(85 days)
Not Found
Not Found
No
The device description and performance studies focus on the materials and physical properties of the tampon and applicator, with no mention of AI or ML technology.
No
Explanation: The device is intended to collect menstrual fluid and vaginal discharge, which is a hygienic function, not a therapeutic one aimed at treating or preventing a disease or condition.
No
The device is described as an applicator tampon intended to absorb menstrual fluid or other vaginal discharge. Its function is purely absorptive/collection, with no mention of diagnosing conditions or providing information for diagnostic purposes. Performance studies focus on safety and equivalence to existing tampons, not diagnostic accuracy.
No
The device description clearly states the device is made of physical materials like cotton, rayon, and cardboard, and is intended for physical insertion. It is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "collect menstrual fluid" and "absorb menstrual fluid or other vaginal discharge." This is a physical collection and absorption function, not a diagnostic test performed in vitro (outside the body) on a sample.
- Device Description: The description details the materials and construction of a tampon and applicator, which are designed for physical absorption.
- Lack of Diagnostic Elements: There is no mention of any components, processes, or intended uses related to analyzing a sample for diagnostic purposes (e.g., detecting biomarkers, identifying pathogens, measuring levels of substances).
- Performance Studies: The performance studies focus on biocompatibility, irritation, and equivalence to existing tampons, which are relevant to the safety and function of a physical absorption device, not a diagnostic test.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
o.b.® Applicator Tampons are inserted into the vagina to collect menstrual fluid. This is the same intended use as current commercial tampons.华 o.b. applicator tampons are used to absorb mentrual fluid or other vaginal discharge.
Product codes (comma separated list FDA assigned to the subject device)
85 HEB
Device Description
o.b.® Applicator Tampons are used to absorb menstrual fluid or other vaginal discharge. These tampons will be available in regular, super and super plus absorbencies. o.b.® Applicator Tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. The applicator consists of a cardboard laminate with a coating.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility and microbiological testing were conducted on extracts of the coated applicator. The results of these tests demonstrate that the modified o.b.® Applicator Tampon is equivalent to legally marketed tampons. The following tests were conducted: • Cytotoxicity • Vaginal Irritation in Rabbits • Microbiological testing. A Repeat Insult Patch Test was conducted to confirm the lack of the potential for human dermal irritation and sensitization. Results of non-clinical and clinical testing indicate that the safety of modified applicator is comparable to current legally marketed, commercial applicator tampons.
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.
The modified o.b.® Applicator Tampon is substantially equivalent to the current commercial o.b.® Applicator Tampon.
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
§ 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
pages of 2
JUN 100 1997
Appendices
Appendix A - 510(k) Summary
| Device Name | Trade name :o.b.® Applicator Tampon
Classification name: unscented menstrual tampon |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Equivalence to
legally
marketed
device | The modified o.b.® Applicator Tampon is substantially equivalent to the
current commercial o.b.® Applicator Tampon. |
| Device
description | o.b.® Applicator Tampons are used to absorb menstrual fluid or other vaginal
discharge. These tampons will be available in regular, super and super plus
absorbencies. |
| | o.b.® Applicator Tampons are made of cotton and rayon, a
polyethylene/polyester cover, and cotton or rayon string. |
| | The applicator consists of a cardboard laminate with a coating. |
| Intended use | o.b.® Applicator 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 applicator tampon and the
predicate device is the composition of the coating on the applicator. All other
technological characteristics are the same for the modified and the predicate
device. |
| | There is no impact on the function of the device because of the change in
applicator coating. |
1
| Performance
data
Non-clinical
testing | Biocompatibility and microbiological testing were conducted on extracts of
the coated applicator. The results of these tests demonstrate that the modified
o.b.® Applicator Tampon is equivalent to legally marketed tampons. The
following tests were conducted:
• Cytotoxicity
• Vaginal Irritation in Rabbits
• Microbiological testing |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
data
Clinical testing | A Repeat Insult Patch Test was conducted to confirm the lack of the potential
for human dermal irritation and sensitization. |
| Conclusion | Results of non-clinical and clinical testing indicate that the safety of modified
applicator is comparable to current legally marketed, commercial applicator
tampons. |
| Contact | Submitted by Personal Products Company
199 Grandview Road
Skillman, NJ, 08558-9418
Contact person: Ralph A. Petrone
Manager, Regulatory Affairs
J&J Consumer Franchises Worldwide
908 874 1214 |
| Date | This Summary was prepared on February 21,1997 |
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
Image /page/2/Picture/15 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 100 1997
Mr. Ralph Petrone Manager, Regulatory Affairs ......... Johnson & Johnson Consumer Franchises Worldwide 199 Grandview Road Skillman, New Jersey 08558-9418 Re: K970954 o.b. Applicator Tampon Dated: April 17, 1997 Received: April 21, 1997 Regulatory class: II 21 CFR §884.5470/Product code: 85 HEB
14 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 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.
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 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 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 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 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) 594-4616. 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,
Lillian Yin, Ph.D.
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
3
INDICATION FOR USE
510(k) Number (if known): __ K 9 2 09 54
Device Name: o.b. applicator tampon
Indications for Use:
华 o.b. applicator tampons are used to absorb mentrual fluid or other vaginal discharge.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
Prescription Use (Per 21 CFR 801.109)
OR
510(k) Number .
Over-The-Counter Use 1
R.k.D. Aitham/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
(Optional Format 1-2-96)
h: winword vap97 inforuse. doc