(79 days)
Not Found
No
The description focuses on standard gas measurement technologies (infrared and paramagnetic) and signal processing, with no mention of AI or ML terms or functionalities.
No
The device measures and monitors gas concentrations, providing diagnostic information about the patient's respiratory gases. It does not actively treat a condition or restore a function.
Yes
The device measures and monitors physiological parameters (CO2 concentration, N2O, O2, and anesthetic gas concentrations) in ventilated patients during anesthesia. This directly provides information about the patient's physiological state to assist the physician in making medical decisions, which aligns with the definition of a diagnostic device.
No
The device description explicitly states it provides "nondispersive infrared measurement of respiratory and anesthetic gases and a paramagnetic measurement of oxygen," which are hardware-based measurement technologies. It also describes physical components like gas modules and a digital interface.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure and monitor gases in the airway of ventilated patients. This is a measurement of gases within the body's respiratory system, not a test performed on a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description details the measurement of respiratory and anesthetic gases directly from the airway. This is an in-vivo measurement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or performing tests on specimens outside the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device measures gases directly from the patient's airway, which falls under the category of patient monitoring rather than in-vitro diagnostics.
N/A
Intended Use / Indications for Use
The IntelliVue gas modules are indicated for measuring and monitoring CO2 concentration and the concentrations of N2O, O2, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane.
Federal law restricts this device to sale by or on the order of a physician.
Product codes
73CCK, 73CBR, 73CBQ, 73CBS, 73NHO, 73NHP, 73NHQ, 73CCL
Device Description
The IntelliVue G5 M1019A / G1 M1013A gas modules provide a nondispersive infrared measurement of respiratory and anesthetic gases and a paramagnetic measurement of oxygen (Fast O2).
They are designed to work with Philips IntelliVue through a digital interface (RS232). They are intended for measuring the airway gases of ventilated patients during the induction of, maintenance of, and emergence from anesthesia.
The modules produce display waves for O2, CO2, N2O, and anesthetic agents, together with numerics for inspired and end-tidal values for O2, CO2, N2O, anesthetic agents, and airway respiration rate. Automatic identification of up to two anesthetic aqents and measurement of mixtures of up to two anesthetic agents are available as options. Return of the sample gas into the breathing circuit is available optional.
An automatic zero calibration is performed by the IntelliVue gas module as required to maintain measurement accuracy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
K012139, K040847, K031340, K051628, K040917, K041956
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).
0
Drägermedical
A Dräger and Siemens Company
510(k) Summary (Section 10)
ਗੁਰੂਰ re Bour
Summary of Safety and Effectiveness
Applicants Name and Address
Draeger Medical AG & Co. KGaA Moislinger Allee 53-55 D-23542 Luebeck Germany
Applicants Contact Person
Dr. Karin Luebbers Senior Manager Regulatory Affairs
| Tel. No.: | 011 49 (451) 882-5367 |
|---|---|
| Fax No.: | 011 49 (451) 882-7-5367 |
Applicants US Contact Person
Ms Monica Ferrante Director of Regulatory Affairs
| Tel. No .: | (215) 721-5400 |
|---|---|
| Fax No.: | (215) 721-5412 |
Date the Summary was prepared
October 31, 2005
Device Name
a
| Trade Name: | IntelliVue G5 M1019A / IntelliVue G1 M1013A |
|---|---|
| Common Name: | Anesthetic Multi Gas Monitor |
Classification
| Regulation No. | Device | Product Code |
|---|---|---|
| 868.1400 | Analyzer, Gas, Carbon Dioxide, Gaseous Phase | (73CCK) |
| 868.1700 | Analyzer, Gas, Nitrous Oxide, Gaseous Phase | (73CBR) |
| 868.1500 | Analyzer, Gas, Enflurane, Gaseous Phase | (73CBQ) |
| 868.1620 | Analyzer, Gas, Halothane, Gaseous Phase | (73CBS) |
| 868.1500 | Analyzer, Gas, Desflurane, Gaseous Phase | (73NHO) |
| 868.1500 | Analyzer, Gas, Sevoflurane, Gaseous Phase | (73NHP) |
| 868.1500 | Analyzer, Gas, Isoflurane, Gaseous Phase | (73NHQ) |
| 868.1720 | Analyzer, Gas, Oxygen, Gaseous-Phase | (73CCL) |
1
Legally marketed device to which Substantial Equivalence is claimed
VAMOS (K012139, K040847) Manufactured by Draeger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc.
