(196 days)
Not Found
No
The description focuses on standard electronic and mechanical ventilation controls and features, with no mention of AI or ML algorithms for decision-making, parameter adjustment, or data analysis. The "internal calculations" mentioned are likely standard control algorithms, not AI/ML.
Yes
The device is a ventilator, which is used to support breathing and maintain ventilation in patients, directly contributing to their physiological well-being or recovery. Therefore, it is a therapeutic device.
No
The device, Divan, is described as an electronic ventilator intended to ventilate patients as part of an anesthesia workstation. Its function is to support breathing, which is a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states the Divan is an "electronic ventilator with an integrated breathing system, and operator control panel," and mentions hardware components like a "piston assembly" and a "heater." This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, the Divan device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Divan is for ventilating patients. This is a direct medical intervention on a living patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a mechanical ventilator with a breathing system, controls for ventilation parameters, and different ventilation modes. This aligns with the function of a life support device, not a diagnostic test.
- Lack of IVD Characteristics: The text 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 samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The Divan is a medical device used for respiratory support, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Divan is intended to ventilate patients as an integrated part of a North American Dräger anesthesia workstation.
The Divan is indicated for ventilating patients as an integrated part of specific North American Dräger anesthesia machines. Federal law restricts this device to sale by or on the order of a physician.
Product codes
73BSZ, 73 CBK
Device Description
The Divan is an electronic ventilator with an integrated breathing system , and operator control panel.
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 Divan included hazard analysis, functional testing, communication testing, environmental testing, and electromagnetic compatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
AUG 4 1998
Summary of Safety and Effectiveness Data Relating to Substantial Equivalence
Divan Anesthesia Ventilator Proprietary Name:
Gas-Machine, Anesthesia 73BSZ Classification Name:
73 CBK
868.5895
Ventilator
ventilator
Device Class: Class II
North American Dräger Manufacturer: 3135 Quarry Road Telford, Pennsylvania 18969
Establishment Registration Number: 2517967
Devices to which substantial equivalence is claimed:
Narkomed AV2+ Anesthesia Ventilator K953228
Device Description:
The Divan is an electronic ventilator with an integrated breathing system , and operator control panel.
Intended Use:
The Divan is intended to ventilate patients as an integrated part of a North American Dräger anesthesia workstation.
Substantial Equivalence:
The Divan is substantially equivalent to North American Dräger's (NAD's) AV2+ Anesthesia Ventilator (AV2+) in that both are an integral subassembly of Narkomed Anesthesia Systems. They are both volume preset, time cycled, pressure limited ventilators with electronic timing, pneumatic circuitry, and independent controls for frequency, inspiratory to expiratory (I:E) ratio, inspiratory flow rate, tidal volume, and inspiratory pressure limit.
Both the Divan and AV2+ are microprocessor controlled. The Divan utilizes a keypad and incremental encoder as compared to the individual knobs and switches on the AV2+ for adjusting ventilation parameters.
The Divan and the AV2+ provide automatic, manual, and spontaneous modes of patient ventilation. Additionally, the Divan offers synchronized intermittent mandatory ventilation (SIMV), and pressure mode.
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The Divan's inspiratory to expiratory (I.E) ratios are adjustable from 1:3 to 2:1. The AV2+ I:E ratios are adjustable from 1:4.5 to 4:1.
The Divan incorporates an integrated breathing system, while the AV2+ works with the breathing system of the Narkomed anesthesia workstation.
In place of the bellows assembly of the AV2+, the Divan uses a piston assembly. Both the bellows assembly of the AV2+ and the piston assembly of the Divan control the amount of tidal volume delivered to the patient during automatic ventilation based on parameters selected by the operator.
The Divan differs from the AV2+ in that: It provides a heater to maintain the warmth of the patient gas in the breathing circuit. During mechanical ventilation the Divan provides more precise control of tidal volume delivery through internal calculations, stops inspiration and starts expiration if the airway pressure increases by more than 5cmH2O over the set maximum pressure (e.g. if the patient coughs), and automatically performs a periodic leak check. While power is on, the Divan performs self checks. If it detects the same equipment fault twice within 5 minutes it attempts to change to it's "safe state". The safe state allows the user to continue to ventilate the patient using the reservoir bag provided with the Divan. If a fault condition occurs that renders the Divan incapable of ventilation, the user can override the Divan and use the reservoir bag to continue ventilating the patient.
Qualification of the Divan included hazard analysis, functional testing, communication testing, environmental testing, and electromagnetic compatibility.
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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 to the right, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the left side of the bird. The bird symbol is composed of three overlapping profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 4 1998
Mr. James J. Brennan North American Drager 3135 Quarry Road Telford, PA 18969
K980208 Re: Divan Anesthesia Ventilator Requlatory Class: II (two) Product Code: 73 CBK May 7, 1998 Dated: Received: May 8, 1998
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 leqally 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). 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 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 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 requlations.
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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 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
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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KG802 510(k) Number (if known):
Device Name: Divan Anesthesia Ventilator (Divan)
Indications for Use:
The Divan is indicated for ventilating patients as an integrated part of specific North American Dräger anesthesia machines. 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) 31-18 N (Division Sign-Off) (Division Sign-On)
Division of Cardiovascular, Respiratory Prescription Use Over-The-Counter Use Division of ogical Devices (Per 21 CFR 801.109) 51Q(k) Number (Optional Format 1-2-96)