(29 days)
The 6981M Lead extender kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a unipolar connector that meets the (IS-1 UNI) standard.
The 6984M Lead Extender Kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a bipolar connector that meets the (IS-1 BI) standard.
The 5866-24M Lead adaptor kit is designed to connect a Medtronic pacing lead with a bipolar connector (5mm bifurcated) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard.
The 5866-38M Lead adaptor kit is designed to connect two pacing leads with unipolar connectors (IS-1 UNI) to a pulse generator featuring a bipolar connector block which meets the (IS-I BI) standard.
The Model 5866-40M Lead Adaptor Kit is designed to connect a Medtronic pacing lead with a bipolar connector (3.2 mm low-profile) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard and has a short-pin cavity and no sealing rings.
The 6986M Lead adaptor/Extender kit is designed to extend, by 37 cm (14.6 in.), the length of a 3.2 mm low-profile connector pacing lead system and connect to a pulse generator featuring a bipolar connector block that meets the (IS-1 BI) standard.
The 6981M Lead extender kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a unipolar connector that meets the (IS-1 UNI) standard.
The 6984M Lead Extender Kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a bipolar connector that meets the (IS-1 BI) standard.
The 5866-24M Lead adaptor kit is designed to connect a Medtronic pacing lead with a bipolar connector (5mm bifurcated) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard.
The 5866-38M Lead adaptor kit is designed to connect two pacing leads with unipolar connectors (IS-1 UNI) to a pulse generator featuring a bipolar connector block which meets the (IS-I BI) standard.
The Model 5866-40M Lead Adaptor Kit is designed to connect a Medtronic pacing lead with a bipolar connector (3.2 mm low-profile) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard and has a short-pin cavity and no sealing rings.
The 6986M Lead adaptor/Extender kit is designed to extend, by 37 cm (14.6 in.), the length of a 3.2 mm low-profile connector pacing lead system and connect to a pulse generator featuring a bipolar connector block that meets the (IS-1 BI) standard.
This appears to be a 510(k) summary for a medical device (lead extender and adaptor kits), not a study evaluating software or AI performance. Therefore, many of the requested categories for AI/software studies are not applicable.
Here's an analysis based on the provided text, focusing on the available information regarding acceptance criteria and performance testing for these hardware devices:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Testing | Safety and effectiveness ensured through device design controls | Verification Included: |
| Dielectric Withstanding Voltage Test | Not explicitly stated what the passing criteria are, but implied to meet standards for safety. | Passed through performance testing. |
| Saline Soak / Electrical Impedance | Not explicitly stated what the passing criteria are, but implied to meet standards for safety. | Passed through performance testing. |
| Fluid Leakage | Not explicitly stated what the passing criteria are, but implied to meet standards for safety. | Passed through performance testing. |
| Composite Tensile Integrity | Not explicitly stated what the passing criteria are, but implied to meet standards for physical durability. | Passed through performance testing. |
| Composite Tensile Strength | Not explicitly stated what the passing criteria are, but implied to meet standards for physical durability. | Passed through performance testing. |
| Lead Body Reverse Bend | Not explicitly stated what the passing criteria are, but implied to meet standards for physical durability and lead integrity. | Passed through performance testing. |
| Biocompatibility Assessment | Not explicitly stated, but implied to meet standards for patient safety and biological compatibility. | Verification Included: |
| Cytotoxicity | Not explicitly stated. | Passed through biocompatibility assessment. |
| Sensitization | Not explicitly stated. | Passed through biocompatibility assessment. |
| Irritation or Intracutaneous Reactivity | Not explicitly stated. | Passed through biocompatibility assessment. |
| Systemic Toxicity | Not explicitly stated. | Passed through biocompatibility assessment. |
| Genotoxicity | Not explicitly stated. | Passed through biocompatibility assessment. |
| Implantation | Not explicitly stated. | Passed through biocompatibility assessment. |
| Sterilization Testing | Not explicitly stated, but implied to meet standards for ensuring a sterile product. | Verification Included: |
| Residual Testing | Not explicitly stated. | Passed through sterilization testing. |
Study Proving Device Meets Acceptance Criteria:
The document describes a "Performance Testing" section which details verification tests conducted on the modified Lead Adaptor Kit and Lead Extender Kit products. The study explicitly states: "The assessment of the material change being made to the Lead Adaptor Kit and Lead Extender Kit products was carried out using Design Controls compliant to 21 CFR 820.30. The safety and effectiveness of the product has been ensured through performance testing."
The conclusion states: "Medtronic has demonstrated that the modifications made to the Lead Adaptor Kit and Lead Extender Kit products described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate device(s)."
This implies that the study proving the device meets the acceptance criteria is the comprehensive set of verification tests (Performance, Biocompatibility, Sterilization) conducted under Design Controls (21 CFR 820.30) to establish substantial equivalence to predicate devices. The specific results for each test are not numerical but are reported as "verified" or "passed."
Regarding the AI/Software specific questions (not applicable to this device submission):
This submission is for physical medical devices (lead extenders and adaptors), not a software or AI-driven device. Therefore, the following information is not present and is not relevant to this type of 510(k) submission:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a hardware device. No "data" in the AI sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for hardware performance is established by engineering standards and objective measurements.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For these hardware devices, the ground truth is based on engineering specifications, material properties, and regulatory standards for safety and performance (e.g., electrical impedance measurements, tensile strength, biocompatibility tests).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 870.3620 Pacemaker lead adaptor.
(a)
Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.”