The SCIMED 6 French IMPULSE™ Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.

Device Description

The 6 French SCIMED IMPULSE Angiographic Catheters are single lumen catheters which will be available in Selective, Pigtail and Multipurpose models. The shafts of all models utilize common biocompatible materials and consist of the following three layers: 1) The inner layer provides a smooth surface to allow for dye delivery and ease of guide wire movement. 2) The middle layer provides torque control, kink resistance and support, and 3) The outer layer provides stiffness and curve retention. Radiopaque materials are utilized in the outer layer to allow visualization of the catheter during the procedure. A Pigtail Straightener is available to aid the physician in straightening the Pigtail curve while being introduced into the introducer sheath.

AI/ML Overview

The medical device, SCIMED® 6 French IMPULSE™ Angiographic Catheters, did not provide acceptance criteria in a structured manner but rather demonstrated substantial equivalence to predicate devices through non-clinical functional testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred from Functional Testing)	Reported Device Performance
Pressure burst: Catheter withstands internal pressure without bursting.	Verified as adequate for intended use.
Tip bond tensile: Strength of the bond between catheter tip and shaft.	Verified as adequate for intended use.
Hub tensile: Strength of the bond between catheter hub and shaft.	Verified as adequate for intended use.
Dye flow: Ability to deliver contrast media effectively.	Verified as adequate for intended use.
Tip coefficient of friction: Low friction at the tip for smooth navigation.	Verified as adequate for intended use.
Force transmitted by catheter tip: Ability to transmit force for maneuvering.	Verified as adequate for intended use.
Torque response: Ability to transmit rotational force for steering.	Verified as adequate for intended use.
Torque to fail: Resistance to twisting force before damage occurs.	Verified as adequate for intended use.

Study Details:

Study Type: Non-clinical (in-vitro) functional testing and comparison study for substantial equivalence.
Device: SCIMED® 6 French IMPULSE™ Angiographic Catheters.
Predicate Devices: SCIMED® 6 French EXPO™ Angiographic Catheter and SCIMED 5 French IMPULSE™ Angiographic Catheter.

2. Sample Size and Data Provenance:

Test Set Sample Size: Not explicitly stated. The document mentions "functional testing" but does not quantify the number of catheters or tests performed for each criterion.
Data Provenance: The study was non-clinical (in-vitro) and conducted by SCIMED Life Systems, Inc. The country of origin for the data is not specified beyond being generated by the submitter (SCIMED Life Systems, Inc. in Maple Grove, Minnesota, USA). The study is prospective in the sense that these tests were performed on the new device for regulatory submission.

3. Number of Experts and Qualifications for Ground Truth: Not applicable. This was a non-clinical, in-vitro functional testing study, not a study involving human interpretation or expert consensus for ground truth.

4. Adjudication Method: Not applicable. This was a non-clinical, in-vitro functional testing study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter), not an AI algorithm or imaging device that would typically involve human readers interpreting cases.

6. Standalone Performance Study:
Yes, a standalone study was done in the sense that the device's functional performance was evaluated independently against engineering specifications and industry standards (implicitly, by demonstrating "adequacy for intended use" and "substantial equivalence"). The "algorithm only" context is not relevant here as it is a physical device.

7. Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" was established by pre-defined engineering specifications, performance standards, and the demonstrated performance of predicate devices. For example, a catheter must withstand a certain pressure to pass the pressure burst test.

8. Sample Size for the Training Set: Not applicable. This is not an AI/machine learning study requiring a training set.

9. How Ground Truth for the Training Set was Established: Not applicable. This is not an AI/machine learning study requiring a training set.

Summary

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Section 4

Summary of Safety and Effectiveness

(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)

FEB 2 3 1998

I. General Provisions

Submitter's Nameand Address	SCIMED Life Systems, Inc.One SCIMED PlaceMaple Grove, Minnesota 55311
Contact Person	Melanie Raska(612) 494-2962
Classification Name	Diagnostic Intravascular Catheters(21CFR Part 870.1200)
Common or Usual Name	Diagnostic Intravascular Catheter
Proprietary Name	SCIMED® 6 French IMPULSE™Angiographic Catheters
Name of Predicate Devices	SCIMED® 6 French EXPO™ AngiographicCatheter, and SCIMED 5 FrenchIMPULSE™ Angiographic Catheter

III. Device Description

II.

The 6 French SCIMED IMPULSE Angiographic Catheters are single lumen catheters which will be available in Selective, Pigtail and Multipurpose models.

The shafts of all models utilize common biocompatible materials and consist of the following three layers: 1) The inner layer provides a smooth surface to allow for dye delivery and ease of guide wire movement. 2) The middle layer provides torque control, kink resistance and support, and 3) The outer layer provides stiffness and curve retention. Radiopaque materials are utilized in the outer layer to allow visualization of the catheter during the procedure.

A Pigtail Straightener is available to aid the physician in straightening the Pigtail curve while being introduced into the introducer sheath.

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Section 4

IV. Intended Use

The SCIMED IMPULSE Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.

V. Summary of Technological Characteristics

The 6 French SCIMED IMPULSE Angiographic Catheters are a modification of SCIMED's currently marketed 5 French Impulse Angiographic Catheters.

VI. Non-clinical Test Summary

Functional testing consisted of pressure burst, tip bond tensile, hub tensile, dye flow, tip coefficient of friction, force transmitted by catheter tip, torque response and torque to fail. Test results verified that the 6 French IMPULSE Angiographic Catheters are adequate for their intended use. The 6 French IMPULSE Angiographic Catheters are considered substantially equivalent to angiographic catheters currently marketed by SCIMED based on a comparison of intended use, the design and the results of in-vitro testing and evaluation.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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FEB 2 3 1998

Ms. Melanie Raska Regulatory Affairs Specialist SCIMED Life Systems, Inc. One SCIMED Place Maple Grove, MN 55311-1566

Re: K974559 SCIMED® 6 French IMPULSE™ Angiographic Catheters Regulatory Class: II (two) Product Code: DOO Dated: December 4, 1997 Received: December 5, 1997

Dear Ms. Raska:

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 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, Druq, 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 obligation 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 regulations.

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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) 594-4648. 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" (21 CFR 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/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

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Section 2

Indications for Use

510(k) Number (if known) 1474559

Device Name: SCIMED® 6 French IMPULSE™ Angiographic Catheters

Indications for Use:

The SCIMED 6 French IMPULSE™ Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system ----------during an angiographic procedure.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over The Counter Use

(Division Sign Off)

Division of Cardiovascular, Respirator(Optional Format 1-2-96)
and Neurological Devices

510(k) Number	K974559
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Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).