(38 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 not a therapeutic purpose. Therapeutic devices are meant to treat, cure, or mitigate a disease or condition.
No
The device is described as a tampon used to absorb menstrual or other vaginal discharge, which is a collection function, not a diagnostic one. No mention is made of detecting, monitoring, or diagnosing any medical condition.
No
The device description clearly states it is a physical product (tampons made of rayon and cotton) and does not mention any software component.
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 being inserted into the vagina. 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 physical composition and function of a tampon, which is a medical device for absorption, not for analyzing a biological sample.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
- Anatomical Site: The device is used in vivo (within the body), specifically the vagina. IVDs are used in vitro (outside the body) on samples taken from the body.
Therefore, the Rostam Ltd fragranced plastic applicator tampons are classified as a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Rostam Ltd fragranced plastic applicator tampons are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Product codes
85 HIL
Device Description
Rostam plastic applicators are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 5 absorbencies, junior (MINI), regular, slender regular, super and super plus.
These Tampons are made from rayon and cotton and cotton cord.
The material 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
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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
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Summary of Performance Studies
Non-Clinical Testing: Biocompatibility testing and safety evaluations of tampon components was 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 Ltd. plastic applicator fragranced tampons.
Clinical testing: Repeated Insult Patch Test, 100 human subjects.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5460 Scented or scented deodorized menstrual tampon.
(a)
Identification. A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).
0
KO32080 VII 510K SUMMARY
Device Name: ROSTAM Ltd Plastic Applicator Fragranced Tampons
Legally marketed device: These Tampons are substantially equivalent to legally marketed Rostam Ltd. tampons with paper applicators.
Device description: Rostam plastic applicators are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 5 absorbencies, junior (MINI), regular, slender regular, super and super plus.
These Tampons are made from rayon and cotton and cotton cord.
The material 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 was 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 Ltd. plastic applicator fragranced tampons.
Clinical testing
o Repeated Insult Patch Test, 100 human subjects
1
Image /page/1/Picture/1 description: The image is a black and white logo. The logo is circular in shape and contains an abstract image of a bird in the center. The bird is made up of three curved lines that resemble feathers. The text "TRUST OF HEALTH & HUMAN SERVICES" is written around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2003
Rostam Ltd. % Robert J. Stabb, Ph.D. Official Correspondent Regulatory and Technical Associates 73 Franklin TPK ALLENDALE NJ 07401
Re: K032080
Trade/Device Name: ROSTAM Ltd. Fragranced Plastic Applicator Tampon Regulation Number: 21 CFR 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: 85 HIL
Dated: July 2, 2003 Received: July 7, 2003
Dear Dr. Stabb:
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 (PMA). it may be subject to 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 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.
2
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 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Verl 3 - 4/24/96
Applicant: Rostam Ltd
510(k) Number (if known): Applied for
KU32080
KO 32080
Device Name: ROSTAM Ltd Fragranced Plastic Applicator Tampons
Indications For Use:
As a Class II device, the menstrual tampon is defined as follows: (21CFR884.5460 and 21CFR 884.5470).
Rostam Ltd fragranced plastic applicator tampons are a plug made of cellulosic or synthetic material that is 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)
(Optional Format 1-2-96)
Daniel G. Benson
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032080
L Over-the-Counter Use.