(171 days)
The RAPHAEL Color^sV ventilator is a continuous ventilator designed for ventilation of adult and pediatric patients weighing between 5 and 200 kg. The RAPHAEL ColorASV ventilator is intended for use by properly trained personnel under direct supervision of a licensed physician. The RAPHAEL Color450 is intended for use in a hospital or hospital-type facility, including use at a patient bedside or for intra-facility transport, provided compressed gas is supplied.
The RAPHAEL Color's is a software modified version of the legally marketed device RAPHAEL Color (K052863). The RAPHAEL Color^SV is a full-functioned intensive care ventilator. It can ventilate adult and pediatric patients weighing between 5 and 200 kg. The RAPHAEL Color488 offers a full spectrum of modalities, from the conventional to the new included Adaptive Support Ventilation, ASV. ASV is designed to maintain at least the minute ventilation set by the clinician. ASV does this without exceeding a preset plateau pressure. ASV provides full ventilation in apnea or low-drive conditions, and then automatically returns control to the patient as spontaneous ventilation begins. ASV works automatically by continuous repetition of 3 steps: 1. Assess the patient breath-by-breath. 2. Calculate an optimal breath pattern based on the minimal work of breathing method by Otis (J Appl Physiol 1950: 592-607). 3. Approach the target by automatically adjusting mandatory rate and inspiratory pressure.
The Hamilton Medical RAPHAEL ColorASV is a software-modified version of the RAPHAEL Color (K052863) continuous ventilator, with the addition of the Adaptive Support Ventilation (ASV) mode. The ASV mode itself is comparable to the ASV mode found in the HAMILTON GALILEO GoldASV (K061090) ventilator.
Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not explicitly state numerical acceptance criteria in a typical "Pass/Fail" or quantitative threshold format. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through performance testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence of ASV Mode | The ASV mode of the RAPHAEL ColorASV is stated to be "comparable with the ASV mode of the predicate device HAMILTON GALILEO GoldASV (K061090)." This implies that its functionality and underlying principles are equivalent. The description of ASV's operation (assess patient, calculate optimal breath pattern, automatically adjust mandatory rate and inspiratory pressure) is provided, indicating its intended performance. |
| Overall Performance and Safety (including ASV implementation) | "The performance/qualification testing of the new added feature ASV has been done on modular, integration and system level. There were no performance deviations observed or documented during testing." "The ventilator performance has been further evaluated in accordance to the ASTM Standard F1100-90. No new question rose regarding safety and effectiveness of the complete instrument and its new feature." "the impact of the new software on the microcomputer system was tested and documented. No performance deviations were observed or documented during testing." These statements indicate that all tested aspects of the device, including the new ASV mode and its integration, met performance and safety expectations without deviations. This implicitly means it performed equivalently to or better than established standards and predicate devices in the tested areas. |
| Intended Use and Patient Population | The device is intended for "intensive care ventilation of adult and pediatric patients weighing between 5 and 200 kg." The intended use statement is presented as comparable to predicate devices. The reported performance implies it meets these requirements. |
| Technological Characteristics | "All technological characteristics and performance specifications of the RAPHAEL ColorASV ventilator are equivalent to those of the predicate device RAPHAEL Color (K052863), except for the new added ASV mode." This indicates that elements outside the ASV mode maintained equivalence. The ASV mode itself is deemed comparable to the GoldASV's ASV. |
Study Details:
-
Sample Size used for the test set and the data provenance:
- The submission describes "performance/qualification testing" on "modular, integration and system level." It also mentions evaluation in accordance with "ASTM Standard F1100-90."
- However, specific sample sizes (e.g., number of test conditions, simulated patient scenarios, or test cycles) are not explicitly stated in the provided text.
- The data provenance is internal testing performed by Hamilton Medical AG ("Switzerland" is the country of origin for the 510(k) owner). The testing is non-clinical/bench testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This was a non-clinical, bench testing study. Therefore, there were no human experts establishing ground truth in the context of clinical outcomes or imaging interpretation. The "ground truth" was based on meeting engineering specifications, adherence to standards (ASTM F1100-90), and comparison against the known performance of predicate devices.
