(14 days)
The device is intended to be inserted into the vagina to absorb menstrual fluid.
Cotton menstrual tampons are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
The device is a conventional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. These tampons will be provided as three absorbencies: regular, super and super plus. Each tampon is wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.
The provided documents describe the regulatory submission for "COTTON MENSTRUAL TAMPONS" (also branded as MAXIM MENSTRUAL TAMPONS and ORGANYC MENSTRUAL TAMPONS) seeking substantial equivalence to existing predicate devices. The evaluation focuses on the technical characteristics and functionality of the tampons, rather than complex AI or medical imaging. As such, many of the requested elements for AI/medical device studies (e.g., sample size for test sets, expert qualifications, MRMC studies, training set details) are not applicable to this submission.
Here is an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the characteristics of the predicate devices. The study aims to demonstrate that the proposed device, COTTON MENSTRUAL TAMPONS, has similar technological features and equivalent performance, particularly in absorbency and dimensions, to the predicate devices.
| Characteristic / Feature | Acceptance Criteria (Predicate: TAMPAX® Tampons / NATRACARE TAMPON) | Reported Device Performance (COTTON MENSTRUAL TAMPONS) |
|---|---|---|
| Intended use | Inserted into the vagina to absorb menstrual fluid | Inserted into the vagina to absorb menstrual fluid |
| Indication for use | Absorb menstrual or other vaginal discharge | Absorb menstrual or other vaginal discharge |
| Design | Cylindrical shape; Applicator with silky and rounded tip | Cylindrical shape; Applicator with silky and rounded lip |
| Dimensions (Regular) | Tampon: 47 mm (L), 12.5-13 mm (D) Applicator: 120-125 mm (L), 14 mm (D) | Tampon: 47.5 mm ± 5% (L), 12 mm (D) Applicator: 120 mm ± 5% (L), 14 mm (D) |
| Absorbency (Regular) | 6-9 g | 6-9 g |
| Dimensions (Super) | Tampon: 47 mm (L), 14 mm (D) Applicator: 120-125 mm (L), 16 mm (D) | Tampon: 47.5 mm ± 5% (L), 14 mm (D) Applicator: 120 mm ± 5% (L), 16 mm (D) |
| Absorbency (Super) | 9-12 g | 9-12 g |
| Dimensions (Super Plus) | Tampon: 47 mm (L), 14 mm (D) Applicator: 120 mm (L), 16 mm (D) (Tampax only) | Tampon: 47.5 mm ± 5% (L), 14 mm (D) Applicator: 120 mm ± 5% (L), 16 mm (D) |
| Absorbency (Super Plus) | 12-15 g (Tampax only) | 12-15 g |
| Materials | Predicate 1 (Tampax): Viscose Absorbent Core, Polypropylene / Polystyrene Nonwoven Predicate 2 (Natracare): 100% Organic Cotton Absorbent Core, 100% Organic Cotton Nonwoven Fiber | Proposed Device: 100% Organic Cotton Absorbent Core, 100% Organic Cotton Nonwoven Fiber (Identical to Natracare) |
| Additives/Finishing Agents | No-contain | No-contain |
| Biological Specifications | Non sterile, single-use only | Non sterile, single-use only |
The reported device performance aligns with or is within acceptable deviations from the predicate devices' characteristics, particularly matching the Natracare Tampon in terms of material composition and overall absorbency ranges.
2. Sample size used for the test set and the data provenance
The document indicates "Functional laboratory testing performed in foreseeable operating conditions." This suggests physical testing of the tampons. However, details regarding the specific sample size for these tests (e.g., number of tampons tested for dimensions, absorbency) are not provided in the summary. The data provenance is from the manufacturer, COTTON HIGH TECH SL, located in Spain. The study appears to be part of a prospective evaluation for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to this type of device and study. The "ground truth" (e.g., absorbency, dimensions) is established through standardized laboratory testing methods, not expert consensus in the clinical sense.
4. Adjudication method for the test set
Not applicable. Laboratory test results are typically objective measurements, not subject to adjudication in the way clinical interpretations are.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device, and therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (tampon), not an algorithm or software.
