(471 days)
Not Found
No
The device description and performance studies focus on the physical properties and chemical additive of the tampon, with no mention of AI or ML.
No.
The device is a menstrual tampon for fluid absorption and pH reduction during menses, not a therapeutic device. Its function is to manage a natural physiological process rather than treating or preventing a disease or condition.
No
The device is a menstrual tampon designed to absorb fluid and reduce vaginal pH during menses, not to diagnose a condition.
No
The device is a physical menstrual tampon with an additive, not a software application.
Based on the provided information, the Rostam pH Tampon is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The primary intended use is the "absorption of menstrual fluid" and "reduces the usual vaginal pH increase during menses." While it affects the vaginal environment, it does not involve testing or analyzing a sample (like blood, urine, or tissue) outside of the body to diagnose a disease or condition.
- Device Description: It's described as a "menstrual tampon" with an additive to modify pH. This aligns with a medical device intended for absorption and local effect, not for diagnostic testing.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any substance or marker for diagnostic purposes.
- Predicate Device: The predicate device is a "Tampon with Additive," further supporting its classification as a medical device rather than an IVD.
IVDs are typically used to perform tests on samples taken from the human body to provide information for the diagnosis, treatment, or prevention of disease. The Rostam pH Tampon's function is to absorb menstrual fluid and modify the vaginal pH, which is a therapeutic or preventative action, not a diagnostic one.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
85 HEB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
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.
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
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