Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-A, Pikos E01-A
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K993434 FDA 510(k)
- FDA Product Code
- DXY FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3610 FDA 510(k)
- Regulation Number
- 870.3610 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pikos series comprises implantable pacemaker pulse-generators, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. These devices are classified as Class III medical devices under FDA regulations, intended for patients requiring permanent pacing support due to bradycardia or other conduction disorders.
These pulse-generators are supplied sterile and intended for single-use implantation, adhering to MRI safety standards for Class C (safe up to 3 Tesla). They are distributed in various configurations (01, E01, 01-B, 01-A) and require surgical implantation by trained clinicians. Authorized under FDA 510(k) clearance (K993434), they are regulated under 21 CFR 870.3610 for implantable pacemakers, with no third-party involvement in distribution.
Frequently asked questions
What are the key differences between the PIKOS 01 and PIKOS E01 models, and how do they relate to the ‘-B’ and ‘-A’ variants?
The PIKOS 01 and PIKOS E01 are base configurations of Biotronik’s implantable pacemaker pulse-generators, designed for patients needing permanent pacing support. The ‘-B’ and ‘-A’ suffixes (e.g., PIKOS 01-B or PIKOS E01-A) likely denote specific design variations or features tailored to different clinical needs, such as lead compatibility, pacing modes, or battery chemistry. However, the exact distinctions between these variants are not detailed in the provided data. All variants are sterile, single-use devices intended for surgical implantation by trained clinicians.
Are these pacemaker pulse-generators compatible with MRI scans, and if so, what safety standards do they meet?
Yes, the PIKOS series is designed with MRI safety in mind, adhering to Class C standards, which means they are safe for use in MRI environments up to 3 Tesla. This classification ensures minimal risk of interference or adverse effects during MRI procedures, making them suitable for patients who may require imaging while relying on the device for cardiac rhythm regulation.
How are these devices supplied, and what should clinicians consider regarding sterility and handling?
The PIKOS pulse-generators are supplied sterile and intended for single-use implantation only. Clinicians should handle them using aseptic techniques to maintain sterility before surgical implantation. Since they are sterile-packaged, they should not be reused or reprocessed, as this could compromise their safety and efficacy.
What regulatory pathway was followed for FDA clearance of these devices, and how does this affect their distribution?
The PIKOS series received FDA 510(k) clearance under K993434, classified as a Class III medical device under 21 CFR 870.3610 for implantable pacemakers. The clearance was granted through a substantially equivalent (SESE) determination by the Cardiovascular (CV) Advisory Committee, with no third-party involvement in distribution. This means the devices are regulated strictly for safety and performance, and distribution is handled directly by Biotronik, Inc., ensuring compliance with FDA requirements.
What configurations or models are available, and how might a clinician determine which one is best suited for a patient?
The PIKOS series includes multiple configurations: PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, and PIKOS E01-A. While the exact specifications for each variant are not detailed, the differences likely relate to pacing capabilities, lead compatibility, or other clinical features. Clinicians should consult Biotronik’s technical documentation or product literature to select the appropriate model based on the patient’s specific conduction disorder, pacing requirements, and compatibility with existing leads or systems.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K993434 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K993434 24 fields · synced Sep 18, 2026