(146 days)
Not Found
Not Found
No
The summary describes a standard menstrual tampon and does not mention any AI or ML components or functionalities.
No.
The device is used to absorb menstrual or other vaginal discharge, which is an absorptive function, not a therapeutic one aimed at treating a disease or condition.
No
Explanation: The device is described as a tampon used to absorb menstrual or other vaginal discharge, which is an absorbent function, not a diagnostic one.
No
The device description clearly states it is a physical product (tampons made from rayon and/or cotton, polymeric overwrap, and cotton cord) and the performance studies focus on biocompatibility and absorbency, which are hardware characteristics.
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. This is a physical function within the body, not a diagnostic test performed on a sample in vitro (outside the body).
- Device Description: The description details the materials and function 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 diagnostic information about a disease or condition.
IVD devices are used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / 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
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 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.
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. 0 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
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
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name arranged in a circular fashion around a stylized eagle symbol. The eagle is depicted with its wings spread, suggesting movement and progress. The overall design is simple and professional, reflecting the department's role in public health and human services.
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.
Image /page/1/Picture/10 description: The image shows a logo for the FDA Centennial, which took place from 1906 to 2006. The logo features the letters "FDA" in a stylized font, with the word "Centennial" written below. The text "Protecting and Promoting Public Health" is written in a fancy font below the logo.
2
Page 2 --
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
3
Image /page/3/Picture/0 description: The image shows a logo for the FDA Centennial, celebrating the years 1906-2006. The logo is circular and features the letters "FDA" prominently in the center. Below the letters, the word "Centennial" is written in a smaller font. Three stars are placed beneath the word "Centennial".
. Food and Drug A
Image /page/3/Picture/2 description: The image shows the logo for the Department of Health and Human Services. The logo features a stylized caduceus symbol on the left, with the words "Department of Health and Human Services" to the right of the symbol. The text is stacked in three lines, with "Department of" on the top line, "Health and" on the second line, and "Human Services" on the bottom line.
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