(199 days)
The Transcutaneous Electrical Applicator (TEA) is a transcutaneous electrical nerve field stimulator system intended to be used in adult patients with functional abdominal pain associated with irritable bowel syndrome (IBS) through application to Cranial Nerves V, VI, IX and X, and the occipital nerves, as an aid in the reduction of pain when combined with other therapies for IBS. TEA device is intended to be used for 7-120 hours per week up to 3 consecutive weeks.
The TEA Device is a non-invasive, battery-operated, prescription-based transcutaneous electrical nerve field stimulator indicated for use in adult patients with functional abdominal pain associated with the irritable bowel syndrome (IBS). The system includes the following components: TEA Device, lead cable, USB charging cable, USB power adapter, electrode pads, holding clip, and TEA IBS app. The device can be used in clinical environments (i.e., outpatient clinics and hospitals) and/or at home. The TEA Device is powered by an internal rechargeable lithium polymer battery and uses a microprocessor to control the working modes, the waveform and strength of the output pulse. The electric pulse generator is based on a current source circuit. The power management module contains a DC-DC boost conversion circuit that provides the required voltage for the electric pulse generator. The TEA Device is able to connect with the TEA IBS app, which is located on a smartphone. The user interface is available on both the TEA Device and TEA IBS app. The user can power on/off the device, adjust treatment time and treatment intensity. Treatment time is adjustable within the of range 5~240 minutes per treatment session with a maximal operating time of 8.6 hours per day. In addition, there is over-load, over-current and no-load protection as well as an automatic shut-off function. The Bluetooth transceiver module is responsible for communication between the TEA Device and TEA IBS app located on a smartphone.
The provided document describes the Transtimulation Research Inc.'s Transcutaneous Electrical Applicator (TEA) Device (Model: SNM-FDC01) and its substantial equivalence to a predicate device, the IB-Stim.
The acceptance criteria are derived from the special controls for devices under 21 CFR 876.5340, as well as general performance requirements for medical devices. The study provided focuses on the clinical effectiveness of the device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Patient-contacting components must be demonstrated to be biocompatible (ISO 10993-1, G95-1). | Biocompatibility evaluation conducted (Cytotoxicity, Irritation tests). The TEA pads and Device were evaluated for skin contact for prolonged use (>24 hours to 30 days). Outcome: Testing demonstrated compliance. |
| Electrical Safety & EMC | Electromagnetic compatibility, electrical, mechanical, and thermal safety testing must be performed (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-1-2). | Electrical safety and EMC testing conducted. Outcome: The system complies with IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10 for safety and IEC 60601-1-2 for EMC. |
| Battery Safety | Battery evaluation must be performed (IEC 62133-2). | Battery evaluation conducted. Outcome: Compliance demonstrated to IEC 62133-2. |
| Wireless/Radio Testing | Radio and wireless testing (FCC 47 CFR Part 15 Subpart C, ANSI IEEE C63.27). | Compliance demonstrated to FCC 47 CFR Part 15 Subpart C, ANSI IEEE C63.27 for radio and wireless testing. Outcome: Compliance demonstrated. |
| Electrical Performance | Electrical performance testing of the device and electrodes must be conducted to validate specified electrical output and duration of stimulation. | "The TEA Device and its components were tested to validate the safety and effectiveness of the device. The TEA Device has equivalent performance specifications when compared to the predicate device." "The Model SNM-FDC01 has been previously cleared under K212377 with the identical design and performance specification." Outcome: Implicitly satisfied through testing and previous clearance of a device with identical design/performance. |
| Software Verification & Validation | Software verification, validation, and hazard analysis must be performed (FDA Guidance for Industry and FDA Staff). | Software verification and validation testing conducted, documentation provided. Outcome: Software considered "moderate" level of concern and testing performed as per guidance satisfied requirements. |
| Shelf Life | Shelf-life testing of the electrode pad must be performed to demonstrate continued package integrity and device functionality over labeled shelf life. | Shelf life of the TEA electrode pad demonstrated to be 2 years. Outcome: Satisfied. |
| Clinical Efficacy (for Indication of Use) | Reduction of functional abdominal pain and constipation associated with IBS. | Complete Spontaneous Bowel Movements (CSBMs) per week: TEA group tripled (2.8 ± 2.2) vs. sham (0.9 ± 0.9), P < 0.01. Bristol Stool Form Scale (BSFS) score: TEA group doubled (3.7 ± 1.3) vs. sham (1.8 ± 1.1), P < 0.001. Visual Analog Scale (VAS) for abdominal pain: TEA group was about one third (1.1 ± 1.1) vs. sham (3.1 ± 2.2), P < 0.01. Safety: No adverse effects observed in the TEA group. Outcome: Demonstrated significant benefits in relieving constipation and abdominal pain. |
| Clinical Safety (for Indication of Use) | Device is safe for its intended use. | No adverse effects observed in the TEA group during the 4-week clinical study. Outcome: Device shown to be safe. |
| Labeling | Must include: (i) detailed summary of technical parameters; (ii) warning for clean, intact skin; (iii) instructions for use including electrode placement; (iv) shelf life. | Required labeling components are listed as a special control. The document implies compliance will be met by including these in the final labeling. Outcome: A condition for acceptance, not explicitly tested in this summary. |
2. Sample size used for the test set and the data provenance
- Sample Size for Clinical Study (Test Set): A total of 42 patients (32 female and 10 male) with IBS-C were recruited.
