For Mode 0, Ova+ is indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.

For Modes 1, 2& 3 Ova+ is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

Device Description

The Ova+ is a non-invasive small and convenient unit that can be worn under clothing to provide safe, continuous, drug-free period pain relief whilst maintaining a normal, active lifestyle.

The device is battery powered, single channel home using Transcutaneous Electrical Nerve Stimulation (TENS).

The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients' intact skin by the end user. Electrical stimulation is delivered via these self-adhesive electrodes to superficial nerves.

The unit is intended for home use by the patient and is designed with simplicity and ease of use in mind. It has four preset treatment Modes. The level of electrical stimulation of Ova+ is easily controlled by the end user using manual, push-button controls.

The new device Ova+ uses the same technical principle and substantially equivalent stimulation parameters to the marketed device Livia (K183110) and/or reference predicate device Perfect EMS (K200694)

The Ova+ uses a rechargeable Li-Ion polymer battery and a custom TENS connecting lead with 2mm connecting pins.

The Ova+ is supplied with adhesive electrodes that are similar to those of the predicate devices.

AI/ML Overview

The provided text is a U.S. FDA 510(k) summary for the TensCare Ova+ device, a transcutaneous electrical nerve stimulator (TENS). The document describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, the TensCare Ova+ device is not a device that uses AI/ML or requires a complex study for its acceptance criteria. It is a TENS device that relies on established technology and regulatory pathways for electrical medical devices.

Therefore, many of the requested elements (e.g., acceptance criteria for AI performance, sample sizes for AI test/training sets, expert adjudication for ground truth, MRMC studies, standalone AI performance) are not applicable to this specific device submission.

The acceptance criteria for this device are based on its electrical performance, safety, and functional equivalence to legally marketed predicate TENS devices, as demonstrated through non-clinical bench testing and adherence to recognized consensus standards.

Here's an attempt to answer the relevant questions based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not present explicit "acceptance criteria" in a table format with pass/fail results for each criterion. Instead, it compares the performance characteristics of the Ova+ device to its predicate devices to demonstrate substantial equivalence. The implication is that if the Ova+ device's performance characteristics are similar enough to the cleared predicate devices and meet relevant safety standards, it is considered acceptable.

Below is a summary of the comparative performance from the document (mostly from "Table 3: Comparison of output specifications" and "Table 2: Basic Unit Characteristics Comparison Table" but also other sections). The "Acceptance Criteria" here are implicitly "Substantially Equivalent to Predicate Device(s)" and "Compliance with relevant standards". The "Reported Device Performance" is the stated characteristic of the Ova+ device.

Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (Ova+)	Predicate Livia (K183110) Performance	Predicate Perfect EMS (K200694) Performance	Comparison Outcome (Implicit Acceptance)
Indications for Use	Substantially equivalent to predicate(s)	Mode 0: Dysmenorrhea (w/ OTC pain med); Modes 1,2,3: Sore/aching muscles (shoulder, waist, back, neck, arm, leg)	Same (including dysmenorrhea and general pain)	TENS for sore/aching muscles	Substantially Equivalent (with Livia)
Intended Users	Substantially equivalent to predicate(s), home use, 18+ women	Home use, women aged 18 and above	Women aged 18 and above	Keep away from children	Substantially Equivalent (with Livia)
Power Source	Safe and effective; similar to predicate	3.7V Lithium ion battery (rechargeable)	3.7V Lithium ion battery (rechargeable)	2 x AA alkaline battery	Substantially Equivalent
Method of Line Current Isolation	Safe and effective; similar to predicate	Not possible to connect patient lead and charger at same time; uses same socket	Electrically disabled output when connected to charger	No connection to Line Current	Substantially Equivalent
Patient Leakage Current - Normal Condition	< 10µA (battery powered)	< 10µA (Battery powered)	< 10µA (Battery powered)	< 10µA (Battery powered)	Identical
Patient Leakage Current - Single Fault Condition	< 50µA (battery powered)	< 50µA (Battery powered)	< 50µA (Battery powered)	< 50µA (Battery powered)	Identical
Average DC current through Electrodes (no pulses)	0 µA	0 µA	0 µA	0 µA	Identical
Number of Output Modes	Similar functionality to predicates	4 (1 Dysmenorrhea & 3 Pain)	1 (Dysmenorrhea)	1 (Pain)	Substantially Equivalent
Number of Output Channels	Similar functionality to predicates	1	1	2	Identical (with primary predicate)
Regulated Current or Voltage	Safe and effective output control	Voltage	Current	Voltage	Substantially Equivalent
Software/Firmware/Microprocessor Control	Safe and effective control	Yes	Yes	Yes	Identical
Automatic No-Load Trip	Safety features are adequate even if different from predicates	No	Yes	Yes	Substantially Equivalent (due to intrinsic safety)
Automatic Overload Trip	Safety features are adequate even if different from predicates	No	Yes	Yes	Substantially Equivalent (due to intrinsic safety)
Automatic Shut Off	Safe operation	No	No	Yes	Identical
User Override Control	User control for effectiveness	Yes	Yes	Yes	Substantially Equivalent
Indicator Display	Provides necessary user information	Yes (On/Off, Low Bat, V/C level, Time to cut-off)	Yes	Yes	Identical
Timer Range	Similar to predicate	No Timer	No internal timer	20-40 minutes	Identical (with primary predicate)
Waveform	Biphasic, Equal duration	Biphasic, Equal duration	Bi-phasic, Symmetrical	Biphasic, Equal duration	Substantially Equivalent
Shape	Rectangular	Rectangular	Rectangular	Rectangular	Identical
Max Output Voltage (V) @ 500 ohm	Within safe operating parameters, similar to predicates	26V	50V	50V	Substantially Equivalent
Max Output Voltage (V) @ 2k ohm	Within safe operating parameters, similar to predicates	28V	64V	90V	Substantially Equivalent
Max Output Voltage (V) @ 10k ohm	Within safe operating parameters, similar to predicates	29V	Not specified	125V	Substantially Equivalent
Max Output Current (mA) @ 500 ohm	Within safe operating parameters, similar to predicates	52mA	50mA	100mA	Substantially Equivalent
Max Output Current (mA) @ 2k ohm	Within safe operating parameters, similar to predicates	28mA	31mA	45mA	Substantially Equivalent
Max Output Current (mA) @ 10k ohm	Within safe operating parameters, similar to predicates	3mA	6.4mA	12.5mA	Substantially Equivalent
Dysmenorrhea Mode Pulse Width (μs)	Similar to primary predicate	100μs	100μs	Not applicable	Substantially Equivalent
Dysmenorrhea Mode Frequency (Hz)	Similar to primary predicate	110Hz	100Hz	Not applicable	Substantially Equivalent
General Pain Modes Pulse Width (μs)	Within range of secondary predicate	50μs, 100μs, 150μs, 200μs	Not applicable	50-250μs, in steps of 50μs	Substantially Equivalent
General Pain Modes Frequency (Hz)	Within range of secondary predicate	10 Hz, 100Hz, 110Hz	Not applicable	From 1Hz to 120Hz	Substantially Equivalent
Net Charge (μC per pulse) at 500Ω	Similar to predicates	2.24μC	0	1 μC	Similar
Maximum Phase Charge (μC)	Within safe operating parameters, similar to predicates	9.6μC	6.4μC	20.5μC	Substantially Equivalent
Maximum Current Density (mA/cm²)	Within safe operating parameters, similar to predicates	0.175 (Surface=45cm²)	0.38	0.01013 (Surface=25cm²)	Substantially Equivalent
Maximum Power Density (mW/cm²)	Within safe operating parameters, similar to predicates	0.693 (Surface=45cm²)	2.05	0.53 (Surface=25cm²)	Substantially Equivalent
Compliance with Voluntary Standards	Compliance with relevant electrical safety, EMC, nerve stimulator, home use standards	IEC 60601-1, -1-2, -2-10, -1-11, -6, IEC 62304, IEC 62366-1, ISO 14971	IEC 60601-1, -1-2, -2-10, ISO 10993-1, -5, -10	Most of the above + IEC 60601-1:2005	Substantially Equivalent
Compliance with 21 CFR 898	Yes	Yes	Yes	Yes	Identical
Weight	Similar to predicates (not a specific performance criterion, but a characteristic)	19.5g	37g	146.5g	Similar
Dimensions	Similar to predicates (not a specific performance criterion, but a characteristic)	65 x 38 x 10mm	55 x 55 x 20mm	66 x 136 x 30.7mm	Similar
Housing Materials	Biocompatible and durable	Silicone, ABS plastics	ABS plastics	ABS plastics	Substantially Equivalent
Electrode Biocompatibility	Compliant with ISO 10993	Biocompatibility testing conducted on identical skin-contacting materials (hydro-gel) under K210448.	ISO 10993-1, -5, and -10	Not explicitly detailed for this point	Substantially Equivalent
Software Verification	Meets specifications	10 OVA+ prototypes tested for software verification.	Not explicitly detailed for this point	Not explicitly detailed for this point	Confirmed
Usability	OTC users can adequately understand and use the device	Usability Study according to ISO 62366. Lay operator requires limited training for basic safety and essential performance.	Not explicitly detailed for this point	Not explicitly detailed for this point	Shown acceptable

