📋 FDA Reference
Modification to Biotronik S Sterilization Process
Summary: This device involves a modification to Biotronik's sterilization process, used for ensuring the safety and efficacy of their medical devices. It is primarily utilized by healthcare professionals involved in device implantation and management.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K023803 ↗
Decision Date ?
December 11, 2002
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
This modification to Biotronik's sterilization process was cleared through the FDA 510(k) pathway on December 11, 2002. It is manufactured by Biotronik and classified as a Class III device.
What It Is
The device refers to a modification in the sterilization process used by Biotronik for their medical devices. Sterilization is crucial for preventing infections and ensuring device safety. This process ensures that the devices meet stringent safety standards before being used in clinical settings.
FDA-Cleared Indications
- Sterilization of applicable Biotronik medical devices before use in patients.
- Use with devices for which the modified sterilization process is validated and included in the device labeling.
Clinical Applications
- Preparing applicable Biotronik devices for implantation procedures.
- Sterilizing Biotronik devices used in vascular and interventional procedures when specified in the product labeling.
- Reducing microbial contamination on applicable devices before they are introduced into the body.
Practical Considerations
- This record concerns a manufacturing sterilization-process modification, not a standalone device that is selected or implanted by clinicians.
- Use only with Biotronik devices identified in the applicable FDA clearance and current product labeling.
- Clinicians should verify that the specific product is supplied sterile, check package integrity and expiration dating, and follow the manufacturer's handling instructions.
- MRI safety, device dimensions, implant duration, and contraindications depend on the specific Biotronik device, not on the sterilization process alone.
- Do not reprocess or resterilize a device unless the product labeling specifically permits it.
Procedures that use this device
Frequently Asked Questions
What is the Biotronik sterilization process used for?
It is used to ensure that Biotronik devices are free from contaminants and safe for implantation.
What specialties typically use this device?
Specialties such as cardiology and interventional radiology commonly use devices sterilized by this process.
What are the FDA-cleared indications?
The process is indicated for use with devices like IVC filters to ensure they are safe for preventing pulmonary embolism.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.