- TEA therapy group: 21 patients
- Sham-TEA therapy group: 21 patients (2 dropped out, so 19 completed the study in this group).
- Data Provenance: The document does not specify the country of origin of the data. It was a prospective, randomized sham-controlled clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document does not detail the use of experts to establish a "ground truth" per se for the clinical study. The efficacy outcomes (CSBMs, BSFS, VAS scores) are patient-reported or clinically measured endpoints, rather than requiring expert adjudication of images or diagnoses. No information is provided about the qualifications of the clinicians or researchers who conducted the study or assessed these endpoints.
4. Adjudication method for the test set
- "Adjudication method" typically applies to expert review of diagnostic tasks (e.g., in radiology studies). This clinical study used direct patient outcomes and measurements (CSBMs, BSFS, VAS scores) as endpoints. Therefore, a formal expert adjudication method like 2+1 or 3+1 is not applicable and not mentioned. The study was randomized and sham-controlled to mitigate bias.
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
- No, an MRMC comparative effectiveness study was not done. This device is a direct treatment device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, the clinical study essentially demonstrates the standalone performance of the TEA device as a treatment. Healthcare professionals apply the device and instruct patients on its use, but the device itself delivers the therapy. The study compares the device's therapeutic effect (TEA group) against a sham control, not against human performance.
7. The type of ground truth used
- For the clinical study, the "ground truth" or primary endpoints were:
- Patient-reported outcomes: Complete Spontaneous Bowel Movements (CSBMs) per week, Bristol Stool Form Scale (BSFS), and Visual Analog Scale (VAS) for abdominal pain. These are direct measures of the patient's condition and response to treatment.
8. The sample size for the training set
- The document describes a clinical study to support the safety and efficacy of the device. This is a testing or validation study, not a training set for an AI/machine learning model. Therefore, no "training set" sample size is applicable or provided in this context.
9. How the ground truth for the training set was established
- As this is not an AI/ML development study, there is no "training set" or corresponding ground truth establishment process to describe. The clinical study was designed to validate the device's performance in a controlled environment.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 14, 2023
Transtimulation Research, Inc. % Eric Bannon Regulatory Consultant AlvaMed. Inc 935 Great Plain Ave. Suite 166 Needham, Massachusetts 02492
Re: K230526
Trade/Device Name: TEA Device Regulation Number: 21 CFR 876.5340 Regulation Name: Nonimplanted Nerve Stimulator For Functional Abdominal Pain Relief Regulatory Class: Class II Product Code: QHH Dated: August 17, 2023 Received: August 18, 2023
Dear Eric Bannon:
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.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-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 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.
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name
Transcutaneous Electrical Applicator (TEA), Model: SNM-FDC01
Indications for Use (Describe)
The Transcutaneous Electrical Applicator (TEA) is a transcutaneous electrical nerve field stimulator system intended to be used in adult patients with functional abdominal pain associated with irritable bowel syndrome (IBS) through application to Cranial Nerves V, VI, IX and X, and the occipital nerves, as an aid in the reduction of pain when combined with other therapies for IBS. TEA device is intended to be used for 7-120 hours per week up to 3 consecutive weeks.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | 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."