-
Adjudication method for the test set:
- Not applicable as this was non-clinical performance testing. The "adjudication" would have been through verification against specified performance parameters and standard compliance by the manufacturer's testing personnel.
-
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, an MRMC comparative effectiveness study was not performed as this device is a continuous ventilator, not an AI-assisted diagnostic tool for human readers.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The testing described is essentially "standalone algorithm/device performance" in a simulated, non-clinical environment. The ASV algorithm's performance and the overall ventilator's function were tested without direct human-in-the-loop performance in a clinical setting for this particular submission. The "algorithm" (ASV mode) was tested as an integral part of the device's functionality.
-
The type of ground truth used:
- The "ground truth" for this ventilator was based on engineering specifications, compliance with relevant industry standards (e.g., ASTM F1100-90), and demonstrated equivalence to the performance of legally marketed predicate devices. It was not based on expert consensus, pathology, or patient outcomes data in this submission, as it focused on device safety and functional performance.
-
The sample size for the training set:
- The RAPHAEL ColorASV is a ventilator with an embedded control algorithm (ASV). The ASV mode itself is based on a method described by Otis (J Appl Physiol 1950: 592-607). This is not a machine learning or AI algorithm that undergoes a "training set" in the modern sense. Therefore, there is no stated sample size for a training set. The algorithm's parameters are likely based on physiological models and engineering design rather than data-driven machine learning.
-
How the ground truth for the training set was established:
- As established above, this is not a machine learning algorithm with a training set. The ASV algorithm's underlying "ground truth" or design principles are based on established physiological models of respiratory mechanics and work of breathing, as evidenced by the reference to Otis's method. The development of such control algorithms involves engineering design, mathematical modeling, and physiological understanding, rather than empirical training data with associated ground truth labels.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for Hamilton Medical. The logo consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other in a bold, sans-serif font. To the right of the word "HAMILTON" is a stylized "H" enclosed in a circle. Below the word "MEDICAL" is the tagline "MAKING TECHNOLOGY SERVE MANKIND" in a smaller, sans-serif font.
OCT 1 8 2007
510(k) Summary
| 510(k) OWNER: | HAMILTON MEDICAL AGVia Crusch 8CH-7402 BonaduzSwitzerland |
|---|---|
| CONTACT PERSON: | Joerg SchneiderPhone: +41 81 660 64 79Fax:+41 81 660 60 20e-mail: jschneider@hamilton-medical.ch |
| PREPARATION DATE: | September 26, 2007 |
| TRADE NAME: | RAPHAEL ColorASV |
| COMMON NAME: | Continuous Ventilator |
| CLASSIFICATION NAME: | Ventilator, Continuous, Facility Use(21 CFR 868.5895, Product Code CBK) |
| REASON FOR THIS 510(K)SUBMISSION: | The RAPHAEL ColorASV is a softwaremodified version of the legally marketeddevice RAPHAEL Color (K052863) |
| LEGALLY MARKETED DEVICESTO WHICH EQUIVALENCE ISBEING CLAIMED: | HAMILTON RAPHAEL Color510(k) Number: K052863 |
| HAMILTON GALILEO GoldASV510(k) Number: K061090 |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for Hamilton Medical. The logo is in black and white and features the words "HAMILTON" and "MEDICAL" in large, bold letters. Below the word "MEDICAL" is the tagline "MAKING TECHNOLOGY SERVE MANKIND" in smaller letters. The logo is simple and professional, and it conveys the company's focus on medical technology.
DEVICE DESCRIPTION
The RAPHAEL Color's is a software modified version of the legally marketed device RAPHAEL Color (K052863).
The RAPHAEL Color^SV is a full-functioned intensive care ventilator. It can ventilate adult and pediatric patients weighing between 5 and 200 kg. The RAPHAEL Color488 offers a full spectrum of modalities, from the conventional to the new included Adaptive Support Ventilation, ASV.