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set (Non-clinical Bench Testing): The document mentions "A current production model of the Livia was also tested using the same test instruments for a direct comparison." and "Softrware verification testing on 10 OVA+ prototypes demonstrated that the software of Ova+ meets the requirements of the specifications."
- Sample Size:
  - For the Livia predicate comparison: "A current production model" (suggests N=1).
  - For Ova+ software verification: "10 OVA+ prototypes".
- Data Provenance: The testing was "bench testing," meaning physical performance measurements. The location of the testing is not specified, but the manufacturer is based in the UK, and the manufacturing facility is in China. The data would be prospective data from lab tests.
Clinical Data (from Predicate): The document states that the primary predicate device Livia (K183110) obtained clearance based on clinical performance data. It explicitly states: "The predicate device's manufacturer (LifeCare Ltd.) conducted a clinical trial designed to show the safety and effectiveness of the Livia device for the indication of temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication."
- Sample Size: Not specified in this 510(k) summary, as it refers to the predicate's original submission.
- Data Provenance: Not specified for the predicate's clinical trial in this document (e.g., country, retrospective/prospective). However, clinical trials for FDA submissions are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable for this device. Ground truth established by experts is typically for diagnostic devices, especially those using AI/ML where human interpretation is the gold standard. For a TENS device, the "ground truth" for performance is based on electrical measurements, adherence to standards, and user usability, not expert interpretation of outputs.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are used in studies where there is subjective interpretation (e.g., medical image reading) to establish consensus or resolve discrepancies in ground truth. The "test set" for this device involved bench testing and software verification, which are objective measurements.

5. 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

This is not applicable. MRMC studies are specific to diagnostic devices, particularly those involving human readers (e.g., radiologists) interpreting cases, often with and without AI assistance, to assess diagnostic performance. This device is a therapeutic TENS device, not a diagnostic one, and does not involve human "readers" or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This question pertains to AI/ML software performance. The Ova+ device is a physical TENS unit; while it contains software for control, it's not a standalone AI algorithm in the context of diagnostic performance evaluation. Its "standalone" performance would be its electrical output and safety characteristics, which were assessed via bench testing as described in Section 1.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the Ova+ device itself: The "ground truth" for its performance and safety is its adherence to electrical safety standards (e.g., IEC 60601 series), electromagnetic compatibility (EMC) standards, biocompatibility (ISO 10993), and functional specifications measured via bench testing. For usability, it's performance against ISO 62366 usability standards, demonstrated through a usability study.
For the predicate device Livia's clinical clearance: The ground truth for its effectiveness was clinical outcomes data from a clinical trial, demonstrating temporary pain relief for dysmenorrhea.

8. The sample size for the training set

This is not applicable. This question relates to AI/ML models. The Ova+ device is a hardware TENS unit. It has no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This is not applicable, as there is no "training set" for this type of device.

Summary

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December 15, 2023

TensCare Ltd Saskia Eldridge-Hinmers Regulatory Affairs Associate 9 Blenheim Road Epsom, Surrey KT19 9BE United Kingdom

Re: K230926

Trade/Device Name: Ova+ (K-OVAP-USA) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: November 13, 2023 Received: November 13, 2023

Dear Saskia Eldridge-Hinmers:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).

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Sincerely,

Doe W. Kumsa -S

for Pamela Scott, MS Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230926

Device Name Ova+ (K-OVAP-USA)

Indications for Use (Describe)

For Mode 0, Ova+ is indicated for temporary relief of pain associated with dysmenorthea (menstrual cramps) when used with over-the-counter pain medication.

