(146 days)
Rostam Ltd. Fragranced and Unfragranced plastic applicator tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to apsorb menstrual or other vaginal discharge
Rostam plastic applicator tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided as two absorbencies, slender regular and light. 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.
This document is a 510(k) summary for Rostam Scented and Unscented Plastic Applicator Tampons, indicating the device's substantial equivalence to legally marketed predicate devices. It primarily focuses on the regulatory submission and does not contain detailed information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical trial or algorithm performance study would for, for instance, a medical imaging AI.
Here's an analysis based on the provided text, addressing the requested points:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, explicit acceptance criteria and corresponding reported device performance for specific quantitative metrics are not available. The submission focuses on substantial equivalence to existing legally marketed tampons rather than setting new quantitative performance benchmarks.
The document states:
- "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."
While "equivalent in terms of safety and effectiveness" and "confirmed the absorbency" are positive statements, they don't provide a table of precise criteria or numerical performance data against those criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The only specific test mentioned with a sample size is:
- Test: Repeated Insult Patch Test
- Sample Size: 100 human subjects
- Data Provenance: Not specified, but likely prospective given it's an "insult patch test" on human subjects. Country of origin not mentioned.
Other tests are alluded to (biocompatibility, safety evaluations, Syngyna testing) but without specific sample sizes or details on data provenance.
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)
This question is not applicable in the context of this device and testing. The "ground truth" concept, often used in AI or diagnostic device studies where expert consensus or pathology confirms a condition, does not apply directly to tampon safety and absorbency testing. The Repeated Insult Patch Test uses human subjects as direct biological indicators of irritation/sensitization, not as adjudicators of a "ground truth" diagnosis. Absorbency testing (Syngyna) uses a standardized in-vitro method, not expert judgment for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the testing methodologies (patch test, Syngyna) do not involve human adjudication in the sense of reviewing diagnostic outcomes.
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
Not applicable. This is a medical device for menstrual fluid absorption, not a diagnostic imaging or AI-assisted system. No MRMC studies or AI involvement is mentioned or relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained previously, the concept of a "ground truth" in the diagnostic sense is not directly applicable here.
- For the Repeated Insult Patch Test, the "ground truth" is the observed skin reaction (or lack thereof) on the human subjects. This is a direct biological outcome.
- For Syngyna testing, the "ground truth" for absorbency is determined by the standardized in-vitro method, which measures fluid uptake.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The materials and manufacturing processes are likely validated through standard engineering and quality control procedures, but not by training an algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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KOG 2001
VII
DEC - 7 2006
510K SUMMARY
Device Name: Rostam Scented and Unscented Plastic Applicator Tampons (Various Trade Tampons Sold Under Private Labels As Plastic Applicators)
Legally marketed device: These Tampons are substantially equivalent to legally marketed Rostam 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 as two absorbencies, slender regular and light.
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: These tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
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.
0 Repeated Insult Patch Test, 100 human subjects
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Rostam, Ltd. c/o Robert J. Staab, Ph.D. DABT, RAC RTA, Inc. 73 Franklin Tpk. ALLENDALE NJ 07401
DEC - 7 2006
Re: K062001
Trade/Device Name: Rostam Ltd. Scented and Unscented Plastic Applicator Tampons Regulation Number: 21 CFR §884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Product Code: HIL Regulation Number: 21 CFR §884.5470 Regulation Name: Unscented menstrual tampon Product Code: HEB Regulatory Class: II Dated: October 30, 2006 Received: October 31, 2006
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.
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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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); 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.
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 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), please contact the 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 894.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). 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,
Nancy C Hodgon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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. Food and Drug A
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Indications for Use
510(k) Number (if known): K062001
Device Name: Trade Name: Rostam Ltd Scented and Unscented Plastic Applicator Tampons
Indications for Use:
Rostam Ltd. Fragranced and Unfragranced plastic applicator tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to apsorb menstrual or other vaginal discharge
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of of
(Posted November 13, 2003)
Center for Devices and Radiological Health / CDRH
David A. Seymour
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices,
510(k) Number K062000
§ 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).