(87 days)
The RAPHAEL Color ventilator is a continuous ventilator designed for ventilation of adult, pediatric, and infant patients weighing between 5 and 200 kg. The RAPHAEL Color ventilator is intended for use by properly trained personnel under direct supervision of a licensed physician. The RAPHAEL Color 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 ventilator is a legally marketed intensive care ventilator (K022679). The two modifications included in this application are purely software-related and do not change the hardware of the RAPHAEL ventilator. This application is for the following options to the RAPHAEL Color: . The NIV (Non-Invasive Ventilation) mode is designed to facilitate ventilation assistance in a non-invasive way (e.g. a facial, a nasal mask or a mouth piece) between the ventilator and the patient's airway. TRC (Tube Resistance Compensation) is a feature to minimize the patient's work of . breathing to overcome the additional airway resistance due to the presence of an ET-tube or a tracheotomy tube.
The provided documentation describes the RAPHAEL Color Ventilator Modification 510(k) submission, focusing on the addition of two software-related features: Non-Invasive Ventilation (NIV) mode and Tube Resistance Compensation (TRC). The primary objective of the submission is to demonstrate substantial equivalence to a predicate device, the GALILEO Gold ventilator.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable format with specific benchmarks. Instead, it frames the performance evaluation in terms of demonstrating substantial equivalence to the predicate device (GALILEO Gold) for the new NIV and TRC features. The "acceptance criteria" can be inferred as showing "no significant differences" in technological performance characteristics and "no performance deviations" during testing.
| Feature / Performance Characteristic | Acceptance Criteria (Inferred) | RAPHAEL Color (New Features) Reported Performance |
|---|---|---|
| NIV Mode | ||
| Underlying mode | Pressure support (same as predicate) | Pressure support |
| Inspiration triggered by patient | Yes (same as predicate) | Yes |
| Pressure-limited inspiration | Yes (same as predicate) | Yes |
| Inspiration termination | Flow-cycled (first) / Time-cycled (second) (same as predicate) | Flow-cycled (first) / Time-cycled (second) |
| Indicated patient population | For spontaneously breathing patients only (same as predicate) | For spontaneously breathing patients only |
| Apnea ventilation | Yes (same as predicate) | Yes |
| Overall performance | No performance deviations during modular, integration, and system testing; graphical analysis of waveforms shows no new safety/effectiveness questions. | No performance deviations observed or documented during modular, integration, and system testing. Graphical analysis of waveforms shows no new questions regarding safety and effectiveness. |
| TRC Feature | ||
| Minimize additional WOBpt | Yes (same as predicate) | Yes |
| Compensate ET-tube/tracheostomy resistance | Yes (same as predicate) | Yes |
| Apply instantaneous opposite counter-force | Yes (same as predicate) | Yes |
| Compensation works in both phases | Yes (same as predicate) | Yes |
| User sets tube type, size, intensity | Yes (same as predicate) | Yes |
| Display on-line calculated intra-tracheal pressure | Yes (same as predicate) | Yes |
| Overall performance | No performance deviations during modular, integration, and system testing; graphical analysis of waveforms shows no new safety/effectiveness questions. | No performance deviations observed or documented during modular, integration, and system testing. Graphical analysis of waveforms shows no new questions regarding safety and effectiveness. |
The document explicitly states: "There are no significant differences between the new RAPHAEL Color features and its predicate." and "As presented during the accompanying documentation, there were no performance deviations observed or documented during modular, integration, and system testing." The graphical analysis of waveforms also indicated "no new question raised regarding safety and effectiveness."
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "modular, integration, and system test level" testing. It mentions that "System tests were executed with a complete instrument." However, specific sample sizes for these test sets are not provided.
Regarding data provenance, the testing was conducted by Hamilton Medical AG, a Swiss company, for its product. This implies the data originates from internal company testing. The document does not specify if the testing was retrospective or prospective, but given it's part of a 510(k) submission for new software features, it is likely prospective testing conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number of experts used or their qualifications to establish ground truth for the test set. The evaluation primarily relies on internal engineering and performance testing against the predicate device and established standards (like ASTM F-1100-93).
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method like 2+1 or 3+1. The testing described appears to be technical performance verification performed by the manufacturer's engineers against design specifications and predicate device characteristics, rather than expert-based adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence of the new software features of a medical device (ventilator) to a predicate device based on technical performance testing, not on comparing human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
The performance evaluation described is for the standalone algorithm (software features) integrated into the RAPHAEL Color ventilator. The testing focused on how these new software modes (NIV and TRC) performed within the complete instrument, independent of direct "human-in-the-loop" performance studies in a clinical setting. The "human-in-the-loop" equivalent in this context would be a clinical trial comparing patient outcomes, which is not detailed here.