7. The type of ground truth used
The ground truth used for performance evaluation is based on objective laboratory measurements of physical characteristics (dimensions, absorbency) and chemical/biological testing of materials, adhering to relevant standards for menstrual tampons. The "ground truth" for comparison is the established characteristics and performance of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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. **.
| ANNEX 12 | APR 29 2009 | |
|---|---|---|
| TECHNICAL EVALUATIONDOCUMENTATION | # Document:COTTON MENSTRUAL TAMPONS | |
| SECTION E - UNSCENTED COTTON MENSTRUAL TAMPON:510(k) SUMMARY | ||
| DATE OF SUBMISSION: | 2008-09-01 | |
| SUBMITTER NAME: | COTTON HIGH TECH SL | |
| SUBMITTER ADDRESS: | Ctra Navas a Prats de Lluçanës KM1,508679 GaiáBARCELONASPAIN | |
| CONTACT: | Elena GomezSafety Officer | |
| TELEPHONE: | + 34 93 839 16 28 | |
| FAX: | + 34 93 839 19 44 | |
| e-mail: | egomez@cohitech.net | |
| DEVICE TRADE NAME: | COTTON MENSTRUAL TAMPONSMAXIM MENSTRUAL TAMPONSORGANYC MENSTRUAL TAMPONS | |
| COMMON NAME: | TAMPON, MENSTRUAL, UNSCENTED | |
| CLASSIFICATION NAME: | TAMPON, MENSTRUAL, UNSCENTED(21 CFR 884.5470) | |
| DEVICE CLASS: | II | |
| PREDICATE DEVICE(S): | TAMPAX® Tampons (The Procter & Gamble Company - K061486)NATRACARE TAMPON (Bodywise UK - K954942) | |
| DEVICE DESCRIPTION: | The device is a conventional unscented menstrualtampon consisting of an absorbent pledget, a withdrawalcord, and an applicator.These tampons will be provided as three absorbencies:regular, super and super plus.Each tampon is wrapped in an individual wrapper andpackaged in sealed multi-unit containers for retail sale. | |
| INTENDED USE: | The device is intended to be inserted into the vagina toabsorb menstrual fluid. | |
| SUMMARY OF COMPARISON WITH PREDICATE DEVICE: |
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In the establishment of substantial equivalence, COTTON MENSTRUAL TAMPONS is
compared with another device TAMPAX® Tampons (The Procter & Gamble Company) and with NATRACARE TAMPON (Bodywlse UK). The following table summantzes the similarities of the principal
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| COHITECH | TECHNICAL EVALUATION |
|---|---|
| DOCUMENTATION |
| # Document: | COTTON MENSTRUAL TAMPONS |
|---|---|
| ------------- | -------------------------- |
| SECTION E - UNSCENTED COTTON MENSTRUAL TAMPON: | |
|---|---|
| 510(k) SUMMARY |
technological characteristics and features of both predicate and new devices.
.
.
| Characteristic /Feature | COTTON MENSTRUALTAMPONS | PREDICATES | ||
|---|---|---|---|---|
| TAMPAX® Tampons(The Procter & GambleCompany - K061486) | NATRACARE TAMPON(Bodywise UK -K954942) | |||
| 1. | Intended use | The device is intended to beinserted into the vagina toabsorb menstrual fluid | The device is intended to beinserted into the vagina toabsorb menstrual fluid | The device is intended to beinserted into the vagina toabsorb menstrual fluid |
| 2 | Indication for use | Absorb menstrual or othervaginal discharge | Absorb menstrual or othervaginal discharge | Absorb menstrual or othervaginal discharge |
| 3 | Design | Cylindrical shape.Applicator with silky androunded lip | Cylindrical shape.Applicator with silky androunded tip | Cylindrical shape.Applicator with silky androunded tip |
| 4. | Technological features: | |||
| REGULAR | ||||
| DimensionsLengthdiameter | Tampon: $47.5 mm \pm 5%$Applicator: $120 mm \pm 5%$Tampon: $12 mm$Applicator: $14 mm$ | Tampon: $47 mm$Applicator: $120 mm$Tampon: $12.5 mm$Applicator: $14 mm$ | Tampon: $46 mm$Applicator: $125 mm$Tampon: $13 mm$Applicator: $14 mm$ | |
| Absorbency (grams) foreach level | 6-9 g | 6-9 g | 6-9 g | |
| SUPER | ||||
| DimensionsLengthdiameter | Tampon: $47.5 mm \pm 5%$Applicator: $120 mm \pm 5%$Tampon: $14 mm$Applicator: $16 mm$ | Tampon: $47 mm$Applicator: $120 mm$Tampon: $14 mm$Applicator: $16 mm$ | Tampon: $47 mm$Applicator: $125 mm$Tampon: $14 mm$Applicator: $16 mm$ | |
| Absorbency (grams) foreach level | 9-12 g | 9-12 g | 9-12 g | |
| SUPER PLUS | ||||
| DimensionsLengthdiameter | Tampon: $47.5 mm \pm 5%$Applicator: $120 mm \pm 5%$Tampon: $14 mm$Applicator: $16 mm$ | Tampon: $47 mm$Applicator: $120 mm$Tampon: $14 mm$Applicator: $16 mm$ | NA | |
