ScoutPro Inner Catheters are indicated for the delivery of contrast media or Biotronik devices into the left ventricular coronary venous system. ScoutPro Inner Catheters are not intended to introduce left ventricular leads through their lumen.

Device Description

The Thomas Medical Products, Inc. (TMP) ScoutPro Inner Catheters are intended to access the coronary venous system, either alone or in a telescopic assembly with other introducers. The guide catheters serve as a conduit to guide devices, including guidewires, or to deliver contrast medium into specific branches of the coronary venous system. ScoutPro Inner Catheters are not intended to introduce left ventricular leads through their lumen. They have direct contact to the inner heart. ScoutPro Inner Catheters come with a 50° to 90° tip angle. They are designed as single use devices and for short term application (< 24 hours). Only medical doctors and medical personnel, who are well trained in cardiology, should apply these catheters.

The ScoutPro Inner Catheters are designed for guiding devices, including guidewires, with an outer diameter smaller than 1.1 mm. In addition, the ScoutPro Inner Catheters can work with outer catheters. The ScoutPro Inner Catheters are compatible with the following devices:

ScoutPro Guidewire @ 0.035" (BIOTRONIK #359805) -
ScoutPro hemostatic valve (BIOTRONIK #345779) -
Various ScoutPro 7F catheter shapes (Extended Hook Right BIOTRONIK#35937, Extended Hook -#350369, Straight #359371, MPEP #359373, BIO2 #359374, Amplatz 6.0 #350235, Hook #350236, Multipurpose Hook #350237, Extended Hook Right L #361531, Extended Hook L 3361530, Straight L #361536, MPEP L #361533, BIO2 L #361529, Amplatz 6.0 L #361527, Hook L #361532, Multipurpose Hook L #361534)
Commercially available Guide Wires (0.014" 0.035") -
Commercially available medical devices with male Luer-Lock (stopcocks, syringes) 1
-Commercially available fluid x-ray diagnostic contrast media.

The ScoutPro Inner Catheters have a shaft design with four (4) gradually decreasing stiffness segmentations from proximal to distal. The shaft is reinforced by a metal braid from the proximal end until approximately 32 mm from the distal end. The shaft is coated by a medical-grade coating that provides enhanced lubricity when advanced through an outer catheter or in the coronary vasculature.

The proximal end is equipped with a hub that has a female luer lock connector for adapting a syringe or a three way stopcock with luer lock connections. ,

There are differing versions in the curve form, 50° to 90° curve at the distal end, that is used according to the anatomy of the present coronary vasculature. The distal soft tip has a tapered outer diameter and the distal tip further contains a platinum/iridium marker ring for enhanced x-ray visibility.

Package contents:

One (1) guide catheter
One (1) 3-way stopcock
One (1) Instructions for use manual.

AI/ML Overview

The provided document describes a medical device, the "ScoutPro Inner Catheters," and its 510(k) summary for FDA clearance. This summary focuses on demonstrating "substantial equivalence" to predicate devices, rather than an independent clinical study proving specific acceptance criteria in the manner of a multi-reader multi-case (MRMC) or standalone algorithm study for AI.

Therefore, many of the requested sections regarding AI study design (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC study effect size, standalone algorithm performance, and training set details) are not applicable and cannot be extracted from this document. This document details engineering and bench testing to demonstrate that the device performs similarly to existing, cleared devices.

Here's an analysis based on the provided text, aligning with the sections where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly "Pass" for each test, indicating that the device met pre-defined internal specifications for safe and effective operation comparable to predicate devices. The document does not provide numerical thresholds for these "Pass" criteria but affirms that the device successfully met them.

