(76 days)
The Plug System S Plus is intended for mounting Dräger Vapor 19.1 vaporizers on Selectatec Series Mounted Manifolds.
The Plug System S Plus is a vaporizer mounting adapter that will allow Dräger Vapor 19.1 vaporizers to be mounted on Selectatec Series Mounted Manifolds.
The provided text describes a medical device called the "Plug System S Plus," which is a vaporizer mounting adapter. The document focuses on demonstrating that this device is substantially equivalent to existing devices, primarily the Ohmeda Tec 5 Continuous Flow Vaporizer (Tec 5), to obtain FDA clearance.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative format as one might expect for a diagnostic or AI-based device. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device. The performance is described through comparison and adherence to standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Mounting Dräger Vapor 19.1 vaporizers on Selectatec Series Mounted Manifolds. | The Plug System S Plus is specifically designed for this purpose. The device's description and intended use directly address this. |
| Interlock Mechanism Functionality: Prevent more than one vaporizer being ON at a time when used on Selectatec Manifolds. | The Plug System S Plus, when used with the Vapor 19.1, incorporates an interlock mechanism that prevents more than one vaporizer from being ON at a time. This mechanism functions on the same principle as the predicate Tec 5 vaporizer, using extension rods, and is described as having the "same intended use and principal of operation." |
| Bypass Functionality (Vapor 19 with Plug System S Plus): Internally bypass gas flow when mounted on a Selectatec manifold, similar to a Vapor 19 on a North American Dräger anesthesia machine. | With the Plug System S Plus mounted, the manifold port valves are continually open, and the bypass function is internal to the Vapor 19 vaporizer, matching the bypass route of a Vapor 19 on a North American Dräger anesthesia machine. |
| Compliance with ASTM Standard F 1161-88: Adherence to relevant safety and performance standards for anesthesia vaporizers. | Qualification included testing to demonstrate compliance with ASTM Standard F 1161-88. |
| Compatibility with Ohmeda Anesthesia Machines: Effects of mounting on representative Ohmeda anesthesia machines with Selectatec Series Mounted Manifolds. | Qualification included testing for the effects of mounting the device on representative Ohmeda anesthesia machines with Selectatec Series Mounted Manifolds. |
| Safety: Device operates without introducing new or increased risks. | The entire submission aims to demonstrate that the modifications (addition of the Plug System S Plus) do not alter the fundamental safety or effectiveness of the Vapor 19.1, especially in comparison to the cleared predicate. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of a dataset for an AI model. The "testing" referred to is for hardware qualification.
- Sample Size for Testing: Not explicitly stated numerically (e.g., number of units tested). It mentions "testing to demonstrate compliance" and "testing for the effects of mounting the device on representative Ohmeda anesthesia machines." The term "representative" implies a selection, but no specific count is given.
- Data Provenance: The testing appears to have been conducted by the manufacturer, Drägerwerk AG (Germany) or North American Dräger (USA), as part of their qualification process. It is an internal prospective testing related to device development and regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable to this document. The device is a mechanical adapter, not a diagnostic tool requiring expert interpretation of results. "Ground truth" in this context would be engineering specifications and functional performance. The "experts" involved would be the engineers and technicians performing the qualification tests. Their specific number and detailed qualifications are not provided, but it's assumed they are qualified personnel for device testing.
4. Adjudication Method for the Test Set
This is not applicable. There's no interpretive task that would require an adjudication method like 2+1 or 3+1. Performance is based on objective measurements and compliance with engineering specifications and standards.
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. This device is a mechanical adapter. It is not an AI-based system, nor does its function involve human interpretation of cases or data. Therefore, an MRMC study and effect size in human reader improvement with AI are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a mechanical component. There is no algorithm or AI component involved, standalone or otherwise.
7. The Type of Ground Truth Used
The "ground truth" for this type of device is based on:
- Engineering Specifications: The design parameters and functional requirements of the Plug System S Plus.
- Predicate Device Performance: The known and accepted performance characteristics of the Dräger-Vapor® 19.1 and the Ohmeda Tec 5 Continuous Flow Vaporizer. This includes their interlock mechanisms and vaporizer bypass functions.
- Industry Standards: Compliance with ASTM Standard F 1161-88.
- Functional Testing: Demonstrating that the device performs its intended function (mounting, interlock, bypass) correctly on representative machines.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and testing are based on engineering principles and established medical device standards.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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Summary of Safety and Effectiveness Data Relating to Substantial Equivalence
| Proprietary Name: | Plug System S Plus |
|---|---|
| Classification Name: | Vaporizer, Anesthesia, Non-heated |
| Device Class: | Class II |
| Initial Distributor: | North American Dräger3135 Quarry RoadTelford, Pennsylvania 18969 |
| Establishment Registration Number: 2517967 | |
| Manufacturer: | Drägerwerk AGLübeck, Germany |
| OCT 30 1997 | |
| Establishment Registration Number: 9611500 | |
| Devices to which substantial equivalence is claimed: Dräger-Vapor® 19.1 K942055 |
Tec 5 Continuous Flow Vaporizer K942091
Device Description:
The Plug System S Plus is a vaporizer mounting adapter that will allow Dräger Vapor 19.1 vaporizers to be mounted on Selectatec Series Mounted Manifolds.
Intended Use:
The Plug System S Plus is intended for mounting Dräger Vapor 19.1 vaporizers on Selectatec Series Mounted Manifolds.
Substantial Equivalence:
The addition of the Plug System S Plus mounting adapter is the only modification to the Dräger-Vapor 19.1 (K942055).
The 19.1 with Plug System S Plus is also substantially equivalent to the Ohmeda Tec 5 Continuous Flow Vaporizer (Tec 5) (K942091) in that they both incorporate an interlock mechanism designed to be used on Selectatec Series Mounted Manifolds (Selectatec Manifolds). In both systems the interlock mechanism uses extension rods to prevent more than one vaporizer being ON at a time.
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The Vapor 19 with Plug System S Plus differs from the Tec 5 in that the Vapor 19 with Plug System S Plus is meant to be installed and removed only by an authorized Dräger Service Representative. A Tec 5 vaporizer maybe installed and removed by a user.
With a Vapor 19 with Plug System S Plus mounted on a Selectatec manifold, the manifold port valves are continually open. The bypass function is internal to the Vapor 19 vaporizer. This is the same bypass route as a Vapor 19 that is mounted to a North American Dräger anesthesia machine.
The Plug System S Plus and the Tec 5 interlock mechanisms have the same intended use and principal of operation.
Qualification of the Vapor 19.1 with Plug System S Plus included testing to demonstrate compliance with ASTM Standard F 1161-88, and the effects of mounting the device on representative Ohmeda anesthesia machines with Selectatec Series Mounted Manifolds.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 30 1997
Mr. James J. Brennan North American Drager 3135 Quarry Road Telford, Pennsylvania 18969
Re: K973051 Drager Vapor® 19.1 with Plug System S Plus Regulatory Class: II (two) Product Code: 73 CAD Dated: October 13, 1997 Received: October 14, 1997
Dear Mr. Brennan:
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, Druq, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 - Mr. James J. Brennan
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 requlation 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. Callahon
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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510(k) Number (if known):
Device Name: Plug System S Plus
Indications For Use:
The Plug System S Plus is indicated for mounting Dräger-Vapor 19.1 vaporizer on Selectatec Series Mounted Manifolds. Federal law restricts this device to sale by or on the order of a physician.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Christy Loumen
7-14-83
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_197305
§ 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).