(103 days)
The First Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for multiple treatments up to 56 days for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy.
The First Relief is designed to aid in the treatment of chronic pain symptoms by the method of cranial electrical stimulation at the auricular stimulation points. The First Relief is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over seven days / 168 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 168 hours. There 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.
Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and the study proving it:
The provided 510(k) Summary for the "First Relief" device (K212859) describes a clinical study to support its substantial equivalence to a predicate device. However, it does not present specific quantitative acceptance criteria or reported device performance in a direct comparison table as requested. Instead, it discusses the outcomes of the clinical study, focusing on statistical significance of pain and other related scores, and states that these "demonstrated the safety of the therapy" and "showed similar improvements."
There is no mention of a "test set" and its specific characteristics (sample size, data provenance), "ground truth" establishment, "adjudication method," or "MRMC comparative effectiveness study" in the context of specific quantitative metrics for acceptance. The study is a comparative clinical trial, not an AI or imaging-based device study that would typically involve those details.
Based on the provided text, I will present the information that is available and clearly state what is not available as per your request.
1. Table of acceptance criteria and the reported device performance:
As mentioned, the document does not explicitly state quantitative acceptance criteria (e.g., "VAS score reduction of X points is acceptable") or a direct comparison table of these criteria against reported device performance, which is common for algorithm-based devices. Instead, it describes the results of a clinical trial designed to show improvement. Therefore, the "reported device performance" below reflects the observed clinical outcomes rather than directly matching pre-defined acceptance criteria.
| Acceptance Criteria (Explicitly stated in document) | Reported Device Performance (Observed Clinical Outcomes) |
|---|---|
| Primary Efficacy Endpoint: | |
| Visual Analog Scale (VAS) score reduction | Group B (First Relief): Significant reduction that persisted for 90-day follow-up. |
| Group A (First Treatment Arm - likely a different configuration or use of First Relief): Marked improvement (3.12 reduction). | |
| Group C (Sham): 1.18 reduction (control). | |
| Secondary Efficacy Endpoints: | |
| Vibration Perception Threshold (VPT) value | Showed similar improvements to pain score. |
| Insomnia Severity Index (ISI) | Showed similar improvements to pain score, significant improvement in sleep. |
| Overall Neuropathy Limitations Scale (ONLS) | Group B: Significant difference in reduction compared to Group C (Adj. P-value = 0.007). |
| Hamilton Rating Scale for Anxiety - A (HAM-A) | Group B: Significant difference in reduction compared to Group C (Adj. P-value <0.001). |
| Safety: | |
| No serious adverse events | No serious adverse events observed during the study and follow-up. |
Note: The document distinguishes between "Group A" and "Group B" as "First Treatment Arm" and "Second Treatment Arm," respectively. However, in the section "However, treatment B (First Relief device) was the more effective one at reducing the ONLS and HAM scores over the long term," it clarifies that "treatment B" refers to the First Relief device, while also stating earlier that "Patients in two out of the three arms received the First Relief (Group A - first treatment arm)". This creates a slight ambiguity in direct mapping, but the key takeaway is that the First Relief device was associated with significant improvements in Group B.
2. Sample size used for the test set and the data provenance:
- Sample Size (Clinical Study): 63 patients
- Data Provenance: Single center, prospective study. The document does not specify the country of origin, but given the FDA submission, it is likely a US-based study or a study accepted by the FDA.
- Test Set Description: Patients (30-74 years old; mean age = 57.0 ± 9.1 years) with Type II diabetes and diabetic peripheral neuropathy. Included patients were 18-75 years of age, with known diabetes mellitus for a minimum of 5 years, and diabetic neuropathic pain based on Toronto Expert Panel criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The clinical trial relied on patient-reported outcomes (e.g., VAS, ISI, HAM-A) and objective measurements (VPT, ONLS) that are standard in clinical research, rather than expert-established ground truth in the context of interpretation of medical images or diagnostic tests. Diabetic peripheral neuropathy diagnosis was made after "a careful clinical examination."
