(89 days)
Not Found
Not Found
No
The device description and performance studies focus on the material composition and biological safety of tampons, with no mention of AI or ML technologies.
No
The device is used to absorb menstrual fluid, which is not a therapeutic function. Therapeutic devices are typically used for diagnosis, treatment, or prevention of disease.
No
The document describes tampons, which are used to absorb menstrual fluid and do not fit the description of a diagnostic device. There is no mention of diagnosing any condition.
No
The device description clearly states the device is made of physical materials (cotton, rayon, polyethylene/polyester cover, string) and is intended to absorb menstrual fluid, indicating 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 "absorb menstrual fluid or other vaginal discharge." This is a physical function, not a diagnostic test performed in vitro (outside the body) on a sample.
- Device Description: The description details the materials and function of a tampon, which is a physical absorbent device.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample, detecting biomarkers, or providing any kind of diagnostic information about a patient's health status.
- Anatomical Site: While the anatomical site is the vagina, the device's function is absorption within the body, not in vitro analysis of a sample from that site.
IVD devices are typically used to examine specimens such as blood, urine, tissue, or other body fluids to diagnose diseases, conditions, or infections. This device does not perform such a function.
N/A
Intended Use / Indications for Use
o.b. ® Tampons are used to absorb menstrual fluid or other vaginal discharge.
Product codes (comma separated list FDA assigned to the subject device)
85 HEB
Device Description
o.b. ® non-applicator and applicator Tampons are used to absorb menstrual fluid. The modified tampon will be available in Regular, Super, and Super Plus syngyna absorbency ranges.
o.b.® non-applicator and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical Evaluations
• Cytotoxicity
• Microbiological Evaluation
• Acute Systemic Toxicity
• Intracutaneous Toxicity
• Vaginal Irritation
• Ames Mutagenicity
• Chromosome Aberation Assay
• Unscheduled DNA Synthesis
Clinical Evaluations
• Human Sensitization
• Vaginal Microflora Study
• Human Vaginal Irritation Study
Results of preclinical and clinical testing indicate that the safety of the modified tampon is comparable to current legally marketed, commercial 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.® Tampon is substantially equivalent to current commercial o.b.® non-applicator and applicator Tampons.
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
:
510(k) Summary
| Device name | Trade name: o.b.® Tampons
Classification name: unscented menstrual tampons |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
description | o.b. ® non-applicator and applicator Tampons are used to absorb menstrual
fluid. The modified tampon will be available in Regular, Super, and Super
Plus syngyna absorbency ranges. |
| | o.b.® non-applicator and applicator Tampons are made of commercial cotton
and rayon, a polyethylene/polyester cover, and cotton or rayon string. |
| Equvalence to a
legally
marketed
device | The modified o.b.® Tampon is substantially equivalent to current commercial
o.b.® non-applicator and 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 o.b.® Tampons and the predicate
tampons is the substitution of an alternate fiber finish on the rayon and cotton
components of the tampon. |
1
| Biocompat-
ability | Biocompatability and microbiological testing has been conducted on the
modified tampons and the fiber finish material. The results of these tests
demonstrate that the modified o.b.® Tampon is equivalent to legally
marketed tampons. This testing included : |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Preclinical Evaluations
• Cytotoxicity
• Microbiological Evaluation
• Acute Systemic Toxicity
• Intracutaneous Toxicity
• Vaginal Irritation
• Ames Mutagenicity
• Chromosome Aberation Assay
• Unscheduled DNA Synthesis |
| | Clinical Evaluations
• Human Sensitization
• Vaginal Microflora Study
• Human Vaginal Irritation Study |
| 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 (phone)
908 874 1118 (Fax) |
| Date | This Summary was prepared on March 3, 1999 |
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:
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2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 1999
Mr. Ralph Petrone Manager, Regulatory Affairs Personal Products Company 199 Grandview Road Skillman, NJ 08558-9418
Re: K991118 o.b.® Tampons, GML fiber finish, applicator and non-applicator versions, unscented Dated: March 31, 1999 Received: April 1, 1999 Regulatory Class: Il 21 CFR §884.5470/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.
If your device is classified (see above) into either 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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiance 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,
CART. Daniel C. Stutts, M.P.
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
Enclosure
3
Appendix C- Indications for Use Statement
510(k) Number (if known) K 99 111 8
Device Name: 0.b. 0 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------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________ Use (per 21 CFR 801.109)
OR ✓ Over-The-Counter-
David A. Eygenson
(Division Sig Ander inal, ENT, Division of Roper "הנייע and Rach Beckler 510(k) Number