(84 days)
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Not Found
No
The description explicitly states the device is "manually-controlled" and ventilation is accomplished by "manual, intermittent jetting of oxygen." There is no mention of automated decision-making, learning algorithms, or any other characteristic associated with AI/ML.
Yes
The device is described as an oxygen delivery system used for transtracheal ventilation to relieve upper airway obstructions, which directly treats a medical condition.
No
The device is described as an oxygen delivery system used for transtracheal ventilation, which is a therapeutic intervention, not a diagnostic one. It is used to provide ventilation in emergency situations, not to diagnose a condition.
No
The device description explicitly states it is a "Manually-controlled oxygen delivery system" and describes the use of physical components like a "transtracheal catheter, or cricothyrotomy needle" and the "manual, intermittent jetting of oxygen," indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is a "Manually-controlled oxygen delivery system used for transtracheal ventilation." It is used to deliver oxygen directly into the airway to assist breathing.
- Lack of Sample Analysis: The device does not analyze any biological samples. Its function is purely mechanical/pneumatic, delivering a substance (oxygen) to the patient.
Therefore, this device falls under the category of a therapeutic or life-support device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Manually-controlled oxygen delivery system used for transtracheal ventilation.
Product codes
73 BTL
Device Description
The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions. These systems are used in conjunction with a transtracheal catheter, or cricothyrotomy needle, which is inserted through the cricothyroid membrane. Ventilation is accomplished by the manual, intermittent jetting of oxygen through the catheter for subsequent lung inflation.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 7 1999
Ms. Tricia Wood Regulatory Affais/Quality Assurance Manager Instrumentation Industries, Inc. 2990 Industrial Boulevard Bethel Park, PA 15102
Re: K991785 Manual Jet Ventilator Requlatory Class: II (two) Product Code: 73 BTL Dated: May 20, 1999 Received: May 25, 1999
Dear Ms. Wood:
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 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 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.
1
Page 2 - Ms. Tricia Wood
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 requlation (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. Collehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
INDICATION FOR USE STATEMENT
BE 183-SUR and BE 183-SU Manual Jet Ventilators Device:
Manually-controlled oxygen delivery system used for transtracheal ventilation. Summary:
The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions. These systems are used in conjunction with a transtracheal catheter, or cricothyrotomy needle, which is inserted through the cricothyroid membrane. Ventilation is accomplished by the manual, intermittent jetting of oxygen through the catheter for subsequent lung inflation.
Tμci W
Signature
Signature
Tricia Wood Typed Name
5/21/99
Date
991785
Premarket notification (510(k)) number
Mr. Pruf
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number