(193 days)
o.b. Tampons are used to absorb menstrual fluid or other vaginal discharge.
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.
The provided text describes a 510(k) summary for a modified o.b.® Tampon. The objective of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new performance criteria for a novel device. Therefore, the information provided does not align with the typical structure of reporting acceptance criteria and a study proving a device meets those criteria for a new or significantly modified medical device that requires clinical performance evaluation.
Specifically, the document focuses on substantial equivalence for the modified o.b.® Tampons. The "acceptance criteria" here are implicitly tied to demonstrating that the modified tampon is as safe and effective as the predicate device.
However, based on the provided text, I can extract the following information relevant to the intent of the questions, reinterpreting "acceptance criteria" as the characteristics that needed to be equivalent or demonstrated as safe.
Here's a breakdown of the available information in response to your questions:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Technological Characteristics: Equivalent absorbency within a specific range, and similar materials, weight, and dimensions. | The only difference between the modified o.b.® tampons and the predicate tampons is that 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. The tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string, which are the same materials as the predicate. (The specific absorbency range of the predicate is not explicitly stated, but the modified tampon falls within established regulatory ranges, and the submission argues this change does not alter substantial equivalence.) |
| Intended Use: Same as the predicate device. | The modified o.b.® Tampons are inserted into the vagina to collect menstrual fluid. This is the same intended use as current commercial tampons. |
| Biocompatibility: No adverse biological reactions. | Biocompatibility testing has been conducted on tampons made with these commercial materials. The results of these tests demonstrate that the modified o.b.® Tampon is equivalent to legally marketed tampons. This testing included Microbiological testing. |
| Safety (Clinical): No new or increased safety risks. | Clinical Testing has been conducted. Results of preclinical and clinical testing indicate that the safety of the modified tampon is comparable to current legally marketed, commercial tampons. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for either biocompatibility or clinical testing.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document only mentions "preclinical and clinical testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the regulatory submission focuses on demonstrating substantial equivalence through specific tests (e.g., syngyna absorbency, biocompatibility, clinical safety comparable to existing products) rather than a diagnostic performance study requiring expert ground truth in the traditional sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable/not provided for this type of submission. Adjudication methods are typically used in studies where a new diagnostic or prognostic tool's output is compared against a consensus expert reading for ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not applicable/not provided. The device is a tampon, not an AI-assisted diagnostic or imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable/not provided. The device is a tampon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For absorbency, the ground truth is established by the syngyna test method (21 CFR 801.430), which is a standardized laboratory procedure.
- For biocompatibility, the ground truth would be established by standardized microbiological testing and potentially other biological assays, demonstrating no significant adverse reactions compared to established safety profiles.
- For clinical safety, the ground truth would be based on clinical observation and outcomes data from the "Clinical Testing" to show comparability to legally marketed tampons, likely looking for adverse event rates, irritation, or other safety endpoints. Specific methods are not detailed.
8. The sample size for the training set:
- This information is not applicable/not provided. There is no "training set" in the context of this device and its testing methodology.
9. How the ground truth for the training set was established:
- This information is not applicable/not provided.
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Appendices
510(k) Summary of Safety and Effectiveness (App. A)
| Device name | Trade name: o.b.® TamponsClassification 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 tamponsmade with these commercial materials. The results of these tests demonstratethat 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 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 |
| Date | This Summary was prepared on February 1, 1999 |
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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
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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.
§ 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).