7. The Type of Ground Truth Used:
The "ground truth" for the test set is established by the performance specifications of the new software features and their demonstrated equivalence to the characteristics of the legally marketed predicate device (GALILEO Gold), as well as compliance with relevant standards (ASTM F-1100-93). This is a technical, engineering-based ground truth, not based on expert consensus, pathology, or outcomes data in the usual sense of a diagnostic medical device.
8. The Sample Size for the Training Set:
The document does not mention any training set size. This is because the new features (NIV and TRC) are described as "purely software-related" modifications to an existing ventilator. The development of these modes likely involves engineering design and validation, not machine learning or AI models that require explicit training data sets.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set, there is no information on how its ground truth was established. The development of these software features for a ventilator typically involves engineering principles, physiological models, and adherence to established ventilation protocols rather than a data-driven "training" approach.
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Project-Name : Doc.-Title : RAPHAEL Color Ventilator Modification 510(k) Summary Doc.-Version : 1.0
JAN 6 2006
SUMMARY 52863 APPLICANTS NAME AND Hamilton Medical AG ADDRESS : Via Crusch 8 CH-7402 Bonaduz Switzerland Establishment Registration 3001421318 OFFICIAL Curdin Danuser CORRESPONDENT: HAMILTON MEDICAL AG Via Nova CH-7403 Rhaezuens Switzerland Phone: +41 81 660 60 10 Fax: +41 81 660 60 20 e-mail: cdanuser@hamilton-medical.ch SUBMISSION same as Official Correspondent CORRESPONDENT: COMMON NAME: Continuous Ventilator PROPRIETARY NAME: RAPHAEL Color PURPOSE OF New features for existing, legally marketed instrument in the JUBMISSION: US (K022679) CLASSIFICATION: Name: Ventilator, Continuous (per 21 CFR 868.5895) Panel: Anesthesiology Code: CBK REGULATORY STATUS: 1. Current Device Class: Class 2 2. Performance Standards and Special Controls: None Exist
PREDICATE DEVICE IDENTIFICATION:
| Legally marketed device to which equivalence is being claimed | |||
|---|---|---|---|
| Predicate Device | Manufacturer | 510(k) number(s) | Classification |
| NIV mode and TRC feature | |||
| GALILEO Gold | HAMILTON MEDICALAG | K982910, K001686, K040574 | Ventilator, Continuous,Facility Use per 21CFR 868.5895 |
Page 2 of 5
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| Project-Name : | RAPHAEL Color US 510(k) Submission | HAMILTON MEDICAL AG | Doc.-No.: | E42101 |
|---|---|---|---|---|
| Doc.-Title : | RAPHAEL Color Ventilator Modification 510(k) Summary | Doc.-Version : | 1.0 |
DEVICE DESCRIPTION
The RAPHAEL ventilator is a legally marketed intensive care ventilator (K022679). The two modifications included in this application are purely software-related and do not change the hardware of the RAPHAEL ventilator.
This application is for the following options to the RAPHAEL Color:
- . The NIV (Non-Invasive Ventilation) mode is designed to facilitate ventilation assistance in a non-invasive way (e.g. a facial, a nasal mask or a mouth piece) between the ventilator and the patient's airway.
- TRC (Tube Resistance Compensation) is a feature to minimize the patient's work of . breathing to overcome the additional airway resistance due to the presence of an ET-tube or a tracheotomy tube.
INTENDED USE
The RAPHAEL Color ventilator is a continuous ventilator in intensive care units.
INTENDED OPERATOR
The RAPHAEL Color ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician.
INTENDED PATIENT POPULATION
The RAPHAEL Color is intended for ventilation of adult. pediatric, and infant patients weighing between 5 and 200 kg.
INTENDED USE ENVIRONMENT
The RAPHAEL Color ventilator is intended for use in a hospital-type facility, including use at a patient bedside or for intrafacility transport, provided compressed air is supplied.
The RAPHAEL Color is not to be used in the presence of flammable anesthetic agents or other ignition sources.
The RAPHAEL Color is not to be used in an environment with magnetic resonance imaging (MRI) equipment.
SUBSTANTIAL EQUIVALENCE
The NIV and TRC modes of the RAPHAEL Color are substantially equivalent to the NIV and TRC modes of the GALILEO Gold ventilator.
