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Summaries of Equivalence for 510(k) for life supporting, life sustaining and implantable devices. These summaries should: Specify the device or devices to which the manufacturer is claiming equivalence design, materials (for devices which are implants or which are designed to to come into contact with the body), performance and indications.

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This 510(k) summary (K943657) describes a change in a contract sterilization company for Telectronics Pacing Systems' leads, pacers, and accessories. It does not describe a diagnostic device or an AI/ML algorithm that would have acceptance criteria related to its performance in classifying or analyzing data.

Therefore, your request for the following information is not applicable to this specific 510(k) submission:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone performance study
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

This 510(k) is about demonstrating that a change in a manufacturing process (sterilization) does not alter the safety or effectiveness of an already approved device. The "study" described is the validation of the new contract sterilizer (Griffith Micro Science, Inc.) and the change to 100% EtO gas sterilization. The submission states: "The Documentation and data regarding the change to another contract sterilization company provided in this submission demonstrate that the change is safe and effective."

The acceptance criteria for this type of submission would revolve around:

• Sterility Assurance Level (SAL): Ensuring the new sterilization process achieves the required SAL (typically 10^-6 for implantable devices).
• Material Compatibility: Verifying that the new sterilization method (100% EtO) does not adversely affect the materials of the leads, pacers, and accessories (e.g., degradation, residue levels).
• Biocompatibility: Confirmation that EtO residuals on the device are within acceptable limits after sterilization and aeration.
• Functional Performance: Ensuring the device still functions as intended after the new sterilization process.

The "study" that proves the device meets these acceptance criteria would be the validation data provided by Telectronics Pacing Systems in conjunction with Cordis Corporation and Griffith Micro Science, Inc. This would typically involve:

• Microbiological challenge studies: To confirm SAL.
• Chemical residue testing: To measure EtO residuals.
• Physical and mechanical testing: To ensure device integrity and performance are maintained post-sterilization.

Since the provided text excerpt is a summary and doesn't contain the detailed validation report, it cannot provide specific numbers for these tests or the exact methodology beyond stating that "Documentation and data... demonstrate that the change is safe and effective."

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