(76 days)
Not Found
No
The summary describes a mechanical bone screw system and its intended use for fixation. There is no mention of AI, ML, image processing, or any software component that would suggest the use of such technologies. The performance studies focus on mechanical properties and simulated use, not algorithmic performance.
No
The device is a bone screw system for fixation of fractures and osteotomies, which is a structural support device rather than a therapeutic one. It facilitates healing but does not directly treat a disease or condition in a therapeutic manner (e.g., drug delivery, radiation, heat).
No
The device is a bone screw system designed for fixation, not for diagnosing conditions. Its primary function is therapeutic (stabilization), not diagnostic (identification or assessment of disease).
No
The device description explicitly states it is a "stainless-steel bone screw system" and describes physical components like cannulated screws with a headless design. The performance studies involve testing physical properties like torque and strength, which are characteristic of hardware devices, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly states that the ExsoMed INnate Cannulated Screw System is a surgical implant used for the fixation of bones and joints. It is a physical device inserted into the body during surgery.
The description focuses on the mechanical properties and surgical application of the screw system, not on analyzing biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones and small bone fragments; small joints; scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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
- 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.
Key Metrics
Not Found
Predicate Device(s)
ExsoMed™ ITN Cannulated Screw System K171558, Synthes 3.0mm Headless Compression Screws K050636
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
March 12, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in blue, followed by the words "U.S. Food & Drug Administration" in blue.
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
1
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
2
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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3
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
5
- . 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.