(341 days)
K# 061486
Not Found
No
The device description and intended use clearly describe a conventional menstrual tampon made of cotton, with no mention of any computational or data-driven features that would indicate the presence of AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is described as a "menstrual tampon for the absorption of menstrual fluid," which is a personal hygiene product, not a device intended for treating or preventing disease or for use in therapy.
No
The provided text describes menstrual tampons for the absorption of menstrual fluid, which are not used for diagnosing medical conditions.
No
The device description clearly states it is a physical tampon made of cotton, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the absorption of menstrual fluid." This is a physical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical product (tampon) designed for absorption. There is no mention of reagents, analysis of biological samples, or any diagnostic purpose.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the Cottons Ltd, 100% Cotton Tampons are a medical device, but they fall under a different classification than In Vitro Diagnostics. They are a Class II medical device intended for menstrual fluid absorption.
N/A
Intended Use / Indications for Use
Cottons Ltd, 100% Cotton Tampons are unscented, digital and applicator menstrual tampons for the absorption of menstrual fluid.
Product codes (comma separated list FDA assigned to the subject device)
HEB
Device Description
The device is a 100% cotton, conventional unscented menstrual tampon. The device consists of a 100% cotton pledget, a withdrawal cord, with and without an applicator. Three absorbencies are offered as shown above.
The cotton absorbent pledget consists of a pad of 100% cotton compressed into the traditional bullet shape. The absorbent pledget is overwrapped with cellophane. A cotton withdrawal cord is sewn to the pad.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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, PMN K# 061486
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
K080733
Confidential Cottons Ltd, 100% Cotton Tampons 510(k)
Chapter 1 - 510(k) Summary
Submitted by:
Richard Arbon Cottons Pty, Ltd., 66-72 Mercedes Dr. Thomastown, Victoria 3074 Australia 61 3 9465 5033 (phone) 61 3 9465-5044 (fax)
Contact Person:
Robert Seiple Bentley Biomedical Consulting, LLC 3817 Seville Rd Denton, TX 76205-8409 (940) 390-0961 (phone) E-Mail: rseiple@bentleybiomed.com
Date Prepared: Device Name: Trade Name: Common Name: Classification Name: Device Class: Product code: CFR Reference: Predicate Devices:
February 28, 2008
Digital & Applicator Menstrual Tampons
Cottons 100% Natural Cotton Tampons
Unscented menstrual tampons
Unscented menstrual tampon
II
HEB
21 CFR 884.5470
Tampax® Tampons, PMN K# 061486
Bentley Biomedical Consulting, LLC
Page 10 of 26
Confidential
28241 Crown Valley Pkwy, Ste 510, Laguna Niguel, CA 92677 (tel) 561-308-7267 (fax) 949-454-8019
1
Confidential Cottons Ltd, 100% Cotton Tampons 510(k)
SUMMARY REPORT - continued
Device Description and Intended Use:
Cottons Ltd Digital (non applicator) 100% Cotton Tampons
| Absorbencies: | - Regular | 6-9 gms |
|---|---|---|
| - Super | 9-12 gms | |
| - Super Plus | 12-15 gms |
Cottons Ltd Applicator 100% Cotton Tampons
| Absorbencies: | - Regular | 6-9 gms |
|---|---|---|
| - Super | 9-12 gms | |
| - Super Plus | 12-15 gms |
Component Materials (including additives):
Cottons Ltd 100% Cotton Tampons are constructed from 100% natural cotton which is not chlorine bleached and is chemical free (no additives, no fragrances)
The device is a 100% cotton, conventional unscented menstrual tampon. The device consists of a 100% cotton pledget, a withdrawal cord, with and without an applicator. Three absorbencies are offered as shown above.
The cotton absorbent pledget consists of a pad of 100% cotton compressed into the traditional bullet shape. The absorbent pledget is overwrapped with cellophane. A cotton withdrawal cord is sewn to the pad.
Absorbency ranges - both digital and applicator tampons
| Regular | (--) |
|---|---|
| r | gms |
| Class Comments of Concessione Comments of Concessione Comments of Concessione Comments of Concessione Comments of Concessione Commentarial Commental Commental Commental Comme | 0 10 |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
- Super 9-12 gms
- Super Plus 12-15 gms
Bentley Biomedical Consulting, LLC
Page 11 of 26
Confidential
28241 Crown Valley Pkwy, Ste 510, Lagima Niguel, CA 92677 (tel) 561-308-7267 (fax) 949-454-8019
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2009
Cottons Ptv., Ltd. c/o Robert Seiple, RAC Consultant Bentley Biomedical Consulting, LLC 3817 Seville Road DENTON TX 76205-8409
K080733 Re:
Trade/Device Name: Cottons Ltd., 100% Cotton Tampons Regulation Number: 21 CFR §884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: February 11, 2009 Received: February 12, 2009
Dear Mr. Seiple:
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, subjectio the general controls prosissions 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 such 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.
3
Page 2
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 cievice on our labeling regulation (21 CFR Part 801); please contact the Office of Compliance at one of the following numbers, based on the regulation namber 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, 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.suppor/index.html.
Sincerely yours,
Ramona B. Morris
anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Image /page/4/Picture/0 description: The image shows the word "cottons" in a stylized font, with a cotton boll graphic replacing the second "t". Below the word "cottons" is the phrase "be natural" in a smaller, simpler font. The text and graphic are black and white. The overall design is simple and clean, suggesting a natural or organic theme.
Image /page/4/Picture/1 description: The image shows the logo for "Comforts by Cottons". The word "Comforts" is written in a stylized font, with a design to the left of the word. Below the word "Comforts" is the phrase "by Cottons" in a smaller font.
Confidential
Chapter 3 - Indications for Use
510(k) Number (if known): K_080733
Cottons Ltd., 100% Cotton Tampons Device Name:
Indications for Use:
Cottons Ltd, 100% Cotton Tampons are unscented, digital and applicator menstrual tampons for the absorption of menstrual fluid.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal and Radiological Devices | Page 1 of 1 |
| 510(k) Number | K080733 |
Bentley Biomedical Consulting, LLC
Page 1 of 1
Confidential
28241 Crown Valley Pkwy, Sto 510, Laguna Niguel, CA 92677