalent to the predicate devices for the intended use. |
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