(469 days)
Not Found
Not Found
No
The summary describes a simple medical device (tampon) and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No.
The indications for use describe the device as absorbing menstrual fluid and/or other vaginal discharge, which is a common function for a personal hygiene product rather than a medical treatment or therapy.
No
The device is described as a tampon intended to absorb menstrual fluid and/or other vaginal discharge, which is a collection function, not a diagnostic one.
No
The device is described as a "tampon," which is a physical object used for absorbing menstrual fluid. This description clearly indicates a hardware component, not a software-only device.
Based on the provided information, the Vipon tampon is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to absorb menstrual fluid and/or other vaginal discharge. This is a physical function, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: While the description is "Not Found," the intended use clearly indicates a non-diagnostic purpose.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
- Anatomical Site: While it interacts with a bodily fluid, the purpose is absorption, not analysis of the fluid for diagnostic purposes.
Therefore, the Vipon tampon, as described, functions as a medical device for managing bodily fluids, not as a diagnostic tool.
N/A
Intended Use / Indications for Use
The Vipon tampon is indicated for females to absorb menstrual fluid and/or other vaginal discharge.
Product codes
85 HEB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5470 Unscented menstrual tampon.
(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
6 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re:
K992493 Vipon™ Menstrual Tampon, with applicator Regulatory Class: II 21 CFR §884.5470/Procode: 85 HEB Dated: September 8, 2000 Received: September 11, 2000
Mr. Steven A. Kilgore Chief Executive Officer AnotherWay Products, L.L.C. c/o Mr. Gerard D. Eftink Van Hooser, Olsen, & Eftink, P.C. 704 W. Foxwood Drive P.O. Box 1280 RAYMORE MO 64083-1280
Dear Mr. Eftink:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have desiness We have reviewed your Section 310(x) nother of mone stated in the enclosure) to legally marketed brecicale devices device is substantially equivalent (ur the multations for use at the Medical Device Amendments, or to devices Amendments, or to devices of to detice Art (Act Act Act (Act Act marketed in interstate commerce provisions of the Federal Food, Drug, and Comment Act (Act, You may, that have been reclassified in accordates with the provisions of the Act. The genral controls of the Act include therefore, market the device, subject to the gelleral confrolls of the reast and growth and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval); in the Code of Federal Regulations If your device is classified (see above) nine ellier class in (openin Control in the Code of Federal Regulations, to such additional controls. Existing major regulations are miliation with the Current Good Manufacturing Parts Party Parts Title 21, Parts 800 to 895. A substantialion (QS) for Medical Devices: General regulation (21 CFR Pat Practice requirements, as set form in the Quanty Dysterial (FDA) will verify such assumption . Failure 820) and that through periodic QS inspections, the room and Prag Transmission of Statisfaction submission does to comply with the GMP regulation may result in regulation in premarket notification sumission does not concerning your device in the Federal Regisel. Trease note: and response to your production of 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 $10(k) premarke notification for your device and This letter will allow you to begally marketed predicated in your beging 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), please contact the Office of If you desire specific advice for your device on our labertising of your device, of your device ontact the Office of Compliance at (301) 594-4639. Also, please not the regulation entitled, "Misbranding by reference to premarke Office of Colliptalice at (501) 594-457. Filse, promotion on your responsibilities under the Att may be obtained from the notition of Small Manufacturers Assistance at is toll-free number (800) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Daniel G. Schultz, M Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
| 510(k) Number (if known): | K992493 |
|---|---|
| Device Name: | VIPON |
Indications For Use:
The Vipon tampon is indicated for females to absorb menstrual fluid and/or other vaginal discharge.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE ÌF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over-the-Counter Use_
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(Optional Formal 3-10-98)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number.