(124 days)
The Primary Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for up to 3 days for symptomatic relief of post-operative pain following cesarean section delivery.
The Primary Relief is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over 3 days / 72 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the branches of cranial nerves on the ear through a set of wire assembly and stimulation needles. Three zinc air batteries with 1.4 V each provide the required stimulation energy for 72 hours. There are three stimulation electrode and one ground electrode which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The stimulation pattern consists of rectangular pulses with differing inter-pulse intervals. A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.
Here's a breakdown of the acceptance criteria and study details for the DyAnsys Primary Relief device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list "acceptance criteria" in the traditional sense of specific quantitative thresholds the device needed to meet. Instead, it focuses on demonstrating substantial equivalence to a predicate device (SPRINT PNS System) and safety/effectiveness through clinical and non-clinical testing.
Here’s a table summarizing the performance aspects evaluated and the reported results:
| Feature/Criterion | Acceptance/Evaluation Approach | Reported Device Performance | Comments |
|---|---|---|---|
| Preamble (Substantial Equivalence) | Comparison to predicate device (SPRINT PNS System K202660) and reference device (Drug Relief K173861) based on intended use, indications for use, and basic operating principle. | Demonstrated substantial equivalence to identified predicate device. | Formally stated as the conclusion of the 510(k) submission. |
| Indications for Use | Show that the indications for use do not alter the intended therapeutic use or affect safety/effectiveness relative to the predicate. | "The Primary Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for up to 3 days for symptomatic relief of post-operative pain following cesarean section delivery." | Differs from predicate but deemed not to raise new safety/effectiveness questions. |
| Technological Characteristics | Comparison of design, power, pulse characteristics, battery, dimensions, materials, etc., with predicate(s). | Minor technological differences (electrode placement, duration of patient contact) do not raise new safety/effectiveness questions. | Detailed comparisons provided in Tables 6.1 and 6.2. |
| Electrical Safety (EMC & Safety) | Nonclinical testing | Performed and validated effectiveness. | Standard regulatory requirement for electrical devices. |
| Biocompatibility | Nonclinical testing | Performed. | Essential for devices with tissue contact. |
| Performance Bench Testing | Validate effectiveness of each unit, verify and compare effectual output with reference device, monitor continuous performance for 72 hours. | Equivalent performance specifications when compared to predicate and reference devices. Pulse width, duration, amplitude, and current values captured for Drug Relief. | Confirms functional integrity and consistency. |
| Software Verification & Validation | Nonclinical testing | Performed. | Ensures software functions as intended and safely. |
| Primary Efficacy Endpoint (Pain Intensity Reduction) | Clinical study: Comparison of pain scores (NRS) between intervention (Primary Relief) and control (standard analgesics) groups. | Minimally invasive nerve stimulation reduces pain score faster. High least-square means difference post six hours (p-value < 0.001) suggests intervention is more effective. | Specific quantitative acceptance criteria (e.g., % reduction) for pain relief are not explicitly stated, but statistical significance is reported. |
| Secondary Efficacy Endpoints (Quality of Life) | Clinical study: Assessment of six quality of life measures using NRS. | Significant positive response in the device intervention group (p-value < 0.04) compared to the control group. | Shows improvement beyond just pain scores. |
| Safety (Adverse Events) | Clinical study: Monitoring for complications and adverse events during the study and follow-up. | No complications or adverse events were observed in any participants during the study period across the two arms. | Crucial for demonstrating safety. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: 44 participants.
- Intervention group: 22 participants (mean age = 24.7 ± 2.6 years)
- Control group: 22 participants (mean age = 26.6 ± 3.9 years)
- Data Provenance: Single center, prospective study. The country of origin is not explicitly stated in the provided text, but the company address is San Mateo, CA, USA, suggesting the study likely took place in the US or was conducted under US regulatory standards.
3. Number of Experts and Qualifications for Ground Truth
- The ground truth in this study is based on patient-reported outcomes using the Numerical Rating Scale (NRS) for pain intensity and quality of life measures.
- No external experts were explicitly stated to establish ground truth for individual cases in the test set. The patients themselves provided the primary data. Medical professionals would have been involved in the administration of the study, data collection, and assessment of participants, but not in establishing an "expert ground truth" as might be seen in imaging studies.
