The Model 2188 coronary sinus lead is designed for atrial pacing and sensing in the coronary sinus. The lead has application where permanent atrial or dual-chamber pacing systems are indicated.

Device Description

The Model 2188 coronary sinus lead is a bipolar coaxial polyurethane lead with an IS-1 connector and a porous tip electrode which is canted toward the lead body. The distal portion of the lead is pre-shaped at a 45° angle. The conductor coils utilize a platinum sputtered MP35N nickel-alloy material.

AI/ML Overview

This document describes the testing and acceptance criteria for the Medtronic Model 2188 Coronary Sinus Lead.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with specific numerical thresholds for each test. Instead, it states that the device "passed all of the in vitro bench test requirements" and that the in vivo canine testing "demonstrated that the pacing and sensing thresholds produced by the Model 2188 coronary sinus lead is substantially equivalent to the Model 6992A coronary sinus lead."

To create a table, we must infer the acceptance criteria from the descriptions.

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria (Inferred from Text)	Reported Device Performance
In Vitro/Bench Testing	Environmental Conditioning	Pass all requirements (implies meeting predefined standards for durability, integrity under various environmental stresses)	Passed all in vitro bench test requirements.
	Mechanical Testing	Pass all requirements (implies meeting predefined standards for strength, flexibility, resistance to damage)	Passed all in vitro bench test requirements.
	Electrical Testing	Pass all requirements (implies meeting predefined standards for conductivity, insulation integrity, impedance)	Passed all in vitro bench test requirements.
In Vivo Testing (Animal)	Pacing Thresholds	Substantially equivalent to Model 6992A coronary sinus lead	Demonstrated substantial equivalence to Model 6992A coronary sinus lead.
	Sensing Thresholds	Substantially equivalent to Model 6992A coronary sinus lead	Demonstrated substantial equivalence to Model 6992A coronary sinus lead.
Package Qualification	Ethylene Oxide (EtO) Sterilization Conditioning/Testing	Suitability for sterilization and maintenance of sterile barrier (implies resistance to EtO effects)	Demonstrated suitability of the new package.
	Visual Inspection Testing	No significant defects affecting product integrity or usability	Demonstrated suitability of the new package.
	Packaging Conditioning/Testing	Maintain integrity and protection of lead under various conditions	Demonstrated suitability of the new package.
	Lead Mechanical Testing (within package)	Lead remains undamaged and functional after packaging stress tests	Demonstrated suitability of the new package.
	Lead Electrical Testing (within package)	Lead remains electrically functional after packaging stress tests	Demonstrated suitability of the new package.
	Shelf Life Testing	Maintain product integrity and sterility over specified shelf life	Demonstrated suitability of the new package.
Biocompatibility	Lead Materials	Approved for use with Medtronic CapSure SP Model 4524 (implying non-toxic, non-allergenic, non-irritating)	Materials were approved for use with Medtronic CapSure SP Model 4524.
	Uncoated PETG Package	Approved for use with Medtronic pulse generators (PMA Supplements P850051/S44, P850051/S49 and P890003/S30)	Approved for use with Medtronic pulse generators.
	Silicone-coated PETG Package	Proven biocompatible (implying non-toxic, non-allergenic, non-irritating)	Proved to be biocompatible.
Sterilization Validation	EtO Sterilization Process	Validated as appropriate for sterilizing the Model 2188 lead (implies achieving sterility assurance level)	A process appropriate for sterilizing the Model 2188 coronary sinus lead was validated.

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

Sample Size for Test Set: The document does not specify a numerical sample size for the "in vivo canine testing." It simply states "The data generated as a result of this testing..."
Data Provenance: The in vivo testing was conducted using canine subjects, meaning it was animal-based (not human). It was conducted prospectively as part of the device development and validation. The country of origin is not explicitly stated but is implied to be within Medtronic's operational regions, likely the USA, given the submission context.

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

This information is not provided. For animal studies, "ground truth" would typically be derived from physiological measurements and observations by veterinary specialists and animal researchers, but their number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of a device performance study in animals, "adjudication" in the sense of expert consensus on human clinical outcomes is less applicable. Performance metrics (pacing/sensing thresholds) would be measured objectively.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is for a medical device (pacing lead), not an AI diagnostic or interpretive system. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

No, this question is not applicable. The Model 2188 is a physical pacing lead, not an algorithm.

7. The Type of Ground Truth Used

For the in vivo canine testing, the ground truth was based on physiological measurements (pacing and sensing thresholds) directly obtained from the animals. These are objective, quantitative measurements reflecting the lead's electrical performance in a living system.

8. The Sample Size for the Training Set

This product is a physical medical device, not a machine learning model. Therefore, the concepts of a "training set" and "sample size for a training set" as typically understood in AI/ML are not applicable. The device's design was informed by Medtronic's extensive experience and previous models (e.g., Model 6992A, 4524, 4582, 6990, 6991A), which could be considered an analogous form of "prior data" or "design input" but not a formal training set for an algorithm.

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

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

Summary

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Image /page/0/Picture/1 description: The image shows the words "MEDTRONIC CONFIDENTIAL" in bold, black, sans-serif font. Below that is a handwritten number, "K961936", in black ink. The number is written in a cursive style, with the letters and numbers connected.

