(14 days)
Not Found
No
The device description and performance studies indicate a conventional mechanical device without any mention of AI/ML components or data processing.
No
The device is a menstrual tampon intended for absorbing menstrual fluid, which is a hygiene product, not a medical treatment for a disease or condition. Its function is to absorb, not to treat, cure, mitigate, or prevent disease.
No.
The device's intended use is to absorb menstrual fluid, not to diagnose any medical condition or disease.
No
The device description clearly states it is a physical tampon with an absorbent pledget, withdrawal cord, and applicator, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "absorb menstrual fluid" by being "inserted into the vagina." This is a physical function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details a physical absorbent product (tampon) with an applicator and withdrawal cord. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Lack of Diagnostic Elements: The document explicitly states "Not Found" for mentions of image processing, AI/DNN/ML, input imaging modality, training/test sets, and key metrics like sensitivity, specificity, etc. These are common elements in IVD submissions.
- Performance Studies: The performance studies focus on "correct operation of the device as per its intended use and absorbency requirements," which are functional aspects of a physical product, not diagnostic accuracy.
- Predicate Devices: The predicate devices listed are other menstrual tampons, which are not IVDs.
In summary, the device is a physical product designed for absorption within the body, not for diagnosing a condition or analyzing a biological sample in vitro.
N/A
Intended Use / Indications for Use
The device is intended to be inserted into the vagina to absorb menstrual fluid.
Indications for Use: Cotton menstrual tampons are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Product codes (comma separated list FDA assigned to the subject device)
HEB
Device Description
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.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
TAMPAX® Tampons (The Procter & Gamble Company - K061486), NATRACARE TAMPON (Bodywise UK - K954942)
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
. **.
| ANNEX 12 | APR 29 2009 | |
|---|---|---|
| TECHNICAL EVALUATION | ||
| DOCUMENTATION | # 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 KM1,5 | |
| 08679 Gaiá | ||
| BARCELONA | ||
| SPAIN | ||
| CONTACT: | Elena Gomez | |
| Safety Officer | ||
| TELEPHONE: | + 34 93 839 16 28 | |
| FAX: | + 34 93 839 19 44 | |
| e-mail: | egomez@cohitech.net | |
| DEVICE TRADE NAME: | COTTON MENSTRUAL TAMPONS | |
| MAXIM MENSTRUAL TAMPONS | ||
| ORGANYC 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 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. | ||
| INTENDED USE: | The device is intended to be inserted into the vagina to | |
| absorb 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
1
| 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 MENSTRUAL
TAMPONS | PREDICATES | |
|----|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| | | | TAMPAX® Tampons
(The Procter & Gamble
Company - K061486) | NATRACARE TAMPON
(Bodywise UK -
K954942) |
| 1. | Intended use | The device is intended to be
inserted into the vagina to
absorb menstrual fluid | The device is intended to be
inserted into the vagina to
absorb menstrual fluid | The device is intended to be
inserted into the vagina to
absorb menstrual fluid |
| 2 | Indication for use | Absorb menstrual or other
vaginal discharge | Absorb menstrual or other
vaginal discharge | Absorb menstrual or other
vaginal discharge |
| 3 | Design | Cylindrical shape.
Applicator with silky and
rounded lip | Cylindrical shape.
Applicator with silky and
rounded tip | Cylindrical shape.
Applicator with silky and
rounded tip |
| 4. | Technological features: | | | |
| | | REGULAR | | |
| | Dimensions
Length
diameter | 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) for
each level | 6-9 g | 6-9 g | 6-9 g |
| | | SUPER | | |
| | Dimensions
Length
diameter | 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) for
each level | 9-12 g | 9-12 g | 9-12 g |
| | | SUPER PLUS | | |
| | Dimensions
Length
diameter | 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) for
each level | 12-15 g | 12-15 g | NA |
| 5. | Materials | REGULAR, SUPER AND
SUPER PLUS
100% Organic Cotton
Absorbent Core
100% Organic Cotton
Nonwoven Fiber
Cardboard Applicator
Withdrawal cord, cotton yarn | Viscose Absorbent Core
Polypropylene / Polystyrene
Nonwoven
Cardboard Applicator
Withdrawal cord, cotton yarn | 100% Organic Cotton
Absorbent Core
100% Organic Cotton
Nonwoven Fiber
Cardboard Applicator
Withdrawal cord, cotton yarn |
・
2
TECHNICAL EVALUATION COHITECH # Document: COTTON MENSTRUAL TAMPONS DOCUMENTATION SECTION E - UNSCENTED COTTON MENSTRUAL TAMPON: 510(k) SUMMARY
| PREDICATES | ||||
|---|---|---|---|---|
| # | Characteristic / | |||
| Feature | COTTON MENSTRUAL | |||
| TAMPONS | TAMPAX® Tampons | |||
| (The Procter & Gamble | ||||
| Company - K061486) | NATRACARE TAMPON | |||
| (Bodywise UK - | ||||
| K954942) | ||||
| Sewing yarn, 66% Polyester, | ||||
| 34% Collon | ||||
| Wrapping foil, cellulose paper | Sewing yarn, 66% Polyester, | |||
| 34% Collon | ||||
| Wrapping foil, cellulose paper | Sewing yarn, 66% Polyester, | |||
| 34% Collon | ||||
| Wrapping foil, cellulose paper | ||||
| 6. | Additives and finishing | |||
| Agents | No contain | No contain | No contain | |
| 7. | Biological | |||
| Specifications | 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.
3
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.
4
Page 2
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
5
Image /page/5/Picture/0 description: The image is a document with the title "TECHNICAL EVALUATION DOCUMENTATION." It includes the text "COTTON MENSTRUAL TAMPONS" and "SECTION D - UNSCENTED COTTON MENSTRUAL TAMPON: INDICATIONS FOR USE STATEMENT." The document also features the COHITECH logo.
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
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