(134 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a surgical pin, with no mention of AI or ML technologies.
Yes
The device is used to apply traction to the skeletal system, which is a therapeutic intervention for medical conditions.
No
Explanation: The device, SteriTrak, is intended for skeletal traction by providing an anchor in the bone. Its purpose is purely mechanical (support and traction), not to diagnose a condition or disease.
No
The device description clearly states that SteriTrak is a physical, implantable Kirschner wire made of stainless steel, which is a hardware component.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for implantation through the skin and bone to apply skeletal traction. This is a therapeutic/surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical implantable pin used for mechanical support (traction). It does not analyze biological samples or provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of providing diagnostic results or information about a patient's health status based on laboratory analysis.
Therefore, SteriTrak™ falls under the category of a surgical/orthopedic device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SteriTrak is indicated for implantation through the skin and bone so that traction may be applied to the skeletal system.
Product codes
JEC (Component, Traction, Invasive)
Device Description
SteriTrakTM is a sterile, temporarily implantable Kirschner wire (K-wire). SteriTrakTM is intended to be implanted into the bone for the purposes of providing an anchor for skeletal traction. SteriTrakTM is intended to be inserted while the patient is in the Emergency Room, prior to admittance to the Operating Room for surgery. When the patient is transferred to the Operating Room for surgery, skeletal traction is released and SteriTrakTM is removed.
The SteriTrakTM surgical grade 316L stainless steel pin is implantable up to 30 days. SteriTrakTM is provided with a guiding handle intended to be used as a pin stabilizing holder for the orthopedic surgeon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skeletal system / bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopedic surgeon, Emergency Room, Operating Room
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing of SteriTrakTM in support of this submission included the following activities:
- Biocompatibility assessment to ISO 10993-1
- Usability testing to IEC 62366-1
- Pin torque transfer to ASTM F-138-19 and ISO 5832-1
- Label legibility testing to ISO 14630:2012
These activities demonstrate that SteriTrakTM is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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April 23, 2021
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 with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym in a blue square and the full name "U.S. Food & Drug Administration" in blue text.
Arbutus Medical Inc. Mr. Michael Cancilla Director, Engineering & Partnerships 828 10th Ave W, Suite 560 Vancouver, British Columbia V5Z 1L8 Canada
Re: K203605
Trade/Device Name: SteriTrakTM Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: JEC Dated: March 26, 2021 Received: April 1, 2021
Dear Mr. Cancilla:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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,
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal 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) K203605
Device Name SteriTrak
Indications for Use (Describe)
SteriTrak is indicated for implantation through the skin and bone so that traction may be applied to the skeletal system.
| 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
| 510(k) Applicant: | Arbutus Medical Inc.
828 10th Ave W, Suite 560
Vancouver, British Columbia
Canada, V5Z 1L8 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Michael Cancilla
Director, Engineering & Partnerships
Mobile: +1 778 773 6477
michael.cancilla@arbutusmedical.ca |
| Date Prepared: | November 30, 2020 |
| Device Trade Name: | SteriTrak™ |
| Device Common Name: | Skeletal Traction Pin |
| Device Classification Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
| Regulation Number: | 888.3040 |
| Product Code: | JEC (Component, Traction, Invasive) |
| Classification: | II |
| Panel: | Orthopedic |
| Primary Predicate Device: | K960385 - Sterile Kirschner Wires and Steinmann Pins |
| Predicate Device: | K761088 - Modified Skeletal Traction Pin |
SteriTrak™ is a sterile, temporarily implantable Kirschner wire (K-wire). Device Description: SteriTrak™ is intended to be implanted into the bone for the purposes of providing an anchor for skeletal traction. SteriTrak™ is intended to be inserted while the patient is in the Emergency Room, prior to admittance to the Operating Room for surgery. When the patient is transferred to the Operating Room for surgery, skeletal traction is released and SteriTrak™ is removed.
The SteriTrak™ surgical grade 316L stainless steel pin is implantable up to 30 days. SteriTrak™ is provided with a guiding handle intended to be used as a pin stabilizing holder for the orthopedic surgeon.
Indications for Use: SteriTrak™ is indicated for implantation through the skin and bone so that traction may be applied to the skeletal system.
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Substantial Equivalence: The indicated use, design and technological characteristics for SteriTrak™ are the same as the predicate devices. The intended use for SteriTrak™ is identical to the primary predicate device. The applied part of the SteriTrak™, the stainless steel K-wire, is exactly the same as the primary predicate device. Human factors and usability testing demonstrates that the polycarbonate guide is effective in stabilizing the SteriTrak™ implantable pin during insertion and does not raise any concerns regarding the safe and effective use of SteriTrak™.
Non-clinical testing of SteriTrak™ in support of this submission included the Performance Testing: following activities:
- Biocompatibility assessment to ISO 10993-1
- . Usability testing to IEC 62366-1
- Pin torque transfer to ASTM F-138-19 and ISO 5832-1
- Label legibility testing to ISO 14630:2012
These activities demonstrate that SteriTrak™ is substantially equivalent to the predicate devices.