(114 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological safety of conventional menstrual tampons, with no mention of AI or ML.
No
The device is described as absorbing menstrual fluid, which is a supportive function, not a therapeutic one that treats or prevents a disease.
No
Explanation: The device is described as a menstrual tampon used to absorb menstrual fluid, not to diagnose any medical condition.
No
The device description clearly states it is a physical product (tampons) and the performance studies focus on physical and biological properties, not software performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the tampons are "inserted into the vagina and used to absorb menstrual fluid." This is a physical function within the body, not an examination of a specimen outside the body.
- Intended Use: The intended use is for absorbing menstrual fluid, which is a physiological process, not a diagnostic test.
- Performance Studies: The performance studies listed focus on the physical properties of the tampon (absorbency, strength, integrity, etc.) and its interaction with the vaginal environment (biocompatibility, microbial effects). These are not diagnostic performance metrics.
Therefore, based on the provided information, the Cohitech tampons are not IVD devices. They are considered medical devices, but not in the category of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Cohitech Non Applicator Organic Cotton Tampons and Cohitech Compact Cotton Tampons (regular, super and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.
Product codes
HEB
Device Description
The devices are conventional unscented menstrual tampons consisting of an absorbent pledget, with or without polyethylene/polyester cover and a withdrawal cord. These tampons will be provided as three absorbencies: regular, super and super plus.
Each non applicator organic cotton tampon is wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.
Each compact applicator organic cotton tampon is inserted into a plastic compact applicator and wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.
Device trade names COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS and COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS could be put into the market with various brands. COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS will be marketed with "MAXIM" brand and COMPACT APPLICATOR ORGANIC COTTON TAMPONS will be marketed with "ORGANYC" brand.
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)
The non-clinical performance data provided including the following:
- Biocompatibility Testing cytotoxicity, sensitization, and acute systemic toxicity ●
- Syngyna Absorbency Testing
- Fiber Composition ●
- Withdrawal Cord Strength ●
- Fiber Shedding
- . Expulsion Force
- . Tampon Integrity
- Dimensional analysis
- . Chemical residues
- Preclinical Microbiology, demonstrating that the tampon does not ●
- Enhance the growth of Staphylococcus aureus (S. aureus)
- Increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1)
- Alter the growth of the normal vaginal microflora
- Total Microbial Count (TAMC)
- . Fungal/Yeast/Mold Limits
- Absence of Pathogenic Organisms (Escherichia coli, Pseudomonas aeruginosa, ● Staphylococcus aureus, and Candida albicans)
The results of the non-clinical performance data 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 4, 2015
Cotton High Tech S.L. Anna Garcia Quality Manager Colonia La Rabeia s/n 08660 - Balsareny Barcelona, Spain
Re: K152284
Trade/Device Name: Cohitech Non Applicator Organic Cotton Tampons Cohitech Compact Applicator Organic Cotton Tampons Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: Class II Product Code: HEB Dated: September 3, 2015 Received: September 8, 2015
Dear Anna Garcia,
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 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Joyce M. Whang -S
for
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152284
Device Name
Cohitech Non Applicator Organic Cotton Tampons Cohitech Compact Applicator Organic Cotton Tampons
Indications for Use (Describe)
Cohitech Non Applicator Organic Cotton Tampons and Cohitech Compact Cotton Tampons (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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3
510(k) Summary 807.92(c)
| SUBMITTER NAME: | COTTON HIGH TECH SL |
|---|---|
| SUBMITTER ADDRESS: | Colònia La Rabeia, s/n |
| 08660 Balsareny | |
| BARCELONA | |
| SPAIN | |
| CONTACT: | Anna Garcia |
| Quality Manager | |
| TELEPHONE: | + 34 93 839 16 28 |
| FAX: | + 34 93 839 19 44 |
| e-mail: | agarcia@cohitech.net |
| Summary Preparation Date: | 7/27/2015 |
| DEVICE TRADE NAME: | COHITECH NON APPLICATOR ORGANIC |
| COTTON TAMPONS | |
| COHITECH COMPACT APPLICATOR ORGANIC | |
| COTTON TAMPONS | |
| COMMON NAME: | TAMPON, MENSTRUAL, UNSCENTED |
| CLASSIFICATION NAME: | TAMPON, MENSTRUAL, UNSCENTED |
| (21 CFR 880.5470, Product Code HEB) | |
| DEVICE CLASS: | II |
PREDICATE DEVICE
Legally Marketed Equivalent Device
| Company | Product | 510(k)# |
|---|---|---|
| Personal Products Company | O.b. non applicator tampons | K991118 |
| Cotton High Tech S.L. | Cotton menstrual tampons | K091084 |
DEVICE DESCRIPTION:
The devices are conventional unscented menstrual tampons consisting of an absorbent pledget, with or without polyethylene/polyester cover and a withdrawal cord. These tampons will be provided as three absorbencies: regular, super and super plus.
