The electrode catheter is intended for intracardiac electrogram recording and pacing for the purpose of determining conduction times from one cardiac location to another, to localize aberrant conduction pathways and to test for the susceptability of the cardiac chambers to arrhythmias.

Device Description

The catheters are typically placed percutaneously through femoral or jugular access sites and directed through the vasculature into the cardiac chambers. The catheter is reinforced with a stainless steel braid to enhance torque control and allow easier maneuverability and has a soft tip to reduce the potential for vessel trauma during placement of the catheter. The tip of the catheter is fitted with up to ten platinum electrodes. No new electrode geometries are introduced. Catheters with various curve styles are also available to meet anatomical constraints as well as physician preference and technique.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the medical device:

The provided document describes a 510(k) premarket notification for an electrode recording catheter. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" and "study" described in the document are focused on showing that the new device performs similarly and is as safe and effective as the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance
Mechanical Integrity	Strength of each bond (tip electrode/tubing, shaft/tip tubing, connector/shaft)	Tensile testing demonstrated functional integrity.
	Resistance to rotation until failure (tip electrode fixed)	Demonstrated functional integrity.
Electrical Performance	Recording capabilities	Demonstrated functional integrity and performance characteristics.
	Pacing capabilities	Demonstrated functional integrity and performance characteristics.
Torque Performance	Torque performance testing	Demonstrated functional integrity and performance characteristics.
Biocompatibility	Compliance with Tripartite and ISO Guidelines for Medical Devices	Materials suitable for short-term, human intravascular use.
Sterilization	Ethylene oxide gas residuals compliance	Monitored for compliance to maximum releasable limits; no detrimental effects.
	Bacterial endotoxin levels compliance	Monitored for compliance to maximum releasable limits; no detrimental effects.
Overall Equivalence	Substantial equivalence to predicate devices (ELECATH's Investigator and DAIG's Response) in design and performance.	Demonstrated through comparative characteristics (Table 1) and functional testing.

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

Sample Size for Test Set: The document does not specify the exact sample sizes used for the mechanical, electrical, and torque performance tests. It refers to "testing" and "bench top models" without numerical specifics for the devices tested. For biocompatibility, it states "All testing was performed on sterilized samples" but again, no number is given.
Data Provenance: The data appears to be prospective as it describes tests conducted on the proposed device. The source is Boston Scientific Corporation's internal testing. There is no mention of country of origin for the data; it's implicit to be from the manufacturer's testing facilities (likely in the USA, given the address).

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

Not Applicable. This type of information (experts establishing ground truth) is typically relevant for studies involving human interpretation or clinical endpoints (e.g., diagnostic imaging studies). For a device like an electrode recording catheter, ground truth for performance characteristics is established through engineering and biomaterial testing against predefined technical specifications and standards, not through expert consensus in the clinical sense.

4. Adjudication Method for the Test Set:

Not Applicable. As mentioned above, adjudication methods like 2+1 or 3+1 consensus are used when human interpretation or clinical outcomes require agreement among experts. The performance testing described (tensile strength, electrical recording, etc.) relies on instrumental measurements and objective criteria, not subjective adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is not mentioned and would not be relevant for this type of device submission. MRMC studies are used to evaluate the impact of a new diagnostic aid (like AI software) on human reader performance in interpreting medical images. This submission is for a physical medical device (catheter).

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

No. This question is also not applicable. This is a physical medical device, not an algorithm or software device.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance is based on engineering specifications, established industry standards (e.g., for biocompatibility via Tripartite and ISO Guidelines), and functional testing results. For the comparative aspect, the ground truth is the established performance and design of the predicate devices. The claim is "functional integrity and performance characteristics that were substantially equivalent and acceptable."

8. The Sample Size for the Training Set:

Not Applicable. This device is not an AI/ML algorithm that requires a "training set." It is a physical medical device.

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

Not Applicable. As above, no training set for an algorithm is involved.

In summary, the provided document focuses on demonstrating the substantial equivalence of a new electrode recording catheter to existing predicate devices through comprehensive engineering, electrical, and biocompatibility testing. The "acceptance criteria" are implied by the stated performance characteristics and the assertion that these characteristics are "substantially equivalent and acceptable" given the predicate devices' established safety and effectiveness.

