(90 days)
No
The device description and performance studies focus on the mechanical properties and functionality of a guide wire, with no mention of AI or ML.
No
The device is described as a "guide wire" intended to "facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices", indicating it aids in the use of therapeutic devices rather than being therapeutic itself.
No
The device is a guide wire intended to facilitate the placement and exchange of other therapeutic devices, not for diagnosing a condition.
No
The device description clearly describes a physical guide wire, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the guide wires are used to "facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures." This describes a device used in vivo (within the body) to assist in a medical procedure.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical guide wire designed to be inserted into blood vessels.
The information provided consistently points to a device used directly within the patient's body during a procedure, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The SCIMED Quest Floppy and Moderate Support Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The Quest Floppy and Moderate Support Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.
Product codes (comma separated list FDA assigned to the subject device)
DOX
Device Description
The SCIMED Quest Floppy and Moderate Support Guide Wires are steerable guide wires available in a nominal diameter of 0.014 inches and nominal lengths of 182 and 300 centimeters. The available tip flexibilities will be Floppy and Moderate Support. The distal two centimeters of both models are radiopaque and available in either a straight shapeable or a pre-formed J-Tip.
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)
Testing and evaluation of the guide wires included tip tensile strength, tip torsion strength, combined load strength, tip flexibility, tip prolapse, J-tip curve retention, torque response, proximal spring coil joint shear strength, PTCA catheter compatibility/wire movement and lubricious coating adherence. Shelf Life testing is currently being conducted and will be submitted when it is completed.
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.
K943192, K945129, K950113, K950141, K961015, K964551, K965023, K970244
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.
K973945, K942333, K946240, K950534, K960563
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.
0
APR 2 9 1998
510(k) Notification SCIMED® Quest™ Guide Wires
1980560
Summary of Safety and Effectiveness
Section 4
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
| General Provisions | Submitter's Name and Address | SCIMED Life Systems, Inc.
One SCIMED Place
Maple Grove, MN 55311 |
|------------------------------|------------------------------|------------------------------------------------------------------------------------------------------|
| | Contact Person | Jill Townsend
(612) 494-2359 |
| | Classification Name | Catheter Guide Wire |
| | Common or Usual Name | PTCA Guide Wire |
| | Proprietary Name | SCIMED ® Quest ™ Floppy and
Moderate Support Guide Wires |
| Name of Predicate
Devices | Predicate Device | 510(k) Reference No.
K943192, K945129, K950113,
K950141, K961015, K964551,
K965023, K970244 |
| | Luge Guide Wire | K973945 |
| | Sceptor and Sceptor Exchange | K942333, K946240, K950534,
K960563 |
1
్టేటు వ
Summary of Safety and Effectiveness, continued
| Device Description | The SCIMED Quest Floppy and Moderate Support Guide Wires are
steerable guide wires available in a nominal diameter of 0.014 inches
and nominal lengths of 182 and 300 centimeters. The available tip
flexibilities will be Floppy and Moderate Support. The distal two
centimeters of both models are radiopaque and available in either a
straight shapeable or a pre-formed J-Tip. |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The SCIMED Quest Floppy and Moderate Support Guide Wires are
intended to facilitate the placement and exchange of balloon
dilatation catheters or other therapeutic devices during PTCA or other
intravascular interventional procedures. The Quest Floppy and
Moderate Support Guide Wires are not intended for use in the
cerebral vasculature. The devices are provided sterile and intended
for one procedure only. |
| Summary of
Technological
Characteristics | The SCIMED Quest Floppy and Moderate Support Guide Wires
utilize the same materials and methods of construction as the
currently marketed SCIMED Guide Wires (ChoICE, Luge and
Sceptor Families of Guide Wires). |
| Non-Clinical Test
Summary | Testing and evaluation of the guide wires included tip tensile
strength, tip torsion strength, combined load strength, tip flexibility,
tip prolapse, J-tip curve retention, torque response, proximal spring
coil joint shear strength, PTCA catheter compatibility/wire movement
and lubricious coating adherence. Shelf Life testing is currently
being conducted and will be submitted when it is completed. |
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
APR 2 9 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jill Townsend Requlatory Affairs Associate SCIMED Life Systems, Incorporated One SCIMED Place Maple Grove. MN 55311-1566
Re : K980360 SCIMED® Quest™ and Zig Zag Guide Wires Trade Name: Regulatory Class: II Product Code: DOX Dated: March 17, 1998 Received: March 18, 1998
Dear Ms. Townsend:
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 leqally 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 895. A substantially equivalent determination assumes compliance with 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 Drug Administration (FDA) will verify such assumptions.. Failure to comply with the GMP requlation may result in regulatory 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
3
Page 2 - Ms. Jill Townsend
obligation you miqht have under sections 531 through 542 of the Act for devices 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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.gov/cdrh/dsma/dsmamain.html".
. Sincerely yours,
Thomas J. Callahan, M.D.
Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Notification SCIMED® Quest™ Guide Wires
Indications for Use
| 510(k) Number | |
|---|---|
| Device Name | SCIMED® Quest™ Guide Wires |
| Indications for Use | The SCIMED Quest Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The SCIMED Quest Guide Wires are not intended for use in the cerebral vasculature. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ----
Concurrence of CDRH, Office of Device Evaluation (ODE) Over The Counter Use_ OR Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) 101 (Nusion Sign-Off) ് T ar urbin and Devices ﺘﺮ ్లా 4KI Number ___________________________________________________________________________________________________________________________________________________________________ 180360