(88 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest AI/ML capabilities.
No.
The device is a continuous flow anesthesia system, which is used to deliver anesthesia and monitor vital signs during medical procedures, rather than to treat a specific disease or condition.
No
Explanation: The device is described as a continuous flow anesthesia system used for ventilation, delivery of gases, anesthetic vapor, and monitoring of oxygen concentration, breathing pressure, and respiratory volume. While it monitors vital signs, its primary function is therapeutic (anesthesia and ventilation), not to diagnose a disease, condition, or state of health.
No
The device description clearly states it is a "continuous flow gas anesthesia system," which is a hardware device. The performance studies also mention hardware-related testing like environmental and electromagnetic compatibility.
Based on the provided information, the Julian device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "continuous flow anesthesia system" used for delivering gases, anesthetic vapor, and monitoring physiological parameters like oxygen concentration, breathing pressure, and respiratory volume. This is a system used on a patient, not for testing samples from a patient in vitro.
- Device Description: The description reinforces its function as a "continuous flow gas anesthesia system."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, the Julian is a medical device used for anesthesia and ventilation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Julian may be used for spontaneous, manually assisted, or automatic ventilation of patients during anesthesia, and delivery of gases and anesthetic vapor. The Julian can monitor oxygen, breathing pressure, respiratory volume, CO2, N2O, and anesthetic agent identification and concentration.
The Julian is indicated as a continuous flow anesthesia system. The Julian may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of oxygen concentration, breathing pressure, and respiratory volume. Federal law restricts this device to sale by or on the order of a physician.
Product codes
73BSZ
Device Description
The Julian is a continuous flow gas anesthesia system.
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
physician
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 Julian included hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K980553, K980280, K970165, K964239
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).
0
JAN 1 1 1999
Summary of Safety and Effectiveness Data Relating to Substantial Equivalence
Julian Anesthesia Workstation Proprietary Name:
Gas-Machine, Anesthesia 73BSZ Classification Name:
Device Class: Class II
Manufacturer: Dräger Medizientechnik GmbH 53/55 Moislinger Allee Lübeck, Germany 23558
Establishment Registration Number: 9611500
Devices to which substantial equivalence is claimed:
| Narkomed 6000 Anesthesia System | K980553 |
|---|---|
| Divan | K980280 |
| Evita 2 Dura | K970165 |
| Combination Oximeter/Carbon Dioxide Gas Analyzer | K964239 |
Device Description:
The Julian is a continuous flow gas anesthesia system.
Intended Use:
The Julian may be used for spontaneous, manually assisted, or automatic ventilation of patients during anesthesia, and delivery of gases and anesthetic vapor. The Julian can monitor oxygen, breathing pressure, respiratory volume, CO2, N2O, and anesthetic agent identification and concentration.
Substantial Equivalence:
Like the NM6000 the Julian is an anesthesia system with integrated monitors providing measurement and display of inspired oxygen, breathing pressure, respiratory volume, CO2, N2O, anesthetic agent concentration, and agent identification. The NM6000 does not offer pulse oximetry, the Julian pulse oximetry module is also used in the Combination Oximeter/Carbon Dioxide Gas Analyzer.
Both the Julian and the Evita 2 Dura use thermo anemometry to measure respiratory volume.
1
The theory of operation of the Julian gas delivery system from pipeline to the ventilator function is similar to the Evita 2 Dura.
The Julian can simultaneously deliver up to two gases and one agent, while the NM6000 can simultaneously deliver up to three gases and one anesthetic agent.
Both the Julian and the NM6000 use a compact breathing system. The Julian's system uses a bellows in place of the piston assembly in the NM6000.
Both the NM6000 and the Julian incorporate RS-232 and RS-422 serial communication ports.
Both the Julian and the NM6000 can accommodate up to two vaporizers. The NM6000 also provides a bracket for storage of a third vaporizer on the back of the machine.
The exclusion system of the Julian is identical to the NM6000. Both systems prevent more than one vaporizer from being used at one time.
Qualification of the Julian included hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing.
2
Image /page/2/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus with three snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 1999
Ms. Gale E. Winarsky North American Drager 3135 Quarry Road Telford, PA 18969
K983635 Re: Julian Anesthesia Workstation Requlatory Class: II (two) Product Code: 73 BSZ Dated: October 15, 1998 Received: October 15, 1998
Dear Ms. Winarsky:
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 legally 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 requlation 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 - Ms. Gale E. Winarsky
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 Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 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. Callehan
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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1983635 510(k) Number (if known):
Device Name: Julian Anesthesia Workstation
Indications for Use:
The Julian is indicated as a continuous flow anesthesia system. The Julian may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of oxygen concentration, breathing pressure, and respiratory volume. 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 | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR Over-The-Counter Use
Mark Kramer
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 493636 510(k) Number.
(Optional Format 1-2-96)