(193 days)
Not Found
Not Found
No
The summary describes a standard medical device (tampon) and explicitly states that AI/ML terms were "Not Found".
No
The device is described as absorbing menstrual fluid, which is a hygienic function, not a therapeutic one intended to treat or cure a medical condition.
No
Explanation: The device is described as being used to absorb menstrual fluid or other vaginal discharge, which is a therapeutic or supportive function, not a diagnostic one. There is no mention of the device being used to identify, detect, or monitor a medical condition.
No
The device description clearly states the device is a physical tampon made of cotton, rayon, and other materials, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "absorb menstrual fluid or other vaginal discharge." This is a physical function within the body, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details the materials and function of a tampon, which is a medical device used for absorption, not for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, or tissue), detecting specific substances, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies mentioned focus on biocompatibility and microbiological testing, which are relevant for a medical device used internally, but not for an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This description clearly falls outside that definition.
N/A
Intended Use / Indications for Use
o.b. Tampons are used to absorb menstrual fluid or other vaginal discharge.
Product codes
85 HEB
Device Description
o.b. ® Non-applicator Tampons are used to absorb menstrual fluid. The modified tampon will be available in the 15-18 gram syngyna absorbency range.
o.b.® Non-applicator Tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
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
Results of preclinical and clinical testing indicate that the safety of the modified tampon is comparable to current legally marketed, commercial tampons.
Key Metrics
Not Found
Predicate Device(s)
current commercial o.b.® Non-applicator Tampons.
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).
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Appendices
510(k) Summary of Safety and Effectiveness (App. A)
| Device name | Trade name: o.b.® Tampons
Classification name: unscented menstrual tampons |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description | o.b. ® Non-applicator Tampons are used to absorb menstrual fluid. The modified tampon will be available in the 15-18 gram syngyna absorbency range.
o.b.® Non-applicator Tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. |
| Equivalence to a legally marketed device | The modified o.b.® Tampon is substantially equivalent to current commercial o.b.® Non-applicator Tampons. |
| Intended use | The modified o.b.® Tampons are inserted into the vagina to collect menstrual fluid. This is the same intended use as current commercial tampons. |
| Technological characteristics | The only difference between the modified ob® tampons and the predicate tampons is the absorbency has increased to 15-18 grams absorbency measured by the syngyna test method (21 CFR 801.430). This is accomplished by slight increases in the weight and dimensions of the tampons. |
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K990536
| Biocompat-
ability | Biocompatability and microbiological testing has been conducted on tampons
made with these commercial materials. The results of these tests demonstrate
that the modified ob® Tampon is equivalent to legally marketed tampons.
This testing included :
• Microbiological testing
• Clinical Testing |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Results of preclinical and clinical testing indicate that the safety of the
modified tampon is comparable to current legally marketed, commercial
tampons. |
| Contact | Submitted by Personal Products Company
199 Grandview Road
Skillman NJ 08558-9418
Contact person: Ralph Petrone
Manager, Regulatory Affairs
Personal Products Worldwide
908 874 1214 |
| Date | This Summary was prepared on February 1, 1999 |
i
:
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
AUG 3 1 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ralph Petrone Manager, Regulatory Affairs Personal Products 199 Grandview Road Skillman, New Jersey 08558-9418
Re: K990536
o.b. @Ultra Absorbency, non-applicator tampon (15-18 grams) Dated: June 3,1999 Received: June 4,1999 Regulatory Class: II 21 CFR 884.5435/Procode 85 HEB
Dear Mr. Petrone:
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 legally marketed predicate 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 practice, labeling, and prohibitions against misbranding and adulteration.
The agency is currently reviewing the comments that have been received in response to the proposed rule for labeling tampons with this absorbency (Labeling of Menstrual Tampons; Ranges of Absorbency; FR January 21, 1999). Please be advised that, depending on the term specified in the final rule, you may have to change your labeling.
If your device is classified (see above) into either class II (Special Controls) or 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 requirements, 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
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Page 2 - Mr. Ralph Petrone
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 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 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Appendix C- Indications for Use Statement
510(k) Number (if known) K9905 36
ﺔ ﺍﻟﻤ
Device Name: o.b. non applicator Tampons, Indications for Use:
o.b. Tampons are used to absorb menstrual fluid or other vaginal discharge.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Use
Over-The-Counter-
P
(per 21 CFR 801.109)
(Division Sign-Off) ( Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number.