SUMMARY OF PERFORMANCE TESTS
The performance/qualification testing of the new added features of the RAPHAEL Color ventilator (NIV and TRC modes) has been done on modular, integration, and system test level. The modular and integration testing of the new software-based features have been successfully. net modular each individual new mode. System tests were executed with a complete instrument, i.e. the new software together with the existing RAPHAEL Color hardware. As presented during the accompanying documentation, there were no performance deviations observed or documented during modular, integration, and system testing,
The ventilator performance has been further evaluated in accordance to the ASTM Standard F-1100-93. The graphical analysis of the waveforms shows that there are no new question raised regarding safety and effectiveness of the complete instrument and its new features.
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| Project-Name : | RAPHAEL Color US 510(k) Submission HAMILTON MEDICAL AG | Doc.-No.: | E42101 |
|---|---|---|---|
| Doc.-Title : | RAPHAEL Color Ventilator Modification 510(k) Summary | Doc.-Version : | 1.0 |
^s the implementation of the new software features in the RAPHAEL Color ventilator did not clude any new hardware, certain tests could be omitted (e.g. the ASTM F-100 endurance testing, the EMC testing and the EN-60601-1 and EN 60601-2).
COMPARISON OF RAPHAEL NEW FEATURES TO PREDICATE DEVICES
The following tables compare the major technological performance characteristics of the new RAPHAEL Color features to its predicate device. There are no significant differences between the new RAPHAEL Color features and its predicate.
| Function | NIV | NIV | Discussion of thedifferences |
|---|---|---|---|
| Product name | RAPHAEL Color | GALILEO Gold | --- |
| Manufacturer | Hamilton Medical AG | Hamilton Medical AG | --- |
| The 510(k) numbers | To be assigned | K982610, K001686,K040574 | --- |
| Underlying mode | Pressure support | Pressure support | No differences |
| inspiration triggered bypatient | Yes | Yes | No differences |
| Pressure-limitedinspiration | Yes | Yes | No differences |
| Inspiration termination | Flow-cycled (first)Time-cycled (second) | Flow-cycled (first)Time-cycled (second) | No differences |
| Indicated patientpopulation | For spontaneouslybreathing patients only | For spontaneouslybreathing patients only | No differences |
| Apnea ventilation | Yes | Yes | No differences |
NIV MODE (Non Invasive Ventilation)
TRC (Tube Resistance Compensation)
| Function | NIV | NIV | Discussion ofthe differences |
|---|---|---|---|
| Product name | RAPHAEL Color | GALILEO Gold | --- |
| Manufacturer | Hamilton Medical AG | Hamilton Medical AG | --- |
| The 510(k) number | To be assigned | K982610, K001686,K040574 | --- |
| To minimize additional WOBptcaused by ET-tube ortracheostomy tube | Yes | Yes | No difference |
| Compensate the resistancefrom an ET-tube or atracheostomy tube | Yes | Yes | No difference |
| Apply instantaneous oppositecounter-force to offset theresistance | Yes | Yes | No difference |
| Compensation works in bothinspiration and expirationphases | Yes | Yes | No difference |
| User must set up tube type,size and compensationintensity | Yes | Yes | No difference |
| Display on-line a calculatedintra-tracheal pressure curve | Yes | Yes | No difference |
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| Project-Name : | RAPHAEL Color US 510(k) Submission | HAMILTON MEDICAL AG | Doc.-No.: E42101 |
|---|---|---|---|
| Doc.-Title : | RAPHAEL Color Ventilator Modification 510(k) Summary | Doc.-Version : 1.0 |
CONCLUSION:
The tests executed and documented in this application indicate that the RAPHAEL Color including the two modifications meets its performance specifications, is substantially equivalent in terms of performance features and specifications of the predicate device referenced within this premarket 510(k) notification, and is safe and effective for its intended use.
| © Copyright by HAMILTON MEDICAL AG | Page 5 of 5 | Jul 25 2005Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Commen |
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| CONFIDENTIAL I |
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
JAN 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Curdin Danuser Official Correspondent Hamilton Medical AG Via Crusch 8 CH-7402 Bonaduz SWITZERLAND
Re: K052863
Trade/Device Name: RAPHAEL Color Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: October 6, 2005 Received: October 12, 2005
Dear Mr. Danuser:
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 111 (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.
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Page 2 - Mr. Danuser
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) 276-0120. 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,
Satte y. Michui Omd.
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
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Indications for Use
510(k) Number (if known):
Device Name: RAPHAEL Color
Indications for Use:
8
The RAPHAEL Color ventilator is a continuous ventilator designed for ventilation of adult, pediatric, and infant patients weighing between 5 and 200 kg. The RAPHAEL Color ventilator is intended for use by properly trained personnel under direct supervision of a licensed physician. The RAPHAEL Color 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.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Scriple H. Michan (MD)
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| © Copyright by HAMIL.TON MEDICAL AG |
§ 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).