(79 days)
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.
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.
The provided document is a 510(k) summary for the IntelliVue G5 M1019A / IntelliVue G1 M1013A Anesthetic Multi Gas Monitor. This type of document is generally focused on establishing substantial equivalence to previously cleared devices rather than presenting detailed performance studies against specific acceptance criteria.
Therefore, the document does not contain the detailed information required to answer all parts of your request. Specifically, it lacks a table of acceptance criteria, detailed study designs, sample sizes for test and training sets, ground truth establishment methods, or information on multi-reader multi-case studies.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., accuracy, precision) or a table comparing them to reported device performance. It generally states:
"The testing and analysis of results provide assurance that the devices meet their specifications and are safe and effective for their intended use."
This implies that internal specifications were met, but these specifications are not detailed in the summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided 510(k) summary. The device is a gas monitor, and its "ground truth" would likely be established by reference gas mixtures or other calibrated instruments, not human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided 510(k) summary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable to this device. The IntelliVue gas modules are anesthetic multi-gas monitors, not AI-powered diagnostic tools interpreted by human readers. Therefore, an MRMC study related to human reading improvement with AI is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a standalone measurement instrument. Its performance would inherently be "algorithm only" (or rather, the device's sensor and processing capabilities) as it provides direct gas concentration readings. The summary implies performance testing was done on the device's ability to measure gases, but details of such testing (e.g., in isolation or integrated) are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
While not explicitly stated, for a gas monitor, the "ground truth" would typically be established using calibrated gas mixtures with known concentrations, or by comparison to a reference standard gas analyzer. It would not involve expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not available in the provided 510(k) summary. For device verification and validation, there isn't typically a "training set" in the machine learning sense. The device's internal algorithms are designed and then verified/validated.
9. How the ground truth for the training set was established
This information is not available in the provided 510(k) summary. Similar to point 8, the concept of a "training set" ground truth in this context is not directly applicable. If any internal calibration or development involved reference data, it would likely be from calibrated gas mixtures or reference instruments.
In summary of what is available:
The document focuses on establishing substantial equivalence to predicate devices based on intended use and technical characteristics, stating that "The technical characteristics of the IntelliVue gas modules do not raise new questions regarding safety or effectiveness." It also notes that "Design, development, verification and validation of the device was performed in accordance with FDA regulations and guidance and company internal standards," concluding that "The testing and analysis of results provide assurance that the devices meet their specifications and are safe and effective for their intended use." However, it does not provide the specific details of these "specifications," "testing," or "results" in this public summary.
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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) |
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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.
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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.
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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.
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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
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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
§ 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).