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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The Queen's Award
For Enterprise:
International
Trade 2021

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TensCare LTD. PainAway House 9 Blenheim Road Longmead Business Park Epsom, Surrey, KT19 9BE United Kingdom

510(k) SUMMARY

1. Submitters Identification

Submitter:	TensCare Ltd
Address:	9 Blenheim Road, Epsom,Surrey, KT19 9BE, United Kingdom
Tel :	+44(0)1372 723 434
Fax :	+44(0)1372 745 434
FDA Establishment Registration No:	3003446042

Contact person:	Saskia Eldridge-Hinmers
	Regulatory Affairs Associate
Contact Phone:	+44(0)7879424785
Contact Email:	Saskia.Eldridge-Hinmers@tenscare.co.uk
Date Prepared:	15th November 2022

Address of the manufacturing facility:

EasyMed Instruments Co Ltd 3/F, 5F/6F, Block A, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Daliang, 528300 Shunde, Foshan, Guangdong, China,

FDA Establishment Registration No: 3004049909

Address of American Representative:

Contact First Name;	SCOTT A
Contact Last Name:	BEDNAR
Title:	MR
Business Name:	QA/RA CONSULTING GROUP, INC. Full
Address:	3335 TUSCARAWAS ROADBEAVER , PENNSYLVANIA , 15009 , UNITED STATES
E-mail:	sbednar@qaraconsultinggroup.com
Phone Number:	412 -4188066

Tenscare Ltd., Traditional 510(k) Ova+

18-11-2021

tenscare.co.uk +44 (0)1372 723434 sales@tenscare.co.uk

TENSCARE LTD IS AN EMPLOYEE OWNED BUSINESS MANAGING DIRECTOR - N.C. WRIGHT, SALES DIRECTOR - E.G. SLAVOVA, FINANCE DIRECTOR - C.S.K. SMITH. REGISTERED ADDRESS AS SHOWN ABOVE REGISTERED IN ENGLAND NO. 02839925.

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2. Subject Device

Manufacturer	: Tenscare Limited
Trade/Device Name	: Ova+ (K-OVAP-USA)
510(k) Number	: K230926
Device Classification Name	: Stimulator, Nerve, Transcutaneous, Over-the-counter
Common Name:	: Transcutaneous Electrical Nerve Stimulator for Pain Relief
Classification Name	: Stimulator, Nerve, Transcutaneous, Over-The-Counter
CFR Regulation Number	: 21 CFR 882.5890
Product Code	: NUH
FDA Device Classification	: Class II Medical Device
Device Type ID	: 3755
Device Definition	: TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHINGMUSCLES

3. Predicate Devices

3.1. Primary Predicate Device

Manufacturer	:Life Care Limited.
Trade/Device Name	:Livia
510(k) Number	:K183110
Device Classification Name	:Stimulator, Nerve, Transcutaneous, Over-the-counter
Regulation Description	:Transcutaneous Electrical Nerve Stimulator for Pain Relief
CFR Regulation Number	:21 CFR 882.5890
Product Code	:NUH
FDA Device Classification	:Class II Medical Device
Device Type ID	3755
Device Definition	: TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHINGMUSCLES

3.2. Secondary Predicate Device

Manufacturer	:TensCare Ltd
Trade/Device Name	:Perfect EMS_OTC
510(k) Number	:K200694
Device Classification Name	:Stimulator, Nerve, Transcutaneous,Over-the-counter, Powered muscle stimulator
Regulation Description	:Transcutaneous Electrical Nerve Stimulator for Pain Relief
CFR Regulation Number	:21 CFR 882.5890
Product Code	:NUH (Stimulator, Nerve, Transcutaneous, Over-The-CounterNGX (Stimulator, Muscle, Powered, For Muscle Conditioning
Classification Panel:	Neurology; Physical Medicine
FDA Device Classification	:Class II Medical Device

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4. Device Description

The Ova+ is a non-invasive small and convenient unit that can be worn under clothing to provide safe, continuous, drug-free period pain relief whilst maintaining a normal, active lifestyle.

The device is battery powered, single channel home using Transcutaneous Electrical Nerve Stimulation (TENS).

The Ova+ uses a rechargeable Li-Ion polymer battery and a custom TENS connecting lead with 2mm connecting pins.

The Ova+ is supplied with adhesive electrodes that are similar to those of the predicate devices.

5. Indication For Use/Intended Use

For Mode 0, Ova+ is indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.

Intended Use

The Ova+ is intended for use in the home. lt should be used only by women aged 18 and above.

