(54 days)
The catheter is designed to aid in controlling nasal hemorrhage due to trauma from injury. The device may r he baneler is a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.
Disposable Sillicone Epistaxis Catheter
I am sorry, but without further information about the device and its performance, I cannot provide a detailed answer to your request. The provided text is a letter from the FDA regarding a 510(k) premarket notification for a "Disposable Silicone Epistaxis Catheter." It confirms the device's substantial equivalence to a predicate device and its regulatory classification. However, it does not contain any information about:
- Acceptance criteria for performance.
- Reported device performance data.
- Study details (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth type, training set details).
To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) summary that includes performance data and study design.
If you can provide a document that contains this information, I would be happy to help you extract and present it according to your requested format.
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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1997
T. Jan Varner President & C.E.O. Specialty Surgical Products, Inc. P.O. Box 218 Hamilton, Montana 59840
Re:
K973656 Disposable Sillicone Epistaxis Catheter Dated: September 22, 1997 Received: September 25, 1997 Regulatory class: I 21 CFR 874.4100/Procode: 77 EMX
Dear Mr. Varner:
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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 requirement, 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 Radiation Control provisions, or other Federal laws or regulations.
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) 594-4613. 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/dsmamain.html".
Sincerely yours.
h. Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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kg+3656 510(k) Number (if known):__
Device Name: Epistaxis Catheter
Indications For Use:
The catheter is designed to aid in controlling nasal hemorrhage due to trauma from injury. The device may r he baneler is a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.
(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 Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _
Prescription Use
(Per 21 CFR 801.109)
.
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 874.4100 Epistaxis balloon.
(a)
Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.