(71 days)
"Snuffer" - Vacumed, Ventura CA, Noseclip - Qosinna, Edgewood NY, Noseclip - AMSCO, Pittsburgh PA
Not Found
No
The device description and intended use describe a simple mechanical noseclip with no mention of AI or ML capabilities.
No
The device is described as a noseclip used to treat nosebleeds, which falls under the category of a medical device but not specifically a therapeutic device that delivers therapy in a more active sense (e.g., drug delivery, electrical stimulation, etc.). It addresses a medical condition (nosebleeds) but primarily by physical compression rather than by therapeutic active intervention. The intended use is for "treatment" of nosebleeds, which broadly includes devices that manage conditions. However, the term "therapeutic device" often implies a more direct and active therapeutic mechanism beyond simple physical application for management. In regulatory contexts, simple physical devices like noseclips, while having a medical purpose, are often classified differently than devices that actively provide therapy.
No
Explanation: The device is intended for the treatment of nosebleeds, which is a therapeutic purpose, not a diagnostic one. It does not identify, assess, or monitor a disease or condition.
No
The device description explicitly states it is an "Existing respiratory noseclip," which is a physical hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The described device is a noseclip applied externally to the nose to treat nosebleeds. It does not involve the examination of any bodily specimens.
- Intended Use: The intended use is the physical treatment of a nosebleed by applying pressure, not the analysis of biological samples for diagnostic purposes.
Therefore, this device falls under the category of a non-IVD medical device.
N/A
Intended Use / Indications for Use
The treatment of simple anterior (front) nosebleeds by application of a noseclip to the external nose in adults and children. Not for use on infants.
Product codes (comma separated list FDA assigned to the subject device)
77 EMX
Device Description
Existing respiratory noseclip is to be used to treat simple anterior (front) nosebleeds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
external nose
Indicated Patient Age Range
Adult and children (not for use on infants)
Intended User / Care Setting
Anywhere the device may be safely applied: home, work, school, or hospital.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
"Snuffer" - Vacumed, Ventura CA, Noseclip - Qosinna, Edgewood NY, Noseclip - AMSCO, Pittsburgh PA
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 a date, "AUG 17 1998". The month is August, the day is the 17th, and the year is 1998. The text is in a bold, sans-serif font. The image is a close-up of the date.
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters. The sequence starts with the letter 'K', followed by the numbers '981966'. The numbers are written in a cursive style, with some of the digits connected to each other.
Image /page/0/Picture/2 description: The image shows four arrows pointing towards the center. The arrows are shaded with a dot pattern. The text "AUG 17" is in the upper right corner of the image, and the text "Mich" is in the lower right corner.
Michael M. Knott, M.D., Inc.
Michael M. Knott, M.D. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
P.O. Box 5577 355 Rose Pine Ct. Tahoe City, CA 96145 (530) 583-9371 Fax (530) 583-8824 Pager (530) 583-0266 Box #1906 Email mmknott@mail.telis.org
Non-Confidential Summary of Safety and Effectiveness
June 3, 1998
Michael M. Knott, MD 355 Rose Pine Court Tahoe City CA 96145-5577 Tel (530) 583-9371
Official Contact: Proprietary or Trade Name: Common/Usual Name: Classification Name: Predicate Devices:
Michael M. Knott, MD Nosebleed Noseclip Noseclip Anesthesiology "Snuffer" - Vacumed, Ventura CA Noseclip - Qosinna, Edgewood NY Noseclip - AMSCO, Pittsburgh PA
Existing respiratory noseclip is to be used to treat simple anterior (front) nosebleeds.
Indicated Use - The treatment of simple anterior (front) nosebleeds.
Environment of Use - Anywhere the device may be safely applied: home, work, school, or hospital.
Patient Population - Adult and children (not for use on infants)
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG | 4 1998
Michael M. Knott, M.D. P.O. Box 5577 355 Rose Pine Ct. Tahoe City, CA 96145 Re:
K981966 Nosebleed Noseclip Dated: May 28, 1998 Received: June 4, 1998 Regulatory class: I 21 CFR 874.4100/Procode: 77 EMX
Dear Mr. Knott:
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 and prohibitions against misbranding and adulteration.
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 can be found in the Code of Fecteral 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 (OS) 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 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 510ks) 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/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin
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
2
ICATIONS FOR USE
Pursuant to the Notice of February 6, 1996 regarding listing of Indication for Use on a separate sheet, the following is per that request.
| 510(k) Number: | 981966 (To be assigned) |
|---|---|
| Device Name: | Nosebleed Noseclip |
| Intended Use: | The treatment of simple anterior (front) nosebleeds by application of a noseclip to the external nose in adults and children. Not for use on infants. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seppman
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per CFR 801.109)
:
or
Over-the-counter Use __