(64 days)
The Unscented Interiabial Menstrual Pad can be wom 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 device has 3 primary components: 1. The permeable topsheet allows fluid to pass through into the core. 2. The absorbent core acquires and stores the fluid. 3. The impermeable backsheet prevents fluid transfer beyond the core. The absorbent core is held in place between the topsheet and backshoet, which are bonded at the perimeter to form an ovoid trilaminate structure. A tab formed from 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,
The provided text describes a 510(k) submission for an Unscented Interlabial Menstrual Pad, not an AI-powered device or a study with defined acceptance criteria in the manner typically associated with medical device performance studies for diagnostic or treatment technologies. Therefore, I cannot extract the information requested in points 1-9 as they pertain to such studies.
The document discusses non-clinical and clinical performance in the context of demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway than proving performance against specific quantitative acceptance criteria for an AI-driven medical device.
However, I can extract the relevant information regarding the performance and studies mentioned for this specific product:
Acceptance Criteria and Device Performance (as interpreted from the document's context):
The document does not explicitly state quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI device. Instead, the performance evaluations aim to demonstrate safety and effectiveness for its intended use, and substantial equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: | |
| - Microbiological stability of product materials | Microbiological (in vitro) testing of the backsheet material and of the whole product confirmed the microbiological stability of the product. |
| - Stability of backsheet material | Analytical testing of the backsheet material confirmed the stability of the backsheet. |
| - Absence of adverse dermatological effects | Under the conditions of the study, the results of Cumulative Irritation and Sensitization tests of components showed that the materials used do not have any adverse dermatological effects. |
| - No negative impact on vulvar skin or microflora | A clinical study using the whole product indicated that this interlabial pad had no negative impact on vulvar skin or on vulvar and vaginal microflora. |
| - Minimal and non-medically-significant complaints | A small percentage of users reported minor complaints related to discomfort (itching, chafing, etc.), none of which required medical intervention. |
| Effectiveness (Implied): | |
| - Ability to absorb fluids | The device is designed to absorb fluids emanating from the female urogenital region. Its ability to absorb fluid is based on an absorbent fiber core, similar to predicate devices. Intended uses include absorption of menstrual or other vaginal discharge and slight urine loss. |
| - Consumer satisfaction | Consumer preference testing showed a high level of satisfaction among women who used the product. |
| - Substantial equivalence to predicate devices | The results of preclinical and clinical testing demonstrate that it is safe for its intended uses, and that it is substantially equivalent to the cited predicate devices with regard to safety and effectiveness. (Predicate devices: Fresh 'n Fit Padette®, K881384; Always® Unscented Pantiliners, K844601) |
Information Not Applicable or Not Provided in the Given Text (for AI/diagnostic studies):
The following points are not applicable to this 510(k) submission for an interlabial menstrual pad or the provided text does not contain the information required for these points, which are typically relevant for AI/diagnostic medical devices:
- Sample size used for the test set and the data provenance: Sample sizes for irritation/sensitization tests and the clinical study are not specified. Data provenance (country of origin, retrospective/prospective) is not detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a menstrual pad's safety and performance involves clinical observation, laboratory testing, and user feedback, not expert consensus on diagnostic imaging or signals.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance for tasks like image interpretation.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithmic device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for safety involved laboratory analyses (microbiological, analytical), clinical observations (dermatological effects, vulvar health), and user reports. For effectiveness, it included absorption capability inherently and user satisfaction.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
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FEB 1 4 2000
| Page - 1 - 1 | . 510(k) Summary | |
|---|---|---|
| we for the most of the country of the country of the county of |
Submitted by: The Procter & Gamble Company 6100 Center Hill Avenue Cincinnati, OH 45240
Contact Person: Mark M. Anderson, Regulatory Affairs Manager (513) 634-5196 (voice) (513) 634-7364 (FAX)
Date Summary Prepared: November 11, 1999
| Trade Name: | Unscented Interlabial Menstrual Pad |
|---|---|
| ------------- | ------------------------------------- |
Common Name: Interlabial Pad
Classification Name: Unscented Menstrual Pad (per 21 CFR 884.5435)
-
Predicate Devices: Fresh 'n Fit Padette®, Xtramedics, Inc., K881384 Always® Unscented Pantiliners, Procter & Gamble, K844601
Device Description: The 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 backshoet, which are bonded at the perimeter to form an ovoid trilaminate structure. A tab formed from 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 both predicate devices. The trilaminate structure of the device is similar to the laminate structure of the Always® Pantiliner predicate device. The familiate studeure of the larger of the
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characteristics of the device are similar to those of the Fresh 'n Fit Padette® predicate device.
- Non-Clinical Performance: Microbiological (in vitro) testing of the backsheet material and of the whole product confirmed the microbiological stability of the product. Analytical testing of the backsheet material confirmed the stability of the backsheet.
- Under the conditions of the study the results of Clinical Performance: Cumulative Irritation and Sensitization tests of components of the interlabial pad showed that the materials used in the product do not have any adverse dermatological effects. A clinical study using the whole product indicated that this interlabial pad had no negative impact on vulvar skin or on vulvar and vaginal microflora. Consumer preference testing showed a high level of satisfaction among women who used the product. A small percentage of users reported minor complaints related to discomfort (itching, chafing, etc.), none of which required medical intervention.
- The results of the preclinical and clinical testing of this device Conclusions: demonstrate that it is safe for its intended uses, and that it is substantially equivalent to the cited predicate devices with regard to safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
FEB 1 4 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mark M. Anderson, Ph.D. Regulatory Affairs Manager Procter & Gamble Winton Hill Technical Center 6100 Center Hill Avenue Cincinnati, OH 45224-1788
Re: K993870 Unscented Interlabial Menstrual Pad Regulatory Class: I 21 CFR §884.5435/Procode: 85 HHD Dated: November 11, 1999 Received: November 15, 1999
Dear Dr. Anderson:
This letter corrects our substantially equivalent letter of January 18, 2000, regarding the change in the trade name.
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predically of the middling for the middling for use prior to May 28, 1976, the enactment date of the Medical In microsiate comments or to devices that have been rcclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, thereforc, 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 (Premarket Approval) it may be subject to such additional controls) or class III
offectives and affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulation regulation regulation regulation regulation regulation regulation regulation regul action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Dr. Mark Anderson
This letter will allow you to continue 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-1639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely yours,
CAPT Daniel G. Schultz, M.D.
Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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3._Statement of Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Unscented Interlabial Menstrual Pad
Indications for Use:
The Unscented Interiabial Menstrual Pad can be wom 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.
(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 ✓ |
|---|---|---|
| --------------------------------------- | ---- | ------------------------------------------------------------------------------------------------------------------------------------------ |
| (Division Sign-Off) | (Optional Format 1-2-96) | |
|---|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | Page 3.1 | |
| 510(k) Number | K993870 |
§ 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.