The PROGREAT Catheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels in the lower and upper extremities and all coronary vessels. The PROGREAT Catheter is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Catheter should not be used in cerebral vessels.

Device Description

The PROGREAT catheter is available with or without the following accessories: guide wire, inserter, mandrel (stylet), syringe, wire stopper, and Y-connector. The catheter consists of metal coil reinforced multi-layer polymer tubing. The coil is embedded in the catheter wall the entire length of the catheter. This increases the flexibility, kink resistance, and pressure resistance of the catheter. The inner layer of the catheter is made of PTFE (polytetrafluoroethylene) to ensure smooth movement of devices such as the guide wire. The outer surface of the catheter is coated with a hydrophilic polymer which becomes lubricious when wet with saline solution or blood.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the PROGREAT Catheter, asserting its substantial equivalence to a predicate device, the GT LEGGIERO (K981359). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance tests conducted to demonstrate this substantial equivalence.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table labeled "acceptance criteria." Instead, it lists "verification tests" performed to demonstrate substantial equivalence to the predicate device. For each test, it implicitly states that the performance was satisfactory to deem the device substantially equivalent, meaning it met an internal standard set by the manufacturer to compare to the predicate.

Verification Test (Acceptance Criteria)	Reported Device Performance
Ease of removal from holder	Met (No new issues of safety and effectiveness raised)
Frictional resistance of catheter and guide wire	Met (No new issues of safety and effectiveness raised)
Joint strength of hub on catheter and guide wire	Met (No new issues of safety and effectiveness raised)
Pressure resistance of catheter	Met (No new issues of safety and effectiveness raised)
Kink resistance	Met (No new issues of safety and effectiveness raised)

In addition to these performance tests, the device also met biological and sterilization acceptance criteria:

Acceptance Criteria	Reported Performance
Biocompatibility (for blood contacting materials)	Blood contacting materials tested in accordance with FDA G95-1; results demonstrate biocompatibility.
Sterilization	Validated in accordance with AAMI/ANSI/ISO 11135 to a SAL of 10⁻⁶; ETO residuals within limits.

2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the specified verification tests (e.g., Ease of removal, Frictional resistance, etc.). These are likely internal engineering tests, and the exact number of units tested is not typically disclosed in the public summary. The data provenance is internal to the manufacturer, Terumo Medical Corporation, for the "modified device (PROGREAT catheter)." These would be prospective tests performed during the development and verification phase of the PROGREAT catheter.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this 510(k) submission. The "ground truth" for the performance tests mentioned (e.g., frictional resistance, kink resistance) would be the physical properties and performance characteristics of the predicate device (GT LEGGIERO K981359) and established engineering standards. There is no mention of human expert consensus being used to establish the "ground truth" for these physical device performance characteristics.

4. Adjudication Method for the Test Set
Not applicable. The verification tests are objective physical and mechanical tests, not subjective evaluations requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a physical medical device (angiographic catheter), not an AI imaging or diagnostic algorithm. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence for the PROGREAT Catheter primarily relied on:

Predicate Device Performance: The established performance characteristics of the GT LEGGIERO (K981359) served as the benchmark for comparison.
Engineering Standards: Standardized tests for mechanical properties (e.g., pressure resistance, kink resistance, joint strength) and material properties were used.
Regulatory Standards: Biocompatibility was assessed against FDA General Program Memorandum #G95-1 (ISO-10993), and sterilization against AAMI/ANSI/ISO 11135.

8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no training set for this type of device submission.

Summary

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SECTION II. SUMMARY AND CERTIFICATION

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

Device Name A.

Proprietary Name	PROGREAT
Classification Name	Diagnostic Intravascular Catheter
Common Name	Angiographic Catheter

B. Intended Use

Note: This is the same intended use as the predicate device - GT LEGGIERO K981359.

C. Device Description

The PROGREAT catheter is available with or without the following accessories: guide wire, inserter, mandrel (stylet), syringe, wire stopper, and Y-connector.

The catheter consists of metal coil reinforced multi-layer polymer tubing. The coil is embedded in the catheter wall the entire length of the catheter. This increases the flexibility, kink resistance, and pressure resistance of the catheter. The inner layer of the catheter is made of PTFE (polytetrafluoroethylene) to ensure smooth movement of devices such as the guide wire. The outer surface of the catheter is coated with a hydrophilic polymer which becomes lubricious when wet with saline solution or blood.

The following are accessories to the catheter and will be supplied in different configurations depending on the product code:

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The guide wire has a super-elastic alloy core and is surface coated with a hydrophilic polymer. This enhances advancement of the guide wire into a peripheral vessel.

The inserter is used to assist the physician in the placement of the guide wire within the catheter.

The mandrel (stylet) is used in the shaping of the catheter for procedures that require a catheter with a tip configuration other than straight.

The syringe is used in the priming of the catheter. The syringe can be filled with heparinized saline solution and then this solution can be injected into the catheter.

The wire stopper can be clipped onto the guide wire to adjust the protruding length of the guide wire.

The Y-connector can be used to connect a power injector unit to the end of the catheter for infusion of contrast media.

Principle of Operation / Technology D.

The PROGREAT catheter and the accessorics included in this 510(k) are operated manually or by a manual process.

Design / Materials E.

Differences in materials between the PROGREAT catheter and the GT LEGGIERO K981359 raise no new issues of safety and effectiveness.

