(53 days)
Not Found
No
The device description and intended use are for a simple absorbent pad with no mention of AI/ML technology or any computational processing.
No.
The device functions as an absorbent for bodily fluids, rather than preventing, diagnosing, or treating a disease or condition.
No
Explanation: The device is a menstrual pad and its primary function is to absorb fluid. There is no indication that it is used to diagnose any medical condition.
No
The device description clearly outlines physical components (topsheet, absorbent core, backsheet, tab) and their material properties and construction, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is an absorbent pad designed to manage menstrual flow, vaginal discharge, and slight urine loss. It physically absorbs fluids from the body.
- Intended Use: The intended use is for managing bodily fluids externally, not for analyzing them to diagnose a condition.
- Device Description: The components (topsheet, absorbent core, backsheet) are consistent with an absorbent product, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of reagents, test strips, or any mechanism for analyzing the composition of the absorbed fluids.
The device is a personal hygiene product designed for external absorption of bodily fluids.
N/A
Intended Use / Indications for Use
The P&G Miniform #3 Unscented Interlabial Menstrual Pad can be worn any time of the day or night in the following ways:
- Alone for light and medium (menstrual) flow .
- In combination with tampons or pads for extra protection during heavy . (menstrual) flow
- Alone for vaginal discharge or slight urine loss associated with laughs, . coughs, and sneezes.
The P&G Unscented Menstrual Pad can be worn any time of the day or night in the following ways:
- For menstrual flow or other vaginal discharge.
Product codes
85 HHD
Device Description
The interlabial pad device has 3 primary components:
-
- The permeable topsheet allows fluid to pass through into the core.
-
- The absorbent core acquires and stores the fluid.
-
- The impermeable backsheet prevents fluid transfer beyond the core.
The absorbent core is held in place between the topsheet and backsheet, which are bonded at the perimeter to form an ellipse-shaped trilaminate structure. An attached tab glued onto the backsheet extends from the back of the device as an aid for application and removal.
The device will be individually wrapped 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
female urogenital region, labia, exterior of the vagina, introital opening, urethral meatus.
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)
Clinical Performance: The safety profile of the new device is substantially equivalent to the safety profile of the predicate device, based on the results of biocompatibility testing of component materials of the new device and on the results of a clinical safety test of the new device. The predicate device has been available in a limited test market. There have been no skin or health-related consumer comments regarding this product.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 884.5435 Unscented menstrual pad.
(a)
Identification. An unscented menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. This generic type of device includes sterile unscented menstrual pads used for medically indicated conditions, but does not include menstrual pads treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9 only when the device is made of common cellulosic and synthetic material with an established safety profile.
0
OCT - 5 2001
K012629
Page 1 of 2
4. 510(k) Summary
| Submitted by: | The Procter & Gamble Company
6110 Center Hill Avenue
Cincinnati, OH 45224 |
|------------------------|---------------------------------------------------------------------------------------------|
| Contact Person: | Mark M. Anderson, Regulatory Affairs Manager
(513) 634-5196 (voice) (513) 634-7364 (FAX) |
| Date Summary Prepared: | August 9, 2001 |
| Trade Name: | P&G Miniform #3
P&G Unscented Menstrual Pad |
| Common Name: | Interlabial Pad, Miniform |
| Classification Name: | Unscented Menstrual Pad (per 21 CFR 884.5435 |
| Predicate Device: | P&G Miniform #2, K003843 |
The interlabial pad device has 3 primary components: Device Description:
-
- The permeable topsheet allows fluid to pass through into the core.
-
- The absorbent core acquires and stores the fluid.
-
- The impermeable backsheet prevents fluid transfer beyond the core.
The absorbent core is held in place between the topsheet and backsheet, which are bonded at the perimeter to form an ellipse-shaped trilaminate structure. An attached tab glued onto the backsheet extends from the back of the device as an aid for application and removal.
The device will be individually wrapped and packaged in sealed multi-unit containers for retail sale.
- Intended Uses: For absorption of menstrual or other vaginal discharge, and for absorption of slight urine loss associated with light incontinence.
- Technological Characteristics: The device is designed to absorb fluids emanating from the female urogenital region. It is folded in half longitudinally for application, and held in place by the labia (without adhesives) at the exterior of the vagina, covering the introital opening and urethral meatus. The device is removed by urination or may be removed manually.
The device's ability to absorb fluid is based on an absorbent fiber core, and is similar to the absorbent technology of the predicate device. The
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1
K012629
Page 2 of 2
placement, retention and removal characteristics of the device are identical to those of the predicate device.
-
Clinical Performance: The safety profile of the new device is substantially equivalent to the safety profile of the predicate device, based on the results of biocompatibility testing of component materials of the new device and on the results of a clinical safety test of the new device.
The predicate device has been available in a limited test market. There have been no skin or health-related consumer comments regarding this product. -
Conclusions: The similarity of the safety profile of the new device to the predicate device and the lack of negative comments from the predicate device market experience to date indicates that the new device is safe for its intended uses, and that it is substantially equivalent to the cited predicate device with regard to safety and effectiveness.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 5 2001
Mark M. Anderson, Ph.D. Regulatory Affairs Manager Procter & Gamble Company Feminine Care Global Business Unit 6110 Center Hill Avenue CINCINNATI OH 45224
Re: K012629
Trade/Device Name: Always® Duets-Unscented Interlabial Pad (Miniform #3) and Menstrual Pad Regulation Number: 21 CFR 884.5435 Regulation Name: Unscented menstrual pad Regulatory Class: I Product Code: 85 HHD Dated: August 9, 2001 Received: August 13, 2001
Dear Dr. Anderson:
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 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 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.
3
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of 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 If you the office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
. ...........
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
3. Statement of Indications for Use
KD12629 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
P&G Miniform # 3 Unscented Interlabial Menstrual Pad and Device Name: _ P&G Unscented Menstrual Pad
Indications for Use:
The P&G Miniform #3 Unscented Interlabial Menstrual Pad can be worn any time of the day or night in the following ways:
- Alone for light and medium (menstrual) flow .
- In combination with tampons or pads for extra protection during heavy . (menstrual) flow
- Alone for vaginal discharge or slight urine loss associated with laughs, . coughs, and sneezes.
The P&G Unscented Menstrual Pad can be worn any time of the day or night in the following ways:
- For menstrual flow or other vaginal discharge .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use /
Carolyn Y Newland
(Optional Format 1-2-96)
Page 3.1