(436 days)
K 001686, K 970165, K 010925, K984535
No
The description focuses on standard microprocessor control and user interface elements typical of ventilators, with no mention of AI, ML, or related concepts.
Yes
The device is a ventilator, which is used to provide continuous ventilation to patients, directly supporting and maintaining a vital physiological function (breathing), thus serving a therapeutic purpose.
No
The device is described as a "continuous ventilator designed for ventilation," which provides "mandatory or spontaneous breaths with the preset oxygen concentration to provide continuous ventilation." Its primary function is to deliver respiratory support, not to diagnose medical conditions.
No
The device description explicitly details hardware components such as a microprocessor, LCD display, keyboard, rotary dial knob, AC power with battery backup, and connections for patient airway accessories. This indicates it is a physical medical device with integrated software, not a standalone software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- RAPHAEL Ventilator Function: The description clearly states the RAPHAEL ventilator is a continuous ventilator designed to provide ventilation to patients. It directly interacts with the patient's respiratory system by supplying air and oxygen.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens (blood, tissue, urine, etc.) from the patient. Its function is to support breathing, not to diagnose conditions based on laboratory analysis.
The RAPHAEL ventilator is a life support device that provides mechanical ventilation, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The RAPHAEL ventilator is a continuous ventilator designed for ventilation of adult, pediatric, and infant patients weighing between 5 and 200 kg, The RAPHAEL ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The RAPHAEL ventilator 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 is an microprocessor controlled critical care ventilator system.
RAPHAEL supplies mandatory or spontaneous breaths with the preset oxygen concentration to provide continuous ventilation for adult, pediatric, and infant patients weighing between 5 and 200kg.
It is powered by AC with a battery backup to protect against power failure or unstable power and to facilitate intrahospital transport.
The user interface consists of a LCD-display, a display panel keyboard to open windows, and central rotary dial knob (press-and-turn element) for selecting, setting, and confirming inside the window.
The user provides inputs to the RAPHAEL microprocessor system through the keys and the press-and-turn element. RAPHAEL provides audible and visual patient-related, and ventilator-related alarms.
Accessories to connect RAPHAEL to the patient airway opening are the same as for GALILBO, found substantially equivalent in the 510(k) file number K001686.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, pediatric, and infant patients
Intended User / Care Setting
properly trained personnel under the direct supervision of a licensed physician. The RAPHAEL ventilator 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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 001686, K 970165, K 010925, K984535
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 2 2 2003
K022679, RAPHAEL 510(k) Submission
510(k) Summary
| APPLICANTS NAME AND ADDRESS | Hamilton Medical AG
Via Nova
CH-7403 Rhaezuens
Switzerland |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| APPLICANTS CONTACT PERSON | Mr. Andreas Scheibe
Phone: +41 81 6606010
Fax: +41 81 6606020
e-mail: ascheibe@hamilton-medical.ch |
| APPLICANTS CONTACT PERSON IN
THE USA | Hamilton Medical Inc.
Mr. David Thompson
Phone: 775-858-3200
Fax: 775-856-5621
e-mail: thompson@hammed1.com |
| DATE THE SUMMARY WAS
PREPARED | 08/07/2003 |
| COMMON NAME | Continuous Ventilator |
| PROPRIETARY NAME | RAPHAEL |
| PURPOSE OF SUBMISSION | New device |
| CLASSIFICATION | Name: Ventilator, Continuous (per 21 CFR 868.5895)
Panel: Anesthesiology
Code: CBK |
| REGULATORY STATUS | 1. Current Device Class: Class 2
2. Performance Standards & Special Controls: None Exist |
LEGALLY MARKETED DEVICES TO WHICH HAMILTON MEDICAL IS CLAIMING SUBSTANTIAL
EQUIVALENCE
| Galileo | 510(k)#: K 001686 | -Manufactured by Hamilton Medical AG |
|---|---|---|
| Dräger Evita 2 Dura | 510(k)#: K 970165 | -Manufactured by Dräger Medizintechnik |
| Siemens Servo-i | 510(k)#: K 010925 | -Manufactured by Siemens-Elema AB |
| Puritan Bennett 840 | 510(k)#: K984535 | -Manufactured by Nellcor Pruritan Benne |
DEVICE DESCRIPTION
The RAPHAEL is an microprocessor controlled critical care ventilator system.
RAPHAEL supplies mandatory or spontaneous breaths with the preset oxygen concentration to provide continuous ventilation for adult, pediatric, and infant patients weighing between 5 and 200kg.
It is powered by AC with a battery backup to protect against power failure or unstable power and to facilitate intrahospital transport.
The user interface consists of a LCD-display, a display panel keyboard to open windows, and central rotary dial knob (press-and-turn element) for selecting, setting, and confirming inside the window.
The user provides inputs to the RAPHAEL microprocessor system through the keys and the press-and-turn element. RAPHAEL provides audible and visual patient-related, and ventilator-related alarms.
Accessories to connect RAPHAEL to the patient airway opening are the same as for GALILBO, found substantially equivalent in the 510(k) file number K001686.
1
C
INTENDED USE
The RAPHAEL ventilator is designed for intensive care ventilation of adult, pediatric, and infant patients weighing between 5 and 200 kg.
INTENDED OPERATOR
The RAPHAEL ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician.
INTENDED PATIENT POPULATIONS
Patients with body weight between 5 kg and 200 kg.
INTENDED USE ENVIRONMENT
The RAPHAEL ventilator is intended for use at the bedside and for transport within a hospital -type facility, provided compressed gas is supplied.
The RAPHAEL ventilator is not to be used in the presence of flammable anesthetic agents. The RAPHAEL ventilator is not to be used in a magnetic field of a MRI equipment.
SUBSTANTIAL EQUIVALENCE
The functionality for the RAPHAEL critical care ventilator is equivalent to the GALILEO and partly also to Servo i, Evita 2 Dura and Puritan Bennett 840.
The design of RAPHAEL and the pneumatic concept are similar to those of GALILEO.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2003
Mr. J. David Thompson Hamilton Medical, Incorporated Post Office Box 30008 Reno, Nevada 89520
Re: K022679
Trade/Device Name: Raphael Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 21, 2003 Received: July 30, 2003
Dear Mr. Thompson:
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.
3
Page 2 -Mr. Thompson
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 your 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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours.
Susan Runno
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
4
Page 1 of 1
INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K022679 |
|---|---|
| Device Name: | RAPHAEL ventilator |
| Indication for Use: | The RAPHAEL ventilator is a continuous ventilator designed for ventilation of |
| adult, pediatric, and infant patients weighing between 5 and 200 kg, The | |
| RAPHAEL ventilator is intended for use by properly trained personnel under the | |
| direct supervision of a licensed physician. The RAPHAEL ventilator 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. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lihua W. Pinto for JHW
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number _ KO226079
Prescription Use:
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________