(48 days)
The catheter is designed to aid in controlling nasal hemorrhage due to trauma from injury. The device may also be used as a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.
Epistaxis Catheter
The provided text details an FDA 510(k) clearance letter for the Vyker Silicone Epistaxis Catheter and its intended use. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Therefore, I cannot provide the requested information based on the input document. The document is solely an FDA clearance letter confirming substantial equivalence to a predicate device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a black and white logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three wavy lines that resemble a person's head and shoulders.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Briant Benson President & CEO Bentec Medical 4234 North Fwy. Blvd. Jack Sacramento, CA USA 95834 Re: K971411 Vyker Silicone Epistaxis Catheter Dated: April 15, 1997 Received: April 16, 1997 Regulatory class: I 21 CFR 874.4100/Procode: 77 EMX
Dear Mr. Benson:
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 easement date of the Medically Devices that have been reclassified in eccordance with the provisions of the Federal Food, Drug, and Comments 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, and probibitions against misbranting and adulteration.
JUN - 3 1997
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that through periodic GMP 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 concension your device in the Enderal Register. Please note: this response to your premarket notification does not affect any chigation you might have where sections 51 through 542 of the Act for devices under the Electronic Product 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 nosification. 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 vitco diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Eac, Nose and Throat devices. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation casibled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities value 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/cdrtv/dsmamain.html".
Sincerely yours,
Nllaiy
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
{1}------------------------------------------------
510(k) Number (if known):
MINE 50 (H-11-22-1)
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 also be used as a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.
2071411
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thuriel G. Severson
(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.