(29 days)
The indications/contraindications for use of the PIKOS products are identical to those for all single chamber (AAI or VVI) pulse generators.
The use of multi-programmable, single chamber pacemakers is indicated as a therapeutic modality for control of heart rate, provided that implantation is preceded by an adequate diagnostic check, and no parameter values dangerous for the patient are programmed. The use of the pacemaker in the atrium is contraindicated in the case of AV conduction disorder, and if atrial fibrillation or atrial flutter are exhibited. Ventricular pacing is not indicated in patients who already showed a pacemaker syndrome especially if a dual chamber pacemaker can be used.
Pikos single chamber pacemakers, Models 01/01-A/E01/LP 01/LP E01/E01-B pacemakers are indicated for the following:
- Symptomatic paroxysmal or permanent second or third-degree AV block .
- Symptomatic bilateral bundle branch block .
- Symptomatic paroxysmal or transient sinus node dysfunctions with or without . associated AV conduction disorders
- . Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias
- Vasovagal syndromes or hypersensitive carotid sinus syndromes .
BIOTRONIK requests clearance of the NIPS (Non-Invasive Programmed Stimulation) feature for BIOTRONIK's family of Pikos pulse generators. NIPS is provided as a feature in each of these pulse generators by allowing access to the NPS software drivers that were previously locked out. Each of these pulse generators has been FDA approved for use with P950037/S8, dated 08-24-99). The affected members of the Pikos family are comprised of the following pulse generators.
Unlocking the NIPS feature within the programmer software allows a previously implanted pulse generator and lead system to invoke high rate pacing and perform a variety of cardiac electrophysiological (EP) studies.
The NIPS feature is generated entirely through the existing pulse generator and lead system. This feature is controlled by the programmer and activates the pulse generator only when the wand is placed directly over the device. There are no other external devices required for this system. The NIPS feature is approved for each pulse generator listed above outside the US, but has been blocked from the Pikos devices through BIOTRONIK's software lock. The NIPS feature will be unlocked for each member of the Pikos family with a release code to the B-HXX.0.U programmer software. BIOTRONIK will identify the software version as B-H02.0.U.
There are no hardware changes to any of the pulse generators or the EPR 1000"-10 programmer system to allow this feature. The primary functions of these pulse generators, th system and the B-H02.0.U software remain the same.
The provided text does not contain detailed information regarding acceptance criteria, device performance metrics, or study designs typically used to prove that a device meets specific acceptance criteria in the context of device performance. This document is a 510(k) submission summary for the NIPS (Non-Invasive Programmed Stimulation) feature for BIOTRONIK's Pikos family of pulse generators, focusing on regulatory clearance based on substantial equivalence.
The core of the submission is that the NIPS feature is being "unlocked" from existing, previously FDA-approved pulse generators (Pikos family) and utilizes existing hardware and software drivers. The clearance is based on the premise that there are no hardware changes to the pulse generators or programmer system, and the primary functions remain the same. Therefore, the regulatory decision appears to be based on the substantial equivalence to the previously cleared devices rather than a new performance study with specific acceptance criteria as one might find for a novel device or feature requiring extensive clinical validation.
Without direct information from the text, I cannot complete the requested tables and descriptions. Many of the requested fields (sample size, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth establishment, training set details) are relevant to studies demonstrating new device efficacy or accuracy, which does not appear to be the focus of this 510(k) submission.
However, based on the information provided, here's what can be inferred or stated about the "acceptance criteria" and "study" in a regulatory context:
Implied Acceptance Criteria (Regulatory):
The implied acceptance criteria for this 510(k) submission relate to the device's safety and effectiveness compared to a predicate device, as per FDA's substantial equivalence pathway.
- Safety: The NIPS feature, when unlocked, does not introduce new safety risks compared to the predicate devices. This is supported by the statement that "There are no hardware changes to any of the pulse generators or the EPR 1000"-10 programmer system to allow this feature" and that the "primary functions... remain the same."
- Effectiveness (Functional Equivalence): The NIPS feature performs its intended function (high rate pacing and EP studies) in a manner equivalent to how it would perform on previously approved devices or off-label use, or devices cleared outside the US. The fact that it's an "unlocked" feature using existing software drivers suggests its fundamental functionality is already established within the existing hardware.
