K Number
K971411
Device Name
DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K
Date Cleared
1997-06-03

(48 days)

Product Code
Regulation Number
874.4100
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
Epistaxis Catheter
More Information

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 described as aiding in controlling nasal hemorrhage and used as postoperative nasal packing, which are therapeutic interventions.

No
The device is described as a catheter designed to aid in controlling nasal hemorrhage and as a postoperative nasal packing. These are therapeutic or supportive functions, not diagnostic ones. It does not identify, detect, or monitor a medical condition.

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

Not Found

Mentions image processing

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Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

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 (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.

Not Found

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

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 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)