(40 days)
First Quality Hygienic 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.
First Ouality Hygienic Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed in four absorbencies: junior regular, super and super plus. These Tampons are made from rayon and cotton cord. The material used in these tampons are similar to those used in other legally marketed tampons in the US.
Here's a summary of the acceptance criteria and study information for the "Femtex" Tampons, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For the "Femtex" Tampons, the key performance standard mentioned is absorbency, measured by the Syngyna methodology. The acceptance criteria are defined by absorbency ranges for each tampon type. The reported device performance aligns with these ranges.
| Absorbency Type | Acceptance Criteria (Syngyna methodology - grams) | Reported Device Performance (Syngyna methodology - grams) |
|---|---|---|
| Junior | Max: 6 | Implied to meet, as "Standard Syngyna testing confirmed the absorbency of these Tampons." |
| Regular | Min: 6, Max: 9 | Implied to meet, as "Standard Syngyna testing confirmed the absorbency of these Tampons." |
| Super | Min: 9, Max: 12 | Implied to meet, as "Standard Syngyna testing confirmed the absorbency of these Tampons." |
| Super Plus | Min: 12, Max: 15 | Implied to meet, as "Standard Syngyna testing confirmed the absorbency of these Tampons." |
(Note: While the document states "Standard Syngyna testing confirmed the absorbency of these Tampons," it doesn't explicitly list the exact absorbency values obtained for each specific absorbency type. It relies on the assertion that these values were confirmed to be within the defined ranges.)
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the Syngyna absorbency testing or the other non-clinical tests mentioned (irritation, sensitization, acute oral toxicity, eye irritation, cytotoxicity).
The data provenance is implied to be historical testing and a review of existing toxicological data in the public literature. There is no mention of specific country of origin for the data or if it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The Syngyna absorbency test is a standardized laboratory test, and the other tests are standardized non-clinical evaluations, not typically requiring "expert" establishment of ground truth in the way a clinical study might (e.g., diagnosing a disease from images).
4. Adjudication Method for the Test Set
This information is not applicable as the tests described are laboratory and non-clinical evaluations, not interpretive assessments that would require human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is not an AI-assisted diagnostic tool but a physical menstrual product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm study was not done. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for absorbency was established through standardized laboratory testing (Syngyna methodology), which provides objective, quantifiable data. For biocompatibility and safety, the ground truth was established through standardized non-clinical testing (irritation, sensitization, acute oral toxicity, eye irritation, cytotoxicity) and review of existing toxicological data in public literature.
There is no mention of expert consensus, pathology, or outcomes data being the primary ground truth for the performance of this specific device, as these are typically more relevant for diagnostic or clinical devices.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI model that requires a "training set." The testing described is for performance and safety evaluation, not for training an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this device.
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NOV 2 6 2002
510K SUMMARY
Device Name: "Femtex" Tampons and other Private Label Plastic Applicator Tampons
VII
Legally marketed device: These Tampons are substantially equivalent to legally marketed predicate tampons with applicators.
Device description: First Ouality Hygienic Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed in four absorbencies: junior regular, super and super plus.
These Tampons are made from rayon 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 of raw materials were historically conducted and are relevant to the safety of First Quality Hygienic plastic applicator tampons.
- ◇ irritation testing
- 0 sensitization testing
- 0 acute oral toxicity
- � eve irritation testing
- cytotoxicity testing ◇
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Menstrual Tampon
VIII Substantial Equivalence Comparison Chart
| Comparison Element | New device | Predicate Device |
|---|---|---|
| Device Name | First Quality HygienicPrivate labelplasticapplicator tampons | Kotex plasticapplicatortampons |
| Manufacturer | First Quality Hygien.. | Kimberly Clark |
| 510 (k) # | requested | K896994 |
| Intended Use | Absorb MensesIntravaginally | Absorb MensesIntravaginally |
| Device Design | spec.Junior 1.80 g 35mmReg. 2.20g, c.44mmSup. 3.30 g c. 45 mmSupPl. 3.6 g, 53 mmcord, 125 mm (all) | Kotex est.Reg 2.30 g, 42 mmSup. 3.30 g, 45 mmSupPl.c.4.4g, 55 mmcord, 130 mm (all) |
| Component Materials | plug:rayonPEG stearate palmitate, orpolyoxyethylene 20sorbitan monolaurate | plug: rayon/cotton mixfatty acid polyglycolester/fatty alcohol poly-glycol ether, Leomin,glycerol finishes |
| sewing thread: cotton | sewing thread: cotton | |
| wax | w/drawal cord: cottonw/ paraffinic wax base | w/drawal cord: cottonw/ paraffinicbase |
| Applicator | food grade polyethylenelinear | food gradepolyethylenelinear mix |
મિન્મનીપાઝ
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Absorbency range in grams per Syngyna methodology
| junior | regular/ | super | super plus | |
|---|---|---|---|---|
| maximum | 6 | 9 | 12 | 15 |
| minimum | - | 6 | 9 | 12 |
| required accessorydevices | none | none | none | none |
| Other features | none | none | none | none |
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and head. The bird is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the bird.
NOV 2 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
First Quality Hygienic, Inc. % Robert J. Staab. Ph.D Official Correspondent Regulatory and Technical Associates 73 Frankllin TPK ALLENDALE NJ 07401
Re: K023479
Trade/Device Name: "Femtex" Tampons and other Private Label Plastic Applicator Tampons Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: 85 HEB Dated: October 17, 2002 Received: October 17, 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 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.
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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 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:
| 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" (21 CFR Part 807.97). 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. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_ 2012
510(k) Number (if known): 长安33479
Arsieris no of Device Name: ERSS Quariel Plastic Applicaron
Indications For Use:
INDICATIONS FOR USE
As a Class II device, the menstrual tampon is defined as follows: (21 CFR 884.5460 and 21 CFR 884.5470).
First Quality Hygienic 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)
David A. Segeum
(Division Sign-off)
Reproductive, Abdominal
Over The Counter
Prescription Use (Per 21 CFR 801
§ 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).