(112 days)
The HAMILTON-C2 ventilator is intended to provide positive pressure ventilatory support to adults and paediatrics.
Intended areas of use:
• In the intensive care ward or in the recovery room.
• During transfer of ventilated patients within the hospital.
The HAMILTON-C2 ventilator is a restricted 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.
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.
Here's an analysis of the provided text regarding the HAMILTON-C2 ventilator, focusing on acceptance criteria and supporting studies:
It is important to note that the provided 510(k) summary for the HAMILTON-C2 ventilator (K090468) describes non-clinical performance tests and does not include information about clinical studies, MRMC studies, or specific AI/algorithm performance criteria. This device is a continuous ventilator, which generally undergoes extensive engineering and safety testing rather than clinical performance studies in the same way an AI diagnostic tool would.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device meets applicable safety standards. | "Safety testing of the HAMILTON-C2 was conducted according to IEC60601-1, IEC60601-1-2, IEC 60601-2-12 and other applicable standards. The test results show that the device is safe and effective for its intended use." |
| Effectiveness: Device is effective for its intended use. | "The test results show that the device is safe and effective for its intended use." |
| Performance (Waveform): Substantially equivalent to legally marketed devices. | "The ventilator was further subject to wave-form performance testing as described in the standard ASTM F1100-90. The data provided from these tests, were shown to be substantially equivalent to a legally marketed device [presumably the predicate devices: HAMILTON-G5 (K081521) and Dräger SAVINA (K023289)]." |
| Software Functionality: All specified requirements are correctly and completely implemented. | "The results of the software verification and validation testing demonstrate that all specified requirements have been implemented correctly and completely." |
| Substantial Equivalence: To predicate devices in indications, technological characteristics, and performance. | "The indication statements for the HAMILTON-C2 ventilator are comparable to those for the predicate devices. Technological characteristics and performance specifications of the HAMILTON-C2 ventilator are substantially equivalent to those of the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given 510(k) summary. The testing described focuses on engineering and safety standards (IEC, ASTM) rather than clinical data sets. Therefore, concepts like a "test set" in the context of clinical data are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided and is not applicable to the type of testing described (engineering, safety, and performance standards for a ventilator). Ground truth based on expert consensus is typically relevant for diagnostic devices or AI algorithms that interpret medical images or data.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices, especially those incorporating AI, where the performance of human readers with and without AI assistance is evaluated. The HAMILTON-C2 is a ventilator, a life-support device, and its evaluation focuses on its technical safety and performance, not on human interpretation or diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not explicitly stated in a manner relevant to AI algorithms. The HAMILTON-C2 is an electronically controlled ventilator, and its "performance" is inherently "standalone" in how it delivers ventilation based on its internal programming and user settings. The software verification and validation ensure its internal logic performs as designed, which is analogous to "standalone" performance for its specific function. However, it's not an AI algorithm acting independently in a diagnostic capacity.
7. The Type of Ground Truth Used
The "ground truth" for the HAMILTON-C2 ventilator's performance is established by:
- Engineering Standards: Adherence to international and industry standards like IEC60601-1, IEC60601-1-2, IEC 60601-2-12 for safety and ASTM F1100-90 for waveform performance.
- Predicate Device Performance: The functional performance, especially related to waveform, is compared against legally marketed predicate devices to demonstrate substantial equivalence.
- Software Specifications: The software's "ground truth" is its design specifications, validated through verification and validation testing.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. The device is not described as involving machine learning or AI that would require a "training set" of data in the typical sense.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable, as there is no mention of a training set for machine learning or AI.
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JUN 1 5 2009
510(k) Summary
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
| SUBMITTER: | HAMILTON MEDICAL AGVia Crusch 87402 Bonaduz, Switzerland |
|---|---|
| CONTACT PERSON: | Joerg SchneiderPhone: +41 81 660 64 79Fax: +41 81 660 60 20e-mail: jschneider@hamilton-medical.ch |
| PREPARATION DATE: | May 26, 2009 |
| TRADE NAME: | HAMILTON-C2 |
| COMMON NAME: | Continuous Ventilator |
| CLASSIFICATION NAME: | Ventilator, Continuous, Facility Use(21 CFR 868.5895, Product Code: CBK) |
| LEGALLY MARKETEDDEVICES TO WHICHEQUIVALENCE ISBEING CLAIMED: | HAMILTON-G5510(k) Number: K081521 |
| Dräger SAVINA510(k) Number: K023289 |
:
and the state of the state of the states of the states and
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DEVICE DESCRIPTION
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.
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.
INTENDED USE
The HAMILTON-C2 ventilator is intended to provide positive pressure ventilatory support to adults and paediatrics.
Intended areas of use:
- · In the intensive care ward or in the recovery room.
- · During transfer of ventilated patients within the hospital.
The HAMILTON-C2 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
SUMMARY OF THE TECHNOLOGY AND PERFORMANCE SPECIFICATIONS COMPARISON WITH THE PREDICATED DEVIGES
The indication statements for the HAMILTON-C2 ventilator are comparable to those for the predicate devices.
Technological characteristics and performance specifications of the HAMILTON-C2 ventilator are substantially equivalent to those of the predicate devices.
HAMILTON MEDICAL has demonstrated the HAMILTON-C2 ventilator to be safe and effective.
The HAMILTON-C2 is considered to be substantial equivalent to currently marketed predicate devices which have been previously cleared by FDA.
NON-CLINICAL PERFORMANCE TESTS
Safety testing of the HAMILTON-C2 was conducted according to IEC60601-1, IEC60601-1-2, IEC 60601-2-12 and other applicable standards. The test results show that the device is safe and effective for its intended use. The ventilator was further subject to wave-form performance testing as described in the standard ASTM F1100-90. The data provided from these tests, were shown to be substantially equivalent to a leqally marketed device. The results of the software verification and validation testing demonstrate that all specified requirements have been implemented correctly and completely.
CONCLUSION
The results of verification, validation, and testing activities demonstrate that the HAMILTON-C2 ventilator is as safe, as effective, and performs as well as or better than the legally marketed devices identified above.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling a person embracing another person. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
2 2009 JUL
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joerg Schneider Quality Engineer Hamilton Medical AG Via Crush 8 Bonaduz 7402 SWITZERLAND
Re: K090468
Trade/Device Name: HAMILTON-C2 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: May 26, 2009 Received: June 15, 2009
Dear Mr. Schneider:
This letter corrects our substantially equivalent letter of June 15, 2009.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Schneider
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K090468 |
|---|---|
| Device Name: | HAMILTON-C2 |
| Indication for Use: | The HAMILTON-C2 ventilator is intended to provide positive pressure ventilatory support to adults and paediatrics.Intended areas of use:• In the intensive care ward or in the recovery room.• During transfer of ventilated patients within the hospital.The HAMILTON-C2 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications. |
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schultze
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 090468
.
§ 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).