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 and all coronary vessels. The Progreat is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Progreat should not be used in cerebral vessels.

Device Description

The Progreat catheter consists of metal coil reinforced multi-layer polymer tubing with a hydrophilic coating. The guidewire is comprised of an alloy core wire with radiopaque marker and hydrophilic coating. The subject 2.4 Fr Progreat catheter and 0.018" guidewire will be marketed as a combined unit and will be an extension of the existing Progreat product family. The design and technological characteristics of the subject 2.4 Fr Progreat with 0.018" guidewire are identical to the predicate 2.7 Fr Progreat with 0.021" guidewire.

The Progreat catheter is available with or without accessories. The accessories to the catheter are supplied in different configurations depending on the product code:

The Guidewire has a super-elastic alloy core and is surface coated with a hydrophilic polymer.
I The Inserter is used to assist the physician in the placement of the guidewire within the catheter.
I The Catheter Mandrel (stylet) is used in the shaping of the catheter for procedures that require a catheter with a tip configuration other than straight.
I The Syringe is used in the priming of the catheter.
. The Wire Stopper can be clipped onto the guide wire to adjust the length of the guidewire that extends past the catheter tip.
I The Catheter Stopper S can be clipped onto the catheter to adjust the insertion length of the catheter.
. The Y-connector can be used to connect a power injector unit to the end of the catheter for infusion of contrast media.

AI/ML Overview

The provided text is a 510(k) summary for the Progreat catheter, which is a medical device. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML-driven medical device.

Therefore, many of the requested criteria for AI/ML device studies (such as types of ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, I can extract information related to the device's technical specifications and the non-clinical tests performed to assess its performance against predetermined criteria.

Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria

This 510(k) submission for the Progreat (2.4 Fr Catheter with 0.018" Guidewire) aims to demonstrate substantial equivalence to its predicate device (K033583, Terumo Progreat). The acceptance criteria for this submission are primarily focused on ensuring that the modified device maintains the safety and effectiveness of the predicate device and conforms to applicable external and internal standards. The study supporting this is a series of non-clinical performance tests.

1. Table of Acceptance Criteria and the Reported Device Performance

The document states that "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life." While the specific numerical acceptance criteria for each test are not explicitly detailed in this summary, the types of performance tests conducted serve as the basis for these criteria.

Acceptance Criteria Category/Test Type	Reported Device Performance
Material/Surface Integrity	Met predetermined criteria
Radio-detectability	Met predetermined criteria
Mechanical Integrity:
- Fracture test	Met predetermined criteria
- Flexing test	Met predetermined criteria
- Peak tensile force of guidewire	Met predetermined criteria
- Torque Strength	Met predetermined criteria
- Torqueability	Met predetermined criteria
- Tip Flexibility	Met predetermined criteria
- Bending strength	Met predetermined criteria
Functional Performance:
- Sliding resistance	Met predetermined criteria
- Particulate evaluation	Met predetermined criteria
- Hermeticity test	Met predetermined criteria
- Shaping test	Met predetermined criteria
Dimensional Conformance	Met predetermined criteria
Biocompatibility	Deemed equivalent to predicate (materials, formulation, processing, sterilization, geometry are identical or not raising new concerns)
Sterilization	Deemed equivalent to predicate (identical method, not raising new concerns)
Shelf Life	2 years (Identical to predicate)

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

The document does not explicitly state the specific sample sizes for each non-clinical test conducted. It mentions that tests were performed on "non-aged and accelerated aged samples." The provenance of the data is from Terumo Corporation's Ashitaka Factory in Japan, where the device is manufactured and where these non-clinical tests were presumably conducted. This is retrospective in the sense that the testing was performed on manufactured devices to support the 510(k) submission.

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

This information is not applicable as the device is a physical medical instrument, not an AI/ML diagnostic tool requiring expert interpretation for ground truth. Performance was assessed against engineering specifications and industry standards.

4. Adjudication Method for the Test Set

This information is not applicable for a physical device's non-clinical performance testing. Adjudication methods like 2+1 or 3+1 typically apply to human interpretation of diagnostic images or data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, and such a study is not applicable for this type of medical device (intravascular catheter). This type of study is relevant for evaluating the impact of AI assistance on human reader performance in diagnostic tasks.

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

A standalone algorithm-only performance assessment was not conducted, as this device is a physical catheter and not an algorithm. This criterion is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests effectively refers to predetermined engineering specifications, design requirements, and relevant industry standards for intravascular catheters (e.g., ISO standards for medical devices, internal Terumo specifications). The tests confirm if the device meets these established benchmarks.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" applies to machine learning models, not to the manufacturing and testing of a physical medical device.

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

This information is not applicable for the reasons stated above.

