(13 days)
The Plug System S Plus is indicated for mounting Dräger-Vapor 19.1 vaporizers on Selectatec Series Mounted Manifolds.
The Plug System S Plus (Modified) is a vaporizer mounting adapter that will allow Dräger Vapor 19.n vaporizers to be mounted to Selectatec Manifolds. The Plug System S Plus (Modified) is a modification to the currently distributed Plug System S Plus (K973051).
The provided text describes a traditional medical device (vaporizer mounting adapter) rather than an AI/ML-based device. Therefore, many of the requested fields, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," “sample sized used for the test set,” “number of experts,” “adjudication method,” and “sample size for the training set,” are not applicable.
Here's the information extracted from the provided text, adapted for a traditional device context:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstrated Compliance) | Reported Device Performance |
|---|---|
| Compliance with ASTM Standard 1161-88, Sections 8 and 12 | The Plug System S Plus (Modified) was tested and/or analyzed to demonstrate compliance with these sections. |
| Compatibility of the mounting device with lever mechanism and vaporizer specific identification label | The device demonstrated compatibility with representative Ohmeda anesthesia machines with Selectatec Series Mounted Manifolds. |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of data for an algorithm. Instead, it refers to "representative Ohmeda anesthesia machines with Selectatec Series Mounted Manifolds" for the compatibility testing. The exact number of machines or specific test cases is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - This concept does not apply to the testing of this traditional device. Testing involved physical and functional verification against standards and compatibility with other hardware.
4. Adjudication method for the test set
N/A - This concept does not apply to the testing of this traditional device.
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
N/A - This is not an AI/ML device, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A - This is not an AI/ML device. The device's performance is inherently "standalone" in that it performs its function without AI or human intervention in its direct operation, but it requires human users for its application.
7. The type of ground truth used
The "ground truth" for this device's performance was based on:
- Compliance with an established industry standard (ASTM Standard 1161-88, Sections 8 and 12).
- Functional compatibility with specified existing medical equipment (Dräger Vapor 19.n vaporizers and Selectatec Series Mounted Manifolds, and Ohmeda Tec 5 interlock mechanism).
8. The sample size for the training set
N/A - This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
N/A - This is not an AI/ML device.
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7 1998 MAY
Summary of Safety and Effectiveness Data Relating to Substantial Equivalence
| Proprietary Name: | Plug System S Plus (Modified) | |
|---|---|---|
| Classification Name: | Vaporizer, Anesthesia, Non-heated | |
| Device Class: | Class II | |
| Initial Distributor: | North American Dräger3135 Quarry RoadTelford, Pennsylvania 18969 USA | |
| Establishment Registration No.: | 2517967 | |
| Manufacturer: | Dräger Medizintechnik GmbHLübeck, Germany | |
| Establishment Registration No.: | 9611500 | |
| Predicate Device: | Plug System S Plus (K973051)Ohmeda Tec 5 (K942091) |
Device Description
The Plug System S Plus (Modified) is a vaporizer mounting adapter that will allow Dräger Vapor 19.n vaporizers to be mounted to Selectatec Manifolds. The Plug System S Plus (Modified) is a modification to the currently distributed Plug System S Plus (K973051).
Intended Use
The Plug System S Plus (Modified) is a vaporizer mounting adapter intended for mounting the Dräger Vapor 19.n on Selectatec Series Mounted Manifolds.
Substantial Equivalence
The right-angle lever mechanism and vaporizer specific identification label are the only modifications to the currently distributed Plug System S Plus mounting adapter (K973051).
The Plug System S Plus (Modified) is also substantially equivalent to the Ohmeda Tec 5 Continuous Flow Vaporizer (Tec 5) (K942091) interlock mechanism. Each is designed to be used on Selectatec Series Mounted Manifolds. And, the interlock mechanism of each device uses extension rods to allow only one vaporizer to be ON at a time.
The Plug System S Plus (Modified) differs from the current Plug System S Plus in that the S Plus (Modified) allows for simple replacement without the use of a special tool. With the S Plus
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(Modified), locking is performed by means of a right-angle lever. This feature is similar to that of the Tec 5 Continuous Flow Vaporizer.
The principle of operation, performance characteristics and intended use of the S Plus (Modified) are identical to the currently distributed S Plus when mounted to a Selectatec Manifold.
The S Plus has been modified to include a vaporizer specific identification label. Anesthesia systems fitted with a vaporizer identification unit use the label to identify the vaporizer drug type. This is also a feature of the Tec 5 Continuous Flow Vaporizer.
Qualification of the Plug System S Plus (Modified) included testing and/or analysis to demonstrate compliance with ASTM Standard 1161-88, Sections 8 and 12 and the compatibility of the mounting device with lever mechanism and vaporizer specific identification label on representative Ohmeda anesthesia machines with Selectatec Series Mounted Manifolds.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1998 MAY
Ms. J. Teresa Dorriety North American Drager 3135 Quarry Road Telford, PA 18969
Re : K981472 Plug System S Plus (Modified) Requlatory Class: II (two) 73 CAD Product Code: April 23, 1998 Dated: Received: April 24, 1998
Dear Ms. Dorriety:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. J. Teresa Dorriety
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Gillehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ 1 __ of __ 1 __
K461472 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Device Name: Plug System S Plus
Indications for Use:
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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The Plug System S Plus is indicated for mounting Dräger-Vapor 19.1 vaporizers on Selectatec Series Mounted Manifolds.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, | |
| and Neurological Devices | |
| 510(k) Number | K981472 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
10 - 2019
(Optional Format 1-2-96)
§ 868.5880 Anesthetic vaporizer.
(a)
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.(b)
Classification. Class II (performance standards).