(27 days)
The St. Jude Medical Pacel™ Bipolar Pacing Catheters are intended for use in the intracardiac pacing and/or ECG recording.
The Pacel™ Bipolar Pacing Catheters are designed to establish temporary right ventricular pacing with fluoroscopy guidance for placement. Electrodes at the catheter tip enable ECG monitoring and bipolar pacing. The distal end of the catheter includes a stainless steel electrical connector ring and a tip electrode. The proximal end of the catheter includes a two pin electrical connector. The electrical signals can be transmitted to external equipment or from external equipment to the heart.
This document is a 510(k) premarket notification for the "Pacel™ Bipolar Pacing Catheters" from St. Jude Medical. It states that the device is substantially equivalent to a previously cleared predicate device (K875059).
The core of this submission is about a manufacturing process change for the catheter shaft, not the introduction of a new or significantly altered device. Therefore, the "study" described focuses on validating that this process change does not adversely affect the device's safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | The catheters with the modified surface morphology of the proximal shaft demonstrated an acceptable biocompatibility profile in accordance with ISO 10993. |
| Product Performance Specifications | The catheters manufactured with the proposed new process met all the product performance specifications. (Specific specifications are not detailed in this summary, but are implied to be the same as the predicate device). |
| Safety and Effectiveness (overall) | Biocompatibility and design verification (DV) testing demonstrate that the catheter shaft manufacturing process change does not adversely affect the device safety and effectiveness. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for biocompatibility or design verification testing. It also does not explicitly state the data provenance (country of origin, retrospective/prospective). However, given it's a 510(k) for a manufacturing change, the testing would typically be prospective, a part of the design verification and validation process conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable in the context of this 510(k) submission. The "ground truth" here is established through objective engineering and biocompatibility testing against defined standards and specifications, not through expert human interpretation of medical data (like in AI/diagnostic device studies).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or data by multiple human readers. For manufacturing process changes and device performance testing, the results are typically objectively measured and evaluated against predetermined criteria, without human adjudication in this sense.
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
This is not applicable. This document is for a traditional medical device (pacing catheter) and relates to a manufacturing process change, not an AI or diagnostic device. Therefore, no MRMC or AI-related comparative effectiveness study was conducted or is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a pacing catheter, a physical medical device. It does not involve algorithms or AI for standalone performance evaluation in the way a diagnostic software might.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is based on:
- Established Biocompatibility Standards (ISO 10993): The device's interaction with the biological system is assessed against these international standards.
- Pre-defined Product Performance Specifications: These are objective, measurable criteria (e.g., electrical properties, mechanical strength, dimensional integrity) that the device must meet to ensure it functions as intended and is safe. These specifications would have been established during the original predicate device's development and are maintained for the modified device.
8. The sample size for the training set
This is not applicable. This submission is not about an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. There is no training set for this type of device submission.
§ 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.