(135 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological compatibility of a conventional menstrual tampon, with no mention of AI or ML.
No.
A therapeutic device is used to treat, cure, or prevent a disease or to alleviate symptoms, and this device is solely intended for absorbing menstrual fluid.
No
The device is a menstrual tampon, used to absorb menstrual fluid, and its description and intended use do not mention any diagnostic capabilities.
No
The device description clearly indicates it is a physical product (tampons) made of organic cotton, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The COHITECH Organic Cotton Non-Applicator Cottonlock Tampons are designed to be inserted into the vagina to absorb menstrual fluid. This is a physical function within the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states the purpose is to absorb menstrual fluid, not to diagnose or test for any condition.
- Device Description: The description details the physical components of the tampon, not reagents or testing mechanisms.
- Performance Studies: The performance studies focus on physical characteristics, biocompatibility, and microbiological impact within the vaginal environment, not on the accuracy or reliability of a diagnostic test.
Therefore, based on the provided information, this device falls under the category of a medical device used for absorption, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
COHITECH Organic Cotton Non-Applicator Cottonlock Tampons (light, regular, super, and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.
Product codes
HEB
Device Description
The subject device is a conventional unscented menstrual tampon consisting of an organic cotton absorbent pledget ("absorbent core"), completely surrounded by an organic cotton cover ("security veil") and with an organic cotton string ("withdrawal cord"). These tampons will be provided on four absorbencies: light (6g and under), regular (6-9g), super (9-12g) and super plus (12-15g).
Each organic cotton non-applicator Cottonlock tampon is wrapped in a cellulose paper 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
The following performance characteristics were assessed in accordance with the Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) issued on July 27, 2005:
- Absorbency (Syngyna testing per 21 CFR 801.430(f)(2))
- Chemical residues
- Tampon integrity
- String strength
- Fiber shedding
- Dimensional analysis
- Preclinical Microbiology
Preclinical microbiology was conducted per Guidance for Industry and FDA Staff -Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) issued on July 27, 2005 and demonstrate that the subject device in its final, manufactured form, does not:
- Enhance the growth of Staphylococcus aureus
- Increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1)
- Alter the growth of the normal vaginal microflora
The results of the non-clinical testing were acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The full name reads "U.S. Food & Drug Administration".
October 22, 2021
Cotton High Tech S.L. Míriam Carrero Quality Technician Colònia La Rabeia, S/N Balsareny, Barcelona 08660 Spain
Re: K211775
Trade/Device Name: COHITECH Organic Cotton Non-Applicator Cottonlock Tampons Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: September 17, 2021 Received: September 20, 2021
Dear Míriam Carrero:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211775
Device Name
COHITECH Organic Cotton Non-Applicator Cottonlock Tampons
Indications for Use (Describe)
COHITECH Organic Cotton Non-Applicator Cottonlock Tampons (light, regular, super, and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for COHITECH, a company named Cotton High Tech S.L. The logo features the company name in bold, black letters at the top, with the full name in smaller, gray letters underneath. Below the text is a blue circle with a white center, creating a ring shape.
SECTION 5: 510(k) SUMMARY
510(k) Summary
| SUBMITTER NAME: | Cotton High Tech S.L. |
|---|---|
| SUBMITTER ADDRESS: | Colònia La Rabeia, s/n |
| 08660 | |
| Balsareny | |
| Barcelona | |
| Spain | |
| PHONE: | + 34 93 839 16 28 |
| FAX: | + 34 93 839 19 44 |
| CONTACT: | Míriam Carrero |
| Quality Technician | |
| e-mail: | mcarrero@cohitech.net |
| Summary Preparation Date: | 10/18/2021 |
| DEVICE TRADE NAME: | COHITECH Organic Cotton Non- |
| Applicator Cottonlock Tampons | |
| COMMON/USUAL NAME: | Menstrual Tampon |
| REGLATION NUMBER: | 21 CFR 884.5470 |
| REGULATION NAME: | Unscented Menstrual Tampon |
| PRODUCT CODE: | HEB (Unscented Menstrual Tampon |
| REGULATORY CLASS: | II |
PREDICATE DEVICE
Legally Marketed Equivalent Device
| Company | Device name | Code | 510k# |
|---|---|---|---|
| Cotton High Tech S.L. | Cohitech Non Applicator Organic Cotton Tampons | ||
| Cohitech Compact Applicator Organic Cotton | |||
| Tampons | HEB | K152284 |
The predicate device has not been subject to a design-related recall.
