(119 days)
The HAMILTON-C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants, and neonates. Intended areas of use: • In the intensive care ward or in the recovery room. • During secondary transport from one hospital to another. • During transfer of ventilated patients within the hospital. The HAMILTON-C2 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
The HAMILTON-C2 is an electronically controlled pneumatic intensive care ventilator. Due to its compact design, a weight of only 9.5 kg, built-in, hot-swappable batteries, and an ultra-quiet turbine, this ventilator can accompany a patient everywhere within a hospital, independently of central gas and power supplies, and during sconnal a transport from one hospital to another. The device offers ventilation modes that provide full and partial ventilatory support. The ventilator's ergonomic design, including a 10.4 in. color touch screen, a press-and-turn knob, and keys, let the user access the ventilator settings and monitored parameters. The graphical user interface can be tilt up to 45°. The HAMILTON-C2 can be customized so that it starts up with institution-defined settings.
This document describes a 510(k) premarket notification for the HAMILTON-C2 continuous ventilator. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than a novel AI algorithm requiring a specific set of acceptance criteria based on diagnostic performance.
Therefore, the requested information regarding AI algorithm performance (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, effect size) is not applicable to this submission. This is a traditional medical device submission for a ventilator, not an AI-powered diagnostic or assistive technology.
Here's a breakdown of the available information regarding acceptance criteria and the study that proves the device meets them, keeping in mind the device's nature:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implicitly based on standards and predicate devices) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with IEC 60601-1 (general safety) | "The test results show that the device is safe..." |
| Compliance with IEC 60601-1-2 (electromagnetic compatibility) | "The test results show that the device is safe..." | |
| Compliance with IEC 60601-2-12 (particular requirements for critical care ventilators) | "The test results show that the device is safe..." | |
| Compliance with other applicable safety standards | "The test results show that the device is safe..." | |
| Effectiveness/Performance | Wave-form performance testing as described in ASTM F1100-90 | "The data provided from these tests, were shown to be substantially equivalent to a legally marketed device." |
| Software verification and validation (requirements met) | "The results of the software verification and validation to ting demonstrate that all specified requirements have been implemented correctly and completely." | |
| Substantial Equivalence | Comparable indications for use to predicate devices | "The indication statements for the modified HAMILTON-C2 ventilator are comparable to those for the predicate devices." |
| Substantially equivalent technological characteristics and performance specifications to predicate devices | "Technological characteristics and performance specifications of the HAMILTON-C2 ventilator are substantially equivalent to those of the predicate devices." | |
| Overall safety and effectiveness compared to predicate devices | "The modified HAMILTON-C2 ventilator is as safe, as effective, and performs as well as or better than the legally marketed devices identified above." | |
| Intended Use | Ability to provide positive pressure ventilatory support to adults, pediatrics, infants, and neonates in specified environments | Explicitly stated in the "Intended Use" section and confirmed by FDA's substantial equivalence determination. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable for this type of submission. This is not an AI/diagnostic device that uses a "test set" of patient data in the way an algorithm would be evaluated. The testing described is hardware and software verification/validation against engineering standards and functional performance, not a clinical study on patient data to assess diagnostic accuracy or similar metrics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The "ground truth" for a ventilator's performance is defined by established engineering and medical device standards (e.g., IEC, ASTM) and its ability to meet specified physical and functional parameters. There's no "expert consensus" on ground truth in the context of diagnostic accuracy for this device.
4. Adjudication Method:
- Not applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is not an AI-assisted diagnostic or interpretation device that would involve human readers.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable. The device is a ventilator, which is a physical medical device with embedded software, not a standalone algorithm. The software verification and validation were done in the context of the device's overall function.
7. Type of Ground Truth Used:
- Regulatory/Engineering Standards and Predicate Device Performance: The "ground truth" against which the HAMILTON-C2 performance was evaluated consists of:
- International Electrotechnical Commission (IEC) Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-12 for electrical safety and specific ventilator requirements.
- American Society for Testing and Materials (ASTM) Standards: ASTM F1100-90 for wave-form performance testing.
- Performance of Legally Marketed Predicate Devices: Performance parameters and safety profiles of HAMILTON-G5, HAMILTON GALILEO, Dräger EvitaXL, Dräger SAVINA, and MAQUET Servo-i.
8. Sample Size for the Training Set:
- Not applicable. Ventilators are not "trained" on data in the same way an AI algorithm is. The development process involves design, engineering, and iterative testing/refinement.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
§ 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).