(246 days)
The EmeTerm CinvStop is a wearable device for the treatment of nausea and vomiting caused by motion sickness and pregnancy.
TENS device-EmeTerm generates the electric pulses with highly specific waveforms, frequency and amplitude to stimulate the median nerve. The accurate pulse signals provide relief through electrical stimulation of the nerves in the patient's wrist.
The provided document is a 510(k) premarket notification from WAT Medical Technology (Ningbo) Co., Ltd for their TENS device-EmeTerm, CinvStop. This document is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device (ReliefBand Device, K020180) rather than presenting a performance study with acceptance criteria and detailed study results typical for an AI/ML medical device.
Therefore, much of the information requested in your prompt (e.g., sample size for test set, number of experts, adjudication methods, MRMC study details, training set size, ground truth establishment for training set) is not available in this type of regulatory submission. This device is a Transcutaneous Electrical Nerve Stimulator (TENS), which is a hardware device, not an AI/ML algorithm.
Based on the provided text, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
For a TENS device, "acceptance criteria" and "device performance" are typically defined in terms of electrical output parameters, safety, and effectiveness in mitigating symptoms (nausea and vomiting). The document focuses on demonstrating substantial equivalence to a predicate device, which means proving it is as safe and effective as a device already on the market. The "performance" is implicitly deemed acceptable if it matches the predicate and meets relevant electrical safety standards.
| Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance (TENS device-EmeTerm) | Notes |
|---|---|---|
| Electrical Characteristics: | Listed values for EmeTerm matched or were very close to the predicate device, indicating substantial equivalence. Differences were stated as "insignificant in terms of safety and effectiveness." | |
| Waveform: AC Sharp Wave | AC Sharp Wave | Matched |
| Phase Duration: 300us(±0.5%) | 300us(±0.5%) | Matched |
| Phase Interval: 10us(±0.5%) | 10us(±0.5%) | Matched |
| Pulse Period: 505us(±0.5%) | 500us(±0.5%) | Very close; stated as insignificant difference. |
| Frequency: 33Hz(±0.5%) | 33Hz(±0.5%) | Matched |
| Net Charge per pulse: 0 µC | 0 µC | Matched |
| Maximum output voltage (@1000 ohms): 39.8V(±0.5%) | 38.2V(±0.5%) | Very close; stated as insignificant difference. |
| Maximum output current (@1000 ohms): 6mA(±0.5%) | 6mA(±0.5%) | Matched |
| Maximum phase charge (@1000Ω): 1.8 µC | 1.78 µC | Very close; stated as insignificant difference. |
| Maximum Current Density (@1000Ω): 4.32 mA/cm² | 4.30 mA/cm² | Very close; stated as insignificant difference. |
| Safety Testing: | Compliance with these standards indicates acceptance of safety for a TENS device. | |
| Electromagnetic Safety Test (IEC 60601-1-2) | Test performed (Implied Pass) | Explicitly listed as a performed non-clinical test. |
| Electrical Safety Test (IEC 60601-1, IEC 60601-1-11) | Test performed (Implied Pass) | Explicitly listed as a performed non-clinical test. |
| Biocompatibility: In Vitro Cytotoxicity (ISO 10993-5) | Test performed (Implied Pass) | Explicitly listed as a performed non-clinical test. |
| Biocompatibility: Skin Irritation (ISO 10993-10) | Test performed (Implied Pass) | Explicitly listed as a performed non-clinical test. |
| Biocompatibility: Skin Sensitization (ISO 10993-10) | Test performed (Implied Pass) | Explicitly listed as a performed non-clinical test. |
| Intended Use: | The device's stated indication for use matches that of the predicate, which is a key aspect of substantial equivalence for regulatory acceptance. | |
| Treatment of nausea and vomiting caused by motion sickness and pregnancy | Treatment of nausea and vomiting caused by motion sickness and pregnancy | Stated as identical to predicate device, allowing for "Over-The-Counter Use" for both. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: This submission explicitly states "N/A" under "Non-Clinical Tests and Clinical Tests," indicating that a clinical study with human subjects (which would involve a "test set" in the context of an AI/ML device) was not deemed necessary for this 510(k) clearance due to the device's technological characteristics being substantially equivalent to a predicate. The focus was on non-clinical, bench testing to confirm electrical and safety specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided: As no clinical test set was used in the manner of an AI/ML validation, this information is not relevant to this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No clinical test set.
