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 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.

AI/ML Overview

The provided text describes a 510(k) summary for the INNOVO® device intended for treating urinary incontinence. While it details non-clinical performance testing and general acceptance criteria like compliance with electrical safety and EMC standards, it does not contain information about a study proving the device meets specific performance acceptance criteria for its effectiveness in treating urinary incontinence.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, adherence to safety standards (e.g., IEC 60601 series, ISO 14971, ISO 10993), and usability testing for over-the-counter use.

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria and the reported device performance: This document does not present quantitative performance metrics for treating urinary incontinence for the INNOVO® device.
Sample size used for the test set and the data provenance: No clinical test set data for performance is presented. The usability study involved 15 subjects.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study (e.g., diagnostic accuracy for an AI/CAD system) is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable, as this is a medical device for treatment, not an AI/CAD diagnostic system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not described for device efficacy. Usability testing ground truth was expert observation.
The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set in the conventional sense.
How the ground truth for the training set was established: Not applicable.

The "Summary of Non-Clinical Performance Testing" in section VII details testing against various electrical safety, usability, and biological compatibility standards. For example, usability testing involved 15 subjects to assess suitability for safe over-the-counter use, and its findings relate to users understanding instructions and applying treatment safely. However, this is not a clinical study proving the treatment efficacy of the device for urinary incontinence.

The document states: "Performance testing has demonstrated that the INNOVO® is substantially equivalent to the predicate INNOVO®." This implies that the effectiveness is established by comparison to a previously cleared device, not necessarily by new clinical efficacy data for this specific submission, especially when the changes are primarily related to making it available as an Over-The-Counter device (which required Human Factors testing).

Summary

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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

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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

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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)

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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,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:

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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.

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510(k) Summary

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Atlantic Therapeutics Ltd., Parkmore Business Park West, Galway, H91 NHT7, Ireland

TechnologicalCharacteristic	INNOVO®(New Device)	INNOVO®(Predicate Device)	Elitone(ReferenceDevice)	Comparison and Impact onSafety and Performance
Indications forUse	The INNOVO® is atranscutaneous electricalstimulator indicated for thetreatment of stress urinaryincontinence in adult females.	The INNOVO® is atranscutaneous electricalstimulator indicated for thetreatment of stress urinaryincontinence in adult females.	ELITONE is a non-implantedmuscle stimulator designed totreat stress urinary incontinencein women. It appliesstimulation to the pelvic floormuscles and surrounding tissues.	Substantially equivalent as thenew and predicate devices areintended to treat stress urinaryincontinence in women
Type of Use	Rx and OTC	RX	Rx and OTC	Human Factors testing forINNOVO ® has confirmed thenew device as safe and reliablefor use as OTC.
Therapeutics Modality	Transcutaneous ElectricalContinence Device	Transcutaneous ElectricalContinence Device	Transcutaneous ElectricalContinence Device	Identical
Targeted Tissue	Pelvic floor muscles andsurrounding tissues	Pelvic floor muscles andsurrounding tissues	Pelvic floor muscles andsurrounding tissues	Identical
Anatomicsiteofstimulationapplication	Buttocks, lateral pelvis and upperthighs	Buttocks, lateral pelvis and upperthighs	Perineal region	The anatomic site of stimulationapplication is identical for thenew INNOVO® and the predicateINNOVO®.Any differences in anatomic siteof stimulation applicationINNOVO® and Elitone has beenestablished in K183585.
Number of output modes	1	1	1	Identical
No. of output channels	2	2	1	Substantially equivalent(Ref: K183585)
Controls	7 buttons	7 buttons	2 buttons	Substantially equivalent.
Compliancewithvoluntarystandards for electrical safety andEMC.	IEC 60601-1IEC 60601-2-10IEC 60601-1-2	IEC 60601-1IEC 60601-2-10IEC 60601-1-2	IEC 60601-1IEC 60601-2-10IEC 60601-1-2	Identical

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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®.

Regulation Number and Section

§ 876.5330 Transcutaneous electrical continence device.

(a)
Identification. A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must characterize the electrical stimulation, including the following: Waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.
(2) The patient-contacting materials must be demonstrated to be biocompatible.
(3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, thermal safety, and mechanical safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) Instructions for use, including specific instructions regarding the proper placement of electrodes;
(ii) A summary of electrical stimulation parameters; and
(iii) Cleaning instructions and reuse information.