(209 days)
The Nonin Xpod Oximetry Module can be used with Philips Respironics BiPAP C Series therapy devices (BiPAP AVAPS and BiPAP S/T) to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate for adult and pediatric patients. The Oximetry Module may be used in a hospital or home care environment.
The Respironics BiPAP C Series Ventilatory System is intended to provide non-invasive ventilatory support to treat adult and pediatric (> 7 years of age; > 40 lbs) patients with obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Respironics BiPAP C Series Ventilatory System may be used in the hospital or home.
The BiPAP AVAPS C Series device with Oximetry provides access to patient therapy information through the two-way transfer of data between patient devices and clinicians through the appropriate software including therapy efficacy and device setting as requested by the attending physician.
The Respironics Oximetry Module is designed for use with Respironics BiPAP AVAPS C Series and Respironics BiPAP S/T C Series flow generators to help the clinician monitor the end user's sleep and ensure that optimal treatment is provided.
When connected to the flow generator, the Oximetry module records treatment and pulse oximetry data during therapy. The data is stored on a secure digital card. After treatment, the secure digital card containing the data can be removed from the device and sent to the clinician for review.
Both Respironics BiPAP C-Series with Oximetry Module devices are microprocessor controlled blower based positive pressure systems with integrated heated humidifier, like the predicate cleared in K092818. The Respironics BiPAP C-Series System with Oximetry Module also delivers two positive pressure levels (IPAP/EPAP), like the predicate cleared in K092818. The dual pressure levels provide a more natural means of delivering pressure support therapy to the patient resulting in improved patient comfort. In addition, the BiPAP C-Series System includes CPAP mode in which a fixed pressure is delivered. Four bi-level operating modes, S, S/T, T & PC, are also offered which determine how the changes between IPAP and EPAP pressure are made. All therapy modes are unchanged from the previously cleared K092818.
A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters. The therapy device will provide the following indications as to the status of the Oximetry module.
The BiPAP C-Series with Oximetry System is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable. (Unchanged from K092818) These alarms are specific to the ventilator and are not related to oximetry measurements.
Like its predicates, the BiPAP C-Series with Oximetry System is intended for use with a patient circuit that is used to connect the device.to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 19mm tubing, an exhalation device, and a patient interface device.
Device Modifications:
Modifications to the BiPAP AVAPS and BiPAP S/T C Series Ventilatory devices consist of the following:
- Revised labeling (Refer to the request for Additional Information Packet 1, Attachment A) .
- Updated BiPAP C Series software to enable the flow generator and Link module to . communicate and to provide additional display messages of the flow generator LCD to provide feedback to the use on correct connection of the Link Module
- Inclusion of the Oximetry Module System (used as an accessory to the previously cleared . BiPAP C Series Devices, K092818) is a device designed for use with BiPAP C Series Devices to aid the clinician/provider in monitoring oximetry data during therapy. The data is displayed real time and stored on a memory card (SD Card). The SD Card containing the data can be removed from the Oximetry Module System device and sent to a clinician/provider for review.
The Oximetry Module System consists of the:
- Nonin® Xpod® Oximeter Cable t
- Nonin® Oximeter Sensor .
- Philips Respironics Link Module ●
- Carrying Case t
- SD Card and Mailer .
· Link Module is a communication device that attaches to the BiPAP C Series device and collects oximetry data. The module transfers information to and from the Nonin oximeter sensor and the device via a data card and card reader.
· SD Card is a portable memory card that carries information from one data transfer device to another. In this system, the data card is a Secure Digital (SD) card that carries therapy information between the Link module on the BiPAP C Series device and the Encore and Direct View Series software.
· Nonin Oximetry cable and sensors provide a non-invasive measurement of the oxygen saturation levels of hemoglobin.
The BiPAP C Series device with Oximetry Module System provides access to patient therapy information through the two-way transfer of data between patient devices, the Link Module and both Encore and DirectView Patient Management Software (patient data management software).
The provided text does not contain detailed information about acceptance criteria and the study that proves the device meets them in the format requested. The document is a 510(k) summary for a medical device (Philips Respironics BiPAP C Series with Oximetry Module System) and primarily focuses on establishing substantial equivalence to predicate devices.
It states that "Design verification tests were performed... All tests were verified to meet the required acceptance criteria." and "The Respironics BiPAP C-Series with Oximetry System met the required performance criteria and functioned as intended." However, it does not provide the specific acceptance criteria themselves, nor the detailed results of the studies proving the device meets those criteria.
Therefore, most of the requested information cannot be extracted directly from the provided text.
Here's what can be inferred or explicitly stated:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated. The document refers to "required acceptance criteria" and "applicable standards" but does not list them.
- Reported Device Performance: The document generally states that the device "met the required performance criteria and functioned as intended." Specific performance metrics (e.g., accuracy for SpO2 or pulse rate, or detailed ventilatory performance statistics) are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified in the provided text. The document refers to "Design verification tests" but no sample sizes or data provenance are mentioned.
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/Not specified. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, diagnostic decision-making). This device is a ventilatory support system with an oximetry module, and its performance evaluation would likely involve engineering tests against known standards or reference devices, not expert consensus on medical images/diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Similar to point 3, this is generally for studies requiring human interpretation and consensus building.
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 device is not an AI-assisted diagnostic tool for human readers. It's a continuous ventilator with an oximetry module.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device itself is a standalone medical device that performs its intended functions (ventilatory support, oximetry measurement). The "Design verification tests" would have evaluated its standalone performance against specifications. However, the details of these tests are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the oximetry module, the ground truth for SpO2 and pulse rate measurements would likely be established by comparison to co-oximetry (blood gas analysis) or a precisely controlled testing setup with known oxygen saturation levels and pulse rates.
- For the ventilatory functions, ground truth would involve testing against known pressure, flow, and volume measurements from calibrated test lung systems or simulators.
- These specific ground truth methods are not detailed in the provided text, only implied by adherence to standards.
8. The sample size for the training set
- Not applicable. This device is hardware and embedded software, not a machine learning model that requires a training set in the conventional sense. Its "training" would be the engineering design and development process.
9. How the ground truth for the training set was established
- Not applicable, as there's no "training set" in the context of AI/ML.
In summary, while the document confirms that design verification tests were conducted and met acceptance criteria, it lacks the specificity regarding the criteria, methodologies, and results that you are requesting. This is common for 510(k) summaries, which aim to establish substantial equivalence rather than provide exhaustive study details. Manufacturers typically have detailed V&V (Verification and Validation) reports that contain this information, but they are not usually included in the public 510(k) summary.
§ 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).