(192 days)
Lead adapters, including silicone adapter sleeves, when used in conjunction with their accessories, provide a means of securely connecting pace/sense leads with otherwise mechanically incompatible pacemaker devices.
BIOTRONIK A1 Series Lead Adapters and the PEH Adapter Sleeve are designed to be chronically implantable, safe and effective through design functionality, simplicity and material biocompatibility. Both devices were cleared for distribution pursuant to FDA review of the 1990 510(k).
For A 1 Series Lead Adapters, the following changes are proposed:
- a titanium alloy (Ti4) will be used for the manufacture of the device set screw; ●
- . the silicone of the lead connector receptacles and connectors will change from DOW Corning HTV silicones to Silopren LSR-4070;
- NuSil MED 1137 will be used as a silicone tube adhesive; .
- slight design improvements and modifications related to the above described silicone . material changes;
- blister packaging material will change from XT Polymer to PETG; .
- the catalog number will change. .
For the PEH Adapter Sleeve, the following changes are proposed:
- the main silicone-based MOC will change from DOW Corning HTV silicones to . Silopren LSR-4070;
- . the catalog number will change.
The following devices were submitted within the 1990 510(k):
| A1-A: | adapts one 5 mm unipolar connector to fit IS-1 connector receptacle |
|---|---|
| A1-B: | adapts one 6 mm unipolar connector to fit IS-1 connector receptacle |
| A1-ABP: | adapts two 5 mm unipolar connectors to fit IS-1 connector receptacle |
| A1-MBP: | adapts one 3.2 mm "in line" bipolar connector to fit IS-1 connector receptacle; or, adapts one 3.2 mm unipolar connector to fit IS-1 connector receptacle. |
| A1-Z: | adapts one unipolar connector without a connector to fit IS-1 connector receptacle |
| A6-A: | adapts one unipolar connector without a connector to fit 5 mm unipolar connector receptacle |
| A6-B: | adapts one unipolar connector without a connector to fit 6 mm unipolar connector receptacle |
PEH Sleeve: adapts one unipolar lead with 5 mm connector to fit 6 mm connector receptacle.
The provided document largely describes changes proposed for existing BIOTRONIK A1 Series Lead Adapters and PEH Adapter Sleeves, and the FDA's subsequent approval of these changes under a 510(k) submission. It focuses on demonstrating that the changes will not adversely affect the overall safety and effectiveness of the existing, already cleared devices.
As such, this document is a 510(k) premarket notification for device modifications, not for a novel AI device requiring a standalone performance study with a test set, ground truth established by experts, or MRMC studies. The acceptance criteria and "device performance" in this context refer to manufacturing and biocompatibility tests, not the diagnostic or therapeutic performance of an AI algorithm.
Therefore, many of the requested categories for AI device evaluation are not applicable here.
Here's an attempt to answer the questions based on the provided text, indicating where information is not available or not applicable:
Acceptance Criteria and Study for BIOTRONIK A1 Series Lead Adapters and PEH Adapter Sleeves (Modified Devices)
Note: This document describes a 510(k) submission for modifications to existing, cleared devices. The "acceptance criteria" and "device performance" primarily relate to engineering, material, and safety testing to ensure the modifications do not compromise the previously established safety and effectiveness. This is not an evaluation of an AI-powered diagnostic or therapeutic device requiring a clinical study with human readers or specific statistical performance metrics.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Tests Performed) | Reported Device Performance |
|---|---|
| A1 Series Lead Adapters: | All production and biocompatibility test results were within specifications. |
| IS-1 connector seal integrity testing | Within specifications |
| Lead receptacle seal integrity testing | Within specifications |
| 500-hour in-vitro tests | Within specifications |
| 2000-hour in-vitro tests | Within specifications |
| Insertion/extraction forces of IS-1 connector | Within specifications |
| Insertion/extraction forces of lead connector(s) within adapter's receptacle(s) | Within specifications |
| Connector port stop force | Within specifications |
| Flex testing of the receptacle connection | Within specifications |
| Device handling | Within specifications |
| Deformation testing of IS-1 connector upon set screw clamp-down | Within specifications |
| Strength of connector/receptacle connection | Within specifications |
| Abrasion testing | Within specifications |
| Tensile strength and micrographic examination of welded connections | Within specifications |
| Destructive pressure testing of silicone tubing | Within specifications |
| Ability of lead receptacle to withstand binding by ligature | Within specifications |
| Ability of device to withstand temperature change during shipping | Within specifications |
| Various dimensional and visual inspections during device manufacture | Within specifications |
| PEH Adapter Sleeves: | All production and biocompatibility test results were within specifications. |
| Seal integrity testing | Within specifications |
| Device handling | Within specifications |
| 500-hour in-vitro tests | Within specifications |
| 2000-hour in-vitro tests | Within specifications |
| Ability of device to withstand temperature change during shipping | Within specifications |
| Various dimensional and visual inspections during device manufacture | Within specifications |
| General: | |
| Biocompatibility tests | Within specifications |
| Packaging and transportation durability | Performed; quality and sterility ensured |
| Sterilization procedures | Performed; quality and sterility ensured |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample sizes for the individual engineering or material tests. These would typically be determined by internal quality control procedures and regulatory standards for device components/materials.
- Data Provenance: The tests are indicated as "in-vitro tests" and "production and biocompatibility test results," suggesting laboratory-based testing conducted by the manufacturer, BIOTRONIK. No information on geographical origin of data or retrospective/prospective nature is provided beyond the nature of the tests themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. For this type of device modification submission, "ground truth" is established through adherence to engineering specifications, material properties, and established test methodologies, rather than expert clinical consensus on diagnostic findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation (e.g., radiology reads). The tests described are laboratory/engineering tests with objective metrics.
5. 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. This is not an AI device, and no MRMC study was conducted. The document focuses on material and design changes to an implantable medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device, and thus no standalone algorithm performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed on these devices is the adherence to pre-defined engineering specifications, material standards, and safety parameters established by BIOTRONIK and regulatory bodies for the safe and effective functioning of lead adapters.
8. The sample size for the training set
Not applicable. This is not an AI device and does not involve machine learning training sets.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 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.”