| Absorbency (grams) foreach level | 12-15 g | 12-15 g | NA | |
| 5. | Materials | REGULAR, SUPER ANDSUPER PLUS100% Organic CottonAbsorbent Core100% Organic CottonNonwoven FiberCardboard ApplicatorWithdrawal cord, cotton yarn | Viscose Absorbent CorePolypropylene / PolystyreneNonwovenCardboard ApplicatorWithdrawal cord, cotton yarn | 100% Organic CottonAbsorbent Core100% Organic CottonNonwoven FiberCardboard ApplicatorWithdrawal cord, cotton yarn |
・
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TECHNICAL EVALUATION COHITECH # Document: COTTON MENSTRUAL TAMPONS DOCUMENTATION SECTION E - UNSCENTED COTTON MENSTRUAL TAMPON: 510(k) SUMMARY
| PREDICATES | ||||
|---|---|---|---|---|
| # | Characteristic /Feature | COTTON MENSTRUALTAMPONS | TAMPAX® Tampons(The Procter & GambleCompany - K061486) | NATRACARE TAMPON(Bodywise UK -K954942) |
| Sewing yarn, 66% Polyester,34% CollonWrapping foil, cellulose paper | Sewing yarn, 66% Polyester,34% CollonWrapping foil, cellulose paper | Sewing yarn, 66% Polyester,34% CollonWrapping foil, cellulose paper | ||
| 6. | Additives and finishingAgents | No contain | No contain | No contain |
| 7. | BiologicalSpecifications | Non sterile, single-use only | Non sterile, single-use only | Non sterile, single-use only |
| 8. | Other features | - | - | - |
Table 5.1 - Summary comparison of proposed device with predicate devices
From the above table, it can be established that the new device and the predicates devices Tampax Tampons and Natracare Tampons have identical intended uses and indications and similar technological features (dimensions and absorbency).
Also, the materials used in the construction of the proposed device and those used in the predicate device Natracare are identical.
SUMMARY DISCUSSION OF NON-CLINICAL DATA:
All materials used in the construction of COTTONIMENSTRUAL TAMPONS have been subject to chemical and biological testing in accordance with the applicable requirements taking account of its intended use. The results of these safety tests support the conclusion that this device is safe for use.
Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use and absorbency requirements. Therefore the proposed devices are equivalent to the predicates in terms of effectiveness.
CONCLUSIONS:
We believe the intended use, the indications for use, the safety, effectiveness and functionality of COTTON MENSTRUAL TAMPONS and the TAMPAX and NATRACARE predicate devices as unscented menstrual tampon are essentially the same. Also, the materials used in the construction of the proposed device and those used in the predicate device NATRACARE are identical. Hence, substantial equivalence of COTTON MENSTRUAL TAMPONS with the legally marketed devices may be established.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles an eagle or bird with stylized wings and tail feathers. The symbol is rendered in black and has a modern, minimalist design.
APR 9 9 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cotton High Tech SL c/o Mr. Casey Conry Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747
Re: K091084
Trade/Device Name: COTTON MENSTRUAL TAMPONS MAXIM MENSTRUAL TAMPONS ORGANYC MENSTRUAL TAMPONS
Regulation Number: 21 CFR §884.5470 Regulation Name: Unscented menstrual tampons Regulatory Class: II Produce code: HEB Dated: April 13, 2009 Received: April 15, 2009
Dear Mr. Conry:
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) 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 892.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). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
COTTON MENSTRUAL TAMPONS: MAXIM MENSTRUAL TAMPONS ORGANYC MENSTRUAL TAMPONS
Indications for Use:
Cotton menstrual tampons are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Prescription Use (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X . (21 CFR 801 Subpart C)
(Do not write below this line. Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Huls Perna
(Division Sign-Off)
Division of Reproductive, Abdomin and Radiological Devices
510(k) Number K891084
Page 1 of 1
§ 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).