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Terumo Medical Corporation Special 510k - PROGREAT Section II. Summary and Certification

Part	Progreat Catheter	GTLEGGIEROK981359
Available Sizes (Fr.)	2.8/2.7/2.4/2.0	2.9
Catheter length	100-150	100-150
Guide wire size	0.021"	none
Accessories	With guide wire-Syringe, inserter, Y-connector, mandrel (stylet),and wire stopper	Y-connector,mandrel(stylet)
	Without guide wire-Mandrel (stylet)

Specifications F.

Note: The syringe (2.5ml) is cleared under 510(k) K771205. The guide wire, inserter, Y-connector, and mandrel (stylet) are the same devices cleared under 510(k) K915414, Terumo Angiographic Catheter and K981359, GT Leggiero Catheter.

G. Performance

The PROGREAT catheter is available with or without the following accessories: guide wire, inserter, mandrel (stylet), syringe, wire stopper, and Y-connector. The wire stopper is a new accessory, all of the additional accessories are the same as the ones used with currently approved devices.

The following verification tests were performed to demonstrate the substantial equivalence of the modified device (PROGREAT catheter) to the unmodified device (GT LEGGIERO K981359).

Ease of removal from holder .
Frictional resistance of catheter and guide wire .
Joint strength of hub on catheter and guide wire .
Pressure resistance of catheter .
Kink resistance �

None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.

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Therefore the performance of the Progreat Catheter is substantially equivalent to the performance of the GT LEGGIERO, cleared under K981359.

H. Additional Safety Information

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

The PROGREAT catheter is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (<24 hrs). The device's 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". Results of the testing demonstrate that the blood contacting materials are biocompatible.

Sterilization conditions have been validated in accordance to AAMI/ANSI/ISO 11135 Medical Devices-Validation and Routine Control of Ethylene Oxide Sterilization. The device is sterilized to a SAL of 10℃. ETO residuals for the PROGREAT will not exceed the maximum limits proposed for Part 821 of Title 21 in FR June 23, 1978 (or as finalized or amended).

I. Substantial Equivalence

The PROGREAT catheter is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the Terumo GT LEGGIERO, cleared under K981359. Differences between the two devices do not raise any significant issues of safety or effectiveness.

J. Submitter Information

Prepared By:	Mr. Mark UnterreinerRegulatory Affairs Specialist
Prepared For:	Terumo Medical Corporation125 Blue Ball RoadElkton, MD 21921Phone: (410) 392-7213Fax: (410) 398-6079Email: mark.unterreiner@terumomedical.com
Date Prepared:	November 11, 2003

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three overlapping shapes that resemble human profiles or abstract forms, creating a sense of unity and connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2003

Terumo Medical Corporation c/o Mr. Mark Unterreiner Regulatory Affairs Specialist 125 Blue Ball Road Elkton, MD 21921

K033583 Re:
PROGREAT Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO Dated: November 11, 2003 Received: November 13, 2003

Dear Mr. Unterreiner:

We have reviewed your Section 510(k) premarket notification of intent to market the device
ty the indication in the classis of the device is substantially equivalent (for the We have reviewed your Section > IQC) premixited in Ur equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and have deemined the usedicate devices marketed in interstate
for use stated in the enclosure) to legally matered president device Device Amendments, for use stated in the enclosure) to legally market production in the vevice Amendments, or to
commerce prior to May 28, 1976, the enactment and of the Federal Food, Drug, commerce prior to May 28, 1976, the encordance with the provisions of the Federal Food, Drug,
devices that have been reclassified in accordance with the provisions of the Fed devices that have been reclassified in accordance wan the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a proval application (PMA).
The Act and Cosmetic Act (Act) that do not require apply of the general controls. Provisions of the Act. The
You may, therefore, market the device, subject to the general contralie You may, therefore, market the device, subject to the general veamnal registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act Include requirements as anst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
em If your device is classified (see above) nito entire) cass it topes affecting your device can
may be subject to such additional controls. Exist. In addition. FDA In additio may be subject to such additional controls. Existing major regal to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In a be found in the Code of Federal Regulations, True 20, and 20, and 2017 and Register.
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 Please be advised that FDA's issuance of a substinat optives with other requirements of the Act
that FDA has made a determination that your device enders . You must that FDA has made a determination inalyon dovice Federal agencies. You must
or any Federal statutes and regulations administered by registration and listin or any Federal statutes and regulations administered to registration and listing (21 l
comply with all the Act's requirements, including, but not limited to set comply with all the Act s requirements, including, but her mint of the only of the many as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirem

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Page 2 -- Mr. Mark Unterreiner

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (becalems or device as described in your Section 510(k) This letter will anow you to oegin manieting of substantial equivalence of your device to a legally premarket notification: "The PDA miding of casion 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 If you ucate specific advice 101 Jour 2011) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gelleral informational 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,

Thrashtz fr

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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Note: This is the same intended use as the predicate device, K981359

510(k) Number (if known):	K033583
Device Name:	PROGREAT

Indications For Use:

The PROGREAT Catheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels in the lower and upper vessers up to and morating vessels. The PROGREAT Catheter is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Catheter should not be used in cerebral vessels.

(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)	OR	Over-The-Counter Use
		(Optional Format 1-2-96)
(Division Sign-off)Division of Cardiovascular Devices
		12/14/03

510(K) Number K033583 (SM. K)

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).