SCIMED INFORMER PRESSURE WIRE SYSTEM by SCIMED LIFE SYSTEMS, INC.

The SCIMED Informer™ Pressure Wire System is intended to monitor the mean intravascular blood pressure and to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The phasic wave signal of the INFORMER Pressure Wire System is intended to facilitate placement of the wire. The INFORMER Pressure Wire is not intended for use in the cerebral vasculature. The SCIMED INFORMER Pressure Wire System is not intended to be used in combination with any H.F. surgical equipment. The SCIMED INFORMER Pressure Wire System is indicated for use with all physiological monitors that meet IEC 601-1, IEC 601-2-34 standards. These monitors are required to meet electrical isolation for Type CF applied parts.

Device Description

The SCIMED® Informer™ Pressure Wire System consists of the following components:

· a guide wire,
· a disposable transducer with attached cable, and
· a permanent cable.
The guide wire is a steerable coronary guide wire available in a nominal diameter of 0.014 inches, overall lengths of 185 and 300 centimeters, radiopaque tip lengths of 3 and 5 centimeters, straight and J-tip configurations and one tip flexibility that falls between the ChoICE Floppy and Intermediate models, similar to the ChoICE Extra Support. The guide wire is designed to monitor intravascular pressures and to facilitate the placement of balloon dilatation catheters.
The disposable transducer with attached cable converts hemodynamic pressure signals from the guide wire into electrical signals. This transducer interfaces with standard physiologic monitors to display the electrical signals in phasic waveforms via the permanent cable.

AI/ML Overview

The provided text describes a submission for a medical device called the SCIMED® Informer™ Pressure Wire System, seeking 510(k) clearance from the FDA. This type of submission focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than establishing de novo acceptance criteria and proving they are met through a specific study with statistical performance metrics.

Therefore, the requested information (acceptance criteria, specific study, sample sizes, expert ground truth, adjudication, MRMC, standalone performance, training set details) related to proving a device meets acceptance criteria is largely not applicable in the context of this 510(k) summary.

However, I can extract information related to the testing performed to demonstrate substantial equivalence, which serves a similar purpose in this regulatory pathway.

Here's a breakdown of the available information and what is not available based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria/Performance Metrics: Not explicitly stated as pass/fail criteria with numerical thresholds. The submission focuses on demonstrating "substantial equivalence" to predicate devices through various tests.
Reported Device Performance: The "Non-Clinical Test Summary" section briefly mentions the types of tests conducted.

Test Category	Description of Test / Performance Assessment
In-Vitro Tests
Informer™ Guide Wire	Standard guide wire tests were used to evaluate. (No specific performance metrics provided in this summary)
Disposable Transducer	Experienced standard ANSI/AAMI BP-22 testing. (No specific performance metrics provided in this summary)
Cable Testing	Included Cable Connection Cycling, Disposable Transducer Cable Connector Tensile, Transducer Housing/Cable Tensile, Strain Relief and Permanent Cable Connector Tensile. (No specific performance metrics provided in this summary)
Complete Informer™ System	System Response and Shelf Life testing was conducted. (No specific performance metrics provided in this summary)
In-Vivo Tests
Comparative Testing	Performed to compare pressure reading capabilities and guide wire performance characteristics to currently marketed devices. (No specific performance metrics provided, but implies comparison to predicates)

2. Sample sizes used for the test set and the data provenance:

Test Set Sample Size: Not specified in the provided text for any of the in-vitro or in-vivo tests.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The in-vivo testing suggests real-world data, but details are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. The safety and effectiveness summary for a 510(k) primarily relies on engineering performance tests and comparison to predicates, not expert-adjudicated ground truth in a clinical sense for a test set. The in-vivo tests would likely have involved medical professionals, but their role in establishing "ground truth" (e.g., for diagnostic accuracy) is not elaborated upon as this is not a diagnostic device.

