(84 days)
Manually-controlled oxygen delivery system used for transtracheal ventilation.
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.
Manually-controlled oxygen delivery system used for transtracheal ventilation.
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.
The provided text is a 510(k) clearance letter from the FDA for a Manual Jet Ventilator (K991785). This document primarily focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices that are not novel.
Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
In a 510(k) submission for a device like a manual jet ventilator, the focus is typically on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, and that any differences do not raise new questions of safety and effectiveness. This often involves:
- Comparison to a Predicate Device: A detailed comparison of the new device's design, materials, performance, labeling, and other relevant characteristics to a legally marketed predicate device.
- Performance Testing (Bench Testing): This would likely include tests to ensure the device meets its own design specifications (e.g., oxygen flow rates, pressure delivery, valve function, material biocompatibility, sterile packaging integrity if applicable). However, the specific acceptance criteria and detailed results of such tests are not present in this summary letter.
- No Clinical Studies: For a Class II device like this, especially when demonstrating substantial equivalence to a well-established predicate, clinical studies are often not required. The letter confirms this by stating equivalence to legally marketed predicate devices without mentioning clinical data.
To answer your request, based only on the provided text, I can state:
- No information on acceptance criteria or a specific study proving device meets acceptance criteria is provided in this FDA 510(k) clearance letter.
- The letter describes the Manual Jet Ventilator's intended use as a "manually-controlled oxygen delivery system used for transtracheal ventilation" in "specific emergency situations of upper airway obstructions."
Therefore, I cannot populate the table or provide the requested details because the source document does not contain this information.
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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.
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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
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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
§ 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).