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6. Indication for Use comparison

Characteristic	New DeviceOva+	Primary PredicateDeviceLivia	Secondary PredicateDevice Perfect EMSOTC
Manufacturer	Tenscare Limited	Life Care Ltd.	TensCare Ltd
510(k) No.	K230926	K183110	K200694
Indications forUse	For Mode 0, Ova+ isindicated for temporaryrelief of pain associatedwith dysmenorrhea(menstrual cramps) whenused with over-the-counter pain medication.For Modes 1, 2& 3 Ova+is indicated for temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist, back, neck, upperextremities (arm) andlower extremities (leg)due to strain fromexercise or normalhousehold work activities.	The Livia is designed forsymptomatic relief andmanagement of chronicpain, and for temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist, back, neck, upperextremities (arm) andlower (extremities) legdue to strain fromexercise or normalhousehold work activities.The Livia is also indicatedfor temporary relief ofpain associated withdysmenorrhea (menstrualcramps) when used withover-the-counter painmedication.	TENS: The device isdesigned to be usedfor temporary relief ofpain associated withsore and achingmuscles in theshoulder, waist, back,neck, upperextremities (arm),lower extremities (leg),abdomen and bottomdue to strain fromexercise or normalhousehold workactivities
Intended Users	The Ova+ is intended foruse in the home.It should be used only bywomen aged 18 andabove.	Livia should be used onlyby women aged 18 andabove.	Keep away fromchildren
Class	ll	ll	ll
Product code	NUH	NUH	NUH
Regulation number	21 CFR 882.5890	21 CFR 882.5890	21 CFR 882.5890
OTC Use	Yes	Yes	Yes
Single Use orReusable	ReusableFor single patient use	ReusableFor single patient use	ReusableFor single patient use
Characteristic	New Device	Primary PredicateDevice	Secondary PredicateDevice	Comparison
DeviceName/Model	Ova+	Livia	Perfect EMS
510(k)	K230926	K183110	K200694
Manufacturer	TensCare Ltd	LifeCare Ltd.	TensCare Ltd
Power Source(s)1	3.7V Lithium ionbattery(rechargeable)	3.7V Lithium ionbattery(rechargeable)	2 x AA alkaline battery	Internal powersourceSubstantiallyEquivalent.
Method of Linecurrent Isolation	Not possible toconnect patient leadand charger at sametime - use samesocket	Output is electricallydisabled whenconnect to charger, bymeans ofmicroprocessorcharging circuit	No connection to LineCurrent	SubstantiallyEquivalent.
Patient LeakageCurrent- Normal Condition(μΑ)	Batterypowered(< 10μA)	Batterypowered(< 10μA)	Batterypowered(< 10μA)	Identical
Patient LeakageCurrent- Single FaultCondition (μΑ)	Batterypowered(< 50μA)	Batterypowered(< 50μA)	Batterypowered(< 50μA)	Identical
Average DC currentthrough Electrodeswhen device is onbutno pulses are beingapplied (μΑ)	0 µA	0 µA	0 µA	Identical withprimarypredicate
Number of OutputModes	41 Dysmenorrhea &3 Pain	1 Dysmenorrhea	1 Pain	Substantiallyequivalent
Number of OutputChannels	1	1	2	Identical withprimarypredicate
Regulated Currentor Voltage?	Voltage	Current	Voltage	SubstantiallyEquivalent.
Software/Firmware/MicroprocessorControl?	Yes	Yes	Yes	Identical
Automatic No-LoadTrip?	No	Yes	Yes	SubstantiallyEquivalent.
Automatic OverloadTrip?	No	Yes	Yes	SubstantiallyEquivalent.
Automatic Shut Off?	No	No	Yes	Identical
Characteristic	New Device	Primary PredicateDevice	Secondary PredicateDevice	Comparison
DeviceName/Model	Ova+	Livia	Perfect EMS
User OverrideControl?	Yes	Yes	Yes	SubstantiallyEquivalent.
Indicator Display:-On/Off status-Low battery-Voltage/Currentlevel-Time to cut-off	YesYesYesYes	YesYesYesYes	YesYesYesYes	Identical
Timer Range(minutes)	No Timer	The Livia has nointernal timer	20-40	Identical withprimarypredicate
Compliance withVoluntaryStandards?	IEC 60601-1,IEC 60601-1-2IEC 60601-2-10IEC 60601-1-11IEC 62304ISO 14971IEC 60601-1-6IEC 62366-1	IEC 60601-1,IEC 60601-1-2,IEC 60601-2-10,ISO 10993-1, -5 and -10	IEC 60601-1:2005IEC 60601-1-2IEC 60601-2-10 IEC60601-1-11IEC 62304ISO 14971	SubstantiallyEquivalent.
Compliance with 21CFR 898?	Yes	Yes	Yes	Identical
Weight g	19.5	37	146.5	Similar
Dimensions (mm)	65 x 38 x 10	55X 55 X 20	66×136×30.7	Similar
Housing Materialsand Construction	Silicone, ABSplastics	ABS plastics	ABS plastics	SubstantiallyEquivalent.
Sterilization	N/A	N/A	N/A	Identical
Parameter	New Device	Primary PredicateDevice	SecondaryPredicateDevice	Comparison
DeviceName/Model	Ova+	Livia	Perfect EMSOTC
510(k)	K230926	K183110	K200694
Manufacturer	TensCare Ltd	LifeCare Ltd.	TensCare Ltd
Waveform	Biphasic,Equal duration	Bi-phasic,Symmetrical	BiphasicEqual duration
Shape	Rectangular	Rectangular	Rectangular
Maximum OutputVoltage (V)500 ohm2k ohm10k ohm	26V28V29V	50V64V	50V90V125V	SubstantiallyEquivalent
Maximum OutputCurrent (mA)500 ohm2k ohm10k ohm	52mA28mA3mA	50mA31mA6.4mA	100mA45mA12.5mA	SubstantiallyEquivalent
DysmenorrheaMode
Pulse Width (μs)	100μs,	100μs		SubstantiallyEquivalent
Frequency(Hz)	110Hz	100Hz		SubstantiallyEquivalent
Pain Modes 1,2&3
Pulse Width (μs)	50μs, 100μs, 150μs,200μs		TENS 50-250μs,in steps of 50μs	SubstantiallyEquivalent
Frequency(Hz)	10 Hz, 100Hz, 110Hz		TENS From 1Hzto 120Hz	SubstantiallyEquivalent
Net Charge (μCper pulse) at 500Ω	2.24μC	0	1 μC	Similar.
Maximum PhaseCharge, (μC)	9.6μC	6.4μC	20.5μC	SubstantiallyEquivalent
Maximum CurrentDensity6, (mA/cm²)	0.175Surface= 45cm²	0.38	0.01013mA/cm2	SubstantiallyEquivalent
Maximum PowerDensity6,(mW/cm²)	0.693Surface= 45cm²	2.05	0.53mW/ cm2Surface= 25cm²	SubstantiallyEquivalent