4. Adjudication method for the test set:
This information is not provided as it is not a study focused on a "test set" in the context of independent evaluation of output from an algorithm needing adjudication. The clinical trial was double-blinded, implying that neither the patients nor the clinicians assessing outcomes knew if the patient was receiving the active device, the sham device, or the comparison device. This is a form of blinding to reduce bias, but not "adjudication" in the sense of resolving discrepancies in expert interpretations.
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 type of study is typically performed for AI/CADe systems that assist human readers in tasks like image interpretation. The "First Relief" is a therapeutic electrical nerve stimulator, not an AI software intended to assist human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a physical medical device with a specific therapeutic function, not an AI algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable. The device operates independently once applied, delivering electrical stimulation.
7. The type of ground truth used:
- The "ground truth" in this clinical study (rather than an imaging or diagnostic study context) was based on patient-reported outcomes and objective clinical assessments of pain, nerve function, sleep, and anxiety.
- Pain Intensity: Visual Analog Scale (VAS) score (patient-reported).
- Nerve Function: Vibration Perception Threshold (VPT) value (objective measurement).
- Insomnia: Insomnia Severity Index (ISI) (patient-reported).
- Neuropathy Limitations: Overall Neuropathy Limitations Scale (ONLS) (likely clinician-assessed based on functional limitations).
- Anxiety: Hamilton Rating Scale for Anxiety - A (HAM-A) (clinician-assessed based on interview).
- Diabetic peripheral neuropathy diagnosis: "made after a careful clinical examination" based on Toronto Expert Panel criteria.
8. The sample size for the training set:
This information is not applicable and not provided. The "First Relief" is a physical medical device, not an AI/ML algorithm that requires a "training set." The clinical study described served as validation for its safety and effectiveness.
9. How the ground truth for the training set was established:
This information is not applicable and not provided for the reasons stated in point 8.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
December 20, 2021
DyAnsys, Inc. Srini Nageshwar CEO 300, North Bayshore Boulevard San Mateo. California 94401
Re: K212859
Trade/Device Name: First Relief Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NHI Dated: August 26, 2021 Received: September 8, 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
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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 (OS) 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,
for Amber Ballard, PhD Assistant Director, Neurodegenerative Devices Team 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) K212859
Device Name First Relief
Indications for Use (Describe)
The First Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for multiple treatments up to 56 days for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
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 red stylized "D" shape followed by the text "DyAnsys" in black. A circled "R" symbol is located to the upper right of the text.
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: K212859
I. SUBMITTER
| Date Prepared: | |
|---|---|
| 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: | First Relief |
|---|---|
| Classification Name: | Percutaneous Electrical Nerve Stimulation (PENS) device(21 CFR 882.5890) |
| Device Class: | Class II |
| Product Code: | NHI |
III. PREDICATE DEVICE
Model Name: SPRINT PNS System (K202660, K181422, K170902, K161154) Manufacturer: SPR Therapeutics, Inc.
First Relief v1 (K202940) manufactured by our company has been used as reference device in this submission.
Both the predicate and reference devices have not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The First Relief is designed to aid in the treatment of chronic pain symptoms by the method of cranial electrical stimulation at the auricular stimulation points. The First Relief is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over seven days / 168 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 168 hours. There 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.
510(k) Number: K212859
Confidential
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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 registered trademark symbol is located to the upper right of the company name.
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 First Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for multiple treatments up to 56 days for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy.
The Indications for Use statement of First 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. Both the subject and predicate devices have the same intended use of symptomatic relief and management of pain through the delivery of short-term electrical stimulation.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The DyAnsys, Inc First Relief system is substantially equivalent to the legally marketed predicate device SPRINT PNS System (K202660). It was evaluated through performance and non-clinical testing.
