The device is a single use vaginal pessary, inserted into the vagina, by the user, using a tampon-like applicator. The device is composed of a high density polyethylene core, a nonwoven overwrap, and a withdrawal cord. The overwrap helps to facilitate ease of insertion and removal. The device is removed by a withdrawal cord made from tampon withdrawal cord material. Upon removal, the device is disposed of in a trash receptacle. The pessary is a single-use device. It is designed for daily use up to 12 hours in 24 hours. The device is available in one size and is sold over-the-counter.

AI/ML Overview

This document details the premarket notification for the "Always/Tampax bladder supports" device. However, it does not contain information about the acceptance criteria or a study proving the device meets specific performance acceptance criteria related to its primary function of managing stress urinary incontinence (SUI).

Instead, the document focuses on:

Substantial Equivalence: Demonstrating that the device is substantially equivalent to a legally marketed predicate device (Improve Bladder Supports/TIPI OTC K131198). This is the primary goal of a 510(k) submission.
Safety and Efficacy Studies: Two clinical studies (a safety study and an efficacy and safety study) were conducted to support the device's safety and effectiveness. However, these studies evaluated the device's performance in general terms (e.g., well-tolerated, minimal effect on vaginal wall, statistically significant and clinically meaningful improvement in symptoms, able to self-administer appropriately) rather than against specific, quantifiable performance acceptance criteria for SUI management.
Non-Clinical Tests: These tests focused on design verification (e.g., applicator force, withdrawal cord strength, core stiffness, dimensions) and biocompatibility (cytotoxicity, sensitization, irritation, genotoxicity, systemic toxicity, local effects after implantation, TSS risk). These are about the device's physical and biological properties.
Label Comprehension and Self-Selection: A study to ensure users understand the labeling and can self-select the product appropriately for an OTC device.

Therefore, many of the requested items cannot be answered directly from the provided text as the information is not present in the content.

Based on the provided text, here is what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, the document does not explicitly define specific, quantitative acceptance criteria for the device's performance related to SUI management (e.g., "reduce SUI episodes by X%" or "reduce pad weight by Yg"). The clinical studies conclude that the device was effective and safe, and provided a "statistically significant and clinically meaningful improvement" in SUI symptoms and pad weight gain, but without defining a specific benchmark for "improvement" as an acceptance criterion.

The non-clinical tests (e.g., cytotoxicity, withdrawal cord strength) do have implied acceptance criteria (e.g., "non-cytotoxic," "not broken or detached") but these are for device safety and integrity, not the clinical performance in managing SUI.

Acceptance Criteria (Explicitly stated for performance)	Reported Device Performance (Related to SUI management)
Not explicitly defined in terms of SUI management metrics within the provided text for acceptance against a specific threshold.	"statistically significant and clinically meaningful improvement in the symptoms that were most important to each woman, whether it was a reduction in SUI episode frequency, a reduction in pad load, or both."
"Well-tolerated" / "Safe"	"device was well-tolerated, with no serious AEs." "majority of the AEs that were observed were 'mild' and spontaneously resolved." "minimal effect on the vaginal wall and surrounding structures."
"Appropriate self-administration"	"women were able to appropriately... self-administer the device."

2. Sample Size Used for the Test Set and Data Provenance

Efficacy and Safety Study (Clinical Tests):
- Sample Size: Not explicitly stated. The text mentions it was a "single-arm, open label, multi-center, 4-week efficacy study."
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies were "multi-center." They are prospective as they are described as "studies performed" to evaluate the device.
Safety Study (Clinical Tests):
- Sample Size: Not explicitly stated. Described as "A randomized, 2-arm (pad control), single-blind (vaginal examiner), multi-center, 3-month safety study."
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies were "multi-center." They are prospective.
Label Comprehension and Self-Selection Study:
- Sample Size: Not explicitly stated. It describes "Three cohorts were tested: 1) A population of women... ages 18 and older; 2) A population of women... ages 18 and older with low literacy; 3) A population of women... ages 65 and older."
- Data Provenance: Not explicitly stated (e.g., country of origin). Likely prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document for any of the clinical studies. The clinical studies evaluated patient-reported outcomes (SUI episode frequency, pad weight gain) and physician observations (vaginal examinations), but there is no mention of "ground truth" being established by a panel of experts. The safety study explicitly mentions a "single-blind (vaginal examiner)," implying a single expert for certain assessments in that study, but their qualifications are not provided.