TABLE 1: Indication For Use Comparison Table

The Indication for Use of the Ova+ is identical with that of the primary predicate device Livia

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7. Technological comparison

Table 2: Basic Unit Characteristics Comparison Table

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Table 3: Comparison of output specifications

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8. Summary of Technological Characteristics Compared to the Predicate Devices

. Basic Design Features and Technological Characteristics (7, Table 2) Comparison Tables 1 above summarizes the shared and unique technological elements between the Ova+, Livia (K183110), and Perfect EMS OTC (K200694).
-Output Requlation (Requlated Current or Voltage?) The stimulation current required for TENS depends on electrode position and the individual patient's nervous system. To deliver appropriate substantially equivalent stimulation, TENS intensity must be controlled in accordance with the patient's sensation..

With regard to safety, there is little difference between the two control methods. Constant current would give a slightly higher risk of burn due to current density changes with detaching electrode if the maximum voltage were not limited.

● Safety Features - Automatic No-Load Trip and Automatic Overload Trip

The main risks caused by short circuit are

a. Damage to device causing it not to function correctly.
Ova+ is not damaged by short circuit. Additionally, the device does not perform any clinical functions whose loss or degradation would present an unacceptable clinical risk, and improper device function caused by a short circuit would not foreseeably result in any greater risk to the patient than the occurrence of a short circuit in the predicate device.

b. Overheating causing fire or injury.

The single fault test in the provided evidence of testing to IEC 60601-1 showed that even short-circuiting the battery does not generate hazardous temperatures.

Although Ova+ does not incorporate automatic no-load and overload trips, the intrinsic safety of its design assures that the is no adverse effect on safety or effectiveness.

. Accessories and biocompatibility

Ova+ uses single patient use, disposable skin electrodes (510(k) number K210448) that connect to a patient lead. Livia uses a reusable electrode with integral lead, and a disposable qel pad.

