(205 days)
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No
The device description and performance studies focus on the physical integrity and electrical properties of a ground cable, with no mention of AI or ML technologies.
No
The device is described as a "UNIPOLAR IPG GROUND CABLE", which sounds like an electrical component, and there is no information on its intended use or indications that would suggest it provides therapy. The performance studies focus on device integrity and reliability, not therapeutic outcomes.
No
The device description and performance studies indicate it is a cable assembly used for grounding, undergoing integrity tests like life cycle and sterilization, not for diagnosing conditions.
No
The device description explicitly states "UNIPOLAR IPG GROUND CABLE, Model 5473", indicating a physical cable. The performance studies also describe testing of "cable assemblies", further confirming it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description and testing information focus on the physical integrity and functionality of a cable assembly (UNIPOLAR IPG GROUND CABLE). There is no indication that this device is used to examine specimens derived from the human body for the purpose of providing information about a physiological state, health, or disease.
- Focus on physical performance: The performance studies described are related to the durability and functionality of the cable itself (autoclave sterilization, life cycling, rotational flex). These are typical tests for medical devices that are used externally or as part of a larger system, not for devices that perform in vitro diagnostic tests.
- Lack of IVD-specific information: There is no mention of analytes, assays, or any other terms associated with in vitro diagnostics.
Therefore, based on the available information, the UNIPOLAR IPG GROUND CABLE, Model 5473 is not an IVD. It appears to be an accessory or component for a medical device, likely related to an implantable pulse generator (IPG).
N/A
Intended Use / Indications for Use
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Product codes
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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
A total sample size of thirty (30) cable assemblies were used for the Model 5473 performance testing. Twenty (20) cable assemblies were exposed to life cycle testing, providing a 90% confidence level with a minimum reliability of 89%. Ten (10) cable assemblies were exposed to autoclave sterilization testing, providing a 90% confidence level with a minimum reliability of 79%. Rotational flex testing required a sample size of eight (8) cable assemblies to gain a 90% confidence with a minimum reliability of 74%. Lower sample sizes for the sterilization and rotational flex testing were deemed adequate due to the proven history that these materials have in many other Medtronic surgical cable assemblies.
Autoclave Sterilization:
Objective: To verify the device can be sterilized without loss of function.
Test Method: The samples are subjected to an initial visual inspection, a contact resistance measurement, and a grip force measurement. The samples are subjected to one hundred (100) flash autoclave sterilization at 2700 F for 10 minutes at a pressure of 21 psi. After sterilization, the samples are subjected to a visual inspection, a contact resistance measurement, and a grip force measurement.
Grounding Clip Life Cycling:
Objective: To verify the device can be reused without loss of function.
Test Method: The samples are subjected to an initial visual inspection, a contact resistance measurement, and a grip force measurement. The samples are subjected to 250 cycles of opening and closing of the IPG grounding clip. After cycling, the samples are subjected to a visual inspection, a contact resistance measurement, and a grip force measurement.
Rotational Flex:
Objective: To verify the device can be reused without loss of function.
Test Method: The samples are subjected to an initial visual inspection, and a contact resistance measurement. The samples are subjected to 1000 cycles of rotational flex by clamping the IPG ground clip to a rotating platform, with a one (1) ounce weight six (6) inches from the ground clip. After cycling, the samples are again subjected to visual inspection, and a contact resistance measurement.
Summary of Performance Studies
Study Type: Device Integrity Testing
Sample Size:
- Autoclave Sterilization: 10 devices tested
- Grounding Clip Life Cycling: 20 devices tested
- Rotational Flex: 8 devices tested
Key Results: All tests passed.
- Autoclave Sterilization: Devices remained within specification after flash autoclave sterilization.
- Grounding Clip Life Cycling: Devices were capable of grasping and holding a minimum of 2 ounce weight in the vertical direction, and had acceptable contact resistance.
- Rotational Flex: Devices were reusable.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Image /page/0/Picture/0 description: The image shows the text "K961520" in a handwritten style at the top. Below this, the words "MEDTRONIC CONFIDENTIAL" are printed in a bold, sans-serif font. The text suggests that the document is confidential and related to Medtronic, possibly indicating a product or project identifier.
NOV 13 100
Section 7 - Performance Data Demonstrating Safety and Effectiveness
1. Device Integrity Testing
The following table identifies the tests which were performed to verify that the UNIPOLAR IPG GROUND CABLE, Model 5473 meets the device integrity requirements. The table includes a summary of the requirements for each test. Following the table, a summary of each test objective and method is provided.
2. Sample Size
A total sample size of thirty (30) cable assemblies were used for the Model 5473 performance testing. Twenty (20) cable assemblies were exposed to life cycle testing, providing a 90% confidence level with a minimum reliability of 89%. Ten (10) cable assemblies were exposed to autoclave sterilization testing, providing a 90% confidence level with a minimum reliability of 79%. Rotational flex testing required a sample size of eight (8) cable assemblies to gain a 90% confidence with a minimum reliability of 74%. Lower sample sizes for the sterilization and rotational flex testing were deemed adequate due to the proven history that these materials have in many other Medtronic surgical cable assemblies.
| Test | Test Requirement | Devices
Tested | Test
Results |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-----------------|
| Autoclave
Sterilization | Devices shall remain within specification
following flash autoclave sterilization. | 10 | Pass |
| Grounding
Clip Life
Cycling | Devices shall be capable of grasping and
holding a minimum of 2 ounce weight in the
vertical direction, and shall have acceptable
contact resistance. | 20 | Pass |
| Rotational
Flex | Devices shall be reusable | 8 | Pass |
Table 4: Device Integrity Tests
3. Device Integrity Test Objectives and Methods
A. Autoclave Sterilization
Objective
To verify the device can be sterilized without loss of function.
1
Test Method
The samples are subjected to an initial visual inspection, a contact resistance measurement, and a grip force measurement. The samples are subjected to one hundred (100) flash autoclave sterilization at 2700 F for 10 minutes at a pressure of 21 psi. After sterilization, the samples are subjected to a visual inspection, a contact resistance measurement, and a grip force measurement.
B. Grounding Clip Life Cycling
Objective
To verify the device can be reused without loss of function.
Test Method
The samples are subjected to an initial visual inspection, a contact resistance measurement, and a grip force measurement. The samples are subjected to 250 cycles of opening and closing of the IPG grounding clip. After cycling, the samples are subjected to a visual inspection, a contact resistance measurement, and a grip force measurement.
C. Rotational Flex
Objective
To verify the device can be reused without loss of function.
Test Method
The samples are subjected to an initial visual inspection, and a contact resistance measurement. The samples are subjected to 1000 cycles of rotational flex by clamping the IPG ground clip to a rotating platform, with a one (1) ounce weight six (6) inches from the ground clip. After cycling, the samples are again subjected to visual inspection, and a contact resistance measurement.