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510(k) Data Aggregation
(315 days)
Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient.
The device will be available in two models: (Details below) FLOWSTAR TOUCH DIGITAL MIXER FLOWMETER 50 %, and FLOWSTAR TOUCH DIGITAL MIXER FLOWMETER 70 %.
50% and 70% represent the maximum nitrous oxide concentration. The FlowStar Touch O2- N₂O Mixer for Analgesia is a device which can precisely dose a mixture of medical oxygen and medical nitrous oxide, depending on the adjusted mixture, for the sedation of patients in hospitals and at the dentist. The operator, a doctor or a dentist is able to adjust the total flow and the concentration of nitrous oxide of this flow. Depending on these settings the level of sedation of the patient can be controlled by the operator. The Baldus® Touch O2- N2O Mixer for Analgesia device has been created with the following safety features. The total flow emitted can consist of a maximum of 70 % nitrous oxide, the mix up of gas types is prevented by mechanical encodings and the flow of pure nitrous oxide in the absence of a missing oxygen supply is prevented by a fail-safe device. An integrated Touch pad is used to select the desired N₂O /O2 gas mixture. The total flow can consist of between 0 (100% O2) and 70 (30% O2) percent N₂O. The minimum output of 30 % O2 prevents from a hypoxic mixture for the patient. The FlowStar TouchO2- N2O Mixer for Analgesia device has an integrated O2 Flush function which delivers at least 30 l/min of pure oxygen to flush the N20 out of the patient circuit after the treatment. The FlowStar TouchO2- N₂O Mixer for Analgesia device has an alarm system which generates an alarm in the case of an insufficient O2 supply. The device will shut off the sedation when the O2 supply reaches a critical level. The gas mixture output of the FlowStar TouchO2- N2O Mixer for Analgesia device is connected to the Bag T. The Bag T is a device with two inputs and two outputs. One input is the gas mixture from the mixing device. The other input is a valve which opens when the adjusted total flow is too low for the patient. The gas mixture is then enriched with additional ambient air. The first output of the Bag T is for the connected breathing bag which is filled when the patient exhales and is emptied when the patient inhales. The second output leads the gas mixture to the scavenger system and finally to the patient. The main accessories for the proposed device are a Breathing Bag and a Double Mask Scavenger System.
The device includes a microprocessor-controlled valve system that precisely meters Oxygen and Nitrous Oxide gases for analgesic purposes. The inputs of the touchpad influence the gas flow inside of the device. The firmware is considered to be of a moderate level of concern.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the FlowStar Touch Digital Mixer Flowmeter:
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a tabulated format with specific numerical targets. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Accutron Digital Ultra K052335) through comparisons of characteristics and compliance with recognized standards. The "performance" is implicitly demonstrated by meeting the standards and showing similar or improved characteristics compared to the predicate.
Below is a table summarizing the characteristics where performance could be inferred or compared:
| Characteristic | Acceptance Criteria (Inferred from predicate/standards) | Reported Device Performance (FlowStar Touch Digital Mixer Flowmeter) |
|---|---|---|
| Intended Use | Administer adjustable mixture of Nitrous Oxide and Oxygen to a conscious, spontaneously breathing patient. | Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient. (Functionally identical) |
| Max N2O Concentration | 70% (for 70% model) | 70% (FlowStar Touch Digital Mixer Flowmeter 70%) |
| Min O2 Concentration | 30% | 30% (Prevents hypoxic mixture for patient) |
| Oxygen Flush | Minimum 20 LPM | 40-55 l/min (Improved/Higher) |
| Oxygen Flow | 1.0 LPM - 9.9 LPM | 1.0 - 18 l/min (Wider Range/Improved) |
| Oxygen Resuscitator Flow | Minimum 100 LPM | 100 - 250 l/min (Wider Range/Improved) |
| Nitrous Oxide Flow | 0 - 6.9 LPM | 0 - 12.6 l/min (Wider Range/Improved) |
| Mixed Gas Flow | 1.0 - 9.9 LPM | 3 – 18 l/min (Wider Range/Improved) |
| Power Source | 100-240 V AC, 50/60 Hz | 110-230 V 50-60 Hz (Essentially the same) |
| Controls | Touch Panel | Touch Panel (Same) |
| Safety Standards Compliance | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 (SAME), ISO 11195, CGA V-5, CGA C-9, ISO 5356-1 |
| Alarms (O2 Fail-Safe) | O₂ ceases if O₂ supply interrupted/reduced; alarm sounds, N₂O flow ceases. | If no oxygen supplied, visual/acoustic signals emitted. Unit shuts off sedation if O2 reaches critical level. (Equivalent) |
