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.

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.

AI/ML Overview

Acceptance Criteria and Study for SCIMED® Quest™ Guide Wires

Based on the provided document, the "performance" of the device is assessed through "Non-Clinical Test Summary" which lists various physical and mechanical properties. The acceptance criteria are implicit in the successful completion of these tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Adequate tip tensile strength	Testing and evaluation of the guide wires included tip tensile strength. (Implies successful testing, as the device received clearance.)
Adequate tip torsion strength	Testing and evaluation of the guide wires included tip torsion strength. (Implies successful testing, as the device received clearance.)
Adequate combined load strength	Testing and evaluation of the guide wires included combined load strength. (Implies successful testing, as the device received clearance.)
Adequate tip flexibility	Testing and evaluation of the guide wires included tip flexibility. (Implies successful testing, as the device received clearance.)
Acceptable tip prolapse characteristics	Testing and evaluation of the guide wires included tip prolapse. (Implies successful testing, as the device received clearance.)
Adequate J-tip curve retention (for J-tip models)	Testing and evaluation of the guide wires included J-tip curve retention. (Implies successful testing, as the device received clearance.)
Acceptable torque response	Testing and evaluation of the guide wires included torque response. (Implies successful testing, as the device received clearance.)
Adequate proximal spring coil joint shear strength	Testing and evaluation of the guide wires included proximal spring coil joint shear strength. (Implies successful testing, as the device received clearance.)
Compatibility with PTCA catheters and wire movement	Testing and evaluation of the guide wires included PTCA catheter compatibility/wire movement. (Implies successful testing, as the device received clearance.)
Adequate lubricious coating adherence	Testing and evaluation of the guide wires included lubricious coating adherence. (Implies successful testing, as the device received clearance.)
Satisfactory Shelf Life (ongoing)	Shelf Life testing is currently being conducted and will be submitted when it is completed. (This indicates that full shelf life data was not available at the time of this submission but was considered an ongoing requirement.)
Use of same materials and construction methods as predicates	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). (This is a key component of substantial equivalence.)
Not intended for use in the cerebral vasculature	The device's intended use explicitly excludes the cerebral vasculature. (This is a limiting factor for device application, not a performance metric.)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the "Non-Clinical Test Summary." It mentions "testing and evaluation of the guide wires," which generally implies a sufficient number of samples were tested to demonstrate robust performance for each characteristic.

The data provenance is prospective as the testing was conducted on the physical device itself for the purpose of demonstrating its safety and effectiveness for a 510(k) submission. There is no information regarding the country of origin of the data, but it can be inferred that the testing was performed by the manufacturer, SCIMED Life Systems, Inc., which is based in Maple Grove, MN, USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable to this type of device and study. The "Non-Clinical Test Summary" describes physical and mechanical property testing, not subjective assessments by experts. The "ground truth" for these tests would be objective measurements against defined engineering specifications.

4. Adjudication Method for the Test Set

This information is not applicable. Since the testing involved objective physical and mechanical measurements, an adjudication method for different expert opinions would not be relevant.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or other data. The SCIMED Quest Guide Wires are interventional devices, and their performance is assessed through physical and mechanical testing, not by comparing human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This information is not applicable. The SCIMED Quest Guide Wires are physical medical devices, not algorithms or AI. Therefore, the concept of "standalone performance" for an algorithm is irrelevant in this context.

7. The Type of Ground Truth Used

The ground truth used for the "Non-Clinical Test Summary" was based on objective engineering and material science specifications and established testing methodologies. For example:

Physical measurements: For parameters like tip flexibility, torque response, etc.
Mechanical strength standards: For tensile strength, torsion strength, shear strength.
Material properties: For coating adherence and compatibility.
Predicate device performance: The document explicitly states that the device "utilize the same materials and methods of construction as the currently marketed SCIMED Guide Wires (ChoICE, Luge and Sceptor Families of Guide Wires)," implying that the predicate devices set a benchmark for acceptable performance.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant to machine learning and AI, which are not involved in the development or testing of this physical medical device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

{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 PlaceMaple 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 andModerate Support Guide Wires
Name of PredicateDevices	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 aresteerable guide wires available in a nominal diameter of 0.014 inchesand nominal lengths of 182 and 300 centimeters. The available tipflexibilities will be Floppy and Moderate Support. The distal twocentimeters of both models are radiopaque and available in either astraight shapeable or a pre-formed J-Tip.
Intended Use	The SCIMED Quest Floppy and Moderate Support Guide Wires areintended to facilitate the placement and exchange of balloondilatation catheters or other therapeutic devices during PTCA or otherintravascular interventional procedures. The Quest Floppy andModerate Support Guide Wires are not intended for use in thecerebral vasculature. The devices are provided sterile and intendedfor one procedure only.
Summary ofTechnologicalCharacteristics	The SCIMED Quest Floppy and Moderate Support Guide Wiresutilize the same materials and methods of construction as thecurrently marketed SCIMED Guide Wires (ChoICE, Luge andSceptor Families of Guide Wires).
Non-Clinical TestSummary	Testing and evaluation of the guide wires included tip tensilestrength, tip torsion strength, combined load strength, tip flexibility,tip prolapse, J-tip curve retention, torque response, proximal springcoil joint shear strength, PTCA catheter compatibility/wire movementand lubricious coating adherence. Shelf Life testing is currentlybeing 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

Regulation Number and Section

§ 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.