(85 days)
o.b.® Applicator Tampons are inserted into the vagina to collect menstrual fluid. This is the same intended use as current commercial tampons.
o.b. applicator tampons are used to absorb mentrual fluid or other vaginal discharge.
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.
This document describes the premarket notification (510(k)) for the o.b.® Applicator Tampon, focusing on its substantial equivalence to an already marketed device. The changes relate to the applicator coating, not the tampon itself.
Here's an analysis of the provided text in the context of your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity Test | Demonstrated equivalence to legally marketed tampons. |
| Vaginal Irritation in Rabbits | Demonstrated equivalence to legally marketed tampons. |
| Microbiological Testing: | Demonstrated equivalence to legally marketed tampons. |
| Human Dermal Safety: | |
| Lack of potential for human dermal irritation | Confirmed by Repeat Insult Patch Test. |
| Lack of potential for human dermal sensitization | Confirmed by Repeat Insult Patch Test. |
| Overall Conclusion: Safety of modified applicator comparable to current legally marketed, commercial applicator tampons. | Overall Conclusion: Results of non-clinical and clinical testing indicate that the safety of modified applicator is comparable to current legally marketed, commercial applicator tampons. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Non-clinical testing: Not explicitly stated how many samples were used for cytotoxicity, vaginal irritation, and microbiological testing. It only mentions extracts of the coated applicator were tested.
- Clinical testing (Repeat Insult Patch Test): The sample size for this human study is not specified in the provided document.
- Data Provenance: Not specified. Given the manufacturer (Personal Products Company, Skillman, NJ), the testing was likely conducted in the USA or a region adhering to similar regulatory standards, but this is an inference, not explicit in the text. The type of study is a premarket approval study for a medical device modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable to this type of submission. This 510(k) is comparing a modified device to a predicate device based on specific non-clinical and clinical tests, not evaluating interpretations by human experts or establishing a "ground truth" for diagnostic purposes. The "ground truth" here is the safety of the materials as determined by established scientific laboratory and human safety testing protocols.
4. Adjudication Method for the Test Set
- Not applicable. As above, this submission does not involve adjudication of expert readings or diagnoses. The "adjudication" is essentially the FDA's review and concurrence with the testing results presented by the manufacturer.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not a diagnostic device or an AI-based system, so an MRMC study is not relevant to this submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. This is a physical medical device (tampon applicator), not an algorithm or AI system.
7. The Type of Ground Truth Used
- The ground truth used here is based on scientific laboratory test results (biocompatibility, microbiological) and human safety study outcomes (dermal irritation/sensitization). The "ground truth" is that the modified material is safe and comparable to the predicate device, as evidenced by these tests.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device. There is no "training set" in the context of an AI/ML algorithm. The "training" for the device design would be based on general scientific and engineering principles and prior knowledge about materials used in similar devices.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As mentioned, there is no "training set" in the AI/ML sense. The "ground truth" for the development of medical devices generally relies on established scientific literature, regulatory standards, and previous experience with similar materials and designs. Any modifications are then rigorously tested against these established safety and performance benchmarks.
In summary, the provided document details a 510(k) summary for a modified tampon applicator. The focus is on demonstrating substantial equivalence to a predicate device through non-clinical biocompatibility and microbiological testing, and a clinical (human) patch test for dermal safety. It does not involve AI, diagnostic accuracy, or expert consensus on interpretations, which explains why many of your questions are not applicable to this specific submission.
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JUN 100 1997
Appendices
Appendix A - 510(k) Summary
| Device Name | Trade name :o.b.® Applicator TamponClassification name: unscented menstrual tampon |
|---|---|
| Equivalence tolegallymarketeddevice | The modified o.b.® Applicator Tampon is substantially equivalent to thecurrent commercial o.b.® Applicator Tampon. |
| Devicedescription | o.b.® Applicator Tampons are used to absorb menstrual fluid or other vaginaldischarge. These tampons will be available in regular, super and super plusabsorbencies. |
| o.b.® Applicator Tampons are made of cotton and rayon, apolyethylene/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 menstrualfluid. This is the same intended use as current commercial tampons. |
| Technologicalcharacteristics | The only difference between the modified applicator tampon and thepredicate device is the composition of the coating on the applicator. All othertechnological characteristics are the same for the modified and the predicatedevice. |
| There is no impact on the function of the device because of the change inapplicator coating. |
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| PerformancedataNon-clinicaltesting | Biocompatibility and microbiological testing were conducted on extracts ofthe coated applicator. The results of these tests demonstrate that the modifiedo.b.® Applicator Tampon is equivalent to legally marketed tampons. Thefollowing tests were conducted:• Cytotoxicity• Vaginal Irritation in Rabbits• Microbiological testing |
|---|---|
| PerformancedataClinical testing | A Repeat Insult Patch Test was conducted to confirm the lack of the potentialfor human dermal irritation and sensitization. |
| Conclusion | Results of non-clinical and clinical testing indicate that the safety of modifiedapplicator is comparable to current legally marketed, commercial applicatortampons. |
| Contact | Submitted by Personal Products Company199 Grandview RoadSkillman, NJ, 08558-9418Contact person: Ralph A. PetroneManager, Regulatory AffairsJ&J Consumer Franchises Worldwide908 874 1214 |
| Date | This Summary was prepared on February 21,1997 |
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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
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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
§ 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).