(64 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on electrical stimulation for neuromuscular reeducation.
Yes
The device is described as providing electrical stimulation and neuromuscular reeducation for the rehabilitation of weak pelvic floor muscles to treat urinary incontinence, which is a therapeutic purpose.
No.
The intended use describes stimulation and re-education for rehabilitation of weak pelvic floor muscles, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states "Non-Implanted Electrical Continence Device, Model InWave," indicating it is a hardware device that provides electrical stimulation.
Based on the provided information, the InWave device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides electrical stimulation and neuromuscular reeducation for the treatment of urinary incontinence. This is a therapeutic intervention applied directly to the patient's body.
- Device Description: The description "Non-Implanted Electrical Continence Device" further reinforces that it's a device used on or in the body, not for testing samples outside the body.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Using reagents or assays
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The InWave device's function is to treat a condition through electrical stimulation, which falls under the category of therapeutic or rehabilitative devices, not IVDs.
N/A
Intended Use / Indications for Use
The InWave is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress urge and mixed urinary incontinence in women.
Product codes
KPI
Device Description
Non-Implanted Electrical Continence Device, Model InWave.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor muscles
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle symbol. The logo is in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 2 4 2012
Mr. Jim Arnold OA Manager Zynex Medical, Inc. 9990 Park Meadows Dr. LONE TREE CO 80124
Re: K121820
Trade/Device Name: Non-Implanted Electrical Continence Device, Model InWave Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI Dated: August 15, 2012 Received: August 15, 2012
Dear Mr. Arnold:
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 10 more 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 your device 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 I lease of as need a determination that your device complies with other requirements of the Act that I Dr has made a avod regulations administered by other Federal agencies. You must of any I cuttated and the Act's requirements, including, but not limited to: registration and listing Comply with an the Pre- Pre (21 CFR Part 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin K. Tuchs
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
Image /page/2/Picture/0 description: The image shows the logo for Zynex Medical. The logo features the word "ZYNEX" in large, bold, sans-serif font, with the word "MEDICAL" in a smaller font size underneath. A curved line arches over the word "ZYNEX", adding a dynamic element to the design. The overall design is simple, clean, and professional.
Zynex Medical
9990 Park Meadows Dr Lone Tree, CO 80124 Main Office: 800-495-6670 Main Fax: 800-495-6695 www.zynexmed.com
INDICATIONS FOR USE
510(k) Number: K121820
Device Name: Non-Implanted Electrical Continence Device, Model InWave.
Indications for Use:
The InWave is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress urge and mixed urinary incontinence in women.
Prescription Use
(Part 21 CFR 801 Subpart D)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K121820
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