The Thomas Medical Products, Inc. (TMP) Coronary Sinus Guide & Lateral Vein Introducer Kits (CSG/LVI) are intended to access the coronary venous system. either alone or in a telescopic assembly with other introducers. The CSG/LVI Introducers serve as a conduit to quide devices, including guidewires, pacemaker or defibrillator leads, and catheters, or to deliver contrast medium into specific branches of the coronary venous system. CSG/LVI introducers are intended to introduce left ventricular leads through their lumen. They have direct contact to the inner heart. CSG/LVI introducers come with various curve configurations and lengths to facilitate access to the coronary sinus OS and sub-selective access to angulated lateral vein branches. CSG/LVI introducers 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 introducers.

The Coronary Sinus Guide Introducer has a peel-away sheath with break-away hemostasis valve. The Lateral Vein Introducer has a break-away hub with integrated handle that requires no cutting and provides a secure grip during slicing, reducing, reducing the risk of lead displacement.

The Lateral Vein Introducers have a shaft design with three (3) gradually decreasing stiffness segmentations from proximal to distal. The shaft is reinforced by a metal broid from the proximal end until approximately 0.175 inch from the distal end. The shaft is coated by a medical-grade coating that provides enhanced lubricity when advanced through the Coronary Sinus Guide Introducer.

The proximal end of the CSG/LVI Introducers are equipped with a hemostasis valve that reduces the risk of blood loss and air embolism and a side-port with 3-way stopcock to allow fluid infusion and contrast injection.

There are differing various versions of the introducer curves that are used according to the anatomy of the present coronary vasculature. The distal soft tip has a tapered outer diometer and the distal tip further contains a polymeric x-roy marker for enhanced visibility under fluoroscopy.

Package contents (Coronary Sinus Guide Introducer Kit):

One (1) Coronary Sinus Guide Introducer
One (1) P.T.F.E. coated guidewire
One (1) Curved braided guiding core or non-braided guiding core
One (1) Straight vessel dilator
One (1) Transvalvular Insertion Tool (T.V.I.)
One (1) 18 g XTW needle
One (1) 12 cc syringe

Package contents (Lateral Vein Introducer Kit):

One (1) Lateral Vein Introducer
One (1) Transvalvular Insertion Tool (T.V.I.)
One (1) Slicer
One (1) Target Vein Selector Merit Impress Radiology Catheter, K053171

AI/ML Overview

The provided document describes the Coronary Sinus Guide & Lateral Vein Introducer Kits. The study presented focuses on demonstrating the substantial equivalence of the modified device to its predicate devices through various tests.

Here's an analysis of the acceptance criteria and study as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Test Description	Acceptance Criteria	Reported Device Performance
Biocompatibility	USP Pyrogen Study, Material Mediated (XD-3050-00, Gen. III CSG Sheath)	Non-pyrogenic	Pass, non-pyrogenic
	Cytotoxicity Study (ISO elution method)	< grade 2 (low cytotoxicity)	Pass, < grade 2
	ISO Maximization Sensitization Study - Extract	Not considered a sensitizer	Pass, not considered a sensitizer
	ISO Intracutaneous Study, Extract	Control/test Δ <1.0 (non-irritant)	Pass, control/test Δ <1.0
	ISO Systemic Toxicity Study - Extract	No mortality or evidence of systemic toxicity	Pass, no mortality or evidence of systemic toxicity
	ASTM Hemolysis	Hemolytic index = 0.0%	Pass, hemolytic index = 0.0%
	Physicochemical testing (alternative extract)	N/A (implied to meet requirements)	Pass
	USP Physicochemical Testing - Plastics (Complete)	Meets USP limits	Pass, meets USP limits
	L929 MEM Elution Test (XD-2186-04, Printed braided Pebax tubing)	Grade 0 (no cytotoxicity)	Pass, Grade 0
	Kligman Maximization Test - ISO	Grade 1 (non-sensitizer)	Pass, Grade 1
	Intracutaneous Injection Test - ISO	Negligible irritant	Pass, considered negligible irritant
	Systemic Injection Test - ISO	Negative (no systemic toxicity)	Pass, considered negative
	Hemolysis - Rabbit Blood - ISO	0.0% hemolysis	Pass, 0.0% hemolysis
Simulated Use Testing	Sheath separation (CSG only)	Function as intended	Pass
	Hub break force	Function as intended	Pass
Physical/Dimensional Testing	Tip pull test	Function as intended	Pass
	Tip integrity test	Function as intended	Pass
	Bend-back testing	Function as intended	Pass
	Joint interface length (CSG only)	Within specified dimensions	Pass
	Hub pull force	Function as intended	Pass
	Tip I.D.	Within specified dimensions	Pass

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

The document specifies the following test samples:

Biocompatibility (Coronary Sinus Guide & Lateral Vein Introducer components w/ UV and heat stabilization): XD-3050-00, Gen. III CSG Sheath, Lot 36564 (proposed device).
Biocompatibility (Lateral Vein Introducer and braided core components): XD-2186-04 (representative sample of proposed device).
Simulated Use Testing: FCL-156-00 (LVI), FDL-050-00 (BC), XD-3050-00 (CSG) - proposed devices.
Physical/Dimensional Testing: FCL-156-00 (LVI), FDL-050-00 (BC), XD-3050-00 (CSG) - proposed devices.