4. Adjudication Method
- None as described. The primary and secondary endpoints were measured directly from patient self-reports using the Numerical Rating Scale (NRS). This method does not typically involve an adjudication process among experts for interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This was a clinical trial comparing a device to a control group for pain relief, not an MRMC study comparing human reader performance with and without AI assistance for interpretation tasks. The device itself is a therapeutic stimulus, not an AI diagnostic aid.
6. Standalone (Algorithm Only) Performance
- Yes, in the sense of the device operating independently. The Primary Relief device is a therapeutic device that delivers electrical stimulation. Its "performance" refers to its ability to generate specific electrical pulses and the clinical outcome from those pulses.
- The "standalone performance" was evaluated through:
- Performance bench testing: Validating effectiveness of each unit, comparing effectual output with a reference device, and monitoring continuous performance for 72 hours.
- Clinical study: The device was administered to the intervention group without human-in-the-loop interpretation or modification of its core function during the treatment period. The human "in the loop" was the prescriber and the patient. While a healthcare professional inserts the needles, the device then operates autonomously to deliver stimulation.
7. Type of Ground Truth Used
- Patient-reported outcomes: Specifically, the Numerical Rating Scale (NRS) for:
- Pain intensity (primary efficacy endpoint)
- Six measures intended to assess quality of life (secondary efficacy endpoints)
8. Sample Size for the Training Set
- Not applicable / Not explicitly mentioned. The provided document describes a clinical study to evaluate the device, not a machine learning model that would have a "training set." The Primary Relief device is a hardware therapeutic device, not an AI algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no machine learning component described, there is no "training set" or "ground truth for the training set" in the context of AI development.
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January 31, 2022
DyAnsys, Inc. Srini Nageshwar CEO 300, North Bayshore Boulevard San Mateo, California 94401
Re: K213188
Trade/Device Name: Primary Relief Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NHI Dated: December 25, 2021 Received: December 27, 2021
Dear Srini Nageshwar:
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.
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
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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 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).
Sincerely,
Amber Ballard, PhD 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
Enclosure
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Indications for Use
510(k) Number (if known) K213188
Device Name Primary Relief
Indications for Use (Describe)
The Primary Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for up to 3 days for symptomatic relief of post-operative pain following cesarean section delivery .
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a stylized red symbol resembling an arrow or a checkmark, followed by the company name "DyAnsys" in black font. A circled "R" symbol, indicating a registered trademark, is positioned to the upper right of the company name.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87 and 21 CFR 807.92.
510(k) Number: K213188
I. SUBMITTER
| Date Prepared: | January 31, 2022 |
|---|---|
| Name: | DyAnsys, Inc |
| Address: | 300, North Bayshore Boulevard,San Mateo, CA 94401, USA |
| Contact Person: | Srini Nageshwar |
| Phone Number: | 408.480.4700 |
| Facsimile Number: | (650)-556-1621 |
II. DEVICE INFORMATION
Trade Name: Primary Relief Classification Name: Percutaneous Electrical Nerve Stimulation (PENS) devices (21 CFR 882.5890) Device Class: Class II Product Code: NHI
III. PREDICATE DEVICE INFORMATION
Model Name: SPRINT PNS System (K202660) Manufacturer: SPR Therapeutics, Inc. Classification Name: Percutaneous Electrical Nerve Stimulation (PENS) devices (21 CFR 882.5890) Device Class: Class II Product Code: NHI
Drug Relief (K173861) manufactured by our company has been used as reference device in this submission.
IV. DEVICE DESCRIPTION
The Primary Relief is designed to aid in the reduction of post-operative pain by the method of cranial electrical stimulation at the auricular stimulation points. The Primary Relief is a wearable, batteryoperated device that is designed to administer periodical low level electrical pulses to the ear over 3 days / 72 hours from the time of activation of the device.
The electrical pulse from the device will be delivered to the branches of cranial nerves on the ear through a set of wire assembly and stimulation needles. Three zinc air batteries with 1.4 V each
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Image /page/4/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a stylized red symbol to the left of the company name, "DyAnsys," which is written in black. A circled "R" symbol, indicating a registered trademark, is located in the upper right corner of the logo.
provide the required stimulation energy for 72 hours. There are three stimulation electrode and one ground electrode which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves.
The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device.
This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin.
The stimulation pattern consists of rectangular pulses with differing inter-pulse intervals.
A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance
V. INDICATIONS FOR USE
The Primary Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for up to 3 days for symptomatic relief of post-operative pain following cesarean section delivery.