- No New Indications/Contraindications: The indications/contraindications for use of the PIKOS products with the NIPS feature remain "identical to those for all single chamber (AAI or VVI) pulse generators." This implies no new therapeutic claims are being made that would require novel performance data.
The "Study" (Regulatory Review Process):
The "study" or review that proves the device meets these implied acceptance criteria is the FDA 510(k) Pre-market Notification Review Process.
This process involves:
- Documentation Review: BIOTRONIK submitted documentation (the 510(k) itself) outlining the device description, its intended use, technological characteristics, and comparison to predicate devices.
- Predicate Device Comparison: The core of the "proof" is the argument of substantial equivalence to previously legally marketed predicate devices. The submission highlights that the Pikos family pulse generators were "FDA approved for use with P950037/S8, dated 08-24-99)" and that the NIPS feature is generated "entirely through the existing pulse generator and lead system."
- Risk Assessment (Implied): The FDA implicitly assesses if unblocking this feature introduces new risks or changes the fundamental operating principles in a way that would necessitate a new class of controls or different regulatory pathway. The statement "There are no hardware changes... The primary functions... remain the same" directly addresses this.
- Labeling Review: Ensuring the indications for use align with the predicate device and the safety profile.
Given the nature of the document, the following table and descriptions are based on the regulatory context of substantial equivalence, not a typical performance study for accuracy or diagnostic capability.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Implied Regulatory) | Reported Device Performance/Justification in Submission (Regulatory) |
|---|---|
| Safety: No new safety risks introduced by enabling NIPS feature. | "There are no hardware changes to any of the pulse generators or the EPR 1000"-10 programmer system to allow this feature." |
| "The primary functions of these pulse generators, th system and the B-H02.0.U software remain the same." | |
| The NIPS feature is already approved for these pulse generators outside the US. | |
| Effectiveness/Functional Equivalence: NIPS performs intended function (high rate pacing, EP studies) equivalently to predicate or prior use. | NIPS is provided as a feature by allowing access to existing NPS software drivers that were previously locked out. |
| "Unlocking the NIPS feature within the programmer software allows a previously implanted pulse generator and lead system to invoke high rate pacing and perform a variety of cardiac electrophysiological (EP) studies." | |
| This feature is generated "entirely through the existing pulse generator and lead system." | |
| The NIPS feature is approved for each pulse generator listed above outside the US. | |
| Indications for Use: No expansion or change from predicate. | "The indications/contraindications for use of the PIKOS products are identical to those for all single chamber (AAI or VVI) pulse generators." Specific indications for use are listed on page 4, consistent with single-chamber pacemakers. |
| Technological Characteristics: No significant difference from predicate. | NIPS is implemented purely via software unlock of existing functionality. "There are no hardware changes" to devices or programmer. The affected pulse generators are existing models already cleared by FDA (K914109A, K923026C, K9141937). |
| Device Identification: Clear software version for the unlocked feature. | BIOTRONIK "will identify the software version as B-H02.0.U." |
Additional Requested Information (where applicable from the text or inferred from the 510(k) context):
- Sample size used for the test set and the data provenance: Not applicable in the context of this 510(k) submission. This is a regulatory clearance for a software unlock feature on existing hardware, not a performance study requiring a test set of patient data. The "acceptance" is based on the argument of substantial equivalence.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in a traditional sense for a performance study. Regulatory review team at FDA serves as the "technical experts" assessing the submission.
- Adjudication method for the test set: Not applicable. No test set requiring adjudication of results.
- 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, nor a comparative effectiveness study involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device. The NIPS feature is an integrated function of a pacemaker controlled by a programmer with human input.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a performance study. The "truth" for this submission is regulatory (i.e., substantial equivalence to predicate devices and established safety/efficacy of the base pacemakers).
- The sample size for the training set: Not applicable. This is not a machine learning device that requires a training set. The functionality is based on pre-existing, already developed and tested software drivers within an established device.
- How the ground truth for the training set was established: Not applicable.
§ 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.