(15 days)
Not Found
No
The 510(k) summary describes a standard cotton tampon and its performance testing, with no mention of AI or ML technology.
No.
A tampon is used to absorb menstrual fluid, which is a collection device, not a device intended to treat or prevent a disease or condition.
No
The device, a tampon, is used to absorb menstrual fluid, which is a therapeutic or supportive function, not a diagnostic one. It does not identify, monitor, or predict any medical condition.
No
The device description clearly indicates a physical product (tampon) used for absorbing menstrual fluid, not a software application. The performance studies also relate to physical properties of the tampon.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "absorb menstrual fluid" internally. This is a physical function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description focuses on the physical nature and function of a tampon for absorbing menstrual flow.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific substances, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies listed (Absorbency Rate, Expulsion Force, Fiber Loss, Stability) are related to the physical performance and safety of the tampon, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Maxim Hygiene Organically Grown Cotton Tampon is a tampon used to absorb menstrual fluid. The intended use of the organic cotton tampon is the same as all other products that are legally marketed.
Product codes (comma separated list FDA assigned to the subject device)
HEB
Device Description
A tampon is used for internally absorbing menstrual flow during a period. A range of absorbencies are available designed to cope with various menstrual flows which differ not only from woman to woman, but also during a woman's menstrual life and during each period. Typically 80% of fluid is lost in the first two days and some 60 mls. (an egg cup full) to 90 mls. in a full period. This underlines the need for users to change products throughout their period and for manufacturers to offer a wide range of products for their users.
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 following tests were also performed to support substantial equivalence:
- Determination of Absorbency Rate of Tampons = Syngina Test .
- . Expulsion Force Applicator Tampons
- 8 Fiber Loss ATS Testing Method
- Stability Check on Digital Tampons
Key results: Comparison tables show that the Maxim Hygiene Organically Grown Cotton Tampon has identical physical characteristics (dimensions, weight, material composition) and absorption rates (Syngina Absorption) to the predicate devices (Organic Essentials and Natracare tampons).
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.
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
510(k) SUMMARY
JAN 30 2009
November 24, 2008
Company
Contact:
Maxim Hygiene Products 39 Maple Street Roslyn Heights, NY 11577-1941
Tampon, Menstrual, Unscented
Kenneth Alvandi CEO Phone: 516-6212-3323 Fax: 516-621-3312
Device Classification Name:
Proprietary Name:
Maxim Hygiene Organically Grown Cotton Tampon
21 CFR 884.5470
нев
Predicate Device(s):
Regulation Number:
Product Code:
K983478 Organic Essentials Organic Cotton Tampon K914430 Natracare Tampon
11.0 Intended Use:
Maxim Hygiene Organically Grown Cotton Tampon is a tampon used to absorb menstrual fluid.
The intended use of the organic cotton tampon is the same as all other products that are legally marketed.
Product Description 11.1
A tampon is used for internally absorbing menstrual flow during a period. A range of absorbencies are available designed to cope with various menstrual flows which differ not only from woman to woman, but also during a woman's menstrual life and during each period. Typically 80% of fluid is lost in the first two days and some 60 mls. (an egg cup full) to 90 mls. in a full period. This underlines the need for users to change products throughout their period and for manufacturers to offer a wide range of products for their users.
1
Biocompatibility requirements were addressed in K983478 and K914430 based on the fact that Maxim Hygiene's tampons are identical to the cleared devices found in K983478 and K914430.
12.2 Summary of Safety and Effectiveness
The Maxim Hygiene Organically Grown Cotton Tampon based on the following comparisons demonstrate substantial equivalent. The device subject to this review is manufactured by the same manufacturer and is identical to the predicate devices does not raise any new issues as to safety and effectiveness.
The following tests were also performed to support substantial equivalence:
- Determination of Absorbency Rate of Tampons = Syngina Test .
- . Expulsion Force Applicator Tampons
- 8 Fiber Loss ATS Testing Method
- Stability Check on Digital Tampons �
| Parameters | Maxim Hygiene
Products | Organic Essentials | Bodywise |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K983478 | K914430 |
| Intended Use
Statement | Maxim Hygiene
Organically Grown
Cotton Tampon is a
tampon that is
inserted into the
vagina and used to
absorb menstrual
fluid.
The intended use of
the organic cotton
tampon is the same as
all other products that
are legally marketed. | Organic Essentials
Organically Grown
Cotton Tampon is a
tampon that is
inserted into the
vagina and used to
absorb menstrual
fluid.