The exact numerical sample sizes (e.g., "n=x" for each test) are not explicitly stated in the provided text. The data provenance is retrospective bench testing conducted by the manufacturer, Thomas Medical Products, Inc. (Malvern, PA, USA). The document does not indicate data from any specific country of origin or involve human subjects/clinical data.

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

This information is not applicable as the document describes a 510(k) submission for a medical device (introducer kits), focusing on bench testing and biocompatibility. There is no mention of "ground truth" derived from expert consensus on clinical data or images for the device's performance. The "ground truth" here is the adherence to established industry standards and internal specifications for device safety and performance, as demonstrated by the various "Pass" results.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies in expert interpretations (e.g., in clinical trials or image labeling). Since this study involves bench testing against predefined criteria, there is no expert adjudication process in this context. The results are reported as meeting or failing the criteria for each specific test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. This type of study is typically used to assess the impact of AI on human reader performance, usually in diagnostics or image interpretation. This document pertains to the physical and biological characteristics of a medical device, not an AI or diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study was not done. This concept is relevant to AI algorithms. As explained in point 5, this submission is for a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context is based on established industry standards and regulatory guidelines for medical device safety and performance. Specifically:

Biocompatibility: USP (United States Pharmacopeia) and ISO (International Organization for Standardization) standards (e.g., ISO 10993 series for biological evaluation of medical devices).
Physical/Dimensional Testing and Simulated Use Testing: Implied internal specifications and engineering requirements to ensure the device performs its intended function safely and effectively, also adhering to general safety principles for catheter introducers.

The study demonstrates that the device, when tested, meets these predefined pass/fail criteria.

8. Sample Size for the Training Set

This is not applicable. The device is a physical medical product, not an AI model requiring a training set.

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

This is not applicable for the reasons stated in point 8.

Summary

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K120158 p.1. of 4

Coronary Sinus Guide & Lateral Vein Introducer Kits

Traditional 510(k

SECTION 5:	510(k) SUMMARY
------------	----------------

[as required by section 807.92(c)]

Submitter's Information: A.

AUG 1 4 2012

Name:	Thomas Medical Products, Inc.
Address:	65 Great Valley Parkway
	Malvern, PA 19355
Telephone Number:	610.651.5000
Facsimile:	610.651.5003
Contact Person:	Tim Stoudt
Title:	Regulatory Affairs Manager
Date Submission Prepared:	January 11, 1012

в. Device Information:

Coronary Sinus Guide & Loteral Vein Introducer Kits Trade name: Classification Name(s): Cotheter Introducer (21 CFR §870.1340) Coronary Sinus Guide & Lateral Vein Introducer Kits Common or usual name(s):

C. Legally marketed device to which equivalence is claimed:

(a) Thomas Medical Products, Inc. SafeSheath Coronary Sinus Guide & Lateral Vein Introducer Kits (K003731)
(b) Merit Medical Systems, Inc. Impress Radiology Catheter (K053171)
(c) Biotronik, Inc. ScoutPro ACS Coronary Sinus Lead Introducer System (K101776)

D. Description of changes:

The reason for this submission is due to improvements made to the SafeSheath Coronary Sinus Guide & Lateral Vein Introducer Kits designed to provide greater protection against environmental factors known to degrade polymers. The specific changes are:

Element ofmodification	Predicate deviceK003731	Modifieddevice	Reason for modification
UV Stabilization	None	0.15 - 0.20%Tinuvin 783w/w	To provide UV stabilization.
Heat Stabilization	None	0.08 - 0.12%Irganox 1010w/w	To provide long-termthermal stabilization
RO tip material	Pebax 4033 w/80% M10 W	Pebax MX-1205 w/80%C5 W	Material optimization toprovide greater stabilityagainst degradation.

Description of the device:

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term application (< 24 hours). Only medical doctors and medical personnel, who are well trained in cardiology, should apply these introducers.

Package contents (Coronary Sinus Guide Introducer Kit):

One (1) Coronary Sinus Guide Introducer
One (1) P.T.F.E. coated guidewire
One (1) Curved braided guiding core or non-braided guiding core
One (1) Straight vessel dilator
One (1) Transvalvular Insertion Tool (T.V.I.)
One (1) 18 g XTW needle
One (1) 12 cc syringe

Package contents (Lateral Vein Introducer Kit):

One (1) Lateral Vein Introducer
One (1) Transvalvular Insertion Tool (T.V.I.)
One (1) Slicer
One (1) Target Vein Selector Merit Impress Radiology Catheter, K053171

Intended use of the device:

Coronary Sinus Guide & Lateral Vein Introducer Kits are indicated for the introduction of various types of pacing or defibrillator leads and catheters.