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
- Not Applicable / Not Provided: This is a TENS device, not an AI/ML diagnostic or assistive device. No human readers or AI assistance are involved in its operation or intended use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: No algorithm component beyond basic device control.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable (for clinical performance): For the purpose of regulatory clearance, the "ground truth" for this TENS device is based on engineering specifications and established safety standards (e.g., IEC 60601 series, ISO 10993 series) and the demonstrated equivalence to a legally marketed predicate device with a known safety and effectiveness profile. The electrical characteristics and physical properties of the device are the "ground truth" verified through bench testing.
8. The sample size for the training set
- Not Applicable / Not Provided: There is no "training set" as this is not an AI/ML device that learns from data.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: No training set.
{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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 15, 2021
WAT Medical Technology (Ningbo) Co., Ltd Rodney Zhang Cto Room703-711, No.2 North Taoyuan Road Ningbo, Zhejiang 315600 China
Re: K172478
Trade/Device Name: TENS device-EmeTerm, CinvStop Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ
Dear Rodney Zhang:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter for your device cleared on April 19, 2018. Specifically, FDA is updating this SE letter due to a typo in the clearance date, which was incorrectly dated as April 19, 2019.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Amber Ballard, OHT5: Office of Neurological and Physical Medicine Devices, by email (Amber.Ballard@fda.hhs.gov) or phone (240-402-9983).
Sincerely,
Jitendra V. Virani -S
For Amber Ballard
Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the acronym "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
April 19, 2019
WAT Medical Technology (Ningbo) Co., Ltd Rodney Zhang CTO Room703-711, No.2 North Taoyuan Road Ningbo, 315600 Cn
Re: K172478
Trade/Device Name: TENS device-EmeTerm, CinvStop Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: March 15, 2018 Received: March 20, 2018
Dear Rodney Zhang:
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. 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.
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
{2}------------------------------------------------
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
William J. Heetderks -S 2018.04.19 13:39:37 -04'00'
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K172478
Device Name EmeTerm CinvStop
Indications for Use (Describe)
The EmeTerm CinvStop is a wearable device for the treatment of nausea and vomiting caused by motion sickness and pregnancy.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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."
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for WAT Med. The logo consists of a stylized "W" in blue, green, and pink, followed by the text "WAT Med" in black. The text is in a bold, sans-serif font.
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)]
04/11/2018
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Company Name: | WAT Medical Technology Inc. |
|---|---|
| Company Address: | Room703-711, No.2 North Taoyuan Road, 315600Ningbo, Zhejiang Province, P.R.C |
| Contact Person: | Rodney Zhang |
| Phone: | 86-574-6506-0811 |
| Email: | 13500799711@139.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | TENS device-EmeTerm |
|---|---|
| Common Name: | TENS device-EmeTerm |
| Model No. | YF-ZTY-E1 |
| Product Code: | GZJ |
| Regulation Number: | 21 CFR 882.5890 |
| Device Class: | II |
4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[
The identification of predicates within this submission is as follow:
| Predicate I | |
|---|---|
| Manufacturer: | Woodside Biomedical, Inc. |
| Trade Name: | ReliefBand Device |
| Product Code: | GZJ |
| Classification Name: | Neurology |
| Regulation Number: | 21 CFR 882.5890 |
| Classification: | Class II |
| FDA 510 (k) #: | K020180 |
SECTION 1 - 2 of 6
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image contains the logo for WAT Med. The logo consists of a stylized "W" symbol in green and pink, followed by the text "WAT Med" in bold, black letters. The logo is simple and modern, with a focus on the company's name.
5. Description of the Device [21 CFR 807.92(a)(4)]
TENS device-EmeTerm generates the electric pulses with highly specific waveforms, frequency and amplitude to stimulate the median nerve. The accurate pulse signals provide relief through electrical stimulation of the nerves in the patient's wrist.
There are several names formerly used by proposed product TENS device-EmeTerm. Previous names have been shown within various test reports include: EmeTerm-mo, EmeTerm-mo device for preventing and treating motion sickness, ZHITUYI (hand) and ZHITUYI (shell). The names listed above are all representing the test results of TENS device-EmeTerm.
6. Previous Device Names and Company:
Previous Device Name:
There are several names formerly used by proposed product TENS device-EmeTerm. Previous names have been shown within various test reports include EmeTerm-mo, EmeTerm-mo device for preventing and treating motion sickness, ZHITUYI (hand) and ZHITUYI (shell). The names listed above are all representing the test results of TENS device-EmeTerm.
Previous Company:
The company appears in various test reports is WAT Medical Technology (Ningbo) Co., Ltd, which is the same company as the current WAT Medical Technology Inc.
7. Indication for Use [21 CFR 807.92(a)(5)]
TENS device-EmeTerm is a wearable device for the treatment of nausea and vomiting caused by motion sickness and pregnancy.
