(19 days)
No
The description focuses on standard gas sensing technologies (infrared and paramagnetic) and basic digital interfacing. There is no mention of AI/ML terms, data analysis beyond measurement, or any learning/adaptive capabilities.
No.
The device is a gas monitor intended for measuring and monitoring gas concentrations during anesthesia, not for providing therapy.
No
The device measures and monitors gas concentrations for patient care during anesthesia, but it does not diagnose medical conditions.
No
The device description explicitly states it is a "module" that provides "nondispersive infrared measurement" and "paramagnetic measurement," indicating it is a hardware device with physical sensors, not software only.
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 a patient during anesthesia. This is a measurement taken directly from the patient's respiratory system, not from a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The description confirms it measures "airway gases."
- Lack of IVD Characteristics: There is no mention of analyzing samples of blood, urine, tissue, or other bodily fluids. The measurements are taken directly from the patient's breathing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device measures gases directly from the patient's airway, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
The EGM gas monitor is indicated for measuring and monitoring CO2 concentration and the concentrations of N20, O2, Halothane, Enflurane, Sevoflurane, Sevoflurane and Desflurane. Isoflurane, Sevoflurane and Desflurane, Isoflurane, Sevollurane and Deshurane.
Product codes (comma separated list FDA assigned to the subject device)
73CCK, 73CBR, 73CBQ, 73CBS, 73NHO, 73NHP, 73NHQ, 73CCL
Device Description
The M1013A Essential Gas Module provides a nondispersive infrared measurement of respiratory and anesthetic gases and a paramagnetic measurement of oxygen (Fast O2).
It is designed to work with the Philips IntelliVue MP20/30/40/50/60/70/90 Anesthesia option #H30 through a digital interface (RS232). It is intended for measuring the airway gases of #1100 through a dignal interrace (1020) maintenance of, and emergence from anesthesia.
The module produces display waves for O2, CO2, N2O, and anesthetic agents, together with The module produces display waves for O2, CO2, N2O, anesthetic agents, and airway respiration rate. An anesthetic agent must be selected manually for measurement.
An automatic zero calibration is performed by the Essential 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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 868.1400 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
AUG - 9 2004
EGM – Essential Gas Module
OEM variant of VAMOS
041956
Image /page/0/Picture/2 description: The image shows the logo for Dräger medical. The logo is in black and white, with the word "Dräger" in a bold, sans-serif font. The word "medical" is in a thinner, sans-serif font. Below the logo, it says "A Dräger and Siemens Company" in a smaller font.
510(k) Summary (Section 10)
Summary of Safety and Effectiveness
Applicants Name and Address
Dräger Medical AG & Co. KGaA Moislinger Allee 53-55 D-23542 Lübeck Germany
Applicants Contact Person
Mr. Ulrich Schröder Manager Regulatory Affairs
011 49 (451) 882-3648 Tel. No.: 011 49 (451) 882-4351 Fax No.:
Applicants US Contact Person
Mr James J. Brennan Director Regulatory Affairs
(215) 721-5400 Tel. No.: (215) 721-5412 Fax No.:
Date the Summary was prepared
July 15, 2004
Device Name
Essential Gas Module (EGM) Trade Name: Anesthetic Multi Gas Monitor Common Name:
Classification
| Regulation No. | Device | Product Code | |
|---|---|---|---|
| 868.1400 | Analyzer, Gas, Carbon Dioxide, Gaseous Phase | (73CCK) | L |
| 868.1700 | Analyzer, Gas, Nitrous Oxide, Gaseous Phase | (73CBR) | C |
| 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) |
July 2004
1
Image /page/1/Picture/1 description: The image shows the logo for Dräger medical. The word "Dräger" is in a bold, black font, while the word "medical" is in a thinner, outlined font. Below the logo, it says "A Dräger and Siemens Company" in a smaller font.
