(63 days)
The Office Based Anesthesia Unit - OBA-1™ MRI is intended for administration of general inhalation anesthesia using mixtures of volatile anesthetics, and for providing breathing gas and for either spontaneous ventilation or controlled ventilation of patient lungs. The OBA-1™ MRI can be used in MRI scanner rooms with shielded or unshielded magnets up to 1.5 tesla.
The OBA-1™ MRI is an anesthesia unit which includes these features: Can be connected to a central pipeline or cylinder oxygen/air source. Oxygen flowmeter 0 10 L/min. Air flowmeter 0 10 L/min. Oxygen and air pipeline pressure gauges 0 100 psi. Oxygen Supply Failure Alarm. Vaporizer temperature and pressure compensated. Oxygen Flush valve. Back Pressure Check valve. Indexed Fresh Gas Common outlet with safety lock. Patient Manifold with directional valves inspiratory and expiratory. Adjustable APL valve with 19 mm waste gas outlet connection which can be connected to an active scavenging system. MRI compatible Airway Pressure Gauge. Oxygen sensor port. Circuit Pressure monitor and gauge connection ports. THERMH2OSORB Sodalime CO2 absorber. Bag/Ventilator Switch Valve 22 mm breathing bag port and 22 mm ventilator hose port.
The provided document does not contain acceptance criteria or a study proving the device meets acceptance criteria in the traditional sense of a clinical trial or performance testing with quantitative metrics.
Instead, the submission for the Charles A. Smith OBA-1™ MRI Anesthesia Unit (K012446) is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical effectiveness or specific quantitative performance against acceptance criteria.
The "study" or justification for equivalence is a comparison of attributes between the proposed device and predicate devices.
Here's a breakdown based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present acceptance criteria or reported performance in a quantitative, metrics-based table. Instead, it offers a qualitative comparison table to establish substantial equivalence.
| Attribute | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (OBA-1 MRI) |
|---|---|---|
| Intended to provide anesthesia delivery in office or outpatient setting and MRI scanning rooms | Yes (as per predicate devices) | Yes |
| Can be connected to central pipeline systems or cylinder yokes with regulators | Yes (as per predicate devices) | Yes |
| Two gas flowmeters; 1 (oxygen) 1 (air) | Yes (as per predicate devices) | Yes |
| Utilizes standard flowmeters | Yes (as per predicate devices) | Yes |
| Utilizes a disposable CO2 absorber canister | Yes (as per predicate devices) | Yes |
| Has directional valves (inspiratory/ expiratory) | Yes (as per predicate devices) | Yes |
| Incorporates standard 510(k) cleared vaporizers | Yes (as per predicate devices) | Yes |
| Has an APL valve with gas scavenging | Yes (as per predicate devices) | Yes |
| Manual ventilation via a breathing bag or automatic ventilation with ventilator | Yes (as per predicate devices) | Yes |
| Has oxygen monitoring port | Yes (as per predicate devices) | Yes |
| Has patient pressure monitoring port | Yes (as per predicate devices) | Yes |
| Connects to standard anesthesia breathing circuits | Yes (as per predicate devices) | Yes |
| Has oxygen flush valve | Yes (as per predicate devices) | Yes |
| Materials are standard for use in anesthesia gas machines | Yes (as per predicate devices) | Yes |
| Provided clean, non-sterile | Yes (as per predicate devices) | Yes |
| Can be cleaned and disinfected | Yes (as per predicate devices) | Yes |
| Performance Standards / Specifications | None applicable under Section 514 | None applicable under Section 514 |
Note: The "acceptance criteria" for a 510(k) submission are implicitly demonstrating that the new device shares the same fundamental scientific technology, indications for use, and technological characteristics as the predicate device(s), and does not raise different questions of safety and effectiveness.
Regarding the "Study" that Proves the Device Meets Acceptance Criteria:
The "study" in this context is the substantive equivalence comparison presented in the document, primarily the comparison table and the statement "There are no functional differences between the proposed device and the legally marketed predicate device."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. This is not a study involving patient data or a test set in the traditional sense of a clinical trial. It's a technical and functional comparison.
- Data Provenance: Not applicable for a test set. The data provenance refers to the specifications and characteristics of the device itself and its predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. There is no "test set" and no "ground truth" derived from expert consensus on patient data described here. The "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate devices based on their prior clearance or pre-amendment status.
4. Adjudication Method for the Test Set:
- Not applicable. No adjudication process for a test set 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:
- No. This device is an anesthesia machine, not an AI-assisted diagnostic tool. Therefore, an MRMC study is completely irrelevant.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not a standalone algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the 510(k) submission is the established safety and effectiveness of the predicate devices (e.g., Smith OBA-1™ K000859, Dräger Narkomed MRI Anesthesia System K972848, Penlon Sigma Elite Vaporizer K942545, etc.) based on their prior clearance or legal marketing status. The applicant is asserting that the new device is fundamentally similar enough to these predicates to leverage their "ground truth" of known safety and effectiveness.
8. The Sample Size for the Training Set:
- Not applicable. This is not a machine learning or AI device.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. This is not a machine learning or AI device.
In summary: K012446 is a 510(k) submission for an anesthesia machine, which relies on demonstrating substantial equivalence to pre-existing devices. It does not involve patient studies, AI algorithms, or the kind of acceptance criteria and performance evaluation typically seen in diagnostic device clearances or clinical trials. The "proof" is the detailed comparison of features and intended use against legally marketed predicate devices.
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).