Modification To Biotronik's Sterilization Process
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K023803 FDA 510(k)
- FDA Product Code
- DTB 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
- SESE Substantially Equivalent FDA 510(k)
This modification pertains to Biotronik’s sterilization process for permanent pacemaker electrodes, a critical component in cardiovascular implantable electronic devices. The electrodes are designed for use in cardiac rhythm management, facilitating electrical stimulation and sensing within the heart to regulate abnormal heartbeats.
The process modification was submitted under FDA 510(k) clearance (K023803) and pertains to Class III devices (product code DTB) under regulation 870.3680. The electrodes are intended for single-use applications in sterile conditions, with no explicit mention of MRI safety or reusable components. Biotronik’s manufacturing facility in Lake Oswego, Oregon, oversees production, adhering to regulatory standards for cardiovascular devices.
Frequently asked questions
What is the purpose of this sterilization process modification for Biotronik’s electrodes, and how does it relate to their use in medical settings?
This modification pertains to Biotronik’s sterilization process for permanent pacemaker electrodes, which are critical components in cardiovascular implantable electronic devices. These electrodes are designed to facilitate electrical stimulation and sensing within the heart, helping to regulate abnormal heartbeats. The updated sterilization process ensures these single-use electrodes remain sterile for safe implantation in sterile medical environments, maintaining their reliability for cardiac rhythm management procedures.
Are these electrodes intended for reuse, or are they strictly single-use? How does this impact their handling and storage?
The electrodes are explicitly designed for single-use applications only. This means they must be used once and then discarded to ensure patient safety and sterility. Clinicians should handle them with sterile techniques, store them in their original packaging until use, and avoid reprocessing or reuse, as this could compromise their integrity and risk infection or device malfunction.
What regulatory pathway was followed for this sterilization process modification, and which advisory committee was involved?
This modification was submitted under the FDA 510(k) clearance pathway (K023803) as a Class III device (product code DTB), which falls under regulation 870.3680. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its relevance to cardiovascular implantable electronic devices. The decision was classified as Substantially Equivalent (SESE), confirming the modification maintains the same performance as the original process.
Where is this device manufactured, and what standards does the facility adhere to?
The electrodes are manufactured at Biotronik’s facility located in Lake Oswego, Oregon (97035). The production adheres to regulatory standards for cardiovascular devices, ensuring compliance with quality, safety, and performance requirements for medical-grade components used in life-supporting procedures like cardiac rhythm management.
What types of permanent pacemaker electrodes does this modification apply to, and how can I verify compatibility with my current systems?
This sterilization process modification applies to multiple electrode models listed under the OpenFDA registration numbers (e.g., 3002618605, 1028232, etc.), all categorized under permanent pacemaker electrodes. To verify compatibility, check the device’s unique identification number (FEI) or registration number against Biotronik’s official documentation or contact their technical support team. Ensure the electrode model matches your existing pacemaker system’s specifications, as compatibility depends on both the electrode type and the pacemaker’s programming capabilities.
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: Modification to Biotronik'S Sterilization Process (K023803) — Fda 510 ..., K023803 FDA 510 (k) - MODIFICATION TO BIOTRONIK'S STERILIZATI..., PDF K023803 - Modification to Biotronik'S Sterilization Process
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K023803 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K023803 24 fields · synced Sep 18, 2026