The Indications for Use statement of Primary Relief is not identical to that of the predicate device; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The DyAnsys, Inc Primary Relief system is substantially equivalent to the legally marketed predicate device SPRINT PNS System (K202660). It was evaluated through performance and nonclinical testing.
| MODEL NAME | Primary Relief(Subject) | SPRINT PNS System(K202660 - Predicate) | Drug Relief(K173861 - Reference) |
|---|---|---|---|
| MANUFAC-TURER | DyAnsys Inc. | SPR Therapeutics | DyAnsys Inc. |
| Indications for Use Statement |
| Table 6.1: Comparison of Technological Characteristics | ||||
|---|---|---|---|---|
| INDICATIONSFOR USE | The Primary Relief is apercutaneous electricalnerve stimulator (PENS)system indicated for up to3 days for symptomaticrelief of post-operativepain following cesareansection delivery. | The SPRINT PeripheralNerve Stimulation (PNS)System is indicated for upto 60 days in the back and/or extremities for:• Symptomatic relief ofchronic, intractable pain,post surgical and post-traumaticacute pain;• Symptomatic relief ofpost-traumatic pain;• Symptomatic relief ofpost-operative pain. | The Drug Relief is apercutaneous nerve fieldstimulator system thatcan be used as an aid toreduce the symptoms ofopioid withdrawal,through application tobranches of cranialnerves V, VII, IX and X,and the occipital nervesidentified bytransillumination. | |
| PATIENTPOPULATION | Adults | UNK | Adults | |
| SINGLE USEELECTRODES | Yes | UNK | UNK | |
| PORTABLECOMPONENTS | Yes | UNK | UNK | |
| TECHNOLOGICAL CHARACTERISTICS | ||||
| PULSE GENERATOR | ||||
| PRODUCTDIMENSION(mm) | 50 * 23 * 7 | UNK | 50 * 23 * 7 | |
| MASS (g) | 8 (including battery) | UNK | 6 (including battery) | |
| PRODUCTSHAPE | Rectangle | UNK | Rectangle | |
| POWER | ||||
| FREQUENCY(Hz) | 1 - 100 (Sweep Pattern) | UNK | 1 - 10 | |
| WAVEFORM | Biphasic withRectangular Pulse | UNK | RectangularPulse | |
| BATTERYTYPE | P13 Zinc Air batteries | UNK | P10 Zinc Air batteries | |
| BATTERYCAPACITY(mAh) | 310 | UNK | 100 | |
| NO. xVOLTAGE (V) | 3 x 1.4 V | UNK | 3 x 1.4 V | |
| PULSEWIDTH(ms) | ~ 0.980 | UNK | ~ 0.980 | |
| DUTY CYCLE | Continuous (0 hrs OFF) | UNK | 2 hours ON / 1 min OFF | |
| TYPICALBATTERYOPERATINGTIME (hours) | 72 | -UNK | 120 | |
| ENVIRONMENTAL | ||||
| ENVIRONMENT OF USE | Clinics, Hospital andHome environments | UNK | Clinics, Hospital andHome environments | |
| STERILIZATION OFELECTRODES | EtO Sterilization | UNK | EtO Sterilization | |
| RE-USE | Single use Device | UNK | Single use Device | |
| SHELF LIFE | 6 months | 24 months | 6 months | |
| UNK = Not able to determine from publicly available documents.* = Duty Cycle is mentioned as a percentage in the cleared 510(k) summary of predicate device. |
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Image /page/5/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a stylized symbol resembling an arrow or greater-than sign combined with a curved line, followed by the text "DyAnsys" in a clean, sans-serif font. A circled "R" symbol, indicating a registered trademark, is positioned to the upper right of the text.