4. Adjudication Method for the Test Set

This information is not provided in the document. The studies are described as clinical trials with various designs (randomized, single-blind, open label), but no details on adjudication processes for outcomes are mentioned.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical, over-the-counter vaginal pessary for SUI management, not an AI-based diagnostic or assistive software. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this is not applicable. As mentioned above, the device is a physical medical device, not an algorithm or AI software. There is no algorithm to perform in a standalone capacity.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the clinical efficacy study, the "ground truth" or primary outcome measures appear to be patient-reported outcomes data (SUI episode frequency, reduction in pad weight gain) and possibly clinical observation data from vaginal examinations.
For the safety study, the "ground truth" or outcome measures were adverse events, physical examinations, visual vaginal examinations, clean catch urine collection, and vaginal swabbing.
For the non-clinical tests (e.g., biocompatibility), the ground truth is derived from standardized test methods and their defined pass/fail criteria (e.g., ISO standards, specific observable reactions). For example, "non-cytotoxic" and "non-irritating" serve as the ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set. The clinical studies mentioned are for evaluation of the device itself, not for training an algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, there is no AI/ML algorithm or training set for this device.

Summary

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Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.

Re:

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 18, 2015

Procter & Gamble Lenore Faulhaber Regulatory Affairs Manager 6110 Center Hill Ave. Cincinnati, OH 45224

K151413 Trade/Device Name: Always/Tampax bladder supports Regulation Number: 21 CFR 884.3575 Regulation Name: Vaginal Pessary Regulatory Class: Class II Product Code: HHW Dated: November 19, 2015 Received: November 20, 2015

Dear Lenore Faulhaber,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151413

Device Name Always/Tampax bladder supports

Indications for Use (Describe) For the temporary management of stress urinary incontinence in women

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K151413

Submitter

The Procter & Gamble Company 6110 Center Hill Avenue Cincinnati, OH 45224

Contact Person

Lenore Faulhaber, Ph.D., M.B.A. Regulatory Affairs Manager (513) 634-2466

Date prepared December 11, 2015

Common Name Intravaginal stress incontinence device

Classification Name Vaginal Pessary (21 CFR 884.3575, Product Code HHW)

Proprietary Name Always/Tampax bladder supports

Indications for Use/ Intended Use

For the temporary management of stress urinary incontinence (SUI) in women

Predicate Device

Improve Bladder Supports/TIPI OTC K131198; Manufactured by ConTIPI Ltd.

Device Description

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Comparison Element	510(k) Device	Predicate Tipi OTC [K131198]
Classification Name	Pessary, Vaginal	Pessary, Vaginal
Manufacturer	Procter & Gamble	ConTIPI, Ltd.
Indications for Use	For the temporary managementof stress urinary incontinence(SUI) in women.	For the temporary managementof stress urinary incontinence(SUI) in women.
Intended Population	Any women (18 and older) whohave SUI symptoms	Women 21 years of age or olderwho have SUI
Mode of Action	Increases pressure through theanterior vaginal wall onto theurethra	Tension free, mid-urethralsupport
Wear Time	Up to 12 hours in a 24 hourperiod	Up to 8 hours in a 24 hourperiod
Insertion	Via a tampon-like applicator	Via a tampon-like applicator
Removal	Tampon-like withdrawal cord	Tampon-like withdrawal cord
Single Use?	Yes	Yes
Pessary Core Design	Shaped High DensityPolyethylene core covered by anon-woven overwrap	Soft flexible silicone rubber,multiple armed cores covered bynon-woven mesh
Sizing	Available in one size	Available in multiple sizes
Overwrap	Nonwoven	Nonwoven
Withdrawal Cord	Removal string	Removal string
Applicator	Tampon-like applicator	Tampon-like applicator

Technological Characteristics of Subject Device Compared to Predicate

Summary of Non-Clinical Tests

Design Verification Assessment

Pessary Applicator Force

A quantitative method to measure pessary applicator expulsion using a semi-automated tester to measure tension and compression.

Retraction during Device Removal

Not applicable

Pessary Withdrawal Cord Anchor Strength

This procedure determines the maximum force required to break or detach the pessary withdrawal cord. Reference: Australian / New Zealand Standard (AS 2869-2008)

Removal String Integrity/ String Tensile Testing

Specified string properties (for example, Tensile Strength) are confirmed to meet finished product specifications. Reference Method: ASTM D2256 (1998)

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Stiffness of Core/ Dimension Verification

Specified core properties (dimensions, weight and resin material properties) are confirmed to meet finished product specifications.