{3}------------------------------------------------
| Image: [TRA Transtimulation Research Inc logo] | Traditional 510(k): TEA Device | Page: | 1-1 | |
|---|---|---|---|---|
| 1 | 510(K) SUMMARY (K230526) | |||
| 1.1 | Name and Address of Submitter | |||
| Transtimulation Research, Inc | ||||
| 800 Research Parkway, # 337 | ||||
| Oklahoma City, OK 73104 | ||||
| Phone: 832-202-7068 | ||||
| Jieyun Yin | ||||
| janeyin@transtimulation.com | ||||
| 1.2 | Correspondent/Primary Contact Person | |||
| Eric Bannon | ||||
| Vice President of Regulatory and Clinical Affairs | ||||
| AlvaMed, Inc. | ||||
| ebannon@alvamed.com | ||||
| Phone: +1 (781) 710-8243 | ||||
| Fax: +1 (617) 249-0955 | ||||
| 1.3 | Submission Information | |||
| Date Summary Prepared: | September 9, 2023 | |||
| Device Name: | Transcutaneous Electrical Applicator (TEA), Model: SNM FDC01 | |||
| Common Name: | TEA Device | |||
| Code, Regulation Number: | QHH, 21 CFR 876.5340 | |||
| Regulation Description: | Nonimplanted nerve stimulator for functional abdominal pain relief | |||
| Device Classification: | Class II | |||
| Review Panel: | Neurology |
{4}------------------------------------------------
Page:
Predicate and Reference Device 1.4
The predicate and reference device are listed below:
| Predicate Device | Reference Device | |
|---|---|---|
| 510(k)Number | DEN180057 | K212377 |
| Device Name | IB-Stim | Transcutaneous Electrical Applicator (TEA),Model: SNM-FDC01 |
| SubmitterName | Innovative Health Solutions, Inc. | Ningbo MedKinetic Medical Device Co., Ltd. |
| Regulation | 21 CFR 876.5340 - Nonimplantednerve stimulator for functionalabdominal pain relief | 21 CFR 882.5890 - Transcutaneouselectrical nerve stimulator for pain relief |
| Classification | Class II | Class II |
| Code | QHH | NUH, NYN |
1.5 Device Description
The TEA Device is a non-invasive, battery-operated, prescription-based transcutaneous electrical nerve field stimulator indicated for use in adult patients with functional abdominal pain associated with the irritable bowel syndrome (IBS).
The system includes the following components: TEA Device, lead cable, USB charging cable, USB power adapter, electrode pads, holding clip, and TEA IBS app. The device can be used in clinical environments (i.e., outpatient clinics and hospitals) and/or at home.
The TEA Device is powered by an internal rechargeable lithium polymer battery and uses a microprocessor to control the working modes, the waveform and strength of the output pulse. The electric pulse generator is based on a current source circuit. The power management module contains a DC-DC boost conversion circuit that provides the required voltage for the electric pulse generator. The TEA Device is able to connect with the TEA IBS app, which is located on a smartphone. The user interface is available on both the TEA Device and TEA IBS app. The user can power on/off the device, adjust treatment time and treatment intensity. Treatment time is adjustable within the of range 5~240 minutes per treatment session with a maximal operating time of 8.6 hours per day. In addition, there is over-load, over-current and no-load protection as well as an automatic shut-off function. The Bluetooth transceiver module is responsible for communication between the TEA Device and TEA IBS app located on a smartphone.
{5}------------------------------------------------
Page:
- 1.6 Summary of Substantial Equivalence Comparison to the Predicate Device
The subject device has the same intended use and similar technological characteristics as the predicate device. A minor population difference in the indication (modification in the patient population from pediatric to adult) does not alter the intended use and does not affect the device's safety and efficacy. The reference device was selected to support scientific methodology or standard reference values. The comparison of the subject device with the predicate and reference devices is shown in Table 1.
