(61 days)
Not Found
Not Found
No
The summary describes a physical catheter for nasal hemorrhage and packing, with no mention of software, image processing, AI, or ML.
Yes
The device is intended to control nasal hemorrhage and act as a postoperative nasal packing, which are therapeutic interventions.
No
The device is described as a catheter used to control nasal hemorrhage or as a postoperative nasal packing. These are therapeutic or supportive functions, not diagnostic ones.
No
The device description explicitly states "Epistaxis Catheter," which is a physical medical device, not software. The intended use also describes a physical action ("controlling nasal hemorrhage") performed by a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) to control nasal hemorrhage and for postoperative nasal packing. IVDs are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as an "Epistaxis Catheter," which is a physical device used within the nasal cavity.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Using reagents or assays
- Providing diagnostic information based on laboratory testing
Therefore, this device is a medical device used for a therapeutic and supportive purpose within the body, not an IVD.
N/A
Intended Use / 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.
Product codes
77 EMX
Device Description
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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
Nasal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS) in the United States. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized representation of a human figure, with three abstract shapes representing the head, body, and legs.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 8 1997
Louis R. Matson President & C.E.O. InterView Medical Technology Corporation 3941 Park Drive, Suite 20-325 El Dorado Hills, California 95762
Re:
K972922 Vyker Silicone Epistaxis Catheter V-27030 Dated: August 5, 1997 Received: August 8, 1997 Regulatory class: I 21 CFR 874.4100/Procode: 77 EMX
Dear Mr. Matson:
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, 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 marketd 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.
Wiliau Yu
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
K472422 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 also be used as 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 | K972922 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use ____ |
|---|---|---|
| ------------------------------------------------------------------------------------ | ---- | --------------------------- |
(Optional Format 1-2-96)