(79 days)
Not Found
Not Found
No
The device description and performance studies focus on the material composition and absorbency of a menstrual tampon, with no mention of AI or ML technology. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a menstrual tampon used to absorb menstrual fluid, which is a hygienic product, not one intended to treat or specifically diagnose a medical condition.
No
Explanation: The device, a menstrual tampon, is described as absorbing menstrual or other discharge. Its efficacy is related to absorbency and safety, not the diagnosis of a medical condition.
No
The device description clearly states the device is a menstrual tampon made of physical materials (rayon and cotton) and is inserted into the vagina, indicating it is a physical medical device, 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 discharge" by being inserted into the vagina. This is a physical function, not a diagnostic test performed on a sample outside the body.
- Device Description: The description focuses on the materials and physical characteristics of a menstrual tampon.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
- Classification: It is classified as a Class II device under regulations related to menstrual tampons (21 CFR 884.5460 and 21 CFR 884.5470), which are not IVD classifications.
- Performance Studies: The performance studies described are related to biocompatibility, safety, and absorbency, which are relevant to a physical device for absorption, not a diagnostic test.
IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Rostam applicator tampons are made of cellulosic or synthetic material that is inserted ire the vagina and used to absorb menstrual or other discharge.
Product codes
85 HEB
Device Description
Rostam Interlude Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed in three absorbencies: 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 in the US.
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
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Summary of Performance Studies
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.
- irritation testing
- sensitization testing
- acute oral toxicity
- eye irritation testing
- cytotoxicity testing
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5470 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
510K SUMMARY
Device Name: ROSTAM Interlude and Other Private Label Plastic Applicator Tampons
Legally marketed device: These Tampons are substantially equivalent to legally marketed predicate tampons with applicators.
Device description: Rostam Interlude Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed in three absorbencies: 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 in the US.
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.
-
irritation testing 0
VII -
sensitization testing 0
-
0 acute oral toxicity
-
0 eye irritation testing
-
cytotoxicity testing �
000007
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 9 2002
Received: February 19, 2002
Rostam, Ltd. % Robert J. Staab, Ph.D. Regulatory and Technical Associates 73 Franklin TPK ALLENDALE NJ 07401
Trade/Device Name: Interlude Tampons and Other Under Private Label Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: 85 HEB Dated: February 15, 2002
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 ror answer 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.
Re: K020535
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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonification. The I Dr I missification 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 If you desire of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Addisons of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Comphanes at ( notification" (21 CFR Part 807.97). Other general information on of recreation to premiered the Act may be obtained from the Division of Small Manufacturers, Jour robjonal 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
K020535
Page_ __ ol
510(k) Number (if known):
K020535
applied for
Device Name: Interlude and other private label plastic applicator tampons Indications For Uso:
As a Class II device, the menstrual tampon is defined as follows: (21 CFR 884.5460 and 21 CFR 884.5470)
Rostam applicator tampons are made of cellulosic or synthetic material that is inserted ire the vagina and used to absorb menstrual or other discharge.
(FLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND CONTINUE ON ANOTHER PAGE (IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 801.109)
OR
Over-The-Counter Use /
(Optional Format 1-2-96)
Nancy C Hodgson
Reproductive, Abdomin and Radiological Devices 510(k) Number