(301 days)
The USCI® Balloon Bipolar Pacing Electrodes and the USCI® Special Care Electrodes are used to transmit an electrical stimulus from the pulse generator to the heart and/or to transmit an electrical signal from the heart to a recording device.
The USCI® Balloon Bipolar Pacing Electrodes and USCI® Special Care Electrodes (temporary pacing leads) are flexible, insulated conductors, constructed of a woven filament and a polyurethane base with Benzalkonium Heparin coating and stainless steel electrodes.
This submission is for a medical device, not an AI/ML algorithm. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable in the context of an AI/ML algorithm.
The document describes a 510(k) summary for a USCI® Bipolar Pacing Electrode with a benzalkonium heparin coating. The basis for substantial equivalence is shown through bench testing that compares the coated device to a predicate (uncoated) device.
Here's an interpretation of the "acceptance criteria" and "study" as they relate to this medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Bench Test) | Reported Device Performance (Coated Electrode) |
|---|---|
| Electrical Continuity: Ability to pace the heart. | Demonstrated that the BH coated Bipolar Pacing Electrodes does not affect the ability of the catheter to pace. |
| Inflated Balloon Diameter: Within recommended diameter range. | Confirmed that the BH coated Bipolar Pacing Electrode is within the recommended diameter range. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided text. It refers to "bench test data" and "electrical continuity tests" but does not quantify the number of devices tested.
- Data Provenance: This is not applicable in the context of an AI algorithm. The "data" here refers to physical measurements and functional tests performed on the device itself as part of product development and regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. Ground truth, in this context, would be the physical and electrical properties of the device, measured by standard engineering and medical device testing methods, not by expert interpretation of data.
4. Adjudication Method for the Test Set:
- Not applicable. Bench testing results are typically objective measurements, not subject to adjudication by multiple human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This is a medical device, not an AI algorithm, so an MRMC study is not relevant. The comparison is between a new device design and an existing predicate device using objective bench tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used:
- Bench Test Results/Performance Specifications: The "ground truth" is the established functional and dimensional requirements for such pacing electrodes, against which the performance of both the coated and uncoated devices is measured. These are objective engineering and performance specifications.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML submission that involves training data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
§ 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.