The method of delivery of stimulation, type of conductive medium, and biocompatibility requirements are the same for both devices.

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The skin electrodes are the only components intended for skin contact for more than one hour.

The skin-contacting material in the electrodes is a Hydro-gel whose main ingredients are Distilled water, Medical glycerin and Sodium Chloride.

Biocompatibility - and thus, substantial equivalence - of the electrodes was determined via the declaration of identical skin- contacting materials relative to the E-CM5090 electrodes 510(k)-cleared under K210448, for which biocompatibility testing was conducted according to ISO 10993-1, -5, and -10.

Power Supply. All three devices are battery operated. Ova+ and Livia have internal . rechargeable lithium ion batteries, but this difference has no effect on safety or efficacy.
. Performance Characteristics (7. Table 3) The stimulation parameters of the new device Ova+ are similar to those of primary predicate device Livia (K183110) and Secondary Predicate device Perfect EMS OTC (K200694).
-Ova+ has 4 modes, the first of these, Mode 0 for Dysmennorrhea, uses parameter settings that are very close to those of the primary predicate device Livia (K183110) and are substantially equivalent.
The parameters of Ova+ Modes 1-3 for general pain are in the same range as Secondary -Predicate device Perfect EMS OTC (K200694) when used for temporary relief of pain associated with sore and aching muscles.

The results of bench testing show that the performance characteristics of the subject device are substantially equivalent to those of the predicate devices Livia (K183110) and Perfect EMS (K200694), with any differences limited to minor differences in design and performance that do not raise any new questions of safety or effectiveness.

9. Human Factors

. Electrode positioning

The electrode positioning of the Ova+ device Mode 0 is from side to side on the front of the pelvis or the lower back and is substantially equivalent with the electrode positioning of the primary predicate device Livia (K183110)

The secondary predicate device Perfect EMS (K200694) used a general-purpose TENS electrode positioning guidance insert. The Ova+ device Modes 1,2 &3 use a reduced version of this, with all positions taken from the original quidance document. These positions are identical, and therefore substantially equivalent with, the electrode positioning of the secondary predicate device Perfect EMS (K200694)

. Contraindications, Cautions and warnings are identical and thus substantially equivalent
. Usability Study. Tenscare has conducted a Usability Study according to ISO 62366.

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OTC users were able to adequately understand the instructions and to use the device as intended. There is no evidence that the small differences from the predicate device in technical operation raise additional concerns to operation of the Ova+.

Summary of Non-Clinical Performance Testing as Basis for 10. Substantial Equivalence

The Ova+ was tested to provide data for Table 3: Comparison of output specifications for comparison with data provided in the Livia 510(k) Summary and Perfect EMS 510(k) Summary. A current production model of the Livia was also tested using the same test instruments for a direct comparison.

Results summary is shown in the comparison tables above.

Both Subject and Predicate devices are provided non-sterile, have comparable operations and technology. The design of Ova+ does not introduce any new risks

The new device Ova+ and the marketed devices Livia (K183110) and Perfect EMS (K200694) are certified to comply with same applicable recognized consensus standards for medical device electrical safety, EMC safety, nerve stimulators, and home use as shown in Compliance with Voluntary Standards row in Table 2 above.

Softrware verification testing on 10 OVA+ prototypes demonstrated that the software of Ova+ meets the requirements of the specifications.

Tenscare has made a detailed comparison of Human Factors between the new device and the primary and secondary predicate devices and concluded that they are substantially equivalent.

They also conducted a Usability Study according to ISO 62366.

"Both the FORMATIVE EVALUATION and SUMMATIVE EVALUATION conclude that the LAY OPERATOR requires limited training to intervene and maintain BASIC SAFETY and ESSENTIAL PERFORMANCE with the Ova+ device."

11. Summary of Clinical Testing as Basis for Substantial Equivalence

No clinical testing was considered necessary for the Ova+ subject device.

The primary predicate device Livia (K183110) obtained clearance as an over-the-counter TENS device that included the temporary relief of menstrual pain within its Indications for Use based on clinical performance data.

The predicate device's manufacturer (LifeCare Ltd.) conducted a clinical trial designed to show the safety and effectiveness of the Livia device for the indication of temporary relief of pain

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associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.

Conclusion 11

No clinical tests were performed.

The nonclinical bench tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices listed above.

This conclusion is based upon the devices' similarity in principles of operation, technology, materials, and indications for use.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).