(301 days)
No
The summary describes a physical pacing electrode and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used to transmit an electrical stimulus from a pulse generator to the heart, which is a therapeutic intervention (pacing the heart).
No
This device is described as electrodes used to transmit an electrical stimulus from a pulse generator to the heart (pacing) and/or to transmit an electrical signal from the heart to a recording device. While it transmits signals for recording, its primary purpose is pacing and it does not perform analysis or interpretation of signals for diagnosis.
No
The device description clearly states it is a physical electrode constructed of materials like woven filament, polyurethane, and stainless steel electrodes, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to transmit electrical signals to and from the heart for pacing and recording. This is a direct interaction with the patient's body for therapeutic and diagnostic purposes in vivo.
- Device Description: The description details a physical device (electrodes, conductors, balloon) designed to be inserted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
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. 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. These devices are sold sterile and are for one time use only. In addition to the pacing electrode with BH coating, each catheter is packaged with a needle cannula, an EKG clip, and a syringe to assist in the use of the pacing electrode.
Product codes
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Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Results from bench test data demonstrate that the BH coated USCI Bipolar Pacing Electrodes perform similar to the predicate device, the uncoated USCI® Bipolar Balloon Pacing Electrode. Electrical continuity tests demonstrated that the BH coated Bipolar Pacing Electrodes does not affect the ability of the catheter to pace. The inflated balloon diameter test confirms that the BH coated Bipolar Pacing Electrode is within the recommended diameter range. In conclusion, results from all the bench test data demonstrate that the BH coated Bipolar Pacing Electrodes perform similar to the predicate device, the uncoated Bipolar Balloon Pacing Electrode.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
OCT 11 1996
al and Regulatory Affairs Technology Park Dri Box 7025 rica, MA 01821 667-1300 (508) 670-4326
Image /page/0/Picture/2 description: The image shows the number K955712 at the top. Below the number is the USCI logo. The USCI logo is an oval with the letters USCI in the center.
510(k) SUMMARY FOR THE USCI® BIPOLAR PACING ELECTRODE 6.0
As required under Section 12, part (a)(i)(3A) of the Safe Medical Device Act of 1990, an adequate summary of any information respecting safety and effectiveness follows.
6.1 General Information
� Name and address of submitter:
Tel #: Fax #: Contact Person: Date of Preparation:
USCI, Div. of C.R. Bard,Inc. 1200 Technology Park Drive Billerica, MA 01821 (508) 667-1300 (508) 667-4301 Robert Miragliuolo December 11, 1995
◆ Device Names:
Trade Name(s):
Common Name:
Classification Name:
◆ Predicate Device Name: Trade Name:
USCI® Bipolar Balloon Pacing Electrode USCI® Special Care Electrode Temporary Transvenous Pacing Electrode Temporary Pacemaker Electrode
USCI® Bipolar Balloon Pacing Electrode
Image /page/0/Picture/16 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a three-dimensional appearance. The overall design is simple and eye-catching.
1
General Information con't 6.1
Device Description and Intended Use: �
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.
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. These devices are sold sterile and are for one time use only. In addition to the pacing electrode with BH coating, each catheter is packaged with a needle cannula, an EKG clip, and a syringe to assist in the use of the pacing electrode.
2
Summary of Similarities and Differences 6.2
The coated USCI Bipolar Pacing Electrode is substantially equivalent to the uncoated USCI® Bipolar Balloon Pacing Electrode (covered under #K800298).
The similarities between the current devices, the USCI Bipolar Pacing Electrodes and the predicate device, the USCI® Bipolar Balloon Pacing Electrode, include identical materials: a latex balloon, a polyurethane shaft, and stainless steel electrodes.
The difference between the two devices is that the current USCT® Bipolar Pacing Electrode has been coated with benzalkonium heparin, which is identical to the coating used on the USCI® Safe-T-Cath Thermodilution catheter (#K791873), and the USCI® Temporary Atrio-Ventricular Electrode, (#K830094).
Results from bench test data demonstrate that the BH coated USCI Bipolar Pacing Electrodes perform similar to the predicate device, the uncoated USCI® Bipolar Balloon Pacing Electrode. Electrical continuity tests demonstrated that the BH coated Bipolar Pacing Electrodes does not affect the ability of the catheter to pace. The inflated balloon diameter test confirms that the BH coated Bipolar Pacing Electrode is within the recommended diameter range.
In conclusion, results from all the bench test data demonstrate that the BH coated Bipolar Pacing Electrodes perform similar to the predicate device, the uncoated Bipolar Balloon Pacing Electrode, therefore, a determination of substantial equivalence can be claimed.