(136 days)
The Rostam Fragranced and Unfragranced Compact Applicator Tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge
Rostam plastic applicator tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, Light, regular and super. These Tampons are made from rayon and/or cotton polymeric overwrap and cotton cord. The materials used in these tampons are similar to those used in other legally marketed tampons.
The provided text is for a 510(k) summary for a medical device (tampons). The purpose of a 510(k) summary is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to detail comprehensive device-specific performance studies with specific acceptance criteria and detailed study designs as might be found for novel, higher-risk devices.
Based on the provided text, here's what can be extracted regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility/Safety Equivalence | Demonstrated that tampons are equivalent in terms of safety and effectiveness to legally marketed tampons based on historical testing and review of existing toxicological data. |
| Absorbency | Confirmed by Standard Syngyna testing. |
| Irritation/Sensitization | Repeated Insult Patch Test on 100 human subjects showed acceptable results (implied by overall safety claim). |
2. Sample Size Used for the Test Set and Data Provenance:
- Repeated Insult Patch Test: 100 human subjects.
- Data Provenance: Not explicitly stated for all tests, but "review of existing toxicological data in the public literature" suggests some data is retrospective and potentially sourced broadly. The human patch test is prospective. No country of origin is specified.
- Syngyna Testing: No explicit sample size specified, as it's a standardized in vitro test.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not mention experts being used to establish "ground truth" in the context of diagnostic performance or clinical outcomes. The assessments are primarily for safety and absorbency, which are typically evaluated by laboratory analysis or clinical safety studies, not expert consensus on ground truth in a diagnostic sense. For the patch test, the evaluation would be performed by trained dermatologists or clinicians, but the number is not specified.
4. Adjudication Method for the Test Set:
- Not applicable/Not mentioned. Adjudication methods are typically relevant for studies where multiple readers assess cases against a predefined ground truth, which is not the primary focus here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is not relevant for tampons, as they are not diagnostic devices that involve human readers interpreting results.
6. Standalone Performance Study (Algorithm Only):
- No. This is not applicable. Tampons are not an algorithm-based device.
7. Type of Ground Truth Used:
- Biocompatibility/Safety: Historical testing data, literature review, and direct results (e.g., lack of significant skin reactions in the patch test).
- Absorbency: Standardized laboratory measurements (Syngyna test) which serve as the "ground truth" for absorbency.
8. Sample Size for the Training Set:
- Not applicable. As this device is not an AI/ML diagnostic or image interpretation device, there is no "training set." The reference to "historical data" and "public literature" for safety serves a similar purpose to a knowledge base, but not a supervised machine learning training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set as defined in an AI/ML context.
Summary of Approach:
The K096671 submission for Rostam tampons primarily relies on demonstrating substantial equivalence to a previously legally marketed device (Tampax Compak Pearl Scented and unscented Tampons). This means the focus is on showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
The "studies" mentioned (Biocompatibility testing, Syngyna testing, Repeated Insult Patch Test) are primarily to confirm the safety and functional performance (absorbency) in a manner consistent with established standards for tampons and to demonstrate they meet the safety profile of predicate devices. The phrase "these Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons" is the overarching "acceptance criterion" met by the provided test results.
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MAY 28 2009
ATTCH 6, amended
510K SUMMARY
VII
Device Name: Rostam Scented and unscented plastic COMPACT applicator Tampons (Various Trade Tampons Sold Under Private Labels As Plastic Applicators)
Legally marketed device: These Tampons are substantially equivalent to legally marketed Tampax Compak Pearl Scented and unscented Tampons with plastic applicators.
Device description: Rostam plastic applicator tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, Light, regular and super.
These Tampons are made from rayon and/or cotton polymeric overwrap and cotton cord.
The materials used in these tampons are similar to those used in other legally marketed tampons.
Intended Use: The Rostam Fragranced and Unfragranced Compact Applicator Tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Assessment of Performance Standards: Not Applicable
Non-Clinical Testing: Biocompatibility testing and safety evaluations of tampon components were historically carried out. The results of these tests demonstrate that these Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of these Tampons. In addition to the review of existing toxicological data in the public literature, the following tests were conducted and are relevant to the safety of Rostam plastic applicator tampons.
· � Repeated Insult Patch Test, 100 human subjects
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird, with three curved lines representing its wings or feathers.
Public Health Service
MAY 28 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rostam Limited c/o Robert J. Staab, Ph.D. Official Correspondent Regulatory and Technical Associates (RTA) 30 Neck Road OLD LYME CT 06371
Re: K090071
Trade/Device Name: Rostam Fragranced and Unfragranced Compact Applicator Tampons Regulation Number: 21 CFR §884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: HIL and HEB Dated: May 2, 2009 Received: May 11, 2009
Dear Dr. Staab:
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 adulteration.
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 listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse, events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
[signature]
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTCH 5, amended
Applicant: Rostam Ltd
510(k) Number K090071
Device Name: Rostam Ltd Fragranced and Unfragranced Compact Applicator Tampons.
Indications For Use:
The Rostam Fragranced and Unfragranced Compact Applicator Tampons are inserted into the vagina and used to absorb menstrual 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)
(Per 21 CFR 801.109)
louis R. Whay
(Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
Over-the-Counter Use
§ 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).