The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.

Device Description

The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is a two-layer construction comprised of a stainless steel mesh sandwiched between layers of polyurethane polyamide elastomer. The polyurethane polyamide elastomer contains barium sulfate for visibility and contrast under fluoroscopy. There is a hydrophilic coating on the distal portion of the device. The length of the coating is determined by the product code number.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, the RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP). Given the nature of a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove performance against specific acceptance criteria through a clinical study in the way one might for a novel device requiring a PMA.

Here's an analysis of the provided text in response to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific quantitative acceptance criteria in the way a clinical trial might for a new device's performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating that the device's performance characteristics are substantially equivalent to the predicate device.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance
Intended Use Equivalence: Same intended use as predicate device.	"The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site." This is stated to be substantially equivalent to the predicate.
Design/Materials Equivalence: Same design and materials as predicate device.	"The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) in this submission is the same device that was cleared under K915414, the Terumo Angiographic Catheter. There are no changes in the design or materials."
Technology/Principles of Operation Equivalence: Same technology/principles of operation as predicate device.	"The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is operated manually or by a manual process." This is stated to be substantially equivalent to the predicate.
Performance Equivalence (Risk/Hazard Analysis): Performance characteristics are substantially equivalent, justified by a risk/hazard analysis and comparison to predicate.	"A risk/hazard analysis was conducted according to EN ISO 14971... Performance characteristics for this new indication for use were determined. Then it was justified that the performance of the RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is substantially equivalent to the performance of the Terumo Angiographic Catheter cleared under K915414." Specific performance metrics (e.g., maximum injection pressure by size) are provided as specifications, which are implicitly considered equivalent or acceptable.
Biocompatibility: Blood contacting materials are biocompatible.	"Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1... Results of the testing demonstrate that the blood contacting materials are biocompatible."
Sterilization: Sterilization conditions are validated to a SAL of 10⁻⁶.	"Sterilization conditions have been validated in accordance with EN ISO 11135-1... The device is sterilized to a SAL of 10⁻⁶."
Manufacturing Controls: Visual, functional, dimensional, and sterility tests are in place.	"Manufacturing controls include visual, functional, dimensional and sterility tests."

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

The submission does not describe a test set or data provenance in the context of a clinical study or a performance evaluation against a specific set of clinical data. This is because the submission is for a 510(k) where substantial equivalence is being claimed with a predicate device with no changes in design or materials. The "performance" section refers to a risk/hazard analysis and a justification of equivalence, not a new comparative study using a clinical test set. The biocompatibility and sterilization validation are described, which would use specific samples for those tests, but not a general "test set" for overall device performance in a clinical sense.

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

This information is not applicable and not provided. As explained above, there was no clinical "test set" requiring ground truth established by experts for performance evaluation in this 510(k) submission.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI

This information is not applicable and not provided. This device is a manual, physical catheter; it does not involve AI or any software requiring a multi-reader multi-case study.

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

This information is not applicable and not provided. This device is a medical catheter and does not involve any algorithms.

7. The Type of Ground Truth Used

This information is not applicable and not provided for a clinical performance test set. The "ground truth" here is essentially the already-cleared performance and characteristics of the predicate device (K915414, the Terumo Angiographic Catheter) against which the current device is deemed substantially equivalent due to being the same design and materials.

8. The Sample Size for the Training Set

This information is not applicable and not provided. Since there's no machine learning or AI algorithm involved, there's no concept of a "training set."

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

This information is not applicable and not provided for the same reasons as #8.

Summary of the Study Proving Acceptance Criteria (Substantial Equivalence):

The "study" in this context is the 510(k) submission itself, which argues for substantial equivalence to a predicate device (K915414, the Terumo Angiographic Catheter).

Proof of Equivalence: The key "proof" lies in the explicit statement: "The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) in this submission is the same device that was cleared under K915414, the Terumo Angiographic Catheter. There are no changes in the design or materials."
Risk Analysis: A risk/hazard analysis (according to EN ISO 14971) was performed to ensure that the identical device (now with a slightly different name/marketing) still meets safety standards and that its performance characteristics remain acceptable and equivalent to the already-cleared predicate.
Biocompatibility Testing: Blood contacting materials were tested according to ISO 10993 to confirm biocompatibility.
Sterilization Validation: Sterilization processes were validated according to EN ISO 11135-1 to ensure sterility.
Manufacturing Controls: Ongoing manufacturing controls (visual, functional, dimensional, sterility tests) are in place to ensure consistent quality.

Conclusion:

This 510(k) submission represents a situation where the device is claimed to be identical in design and materials to a previously cleared predicate device. Therefore, the "acceptance criteria" are largely met by demonstrating that the device is the predicate device, and the "study" is the documentation proving this identity and confirming standard manufacturing and biological safety aspects. No new clinical performance studies comparing it to a control or evaluating its accuracy against a ground truth dataset were required or performed because the device itself is not new.

Summary

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FEB = 6 2009

SECTION II. 510(K) SUMMARY

A. Device Name

Proprietary Name:	RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP)
Classification Name:	Diagnostic Intravascular Catheter
Common Name:	Angiographic Catheter

B. Intended Use

C. Device Description

D. Principle of Operation / Technology

The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is operated manually or by a manual process.

E. Design / Materials

The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) in this submission is the same device that was cleared under K915414, the Terumo Angiographic Catheter. There are no changes in the design or materials.

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Terumo Corporation Premarket Notification - RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) Section II. 510(k) Summary

F. Specifications

Available Sizes	4 & 5 Fr.
Catheter Length	30 - 150 cm
Maximum InjectionPressure	4 Fr.: 750 psi5 Fr.: 1000 psi

G. Performance

A risk/hazard analysis was conducted according to EN ISO 14971 Medical Devices -Application of risk management to medical devices. Performance characteristics for this new indication for use were determined. Then it was justified that the performance of the RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is substantially equivalent to the performance of the Terumo Angiographic Catheter cleared under K915414.

H. Additional Safety Information

Manufacturing controls include visual, functional, dimensional and sterility tests.

Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing".

The catheter is classified as Externally Communicating Devices, Circulating Blood, limited Contact (<24 hrs). Results of the testing demonstrate that the blood contacting materials are biocompatible.

Sterilization conditions have been validated in accordance with EN ISO 11135-1, Sterilization of health care products - Ethylene Oxide - Part 1: Requirements for development, validation and routine control of sterilization process for medical devices. The device is sterilized to a SAL of 10°.

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Terumo Corporation Premarket Notification - RADIFOCUs® Glidecath® (or RADIFOCUS Glidecath XP) Section II. 510(k) Summary ・

H. Substantial Equivalence

The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate device the Terumo Angiographic Catheter, cleared under K915414. Differences between the devices do not raise any significant issues of safety or effectiveness.

I. Submitter Information

Prepared By:	Mr. Mark UnterreinerSr. Regulatory Affairs Specialist
Prepared For:	Terumo Medical Corporation950 Elkton Blvd.Elkton, MD 21921
	Phone: (410) 392-7213
	Fax: (410) 398-6079
	Email: mark.unterreiner@terumomedical.com
Date Prepared:	December 22, 2008

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

FEB = 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Terumo Medical Corp. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313

Re: K090040

Trade/Device Name: RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) Common Name: Diagnostic intravascular catheter Regulation Number: 21 CFR 870.1200 Regulatory Class: II Product Code: DQO Dated: January 23, 2008 Received: January 26, 2008

Dear Mr. Job:

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); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Mark Job

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. product rainline in 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0210. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

R-vichner

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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Indications for Use

510(k) Number (if known): K090040

RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) Device Name:

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Vi. Lunes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ko 900 40

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).