8. Non-Clinical Tests and Clinical Tests
N/A
| Non-Clinical Tests | Electromagnetic Safety Test (IEC 60601-1-2) |
|---|---|
| Electronical Safety Test (IEC 60601-1, IEC 60601-1-11) | |
| Biocompatibility: In Vitro Cytotoxicity (ISO 10993-5) | |
| Biocompatibility: Skin Irritation (ISO 10993-10) | |
| Biocompatibility: Skin Sensitization (ISO 10993-10) |
Clinical Tests
SECTION 1 - 3 of 6
{6}------------------------------------------------
W. WAT Med
9. Technological Characteristics [21 CFR 807.92(a) and Substantial Equivalence Comparison [21 CFR 807.92(b)(1) and 807.92(b)(2)]
| Table 1 | Proposed Device | Predicate Device |
|---|---|---|
| Product Name | EmeTerm Device | ReliefBand Device |
| Product Code | GZJ | GZJ |
| Regulation No. | 21 CFR 882.5891 | 21 CFR 882.5890 |
| Classification | Class II | Class II |
| Indication for Use | TENS device-EmeTerm is a wearabledevice for the treatment of nausea andvomiting caused by motion sicknessand pregnancy. | The ReliefBand Devices areindicated for over the counter usein the relief of nausea and vomiting(NV) due to motion sickness, andfor the relief of mild to moderatenausea and vomiting associatedwith pregnancy. |
| 510 (k) Number | N/A | K020180 |
| Table 2 | Proposed Device | Predicate Device | |
|---|---|---|---|
| Device Feature | |||
| Device Name | EmeTerm Device | ReliefBand Device | |
| Power Source | One lithium battery | Two 3V lithium coin cells | |
| Follow Current | Yes | Yes | |
| Voltage OverloadDetection | Yes | Yes | |
| Adjustable Intensity | 5 | 5 | |
| Channel | 1 | 1 | |
| OperationTips | Start | Yes | Yes |
| LowBattery | Yes | Yes | |
| Work | Yes | Yes | |
| User Control | ON/OFF button on frontof device | ON/OFF button on frontof device | |
| Patient overridecontrol method | On/Off and gear adjust button on frontof device | On/Off and gear adjust button onfront of device | |
| Indicator displays | Unit functioningElectrical connection | Unit functioningElectrical connection | |
| Timer Setting | Yes | Yes | |
| Weight | 29.5g | 34g | |
| Dimensions | 4.483.251.4cm | 3.815.081.14cm | |
| Waveform | AC Sharp Wave | AC Sharp Wave | |
| Phase Duration (usec) | 300us(±0.5%) | 300us(±0.5%) | |
| Phase Interval | 10us(±0.5%) | 10us(±0.5%) | |
| Pulse Period | 500us(±0.5%) | 505us(±0.5%) | |
| Frequency (Hz) | 33Hz(±0.5%) | 33Hz(±0.5%) | |
| Net Charge (µC) perpulse | 0 | 0 | |
| Maximum outputvoltage (V):@1000 ohms | 38.2V(±0.5%) | 39.8V(±0.5%) | |
| Maximum outputcurrent (mA):@1000 ohms | 6mA(±0.5%) | 6mA(±0.5%) | |
| Maximum phasecharge (µC) @1000Ω | 1.78 | 1.8 | |
| Maximum CurrentDensity, (mA/cm²,r.m.s.) @1000Ω | 4.30 | 4.32 | |
| Maximum AveragePower Density,(W/cm²) @1000Ω | 0.00002 | 0.00002 | |
| Maximum AverageCurrent (averageabsolute value, mA)@1000Ω | 0.5 | 0.5 | |
| Maximum ChargeDensity (uC/ cm²)@1000Ω | 1.28 | 1.3 | |
| Stimulating SurfaceAreas(cm²) | 2.709 | 2.72 |
SECTION 1 - 4 of 6
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for WAT Med. The logo consists of a stylized "W" made up of three different colors: blue, green, and pink. To the right of the "W" is the text "WAT Med" in a bold, sans-serif font.
SECTION 1 - 5 of 6
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for WAT Med. The logo consists of a stylized "W" formed by three curved lines in blue, green, and pink, followed by the text "WAT Med" in bold, black letters. The logo is simple and modern, with a focus on the company name.
10. Conclusion [21 CFR 807.92(b)(3)]
TENS device-EmeTerm is substantially equivalent to predicate device because both devices use identical technology and same intended use, also testing standards are identical with the predicates. The differences between both devices are insignificant in terms of safety and effectiveness.
§ 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).