(76 days)
No
The device description and performance studies focus on mechanical compatibility and compliance with standards, with no mention of AI/ML or related concepts.
No
The device is described as an adapter for mounting a vaporizer, which is a component of an anesthesia machine, not a therapeutic device itself. Its function is mechanical integration, not direct treatment.
No
Explanation: The device is an adapter for mounting vaporizers; its intended use describes a mechanical function, not diagnostic capabilities.
No
The device description clearly states it is a "vaporizer mounting adapter," which is a physical hardware component. The performance studies also describe testing of the physical mounting system.
Based on the provided information, the Plug System S Plus is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to mount a vaporizer (which delivers anesthetic gas) onto an anesthesia machine manifold. This is a mechanical function related to the delivery of a therapeutic agent, not the examination of specimens derived from the human body.
- Device Description: The description confirms it's a "vaporizer mounting adapter."
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly part of an anesthesia delivery system, which is a medical device used in patient care, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes
73 CAD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dräger-Vapor® 19.1 K942055, Tec 5 Continuous Flow Vaporizer K942091
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 Dräger |
| 3135 Quarry Road | |
| Telford, Pennsylvania 18969 | |
| Establishment Registration Number: 2517967 | |
| Manufacturer: | Drägerwerk AG |
| Lübeck, 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.
1
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure.
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.
3
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
4
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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