4. Adjudication method for the test set:

Not applicable / Not provided. This concept is usually relevant for studies involving human interpretation or subjective assessments, which are not detailed here for this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is not an AI-powered diagnostic tool, and the concept of "human readers improve with AI vs without AI assistance" does not apply. The device's function is to directly measure pressure and facilitate catheter placement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device (guide wire, transducer, cable system) that operates in conjunction with physiological monitors and human clinical procedures. It doesn't have a "standalone algorithm" in the sense of AI or image analysis. Its "performance" is its ability to accurately measure pressure and perform its mechanical functions. The in-vivo and in-vitro tests mentioned describe its standalone operational performance.

7. The type of ground truth used:

For the in-vitro tests, the "ground truth" would be established by the physical standards and measurement techniques defined for each test (e.g., a calibrated pressure source for transducer accuracy, specified forces for tensile tests).
For in-vivo tests, the comparison of "pressure reading capabilities" and "guide wire performance characteristics" implies a comparison against existing, accepted methods or devices within a clinical setting. The specific "ground truth" for accuracy (e.g., what pressure reading is considered correct) would be determined by the reference standard used in the comparison (e.g., simultaneous measurement with a gold-standard pressure measurement system).

8. The sample size for the training set:

Not applicable / Not provided. This device is not an AI/machine learning device that requires a "training set" in the computational sense.

9. How the ground truth for the training set was established:

Not applicable. As above, this device does not utilize a training set.

Summary

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NOV 1 2 1998

Summary of Safety and Effectiveness

GeneralInformation	Submitter's Name and Address	SCIMED Life Systems, Inc.One SCIMED PlaceMaple Grove, MN 55311
	Contact Person	Jill Munsinger(612) 494-2359
	Classification Name(s)	Catheter Guide Wire, 21 CFR Part870.1330; Transducer, BloodPressure, Extra Vascular, 21 CFRPart 870.2850; Patient Transducerand Electrode Cable, 21 CFR Part870.2900
	Common or Usual Name(s)	PTCA Guide WireDisposable Pressure TransducerCable, Patient Transducer
	Proprietary Name(s)	SCIMED® Informer™ PressureWire System
	Product Code(s)	74 DQX (Catheter Guide Wire)74 DRS (Transducer, BloodPressure, Extra Vascular)74 DRA (Patient Transducer andElectrode Cable

Predicate Devices

The SCIMED® Informer™ Pressure Wire is substantially equivalent to the products listed on the following page.

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Summary of Safety and Effectiveness, continued
Intended Use	The SCIMED INFORMER™ Pressure Wire System is intended tomonitor the mean intravascular blood pressure and to facilitate theplacement of balloon dilatation catheters or other therapeutic devicesduring PTCA or other intravascular interventional procedures. Thephasic wave signal of the INFORMER Pressure Wire System isintended to facilitate placement of the wire. The INFORMER PressureWire System is not intended for use in the cerebral vasculature.
	The SCIMED INFORMER Pressure Wire System is not intended to beused in combination with any H.F. surgical equipment.
	The SCIMED INFORMER Pressure Wire System is indicated for usewith all physiological monitors that meet IEC 601-1, IEC 601-2-34standards. These monitors are required to meet electrical isolation forType CF applied parts.
Summary ofTechnologicalCharacteristics	The Informer™ System is substantially equivalent to the currentlymarketed SCIMED ChoICE™ and Sceptor PTCA Families of GuideWires, the Namic Perceptor™ DT Disposable Transducer, the MEDEXTranStar Pressure Transducer, the BAXTER Edwards Permanent CableModel PX-1800 and the Cardiometrics WaveWire/WaveMap PressureSystem.
Non-ClinicalTest Summary	In-Vitro testing and evaluations were performed on the Informer™ GuideWire, the Informer™ Disposable Transducer with Attached Cable, theInformer™ Permanent Cable and the complete Informer™ System.Standard guide wire tests were used to evaluate the Informer™ GuideWire. The Informer™ Disposable Transducer experienced standardANSI/AAMI BP-22 testing while the cable testing included CableConnection Cycling, Disposable Transducer Cable Connector Tensile,Transducer Housing/Cable Tensile, Strain Relief and Permanent CableConnector Tensile. System Response and Shelf Life testing wasconducted on complete Informer™ System units.
	Additionally, In-Vivo testing was conducted to compare pressurereading capabilities and guide wire performance characteristics tocurrently marketed devices.