Each non applicator organic cotton tampon is wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.
Each compact applicator organic cotton tampon is inserted into a plastic compact applicator and wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.
4
Device trade names COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS and COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS could be put into the market with various brands. COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS will be marketed with "MAXIM" brand and COMPACT APPLICATOR ORGANIC COTTON TAMPONS will be marketed with "ORGANYC" brand.
INTENDED USE:
Cohitech non applicator organic cotton tampons and Cohitech compact applicator organic cotton tampons (reqular, super and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.
TECHNOLOGICAL CHARACTERISTICS:
Non applicator organic cotton tampons are similar to the predicate "O.b. non applicator tampons" in terms of overall design and cover composition (when cover it is present). Both the predicate and the subject device have the same cvlindrical-shaped pad of absorbent fibers asymmetrically folded, rolled and compressed; a withdrawal cord looped around the rectangular fiber pad and polyethylene/polyester cover (when it is present).
Non applicator organic cotton tampons are similar to the predicate "Cotton menstrual tampons" in terms of absorbent core and withdrawal cord materials. Both the predicate and the subject device absorbent core and withdrawal cord are made of 100% cotton fibers.
Compact applicator organic cotton tampons are similar to the predicate "O.b. non applicator tampons" in terms of overall design and cover composition (when cover it is present). Both the predicate and the subject device have the same cylindrical-shaped pad of absorbent fibers asymmetrically folded, rolled and compressed; a withdrawal cord looped around the rectangular fiber pad and polvethylene/polvester cover (when it is present).
Compact applicator organic cotton tampons are similar to the predicate "Cotton menstrual tampons" in terms of absorbent core and withdrawal cord materials and how to insert the tampon into the vagina. Both the predicate and the subject device absorbent core and withdrawal cord are made of 100% cotton fibers and are inserted into the vagina with an applicator.
SUMMARY DISCUSSION OF NON-CLINICAL DATA:
The non-clinical performance data provided including the following:
- Biocompatibility Testing cytotoxicity, sensitization, and acute systemic toxicity ●
- Syngyna Absorbency Testing
- Fiber Composition ●
- Withdrawal Cord Strength ●
- Fiber Shedding
- . Expulsion Force
- . Tampon Integrity
- Dimensional analysis
- . Chemical residues
- Preclinical Microbiology, demonstrating that the tampon does not ●
- Enhance the growth of Staphylococcus aureus (S. aureus)
- Increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1)
- Alter the growth of the normal vaginal microflora
- Total Microbial Count (TAMC)
- . Fungal/Yeast/Mold Limits
- Absence of Pathogenic Organisms (Escherichia coli, Pseudomonas aeruginosa, ● Staphylococcus aureus, and Candida albicans)
5
The results of the non-clinical performance data were acceptable.
CONCLUSION:
The COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS and COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS are substantially equivalent to their proposed predicate devices.