Summary

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K955750/5001

MAR I I 1996

SUMMARY OF SAFETY AND EFFECTIVENESS

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness.

A.	GENERAL INFORMATION
	Submitter's Name:	Boston Scientific Corporation
	Address:	One Boston Scientific Place
		Natick, MA 01760-1537 U.S.A
	Date of Preparation:	August 9, 1995
	Contact Person:	Wanda M. Carpinella
	Device Generic Name:	Electrode Recording Catheter
	Device Classification:	74DRF Catheter, Electrode Recording

INDICATIONS

в.

C. DESCRIPTIVE CHARACTERISTICS

The catheters described in this submission are substantially equivalent to Elecath's Investigator and Daig's Response electrophysiology catheters. Descriptive characteristics between the proposed catheter and the Investigator and Response catheters are compared in Table 1.

PERFORMANCE CHARACTERISTICS D.

The strength of each bond in the catheter was determined. Tensile testing evaluated the strength of the following joints; tip electrode/tubing; shaft/tip tubing and connector/shaft. In addition, the tip electrode was fixed in a chuck and the catheter was rotated until failure occurred. Other testing included an evaluation of recording and pacing capabilities and torque performance testing conducted in bench top models. The testing demonstrated functional integrity and performance characteristics that were substantially equivalent and acceptable for the device's intended use and do not affect safety and effectiveness. Biocompatibility tests conducted according to the Tripatite and ISO Guidelines for Medical Devices demonstrated that materials used in the proposed device are suitable for short-term, human intravascular use.

STERILIZATION, PACKAGING and PYROGENICITY E.

The electrode recording catheters are packaged in an innerTyvek-lidded blister pack and an outer Tyvek®/mylar pouch. The device is sterilized using ethylene oxide gas. Ethylene oxide gas residuals and bacterial endotoxin levels are monitored for compliance to maximum releasable limits. All testing was performed on sterilized samples and no detrimental effects from the sterilization process were noted

CONCLUSIONS F.

Mechanical, electrical and biological tests verify that the electrode recording catheter meets the essential requirements that are considered necessary for its intended use.

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SUMMARY OF SAFETY AND EFFECTIVENESS

SUMMARY OF SAFETY AND EFFECTIVENESS
CONMARY OF SAFETY Page 2 of 2 page 2 of 2

Submitter's Name:	Boston Scientific Corporation
Address:	One Boston Scientific PlaceNatick, MA 01760-1537 U.S.A
Date of Preparation:	August 9, 1995
Contact Person:	Wanda M. Carpinella
Device Generic Name:	Electrode Recording Catheter
Device Classification:	74DRF Catheter, Electrode Recording

TABLE 1. SUBSTANTIAL EQUIVALENCE COMPARISON CHART
CHARACTERISTIC	PROPOSED ELECTRODECATHETER	ELECATH'SINVESTIGATOR SERIES	DAIG'S RESPONSESERIES
Distal Tip Design	Soft, non-braidedatraumatic tip	Soft, non-braidedatraumatic tip	Soft, non-braidedatraumatic tip
Tip Curve Styles	CournandJosephsonDamatoMultipurposeSpecial ProcedureConduction Study	CournandJosephsonDamato	CournandJosephsonDamatoCRD-1JSN-1DAO-1
Shaft Materials	Polyurethane/WireBraid Construction	Nylon/Wire BraidConstruction	Not Specified
Electrode Material	Platinum	Platinum	Platinum
Useable Length	100 cm	105 cm	120 cm65 cm
French Size	6F	6F	6F
Electrode Spacing	2 to 10 mm	1 to 5 mm	2 to 10 mm
Connector Type	Quick	Quick	Quick Connect
Tip Electrode Length	1 mm	2 mm	Not Specified
Electrode Number	2, 4, 6, 8, 10	4	2, 4, 6, 8, 10
Proximal Electrode Length	1 mm	2 mm	Not Specified

Image /page/1/Picture/3 description: The image shows a black blob on a white background. The blob is irregularly shaped and appears to be a solid mass. The contrast between the black blob and the white background is stark, making the blob stand out prominently. The image is simple and lacks any additional details or features.

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Regulation Number and Section

§ 870.1220 Electrode recording catheter or electrode recording probe.

(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).