(88 days)
Not Found
No
The device description and performance studies focus on the physical properties and functional equivalence of a guidewire, with no mention of AI or ML technologies.
No
The device is a guidewire, which facilitates the placement of other devices (diagnostic and interventional) and is not intended to provide therapy itself.
No
Explanation: The device description states that the guidewire is used to "facilitate the placement of devices for diagnostic and interventional procedures." This indicates it is a tool for delivery, not for diagnosis itself.
No
The device description clearly details a physical guidewire constructed of materials like Nitinol, stainless steel, and platinum, and mentions physical characteristics like diameter, length, and coating. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To facilitate the placement of devices for diagnostic and interventional procedures." This describes a tool used during a medical procedure, not a device used to perform a diagnostic test on a sample taken from the body (which is the definition of an IVD).
- Device Description: The description details a physical guidewire used to navigate within the body. This aligns with an interventional or diagnostic tool used in vivo, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a medical device used for procedural support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To facilitate the placement of devices for diagnostic and interventional procedures. NOTE: These guidewires are not intended for PTCA use.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Selective™ Guidewire is used to facilitate the placement of devices for diagnostic and interventional procedures. The shaft of the device is constructed of PES (polyethersulfone) coated Nitinol or stainless steel with a tapered distal end secured to a platinum or stainless steel helical coil. A selection of distal tapers imparts different tip flexibilities. The guidewire is coated with silicone fluid to improve lubricity. The Selectiva™ Guidewire will be offered in diameters of 0.018" - 0.035" and lengths of 60 cm - 260 cm. It will be supplied sterile, intended for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The Selectiva™ Guidewire and the predicate device were compared in all functional and safety tests including dimensional, visual, tip flexibility, tensile strength, torqueability, and coating durability, to demonstrate equivalency in terms of safety and effectiveness. Biocompatibility testing of finished devices has been successfully completed in addition to the independent laboratory testing demonstrating equivalence of materials.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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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Section 8 Summary of Safety and Effectiveness
Submitter
NeoMetrics, Inc. 15301 Highway 55 West DEC 0 4 2001 Plymouth, MN 55447 Telephone: (763) 559-4440 Fax: (763) 559-7676 Contact Person: Gene Champeau, President Date: August 31, 2001
Product
Classification Name: Common Name: Trade/Proprietary Name:
Catheter Guidewire (21 CFR 870.1330) Guidewire, catheter guidewire, and wire guide Selectiva™ Guidewire
Substantially Equivalent Product
Lake Region Manufacturing Mandrel Guidewire Assembly (K011084).
Description
The Selective™ Guidewire is used to facilitate the placement of devices for diagnostic and interventional procedures. The shaft of the device is constructed of PES (polyethersulfone) coated Nitinol or stainless steel with a tapered distal end secured to a platinum or stainless steel helical coil. A selection of distal tapers imparts different tip flexibilities. The guidewire is coated with silicone fluid to improve lubricity. The Selectiva™ Guidewire will be offered in diameters of 0.018" - 0.035" and lengths of 60 cm - 260 cm. It will be supplied sterile, intended for one-time use.
Indications for Use
To facilitate the placement of devices for diagnostic and interventional procedures. NOTE: These guidewires are not intended for PTCA use.
Physical Characteristics
The Selectiva™ Guidewire and the predicate device were compared in all functional and safety tests including dimensional, visual, tip flexibility, tensile strength, torqueability, and coating durability, to demonstrate equivalency in terms of safety and effectiveness. Biocompatibility testing of finished devices has been successfully completed in addition to the independent laboratory testing demonstrating equivalence of materials.
Conclusion
Based on performance data and comparisons of intended use, labeling, and design, the Selectiva™ Guidewire is considered substantially equivalent to the currently marketed predicate device.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle is enclosed within a circle, and the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gene Champeau President NeoMetrics, Inc. 15301 Highway 55 West Plymouth, MN 55447
DEC 0 4 2001
Re: K013024 Seletiva™ Guidewire Regulation Number: 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: September 6, 2001 Received: September 7, 2001
Dear Mr. Champeau:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Gene Champeau
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to ough maing of substantial equivalence of your device to a legally prematication. The PDF intently sification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific acriso as for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Furt 007.10 Additionally, for questions on the promotion and advertising of Compliance it (301) 591-1800. The of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Other general information and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Vatty Hill
Bram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 3
Indications for Use ~ K013074
The NeoMetrics Selectiva™ Guidewire is intended to facilitate the placement of devices for diagnostic and interventional procedures.
for thaghostic and interves are not intended for PTCA use.
Division of Cardiovascular & Respiratory Devices
510(k) Number K013624
Prescription Use
(Per 21 CFR 801.109)