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.

Device Description

The Impulse angiographic catheters and packaging materials are the same as the Impulse catheters currently on the market. The packaging materials for all SCIMED Angiographic catheters have recently been tested to support a 3 year shelf life.

AI/ML Overview

The provided document is a 510(k) notification for SCIMED Impulse Angiographic Catheters, specifically focused on extending the shelf life of the packaging to three years. It is not a study proving the device's clinical performance or a standalone algorithm. Therefore, many of the requested elements (like acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications, MRMC studies, and ground truth types) are not applicable to the information presented.

Here's an analysis based on the provided text, focusing on what is available about the shelf-life testing:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria	Reported Device Performance
Packaging Shelf Life	Packaging integrity and functionality maintained for 3 years. (Implied from the goal of the submission)	Packaging materials for all SCIMED Angiographic catheters have recently been tested to support a 3-year shelf life. (Specific test results are not provided in this summary.)

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

Sample Size: Not specified. The document states "Standard packaging testing was conducted to support a 3 year package shelf life," but does not detail the number of units tested.
Data Provenance: Not explicitly stated, but it's internal testing conducted by Boston Scientific SCIMED, Inc. for regulatory approval in the US. It's retrospective as the testing would have been completed prior to this submission.

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

Not applicable. The "ground truth" for packaging shelf life would be determined by laboratory testing results (e.g., burst strength, seal integrity, material degradation over time under accelerated aging conditions), not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As above, this is about physical/chemical testing, not human judgment on performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study relates to the clinical interpretation of medical images or diagnostic outputs by human readers, often with and without AI assistance. This document describes a shelf-life extension for catheter packaging, not a clinical diagnostic device or an AI algorithm.

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

No. This document does not describe an algorithm or AI device.

7. The Type of Ground Truth Used

For the packaging shelf-life study, the "ground truth" would be laboratory test results (e.g., physical integrity tests, sterility barrier tests, material characterization) conducted on aged packaging materials.

8. The Sample Size for the Training Set

Not applicable. No AI algorithm or training set is mentioned.

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

Not applicable. No AI algorithm or training set is mentioned.

Summary of Device and Study Information (Based on provided text):

Device: SCIMED Impulse Angiographic Catheters (specifically, their packaging for a 3-year shelf life).
Intended Use: To provide a pathway for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
Study Purpose: To support a 3-year shelf life for the device's packaging materials.
Study Type: Non-clinical packaging testing.
Conclusion (from the submission): "The packaging materials for all SCIMED Angiographic catheters have recently been tested to support a 3 year shelf life." This indicates the testing was successful in meeting the implicit acceptance criteria for a 3-year shelf life, allowing the FDA to clear the device with this extended shelf life.

Summary

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AUG 23 510(k) Notification SCIMED Impulse Angiographic Catheters 3 Year Shelf Life

Summary of Safety and Effectiveness

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

I. General Provisions

Section 3

Submitter's Nameand Address	Boston Scientific SCIMED, 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® Impulse Catheters
Name of Predicate Devices	SCIMED® Impulse Catheters

III. Device Description

II.

The Impulse angiographic catheters and packaging materials are the same as the I he Impulse anglographic catheters and parkaging materials for all
Impulse catheters currently on the market. The packaging materials for all Impulse cathelers currently on the market. "The parting of o
SCIMED Angiographic catheters have recently been tested to support a 3 year shelf life.

IV. Intended Use

Intended Use
SCIMED Impulse Catheters are designed to provide a pathway to be used for SCIMED Impuise Catherers are designed is provide is provider system during an angiographic procedure.

Summary of Technological Characteristics V.

Same as currently marketed Impulse catheters.

Non-clinical Test Summary VI.

Standard packaging testing was conducted to support a 3 year package shelf life.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 23 1999

Ms. Melanie Raska Boston Scientific SCIMED, Inc. One Scimed Place Maple Grove, MN 55311-1566

K992123 Re: R992123
Trade Name: SCIMED Impulse angiographic Catheters Regulatory Class: II (two) Product Code: 74 DQO Dated: June 22, 1999 Received: June 23, 1999

Dear Ms. Raska:

We have reviewed your Section 510(k) notification of intent to market We have reviewed your section 33 (), we determined the device is the device referenced above and no indications for use stated in the substantially equivalent (for the indreally is marketed in interstate
enclosure) to legally marketed predicate of the Medical enclosure) to regarly markeded promotiment date of the Medical commerce prior to May 20, 1970, const have been reclassified in Device Amendments, of to devices that notes food, Drug, and Cosmetic accordance with the provibions on arrest the device, subject to the
Act (Act). You may, therefore, market The general controls Act (Act). Tou may, choras of the Act. The general controls general controls provisions of the requirements for annual registration, and provisions of the nee moreans
listing of devices, good manufacturing practice, labeling, and fromibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special If your device Is classifica (boo abovel), it may be subject to such Controls) of Class III (Fremaines off additional controls. Existing major boy. Title 21, Parts 800 to a substantially equivalent determination assumes complance with 895. 895. A substancially equivalence as sense requirements, as set forth in the Current Good handralousing -----------------------------------------------------------------------------------------------------------------------------------------------CHE Quality System Regulation (2)
regulation (21 CFR Part 820) and that, through periodic on and manumbing regulation (21 crk rate 620) and 1604 (400) will verify such assumptions.
The Food and Drug Administration (FDA) will as momlatory che rood and Dray hamiliary GMP regulation may result in regulatory In addition, FDA may publish further announcements concerning action. action. In addreton, Ibis may range and of this response to your device in the reasing submission does not affect any obligation your premarket notification basis and submissions of the Act for devices you might have ander observed to Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Melanie Raska

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 at advertising of your device, please contact the promotion and
(301) 594-4639. Also please contact the Office of Compliance at (301) 594-4639. Also, please concace concact the office of Co.
"Misbranding by refer "Misbranding by reference to regulation entified,
"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/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

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510(k) Notification SCIMED Impulse Angiographic Catheters 3 Year Shelf Life

Indications for Use

510(k) Number (if known) __________

Device Name: SCIMED® Impulse Angiographic Catheters

Indications for 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.

Judith Danelson & Chris Sloan 9/22/9.

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

Labels	Values
510(k) Number	K992123

(PLEASE DO NOT WRITE BELOW THIS I INF. - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over The Counter Use_ ___________

(Optional Format 1-2-96)

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).