Summary

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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

July 21, 2017

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

Ashitaka Factory of Terumo Corporation % Lauren Nitahara Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, New Jersey 08873

Re: K170223

Trade/Device Name: Progreat Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DOO Dated: June 30, 2017 Received: June 30, 2017

Dear Lauren Nitahara:

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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Kenneth J. Cavanaugh -S

for

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)

K170223

Device Name

Progreat

Indications for Use (Describe)

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, and all coronary vessels. The Progreat is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Progreat should not be used in cerebral vessels.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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K170223

510(K) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

SECTION

PAGE

A. SUBMITTER INFORMATION (807.92(a)(1))	2
B. DEVICE NAME (807.92(a)(2))	3
C. PREDICATE DEVICE (807.92(a)(3))	3
D. REASON FOR 510(k) SUBMISSION	3
E. DEVICE DESCRIPTION (807.92(a)(4))	4
F. INDICATIONS FOR USE (807.92(a)(5))	6
G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))	6
H. NON CLINICAL TESTS (807.92(b)(1))	8
I. CLINICAL TESTS (807.92(b)(2))	9
J. CONCLUSION (807.92(b)(3))	9

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SUBMITTER INFORMATION (807.92(A)(1)) A.

Prepared by: Lauren P. Nitahara Regulatory Affairs Specialist II Terumo Medical Corporation Tel. (732) 412-4129 Fax (732) 302-4905
Prepared for: Owner/Operator Terumo Corporation 44-1, 2-Chome, Hatagaya Shibuya-ku, Tokyo 151-0072 Japan Owner/Operator Number: 801 002 6

Manufacturer and Sterilization Facility (Applicant)

Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya, Shizuoka 418-0015 Japan Registration Number: 968 183 4

Contact Person: Lauren P. Nitahara Regulatory Affairs Specialist II Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, NJ 08873 USA Tel. (732) 412-4129 Fax (732) 302-4905 E-mail: lauren.nitahara@terumomedical.com

Date Prepared: January 24, 2017

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DEVICE NAME (807.92(A)(2)) B.

Proprietary Name:	Progreat
Common Name:	Continuous Flush Infusion Catheter
Classification Name:	Continuous flush catheter
Regulation Number:	21 CFR 870.1210
Regulatory Class:	Class II
Review Panel:	Cardiovascular
Product Code:	DQO

C. PREDICATE DEVICE (807.92(A)(3))

The legally marketed device(s) to which substantial equivalence is claimed:

. K033583, Terumo Progreat, manufactured by Ashitaka Factory of Terumo Corporation

REASON FOR 510(K) SUBMISSION D.

This Traditional 510(k) is being submitted in order to add a 0.018" guidewire to the 2.4 Fr Progreat catheter (K033583) for the purposes of establishing substantial equivalence to a legally marketed device. The 2.4 Fr Progreat catheter and 0.018" guidewire will be marketed as a combined unit and will be an extension of the existing Progreat product family.

There is no change between the subject and predicate with respect to indications for use or technology as a result of this submission.

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DEVICE DESCRIPTION (807.92(A)(4)) E.

Principle of Operation Technology

The Progreat (2.4 Fr Catheter with 0.018" Guidewire) submitted in this 510(k) and its predicate Progreat (K033583) are operated by a manual process.

Design / Construction

The Progreat catheter is available with or without accessories. The accessories to the catheter are supplied in different configurations depending on the product code:

The Guidewire has a super-elastic alloy core and is surface coated with a hydrophilic polymer.
I The Inserter is used to assist the physician in the placement of the guidewire within the catheter.
I The Catheter Mandrel (stylet) is used in the shaping of the catheter for procedures that require a catheter with a tip configuration other than straight.
I The Syringe is used in the priming of the catheter.
. The Wire Stopper can be clipped onto the guide wire to adjust the length of the guidewire that extends past the catheter tip.
I The Catheter Stopper S can be clipped onto the catheter to adjust the insertion length of the catheter.
. The Y-connector can be used to connect a power injector unit to the end of the catheter for infusion of contrast media.

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Device Specifications

The specifications for the Progreat are provided in the table below:

Name of Component	Modified Progreat	Current Progreat
Catheter*	Catheter Size	2.4 Fr	2.0, 2.4, 2.7, 2.8 Fr
	Catheter OD(Distal End)	0.77 ~ 0.84 mm	2.0 Fr.: 0.64 ~ 0.71 mm2.4 Fr.: 0.77 ~ 0.84 mm2.7 Fr.: 0.87 ~ 0.93 mm2.8 Fr.: 0.90 ~ 0.96 mm
	Catheter OD(Proximal End)	0.88 ~ 0.99 mm	2.0 Fr.: 0.84 ~ 0.94 mm2.4 Fr.: 0.88 ~ 0.99 mm2.7 Fr.: 0.91 ~ 0.99 mm2.8 Fr.: 0.94 ~ 1.00 mm
	Catheter EffectiveLengths‡	100, 110, 130, 150 cm	100 ~ 150 cm
	Part withoutHydrophilic Coating(from the proximal end)	60 cm	60 cm
Guidewire	Wire Diameter	0.018"	0.021"
	Wire Distal Tip Shape	Angled (70 degree) andDouble Angled	Angled (70 degree)
	Wire ProtrudingLength‡	100 mm	5 ~ 300 mm
Accessories	InserterCatheter Mandrel (stylet)2.5 ml Syringe with LockWire StopperCatheter Stopper SY-connector	InserterCatheter Mandrel (stylet)2.5 ml Syringe with LockWire StopperCatheter Stopper SY-connector