| MODEL NAME | First Relief(Subject) | SPRINT PNS System(K202660 - Predicate) | First Relief v1(K202940 - Reference) | |
|---|---|---|---|---|
| MANUFACTURER | DyAnsys Inc. | SPR Therapeutics | DyAnsys Inc. | |
| Intended Use / Indications for Use Statement | ||||
| INTENDED USE | Short-term electricalstimulation is deliveredfor symptomatic reliefand management of pain | Short-term electricalstimulation is deliveredfor symptomatic reliefand management of pain | Short-term electricalstimulation is delivered forsymptomatic relief andmanagement of pain | |
| INDICATIONS FORUSE | The SPRINT PeripheralNerve Stimulation(PNS) System is | The First Relief v1 is apercutaneous electrical nervefield stimulator (PENFS)system intended to be usedin patients 11-18 years of | ||
| The First Relief is apercutaneous electricalnerve stimulator (PENS)system indicated formultiple treatments up to56 days for symptomaticrelief of chronic,intractable pain fromdiabetic peripheralneuropathy. | indicated for up to 60days in the back and/orextremities for:• Symptomatic relief ofchronic, intractable pain,post surgical and post-traumaticacute pain;• Symptomatic relief ofpost-traumatic pain;• Symptomatic relief ofpost-operative pain. | age with functionalabdominal pain associatedwith irritable bowelsyndrome (IBS). The FirstRelief v1 is intended to beused for 120 hours per weekup to 3 consecutive weeks,through application toCranial Nerves V, VII, IXand X, and the occipitalnerves identified by trans-illumination, as an aid in thereduction of pain whencombined with othertherapies for IBS. | ||
| PATIENTPOPULATION | Adults | Adults | Children | |
| SINGLE USEELECTRODES | Yes | Yes | Yes | |
| PORTABLECOMPONENTS | Yes | Yes | Yes | |
| DURATION OFPATIENT CONTACT(days) | 7 days | 60 days | 5 days | |
| NUMBER OFTREATMENTS | 8 times | Once | 3 times | |
| MAXIMUM TOTALDURATION OFTHERAPY (days) | 7 x 8 = 56 days* | 60 x 1 = 60 days | 5 x 3 = 15 days | |
| * Note that the First Relief device is applied for 168 hours per week on alternative weeks for 16 consecutiveweeks resulting in 56 days / 8 weeks of treatment and 49 days / 7 weeks of no device in between. | ||||
| TECHNOLOGICAL CHARACTERISTICS | ||||
| PULSE GENERATOR | ||||
| PRODUCTDIMENSION (mm) | 50 * 23 * 7 | 62 * 37 * 14 | 50 * 23 * 7 | |
| MASS (g) | 5 (including battery) | 24 | 5 (including battery) | |
| PRODUCT SHAPE | Rectangle | Rectangle | Rectangle | |
| POWER | ||||
| FREQUENCY (Hz) | 1 - 10 (Sweep Pattern) | 5 - 100 | 1 - 10 | |
| WAVEFORM | Biphasic withRectangular Pulse | Biphasic withRectangular Pulse | Biphasic withRectangular Pulse | |
| BATTERY TYPE | P10 Zinc Air batteriesthat are non-rechargeable | Rechargeable LithiumIon Polymer cell | P10 Zinc Air batteries thatare non-rechargeable | |
| BATTERYCAPACITY (mAh) | 100 | 240 | 100 | |
| NO. x VOLTAGE (V) | 3 x 1.4 V | 1 x UNK | 3 x 1.4 V | |
| PULSE WIDTH(ms) | 1 | 0.2 | ~1 | |
| DUTY CYCLE | 2 hours ON / 2 hoursOFF | 50 % or 100 % * | 2 hours ON / 2 hours OFF | |
| TYPICAL BATTERYOPERATING TIME(hours) | 168 | 12 - 24 | 120 | |
| ENVIRONMENTAL | ||||
| OPERATINGTEMPERATURE | 5 °C to 45 °C | 5 °C to 40 °C | 5 °C to 45 °C | |
| OPERATINGHUMIDITY | 40% to 80% | 15% to 90% | 40% to 80% | |
| ENVIRONMENT OFUSE | Clinics, Hospital andHome environments | Clinics, Hospital andHome environments | Clinics, Hospital and Homeenvironments | |
| STERILIZATION OFELECTRODES | EtO Sterilization | EtO Sterilization | EtO Sterilization | |
| RE-USE | Single use Device | Single use Device | Single use Device | |
| SHELF LIFE | 6 months | 24 months | 6 months | |
| ACCESSORIES | - First Relief with nonactivated batteries- Top Cover of FirstRelief- Sterile pack of needlesfor use with the FirstRelief device- Adhesive to fasten theneedles- Adhesive for the FirstRelief device- Instruction for use | - OnePass Introducer- MicroLead- Pulse Generator- Hand-Held Remote- Recharging base withpower supply- Mounting pad adhesive- Connectors andAdapter- Adhesive Bandage- Instructions for use | - First Relief v1 with nonactivated batteries- Top Cover of First Reliefv l- Sterile pack of needles foruse with First Relief v1- Adhesive to fasten theneedles- Adhesive for the FirstRelief v1 device- Instruction for use | |
| UNK = Not able to determine from publicly available documents. FDA may have access in cleared 510(k). |
Table 6.1: Comparison of Technological Characteristics
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Image /page/5/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a red symbol resembling a stylized "greater than" sign combined with a curved line, followed by the word "DyAnsys" in black font. A registered trademark symbol is placed to the upper right of the word "DyAnsys".