The intended use of
the organic cotton
tampon is the same as
all other products that
are legally marketed. | Natracare
Tampon is a
tampon that is
inserted into the
vagina and used
to absorb
menstrual fluid.
The intended use
of the organic
cotton tampon is
the same as all
other products
that are legally
marketed. |
| Applicator Tampon
Super with Crown
End | | | |
| Dimensions | | | |
| Total Weight | 5,0-5,9g | 5,0-5,9g | 5,0-5,9g |
| Weight without
applicator | 2,7-3,2g | 2,7-3,2g | 2,7-3,2g |
| Withdrawal Cord | 115-175 mm | 115-175 mm | 115-175 mm |
| Length with
Applicator | 120-125 mm | 120-125 mm | 120-125 mm |
Applicator Tampon Super with Crown End
2
| Length without
| Applicator | 45-50 mm | 45-50 mm | 45-50 mm |
|---|---|---|---|
| Diameter with | |||
| Applicator | 15,9-16,1g | 15,9-16,1g | 15,9-16,1g |
| Diameter without | |||
| Applicator | 14,2-15,7g | 14,2-15,7g | 14,2-15,7g |
| Syngina Absorption | 9,0-12,0g | 9,0-12,0g | 9,0-12,0g |
| Wadding | 100% organic cotton | 100% organic cotton | 100% organic |
| cotton | |||
| Non Woven | 100% organic cotton | 100% organic cotton | 100% organic |
| cotton | |||
| Withdrawal Cord | 100% organic cotton | 100% organic cotton | 100% organic |
| cotton | |||
| Applicator | Cardboard | Cardboard | Cardboard |
· ﺑ
.
/
| Parameters | Maxim Hygiene
Products | Organic Essentials | Bodywise |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K983478 | K914430 |
| Intended Use
Statement | Maxim Hygiene
Organically Grown
Cotton Tampon is a
tampon that is
inserted into the
vagina and used to
absorb menstrual
fluid.
The intended use of
the organic cotton
tampon is the same as
all other products that
are legally marketed. | Organic Essentials
Organically Grown
Cotton Tampon is a
tampon that is
inserted into the
vagina and used to
absorb menstrual
fluid.
The intended use of
the organic cotton
tampon is the same as
all other products that
are legally marketed. | Natracare
Tampon is a
tampon that is
inserted into the
vagina and used
to absorb
menstrual fluid.
The intended use
of the organic
cotton tampon is
the same as all
other products
that are legally
marketed. |
| Digital Tampon
Regular
Dimensions | | | |
| Weight with Single
Packaging | 2,1-2,5g | 2,1-2,5g | 2,1-2,5g |
| Weight Tampon | 2,0-2,4g | 2,0-2,4g | 2,0-2,4g |
| Length with Single
Packaging | 42-26 mm | 42-26 mm | 42-26 mm |
| Diameter with Single
Packaging | 11,8-12,2 mm | 11,8-12,2 mm | 11,8-12,2 mm |
Digital Tampons Regular
.
3
| Withdrawal Cord | 130-160 mm | 130-160 mm | 130-160 mm |
|---|---|---|---|
| Syngina Absorption | 6,0-9,0g | 6,0-9,0g | 6,0-9,0g |
| Wadding | 100% organic cotton | 100% organic cotton | 100% organic |
| cotton | |||
| Withdrawal Cord | 100% organic cotton | 100% organic cotton | 100% organic |
| cotton |
:
:
:
.
. .
1
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4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Maxim Hygiene Products, Inc. c/o Mr. Neil E. Devine, Jr. Sr. Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062
JAN 3 0 2009
Re: K090098
Trade/Device Name: Maxim Hygiene Organically Grown Cotton Tampon Regulation Number: 21 CFR §884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: January 12, 2009 Received: January 15, 2009
Dear Mr. Devine:
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.
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,
5
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 device on our labeling regulation (21 CFR Part 801), please contact the 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" (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/cdrb/industry.suppor/index.html.
Sincerely yours,
anine M. N Acting Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Indications for Use
Kog 009 8 510(k) Number (if known):
Device Name: Maxim Hygiene Organically Grown Cotton Tampon
Indications for Use:
Maxim Hygiene Organically Grown Cotton Tampon is a tampon used to absorb menstrual fluid.
The intended use of the organic cotton tampon is the same as all other products that are legally marketed.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulda Gunn
Page_1 of 2
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X
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number