(698 days)
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.
Not Found
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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510(k) Summary
Telectronics Pacing Systems 510(k) products: Leads, Pacers and Accessories
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.
The change in the contract sterilization company does not change the product performance characteristics and indications for use, and no new materials are used in the manufacture of the Company's products. Devices to which substantial equivalence is claimed is detailed in Exhibit 7.
If the "equivalent" old device is manufactured by the sponsor of the 510(k), discuss the reasons for each of the changes made and a description of any complications or possible adverse side effects related to the "equivalent" old device which led to the changes in the new device.
Cordis Corporation has announced that it will stop sterilizing at their facility as of October 1, 1993. In choosing another contract sterilizer, we have also decided to select a company that will sterilize with 100% EtO gas so that we may be in compliance with the upcoming EPA regulations by eliminating the use of an ozone depleting substance, such as Freon, from our process. Telectronics Pacing Systems has therefore, in conjunction with Cordis Corporation, selected and validated Griffith Micro Science, Inc., as the contract sterilizer. These changes are not related to any complications or adverse side effects.
Provide specific data to show that each of the changes is safe and effective.
The Documentation and data regarding the change to another contract sterilization company provided in this submission demonstrate that the change is safe and effective. This change is not being made as a result of any patient complications.
Include an update of the complications (as current as is presently known to the sponsor) and an update of all the clinical data to within three months of the submission.
Since there are no clinical trials, there have been no adverse effects and thus this portion is not applicable.
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.