Test Description	Acceptance Criteria (Implicit)	Reported Device Performance	Comments
Simulated Use Testing:
ScoutPro Inner Catheter insertion and removal forces of .014" and .035" guidewires	Pass	Pass	Demonstrated ability to safely introduce and withdraw specified guidewires.
insertion and removal forces through outer sheath and valve	Pass	Pass	Confirmed compatibility and ease of use with associated components.
shaft kink and buckling resistance	Pass	Pass	Indicated structural integrity under simulated use.
tip section kink, corrugation, and peel back resistance	Pass	Pass	Confirmed structural integrity of the critical distal tip region.
curve configuration after straightening	Pass	Pass	Ensured the catheter returns to its intended shape after manipulation.
shaft joint integrity when bend around mandrel	Pass	Pass	Verified the robustness of shaft connections under stress.
Physical/Dimensional Testing:
Stopcock leak resistance of stopcock/catheter assembly	Pass	Pass	Ensured secure connections to prevent fluid leakage.
ScoutPro Inner Catheter pull forces of shaft joints	Pass	Pass	Tested the strength of shaft segment connections.
pull force of hub/tube joint	Pass	Pass	Tested the strength of the connection between the hub and the main catheter shaft.
tube shaft O.D.	Pass	Pass	Verified the outer diameter conforms to specifications.
tip section O.D.	Pass	Pass	Verified the outer diameter of the tip conforms to specifications.
tip I.D.	Pass	Pass	Verified the inner diameter of the tip conforms to specifications.
length	Pass	Pass	Verified the overall length conforms to specifications.
curve configuration	Pass	Pass	Verified the shape and angle of the distal curve conform to specifications.

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

Sample Size: The document does not explicitly state the sample size (number of devices) used for each test. It only lists the tests performed and their outcomes ("Pass").
Data Provenance: The tests are described as "Testing" and appear to be bench testing conducted by the manufacturer, Thomas Medical Products - A GE Healthcare Company. This implies an internal, prospective testing methodology rather than a retrospective analysis of clinical data from specific countries.

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

Not Applicable: For this type of 510(k) submission based on bench testing for substantial equivalence, clinical expert ground truth establishment for a "test set" in the context of diagnostic performance is not relevant or described. The "ground truth" here is adherence to engineering specifications and performance in simulated scenarios, which would be assessed by engineers and quality assurance personnel.

4. Adjudication Method for the Test Set

Not Applicable: As this is bench testing against engineering specifications, there is no mention of an adjudication method in the sense of clinical reviewers or consensus. Each test would have pre-defined pass/fail criteria, and results would be recorded.

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 document describes a medical device (catheter) and its physical and mechanical performance, not an AI-powered diagnostic system. Therefore, an MRMC study or effect size related to AI assistance for human readers is not relevant and was not performed.

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

Not Applicable: This document is about a physical medical device (catheter), not an algorithm or AI system.

7. The Type of Ground Truth Used

For the bench and simulated use testing, the "ground truth" is based on engineering specifications and performance standards. These standards would define acceptable ranges for forces, dimensions, structural integrity, and functional performance (e.g., kink resistance, leak resistance). The predicate devices' performance would also serve as a benchmark for what constitutes an acceptable level of performance.

8. The Sample Size for the Training Set

Not Applicable: This document does not describe the development of an AI algorithm with a training set.

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

Not Applicable: This document does not describe the development of an AI algorithm with a training set and its ground truth establishment.

Summary

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K/0/0/5

510(k) SUMMARY

Submitter's Information: A.

Name:

Address:

Title:

SEP 2 3 2010

Thomas Medical Products - A GE Healthcare Company 65 Great Valley Parkway Malvern, PA 19355 Telephone Number: 610.651.5000 Facsimile: 610.651.5003 Contact Person: Tim Stoudt Manager, QA / RA Date Submission Prepared: February 26, 2010

B. Device Information:

Trade name:	ScoutPro Inner Catheters
Classification Name(s):	Percutaneous Catheter (21 CFR §870.1250)
Common or usual name(s):	Guide catheters and accessories