| Alarms (N2O Supply) | Alarm if N₂O supply cannot keep up; alarm sounds, flow switches to 100% O2. | If no nitrous oxide supplied, visual/acoustic signals emitted (including low pressure or measurement failure). (Equivalent) |
| Alarms (Mixed Gas Flow) | Alarm if mixed gas line pressure obstructed. | O₂ minimum flow 3 l/min (visual/acoustic signals if < 3l/min. Mixture never contains < 1L O2). Max flow reached (visual/acoustic signal). Flush flow low message if < 18l/min during O2 flush. (Equivalent/Similar) |
| Dimensions/Weight | 7.5" x 7" x 8.75", 6.3 lbs | 5.3" x 11.8" x 4.75", 5.5 lbs (Similar Size and Weight) |
| Gas Inlet Connectors | DISS connector | DISS connector (SAME) |
| External Interface Connector | Type DB-9 Serial Output for printer | USB Type A for memory sticks (More Convenient) |
| Use Environment | Hospital, Dental Facility, Healthcare Facility | Hospital, Dental Facility, Healthcare Facility (SAME) |
| Biocompatibility | Implicitly safe for breathing gas pathways | ISO 18562-2 and ISO 18562-3 compliance demonstrated for VOCs and particulate matter. |
| Cybersecurity | Implicitly secure given predicate | Compliance with FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (addressed via USB port). |
| Other Bench Testing | Functionality as intended, durability, safety features. | Alarms verified, silicon sealing, ambient air valve performance, pressure differential, marking durability, normal operating conditions, reverse gas flow, ambient temperature range, accessory compatibility, on demand flow, high altitude test, N2O room contamination, O2/N2O empty tests. (All successful) |
2. Sample Size Used for the Test Set and Data Provenance:
The document primarily discusses non-clinical bench testing and compliance with recognized standards. It does not mention any specific "test set" in terms of patient data or clinical samples. The testing for safety and performance appears to have been conducted on the device itself (hardware and firmware).
Therefore, information on:
- Sample size for test set: Not applicable as no human- or patient-based test set is described.
- Data provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
As there is no mention of a human- or patient-based "test set" requiring ground truth establishment, this information is not applicable to the provided document. The ground truth for engineering characteristics would be defined by the specifications of the device and the requirements of the standards.
4. Adjudication Method for the Test Set:
Since no human- or patient-based "test set" is described, an adjudication method for such a dataset is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. The document explicitly states: "Clinical testing was not required to establish substantial equivalence." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed, nor is it relevant given the device type (a gas mixer flowmeter, not an AI diagnostic tool).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This question is not applicable as the device is a medical device (a gas mixer flowmeter), not an AI algorithm. Its performance is inherent in its hardware and software functionality, not as an algorithm independently diagnosing or interpreting data. The "algorithm" refers to the firmware controlling the valve system. Its performance was verified through bench testing.
7. The Type of Ground Truth Used:
For the non-clinical testing, the "ground truth" was established by:
- Engineering specifications and design requirements: How the device should function according to its design.
- Recognized industry standards: Such as IEC 60601-1, IEC 60601-1-2, ISO 11195, CGA V-5, CGA C-9, ISO 5356-1, ISO 18562-2, ISO 18562-3. Compliance with these standards serves as the benchmark for acceptable performance and safety.
- Predicate device characteristics: The functionalities and safety features of the legally marketed predicate device served as the primary comparative "ground truth" to establish substantial equivalence.
8. The Sample Size for the Training Set:
This information is not applicable in the context of this device. The device does not employ machine learning or AI that requires a "training set" of data in the typical sense (e.g., for image recognition or predictive models). The "firmware" is mentioned as being of moderate concern and was likely developed through standard software engineering practices, not through a data-driven training process.
9. How the Ground Truth for the Training Set Was Established:
Since there is no "training set" in the context of this device's type (a gas mixer flowmeter), this question is not applicable.
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