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Image /page/6/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a red abstract symbol on the left, followed by the text "DyAnsys" in black. A registered trademark symbol is located to the upper right of the text. The logo is simple and modern.
- = Duty Cycle is mentioned as a percentage in the cleared 510(k) summary of predicate device.
| System | First Relief | SPRINT PNS System | First Relief v1 |
|---|---|---|---|
| 510(k) Number: K212859 | Confidential | Page 4 of 8 |
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Image /page/7/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a red symbol that looks like a stylized "A" or an arrow pointing to the right, followed by the word "DyAnsys" in black font. A registered trademark symbol is located to the upper right of the word "DyAnsys".
| Characteristic | (Subject) | (K202660 - Predicate) | (K202940 - Reference) |
|---|---|---|---|
| Pulse Generator | |||
| SoftwareControlled | Yes | Yes | Yes |
| Weight (g) | 5 g | 24 g | 5 g |
| Dimensions(mm) | 50 * 23 * 7 mm | 62 * 37 * 14 | 50 * 23 * 7 mm |
| HousingMaterial | ABS Plastic Material | UNK | ABS Plastic Material |
| Electrode Needle Arrays | |||
| IntroductionMethod | Percutaneous | Percutaneous | Percutaneous |
| Tissue Contact | Skin/Tissue | Skin/Tissue | Skin/Tissue |
| Electrode Type | Percutaneous fine needle | Percutaneous fine wire | Percutaneous fine needle |
| StimulatingElectrodeMaterial | Titanium | 316L Stainless Steel | Titanium |
| Stimulatingelectrode shape | Straight | Straight with tine | Straight |
| ElectrodeConfiguration | Single needle in all the 4leads | 1 pair (1 percutaneouselectrode and 1 surfaceelectrode) | Single needle in all the 4leads |
| Number of leads | 4 (3 signal and 1 ground) | 1 | 4 (3 signal and 1 ground) |
| Diameter ofpercutaneousextension (mm) | 0.4 | 0.64 | 0.4 |
| Electrode Length(mm) | 2 | 15.2 | 2 |
| Surface area ofneedle (cm²) | 0.0201 cm² | UNK | 0.0201 cm² |
| Supplied Sterile | Yes | Yes | Yes |
| System Characteristics (Output Specs) | |||
| Pulse Duration(ms) | 1 | 0.2 | 1 |
| Net Charge (µC /pulse) | 0 ( due to the nature of thebiphasic waveform) | 0 | 0 |
| Where and howit is used | Low levels of electricalcurrent are delivered by theexternal stimulator throughelectrodes placedpercutaneously on the ear to | Low levels of electricalcurrent are delivered bythe external stimulatorthrough electrodesplaced percutaneously | Low levels of electricalcurrent are delivered by theexternal stimulator throughelectrodes placedpercutaneously on the ear to |
| target the associated cranialand occipital nerves. | in proximity to a targetperipheral nerveassociated with apainful area. | target the associated cranialand occipital nerves. | |
| Anodes /Cathodes pleaseidentify theground | The ground electrode ofFirst Relief is a singleisolated wire separated fromthe assembly of signal wires,which creates a closedcircuit for safe and properfunctioning of thestimulation device. | The ground electrode ofSmartPatch PNS is thesurface electrode incontact with thepatient's skin, whichcreates a closed circuitfor safe and properfunctioning of thestimulation devicewhereas the activeelectrode is placed nearthe target nerve. | The ground electrode ofFirst Relief v1 is a singleisolated wire separatedfrom the assembly of signalwires, which creates aclosed circuit for safe andproper functioning of thestimulation device. |
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Image /page/8/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a red symbol that looks like a stylized letter "A" or an abstract shape, followed by the text "DyAnsys" in black font. A circled "R" symbol, indicating a registered trademark, is positioned to the upper right of the word "DyAnsys".
