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SX 53/15-BP, Model 124 853; SX 60/15-BP, Model 124 854

FDA 510(k)

Class III (US FDA 510(k))

510(k) K991169

by Biotronik, Inc.

Identifiers

510(k) Number
K991169 FDA 510(k)
FDA Product Code
DTB FDA 510(k)
Models / Variants
124 853 FDA 510(k)
Sx 60 FDA 510(k)
15-Bp FDA 510(k)
Model 124 854 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)

The SX 53/15-BP, Model 124 853 and SX 60/15-BP, Model 124 854 are permanent pacemaker electrodes designed for cardiac rhythm management. These devices are intended for implantation within the heart to deliver electrical stimulation for pacing purposes, ensuring proper heart function in patients with bradycardia or conduction disorders.

These electrodes are supplied sterile and intended for single-use implantation in cardiac electrophysiology procedures. They are classified as Class III devices under FDA regulations (21 CFR 870.3680) and have received a 510(k) clearance (K991169) for substantial equivalence with tracking requirements. The models feature a 15 mm spacing between ring and tip electrodes, consistent with prior approved designs.

Frequently asked questions

What are the primary uses for the SX 53/15-BP and SX 60/15-BP pacemaker electrodes in clinical practice?

These electrodes are designed for permanent implantation in the heart to deliver electrical pacing stimuli. They are specifically intended for patients with bradycardia (slow heart rate) or conduction disorders, helping restore and maintain proper heart rhythm during cardiac electrophysiology procedures.

Are these pacemaker electrodes reusable or intended for single-use, and how are they supplied?

The SX 53/15-BP and SX 60/15-BP electrodes are supplied sterile and are intended for single-use only. They come pre-packaged for direct implantation in cardiac procedures, ensuring sterility and minimizing infection risks.

What distinguishes the SX 53/15-BP (Model 124 853) from the SX 60/15-BP (Model 124 854) in terms of design?

While both models share the same 15 mm spacing between the ring and tip electrodes, the primary distinction lies in their electrode configurations (SX 53 vs. SX 60), which may influence pacing thresholds or lead positioning for specific patient anatomies or clinical needs. The exact differences in electrode design are not specified but are likely optimized for varying patient requirements.

How should these electrodes be stored before use, and what precautions should be taken?

Since they are sterile and single-use, storage should follow manufacturer guidelines to preserve sterility. Typically, this involves keeping them in their sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Always verify the expiration date and ensure the packaging remains intact before use.

What regulatory pathway was followed for FDA clearance of these pacemaker electrodes, and what does that mean for clinicians?

The SX 53/15-BP and SX 60/15-BP electrodes received FDA 510(k) clearance (K991169) under the Traditional pathway, with a decision of *Substantially Equivalent* and subject to tracking. This means they were deemed comparable to a legally marketed predicate device, ensuring compliance with safety and effectiveness standards. Clinicians can rely on this clearance as evidence of regulatory review, though individual facility protocols should still govern implantation procedures.

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: Sx 53/15-bp, Model 124 853, Sx 60/15-bp, Model 124 854, PDF K991169 Sx 53/15-bp, Model 124 853, Sx 60/15-bp, Model, 510(k) Premarket Notification - Food and Drug Administration, www.accessdata.fda.gov, fda.innolitics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biotronik, Inc.

Sources (1)

  • FDA 510(k) K991169 24 fields · synced Oct 6, 2026