INNOVO

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below. January 16, 2020 Atlantic Therapeutics Ltd. Anne-Marie Keenan Quality Regulatory Affairs Specialist Parkmore Business Park West Galway, H91 NHT7 IRELAND Re: K192357 Trade/Device Name: INNOVO® Regulation Number: 21 CFR 876.5330 Regulation Name: Cutaneous Electrode Stimulator for Urinary Incontinence Regulatory Class: II Product Code: QAJ Dated: December 13, 2019 Received: December 16, 2019 Dear Anne-Marie Keenan: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. U.S. Food and Drug Administration 10903 New Hampshire Avenue WO 66/RM G640 Silver Spring, MD 20993 www.fda.gov {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Jessica K. Nguyen, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Number (if known) Device Name INNOVO® Indications for Use (Describe) The INNOVO® is a transcutaneous electrical stimulator indicated for the treas urinary incontinence in adult females. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary Atlantic Therapeutics Ltd., Parkmore Business Park West, Galway, H91 NHT7, Ireland This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92. #### l. General Information on Submitter: | Submitter Name: | Atlantic Therapeutics Ltd., | |--------------------|-----------------------------------------------------------| | Submitter Address: | Parkmore Business Park West,<br>Galway, H91 NHT7, IRELAND | | Contact Name: | Anne-Marie Keenan, QA/RA Specialist | | E-Mail Address: | amkeenan@atlantictherapeutics.com | | Telephone: | +353 91 412421 | | Date Prepared: | 15th January 2020 | #### ll. General Information on Device: | Name of Device: | INNOVO®, Type Number 208 | |----------------------------|---------------------------------------------------------| | Common Name or Usual Name: | Cutaneous Electrode Stimulator for Urinary Incontinence | | Regulation Number: | 21 CFR 876.5330 | | Regulation Name: | Transcutaneous Electrical Continence Device | | Regulatory Class: | Class II | | Product Code: | QAJ | #### lll. Predicate Devices: INNOVO®, Type Number 208 (DEN 170049) Name of Device: Common Name or Usual Name: Cutaneous Electrode Stimulator for Urinary Incontinence Requlation Number: 21 CFR 876.5330 Requlation Name: Transcutaneous Electrical Continence Device Regulatory Class: Class II Product Code: QAJ This predicate has not been subject to a design related recall. | Reference Device: | ELITONE Device (K183585) | |----------------------------|---------------------------------------------------------| | Common Name or Usual Name: | Cutaneous Electrode Stimulator for Urinary Incontinence | | Regulation Number: | 21 CFR 876.5330 | | Regulation Name: | Transcutaneous Electrical Continence Device | | Regulatory Class: | Class II | | Product Code: | QAJ | #### IV. Device Description: The INNOVO® is a powered transcutaneous electrical continence device intended for the treatment of stress urinary incontinence. The device is provided with an internally wired garment which locates eight conductive electrodes around the pelvic area. An electronic controller, which is attached to the garment using a leadwire, delivers an amplitude modulated symmetric biphasic stimulation current to the electrode array to evoke timed muscle contractions in the pelvic floor muscles. A neck strap clips to the unit to allow it to be worn around the neck. The neck strap contains a safety clip which pops open if there is a forceful pull on the neck strap The current amplitude is adjusted {4}------------------------------------------------ by the patient using a push-button intensity control. A treatment lasts for 30 minutes and is self-administered by the patient at home. The electronic controller operates from rechargeable batteries and a mechanical interlock is provided to prevent simultaneous connection to the patient and the charger. The INNOVO® is supplied with a non-sterile, electrically conductive, electrolyte spray. #### V. Indications for Use : The INNOVO® is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females. Type of Use: Over-The-Counter Use or Prescription Use The indications for Use Statement has been updated from the predicate to include Over-the-Counter Use. ### VI. Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Devices : The following table summarizes the similarities and differences between the intended use and technological characteristsics of the new device vs. predicate and reference devices. {5}------------------------------------------------ # 510(k) Summary Image /page/5/Picture/1 description: The image shows the text 'K192357' on the first line. The second line of the image says 'Page 3 of 4'. The text is in a simple sans-serif font and is black against a white background. The image appears to be a page number or document identifier. Atlantic Therapeutics Ltd., Parkmore Business Park West, Galway, H91 NHT7, Ireland | Technological<br>Characteristic | INNOVO®<br>(New Device) | INNOVO®<br>(Predicate Device) | Elitone<br>(Reference<br>Device) | Comparison and Impact on<br>Safety and Performance | |--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | The INNOVO® is a<br>transcutaneous electrical<br>stimulator indicated for the<br>treatment of stress urinary<br>incontinence in adult females. | The INNOVO® is a<br>transcutaneous electrical<br>stimulator indicated for the<br>treatment of stress urinary<br>incontinence in adult females. | ELITONE is a non-implanted<br>muscle stimulator designed to<br>treat stress urinary incontinence<br>in women. It applies<br>stimulation to the pelvic floor<br>muscles and surrounding tissues. | Substantially equivalent as the<br>new and predicate devices are<br>intended to treat stress urinary<br>incontinence in women | | Type of Use | Rx and OTC | RX | Rx and OTC | Human Factors testing for<br>INNOVO ® has confirmed the<br>new device as safe and reliable<br>for use as OTC. | | Therapeutics Modality | Transcutaneous Electrical<br>Continence Device | Transcutaneous Electrical<br>Continence Device | Transcutaneous Electrical<br>Continence Device | Identical | | Targeted Tissue | Pelvic floor muscles and<br>surrounding tissues | Pelvic floor muscles and<br>surrounding tissues | Pelvic floor muscles and<br>surrounding tissues | Identical | | Anatomic<br>site<br>of<br>stimulation<br>application | Buttocks, lateral pelvis and upper<br>thighs | Buttocks, lateral pelvis and upper<br>thighs | Perineal region | The anatomic site of stimulation<br>application is identical for the<br>new INNOVO® and the predicate<br>INNOVO®.<br>Any differences in anatomic site<br>of stimulation application<br>INNOVO® and Elitone has been<br>established in K183585. | | Number of output modes | 1 | 1 | 1 | Identical | | No. of output channels | 2 | 2 | 1 | Substantially equivalent<br>(Ref: K183585) | | Controls | 7 buttons | 7 buttons | 2 buttons | Substantially equivalent. | | Compliance<br>with<br>voluntary<br>standards for electrical safety and<br>EMC. | IEC 60601-1<br>IEC 60601-2-10<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-2-10<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-2-10<br>IEC 60601-1-2 | Identical | {6}------------------------------------------------ Atlantic Therapeutics Ltd., Parkmore Business Park West, Galway, H91 NHT7, Ireland #### VII. Summary of Non-Clinical Performance Testing: The INNOVO® has been subjected to non-clinical performance testing as follows; - IEC 60601-1:2005 & A1:2012 "Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance" - IEC 60601-2-10:2012 "Medical electrical equipment -- Part 2-10: Particular ● requirements for the basic safety and essential performance of nerve and muscle stimulators" - IEC 60601-1-11:2015 "Medical electrical equipment Part 1-11: General . requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment." - IEC 60601-1-2:2014 "Medical electrical equipment Part 1-2: General requirements . for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests" - IEC 60601-1-6:2010 & A1:2013 (Cons Ed. 3.1) "Medical electrical equipment Part ● 1-6: general requirements for basic safety and essential performance - collateral standard: usability" - IEC 62304:2015 "Medical Device Software Software Life Cycle Processes ● - ISO 14971:2007 "Medical devices application of risk management to medical ● devices - ISO 10993-1:2009 "Biological evaluation of medical devices -- Part 1: Evaluation ● and testing within a risk management process" - . ISO 10993-5:2009 "Biological evaluation of medical devices - part 5: tests for in vitro cytotoxicity" - . ISO 10993-10:2010 "Biological evaluation of medical devices - part 10: tests for irritation and skin sensitization" - ANSI/AAMI/IEC 62366:2015 "Medical devices Application of usability ● engineering to medical devices, Part 1" - AAMI HE75:2009 (Reaffirmed 2013) "Human Factors Engineering – Design of Medical Devices" Usability Testing – 15 subjects participated in a human factors / usability study to assess the device's suitability for safe over-the-counter use. Key findings included: - participants with diversity in age, education and familiarity with (1) incontinence were able to self-select as appropriate users of the INNOVO® device based on the user labelling, - (2) participants were able to understand the instructions for use and a qualified Human Factors (observer) verified that they correctly selfidentified as candidates based on the indications for use and contraindications, - (3) participants were able to apply treatment safely and correctly as for intended use. #### VIII. Conclusion The new and predicate device have the same intended use and any differences in technological characteristics do not raise new issues of safety and effectiveness. Performance testing has demonstrated that the INNOVO® is substantially equivalent to the predicate INNOVO®.