(49 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Gas Module SE device:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided document, the device's performance is asserted through a comparative study with predicate devices, rather than explicit numerical acceptance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functionality comparable to predicate devices. Volume Spirometry via a spirometry module | "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." Datascope Gas Module II (K974903) and Datex-Ohmeda Compact Airway Module M-CAIOVX and M-COVX (K001814) |
| Performance characteristics comparable to predicate devices. | "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." |
| Safety and effectiveness comparable to predicate devices. | "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." |
| Accurate real-time, breath-by-breath O2, CO2, N2O gas measurements. | The device "measures in real-time, breath-by-breath O2, CO2, N2O gases." (Implied accuracy by comparison to predicate). |
| Accurate monitoring of anesthetic agents (Halothane, Isoflurane, Sevoflurane, Desflurane, Enflurane). | The device "monitors the anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane." (Implied accuracy by comparison to predicate). |
2. Sample Size Used for the Test Set and Data Provenance:
The document states "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." However, it does not specify any sample size for the test set.
- Data Provenance: The document does not provide information regarding the country of origin of the data or whether it was retrospective or prospective. It only refers to "verification tests."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide any information about the number of experts used or their qualifications for establishing ground truth. The evaluation seems to be based on engineering verification tests against predicate devices rather than human expert interpretation or independent ground truth.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method. Given the nature of the device (gas module measurements), it's highly unlikely that an adjudication method like 2+1 or 3+1 would apply, as these are typically used for subjective assessments. The evaluation appears to be based on objective measurement comparisons.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported. The device is a measurement device for gases and spirometry, not an interpretive AI system that assists human readers with diagnostic tasks. Therefore, the concept of improving human reader performance with AI assistance is not applicable here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, the testing described appears to be a standalone performance evaluation of the device's functionality and measurement capabilities against predicate devices. The "verification tests" would assess the device's ability to accurately measure gases and spirometry without human intervention or interpretation of its outputs.
7. The Type of Ground Truth Used:
The ground truth for this device's evaluation is implicitly based on the accuracy and performance of the predicate devices. The new device's measurements and functionalities are compared against these established medical devices. There's no mention of pathology, expert consensus, or outcomes data being used as ground truth for this type of device.
8. The Sample Size for the Training Set:
The document does not mention a training set or any form of machine learning/AI development. This device is described as a "modified version" of a previously cleared device with an added spirometry module, rather than a novel AI system requiring training data.
9. How the Ground Truth for the Training Set Was Established:
Since there is no mention of a training set, the method for establishing its ground truth is not applicable and not provided.
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510(k) Summary of Safety and Effectiveness
| Date: | September 13, 2006 | NOV - 2 2006 |
|---|---|---|
| Submitter: | Patient Monitoring DivisionDatascope Corp. | |
| Contact Person: | Kathleen KramerSupervisor, Clinical & Regulatory AffairsPatient Monitoring DivisionDatascope Corp.Telephone: (201) 995-8169Fax: (201) 995-8605 | |
| Device trade name: | Gas Module SE | |
| Common/usual name: | Airway gas, pressure and volume, anesthetic agent and agent identification and gasexchange 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 IIK001814 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 waspreviously cleared by FDA under K974903 on March 13, 1998 and now marketed asthe Gas Module SE. There have been no significant changes to the Gas Module SEsince its clearance. At this time, Datascope Corp. has added a new feature to theGas Module SE capabilities, the measurement of spirometry via a spirometrymodule, which is the same spirometry module residing in the Datex-OhmedaCompact Airway Module M-CAIOVX and M-COVX (K001814).The Gas Module SE is an independently powered unit capable of interfacing withDatascope Patient Monitors using the Datascope proprietary communicationsprotocol.The modified Gas Module SE measures in real-time, breath-by-breath O2, CO2, N2Ogases. 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, duringanesthesia and/or assisted respiration. The intended environment of use is theanesthesia department, including the Operating Room (OR) and the post anesthesiacare units (PACU), etc. as summarized in the Operating Instructions. This is thesame intended use as previously cleared for the Gas Module SE, K974903. |
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| Technology: | The Gas Module SE is composed of a spirometry module, a power supply and acommunications interface board that enables the unit to communicate utilizingDatascope's proprietary communications protocol. |
|---|---|
| Test Summary: | The results of verification tests conducted demonstrate that the functionality andperformance characteristics of the Gas Module SE are comparable to the currentlymarketed predicate devices. |
| Conclusion: | The results of all verification testing demonstrate that the Gas Module SE is as safeas effective, and performs as well as the predicate devices. |
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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.
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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
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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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§ 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).