C. Legally marketed device to which equivalence is claimed:

Guidant Corporation Rapido™ Guiding Catheter (K021455) and Merit Medical Systems, Inc. Impress Radiology Catheter (K053171)

D. Description of the device:

ScoutPro Guidewire @ 0.035" (BIOTRONIK #359805) -
ScoutPro hemostatic valve (BIOTRONIK #345779) -
Various ScoutPro 7F catheter shapes (Extended Hook Right BIOTRONIK#35937, Extended Hook -#350369, Straight #359371, MPEP #359373, BIO2 #359374, Amplatz 6.0 #350235, Hook #350236, Multipurpose Hook #350237, Extended Hook Right L #361531, Extended Hook L 3361530, Straight L #361536, MPEP L #361533, BIO2 L #361529, Amplatz 6.0 L #361527, Hook L #361532, Multipurpose Hook L #361534)
Commercially available Guide Wires (0.014" 0.035") -
Commercially available medical devices with male Luer-Lock (stopcocks, syringes) 1
-Commercially available fluid x-ray diagnostic contrast media.

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K101015

The proximal end is equipped with a hub that has a female luer lock connector for adapting a syringe or a three way stopcock with luer lock connections. ,

Package contents:

One (1) guide catheter
One (1) 3-way stopcock
One (1) Instructions for use manual.

E. Intended use of the device:

F. Summary of the technological characteristics of the device compared to the predicate devices:

Features	ScoutProInnerCatheters	GuidantRapidoGuidingCatheterK021455	MeritImpressRadiologyCatheterK053171
Hemostasis valve provided	No	No	No
Compatible with .038" guide wire	Yes	Yes	Yes
Introducer available in 65cm length	Yes	No	Yes
Introducer set available in 7F	Yes	No	No
Multi-durometer catheter shaft	Yes	Yes	Yes
Teflon inner liner	Yes	Yes	Yes
Wire reinforcement completelyencapsulated	Yes	Yes	Yes
Radiopaque tip or marker	Yes	Yes	Yes
Luer lock hub	Yes	Yes	Yes

Testing: G.

	Test Description	Results
Simulated Use Testing
	ScoutPro Inner Catheter
	insertion and removal forces of.014" and .035" guidewires	Pass
	insertion and removal forcesthrough outer sheath andvalve	Pass
	shaft kink and bucklingresistance	Pass
	tip section kink, corrugation,and peel back resistance	Pass
	curve configuration afterstraightening	Pass
	shaft joint integrity when bendaround mandrel	Pass

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Test Description	Results
Physical/Dimensional Testing
Stopcock
leak resistance of stopcock/catheter assembly	Pass
ScoutPro Inner Catheter
pull forces of shaft joints	Pass
pull force of hub/tube joint	Pass
tube shaft O.D.	Pass
tip section O.D.	Pass
tip I.D.	Pass
length	Pass
curve configuration	Pass

H. Substantial equivalence rationale:

The ScoutPro Inner Catheters substantially equivalent to the currently marketed predicate devices. This assessment is based upon analysis of similar technological characteristics, bench testing, and indications for use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the upper portion of the circle.

Public Health Service

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

Thomas Medical Products c/o Mr. Tim Stoudt Manager, QA/RA 65 Great Valley Parkway Malvern, PA 19355

SEP 2 3 2010

Re: K101015

ScoutPro Inner Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: September 8, 2010 Received: September 9, 2010

Dear Mr. Stoudt:

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 - Mr. Tim Stoudt

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/CDRH/CDRHOffices/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.

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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Page 1 of 1

510(k) Number (if known):

ScoutPro Inner Catheters Device Name:

SEP. 2 3 2010

Indications For Use:

ScoutPro Inner Catheters are indicated for the delivery of contrast media or Biotronik devices into the left ventricular coronary venous system.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

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

(Optional Format 11-13-03)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular De nik) Number

510(k) "Indications For Use" Form (Replica of FDA Form)

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).