Table 5.1: Device Specifications
----------------------------------	--

Catheter is 510(k) cleared under K033583.

The length from the proximal anti-kink protector to the catheter distal tip.

: Guide wire protruding length is the length that the guide wire extends past the catheter tip.

Note: For the purposes of this submission, the Progreat under review is referred to as "Progreat (2.4 Fr Catheter with 0.018" Guidewire)." This Progreat (2.4 Fr Catheter with 0.018" Guidewire) will be added to the current products, which include the above specifications as cleared under K033583.

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INDICATIONS FOR USE (807.92(A)(5)) F.

The indications for use are identical to the predicate Progreat (K033583).

SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(A)(6)) G.

The Progreat (2.4 Fr. Catheter with 0.018" Guidewire) is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to:

I K033583, Terumo Progreat, manufactured by Ashitaka Factory of Terumo Corporation
A comparison of the technological characteristics is summarized in the table below.

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Characteristic	Modified Progreat	Current Progreat
Manufacturer	Ashitaka Factory of Terumo Corporation	Identical
Intended Use /Indication for Use	The Progreat is intended for the infusion ofcontrast media into all peripheral vessels upto and including the cervical vessels, allvessels in the lower and upper extremitiesand all coronary vessels. The Progreat is alsointended for drug infusion in intra-arterialtherapy and the infusion of embolicmaterials for hemostasis. The Progreatshould not be used in cerebral vessels.	Identical
OperationPrinciple	Manual	Identical
Design/Construction	The catheter consists of metal coil reinforcedmulti-layer polymer tubing with hydrophiliccoating. The guidewire has a super-elasticalloy core with a hydrophilic coating and0.018" diameter. Accessories consist ofInserter, Catheter Mandrel (stylet), Syringe,Wire Stopper, Catheter Stopper S, Y-connector.	Identical materialand constructionGuidewirediameter: 0.021"
Package	Individual package on which the productlabel and the peel-off labels are attached.The device is provided as 1 unit per package	Identical
Specifications	Effective length: 100, 110, 130, 150 cmCatheter size: 2.4 Fr.Guidewire size: 0.018"	Effective length:100-150 cmCatheter size:2.0, 2.4, 2.7, 2.8 Fr.Guidewire size:0.021"
Sterilization	Ethylene oxide	Identical
Shelf life	2 years	Identical

Table 5.2: Summary of Comparative Information

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NON-CLINICAL TESTS (807.92(B)(1)) H.

Performance Testing

Performance testing was conducted to ensure the safety and effectiveness of the Progreat throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device. The majority of the following performance tests were performed on non-aged and accelerated aged samples; Radio-detectability testing was performed on a non-aged sample since the metallic material which generates radiopacity does not change over time. The following performance tests were performed on the Progreat device:

Surface
Radio-detectability l
. Fracture test
I Flexing test
. Peak tensile force of guidewire
트 Torque Strength
I Torqueability
I Tip Flexibility
I Sliding resistance
l Particulate evaluation
' Bending strength
l Hermeticity test
Shaping test
트 Product dimensions

Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life.

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Biocompatibility

All the materials used in the subject Progreat (2.4 Fr Catheter with 0.018" Guidewire) are identical to the predicate Progreat (K033583). Both the subject Progreat and the predicate Progreat are identical in intended use, materials formulation, processing, sterilization, and geometry (with the addition of the length and guidewire diameter). Therefore, the differences between the subject Progreat and predicate Progreat do not raise any new concerns regarding the biocompatibility of the device.

Sterilization

The sterilization method used in the subject Progreat (2.4 Fr Catheter with 0.018" Guidewire) is identical to the predicate Progreat (K033583). Therefore, differences between the subject Progreat and predicate Progreat do not raise any new concerns regarding the sterilization of the device.

I. CLINICAL TESTS (807.92(B)(2))

This 510(k) does not include data from clinical tests.

J. CONCLUSION (807.92(B)(3))

In summary, the Progreat (2.4 Fr Catheter with 0.018" Guidewire), subject of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the predicate Progreat (K033583), manufactured by Ashitaka Factory of Terumo Corporation.

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).