(49 days)
No
The summary describes a device for monitoring airway gases and spirometry, focusing on hardware components and communication protocols. There is no mention of AI, ML, or related concepts.
No.
The device is described as monitoring airway gases and measuring spirometry, which are diagnostic or monitoring functions, not therapeutic interventions.
No
The device is described as a monitor of airway gases and anesthetic agents, and also measures spirometry. While it provides data that can be used for clinical assessment, its primary function is monitoring physiological parameters rather than providing a diagnosis of a disease or condition.
No
The device description explicitly states it is an "independently powered unit" composed of a "spirometry module, a power supply and a communications interface board," indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Gas Module SE monitors gases in the airway during anesthesia and assisted respiration. This is a measurement of gases being inhaled and exhaled, not a test performed on a biological sample taken from the body.
- Intended Use: The intended use is monitoring airway gases during a medical procedure, not diagnosing a condition based on a biological sample.
Therefore, the Gas Module SE falls under the category of a medical device used for monitoring physiological parameters, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Gas Module SE is the monitoring of airway gases, during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and the post anesthesia care units (PACU), etc. as summarized in the Operating Instructions. This is the same intended use as previously cleared for the Gas Module SE, K974903.
The indications for use for the Gas Module SE include monitoring of airway gases, during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.
Product codes
CBS
Device Description
The subject device is a modified version of the Datascope Gas Module II, which was previously cleared by FDA under K974903 on March 13, 1998 and now marketed as the Gas Module SE. There have been no significant changes to the Gas Module SE since its clearance. At this time, Datascope Corp. has added a new feature to the Gas Module SE capabilities, the measurement of spirometry via a spirometry module, which is the same spirometry module residing in the Datex-Ohmeda Compact Airway Module M-CAIOVX and M-COVX (K001814).
The Gas Module SE is an independently powered unit capable of interfacing with Datascope Patient Monitors using the Datascope proprietary communications protocol.
The modified Gas Module SE measures in real-time, breath-by-breath O2, CO2, N2O gases. Additionally, the Gas Module SE monitors the anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane.
The Gas Module SE is composed of a spirometry module, a power supply and a communications interface board that enables the unit to communicate utilizing Datascope's proprietary communications protocol.
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
anesthesia department, including the Operating Room (OR) and the post anesthesia care units (PACU), etc.
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
The results of verification tests conducted demonstrate that the functionality and performance characteristics of the Gas Module SE are comparable to the currently marketed predicate devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of all verification testing demonstrate that the Gas Module SE is as safe as effective, and performs as well as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1850 Monitoring spirometer.
(a)
Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.(b)
Classification. Class II (performance standards).
0
510(k) Summary of Safety and Effectiveness
| Date: | September 13, 2006 | NOV - 2 2006 |
|---|---|---|
| Submitter: | Patient Monitoring Division | |
| Datascope Corp. | ||
| Contact Person: | Kathleen Kramer | |
| Supervisor, Clinical & Regulatory Affairs | ||
| Patient Monitoring Division | ||
| Datascope Corp. | ||
| Telephone: (201) 995-8169 | ||
| Fax: (201) 995-8605 | ||
| Device trade name: | Gas Module SE | |
| Common/usual name: | Airway gas, pressure and volume, anesthetic agent and agent identification and gas | |
| exchange measurement device and airway gas and patient spirometry accessories. | ||
| Classification names: | 21 CFR 868.1620 - Analyzer, Gas, Halothane, Gaseous- Phase (Anesthetic Conc.) | |
| 21 CFR 868.1850 - Spirometer, Monitoring (w/wo alarm) | ||
| Predicate Devices: | K974903 Gas Module II | |
| K001814 Datex-Ohmeda Compact Airway Module M-CAIOVX and M-COVX | ||
| Device Description: | The subject device is a modified version of the Datascope Gas Module II, which was | |
| previously cleared by FDA under K974903 on March 13, 1998 and now marketed as | ||
| the Gas Module SE. There have been no significant changes to the Gas Module SE | ||
| since its clearance. At this time, Datascope Corp. has added a new feature to the | ||
| Gas Module SE capabilities, the measurement of spirometry via a spirometry | ||
| module, which is the same spirometry module residing in the Datex-Ohmeda | ||
| Compact Airway Module M-CAIOVX and M-COVX (K001814). |
The Gas Module SE is an independently powered unit capable of interfacing with
Datascope Patient Monitors using the Datascope proprietary communications
protocol.
The modified Gas Module SE measures in real-time, breath-by-breath O2, CO2, N2O
gases. Additionally, the Gas Module SE monitors the anesthetic agents Halothane,
Isoflurane, Sevoflurane, Desflurane and Enflurane. | |
| Intended Use: | The intended use of the Gas Module SE is the monitoring of airway gases, during
anesthesia and/or assisted respiration. The intended environment of use is the
anesthesia department, including the Operating Room (OR) and the post anesthesia
care units (PACU), etc. as summarized in the Operating Instructions. This is the
same intended use as previously cleared for the Gas Module SE, K974903. | |
1
| Technology: | The Gas Module SE is composed of a spirometry module, a power supply and a
communications interface board that enables the unit to communicate utilizing
Datascope's proprietary communications protocol. |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Summary: | The results of verification tests conducted demonstrate that the functionality and
performance characteristics of the Gas Module SE are comparable to the currently
marketed predicate devices. |
| Conclusion: | The results of all verification testing demonstrate that the Gas Module SE is as safe
as effective, and performs as well as the predicate devices. |
11 - 11
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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 or bird symbol on the right. To the left of the bird symbol is text arranged in a circular pattern, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathleen Kramer Supervisor, Clinical & Regulatory Affairs Datascope Corporation Patient Monitoring Division 800 Macarthur Boulevard Mahwah, New Jersey 07430
NOV - 2 2006
Re: K062754
Trade/Device Name: Gas Module SE Regulation Number: 21 CFR 868.1620 Regulation Name: Halothane Gas Analyzer Regulatory Class: II Product Code: CBS Dated: September 13, 2006 Received: September 14, 2006
Dear Ms. Kramer:
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 - Ms. Kramer
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 (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-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Cure
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
INDICATION FOR USE STATEMENT
510(k) Number (if known): KO627 SY
Device Name: Gas Module SE
Indications for Use:
The indications for use for the Gas Module SE include monitoring of airway gases, during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.
signature
. Sigm of Anesthesiology, General Hospital, on Control, Dental Devices
Number: K062754
Prescription Use X (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)
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