(13 days)
Not Found
No
The device description and performance studies focus on mechanical compatibility and standards compliance, with no mention of AI or ML.
No
The device is described as a vaporizer mounting adapter, which allows a vaporizer to be mounted. It does not exert any therapeutic effect on a patient.
No
The device is described as a "vaporizer mounting adapter" used to connect vaporizers to manifolds. Its intended use is mechanical mounting, not the diagnosis of a medical condition.
No
The device description clearly states it is a "vaporizer mounting adapter" and a "modification to the currently distributed Plug System S Plus," indicating a physical hardware component. The performance studies also describe testing related to physical standards and compatibility with anesthesia machines.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to mount vaporizers on anesthesia machines. This is a mechanical function related to delivering anesthetic gases to a patient, not performing tests on biological samples in vitro (outside the body).
- Device Description: The description confirms it's a "vaporizer mounting adapter." This further supports its role in the delivery of anesthesia, not in diagnostic testing.
- Lack of IVD Characteristics: The document 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 a component of an anesthesia delivery system, which is a medical device used in vivo (within the body) for patient treatment.
N/A
Intended Use / Indications for Use
The Plug System S Plus is indicated for mounting Dräger-Vapor 19.1 vaporizers on Selectatec Series Mounted Manifolds.
Product codes (comma separated list FDA assigned to the subject device)
CAD
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).
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
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 Dräger | |
| 3135 Quarry Road | ||
| Telford, Pennsylvania 18969 USA | ||
| Establishment Registration No.: | 2517967 | |
| Manufacturer: | Dräger Medizintechnik GmbH | |
| Lübeck, 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
1
(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.
3
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:
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(
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)