(76 days)
The ExsoMed INnate Cannulated Screw System is intended for fixation of intra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The ExsoMed INnate Cannulated Screw System is a stainless-steel bone screw system designed for bone fixation. The INnate system screws are cannulated and feature a headless design that allows for the screw to be countersunk below the surface of the bone. The system is provided sterile. The subject of this submission is the addition of a Ø3.6mm version of the INnate screw to the system to be offered in lengths of 25 to 55mm.
This document is a 510(k) summary for the ExsoMed INnate Cannulated Screw System, which is a line expansion to a previously cleared device. Therefore, it is exempt from needing to provide comprehensive study information typically found in submissions for novel devices or software. The information provided focuses on demonstrating substantial equivalence to a predicate device through performance testing.
Here's the breakdown of the acceptance criteria and study information provided:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Driving Torque (to ensure proper insertion) | Met predetermined acceptance criteria through functionality testing. |
| Torque to Failure (to assess strength/integrity) | Met predetermined acceptance criteria through functionality testing. |
| Torsional Strength (Engineering Calculations) | Met predetermined acceptance criteria through engineering calculations. |
| Bending Strength (Engineering Calculations) | Met predetermined acceptance criteria through engineering calculations. |
| Pullout Resistance (Engineering Calculations) | Met predetermined acceptance criteria through engineering calculations. |
| Simulated Use (to validate user needs) | Met predetermined acceptance criteria through simulated use testing, demonstrating the device performs as intended. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test (e.g., number of screws tested for driving torque, torque to failure). It broadly states that "functionality testing" and "simulated use testing" were performed.
Data Provenance: The tests were conducted by ExsoMed Corporation, the device manufacturer. No information on country of origin of data is provided beyond the manufacturer's location in Phoenix, Arizona, USA. The testing would be considered prospective, as it was performed specifically for this submission to demonstrate equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the submission is for a medical device (screws for bone fixation), not an AI/Software as a Medical Device (SaMD) that relies on expert interpretation for ground truth. The "ground truth" for these tests comes from objective mechanical measurements and engineering calculations.
4. Adjudication Method for the Test Set
This section is not applicable for the reasons outlined in point 3. Mechanical tests and engineering calculations do not involve expert adjudication in the same way clinical or image-based studies do.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for imaging or diagnostic devices where human readers interpret results, and the study aims to assess the impact of AI assistance on their performance. The INnate Cannulated Screw System is a physical implant, not a diagnostic tool requiring human interpretation.
6. Standalone Performance (Algorithm only without human-in-the-loop performance)
This section is not applicable as the device is a physical implant and does not involve an algorithm or AI.
7. Type of Ground Truth Used
The ground truth used for performance testing was based on objective mechanical measurements (e.g., force, torque values) and engineering principles/calculations (e.g., for torsional strength, bending strength, pullout resistance). The criteria for each test would have been established based on industry standards, predicate device performance, and biomechanical requirements for bone fixation.
8. Sample Size for the Training Set
This section is not applicable as there is no "training set" in the context of a physical medical device like cannulated screws. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
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March 12, 2019
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Exsomed Corporation Moira Barton-Varty Director Regulatory Affairs and Ouality Assurance 7227 N. 16th Street. Suite 245 Phoenix, Arizona 85020
Re: K183603
Trade/Device Name: INnate Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: February 22, 2019 Received: February 27, 2019
Dear Moira Barton-Varty:
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name INnate Cannulated Screw System
Indications for Use (Describe)
The ExsoMed INnate Cannulated Screw System is intended for fixation of intra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) Summary is presented in compliance with 21 CFR 807.92
SUBMITTER
ExsoMed Corporation 7227 N. 16th Street, Suite 245 Phoenix, Arizona 85020
CONTACT PERSON
Moira Barton-Varty, RAC Director Regulatory Affairs and Quality Assurance Phone: (602) 410-0204 or (855) 397-6633 mvarty@exsomed.com
510(k) SUMMARY PREPARATION DATE
December 3, 2018
DEVICE NAME AND CLASSIFICATION
Trade Name: ExsoMed INnate 3.6mm Cannulated Screw System Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Classification: 21 CFR 888.3040 Classification: Class II Product Code: HWC
PREDICATE DEVICES
Primary Predicate: ExsoMed™ ITN Cannulated Screw System K Number: K171558 Clearance Date: 09/01/17
Secondary Predicate: Synthes 3.0mm Headless Compression Screws K Number: K050636 Clearance Date: 04/21/2005
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PURPOSE OF THIS SUBMISSION
This Special 510(k) premarket notification is submitted to obtain clearance for a line expansion to the INnate Cannulated Screw System which was originally cleared as the ITN Cannulated Screw System under K171558.
DEVICE DESCRIPTION
The ExsoMed INnate Cannulated Screw System is a stainless-steel bone screw system designed for bone fixation. The INnate system screws are cannulated and feature a headless design that allows for the screw to be countersunk below the surface of the bone. The system is provided sterile.
The subject of this submission is the addition of a Ø3.6mm version of the INnate screw to the system to be offered in lengths of 25 to 55mm.
INDICATIONS FOR USE
The ExsoMed INnate Cannulated Screw System is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
TECHNOLOGICAL CHARACTERISTICS
The proposed modified device is substantially equivalent to the predicate, the ExsoMed ITN Cannulated Screw System. The design, materials, and intended use of the modified device are the same as the predicate devices. The mechanism of action of the 3.6mm INnate Cannulated Screw System is identical to the predicate devices in the same standard mechanical design, materials, shapes and sizes are utilized. There are no changes to the claims, intended use, clinical applications, performance specification or method of operation. Both the subject and predicate Cannulated Screw Systems are cleaned, packaged and sterilized using the same materials and processes. The ExsoMed 3.6mm INnate cannulated screw system differs from the predicate only in diameter, length and pitch.
PERFORMANCE TESTING
Verification analyses consisting of functionality testing were performed to demonstrate the equivalence of the new and predicate devices. Specifically, following tests were performed:
- Driving Torque testing .
- Torque to failure testing ●
ExsoMed Corporation Special 510(k) – INnate Cannulated Screw System
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- . Engineering Calculations for torsional strength, bending strength and pullout resistance
In addition, simulated use testing was performed to validate the modified device meets user needs.
The results from these evaluations demonstrated that the subject INnate 3.6mm Cannulated Screws perform as intended.
CONCLUSION
The information summarized in the Design Control Activities Summary demonstrates that the modified INnate Cannulated Screws met the predetermined acceptance criteria for verification activities identified.
There is no change to the fundamental scientific technology, indicated use or material type for the proposed line extension devices.
ExsoMed concludes that the line extension devices (3.6mm INnate Cannulated Screws) introduce no new issues of safety or effectiveness compared with the predicate device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.