(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.
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JAN 2 1 2011
510(K) SUMMARY
| SUBMITTER: | HAMILTON MEDICAL AGVia Crusch 87402 Bonaduz, Switzerland | ||
|---|---|---|---|
| CONTACT PERSON: | Name: Joerg SchneiderPhone: +41 81 660 64 79Fax: +41 81 660 60 20e-mail: jschneider@hamilton-medical.ch | ||
| PREPARATION DATE: | 2010-09-17 | ||
| 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-G5 (K081521)HAMILTON GALILEO (K080181)Dräger EvitaXL with NeoFlow option (K072412, K983219)Dräger SAVINA (K040642)MAQUET Servo-i (K041223) |
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, 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.
INTENDED USE
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.
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SUMMARY OF THE TECHNOLOGY AND PERFORMANCE SPECIFICATIONS COMPARISON WITH THE PREDICATED DEVICES
The indication statements for the modified 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 modified 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 modified HAMILTON-C2 was conducted according to IEC 60601-1. IEC 60601-1-2, 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 legally marketed device. The results of the software verification and validation to ting demonstrate that all specified requirements have been implemented correctly and completely.
CONCLUSION
The results of verification, validation, and testing activities demonstrate that the modified 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 shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of three stylized human figures. The figures are arranged in a stacked formation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Joerg Schneider Official Correspondent Hamilton Medical AG Via Crusch 8 7402 Bonaduz, Switzerland
JAN 2 1 2011
Re: K102775
Trade/Device Name: HAMILTON-C2 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: January 7, 2011 Received: January 13, 2011
Dear Mr. Schneider:
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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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/Offices/ucm | 15809.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/ReportalProblem/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
for
Anthony D, Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K102775 |
|---|---|
| Device Name: | HAMILTON-C2 |
| Indication for Use: | 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. |
| Prescription Use | X | ||
|---|---|---|---|
| (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)
John and the same of the same of the same of the same of the same of the same of the states of the states and the states of the states of the states of the states of the states of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
§ 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).