DEVICE DESCRIPTION:
The subject device is a conventional unscented menstrual tampon consisting of an organic cotton absorbent pledget ("absorbent core"), completely surrounded by an organic cotton cover ("security veil") and with an organic cotton string ("withdrawal cord"). These tampons will be provided on four absorbencies: light (6g and under), regular (6-9g), super (9-12g) and super plus (12-15g).
Each organic cotton non-applicator Cottonlock tampon is wrapped in a cellulose paper individual wrapper and packaged in sealed multi-unit containers for retail sale.
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Image /page/4/Picture/1 description: The image shows the logo for COHITECH Cotton High Tech S.L. The logo features the word "COHITECH" in bold, black letters at the top. Below the company name is the text "Cotton High Tech S.L." in a smaller, gray font. A blue circle with a white center is located below the company information.
SECTION 5: 510(k) SUMMARY
Device trade name COHITECH Organic Cotton Non-Applicator Cottonlock Tampons could be put into the market with various brands.
Additional information can be found in Table 5.1.
INDICATIONS FOR USE:
COHITECH Organic Cotton Non-Applicator Cottonlock Tampons (light, regular, super, and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.
COMPARISON OF INDICATIONS FOR USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
| Description | Subject Device | Predicate Device |
|---|---|---|
| Device Name | COHITECH Organic Cotton Non- | |
| Applicator Cottonlock Tampons | COHITECH Non Applicator Organic | |
| Cotton Tampons | ||
| Manufacturer/ | ||
| Applicant | Cotton High Tech S.L. | Cotton High Tech S.L. |
| K Number | K211775 | K152284 |
| Product Code | HEB | HEB |
| Regulation Number | 884.5470 | 884.5470 |
| Indications for Use | COHITECH Organic Cotton Non- | |
| Applicator Cottonlock Tampons | ||
| (light, regular, super, and super plus | ||
| absorbencies) are inserted into the | ||
| vagina and used to | ||
| absorb | ||
| menstrual fluid. | Cohitech Non Applicator Organic | |
| Cotton Tampon and Cohitech | ||
| Compact Applicator Organic Cotton | ||
| Tampon are inserted into the vagina | ||
| and used to absorb menstrual fluid. | ||
| Design | Cylindrical Shape | Cylindrical Shape |
| Material composition | ||
| Tampon | 100% without Chlorine (CI) | |
| bleached organic cotton fibers | ||
| With smooth nonwoven organic | ||
| cotton cover (security veil) | 100% without Chlorine (CI) bleached | |
| organic cotton fibers | ||
| With or without smooth nonwoven | ||
| PE/PET cover | ||
| Withdrawal cord | Organic Cotton | Organic Cotton |
| Packaging | Wrapping foil, cellulose paper | Wrapping foil, polypropylene |
| Device specifications - LIGHT | ||
| Length | 36 - 41 mm | N/A |
| Diameter | 11 – 14 mm | N/A |
| Absorbency | 6 g and under | N/A |
| Tampon weight | With wrapping: 1.5 g - 2.3 g | |
| Without wrapping: 1.3 g - 2.1 g | N/A | |
| Absorbent core | ||
| weight | 0.3g – 1.1 g | N/A |
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Image /page/5/Picture/1 description: The image shows the logo for COHITECH, a company named Cotton High Tech S.L. The logo features the company name in bold, black letters at the top, with the full name in smaller, gray letters underneath. Below the name is a blue circle with a white center, resembling a ring or a stylized letter 'O'.
