The IMAGER™II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system. The IMAGER™ Angiographic Catheters are sterile, single-use diagnostic intravascular catheters and are available in a variety of flush and selective curve styles with lengths of 40 cm, 65 cm, 90cm and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy.

AI/ML Overview

This document describes the Boston Scientific Imager™ II 4F Selective Angiographic Catheter, a diagnostic intravascular catheter. The provided text outlines its intended use and demonstrates its substantial equivalence to a predicate device through non-clinical testing. However, it does not contain information about an AI/ML powered device or any study that measures device performance against acceptance criteria in the context of an AI/ML system.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance for an AI/ML device.
Sample size and data provenance for a test set for an AI/ML device.
Number and qualifications of experts for ground truth for an AI/ML device.
Adjudication method for a test set for an AI/ML device.
Multi-reader multi-case (MRMC) comparative effectiveness study information for an AI/ML device.
Standalone performance information for an AI/ML device.
Type of ground truth used for an AI/ML device.
Sample size and ground truth establishment for a training set for an AI/ML device.

The document describes a traditional medical device (catheter) and its regulatory clearance process based on substantial equivalence to existing predicate devices, primarily through mechanical and functional performance testing.

Summary

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

General Provisions 6.1

Submitter's Nameand Address	Boston Scientific CorporationOne Scimed PlaceMaple Grove, Minnesota 55311
Contact Person	Heidi M. Erickson(763) 494-2564
Classification Name	Diagnostic IntravascularCatheters (21CFR Part 970.1200)
Common or Usual Name	Angiographic Catheter
Proprietary Name	Boston Scientific Imager™ II 4F SelectiveAngiographic Catheter
Name of Predicate Device	Boston Scientific Imager™ II 4F, 5F Flushand 5F Selective Angiographic Catheter

6.3 Device Description

6.2.1

6.4 Intended Use

The IMAGER™ II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system.

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Section 6: Summary of Safety and Effectiveness

KO22621

Summary of Technological Characteristics 6.5

Same as currently marketed Imager™ II Angiographic Catheters, cleared for market under K011664, September 7, 2001.

6.6 Non-clinical Test Summary

Functional testing consisted of dimensional verification, guidewire compatibility, tensile strength, torque response, insertion force, static burst strength, and flow rate. Biocompatibility and product shelf life testing were previously conducted on the predicate devices. Test results verified that the 4F Selective Imager™ Angiographic Catheters are adequate for the intended use. The 4F Selective Imager™ II Angiographic Catheters are considered substantially equivalent to the currently marketed 4F and 5F Flush and 5F Selective Imager™ Angiographic catheters based on a comparison of the intended use, the device design, and the results of testing and evaluation.

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Public Health Service

4 2002 SEP

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corporation c/o Ms. Heidi M. Erickson One Scimed Place Maple Grove, MN 55311

Re: K022621

Boston Scientific Imager™ II 4F Selective Angiographic Catheter Regulation Number: 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: 74 DQO Dated: August 6, 2002 Received: August 7, 2002

Dear Ms. Erickson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807);

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Page 2 - Ms. Heidi M. Erickson

labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer 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,

Da Teln

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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022621

Section 4:

Indications for Use

510(k) Number (if known) _______________

Device Name: 4F Selective Imager™ II Angiogaphic Catheter

Indications for Use:

The IMAGER™ II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system.

(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)

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).