Search Results
Found 1 results
510(k) Data Aggregation
(31 days)
D-VAPOR
The D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of an anesthesia delivery system with a controlled amount of anesthetic vapor. The D-Vapor is intended for use with Desflurane. It is not intended for use with Enflurane, Halothane, Isoflurane, or Sevoflurane or for use in a breathing circuit. Federal law restricts this device to sale by or on the order of a physician.
The D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of an anesthesia delivery system with a controlled amount of Desflurane anesthetic vapor in concentrations of 2 to 18 vol.%.
The provided document is a 510(k) premarket notification for a medical device called "D-Vapor," an anesthetic vaporizer. This type of regulatory submission in 2004 did not typically include detailed performance studies with acceptance criteria in the format requested, as it relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting de novo clinical trial data.
Therefore, many of the requested data points (like sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) are not applicable (N/A) or not provided in this type of document for this class of device at this time.
Here's an attempt to answer the questions based only on the provided text, recognizing the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it describes features and functionalities that demonstrate substantial equivalence to predicate devices (Tec 6 Plus and Vapor 2000). The "performance" is implied by matching or having similar characteristics to these existing devices.
| Feature/Characteristic | D-Vapor Performance (as reported) | Acceptance Criteria (Implied by Predicate Devices) |
|---|---|---|
| Agent Delivered | Desflurane anesthetic via electronic vaporizer | Delivers Desflurane |
| Concentration Adjustment | 2-18 Vol.% | Covers a range (e.g., Tec 6 Plus: 1-18 Vol.%) |
| Display Panel | Visual indication of: Operational, No Output, Low Agent Level, Warm Up, Battery Status | Similar visual indications as Tec 6 Plus |
| Alarms | Audible alarms, ability to silence alarms | Similar audible alarms and silencing as Tec 6 Plus |
| Sight Glass | Visual indication of agent level for filling and monitoring | Similar sight glass as Vapor 2000 |
| Quick Connect Systems | Compatible with Vapor 2000 or Tec 6 plug-in systems for Selectatec® | Compatibility with existing quick connect systems |
| Permanent Installation | Block connector with o-rings and screws (like Tec 6 Plus) or conical fittings (like Vapor 2000) | Options for permanent installation |
| Keyed Filling System | Saf-T-Fill™ system for Desflurane bottles only | Keyed system to ensure correct agent (like Tec 6 Plus) |
| Transport Mode | Allows removal from delivery system with agent in vaporizer | Similar transport mode as Vapor 2000 |
| MRI Contraindication | Contraindicated for use in MRI environment | Similar contraindication as Tec 6 Plus |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The submission focuses on device description and comparison to predicates, not a clinical test set.
- Data Provenance: Not applicable for a traditional "test set" in this context. The data provided describes the device's features and its relation to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified. The submission does not describe a process of establishing ground truth with experts for a test set.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. No test set requiring expert adjudication is described.
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
- MRMC Study: No. This device is an anesthetic vaporizer, not an AI-powered diagnostic device, so an MRMC study with human readers assisting AI is not relevant or described.
- Effect Size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of an algorithm. The device's performance is described in terms of its mechanical and electronic functions. The device is a standalone functional unit within an anesthesia delivery system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the sense of a diagnostic or predictive algorithm. The "truth" for this device lies in its ability to accurately deliver a controlled concentration of Desflurane, as verified through engineering tests and comparison to established predicate devices. The document implies that the predicate devices' long-standing safe and effective use serves as a form of "ground truth" for the overall device category's functionality.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
Ask a specific question about this device
Page 1 of 1