(27 days)
Not Found
No
The description focuses on the physical construction and materials of a guidewire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
This device is a guidewire, used to direct catheters, and functions as an accessory to other medical procedures rather than directly providing therapy.
No
Explanation: The device is a guidewire used for directing catheters through blood vessels. Its intended use and description do not mention any diagnostic capabilities; it does not collect information about the patient's condition for diagnosis.
No
The device description clearly states the guidewire is constructed of Nitinol and has a physical structure, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The description clearly states the HyTek Guidewire is designed to fit inside a catheter for directing it through a blood vessel. This is an invasive device used inside the body for a procedural purpose.
- Intended Use: The intended use is for navigating within the peripheral and coronary vasculature, which is a direct intervention within the body.
The information provided describes a medical device used for a procedural purpose within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The 0.025" HyTek guidewire is indicated for use in the peripheral vasculature. The 0.014". 0.016", and 0.018" HyTek Guidewires are indicated for use in the peripheral and coronary vasculature.
Product codes
74 DQX, DOX
Device Description
The MICROVENA HyTek Guidewire is designed to fit inside a catheter, for directing the catheter through a blood vessel.
The main body of the guidewire is constructed of Nitinol. The distal tip is a helical coiled wire wound around the inner core. The guidewire is coated with a hydrophilic coating to facilitate smoother passage.
The HyTek Guidewire is available in diameters of .014" to .025, and in lengths from 80 cm to 300 cm.
MICROVENA's HyTek guidewire has the same indications for use and is technically the same as the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, peripheral and coronary 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
Non-Clinical Tests: The results of these tests demonstrate the functionality and performance characteristics of the guidewire are comparable to the currently marketed device. These tests included: torque, flexibility, and coating adherence.
Key Metrics
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.
0
5/5/99
q91194
Appendix D
Special 510(k) Summary HyTek™ Guidewire (Prepared in accordance with 21 CFR part 807.92)
510(k) Number: K991194
- Submitter: Prepared and Submitted by: 1. MICROVENA Corporation Angela Mallery Sr. Regulatory Affairs Associate 651-777-6700 1861 Buerkle Road White Bear Lake, MN 55110
- Device Name: Guidewire 2. Trade Name: HyTek™ Guidewire Classification Name: Wire, Guide, Catheter Classification Code: 74 DQX
- Substantial Equivalency: The HyTek guidewire is substantially equivalent to K922060. 3.
- Device Description and Intended Use: 4. The MICROVENA HyTek Guidewire is designed to fit inside a catheter, for directing the catheter through a blood vessel.
The main body of the guidewire is constructed of Nitinol. The distal tip is a helical coiled wire wound around the inner core. The guidewire is coated with a hydrophilic coating to facilitate smoother passage.
The HyTek Guidewire is available in diameters of .014" to .025, and in lengths from 80 cm to 300 cm.
- Technological Characteristics ട്. MICROVENA's HyTek guidewire has the same indications for use and is technically the same as the predicate device.
- Non-Clinical Tests 6. The results of these tests demonstrate the functionality and performance characteristics of the guidewire are comparable to the currently marketed device. These tests included: torque, flexibility, and coating adherence.
-
- Conclusions Based on information presented in this 510(k) premarket notification, MICROVENA guidewires are considered substantially equivalent to the currently marketed predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1099 MAY
Ms. Angela Mallery Sr. Requlatory Affairs Associate MICROVENA Corporation 1861 Buerkle Road White Bear Lake, MN 55110
Re: K991194 Trade Name: HyTek™ Guidewire Regulatory Class: II Product Code: DOX Dated: April 7, 1999 Received: April 8, 1999
Dear Ms. Mallery:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval) , 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices
2
Paqe 2 - Ms. Angela Mallery
under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Appendix B
: } ... }
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
HyTek Guidewire
The 0.025" HyTek guidewire is indicated for use in the peripheral vasculature. The 0.014". 0.016", and 0.018" HyTek Guidewires are indicated for use in the peripheral and coronary vasculature.
Please do NOT write below this line - CONTINUE on ANOTHER page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Per 21 CRF 801.109 OR
Over-The-Counter Use (Optional Format 1-2-96)
L. Gardin for Sloan 7/4/99
ion Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number.
HyTek Guidewire Supplementary Information April 30, 1999 Page 4