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Table 6.2: Comparison of System Characteristics
| SystemCharacteristic | Primary Relief(Subject) | SPRINT PNS System(K202660 - Predicate) | Drug Relief(K173861 - Reference) |
|---|---|---|---|
| Pulse Generator | |||
| SoftwareControlled | Yes | UNK | Yes |
| HousingMaterial | ABS Plastic Material | UNK | UNK |
| Electrode Needle Arrays | |||
| IntroductionMethod | Percutaneous | UNK | UNK |
| Tissue Contact | Skin/Tissue | UNK | UNK |
| Electrode Type | Percutaneous fine needle | UNK | UNK |
| StimulatingElectrodeMaterial | Titanium | UNK | Titanium |
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| Stimulatingelectrode shape | Straight | UNK | UNK |
|---|---|---|---|
| ElectrodeConfiguration | Single needle in all the 4leads | UNK | Single needle in all the 4leads |
| Number of leads | 4 (3 signal and 1 ground) | UNK | 4 (3 signal and 1 ground) |
| Diameter ofpercutaneousextension (mm) | 0.4 | UNK | 0.4 |
| Electrode Length(mm) | 2 | UNK | 2 |
| Surface area ofneedle (cm2) | 0.0201 cm² | UNK | 0.0201 cm² |
| Supplied Sterile | Yes | UNK | UNK |
Similar to SPRINT PNS system and Drug Relief, the Primary Relief device is intended to be a prescription (Rx) device for use by or on the order of a licensed healthcare practitioner. All the three devices are body-worn and deliver electrical stimulation therapy for symptomatic relief and management of pain.
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The first minor technological difference lies in the placement of electrodes and the electrode configuration. The flexible SPRINT PNS percutaneous stimulation electrode passes through the skin to a target peripheral nerve associated with a painful area, either in the back or extremities. In contrast, the Primary Relief stimulation electrodes pass through the skin to a depth of 2 mm on the ear to target the associated cranial and occipital nerves of the pain region. The ground electrode of SPRINT PNS is placed transcutaneously whereas that of Primary Relief is placed percutaneously similar to the stimulation electrodes. These differences do not raise any new questions on safety and effectiveness, as both designs pass through the skin and stay in place for the appropriate treatment period, and safely deliver electrical stimulation for the desired short-term period. The clinical study results along with the identical design present in the Drug Relief device show that the device is safe to use on patients for pain management.
The second minor difference is in the duration of patient contact where the SPRINT PNS system is applied for up to 60 days whereas that of the Primary Relief system is up to 3 days. This difference does not raise any new questions on safety and effectiveness.
Results from the clinical study have demonstrated the safety of the therapy and there were no serious adverse events observed during the study and the follow-up period.
Along with results from clinical study, performance bench testing has been performed to establish substantial equivalence of Primary Relief to the cited predicate device. The reference device has been utilized in comparison bench testing to denote the equivalent output characteristics. Hence, evaluation of the effect of the technological differences supports the finding of substantial equivalence.
VII. Performance Data
The nonclinical testing of Primary Relief device included biocompatibility testing, electrical safety (electromagnetic compatibility and safety), performance bench testing and software verification and validation.
The Primary Relief device and its components are subjected to performance bench testing to validate the effectiveness of each unit. The final product testing is performed to verify and compare the effectual output along with that of the reference device. The functional test is performed for 72 hours to monitor the continuous performance. The pulse width, pulse duration, amplitude and current values are captured for the Drug Relief device. The Primary Relief has equivalent performance specifications when compared to the predicate and reference devices.
Clinical testing results presented with this submission have demonstrated the safety of the therapy. No serious adverse events were observed during the study.
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VIII. Summary of Clinical Information
This was a single centre, double arm, randomized, controlled, parallel assignment prospective study involving 44 participants who underwent Cesarean section (C-section) delivery. The subjects were split into the intervention group (mean age = 24.7 ± 2.6 years) who received the Primary Relief device as the primary method of analgesia and the control group (mean age = 26.6 ± 3.9 years) who received standard analgesics for management of post-operative pain.
The primary efficacy endpoint is pain intensity and the secondary efficacy endpoints included six measures intended to assess the quality of life. The Participants were asked to rate the primary and secondary endpoints on the validated and widely used Numerical Rating Scale (NRS) at 23 intervals spanning 72 hours.
The analysis showed that minimally invasive nerve stimulation intervention using Primary Relief device reduces the pain score faster than the standard control treatment. A very high least-square means difference post six hours suggests that the intervention treatment is clearly more effective in reducing the pain score compared to the treatment received by the control arm (p-value < 0.001). Further analysis on the secondary endpoints also showed a sigmificant positive response in the device intervention group (p -value < 0.04) compared to the control group.
No complications or adverse events were observed in any of the participants during the study period across the two arms.
IX. Conclusion
Primary Relief system has been shown to be substantially equivalent to the identified predicate device based on comparison of device classification, intended use, indications for use statement and basic operating principle. Clinical and non-clinical testing shows the suitability of Primary Relief for its intended use of relieving post-operative pain following C-section delivery.
§ 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).