(223 days)
No
The description focuses on the mechanical properties and materials of the guidewire, with no mention of AI or ML capabilities.
No
The device is a guidewire used in diagnostic and interventional procedures, which are generally preparatory steps and do not directly provide therapy.
Yes
The device explicitly states its intended use for "complex diagnostic and interventional procedures."
No
The device description clearly outlines physical components (stainless-steel core wire, PTFE coating, J-tip) and performance studies focus on mechanical and physical properties, indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "mechanical guidewire" for "complex diagnostic and interventional procedures" in the "peripheral vasculature." This describes a device used within the body to facilitate medical procedures, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description details the physical components of a guidewire (core wire, tip, coating) designed for mechanical manipulation within blood vessels. This is consistent with an interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, this device falls under the category of an interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mechanical Guidewire (MGW) is intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide are needed. The guidewire is intended for peripheral vasculature use only, not intended for coronary or neurovascular use.
Product codes
DQX
Device Description
The Mechanical Guidewire consists of a stainless-steel core wire with a flexible, J-tip stainless steel distal tip. A green polytetrafluoroethylene (PTFE) coating is present on the entire length of the guidewire and provides a lubricious surface for tracking through compatible ancillary devices. The distal curve allows visualization under appropriate imaging guidance during diagnostic and interventional procedures. The device is offered in a 180 cm length, with two outside diameters (0.032″ and 0.035″), and one distal curve shape (1-tip). The tip curve radius for the Mechanical Guidewire measures 3 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing was completed to demonstrate performance and substantial equivalence of the subject device to the predicate device. All test requirements were met as specified by applicable standards and test protocols. The device was subjected to Mechanical Testing, General Physical Testing, Biocompatibility Verification, Sterilization Verification, Pyrogen Testing, Packaging Verification, and Benchtop Validation Testing.
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
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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December 19, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Baylis Medical Company Inc. May Tsai Director of Regulatory Affairs 5825 Explorer Dr. Mississauga, ON L4W 5P6, Canada
Re: K221351
Trade/Device Name: Mechanical Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 22, 2022 Received: November 22, 2022
Dear May Tsai:
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 c an 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 (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 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/cdrl-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.
Samuel G. Raben -S
for Lydia Glaw
Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular 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) K221351
Device Name Mechanical Guidewire
Indications for Use (Describe)
The mechanical guidewire is intended for complex diagnostic and interventional procedures where increased body. flexibility, and low surface friction of the wire guide are needed. The guidewire is intended for perpheral vasculature use only, not intended for coronary or neurovascular use.
| 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
Submitter Information
| A. Company Name: | Baylis Medical Company Inc. |
|---|---|
| B. Company Address: | 5825 Explorer Dr |
| Mississauga, Ontario, L4W 5P6 | |
| Canada | |
| C. Company Phone: | +1 (905) 602-4875 |
| E. Contact Person: | May Tsai |
| Director, Regulatory Affairs | |
| F. Summary Prepared on: | 05-May-2022 |
Device Identification
| A. Device Trade Name: | Mechanical Guidewire |
|---|---|
| B. Device Common Name: | Guidewire |
| C. Classification Name: | Wire, Guide, Catheter (21 CFR 870.1330) |
| D. Product Code: | DQX |
| E. Review Panel: | Cardiovascular |
| F. Device Class: | Class II |
Identification of Legally Marketed Device
| A. Predicate Device: | Lunderquist Wire Guide |
|---|---|
| B. Manufacturer: | William Cook Europe ApS |
| C. 510(k) | K061670 |
| D. Indications for Use | Intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide are needed. |
Device Description
The Mechanical Guidewire consists of a stainless-steel core wire with a flexible, J-tip stainless steel distal tip. A green polytetrafluoroethylene (PTFE) coating is present on the entire length of the guidewire and provides a lubricious surface for tracking through compatible ancillary devices. The distal curve allows visualization under appropriate imaging guidance during diagnostic and interventional procedures. The device is offered in a 180 cm length, with two outside diameters (0.032″ and 0.035″), and one distal curve shape (1-tip). The tip curve radius for the Mechanical Guidewire measures 3 mm.
4
Indications for Use
The Mechanical Guidewire (MGW) is intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide are needed. The guidewire is intended for peripheral vasculature use only, not intended for coronary or neurovascular use.
Comparison to Predicate Device
| Characteristic | Comparison Results |
|---|---|
| Intended Use | Identical |
| Indications for Use | Identical |
| Fundamental Scientific Technology | Identical |
| Operating Principles | Identical |
| Mechanism of Action | Identical |
| Materials | Similar |
| Technological Characteristics | Similar |
| Packaging and Sterilization | Identical |
Table 11.1 Comparison of Subject and Predicate Device.
Performance Testing Summary
Performance Testing was completed to demonstrate performance and substantial equivalence of the subject device to the predicate device. All test requirements were met as specified by applicable standards and test protocols. The device was subjected to the following verification and validation activities:
Mechanical Testing
Mechanical verification testing was conducted for the Mechanical Guidewire to ensure compliance with the requirements of the FDA Guidance Document "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommend Labeling" and Baylis Medical Company Inc. self-enforced requirements. The following mechanical tests were performed:
- Flexure Test
- Fracture Test
- Peak Tensile Force Test ●
- . Corrosion Resistance Test
- Torque Strength and Torqueability ●
5
- . Tip Buckling Resistance
General Physical Testing
General physical verification testing for the lubricious green PTFE coating was conducted for the proposed MGW device. This testing was informed by Baylis Medical Company Inc. self-enforced requirements, and the FDA Guidance Document "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommend Labeling". The following tests were performed:
- Coating Particulate Testing
- . Adhesion Testing
Biocompatibility Verification
The biological safety of the proposed MGW device was verified in accordance with the requirements of ISO 10993-1:2020 and the FDA Guidance Document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." The following biocompatibility tests were performed:
- . Cytotoxicity Study
- Sensitization Study .
- Irritation or Intracutaneous Reactivity Study .
- Systemic Toxicity (Acute) Study ●
- Material-Mediated Pyrogenicity Study .
- . Hemocompatibility Study
Sterilization Verification
Sterilization verification for the proposed MGW device was completed in accordance with the requirements of ISO 11135:2014+A1:2019. Sterilization was performed using a validated Ethylene Oxide (EtO) process to a Sterility Assurance Level (SAL) of 10-9. Residual limits for the MGW device are in accordance with ISO 10993-7:2008+A1:2022.
Pyrogen Testing
The Mechanical Guidewire is supplied non-pyrogenic. Limulus Amoebocyte Lysate (LAL) testing was evaluated using the Kinetic Chromogenic method, as per ANSI/AAMI
6
ST72:2019 to verify the subject device meets current FDA and USP pyrogen limit specifications.
Packaging Verification
Packaging performance and stability testing was completed to verify the integrity of the proposed MGW device through the rigors of shipping and handling as well as storage over time. This testing was completed in accordance with ISO 11607-1:2020 over the proposed 1-year intended shelf life of the subject device.
Benchtop Validation Testing
Benchtop validation testing was completed to assess the compatibility of the proposed MGW device with ancillary devices. In addition, the radiopacity and integrity of the green PTFE coating were assessed in a simulated clinical use model.
Conclusion
The intended use and fundamental scientific technology, including principles of operation and mechanism of action, of the subject device are identical to those of the predicate device, the Lunderquist Wire Guide (K061670). Differences in materials and technological characteristics between the subject and predicate devices do not raise new or different types of safety and effectiveness questions. The results of verification and validation activities provide support for substantial equivalence of the proposed Mechanical Guidewire to the predicate device.