(167 days)
Not Found
No
The device description and performance studies do not mention any AI or ML components. The device is a simple mechanical system for douching.
Yes.
The device is intended for the reduction or abatement of perceived vaginal odor, which is addressing a health-related condition. Additionally, the description of clinical trials evaluating its success rate against a control group further indicates its therapeutic intent.
No
The device is indicated for the reduction or abatement of perceived vaginal odor, and its function involves cleaning. It does not identify, assess, or monitor a medical condition.
No
The device description explicitly details physical components (water container, hose, nozzle, hose clamp, plastic loop) and their function, indicating it is a hardware-based medical device.
Based on the provided information, the WaterWorks® Douching Device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The WaterWorks® Douching Device is used to introduce water into the vagina. It does not analyze or test any biological samples.
- The intended use is for reducing perceived vaginal odor and discharge. This is a physical intervention, not a diagnostic test.
- The device description details a physical system for delivering water. It does not involve any reagents, test strips, or analytical components typically found in IVDs.
Therefore, the WaterWorks® Douching Device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The WaterWorks® is indicated for the reduction or abatement of perceived vaginal odor with or without complaints of discharge in women with no infectious cause of vaginitis.
Product codes
HED
Device Description
The Water Works® Douching Device is a reusable system consisting of a customized 32 ounce, water container, connecting hose and a stainless steel nozzle. A hose clamp for controlling water flow through the hose and a plastic loop to attach the container to a shower head are also provided. The container is filled with tepid tap water which flows through the hose to the nozzle. The water container is hung approximately 3 feet above the vagina (eye-level).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
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
A comparative, randomized, and blinded multicenter clinical trial of the Water Works and the predicate device demonstrated that the proportion of subjects in the WaterWorks® Group meeting the success criterion was 78 percent versus a success rate of 38.5 percent for subject in the Control Group. Fisher's exact test comparing the overall success proportions (78.0% for Water Works versus 38.5% for Control) rejects the null hypothesis of no difference at a significance level less that 0.0001. Adverse affects on the vaginal Eco-System were quantified by changes in the lactobacillus score and the Nugent Score according to pre-defined criteria. Results for the WaterWorks Group were similar to that of the Control Group. Other adverse events occurring in both Groups were also similar in nature and frequency.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5900 Therapeutic vaginal douche apparatus.
(a)
Identification. A therapeutic vaginal douche apparatus is a device that is a bag or bottle with tubing and a nozzle. The apparatus does not include douche solutions. The apparatus is intended and labeled for use in the treatment of medical conditions except it is not for contraceptive use. After filling the therapeutic vaginal douche apparatus with a solution, the patient uses the device to direct a stream of solution into the vaginal cavity.(b)
Classification. (1) Class II (performance standards).(2) Class I if the device is operated by gravity feed. Devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
Korozoo
JUL 10 2008
510(k) Summary Abbott Research Group, Inc. WaterWorks® Douching Device
1. SUBMITTER/510(K) HOLDER
Abbott Research Group, Inc. The Abbott Building, 235 Alpha Drive Pittsburgh, PA 15238 Contact: Chun Lim Abbott, President & CEO Phone: 412-426-0053
Date Prepared: January 24, 2008
2. DEVICE NAME
| Proprietary Name: | WaterWorks® Douching Device |
|---|---|
| Common/Usual Name: | Therapeutic Vaginal Douching Apparatus |
| Classification Name: | Douching Apparatus, Vaginal, Therapeutic |
3. PREDICATE DEVICES
Good Health Premium Fountain Style Personal Douche and Enema System
4. DEVICE DESCRIPTION
The Water Works® Douching Device is a reusable system consisting of a customized 32 ounce, water container, connecting hose and a stainless steel nozzle. A hose clamp for controlling water flow through the hose and a plastic loop to attach the container to a shower head are also provided. The container is filled with tepid tap water which flows through the hose to the nozzle. The water container is hung approximately 3 feet above the vagina (eye-level).
5. INTENDED USE
The WaterWorks® is indicated for the reduction or abatement of perceived vaginal odor with or without complaints of discharge in women with no infectious cause of vaginitis.
1
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The WaterWorks® Douching Device is similar in design and method of operation the predicate device, Good Health Premium Fountain Style Personal Douche and Enema System. Both systems are gravity fed and intended to be filled by the user with tap water.
7. PERFORMANCE TESTING
A comparative, randomized, and blinded multicenter clinical trial of the Water Works and the predicate device demonstrated that the proportion of subjects in the WaterWorks® Group meeting the success criterion was 78 percent versus a success rate of 38.5 percent for subject in the Control Group. Fisher's exact test comparing the overall success proportions (78.0% for Water Works versus 38.5% for Control) rejects the null hypothesis of no difference at a significance level less that 0.0001. Adverse affects on the vaginal Eco-System were quantified by changes in the lactobacillus score and the Nugent Score according to pre-defined criteria. Results for the WaterWorks Group were similar to that of the Control Group. Other adverse events occurring in both Groups were also similar in nature and frequency.
2
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" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized lines or waves.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Abbott Research Group, Inc. c/o Rosina Robinson, RN, MEd, RAC Principal Consultant, Regulatory Services Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760
JUL 10 2008
Re: K080200
Trade Name: WaterWork® Douching Device™ Regulation Number: 21 CFR 884.5900 Regulation Name: Therapeutic Vaginal Douche Apparatus Regulatory Class: II Product Code: HED Dated: June 2, 2008 Received: June 3, 2008
Dear Ms. Robinson:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating 1906-2006. The logo features the letters "FDA" in a stylized font, with the word "Centennial" underneath. Three stars are arranged below the word "Centennial". The text "1906-2006" is at the top of the logo.
Protecting and Promoting Public Health
3
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 rcquirements, 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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (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 Manufacturers, 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/cdrh/industry/support/index.html.
Sincerely vours.
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
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Indications for Use
510(k) Number (if known):
Water Works® Douching Device Device Name:
Indications for Use:
The WaterWorks® Douching Device is indicated for the reduction or abatement of perceived vaginal odor with or without complaints of discharge in women with no infectious cause of vaginitis.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use__x (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hal Lum
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number.