(205 days)
Not Found
No
The device description and performance studies focus on the physical properties and clinical efficacy of a mechanical pessary, with no mention of AI or ML.
Yes.
The device is used for the "temporary management of stress urinary incontinence (SUI) in women," which addresses a medical condition, making it a therapeutic device.
No
Explanation: The device is a vaginal pessary intended for the temporary management of stress urinary incontinence (SUI) and does not perform any diagnostic functions.
No
The device description clearly states it is a physical vaginal pessary made of high-density polyethylene, nonwoven overwrap, and a withdrawal cord. It is a single-use, disposable hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "temporary management of stress urinary incontinence (SUI) in women." This describes a physical intervention to support anatomical structures, not a test performed on a sample from the body to diagnose or monitor a condition.
- Device Description: The device is a physical pessary inserted into the vagina. It does not involve any reagents, instruments, or procedures for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other bodily fluids.
- Detecting or measuring specific substances (analytes).
- Providing diagnostic or monitoring information based on laboratory results.
The device is a physical medical device designed to provide mechanical support for the temporary management of a symptom.
N/A
Intended Use / Indications for Use
For the temporary management of stress urinary incontinence in women
Product codes
HHW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vagina
Indicated Patient Age Range
Any women (18 and older) who have SUI symptoms
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)
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.
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
Not Found
§ 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).
0
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
1
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
2
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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3
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
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.
4
| 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 management | |
| of stress urinary incontinence | ||
| (SUI) in women. | For the temporary management | |
| of stress urinary incontinence | ||
| (SUI) in women. | ||
| Intended Population | Any women (18 and older) who | |
| have SUI symptoms | Women 21 years of age or older | |
| who have SUI | ||
| Mode of Action | Increases pressure through the | |
| anterior vaginal wall onto the | ||
| urethra | Tension free, mid-urethral | |
| support | ||
| Wear Time | Up to 12 hours in a 24 hour | |
| period | Up to 8 hours in a 24 hour | |
| period | ||
| 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 Density | |
| Polyethylene core covered by a | ||
| non-woven overwrap | Soft flexible silicone rubber, | |
| multiple armed cores covered by | ||
| non-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)
5
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 | FDA
Recognition
Number |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------|
| Cytotoxicity | ISO 10993-5:2009: Biological
evaluation of medical devices,
Part 5: Tests for in vitro
cytotoxicity. 2009-06-01. | Non-cytotoxic | 2-153 |
| Sensitization | ISO 10993-10:2010: Biological
evaluation of medical devices,
Part 10: Tests for irritation and
skin sensitization. 2010-08-01. | Non-sensitizing | 2-174 |
| Vaginal Irritation | ISO 10993-10:2010: Biological
evaluation of medical devices,
Part 10: Tests for irritation and
skin sensitization. 2010-08-01. | Non-irritating | 2-174 |
| Genotoxicity | N/A | Risk Analysis
Approach | N/A |
| Acute Systemic
Toxicity | N/A | Risk Analysis
Approach | N/A |
| Subchronic
Systemic Toxicity | N/A | Risk Analysis
Approach | N/A |
| Chronic Systemic
Toxicity | N/A | Risk Analysis
Approach | N/A |
| Reproductive/
Developmental
Toxicity | N/A | Risk Analysis
Approach | N/A |
| Carcinogenicity | N/A | Risk Analysis
Approach | N/A |
| Local Effects after
Implantation | ISO 10993-6:2007: Biological
evaluation of medical devices,
Part 6: Tests for local effects
after implantation. 2007-04-15. | No evidence of
microscopic or
macroscopic
tissue 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.
6
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
7
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.