{6}------------------------------------------------
| Image: TRI Transtimulation Research Inc logo | Traditional 510(k): TEA Device | Page: |
|---|---|---|
| TranstimulationResearch Inc | 1-4 |
Table 1: Comparison of Subject Device with Predicate and Reference Devices
I
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| K Number | TBD | DEN180057 | K212377 |
| Manufacturer | Ningbo MedKinetic Medical Device Co., Ltd. | Innovative Health Solutions, Inc. | Ningbo MedKinetic Medical Device Co., Ltd. |
| Device Trade Name | Transcutaneous Electrical Applicator (TEA),Model SNM-FDC01 | IB-Stim | Transcutaneous Electrical Applicator (TEA), ModelSNM-FDC01 |
| Common Name | TEA Device | IB-Stim | TEA Device |
| Regulation Number | 21 CFR 876.5340 | 21 CFR 876.5340 | 21 CFR 882.5890 |
| RegulationDescription | Non-Implanted Nerve Stimulator for PainAssociated with Irritable Bowel Syndrome(IBS) | Non-Implanted Nerve Stimulator for PainAssociated with Irritable Bowel Syndrome (IBS) | Transcutaneous electrical nerve stimulator for painrelief |
| DeviceClassification | Class II | Class II | Class II |
| Product Code | QHH | QHH | NUH, NYN |
| Device Panel | Neurology | Neurology | Neurology |
| Indications for Use | The Transcutaneous Electrical Applicator(TEA) is a transcutaneous electrical nervefield stimulator system intended to be used inadult patients with functional abdominal painassociated with irritable bowel syndrome (IBS)through application to Cranial Nerves V, VII,IX and X, and the occipital nerves, as an aid inthe reduction of pain when combined withother therapies for IBS. TEA device isintended to be used for 7-120 hours per weekup to 3 consecutive weeks. | The IB-Stim is a Percutaneous Electrical NerveField Stimulator (PENFS) system intended to beused in patients 11-18 years of age withfunctional abdominal pain associated with theirritable bowel syndrome (IBS). The IB-Stim isintended to be used for 120 hours per week up to3 consecutive weeks, through application tobranches of Cranial nerves V, VI, IX and X andthe occipital nerves identified by transilluminationas an aid in the reduction of pain when combinedwith other therapies for IBS. | Transcutaneous Electrical Applicator (TEA) is anOver-The-Counter device to be used by adults onlyfor temporary relief of pain associated with sore andaching muscles in the shoulder, waist, back, neck,arm, and leg, due to strain from exercise or normalhousehold work activities and suitable for home use. |
| Location of Use | Cranial Nerves V, VII, IX and X, and theoccipital nerves | Cranial Nerves V, VII, IX and X, and the occipitalnerves | Sore and aching muscles in the shoulder, waist,back, neck, arm, and leg |
| Patient Population | Adult | Child | Adult |
{7}------------------------------------------------
| Image: Logo | Traditional 510(k): TEA Device | Page: |
|---|---|---|
| TRTranstimulationResearch Inc | 1-5 |
1.7 Performance Testing Summary
The TEA Device and its components were tested to validate the safety and effectiveness of the device. The TEA Device has equivalent performance specifications when compared to the predicate device. The Model SNM-FDC01 has been previously cleared under K212377 with the identical design and performance specification. In addition, that the electrode pad has been previously cleared under K182111 with the identical design and performance specification
The following performance data were provided in support of the substantial equivalence:
Biocompatibility Testing
The biocompatibility evaluation for the TEA Device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
Cytotoxicity
Irritation
The TEA pads and Device were evaluated for skin contact for prolonged use (>24 hours to 30 days)
Electrical safety, electromagnetic compatibility, wireless testing
Electrical safety and EMC testinq were conducted on the TEA Device. The system complies with the IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC. Battery evaluation was conducted to IEC 62133-2.
In addition, compliance was demonstrated to FCC 47 CFR Part 15 Subpart C, ANSI IEEE C63.27 for radio and wireless testing.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern,
Shelf Life
The shelf life of the TEA electrode pad was demonstrated to be 2 years.
1.8 Clinical Studies
Data from a randomized sham-controlled clinical study is submitted to support the safety and efficacy of the TEA Device.