SCIO (with Infinity Patient Monitors) (K031340, K051628) Manufactured by Draeger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc.
Philips M1026B Anesthetic Gas Monitor (with IntelliVue Patient Monitors) (K040917) Distributed in the United States by Philips Medical Systems
EGM - Essential Gas Monitor (K041956) Manufactured by Draeger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc.
Description of the Device
The IntelliVue G5 M1019A / G1 M1013A gas modules provide a nondispersive infrared measurement of respiratory and anesthetic gases and a paramagnetic measurement of oxygen (Fast O2).
They are designed to work with Philips IntelliVue through a digital interface (RS232). They are intended for measuring the airway gases of ventilated patients during the induction of, maintenance of, and emergence from anesthesia.
The modules produce display waves for O2, CO2, N2O, and anesthetic agents, together with numerics for inspired and end-tidal values for O2, CO2, N2O, anesthetic agents, and airway respiration rate. Automatic identification of up to two anesthetic aqents and measurement of mixtures of up to two anesthetic agents are available as options. Return of the sample gas into the breathing circuit is available optional.
An automatic zero calibration is performed by the IntelliVue gas module as required to maintain measurement accuracy.
Intended Use
The IntelliVue gas modules are indicated for measuring and monitoring CO2 concentration and the concentrations of N2O, O2, Halothane, Enflurane, Sevoflurane and Desflurane.
Federal Law restricts this device to sale by or on the order of a physician.
2
Substantial Equivalence
The intended use of IntelliVue gas modules is comparable by the referenced predicate devices
- Draeger Medical VAMOS Anesthetic Gas Monitor
- Draeger INFINITY Monitors with SCIO
- Philips M1026B Anesthetic Gas Monitor
- EGM Essential Gas Monitor
The technical characteristics of the IntelliVue gas modules do not raise new questions regarding safety or effectiveness. Furthermore the labeling of the IntelliVue gas module provides similar information as the predicate devices except for the subject of this submission.
Information provided in the 510(k) Premarket Notification supports the determination of substantial equivalence. Design, development, verification and validation of the device was performed in accordance with FDA regulations and guidance and company internal standards. The testing and analysis of results provide assurance that the devices meet their specifications and are safe and effective for their intended use.
In summary Draeger Medical AG & Co. KGaA has demonstrated that the IntelliVue gas modules are safe and effective. They are considered to be substantial equivalent to currently marketed predicate devices which have been previously cleared by the FDA.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Monica Ferrante Director, of Regulatory Affairs Draeger Medical AG & Company KG 3155 Quarry Road
Telford, Pennsylvania 18969
Re: K053204
Trade/Device Name: IntelliVue G5 M1019A / IntelliVue G1 M1013A Regulation Number: 868.1440 Regulation Name: Carbon Dioxide gas analyzer Regulatory Class: II Product Code: CCK Dated: January 24, 2006 Received: January 27, 2006
FEB 3
2006
Dear Mr. Ferrante:
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 - Ms. Ferrante
Please be advised that FDA's issuance of a substantial equivalence determination docs 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 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 (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-firee number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
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
510(k) Number (if known): K O53 このキ
Device Name: IntelliVue G5 M1019A / IntelliVue G1 M1013A
Indications for Use: The IntelliVue gas modules are indicated for measuring and monitoring CO2 concentration and the concentrations of N2O, O2, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane.
Federal law restricts this device to sale by or on the order of a physician.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Auj Sabom
Division of Microbiology, General Hospital,
Infection Control, Dental Devices
K.05.3.2011
510(is) Number
Page 1