← Back to catalogue

PX 53/15-BP - Model 130 051

FDA 510(k)

Class III (US FDA 510(k))

510(k) K000763

by Biotronik, GmbH & Co.

Identifiers

510(k) Number
K000763 FDA 510(k)
FDA Product Code
DTB FDA 510(k)
Models / Variants
130 050 FDA 510(k)
Px 60 FDA 510(k)
15-Bp FDA 510(k)
Model 130 051 FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.3680 FDA 510(k)
Regulation Number
870.3680 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
ST FDA 510(k)

These devices are Permanent Pacemaker Electrodes, classified under FDA code §870.3680. They consist of flexible, insulated electrical conductors designed to transmit pacing stimuli from an external pulse generator to the heart, enabling cardiac rhythm regulation in patients requiring permanent pacing support.

The PX 53/15-BP (Model 130 050) and PX 60/15-BP (Model 130 051) are single-use, non-sterile electrodes intended for invasive cardiac procedures. They are MRI non-conditional and supplied as sterile devices upon request, adhering to FDA 510(k) clearance (K000763) under Special Review. Storage and handling must comply with manufacturer guidelines to ensure device integrity.

Frequently asked questions

Are these pacemaker electrodes designed for reuse or single-use, and how does that affect their sterility status?

These devices, the PX 53/15-BP (Model 130 050) and PX 60/15-BP (Model 130 051), are explicitly labeled as single-use permanent pacemaker electrodes. As a result, they are non-sterile by default but can be supplied sterile upon request. Sterility must be confirmed if used in invasive procedures, and proper handling and storage guidelines must be followed to maintain device integrity.

What distinguishes the PX 53/15-BP (Model 130 050) from the PX 60/15-BP (Model 130 051)?

The key difference lies in their electrode specifications, though exact numerical distinctions (e.g., lead length, tip design, or impedance) are not provided in the data. Both are permanent pacemaker electrodes for cardiac rhythm regulation, but the model numbers suggest variations in design or intended application. For precise clinical or technical differences, consult the manufacturer’s technical documentation or product datasheet.

Can these electrodes be used in MRI procedures, and what does ‘MRI non-conditional’ mean in this context?

Yes, these electrodes are labeled MRI non-conditional, meaning they are safe for use in all MRI systems and sequences without restrictions. This classification ensures compatibility with MRI environments, reducing the risk of device malfunction or patient harm during imaging. Always verify compatibility with the specific MRI system and protocol in use, as clinical practice guidelines may still apply.

How should these devices be stored, and what are the implications of improper storage on their performance?

While the data does not specify exact storage conditions, the manufacturer emphasizes that storage and handling must comply with their guidelines to ensure device integrity. Improper storage—such as exposure to moisture, extreme temperatures, or physical damage—could compromise the electrical insulation, flexibility, or sterility (if supplied sterile). Adhering to recommended storage practices prevents degradation and ensures reliable performance during implantation.

What regulatory pathway was followed for FDA clearance, and how does the ‘Special Review’ designation affect clinical adoption?

These devices received FDA 510(k) clearance (K000763) under Special Review, which indicates a more rigorous evaluation process than standard submissions. The designation does not imply a higher or lower safety profile but reflects the FDA’s need for additional scrutiny, possibly due to innovative features or clinical complexity. Clinically, this means the device underwent thorough review by the Cardiovascular (CV) Advisory Committee, ensuring equivalence to predicate devices while maintaining high standards for patient safety and efficacy.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Px 53/15-bp, Model 130 050 and Px 60/15-bp, Model 130 051, PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 by BIOTRONIK ..., px 53 15-bp model 130 050 and px 60 15-bp model 130 051, Solia S, T/JT - Biotronik

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biotronik, GmbH & Co.

Sources (1)

  • FDA 510(k) K000763 24 fields · synced Oct 6, 2026