{8}------------------------------------------------
| Image: TRI Logo | Traditional 510(k): TEA Device | Page: |
|---|---|---|
| TranstimulationResearch Inc | 1-6 |
A total of 42 patients (32 female and 10 male) with IBS-C were recruited and randomly allocated to: 1) 4-week TEA therapy group or 2) 4-week sham-TEA therapy group. 21 patients were recruited, with 2 patients in the sham-TEA therapy group dropping out during the study, so only 19 patients completed the study in the sham-TEA therapy group. Constipation was evaluated using the complete spontaneous bowel movements (CSBMs) per week and Bristol stool form scale (BSFS), while the abdominal pain was measured using the visual analog scale (VAS).
Evaluations of constibation and abdominal pain were performed at baseline and after the 4week therapy with either therapy performed daily for 1 hour (30 minutes in the morning and 30 minutes in the evening), with two TEA electrode pads applied bilaterally at the auricular cymba concha (one electrode on each cymba concha) and two TEA electrode pads applied bilaterally at the sham location of elbow area (one electrode on each elbow).
After the 4-week period, the number of CSBMs/week in the TEA group tripled in comparison with the sham-TEA group (2.8 ± 2.2 vs. 0.9 ± 0.9, P < 0.01), the BSFS score in the TEA group doubled in comparison with the sham-TEA group (3.7±1.3 vs. 1.8 ± 1.1, P < 0.001), and the VAS score in the TEA group was about one third of that in the sham-TEA group (3.1 ± 2.2 versus 1.1 ± 1.1, P < 0.01). No adverse effects were observed in the TEA group.
Based on these results, the study concluded that the 4-week daily TEA therapy produced considerable benefits to patients in relieving the symptoms of constipation and abdominal pain without introducing any significant risks. In summary, the TEA therapy was shown to be safe and effective treatment of constipation and abdominal pain in IBS.
1.9 Special controls
Per regulation 21 CFR 876.5340 the special controls for this device are as follows:
- . The patient-contacting components of the device must be demonstrated to be biocompatible.
- . Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed.
- . Electrical performance testing of the device and electrodes must be conducted to validate the specified electrical output and duration of stimulation of the device.
- . Software verification, validation, and hazard analysis must be performed.
- Sterility testing of the percutaneous components of the device must be performed. .
- Shelf-life testing of the electrode pad must be performed to demonstrate continued . package integrity and device functionality over the labeled shelf life.
- . Labeling must include the following:
(i) detailed summary of the technical parameters;
{9}------------------------------------------------
| Image: TRI LogoTranstimulation Research Inc | Traditional 510(k): TEA Device | Page:1-7 |
|---|---|---|
| ------------------------------------------------- | -------------------------------- | -------------- |
(ii) warning stating that the device is only for use on clean, intact skin;
- (iii) instructions for use, including the electrode placement on the patient; and
- (iv) shelf life (for the electrode pad)
1.10 Conclusion
The subject device has the same principle of operation and similar technological characteristics as the predicate. A minor population difference in the indication (modification in the patient population from pediatric to adult) does not alter the intended use and does not affect the device's safety and efficacy. Any differences identified in the technological characteristics do not raise any issues of safety or effectiveness.
The subject device has the required performance data, including bench, biocompatibility, and clinical data, indicating compliance with standards.
We therefore consider the Transcutaneous Electrical Applicator (TEA) to be substantially equivalent to the predicate and reference device listed above. The information presented in this 510(k) supports the subject device as safe, effective, and performs as well as the predicate device.
§ 876.5340 Nonimplanted nerve stimulator for functional abdominal pain relief.
(a)
Identification. A nonimplanted nerve stimulator for functional abdominal pain relief is a device that stimulates nerves remotely from the source of pain with the intent to relieve functional abdominal pain. This generic type of device does not include devices designed to relieve pelvic pain.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed.
(3) Electrical performance testing of the device and electrodes must be conducted to validate the specified electrical output and duration of stimulation of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Sterility testing of the percutaneous components of the device must be performed.
(6) Shelf life testing must be performed to demonstrate continued sterility, package integrity, and device functionality over the labeled shelf life.
(7) Labeling must include the following:
(i) A detailed summary of the device technical parameters;
(ii) A warning stating that the device is only for use on clean, intact skin;
(iii) Instructions for use, including placement of the device on the patient; and
(iv) A shelf life.