(474 days)
The Pikos LP 01/LP B01 models, like the Pikos 01/E01 models, are indicated for use in the following conditions:
- · Sinus node arrest or bradycardia with or without AV conduction disorder.
- · Intermittent or complete AV conduction block.
- · Brady/tachy syndrome or other manifestation of sick sinus syndrome which results in symptomatic bradycardia.
- · Atrial fibrillation and ventricular bradyarrhythmia.
The Pikos LP 01/LP B01 is a multi-programmable single chamber pulse generator which is designed and recommended for use with atrial or ventricular leads. The Pikos LP 01/LP E01 models offer a limited number of programmable options compared to those of the Pikos 01/E01 models.
This 510(k) submission (K945627) for the Pikos LP 01/LP B01 Implantable Pacemaker Pulse Generators focuses on demonstrating substantial equivalence to a predicate device (K914109/A, Pikos 01 and Pikos H01) rather than establishing new acceptance criteria through a clinical study. Therefore, most of the requested information regarding a study proving acceptance criteria will not be present.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define a table of new acceptance criteria and corresponding performance metrics from a distinct study for this device. Instead, it relies on demonstrating that the new device performs equivalently to a predicate device (Pikos 01/E01 models) based on pre-established performance of that predicate.
The qualification testing mentioned is primarily for design verification and validation of components and modifications, not for proving clinical performance against new acceptance criteria.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Functional Equivalence: | The Pikos LP 01/LP B01 is a multi-programmable single chamber pulse generator designed for use with atrial or ventricular leads, similar to the Pikos 01/E01 models. |
| Intended Use Equivalence: | "The Pikos LP 01/LP B01 models, like the Pikos 01/E01 models, are indicated for use in the following conditions: Sinus node arrest or bradycardia with or without AV conduction disorder. Intermittent or complete AV conduction block. Brady/tachy syndrome or other manifestation of sick sinus syndrome which results in symptomatic bradycardia. Atrial fibrillation and ventricular bradyarrhythmia." The intended uses are identical to the predicate device. |
| Design/Component Qualification (Modifications): | - Battery Qualification: "identical to that submitted in the Pikos 01/501 premarket notification (K914109/A)." (i.e., meets prior acceptance criteria). |
- Self-Sealing Header: "qualification reports describing the testing conducted for validation... included vibration, shock, temperature and transport tests meeting the applicable IS-1 requirements; header leakage resistance tests. Sterilization... was validated."
- Hybrid Circuit Modifications: "qualified with complete electrical and mechanical testing." (Implies meeting internal design specifications and performance standards). |
| Safety and Effectiveness: | "The product labeling includes instructions for use adequate to assure safe and effective operation of the device." (Relies on the established safety and effectiveness of the predicate device and verification of modifications). |
2. Sample Size Used for the Test Set and the Data Provenance
No specific "test set" in the context of clinical data for proving new acceptance criteria is described. The "qualification testing" refers to engineering and bench testing.
- Sample Size: Not applicable in the context of a clinical test set from human subjects for this submission. The "sample" likely refers to components or finished devices subjected to various engineering tests (e.g., a certain number of self-sealing headers tested for leakage). These numbers are not provided in the summary.
- Data Provenance: Not applicable in the context of clinical data. The qualification testing data would be generated in-house by BIOTRONIK GmbH & Co.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This submission is for a medical device that relies on engineering qualification and demonstrated equivalence, not a diagnostic algorithm requiring expert-established ground truth from a test set of human data.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above.
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-assisted diagnostic device, and no MRMC study or AI components are mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable for the reasons stated above.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the qualification testing of components and modifications (e.g., self-sealing header, hybrid circuits), the "ground truth" would be engineering specifications, international standards (like IS-1 mentioned for the header), and internal design requirements.
For the substantial equivalence claim, the "ground truth" is effectively the established safety and effectiveness profile and performance characteristics of the predicate device (Pikos 01/E01).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
In summary: This 510(k) submission is for an implantable pacemaker pulse generator that relies on demonstrating substantial equivalence to an already approved predicate device. The "qualification testing" described is for verifying the design and manufacturing of the new device and any modifications, ensuring it meets engineering standards and is comparable to the predicate. It does not involve a clinical study with human subjects designed to establish new performance acceptance criteria for a novel device.
§ 870.3610 Implantable pacemaker pulse generator.
(a)
Identification. An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device may include triggered, inhibited, and asynchronous modes and is implanted in the human body.(b)
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 September 20, 2012, for any implantable pacemaker pulse generator device that was in commercial distribution before May 28, 1976, or that has, on or before September 20, 2012, been found to be substantially equivalent to any implantable pacemaker pulse generator device that was in commercial distribution before May 28, 1976. Any other implantable pacemaker pulse generator device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.