(256 days)
No
The device description and performance studies do not mention any AI or ML components. The device uses preset modes and manual controls, which are characteristic of traditional TENS devices.
Yes.
The device is indicated for the temporary relief of pain associated with dysmenorrhea and sore and aching muscles, which are therapeutic claims.
No
The device is indicated for pain relief rather than diagnosis.
No
The device description clearly states it is a "non-invasive small and convenient unit" that is "battery powered, single channel home using Transcutaneous Electrical Nerve Stimulation (TENS)" and is "supplied with self-adhesive electrodes which connect to the control unit by cable and plug". This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Ova+ Function: The Ova+ is a Transcutaneous Electrical Nerve Stimulation (TENS) device. It delivers electrical stimulation to the skin to relieve pain. It does not analyze any biological samples.
- Intended Use: The intended use is for temporary pain relief, not for diagnosing or monitoring a medical condition through the analysis of biological specimens.
- Device Description: The description clearly states it's a non-invasive device that applies electrical stimulation via electrodes placed on the skin.
Therefore, the Ova+ falls under the category of a therapeutic device, specifically a TENS device, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
NUH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg)
Indicated Patient Age Range
18 and above
Intended User / Care Setting
Home use by the patient
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)
Bench Testing: The Ova+ was tested to provide data 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 provided in the document.
Software Verification Testing: Software verification testing on 10 OVA+ prototypes demonstrated that the software of Ova+ meets the requirements of the specifications.
Human Factors / Usability Study: 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. The study concluded that "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."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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"
1
(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).
2
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
3
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.
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.
| 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 ROAD |
| BEAVER , 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.
5
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/ACHING |
| MUSCLES |
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/ACHING |
| MUSCLES |
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-Counter |
| NGX (Stimulator, Muscle, Powered, For Muscle Conditioning | |
| Classification Panel: | Neurology; Physical Medicine |
| FDA Device Classification | :Class II Medical Device |
6
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 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.
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.
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.
Intended Use
The Ova+ is intended for use in the home. lt should be used only by women aged 18 and above.
7
6. Indication for Use comparison
| Characteristic | New Device
Ova+ | Primary Predicate
Device
Livia | Secondary Predicate
Device Perfect EMS
OTC | |
|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Manufacturer | Tenscare Limited | Life Care Ltd. | TensCare Ltd | |
| 510(k) No. | K230926 | K183110 | K200694 | |
| Indications for
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.
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. | The Livia is designed for
symptomatic relief and
management of chronic
pain, and 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.
The Livia is also indicated
for temporary relief of
pain associated with
dysmenorrhea (menstrual
cramps) when used with
over-the-counter pain
medication. | TENS: The device is
designed to be used
for temporary relief of
pain associated with
sore and aching
muscles in the
shoulder, waist, back,
neck, upper
extremities (arm),
lower extremities (leg),
abdomen and bottom
due to strain from
exercise or normal
household work
activities | |
| Intended Users | The Ova+ is intended for
use in the home.
It should be used only by
women aged 18 and
above. | Livia should be used only
by women aged 18 and
above. | Keep away from
children | |
| 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 or
Reusable | Reusable
For single patient use | Reusable
For single patient use | Reusable
For single patient use | |
| Characteristic | New Device | Primary Predicate
Device | Secondary Predicate
Device | Comparison |
| Device
Name/Model | Ova+ | Livia | Perfect EMS | |
| 510(k) | K230926 | K183110 | K200694 | |
| Manufacturer | TensCare Ltd | LifeCare Ltd. | TensCare Ltd | |
| Power Source(s)1 | 3.7V Lithium ion
battery(rechargeable) | 3.7V Lithium ion
battery(rechargeable) | 2 x AA alkaline battery | Internal power
source
Substantially
Equivalent. |
| Method of Line
current Isolation | Not possible to
connect patient lead
and charger at same
time - use same
socket | Output is electrically
disabled when
connect to charger, by
means of
microprocessor
charging circuit | No connection to Line
Current | Substantially
Equivalent. |
| Patient Leakage
Current
- Normal Condition
(μΑ) | Battery
powered
(