Legally marketed device to which Substantial Equivalence is claimed
VAMOS (K012139, K040847) Manufactured by Dräger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc.
SCIO (with Infinity Patient Monitors) (K031340) Manufactured by Dräger 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
Description of the Device
The M1013A Essential Gas Module provides a nondispersive infrared measurement of respiratory and anesthetic gases and a paramagnetic measurement of oxygen (Fast O2).
It is designed to work with the Philips IntelliVue MP20/30/40/50/60/70/90 Anesthesia option #H30 through a digital interface (RS232). It is intended for measuring the airway gases of #1100 through a dignal interrace (1020) maintenance of, and emergence from anesthesia.
The module produces display waves for O2, CO2, N2O, and anesthetic agents, together with The module produces display waves for O2, CO2, N2O, anesthetic agents, and airway respiration rate. An anesthetic agent must be selected manually for measurement.
An automatic zero calibration is performed by the Essential Gas Module as required to maintain measurement accuracy.
Intended Use
The EGM gas monitor is indicated for measuring and monitoring CO2 concentration and the concentrations of N20, O2, Halothane, Enflurane, Sevoflurane, Sevoflurane and Desflurane.
Federal Law restricts this device to sale by or on the order of a physician.
086
2
Substantial Equivalence
The intended use of Savina SW 3.n with LPO Option is comparable by the referenced predicate devices
- Dräger Medical VAMOS Variable Anesthetic Gas Monitor
- Dräger Medical SCIO Multi Gas Monitor
- Philips M1026B Anesthetic Gas Monitor
The technical characteristics of the Essential Gas Module do not raise new questions The lectinical Granacteristics of the Ebomical Sale Resong of the Essential Gas Module regarding "Salety" or "Ghoonvolvoor" "Facebook" - Facept for the subject of this submission.
Information provided in the 510(k) Premarket Notification supports the determination of information provided in the ore(n) verification and validation of the device was Substantial equivalence. Design, dovelopment vonteanship.idances and company internal penomicul in accordance with of results provide assurance that the device meets its specifications and is safe and effective for its intended use.
In summary Dräger Medical AG & Co. KGaA has demonstrated that the Essential Gas Module in Jammary Bragor modio Gas Module is considered to be substantial equivalent to le oars and executives which have been previously cleared by the FDA.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 9 2004
Dräger Medical AG & Company KGaA C/O Mr. James J. Brennan Director, Regulatory Affairs Draeger Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969
Re: K041956
Trade/Device Name: EGM - Essential Gas Module Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: July 15, 2004 Received: July 21, 2004
Dear Mr. Brennan:
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 mendments, 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 the rederal I vou, Drag, Drag, therefore, market the device, subject to the general approvisions 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 (1 Nr.), it hay of buryer in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device to rear rouncements concerning your device in the Federal Register.
4
Page 2 - Mr. Brennan
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 Incan that I DA mas made statutes and regulations administered by other Federal agencies. of the Act of ally I ederal bats enjoyeenents, including, but not limited to: registration You must comply with an the Pieveling (21 CFR Part 801); good manufacturing practice allu fisting (21 CFR Part 067), labeling systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quardy ison 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) I mis letter will anow your to even 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), If you desire specific at no 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 may overn 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,
Qrs
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
EGM - Essential Gas Module Device Name: The EGM gas monitor is indicated for measuring and monitoring CO2
Controller of the country at atrations of N2O, O2, Halothane, Enfluran The EGM gas monitor is indicated for measuring and mornitions of the EGM gas months and the concentration and Indications For Use: Concentration and that the and Desflurane.
Isoflurane, Sevoflurane and Desflurane, Isoflurane, Sevollurane and Deshurane.
Federal Law restricts this device to sale by or on the order of a physician.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ohu Sylvom
(Division Sign-Off)
Page 1 of 1___________________________________________________________________________________________________________________________________________________________________
Division of Anesthesiology, General Hospital, Infection Control, Denta
510(k) Number: