(136 days)
Not Found
Not Found
No
The device description and performance studies focus on material composition, absorbency, and biocompatibility, with no mention of AI or ML.
No.
The device is used to absorb menstrual or other vaginal discharge, which is not a therapeutic function. It does not treat or cure any medical condition.
No
Explanation: The device is a tampon, which is used for absorbing menstrual or other vaginal discharge, not for diagnosing medical conditions. Its intended use and description focus on absorbency and hygiene, not detection or analysis of diseases.
No
The device description clearly states it is a physical product (tampons) made from materials like rayon and cotton, and includes a plastic applicator. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to absorb menstrual or other vaginal discharge by insertion into the vagina. This is a physical function, not a diagnostic test performed in vitro (outside the body) on a sample.
- Device Description: The description details the materials and construction of a tampon, which is a physical absorbent device.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample, detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
IVD devices are typically used to examine specimens such as blood, urine, or tissue to detect diseases, conditions, or infections. This device does not perform such a function.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HIL, HEB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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.
2
Page 2
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
3
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