Test	Standard	P&G Device	FDARecognitionNumber
Cytotoxicity	ISO 10993-5:2009: Biologicalevaluation of medical devices,Part 5: Tests for in vitrocytotoxicity. 2009-06-01.	Non-cytotoxic	2-153
Sensitization	ISO 10993-10:2010: Biologicalevaluation of medical devices,Part 10: Tests for irritation andskin sensitization. 2010-08-01.	Non-sensitizing	2-174
Vaginal Irritation	ISO 10993-10:2010: Biologicalevaluation of medical devices,Part 10: Tests for irritation andskin sensitization. 2010-08-01.	Non-irritating	2-174
Genotoxicity	N/A	Risk AnalysisApproach	N/A
Acute SystemicToxicity	N/A	Risk AnalysisApproach	N/A
SubchronicSystemic Toxicity	N/A	Risk AnalysisApproach	N/A
Chronic SystemicToxicity	N/A	Risk AnalysisApproach	N/A
Reproductive/DevelopmentalToxicity	N/A	Risk AnalysisApproach	N/A
Carcinogenicity	N/A	Risk AnalysisApproach	N/A
Local Effects afterImplantation	ISO 10993-6:2007: Biologicalevaluation of medical devices,Part 6: Tests for local effectsafter implantation. 2007-04-15.	No evidence ofmicroscopic ormacroscopictissue reaction	2-177

Biocompatibility Assessment

Evaluation of Toxic Shock Syndrome Risk

The pessary was evaluated in vitro to determine if it enhances the growth of Staphylococcus aureus, increases the production of Toxic Shock Syndrome Toxin-1 (TSST-1), or alters the growth of normal vaginal microflora. Under the test conditions, the pessary device did not promote or inhibit either bacterial growth or TSST-1 toxin production.

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Label Comprehension and Self-Selection

The labeling was assessed in a combined self-selection and label comprehension study. The study objectives were to evaluate self-selection and comprehension of targeted communication objectives from the external package labeling and Instructions for Use (IFU) that were different from the predicate device (K131198). Three cohorts were tested: 1) A population of women who may use product based on personal medical history, ages 18 and older; 2) A population of women who may use product based on personal medical history, ages 18 and older with low literacy; 3) A population of women who may use product based on personal medical history, ages 65 and older.

Summary of Clinical Tests

Two clinical studies were performed:

Safety study: A randomized, 2-arm (pad control), single-blind (vaginal examiner), multi-center, 3-month safety study, in which safety was assessed by adverse events and physical examination, visual vaginal examinations, clean catch urine collection and vaginal swabbing at baseline, week 2, week 4, and week 12.
This study showed that the device was well-tolerated, with no serious AEs. The majority of the AEs that were observed were 'mild' and spontaneously resolved. The device showed minimal effect on the vaginal wall and surrounding structures, which is a particularly important finding for postmenopausal women who represented over 70% of the study population. This study shows that the device was well tolerated in, and used appropriately by, women with self-identified SUI.
. Efficacy and safety study: A single-arm, open label, multi-center, 4-week efficacy study (2-week baseline followed by a 2-week treatment period) that assessed the change from baseline for both pad weight gain and SUI episode frequency. A clinically meaningful improvement as a composite of the symptoms that are most relevant to the improved QoL for women was evaluated: 1) SUI episode frequency and 2) pad weight gain. Safety of the pessary was assessed by adverse events, clean catch urine collection and vaginal swabbing.
This study demonstrated that the single-use, disposable pessary was effective for women with SUI, and was safe and comfortable. The data show a statistically significant and clinically meaningful improvement in the symptoms that were most important to each woman, whether it was a reduction in SUI episode frequency, a reduction in pad load, or both. The study also showed that women were able to appropriately self-identify symptoms of SUI and appropriately self- administer the device, which is important for an OTC product.

Conclusion

The differences between Always/Tampax bladder supports and its predicate device do not introduce a new intended use and do not raise new issues of safety and effectiveness. Non

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clinical and clinical testing has demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. Therefore, Always/Tampax bladder supports are substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 884.3575 Vaginal pessary.

(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).