The Imager II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system including the carotid arteries.

Device Description

The 4F and 5F Imager™ II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters. These catheters are available in a variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90 cm, and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy. Clinically, flush catheters are used to deliver a bolus of contrast to a patient when obtaining an image of a large area (aorta, leg-run off, etc.). Side-holes are added to disperse the contrast. Selective catheters are used to create images of specific areas of interest.

AI/ML Overview

This 510(k) summary (K120893) describes the Imager™ II Angiographic Catheter, a diagnostic intravascular catheter. The submission focuses on demonstrating substantial equivalence to a predicate device (K050863) regarding its packaging configuration after multiple sterilization, climatic conditioning, and distribution simulation. No clinical studies were conducted for this submission.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for packaging)	Reported Device Performance (Summary of Non-Clinical Testing)
Performance after multiple sterilization, climatic conditioning, and distribution simulation is substantially equivalent to the predicate device.	- Visual Inspection performed.
	- Dye Penetration Testing performed.
	- Peel Testing performed.
	- Catheter Removal Force Testing performed.

Note: The document states "Design verification testing as listed below was performed to verify the performance...is substantially equivalent to the predicate device." It does not provide specific quantitative acceptance criteria or detailed numerical results for each test. Instead, it lists the types of tests conducted to support the claim of substantial equivalence for the packaging.

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

Sample Size: Not explicitly stated for each non-clinical test. The document mentions "Design verification testing" but does not detail the number of units tested.
Data Provenance: The tests are described as "Design verification testing" performed by Boston Scientific Corporation. This implies the data is prospective and generated from internal testing. No country of origin for the data is specified beyond Boston Scientific being based in the US.

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

Not Applicable. This submission is for a medical device (angiographic catheter) and its packaging. The "ground truth" here relates to the physical and mechanical integrity of the packaging, which is assessed through engineering and quality control tests, not expert interpretation of clinical images or data.

4. Adjudication Method (for the test set)

Not Applicable. There is no "adjudication" process in the context of package integrity testing like there would be for image interpretation by clinicians. The tests are objective measurements or observations.

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

No. This was not a clinical or comparative effectiveness study involving human readers.

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

No. This device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests on packaging, the "ground truth" would be established by engineering specifications, industry standards, and internal quality control criteria for package integrity. For example, a "Pass/Fail" result for dye penetration would be determined by whether dye was observed past a certain barrier, which is an objective measurement based on defined criteria.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not Applicable. As above, no training set was involved.

Summary

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K120893 page 1 of 1

MAR 2 9 2012

510(k) Summary per 21 CFR §807.92

Sponsor:	Boston Scientific CorporationOne Boston Scientific PlaceNatick MA 01760
Contact Person:	Anne Rossi
Phone Number:	763-255-0681
Fax Number:	763-494-2222
Prepared:	22 March 2012
Trade Name:	Imager™ II Angiographic Catheter
Common Name:	Diagnostic Intravascular Catheter
Classification:	II
Product Code:	DQO / 21 CFR 870.1200
Predicate Device:	Imager II Angiographic Catheter (K050863; 02 September 2005)

Device Description:

Intended Use:

The Imager II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system including the carotid arteries.

Substantial Equivalence:

The modified Imager II Angiographic Catheter packaging configuration is substantially equivalent to the Imager II Angiographic Catheter (K050863, cleared 02 September 2005) packaging configuration.

Summary of Non-Clinical Testing:

Design verification testing as listed below was performed to verify the performance of the Imager II Angiographic Catheter packaging after multiple sterilization, climatic conditioning and distribution simulation conditioning is substantially equivalent to the predicate device.

� Visual Inspection
� Dve Penetration Testing
Peel Testing �
� Catheter Removal Force Testing

Summary of Clinical Testing:

Clinical Evaluation was not required for these devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the top half of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR 2 9 2012

Boston Scientific Corp. c/o Ms. Anne Rossi Manager, Regulatory Affairs One Scimed Place Maple Grove, MN 55311-1566

Re: K120893

Trade/Device Name: Imager II Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (two) Product Code: DQO Dated: 22 March, 2012 Received: 22 March, 2012

Dear Ms. Rossi:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Ms. Anne Rossi

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): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

C.M.A. Hillebrand

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

Enclosure

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Indications for Use

510(k) Number (if known): K 120893

Device Name: IMAGER II Angiographic 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 including the carotid arteries.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.S. Hillelson

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number K120893

Page 1 of 1

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).