Similar to SPRINT PNS system and First Relief v1, the First 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. All the three devices deliver biphasic electrical stimulation waveforms hence are charge balanced due to the a positive and negative phase between active electrode(s) and the ground electrode.
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 depth of 2-4 cm, to a target peripheral nerve associated with a painful area, either in the lower back or extremities. In contrast, the First 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 First 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 First Relief v1 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 First Relief system is 7 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 First 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.
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Image /page/9/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a stylized red symbol resembling an arrow or checkmark, followed by the text "DyAnsys" in black. A circled "R" symbol, indicating a registered trademark, is positioned to the upper right of the text.
VII. Performance Data
The nonclinical testing of First Relief device included biocompatibility testing, electrical safety (electromagnetic compatibility and safety), performance bench testing and software validation.
The First 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 168 hours to monitor the continuous performance. The pulse duration, amplitude and current values are captured for the First Relief device. The First 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 as the subsequent follow-up period.
VIII. Summary of Clinical Information
This was a single centre, three arm, randomized, controlled, parallel assignment, double blinded, prospective study involving 63 patients (30 - 74 years old; mean age = 57.0 ± 9.1 years) with Type II diabetes established as per American Diabetes Association (ADA guidelines) along with a diagnosis of diabetic peripheral neuropathy made after a careful clinical examination. The inclusion criteria included being 18 to 75 years of age, known diabetes mellitus (KDM) for a duration of minimum of 5 years, and has diabetic neuropathic pain based on Toronto Expert Panel on diabetic neuropathy diagnostic criteria.
Patients in two out of the three arms received the First Relief (Group A - first treatment arm) and sham device (Group C - identical to the subject device but delivers no stimulation and acts as placebo). A third arm included the use of an already cleared FDA device (Group B - 1 Hz stimulation frequency) as the second treatment arm. The devices (treatment and sham) were applied on a bi-weekly basis for 16 weeks and the subjects visited every week either for treatment or followup/removal of the device.
The primary efficacy endpoint is pain intensity measured through Visual Analog Scale (VAS) score and the secondary efficacy endpoints are vibration perception threshold (VPT) value, insomnia severity index (ISI), overall neuropathy limitations scale (ONLS), Hamilton rating scale for anxiety - A (HAM-A). The five endpoints were measured weekly over the study period of 16 weeks. A 30day and 90-day follow-up was also part of the study design to understand the long-term impact of the treatment.
The VAS pain score analysis showed a significant reduction in the pain score in Group B from the start of the treatment to the end. This improvement persisted throughout the 90-day follow-up, suggesting that the treatment was a long term improvement in neuropathic pain and not a short term improvement. Both the treatments showed a marked improvement (3.12 and 3.15 against 1.18 for the control group).
The secondary outcome measures (VPT, Insomnia, ONLS and HAM) also showed similar improvements to the pain score, showing significant improvement in sleep and mood as the neuropathic pain decreased.
510(k) Number: K212859
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Image /page/10/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a red symbol that looks like a stylized "D" or an arrow pointing to the right, followed by the text "DyAnsys" in black. A registered trademark symbol is present to the upper right of the text.
However, treatment B (First Relief device) was the more effective one at reducing the ONLS and HAM scores over the long term.
The post hoc analysis of ONLS scores indicates a significant difference in the reduction of ONLS score in group B compared to group C (Adj. P-value = 0.007). By contrast, the Adj P-value is <0.066 for comparison between A to C for 90-days of follow up.
Similarly, the post hoc analysis of HAM scores indicates a significant difference in the reduction of HAM score in group B compared to group C (Adj. P-value <0.001). In comparison, Adj. P-value is <0.105 for comparison between A to C for 90-days of follow up.
No complications or adverse events were observed in any of the subjects during the study period across three arms.
IX. Conclusion
First 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 First Relief for its intended use.
§ 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).