SECTION 5: 510(k) SUMMARY
| Device specifications - REGULAR | ||
|---|---|---|
| Length | 40 - 45 mm | 43-46 mm |
| Diameter | 12 - 15 mm | 12 - 13mm |
| Absorbency | 6-9 g | 6-9 g |
| Tampon weight | With wrapping: 1.8g - 2.8g | |
| Without wrapping: 1.5g - 2.5g | With wrapping: 2.2-3.2g | |
| Without wrapping: 2.1-3.1g | ||
| Absorbent core weight | 0.4g - 1.4 g | 1.90 - 2.90 g |
| Device specifications - SUPER | ||
| Length | 48 - 53 mm | 48 – 51 mm |
| Diameter | 12 - 15 mm | 12 - 13 mm |
| Absorbency | 9-12 g | 9-12 g |
| Tampon weight | With wrapping: 2.6 g - 3.6 g | |
| Without wrapping: 2.3 g - 3.3 g | With wrapping: 2.5 g - 3.5 g | |
| Without wrapping: 2.4 g - 3.4 g | ||
| Absorbent core weight | 1.0g - 2.0 g | 2.2g - 3.2 g |
| Device specifications - SUPER PLUS | ||
| Length | 50 - 55 mm | 48 – 51 mm |
| Diameter | 15 – 18 mm | 14 - 15 mm |
| Absorbency | 12-15 g | 12 -15 g |
| Tampon weight | With wrapping: 3.6 g – 4.6 g | |
| Without wrapping: 3.3 g - 4.3 g | With wrapping: 3.5 g - 4.5 g | |
| Without wrapping: 3.4 g - 4.4 g | ||
| Absorbent core weight | 2.0 g - 3.0 g | 3.2g - 4.2 g |
Table 5.1 - Comparison of indications for use and technological characteristics
COHITECH Organic Cotton Non-Applicator Cottonlock Tampons are similar to the predicate device "COHITECH Non Applicator Organic Cotton Tampons" in terms of overall design. Both the predicate and the subject device have the same cylindricalshaped ribbon of absorbent fibers asymmetrically folded, rolled and compressed and a string ("withdrawal cord") looped around the rectangular ribbon.
The materials of the pledget ("absorbent core") and the string ("withdrawal cord") of both subject and predicate devices are the same (organic cotton) and they both include regular, super, and super plus absorbencies. The subject device includes a light absorbency while the predicate device does not. The difference in absorbency levels does not raise different questions of safety and effectiveness.
The differences in technological characteristics between the subject and the predicate devices include their weight, dimensions, nonwoven (security veil) material and packaging
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Image /page/6/Picture/1 description: The image shows a logo for a company called "COHITECH Cotton High Tech S.L.". The company name is written in black, with "COHITECH" in a larger font size than "Cotton High Tech S.L.". Below the company name is a blue circle with a white center. The logo is simple and modern, and the colors are clean and professional.
SECTION 5: 510(k) SUMMARY
materials. However, these differences do not raise different questions of safety and effectiveness.
SUMMARY DISCUSSION OF NON-CLINICAL DATA
Biocompatibility
Biocompatibility studies were performed in accordance with the 2020 FDA guidance Use of International Standard ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and standard ISO 10993-1:
- Cytotoxicity (ISO 10993-5:2009) o
- Vaqinal Irritation (ISO 10993-10:2010) o
- Delayed Hypersensitivity (ISO 10993-10:2010) O
- Acute Systemic Toxicity (ISO 10993-11:2017) O
The following performance characteristics were assessed in accordance with the Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) issued on July 27, 2005:
- Absorbency (Syngyna testing per 21 CFR 801.430(f)(2)) O
- Chemical residues O
- Tampon integrity O
- String strength O
- Fiber shedding O
- Dimensional analysis O
- Preclinical Microbiology O
Preclinical Microbiology
Preclinical microbiology was conducted per Guidance for Industry and FDA Staff -Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) issued on July 27, 2005 and demonstrate that the subject device in its final, manufactured form, does not:
- Enhance the growth of Staphylococcus aureus o
- Increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1) O
- Alter the growth of the normal vaginal microflora O
The results of the non-clinical testing were acceptable.
CONCLUSIONS:
The results of the non-clinical testing described above demonstrate that COHITECH Organic Cotton Non-Applicator Cottonlock Tampons are substantially equivalent to the predicate device.