Search Results

The VPAP ADAPT SV is intended to provide non-invasive ventilatory support to treat adult patients with obstructive sleep apnea (OSA) and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

The VPAP TX is indicated for the treatment of patients weighing more than 66 lb (> 30 kg) with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. The VPAP TX is intended to be used in a clinical environment.

The S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30lb (13 kg); all other modes are indicated for patients weighing more than 66lb (30 kg). The S9 VPAP Tx is intended to be used in a clinical environment.

The VPAP Adapt SV is identical to the predicate device VPAP Adapt SV (K051364), using a blower based positive pressure system. The device platform is identical to the VPAP Adapt SV (K051364) and contains a blower (motorfan assembly), flow and pressure sensors, and processing electronics. The blower supplies pressurized air to the patient via a mask and air tubing. The VPAP Adapt SV is a non-invasive flow generator device designed to provide adaptive servo-ventilation therapy to stabilize a patient's ventilation. The device continually measures instantaneous ventilation, and calculates a target ventilation equal to 90% of the patient's recent average ventilation (time constant 100 seconds). It then adjusts the degree of support to servo-control the patient's ventilation to at least equal the target ventilation.

The VPAP Tx is identical to the predicate device VPAP Tx (K092186), using a blower based positive pressure system. The device platform is identical to the VPAP Tx (K092186) and contains a Micro- processor controlled blower system that generates airway pressures as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency. The VPAP Tx system comprises the flow generator, patient interface) and optional humidifier.

The S9 VPAP Tx is identical to the predicate device S9 VPAP Tx (K123511), using a blower based positive pressure system. The device platform is identical to the S9 VPAP Tx (K092186) and contains a Micro- processor controlled blower system that generates airway pressures as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency. The S9 VPAP Tx comprises the flow generator, patient interface) and optional humidifier.

This document is primarily a 510(k) summary for three ResMed devices (VPAP Adapt SV, VPAP Tx, and S9 VPAP Tx), indicating that the submission is for a labeling change to include a contraindication. It states that no further clinical testing was required to show substantial equivalence to the predicate devices because it was a labeling change only. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a performance study for a new device or software.

However, the contraindication is supported by a large-scale clinical study:

SERVE-HF Study Information (relevant to the contraindication):

• Study Design: Randomized, parallel, event-driven, international multicenter study.
• Sample Size: 1325 patients.
• Patient Population: Chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.
• Intervention: Addition of ASV (Adaptive Servo-Ventilation) to guideline-based medical management.
• Outcome Investigated: Effects on survival and cardiovascular outcomes.
• Finding: The addition of ASV did not improve outcomes and showed an increased risk of cardiovascular mortality despite effective control of central sleep apnea. This finding supports the need for a contraindication rather than demonstrating the device's performance against specific acceptance criteria for its intended use outside of this specific high-risk patient group.

Given the nature of the submission (a labeling change based on a clinical trial that identified a contraindication), the following points from your request cannot be directly extracted from the provided text for the device's performance meeting acceptance criteria:

1. A table of acceptance criteria and the reported device performance: Not available, as no new performance study was conducted. The tables provided compare characteristics of the new device to the predicate, stating they are "Equivalent," which is about substantial equivalence, not acceptance criteria performance.
2. Sample size used for the test set and the data provenance: For the contraindication study (SERVE-HF), the sample size was 1325 patients, from an international multicenter study. Data provenance for the device's original clearance is not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this submission's context, as it's a labeling change based on a large clinical trial, not a performance study compared to expert ground truth for a diagnostic AI.
4. Adjudication method: Not applicable here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the SERVE-HF study, the "ground truth" was clinical outcomes data (survival and cardiovascular mortality).
8. The sample size for the training set: Not applicable, as this is a device and a labeling change, not an AI/ML algorithm development with a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary in relation to your request:

The document describes a labeling change for three continuous ventilators (VPAP Adapt SV, VPAP Tx, S9 VPAP Tx). This change is to add a contraindication for ASV therapy in patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.

This contraindication is directly supported by findings from the SERVE-HF study, a large-scale, randomized, parallel, event-driven, international multicenter study involving 1325 patients. The study found that adding ASV to guideline-based medical management in this specific patient population did not improve outcomes and led to an increased risk of cardiovascular mortality. The "ground truth" for the SERVE-HF study was clinical outcomes data (survival and cardiovascular outcomes).

The document explicitly states that no further clinical testing was required for this 510(k) submission because it was only a labeling change, and the device itself (its operating principle, technology, manufacturing process) remains substantially equivalent to its respective predicate devices (K051364, K092186, K123511). Therefore, there are no new acceptance criteria or device performance data against them presented in this document for the device's efficacy in its cleared indications.

Ask a specific question about this device