(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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 22, 2015
St. Jude Medical Parita Mehta Regulatory Affairs Specialist 14901 Deveau Place Minnetonka, Minnesota 55345
Re: K152784
Trade/Device Name: Pacel Bipolar Pacing Catheters Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent Or Temporary Pacemaker Electrode Regulatory Class: Class II Product Code: LDF Dated: September 24, 2015 Received: September 25, 2015
Dear Parita Mehta:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (QS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): _ Device Name: Pacel™ Bipolar Pacing Catheters
Indications for Use: The St. Jude Medical Pacel™ Bipolar Pacing Catheters are intended for use in the intracardiac pacing and/or ECG recording.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use __ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Pacel™ Bipolar Pacing Catheter
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Premarket Notification 510(k)
| 510(k) Summary | |
|---|---|
| 510(k) Number | To be Assigned |
| Submitter Information: | |
| Date Prepared: | September 24, 2015 |
| Submitter Name &Address: | St. Jude Medical14901 DeVeau PlaceMinnetonka, MN 55345Establishment Registration Number: 2182269 |
| Contact Person: | |
| Parita Mehta | |
| Regulatory Affairs Specialist | |
| 5050 Nathan Lane N | |
| Plymouth MN 55426 | |
| Phone (651) 756-4442 | |
| Fax (651) 756-5744 | |
| PMehta@sjm.com | |
| Device Information: | |
| Trade Name: | Pacel™ Bipolar Pacing Catheters |
| Common Name: | Electrode, Pacemaker, Temporary |
| Class | II |
| Classification Name: | 21CFR § 870.3680 – Cardiovascular permanent or temporarypacemaker electrode |
| Predicate Device: | Pacel™ Bipolar Pacing Catheters (K875059) |
| Device Description: | The Pacel™ Bipolar Pacing Catheters are designed to establishtemporary right ventricular pacing with fluoroscopy guidance forplacement. Electrodes at the catheter tip enable ECG monitoringand bipolar pacing. The distal end of the catheter includes astainless steel electrical connector ring and a tip electrode. Theproximal end of the catheter includes a two pin electrical connector.The electrical signals can be transmitted to external equipment orfrom external equipment to the heart. |
| Intended Use:(Indications for Use) | The St. Jude Medical Pacel™ Bipolar Pacing Catheters are intendedfor use in the intracardiac pacing and/or ECG recording. |
| Comparison to PredicateDevices | The Pacel™ Bipolar Pacing Catheter that is the subject of thisapplication remains substantially equivalent to the predicate device.There have been no changes to the device materials, packaging,sterilization, final device specifications or labeling.Biocompatibility and design verification (DV) testing demonstratethat the catheter shaft manufacturing process change does notadversely affect the device safety and effectiveness |
| Summary on Non-ClinicalTesting | Biocompatibility testing was performed in accordance with ISO10993. The catheters with the modified surface morphology of theproximal shaft demonstrated acceptable biocompatibility profile.The catheters manufactured with the proposed new process met allthe product performance specifications. |
| Statement of Equivalence | The Pacel™ Bipolar Pacing Catheters that are subject of thisapplication have the same indications for use and technologicalcharacteristics as the predicate device. Based on this and the dataprovided in this pre-market notification, the subject device remainssubstantially equivalent to the predicate device. |
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Pacel™ Bipolar Pacing Catheter
Premarket Notification 510(k)
§ 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.