(66 days)
The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11lbs.), who require the following types of ventilatory support:
- Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask).
- Assist Control, SIMV, or CPAP modes of ventilation. -
The ventilator is suitable for use in institutional, home, or transport settings.
The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support:
- Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask).
- Assist/Control, SIMV, or CPAP modes of ventilation. .
- Breath types including Volume, Pressure Control and Pressure Support. .
The modification intended to be cleared by this submission is:
The addition of commercially available heated wire breathing circuit inspiratory/expiratory limbs manufactured and distributed by Allegiance Healthcare Corporation (K000697), as an option to the ventilator breathing circuits specified for use
This 510(k) submission (K040790) describes a modification to the LTV 1000 Ventilator, specifically the addition of commercially available heated wire breathing circuits. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a novel device requiring extensive performance testing against acceptance criteria in the traditional sense. Therefore, the details requested regarding a specific "study that proves the device meets the acceptance criteria" and related metrics are not explicitly provided in this document as it pertains to a new device.
However, based on the provided text, we can infer the implicit "acceptance criteria" and "device performance" in terms of establishing substantial equivalence and the testing methods typically involved for such modifications.
Inferred Acceptance Criteria and Reported Device Performance (Table 1)
Given that this is a 510(k) for a modification focused on incorporating existing, cleared components (heated wire breathing circuits) into a cleared ventilator system, the primary "acceptance criterion" is demonstating that the modified system maintains the safety and effectiveness of the predicate device and the added components when integrated. This is typically achieved through:
- Substantial Equivalence: The modified device performs as intended and is as safe and effective as the predicate device(s).
- Performance Testing: Verification of critical ventilator parameters and circuit performance within established engineering specifications and relevant standards. This might involve pressure, flow, volume delivery, temperature control (for the heated circuits), and alarm functionality.
- Biocompatibility: Ensuring that the materials of the new breathing circuits are biocompatible with patient contact.
- Electrical Safety and EMC: Compliance with relevant electrical safety and electromagnetic compatibility standards.
Since the document is a summary for a 510(k), explicit, detailed acceptance criteria values (e.g., "flow rate must be within ±5% of set value") are not laid out, nor are specific performance testing results presented as a report. Instead, the "reported device performance" is implied by the statement of substantial equivalence and the expectation that the combined system meets the performance of its cleared predicate components.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied by Substantial Equivalence and K Numbers) |
|---|---|
| The modified LTV 1000 Ventilator circuit system is substantially equivalent to predicate devices (LTV 1000 Ventilator K981371, Allegiance Airlife Heated Ventilator Breathing Circuits K000697) in terms of safety and effectiveness. | The submission states that the "LTV 1000 Ventilator with breathing circuits with the modification listed are substantially equivalent to the EP 1000 ventilator/breathing circuits (K981371) and the Allegiance Airlife Heated the products = r = 1000 (K000697), intended for use with commercially available ventilators." This is the core finding of the 510(k) clearance process. |
| The heated wire breathing circuits (Allegiance Airlife) function as intended to provide heated and humidified air. | The new components (Allegiance Airlife Heated Ventilator Breathing Circuits, K000697) are commercially available and have a prior 510(k) clearance, indicating their individual performance for this function has already been established. The submission details the specific models of the Allegiance Airlife Heated Wire Inspiratory/Expiratory Limbs being incorporated, replacing previous PSI Adult/Pediatric Inspiratory Limbs. The integration with external, commercially available humidifiers (Fisher & Paykel Models: MR 730 (K913368), MR 850 (K020332)) is also noted, implying their established performance. |
| All specified LTV 1000 Ventilator functions (e.g., ventilation modes, breath types, patient weight range, use settings) are maintained with the modified breathing circuits. | The LTV 1000 Ventilator's core functionalities (Positive Pressure Ventilation, Assist/Control, SIMV, CPAP, Volume, Pressure Control, Pressure Support breath types, for adult/pediatric patients ≥ 5 kg, in institutional/home/transport settings) are explicitly stated to be the same as the predicate device (K981371 and subsequent clearances), and there's no indication that the breathing circuit modification alters these. This is implicit in the substantial equivalence claim. |
| The device modification does not introduce new safety concerns or risks. | The entire purpose of the 510(k) process for modifications is to ensure that new device safety concerns are not introduced. The discussion of differences and similarities (pages 2-3) confirms the component replacement and length reduction in some circuits, but the substantial equivalence claim implies no new safety concerns. The use of already cleared components (K000697 for the breathing circuits, K913368/K020332 for humidifiers) reinforces this. |
Detailed Study Information (Based on 510(k) Modification Context)
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Sample Size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "test set" sample size in terms of patient data. For a 510(k) modification focused on component integration and substantial equivalence, testing would involve engineering verification and validation (V&V) on a sufficient number of device units (physical ventilators with the new circuits) to demonstrate performance against specifications and compliance with standards. The specific number of units tested is not provided in this summary.
- Data Provenance: The data provenance would primarily be from internal engineering and quality testing conducted by Pulmonetic Systems, Inc. on their modified LTV 1000 Ventilator system. Additionally, the pre-existing clearance (K000697) of the Allegiance Airlife Heated Ventilator Breathing Circuits would draw upon its original test data. This is prospective testing related to the manufacturing and verification of the modified device before market entry. Country of origin for testing is implied to be the US (Minneapolis, Minnesota for Pulmonetic Systems, Inc.).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is largely not applicable in the context of this 510(k) modification. "Ground truth" established by external experts (like radiologists for imaging) is relevant for diagnostic devices or AI algorithms where clinical accuracy is being assessed. For a ventilator modification, the "ground truth" for performance is established by engineering specifications, international standards (e.g., ISO for ventilators), and existing predicate device performance. Device validation would be performed by qualified engineers and technicians, not typically by external clinical "experts" establishing a "ground truth" for a test set in the way this question implies. Clinical experts would inform requirements and user needs, but they wouldn't perform ground truth adjudication on device performance data in this manner.
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Adjudication method for the test set:
- Not Applicable in the sense of clinical adjudication. Device performance testing against specifications typically involves defined measurement protocols, acceptance criteria, and verification by qualified test personnel. Discrepancies would be resolved through standard engineering and quality assurance processes, not a multi-reader, multi-case adjudication method.
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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 a ventilator device, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies and "human readers improve with AI" metrics are irrelevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware modification for a ventilator, not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is based on engineering specifications, compliance with recognized national and international standards for medical devices (specifically ventilators and breathing circuits), and the established safety and performance profile of the predicate devices. This includes physical and functional performance measurements, material biocompatibility, electrical safety, and electromagnetic compatibility.
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The sample size for the training set:
- Not Applicable. This is for a hardware modification, not a machine learning or AI algorithm development that requires a training set. The "training" for such a device would be the design and development process adhering to a quality management system.
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How the ground truth for the training set was established:
- Not Applicable. See point 7.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).