Thomas Medical Products – A GE Healthcare Company

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

Features	UV & HeatStabilizedCSG/LVIkits	Non-UV &heatstabilizedCSG kits -K003731	MeritImpressRadiologyCatheterK053171	BiotronikScoutProACS CSLeadDeliverySystemK101776
Hemostasis valve provided	Yes	Yes	No	Yes
Compatible with .038" guide wire	Yes	Yes	Yes	Yes
Lengths: 40 to 50 cm / 62 cm	Yes	Yes / No	No	Yes
French sizes: 9 F.I.D. / 7 F.I.D.	Yes	Yes / No	No	No
Curves: 0 to 180 degree, singleor compound curves	Yes	Yes	Yes	Yes
Peel-away CSG sheath withbreak-away hemostasis valve	Yes	Yes	No	No
Wire braid reinforcementcompletely encapsulated (LVI &Braided Cores)	Yes	No	Yes	Yes
Radiopaque tip or marker	Yes	No	Yes	Yes
Side port for infusion andcontrast injection	Yes	Yes	No	No
UV & heat stabilizers .	Yes	No	No	Unk

H. Summary of testing:

	Test Description	Results
Biocompatibility
	Product applicability: Coronary Sinus Guide & Lateral Vein Introducer componentsw/ UV and heat stabilizationTest Sample: XD-3050-00, Gen. III CSG Sheath, Lot 36564 (proposed device)
	USP Pyrogen Study, MaterialMediated	Pass, non-pyrogenic
	Cytotoxicity Study using theISO elution method	Pass, < grade 2
	ISO MaximizationSensitization Study - Extract	Pass, not considered a sensitizer
	ISO Intracutaneous Study,Extract	Pass, control/test Δ <1.0
	ISO Systemic Toxicity Study -Extract	Pass, no mortality or evidence ofsystemic toxicity
	ASTM Hemolysis	Pass, hemolytic index = 0.0%
	Physicochemical testing usingan alternative extract -complete	Pass
	USP Physicochemical Testing- Plastics - Complete	Pass, meets USP limits

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	Test Description	Results
	Biocompatibility (continued)
	Product applicability: Lateral Vein Introducer and braided core components
	Test Sample: Printed braided Pebax tubing - XD-2186-04 (representative sample of proposed device)
	L929 MEM Elution Test	Pass, Grade 0
	Kligman Maximization Test - ISO	Pass, Grade 1
	Intracutaneous Injection Test - ISO	Pass, considered negligible irritant
	Systemic Injection Test - ISO	Pass, considered negative
	Hemolysis - Rabbit Blood - ISO	Pass, 0.0% hemolysis

	Test Description	Results
	Simulated Use Testing
	Coronary Sinus Guide & Lateral Vein IntroducerTest Sample: FCL-156-00 (LVI)/FDL-050-00 (BC)/XD-3050-00 (CSG) - proposed devices
	Sheath separation (CSG only)	Pass
	Hub break force	Pass
	Test Description	Results
	Physical/Dimensional Testing
	Coronary Sinus Guide & Lateral Vein IntroducerTest Sample: FCL-156-00 (LVI) FDL-050-00 (BC)/XD-3050-00 (CSG) - proposed devices
	Tip pull test	Pass
	Tip integrity test	Pass
	Bend-back testing	Pass
	Joint interface length (CSG only)	Pass
	Hub pull force	Pass
	Tip I.D.	Pass

Substantial equivalence rationale:

Thomas Medical Products, Inc. considers the Coronary Sinus Guide & Lateral Vein Introducer Kits substantially equivalent to the currently marketed predicate devices. This assessment is based upon analysis of similar technological characteristics, bench testing, and indications for use.

Thomas Medical Products - A GE Healthcare Company

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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 stylized eagle with three stripes forming its wing and body. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

AUG 1 4 2012

Thomas Medical Products, Inc. c/o Mr. Timothy Stoudt Regulatory Affairs Manager 65 Great Valley Parkway Malvern, PA 19355

Re: K120158

Trade Name: Coronary Sinus Guide and Lateral Vein Introducer Kits Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II (two) Product Code: DYB Dated: July 30, 2012 Received: July 31, 2012

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. Timothy 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 (OS) 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" (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 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.

MZWillian

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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Page of

K120158 510(k) Number (if known):

Coronary Sinus Guide & Lateral Vein Introducer Kits Device Name:

Indications For Use:

For the introduction of various types of pacing or defibrillator leads and catheters.

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)

M.G. Kelleher

(Division Sign-Off) (Division of Cardiovascular Devices

K120158 510(k) Number_

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).