Summary of Safety and Effectiveness, continued

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Product	510(k)	Clearance Date
ChoICE Guide Wire	K943192	November 22, 1994
ChoICE Guide Wire	K945129	March 3, 1995
ChoICE Guide Wire	K950141	March 3, 1995
ChoICE Guide Wire	K950113	March 31, 1995
ChoICE Guide Wire	K961015	May 15, 1996
ChoICE Guide Wire	K965063	March 4, 1997
ChoICE Guide Wire	K964551	May 21, 1997
Sceptor Guide Wire	K942333	August 31, 1994
Sceptor Guide Wire	K946240	March 31, 1995
Sceptor Guide Wire	K950534	April 28, 1995
Sceptor Guide Wire	K960563	April 29, 1996
Namic Perceptor DTDisposable Transducer	K910764	April 22, 1991
Medex TranStarPressure Transducer	K942377	August 16, 1994
Baxter EdwardsReusable PX-1800	K925638	October 18, 1993
CardiometricsWaveWire/WaveMapPressure System	K965140	August 18, 1997

Summary of Safety and Effectiveness, continued

Device Description

Predicate Devices, continued

The SCIMED® Informer™ Pressure Wire System consists of the following components:

· a guide wire,
· a disposable transducer with attached cable, and
· a permanent cable.

The guide wire is a steerable coronary guide wire available in a nominal diameter of 0.014 inches, overall lengths of 185 and 300 centimeters, radiopaque tip lengths of 3 and 5 centimeters, straight and J-tip configurations and one tip flexibility that falls between the ChoICE Floppy and Intermediate models, similar to the ChoICE Extra Support. The guide wire is designed to monitor intravascular pressures and to facilitate the placement of balloon dilatation catheters.

The disposable transducer with attached cable converts hemodynamic pressure signals from the guide wire into electrical signals. This transducer interfaces with standard physiologic monitors to display the electrical signals in phasic waveforms via the permanent cable.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, depicted in a minimalist, abstract design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 1998

Ms. Jill Munsinger Regulatory Affairs Associate SCIMED Life Systems, Inc. One Scimed Place Maple Grove, MN 55311-1566

Re: K974241 SCIMED® Informer™ Pressure Wire System Trade Name: Requlatory Class: II Product Code: DQX Dated: August 13, 1998 Received: August 14, 1998

Dear Ms. Munsinger:

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 regulation 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 obligation

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Page 2 - Ms. Jill Munsinger

you might 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 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 requlation 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahar , Ph.D Director Division of Cardiovascular, Respiratory And Neurolgoical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number	K974241
Device Name	SCIMED® Informer™ Pressure Wire System
Indications for Use	The SCIMED Informer™ Pressure Wire System is intended to monitor the mean intravascular blood pressure and to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The phasic wave signal of the INFORMER Pressure Wire System is intended to facilitate placement of the wire. The INFORMER Pressure Wire is not intended for use in the cerebral vasculature. The SCIMED INFORMER Pressure Wire System is not intended to be used in combination with any H.F. surgical equipment. The SCIMED INFORMER Pressure Wire System is indicated for use with all physiological monitors that meet IEC 601-1, IEC 601-2-34 standards. These monitors are required to meet electrical isolation for Type CF applied parts.

510(k) Number

K974241

Device Name

SCIMED® Informer™ Pressure Wire System

Indications for Use

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(Division
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and IVC.
510(k) Number K974241
(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 CFR 801.109) OR

Over The Counter Use__________________________________________________________________________________________________________________________________________________________

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.