(89 days)
o.b. ® Tampons are used to absorb menstrual fluid or other vaginal discharge.
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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the modified o.b.® Tampons are primarily based on biocompatibility and user safety, demonstrating equivalence to legally marketed tampons. The performance is reported through the results of specific preclinical and clinical evaluations.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Modified tampons equivalent to legally marketed tampons. | Preclinical |
| Acute Systemic Toxicity | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Intracutaneous Toxicity | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Vaginal Irritation (Preclinical) | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Ames Mutagenicity | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Chromosome Aberration Assay | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Unscheduled DNA Synthesis | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Microbiological Safety | Microbiological Evaluation | Modified tampons equivalent to legally marketed tampons. | Preclinical |
| Clinical Safety/User Experience | Human Sensitization | Safety comparable to legally marketed, commercial tampons. | Clinical |
| Vaginal Microflora Study | Safety comparable to legally marketed, commercial tampons. | Clinical | |
| Human Vaginal Irritation Study | Safety comparable to legally marketed, commercial tampons. | Clinical |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample sizes for the preclinical or clinical evaluations.
- Data Provenance: The document does not explicitly state the country of origin of the data. The studies are referred to as "Preclinical Evaluations" and "Clinical Evaluations," implying that they were conducted specifically for this submission. The nature of these tests (e.g., vaginal irritation, microflora studies) suggests they would be prospective studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The nature of the studies (biocompatibility, clinical safety) suggests that the interpretation of results would have been performed by qualified professionals (e.g., toxicologists, microbiologists, clinicians), but specifics are not given.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or similar devices where different human readers interpret cases. Tampons are a medical device for menstrual fluid absorption, and their evaluation focuses on safety, performance, and biocompatibility, not interpretive tasks for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to the device described. The device is a physical product (tampon), not an algorithm or AI system. Therefore, there is no "standalone" algorithm performance to evaluate.
7. The Type of Ground Truth Used
The "ground truth" for this device's safety and performance is established through experimental data from preclinical and clinical studies, demonstrating the physical, chemical, and biological properties of the modified tampons. The ultimate ground truth essentially compared the modified tampon's characteristics to the known safe and effective profile of the predicate device and general medical standards for such products.
- For biocompatibility: Lab test results (e.g., cytotoxicity assays, genotoxicity assays, irritation studies).
- For clinical studies: Human physiological responses (e.g., absence of sensitization, maintained vaginal microflora, absence of irritation).
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical product, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for this type of device.
{0}------------------------------------------------
:
510(k) Summary
| Device name | Trade name: o.b.® TamponsClassification name: unscented menstrual tampons |
|---|---|
| Devicedescription | o.b. ® non-applicator and applicator Tampons are used to absorb menstrualfluid. The modified tampon will be available in Regular, Super, and SuperPlus syngyna absorbency ranges. |
| o.b.® non-applicator and applicator Tampons are made of commercial cottonand rayon, a polyethylene/polyester cover, and cotton or rayon string. | |
| Equvalence to alegallymarketeddevice | The modified o.b.® Tampon is substantially equivalent to current commercialo.b.® non-applicator and applicator Tampons. |
| Intended use | The modified o.b.® Tampons are inserted into the vagina to collect menstrualfluid. This is the same intended use as current commercial tampons. |
| Technologicalcharacteristics | The only difference between the modified o.b.® Tampons and the predicatetampons is the substitution of an alternate fiber finish on the rayon and cottoncomponents of the tampon. |
{1}------------------------------------------------
| Biocompat-ability | Biocompatability and microbiological testing has been conducted on themodified tampons and the fiber finish material. The results of these testsdemonstrate that the modified o.b.® Tampon is equivalent to legallymarketed 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 themodified tampon is comparable to current legally marketed, commercialtampons. |
| Contact | Submitted by Personal Products Company199 Grandview RoadSkillman NJ 08558-9418Contact person: Ralph PetroneManager, Regulatory AffairsPersonal Products Worldwide908 874 1214 (phone)908 874 1118 (Fax) |
| Date | This Summary was prepared on March 3, 1999 |
・
:
ﺳﺴﺴﺴﺴﺴﺴ
{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
§ 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).