(118 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ventilator technology and controls.
Yes
The device is a ventilator, which provides ventilatory support to patients, directly treating a medical condition and maintaining vital functions.
No
The device is described as a ventilator, providing ventilatory support and delivering gas. While it has a CO2 option for monitoring, its primary function is therapeutic (ventilatory support), not diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states it is an "electronically controlled pneumatic intensive care ventilator ventilation system" and details hardware components like pneumatics, electrical systems, a user interface with an LCD-display, keys, and a knob, and an optional CO2 monitoring component. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides "positive pressure ventilatory support" to patients. This is a direct medical intervention on a living patient, not a test performed on a sample taken from the body.
- Device Description: The description details a "ventilator ventilation system" that delivers gas to the patient. While it has a CO2 monitoring option, this is a measurement of a physiological parameter within the patient, not an analysis of a sample.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, sample handling, or analysis of biological specimens (blood, urine, tissue, etc.).
Therefore, the HAMILTON-G5 ventilator is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HAMILTON-G5 ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally to infant and neonatal patients. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use as a patient bedside for intra-facility transport, provided compressed gas is supplied. The device is not intended for transportation outside the hospital or for use in the home environment.
Product codes
CBK
Device Description
The HAMILTON-G5 is an electronically controlled pneumatic intensive care ventilator ventilation system. It uses oxygen and air or (optionally) heliox to ventilate adults, pediatrics, and optionally infants and neonates. It is powered by ac with battery backup to protect against power failure or unstable power and to facilitate intrahospital transport. The HAMILTON-G5's pneumatics deliver gas, and its electrical systems control pneumatics, monitor alarms, and distribute power. The user interface consists of a LCD-display with touch screen, keys, and a press-andturn knob. The CO2 option allows continuous mainstream monitoring of carbon dioxide.
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 and pediatric patients, and optionally to infant and neonatal patients.
Intended User / Care Setting
hospital and institutional environment where healthcare professionals provide patient care.
intended for use by properly trained personnel under the direct supervision of a licensed physician.
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)
Safety testing of the HAMILTON-G5 with the new options was conducted according to IEC60601-1, IEC60601-1-2, 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 testing demonstrate that all specified requirements have been implemented correctly and completely.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K070513, K041223, K062093, K062710, K051263, K983219
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
Image /page/0/Picture/0 description: The image shows the logo for Hamilton Medical. The logo consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a circle with the letter "H" inside.
Koris21
SEP 2 5 2008
510(k) Summary
| SUBMITTER: | HAMILTON MEDICAL AG
Via Crusch 8
7402 Bonaduz, Switzerland |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Joerg Schneider
Phone: +41 81 660 6479
Fax: +41 81 660 60 20
e-mail: jschneider@hamilton-medical.ch |
| PREPARATION DATE: | May 21, 2008 |
| TRADE NAME: | HAMILTON-G5 |
| COMMON NAME: | Continuous Ventilator |
| CLASSIFICATION NAME: | Ventilator, Continuous, Facility Use
(21 CFR 868.5895, Product Code: CBK) |
| LEGALLY MARKETED
DEVICES TO WHICH
EQUIVALENCE IS
BEING CLAIMED: | HAMILTON-G5
510(k) Number: K070513 |
| | MAQUET Servo-i
510(k) Number: K041223 |
| | Viasys AVEA ventilator
510(k) Number: K062093 |
| | Datex-Ohmeda Engström Carestation
510(k) Number: K062710 |
| | Dräger EvitaXL with NeoFlow Option
510(k) Numbers: K051263, K983219 |
1
Image /page/1/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is composed of two lines of text, with "HAMILTON" on the top line and "MEDICAL" on the bottom line. To the right of the word "HAMILTON" is a circle with the letter "H" inside of it.
DEVICE DESCRIPTION
The HAMILTON-G5 is an electronically controlled pneumatic intensive care ventilator ventilation system.
It uses oxygen and air or (optionally) heliox to ventilate adults, pediatrics, and optionally infants and neonates. It is powered by ac with battery backup to protect against power failure or unstable power and to facilitate intrahospital transport.
The HAMILTON-G5's pneumatics deliver gas, and its electrical systems control pneumatics, monitor alarms, and distribute power.
The user interface consists of a LCD-display with touch screen, keys, and a press-andturn knob.
The CO2 option allows continuous mainstream monitoring of carbon dioxide.
INTENDED USE
The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients.
The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care.
The HAMILTON-G5 ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician.
The HAMILTON-G5 ventilator may be used for transport within a hospital or hospitaltype facility provided compressed gas is supplied. The device is not to be used in the presence of flammable anesthetic agents or other ignition sources. The ventilator is not to be used in an environment with magnetic resonance imaging (MRI) equipment. The device is not intended for transportation outside the hospital or for use in the home environment.
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 HAMILTON-G5 ventilator are comparable to those for the predicate devices.
Technological characteristics and performance specifications of the HAMILTON-G5 ventilator are substantially equivalent to those of the predicate devices.
The Carbon dioxide gas analyzer is considered to be substantial equivalent to the CO2 gas analyzer of the currently marketed predicate device Servo-i.
The heliox option is comparable with the substantial equivalent option of the predicate device AVEA ventilator.
The neonate ventilation characteristics are substantially equivalent to those of the predicate devices Servo-i, Engström Carestation, and Evita XL.
HAMILTON MEDICAL has demonstrated the HAMILTON-G5 ventilator including the new options to be safe and effective.
The HAMILTON-G5 is considered to be substantial equivalent to currently marketed predicate devices which have been previously cleared by FDA.
2
Image /page/2/Picture/0 description: The image shows the words "HAMILTON" and "MEDICAL" stacked on top of each other. The word "HAMILTON" is in a bold, sans-serif font, and the word "MEDICAL" is in a similar font but slightly smaller. To the right of the word "HAMILTON" is a logo that appears to be a stylized "H" inside a circle. The text and logo are all in black, and the background is white.
NON-CLINICAL PERFORMANCE TESTS
Safety testing of the HAMILTON-G5 with the new options was conducted according to IEC60601-1, IEC60601-1-2, 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 testing demonstrate that all specified requirements have been implemented correctly and completely.
CONCLUSION
The results of verification, validation, and testing activities demonstrate that the HAMILTON-G5 ventilator including the new options is as safe, as effective, and performs as well as or better than the legally marketed devices identified above.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle.
SEP 2 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joerg Schneider Quality Engineer, R&D Hamilton Medical AG Via Crusch 8 CH-7402 Bonaduz SWITZERLAND
Re: K081521
Trade/Device Name: HAMILTON-G5 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 12, 2008 Received: September 17, 2008
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.
క్ష
ﻧﻪ ..
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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Thlmulrfled mrs frey
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
| 510(k) Number: | |
|---|---|
| Device Name: | HAMILTON-G5 |
| Indication for Use: | The HAMILTON-G5 ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally to infant and neonatal patients. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use as a patient bedside for intra-facility transport, provided compressed gas is supplied. The device is not intended for transportation outside the hospital or for use in the home environment. |
X 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)
MHh
(Division Sign-Off) (Division of Anesthesiology, General Hospital Division Control, Dental Devices
510(k) Number: _