ASV is designed to maintain at least the minute ventilation set by the clinician. ASV does this without exceeding a preset plateau pressure. ASV provides full ventilation in apnea or low-drive conditions, and then automatically returns control to the patient as spontaneous ventilation begins. ASV works automatically by continuous repetition of 3 steps:
-
- Assess the patient breath-by-breath.
- Calculate an optimal breath pattern based on the minimal work of breathing 2. method by Otis (J Appl Physiol 1950: 592-607).
- Approach the target by automatically adjusting mandatory rate and inspiratory 3. pressure.
INTENDED USE
The RAPHAEL Color $60 ventilator is intended to provide positive pressure ventilatory support in intensive care units.
The ventilator is intended for intensive care ventilation of adult and pediatric patients weighing between 5 and 200 kg.
The device is intended for use by properly trained personnel under the direct supervision of a licensed physician.
The RAPHAEL Color^sy ventilator is intended for use at the bedside and for transport within a hospital or hospital-type facility, provided compressed air is supplied.
The device is not to be used in the presence of flammable anesthetic agents or other ianition sources.
The ventilator is not to be used in an environment with magnetic resonance imaging (MRI) equipment.
In the USA, federal law restricts this device to sale by or on the order of a physician.
SUMMARY OF THE TECHNOLOGY AND PERFORMANCE SPECIFICATIONS COMPARISON WITH THE PREDICATED DEVICES
The indication statements for the RAPHAEL Color 400 ventilator are comparable to those for the predicate devices.
{2}------------------------------------------------
KC71194
Image /page/2/Picture/1 description: The image shows the logo for Hamilton Medical. The logo has the words "HAMILTON" and "MEDICAL" stacked on top of each other in a bold, sans-serif font. To the right of the word "HAMILTON" is a circle with the letter "H" inside. Below the word "MEDICAL" is the phrase "MAKING TECHNOLOGY SERVE MANKIND" in a smaller font.
All technological characteristics and performance specifications of the RAPHAEL Color 58 ventilator are equivalent to those of the predicate device RAPHAEL Color (K052863), except for the new added ASV mode.
The ASV mode is comparable with the ASV mode of the predicate device HAMILTON GALILEO GoldASV (K061090).
SUMMARY OF NON-CLINICAL PERFORMANCE TESTS
The performance/qualification testing of the new added feature ASV has been done on modular, integration and system level. There were no performance deviations observed or documented during testing.
The ventilator performance has been further evaluated in accordance to the ASTM Standard F1100-90. No new question rose regarding safety and effectiveness of the complete instrument and its new feature.
As the implementation of the new software feature does not include any new hardware, certain tests could be omitted. However, the impact of the new software on the microcomputer system was tested and documented. No performance deviations were observed or documented during testing.
CONCLUSION
The ventilator RAPHAEL Color404 is, inclusive the new added ASV mode, substantially equivalent in safety and effectiveness to the HAMILTON RAPHAEL Color (K052863) and the HAMILTON GALILEO GoldASV ventilators.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The text is likely part of a document or sign, indicating an affiliation with a public health organization.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2007
Mr. Joerg Schneider Quality Engineer, R & D Hamilton Medical AG Via Crusch 8 CI-7402 Bonaduz SWITZERLAND
Re: K071194
Trade/Device Name: RAPHAEL Color Asv Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: October 2, 2007 Received: October 5, 2007
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
{4}------------------------------------------------
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Syndie Y. Michael Oud.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
INDICATIONS FOR USE STATEMENT
K071194 510(k) Number:
RAPHAEL ColorAsv Device Name:
- The RAPHAEL Color^sV ventilator is a continuous ventilator Indication for Use: designed for ventilation of adult and pediatric patients weighing between 5 and 200 kg. The RAPHAEL ColorASV ventilator is intended for use by properly trained personnel under direct supervision of a licensed physician. The RAPHAEL Color450 is intended for use in a hospital or hospital-type facility, including use at a patient bedside or for intra-facility transport, provided compressed gas is supplied.
メ 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)
Mirt Kland
(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).