The Progreat™ is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, visceral vessels, and all coronary vessels. The Progreat is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis in procedures including but not limited to Uterine Fibroid Embolization. The Progreat should not be used in cerebral vessels.

Device Description

The Progreat catherer 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

This document outlines an application for clearance of a medical device, the Progreat™ catheter, based on substantial equivalence to a previously cleared device (K033583). As such, it does not contain a study report for the device meeting specific quantitative acceptance criteria in the way a medical AI product might.

Therefore, many of the requested sections (2-9) regarding sample size, ground truth, expert adjudication, and comparative effectiveness studies are not applicable to this type of regulatory submission (a 510(k) for substantial equivalence of a physical device with minor changes/expanded indications where no new performance data was required).

However, I can extract information related to the device description, intended use, and the basis for its perceived performance and safety as presented.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from text)	Reported Device Performance (from text)
Intended Use	Infusion of contrast media into specified peripheral, upper/lower extremity, visceral, and coronary vessels. Drug infusion in intra-arterial therapy and infusion of embolic materials for hemostasis (including UFE).	The Progreat™ is intended for these uses. (This reflects its design purpose, rather than a quantifiable performance metric in this context).
Safety (Biocompatibility)	Blood contacting materials must be biocompatible per FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993.	"Results of the testing demonstrate that the blood contacting materials are biocompatible."
Safety (Sterilization)	Sterilization conditions validated to a SAL of 10^-6 per AAMI/ANSI/ISO 11135 Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization. ETO residuals within maximum limits proposed for Part 821 of Title 21 in FR June 23, 1978.	"Sterilization conditions have been validated in accordance to AAMI/ANSI/ISO 11135... The device is sterilized to a SAL of 10^-6. ETO residuals for the Progreat will not exceed the maximum limits proposed..."
Performance (General)	Demonstrate performance substantially equivalent to the predicate device (K033583). No new issues of safety and effectiveness with expanded indications.	"This device is the identical device cleared under K033583... There were no new issues of safety and effectiveness with regards to the new indication. No additional testing was deemed necessary. Therefore the performance of the Progreat Catheter is substantially equivalent to the performance of the Progreat, cleared under K033583."
Design/Materials	Identical design and materials to previously cleared device (K033583).	"This device is the identical device cleared under K033583. There are no material or design changes therefore there are no new issues of safety and effectiveness."
Risk Management	Risk/hazard analysis conducted according to EN1441 and ISO 14971.	"A risk/hazard analysis was conducted according to EN1441 Medical devices- Risk analysis and ISO 14971 Medical Devices -Application of risk management to medical devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This submission is based on substantial equivalence to a prior device where no new performance testing data (i.e., a "test set") was required for the expanded indications. The performance is deemed identical to the predicate device due to identical design and materials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As no new performance studies were conducted, there was no test set requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set was used for performance evaluation in this submission.

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 is a physical medical device (catheter), not an AI diagnostic tool. No MRMC study was conducted.

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

Not Applicable. This is a physical medical device (catheter), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. Ground truth, in the context of performance studies for diagnostic or AI devices, is not relevant here as no such studies were performed for this substantial equivalence application. The "ground truth" for this device's safety and effectiveness relies on the previously cleared device's performance, safety, and the adherence to recognized standards for biocompatibility and sterilization.

8. The sample size for the training set

Not Applicable. This is a physical medical device. There is no "training set" in the context of AI or machine learning.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set, this question is not relevant.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" here is not an empirical performance trial but rather a demonstration of substantial equivalence to a previously cleared predicate device (K033583) and adherence to recognized standards.

The principal arguments for meeting acceptance criteria are:

Identical Device: The Progreat™ catheter submitted in K033913 is explicitly stated as being the "identical device" cleared under K033583, with no material or design changes. This implies that its performance characteristics (e.g., flexibility, kink resistance, pressure resistance, smooth movement of guide wires) are the same as the predicate.
Expanded Intended Use with No New Safety/Effectiveness Issues: The new application expands the intended use to include additional vessels and specific procedures like Uterine Fibroid Embolization. However, the submitter asserts that "There were no new issues of safety and effectiveness with regards to the new indication. No additional testing was deemed necessary." This implies that the existing safety and performance profile of the identical device is considered sufficient for these expanded indications.
Adherence to Standards:
- Risk Management: A risk/hazard analysis was performed according to EN1441 and ISO 14971, indicating a structured approach to identifying and mitigating risks.
- Biocompatibility: Blood-contacting materials were tested in accordance with ISO-10993, and results demonstrated they are biocompatible.
- Sterilization: Sterilization conditions were validated to a Sterility Assurance Level (SAL) of 10^-6 according to AAMI/ANSI/ISO 11135, and ETO residuals meet regulatory limits.
Accessories: The accessories supplied with the Progreat™ are also the "same as the ones used with the currently cleared device K033583."

In essence, the "proof" that the device meets acceptance criteria is the argument of substantial equivalence based on:

Being the exact same device as a previously cleared one.
Demonstrating that the expanded indications for use do not introduce new safety or effectiveness concerns.
Compliance with established regulatory standards for biocompatibility, sterilization, and risk management.

Summary

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SECTION II. SUMMARY AND CERTIFICATION

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

Device Name A.

Progreat™ Proprictary Name Classification Name Diagnostic Intravascular Catheter Angiographic Catheter Common Name

B. Intended Use

C. Device Description

The Progreat catherer 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:

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

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

The mandrel (stylct) 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 accessories included in this 510(k) are operated manually or by a manual process.

E. Design / Materials

This device is the identical device cleared under K033583. There are no material or design changes therefore there are no new issues of safety and effectiveness.

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Part	Progreat Catheter
Available Sizes (Fr.)	2.8/2.7/2.4/2.0
Catheter length	100-150
Guide wire size	0.021"
Accessories	With guide wire-Syringe, inserter, Y-connector, mandrel (stylet), and wire stopperWithout guide wire-Mandrel (stylet)

Specifications F.

Note: This is the same device cleared under K033583 only the intended use has changed for this premarket notification.

G. Performance

The Progreat catheter is available with or without the following accessories: guide wire, inserter, mandrel (stylet), syringe, wire stopper, and Y-connector. All of the accessories are the same as the ones used with the currently cleared device K033583. This device is the identical device that was cleared under K033583

A risk/hazard analysis was conducted according to EN1441 Medical devices- Risk analysis and ISO 14971 Medical Devices -Application of risk management to medical devices. There were no new issues of safety and effectiveness with regards to the new indication. No additional testing was deemed necessary.

Therefore the performance of the Progreat Catheter is substantially equivalent to the performance of the Progreat, cleared under K033583.

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

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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 106. 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 submitted in this 510(k) is substantially equivalent in intended use, design, technology/principles of operation, materials, and performance to the Progreat Catheter K.033583. It is also substantially equivalent in intended use and design, technology/principles of operation to the Boston Scientific Corporation Fas-Tracker-3256 Infusion Catheter cleared under K030966. Differences between the 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:	December 16, 2003

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Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mar 1 1 2004

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

Re: K033913

Progreat™ Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, continuous flush Regulatory Class: Class II Product Code: KRA Dated: March 2, 2004 Received: March 4, 2004

Dear Mr. Unterreiner:

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.

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Page 2 - Mr. Mark Unterreiner

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 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. 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), please contact the Office of Compliance at (301) 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 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Diana P. Vicheel

A 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): ___________ K033913 ______________________________________________________________________________________________________________________________________________________________________ Device Name:___________ Progreat™

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)

Donna R. Lachner

(Division Sign-Off) Division of Cardiovascular Devices

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510(k) number K033913

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).