(85 days)
Transtracheal catheter for patients requiring high flow supplemental oxygen for the treatment of hypoxemia
SCOOP I, Transtracheal Catheter
The provided document is a 510(k) premarket notification approval letter for the SCOOP I Transtracheal Catheter. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.
The letter from the FDA primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to pre-amendment devices and can proceed to market. It mentions general controls provisions, potential additional controls for Class II/III devices, and compliance with Good Manufacturing Practice.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, expert qualifications, etc.) from the provided text. This information would typically be found in the 510(k) submission itself or a separate clinical/performance study report, neither of which is included in this document.
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Public Health Service
JUN 17 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lewis Ward Transtracheal Systems, Inc. c/o L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301
Re: K981080 SCOOP I Requlatory Class: II (two) Product Code: 73 BTO March 12, 1998 Dated: Received: March 24, 1998
Dear Mr. Ward:
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 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 - Mr. Lewis Ward
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 requlation 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. Callahan
Thomas J. Čallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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Initial 510(k)
1
Device Name: SCOOP I, Transtracheal Catheter
Indications for Use:
Transtracheal catheter for patients requiring high flow supplemental oxygen for the treatment of hypoxemia
(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 K981080 510(k) Number_
Prescription Use UV X (Per 21 CFR 801.109)
OR Over-the-Counter Use ... . . . . . . . . . . . . . . . . . . . . . . .
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.