510(k) Summary 2)

a) Submitter

Medtronic, Inc. 7000 Central Avenue N.E. Minneapolis, MN 55432

Contact: Nora K. Hadding, Product Regulation Associate Telephone: (612) 574-4189 Fax: (612) 574-6424

Name of Device b)

Trade Name: Model 2188 Coronary Sinus Lead

Common Name: Pacing Lead

Classification Name: Cardiovascular permanent or temporary pacemaker electrode (21 CFR 870.3680)

Predicate Device C)

The Model 2188 lead is substantially equivalent to the Model 6992A coronary sinus lead and its predecessors. The Model 6992A coronary sinus lead has been in commercial distribution since at least 1974. Since the Model 6992A was in existence prior to medical device regulations, no FDA document control number can be referenced. In addition, the Model 2188 relies on technology used with Medtronic Models 4524, 4582, 6990, and 6991A (Document Control Numbers P830061/S12, K896313, K780621 and K772104, respectively).

Device Description d)

Intended Use e)

The Model 2188 coronary sinus lead is designed for atrial pacing and sensing in the coronary sinus. The lead has application where permanent atrial or dual-chamber pacing systems are indicated.

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Technological Characteristics f)

1. Lead Characteristics

The Medtronic Model 2188 coronary sinus lead is a bipolar coaxial polyurethane pacing lead with a canted porous electrode tip (5.8 mm²) and an IS-1 connector. The distal portion of the lead is pre-shaped at a 45° angle. The Model 2188 coronary sinus lead is designed for atrial pacing and sensing applications in the coronary sinus. The lead has application where implantable atrial or coronary sinus single- or dual-chamber pacing systems are indicated.

The lead has a porous tip electrode made of platinum alloy that can be positioned in the coronary sinus. In addition, the tip is canted toward the lead body at the end to facilitate contact with the coronary sinus wall.

The lead also has a ring electrode proximal to the tip electrode and an IS-1 bipolar (BI) connector. It features platinum sputtered MP35N nickel-alloy conductor coils and polyurethane 55D insulation. The lead will be packaged in a new packaging configuration but with the same accessories as the Model 6992A pacing lead.

The following section describes in detail the physical characteristics of the Model 2188 in comparison with existing Medtronic leads.

Medtronic Model 4582 Target Tip Pacing Lead (Document Control Number a) K896313)

The Model 2188 utilizes a bipolar coaxial design with an IS-1 connector. The conductor coil is platinum sputtered MP35N nickel alloy. The Medtronic Model 4582 pacing lead features a similar coaxial design with an IS-1 connector and MP35N nickel alloy conductor coils.

b) Medtronic Model 4524 CapSure SP Pacing Lead (Document Control Number P890061/S12)

The Model 2188 pacing lead utilizes 55D polyurethane insulation. The canted electrode is platinum material and has a porous surface electroplated with platinum black. The Model 4524 CapSure SP lead utilizes the same 55D polyurethane insulation and tip electrode technology. However, the Model 2188 does not contain steroid in the tip electrode and it is canted toward the lead body. The Model 2188 and Model 4524 also share an identical IS-1 connector.

Medtronic Models 6990 and 6991A Pacing Leads (Document Control c) Numbers K780621 and K772104)

The Model 2188 coronary sinus lead utilizes an electrode tip which is canted toward the lead body to better facilitate contact with the coronary sinus vein. Models 6990 and 6991A also utilized a canted tip electrode

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Package Characteristics 2.

The Model 2188 coronary sinus lead will be provided in a package which uses an uncoated and silicone-coated polyethylene terephthalate, glycol modified (PETG) material. This package was successfully qualified for use with the Model 2188 lead.

Summary of Studies g)

The following studies were performed to ensure that the Model 2188 lead meets all of its design and performance requirements. In addition, the suitability of the new leads package was evaluated.

In Vitro/Bench Testing 1.

To evaluate the Model 2188 coronary sinus lead, the following in vitro testing was performed:

A. Environmental Conditioning
Mechanical Testing B.
C. Electrical Testing

The Model 2188 pacing lead passed all of the in vitro bench test requirements.

2. In Vivo Canine Testing

The data generated as a result of this testing demonstrated that the pacing and sensing thresholds produced by the Model 2188 coronary sinus lead is substantially equivalent to the Model 6992A coronary sinus lead.

3. Package Qualification Testing

A new package was designed for this lead. Package qualification testing was performed as follows:

Ethylene Oxide (EtO) Sterilization Conditioning/Testing (Environmental A. Conditioning)
Visual Inspection Testing B.
ﺯ Packaging Conditioning/Testing
Lead Mechanical Testing D.
Lead Electrical Testing E.
Shelf Life Testing F.

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The testing demonstrated the suitability of this new package for containing and protecting Medtronic leads.

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4. Biocompatibility Testing

Lead Biocompatibility a)

Biocompatibility information for the materials used in the Model 2188 coronary sinus lead is presented. The materials were approved for use with Medtronic CapSure SP Model 4524 (Document Control Number P830061/S12).

Package Biocompatibility b)

The use of uncoated PETG was approved for use with Medtronic pulse generators in PMA Supplements P850051/S44, P850051/S49 and P890003/S30. Biocompatibility information for the silicone-coated PETG used with the new package was performed and proved to be biocompatible.

Sterilization Validation C)

All Medtronic leads are sterilized using a 100% Ethylene Oxide (EtO) sterilization process. A process appropriate for sterilizing the Model 2188 coronary sinus lead was validated.

ડ. Conclusion

The testing described above provides reasonable assurance that the Medtronic Model 2188 coronary sinus lead will perform as intended when used in accordance with its labeling. Additionally, based on similarities in design, materials, in vitro test data and canine in vivo electrical performance, Medtronic considers the Model 2188 coronary sinus lead to be substantially equivalent to the Model 6992A coronary sinus lead and other Medtronic pacing leads found to be substantially equivalent to preregulation leads.

In addition, the new package met all qualification requirements. As such, the testing demonstrated the suitability of this new package for containing and protecting Medtronic leads.

Regulation Number and Section

§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.

(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.