(471 days)
The Rostam pH Tampon is a menstrual tampon for the absorption of menstrual fluid. The pH Tampon reduces the usual vaginal pH increase during menses.
The Rostam pH Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed at the first stage in two absorbencies: regular and super. The Tampons reduce the usual vaginal pH increase during menses. These Tampons are made from rayon and cotton cord. The materials used in these tampons are similar to those used in other legally marketed tampons in the US, with the exception of an additive that is designed to reduce the usual increase in vaginal pH during menstruation.
The provided text describes a 510(k) summary for the Rostam pH Tampons. It outlines the device description, intended use, and non-clinical/clinical testing. However, it does not provide the specific details required to complete your request for acceptance criteria and the study proving the device meets those criteria.
The document states: "These tests, together with clinical evaluations, demonstrated that the tampon with additive is appropriate for its intended use." This is a general statement of compliance, but it lacks the quantitative results or specific criteria usually found in a detailed study report.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered based on the provided information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document states generally that "clinical evaluations, demonstrated that the tampon with additive is appropriate for its intended use" and that "The Tampons reduce the usual vaginal pH increase during menses." | Not specified in the document. No specific metrics or quantitative results are provided. The document states that the tampon "reduces the usual vaginal pH increase during menses." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified. The document mentions "clinical evaluations" but does not detail the methodology.
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 is not applicable as the device is a menstrual tampon, not an AI-powered diagnostic tool requiring human readability studies. The document does not mention any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as the device is a menstrual tampon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The implicit "ground truth" relates to the tampon's ability to "reduce the usual vaginal pH increase during menses" and its safety profile (irritation, sensitization, TSS-1 testing). The exact methodology for establishing the reduction in pH is not detailed, nor is the specific "ground truth" definition for the clinical evaluations mentioned.
8. The sample size for the training set
- Not applicable/Not specified. The clinical evaluations mentioned are likely for verifying safety and performance, not for training a model.
9. How the ground truth for the training set was established
- Not applicable/Not specified.
Summary of available information:
The provided document, a 510(k) summary, focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory standards for safety and general performance. It lists various preclinical toxicology tests and states that "clinical evaluations" were performed to show the device is appropriate for its intended use, specifically highlighting its ability to "reduce the usual vaginal pH increase during menses." However, it does not offer the granular detail of specific acceptance criteria, study sizes, methodologies, or quantitative performance metrics that would be found in a full study report or a more detailed section on clinical test results.
{0}------------------------------------------------
Page 1 of 2
510(k) Summary
Device Name: Rostam pH Tampons-Plastic Applicator, Regular and Super Absorbency
Manufacturer:
Rostam Ltd. 1 Alon Hatavor St. Caesarea Industrial Park 38900 POB 3541 Israel
Legally marketed predicate devices: These Tampons are substantially equivalent to legally marketed Rostam Plastic Applicator Tampons and Tambrands Tampon with Additive (K960341).
Device description: The Rostam pH Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed at the first stage in two absorbencies: regular and super. The Tampons reduce the usual vaginal pH increase during menses.
These Tampons are made from rayon and cotton cord. The materials used in these tampons are similar to those used in other legally marketed tampons in the US, with the exception of an additive that is designed to reduce the usual increase in vaginal pH during menstruation.
Intended Use: The Rostam pH Tampon is a menstrual tampon for the absorption of menstrual fluid. The pH Tampon reduces the usual vaginal pH increase during menses.
Non-Clinical and Clinical Testing: Preclinical toxicology information was gathered and evaluated in accordance with FDA guidance and applicable standards, including irritation testing, sensitization testing, acute oral toxicity, eye irritation, and cytotoxicity. Toxic syndrome toxin (TSS-1) testing was also performed according to standard methodology. The manufacturing procedures for this tampon precludes dioxin formation to ensure that levels of PCDD's and PCDF's are below the limit of detection achievable by current technology.
These tests, together with clinical evaluations, demonstrated that the tampon with additive is appropriate for its intended use.
{1}------------------------------------------------
K030474
Page 2 of 2
The Rostam pH Tampon conforms with 21 CFR 801.430 (Medical Devices; Labeling for Menstrual Tampons; Ranges of Absorbency).
No materials, ingredients or chemicals not already used in legally marketed menstrual tampons in the US have been added to this tampon, including the pledget, string or plastic applicator. Only the additional chips contain chemicals that are unique in the tampon market but are well known for other medical uses. The pledget and string are fabricated according to the same specifications as the previously cleared Rostam tampons.
1 CLD 133/979423
1 Toxicological Evaluation Danufil V 3.6 dtex
IBR 95-00-2915/00-93
「 21 CFR: 172.615, 175.105.175.300, 176.200, 176.210, 177.1200, 177.1520, 177.2600, 178.3570, 178.3850.
1 21 CFR: 175.105, 175.300, 177.1200, 177.1520, 179.45.
1 Equistar Petrothene GA564000 MSDS 00000000123 10/16/01
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "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
MAY 2 8 2004
Rostam, Ltd. % Mr. Jonathan S. Kahan Official Correspondent Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW WASHINGTON DC 20004-1109 Rc: K030474
Trade/Device Name: Rostam pH Tampon Regular and Super Absorbency Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: 85 HEB Dated: March 1, 2004 Received: March 1, 2004
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 adultcration
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies You must comply with all the Act's requirements, including, but not limited to: registration and fisting (21 CFR Part 807); labeling (21 CFR Part 801), good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) Premarket notification. The FDA finding of substantial equivalence of your device to a legally promated predicated 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Nancy C. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):_K030474
Device Name: Rostam pH Tampon-Regular and Super Absorbency
Indications For Use:
The Rostam pH Tampon is a menstrual tampon for the absorption of menstrual fluid. The pH Tampon reduces the usual vaginal pH increase during menses.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices (030474 510(k) Number_
IIIPH - 90759/0001 - 15078 v1
§ 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).