K Number
K052863
Device Name
RAPHAEL COLOR
Date Cleared
2006-01-06

(87 days)

Product Code
Regulation Number
868.5895
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
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.
More Information

No
The document describes software modifications for ventilation modes (NIV and TRC) and tube resistance compensation. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The focus is on standard ventilation functionalities and their software implementation.

Yes
The device is a ventilator, which is used to assist patients with breathing, directly providing therapy to the patient.

No
Explanation: The device is described as a continuous ventilator designed for ventilation, not for diagnosing medical conditions. Its functions are related to providing respiratory support to patients.

No

The device is a ventilator, which is a hardware device. The 510(k) describes software modifications to an existing hardware ventilator.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The device is a ventilator designed to assist breathing in patients. This is a life support device that directly interacts with the patient's respiratory system.
  • Device Description: It describes a ventilator with software modifications for non-invasive ventilation and tube resistance compensation. These are functions related to delivering air to the patient.
  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform such tests.

The device's function is to provide mechanical ventilation, which is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.

N/A

Intended Use / Indications for Use

The RAPHAEL Color ventilator is a continuous ventilator in intensive care units.
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.

Product codes

CBK

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's airway

Indicated Patient Age Range

adult. pediatric, and infant patients weighing between 5 and 200 kg.

Intended User / Care Setting

properly trained personnel under the direct supervision of a licensed physician.
hospital-type facility, including use at a patient bedside or for intrafacility transport

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
As the implementation of the new software features in the RAPHAEL Color ventilator did not include 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).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K982910, K001686, K040574

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

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 DeviceManufacturer510(k) number(s)Classification
NIV mode and TRC feature
GALILEO GoldHAMILTON MEDICAL
AGK982910, K001686, K040574Ventilator, Continuous,
Facility Use per 21
CFR 868.5895

Page 2 of 5

1

Project-Name :RAPHAEL Color US 510(k) SubmissionHAMILTON MEDICAL AGDoc.-No.:E42101
Doc.-Title :RAPHAEL Color Ventilator Modification 510(k) SummaryDoc.-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.

2

Project-Name :RAPHAEL Color US 510(k) Submission HAMILTON MEDICAL AGDoc.-No.:E42101
Doc.-Title :RAPHAEL Color Ventilator Modification 510(k) SummaryDoc.-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 the
differences |
|-------------------------------------|----------------------------------------------|----------------------------------------------|----------------------------------|
| 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 by
patient | Yes | Yes | No differences |
| Pressure-limited
inspiration | Yes | Yes | No differences |
| Inspiration termination | Flow-cycled (first)
Time-cycled (second) | Flow-cycled (first)
Time-cycled (second) | No differences |
| Indicated patient
population | For spontaneously
breathing patients only | For spontaneously
breathing patients only | No differences |
| Apnea ventilation | Yes | Yes | No differences |

NIV MODE (Non Invasive Ventilation)

TRC (Tube Resistance Compensation)

| Function | NIV | NIV | Discussion of
the 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 WOBpt
caused by ET-tube or
tracheostomy tube | Yes | Yes | No difference |
| Compensate the resistance
from an ET-tube or a
tracheostomy tube | Yes | Yes | No difference |
| Apply instantaneous opposite
counter-force to offset the
resistance | Yes | Yes | No difference |
| Compensation works in both
inspiration and expiration
phases | Yes | Yes | No difference |
| User must set up tube type,
size and compensation
intensity | Yes | Yes | No difference |
| Display on-line a calculated
intra-tracheal pressure curve | Yes | Yes | No difference |

3

Project-Name :RAPHAEL Color US 510(k) SubmissionHAMILTON MEDICAL AGDoc.-No.: E42101
Doc.-Title :RAPHAEL Color Ventilator Modification 510(k) SummaryDoc.-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 2005
Comments 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 |

4

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.

5

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

6

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