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.
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.
The provided text describes a 510(k) submission for the Maxim Hygiene Organically Grown Cotton Tampon. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study involving human subjects or AI algorithms. As such, many of the requested elements for an AI/device performance study are not applicable.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on physicochemical properties and dimensions matching those of predicate devices. The "reported device performance" is effectively the measured values for the Maxim Hygiene tampon, which are shown to be within the ranges of the predicate devices.
| Parameters | Acceptance Criteria (Predicate Devices' Range) | Maxim Hygiene Products (Reported Performance) |
|---|---|---|
| Applicator Tampon Super with Crown End | ||
| Total Weight | 5.0-5.9g | 5.0-5.9g |
| Weight without applicator | 2.7-3.2g | 2.7-3.2g |
| Withdrawal Cord | 115-175 mm | 115-175 mm |
| Length with Applicator | 120-125 mm | 120-125 mm |
| Length without Applicator | 45-50 mm | 45-50 mm |
| Diameter with Applicator | 15.9-16.1g | 15.9-16.1g |
| Diameter without Applicator | 14.2-15.7g | 14.2-15.7g |
| Syngina Absorption | 9.0-12.0g | 9.0-12.0g |
| Wadding Material | 100% organic cotton | 100% organic cotton |
| Non Woven Material | 100% organic cotton | 100% organic cotton |
| Withdrawal Cord Material | 100% organic cotton | 100% organic cotton |
| Applicator Material | Cardboard | Cardboard |
| Digital Tampon Regular | ||
| Weight with Single Packaging | 2.1-2.5g | 2.1-2.5g |
| Weight Tampon | 2.0-2.4g | 2.0-2.4g |
| Length with Single Packaging | 42-26 mm | 42-26 mm |
| Diameter with Single Packaging | 11.8-12.2 mm | 11.8-12.2 mm |
| Withdrawal Cord | 130-160 mm | 130-160 mm |
| Syngina Absorption | 6.0-9.0g | 6.0-9.0g |
| Wadding Material | 100% organic cotton | 100% organic cotton |
| Withdrawal Cord Material | 100% organic cotton | 100% organic cotton |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI or clinical study. The testing performed ("Determination of Absorbency Rate of Tampons - Syngina Test", "Expulsion Force Applicator Tampons", "Fiber Loss ATS Testing Method", "Stability Check on Digital Tampons") would have involved a sample of tampons for physical and absorption testing. The sample size for these specific tests is not provided.
Data provenance is not applicable in the sense of patient data; it refers to the physical tampons manufactured by Maxim Hygiene.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as there is no "ground truth" derived from expert review in this type of submission. The ground truth for physical properties is derived from standardized testing methods.
4. Adjudication method for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device for menstrual fluid absorption, not a diagnostic AI device requiring human reader performance studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used
The "ground truth" for this device is based on physical and chemical properties measured against established standards and validated by comparison to legally marketed predicate devices. This includes:
- Syngina Absorption: A standardized laboratory test to measure absorbency.
- Dimensions and Weight: Direct physical measurements.
- Material Composition: Stated as 100% organic cotton, assumed to be verified through material analysis.
- Biocompatibility: Demonstrated by reference to predicate devices (K983478 and K914430), implying that the materials used are biocompatible as per those previous clearances.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
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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.
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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 HygieneProducts | Organic Essentials | Bodywise |
|---|---|---|---|
| 510(k) Number | K983478 | K914430 | |
| Intended UseStatement | Maxim HygieneOrganically GrownCotton Tampon is atampon that isinserted into thevagina and used toabsorb menstrualfluid.The intended use ofthe organic cottontampon is the same asall other products thatare legally marketed. | Organic EssentialsOrganically GrownCotton Tampon is atampon that isinserted into thevagina and used toabsorb menstrualfluid.The intended use ofthe organic cottontampon is the same asall other products thatare legally marketed. | NatracareTampon is atampon that isinserted into thevagina and usedto absorbmenstrual fluid.The intended useof the organiccotton tampon isthe same as allother productsthat are legallymarketed. |
| Applicator TamponSuper with CrownEnd | |||
| Dimensions | |||
| Total Weight | 5,0-5,9g | 5,0-5,9g | 5,0-5,9g |
| Weight withoutapplicator | 2,7-3,2g | 2,7-3,2g | 2,7-3,2g |
| Withdrawal Cord | 115-175 mm | 115-175 mm | 115-175 mm |
| Length withApplicator | 120-125 mm | 120-125 mm | 120-125 mm |
Applicator Tampon Super with Crown End
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| Length withoutApplicator | 45-50 mm | 45-50 mm | 45-50 mm |
|---|---|---|---|
| Diameter withApplicator | 15,9-16,1g | 15,9-16,1g | 15,9-16,1g |
| Diameter withoutApplicator | 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% organiccotton |
| Non Woven | 100% organic cotton | 100% organic cotton | 100% organiccotton |
| Withdrawal Cord | 100% organic cotton | 100% organic cotton | 100% organiccotton |
| Applicator | Cardboard | Cardboard | Cardboard |
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| Parameters | Maxim HygieneProducts | Organic Essentials | Bodywise |
|---|---|---|---|
| 510(k) Number | K983478 | K914430 | |
| Intended UseStatement | Maxim HygieneOrganically GrownCotton Tampon is atampon that isinserted into thevagina and used toabsorb menstrualfluid.The intended use ofthe organic cottontampon is the same asall other products thatare legally marketed. | Organic EssentialsOrganically GrownCotton Tampon is atampon that isinserted into thevagina and used toabsorb menstrualfluid.The intended use ofthe organic cottontampon is the same asall other products thatare legally marketed. | NatracareTampon is atampon that isinserted into thevagina and usedto absorbmenstrual fluid.The intended useof the organiccotton tampon isthe same as allother productsthat are legallymarketed. |
| Digital TamponRegularDimensions | |||
| Weight with SinglePackaging | 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 SinglePackaging | 42-26 mm | 42-26 mm | 42-26 mm |
| Diameter with SinglePackaging | 11,8-12,2 mm | 11,8-12,2 mm | 11,8-12,2 mm |
Digital Tampons Regular
.
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| 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% organiccotton |
| Withdrawal Cord | 100% organic cotton | 100% organic cotton | 100% organiccotton |
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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,
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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
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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
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(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 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).