(698 days)
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No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The provided text describes what information a 510(k) summary should contain for life-supporting, life-sustaining, and implantable devices, rather than describing a specific device's intended use as a therapeutic device. There is no information present to suggest the device has a therapeutic function.
No
The provided text is a template for summaries of equivalence for 510(k) submissions, outlining what information should be specified for various types of devices, including 'indications'. However, it does not describe a device itself or state that the outlined 'indications' are for diagnostic purposes. The 'Not Found' entries under 'Device Description', 'Input Imaging Modality', and other sections further confirm that no specific device or its diagnostic function is being described.
Unknown
The provided text is a template for a 510(k) summary and does not contain a description of a specific device. Therefore, it's impossible to determine if the device is software-only.
Based on the provided text, there is no information to suggest that this device is an IVD (In Vitro Diagnostic).
The text focuses on the requirements for Summaries of Equivalence for specific types of medical devices (life supporting, life sustaining, and implantable) and the information that should be included in those summaries. It does not describe the device itself or its intended use in a way that would indicate it is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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.