First Relief

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 /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,<br>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<br>(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 {4}------------------------------------------------ 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<br>(Subject) | SPRINT PNS System<br>(K202660 - Predicate) | First Relief v1<br>(K202940 - Reference) | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | MANUFACTURER | DyAnsys Inc. | SPR Therapeutics | DyAnsys Inc. | | | | Intended Use / Indications for Use Statement | | | | | INTENDED USE | Short-term electrical<br>stimulation is delivered<br>for symptomatic relief<br>and management of pain | Short-term electrical<br>stimulation is delivered<br>for symptomatic relief<br>and management of pain | Short-term electrical<br>stimulation is delivered for<br>symptomatic relief and<br>management of pain | | | INDICATIONS FOR<br>USE | | The SPRINT Peripheral<br>Nerve Stimulation<br>(PNS) System is | The First Relief v1 is a<br>percutaneous electrical nerve<br>field stimulator (PENFS)<br>system intended to be used<br>in patients 11-18 years of | | | | The First Relief is a<br>percutaneous electrical<br>nerve stimulator (PENS)<br>system indicated for<br>multiple treatments up to<br>56 days for symptomatic<br>relief of chronic,<br>intractable pain from<br>diabetic peripheral<br>neuropathy. | indicated for up to 60<br>days in the back and/or<br>extremities for:<br>• Symptomatic relief of<br>chronic, intractable pain,<br>post surgical and post-<br>traumatic<br>acute pain;<br>• Symptomatic relief of<br>post-traumatic pain;<br>• Symptomatic relief of<br>post-operative pain. | age with functional<br>abdominal pain associated<br>with irritable bowel<br>syndrome (IBS). The First<br>Relief v1 is intended to be<br>used for 120 hours per week<br>up to 3 consecutive weeks,<br>through application to<br>Cranial Nerves V, VII, IX<br>and X, and the occipital<br>nerves identified by trans-<br>illumination, as an aid in the<br>reduction of pain when<br>combined with other<br>therapies for IBS. | | | PATIENT<br>POPULATION | Adults | Adults | Children | | | SINGLE USE<br>ELECTRODES | Yes | Yes | Yes | | | PORTABLE<br>COMPONENTS | Yes | Yes | Yes | | | DURATION OF<br>PATIENT CONTACT<br>(days) | 7 days | 60 days | 5 days | | | NUMBER OF<br>TREATMENTS | 8 times | Once | 3 times | | | MAXIMUM TOTAL<br>DURATION OF<br>THERAPY (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 consecutive<br>weeks resulting in 56 days / 8 weeks of treatment and 49 days / 7 weeks of no device in between. | | | | | | TECHNOLOGICAL CHARACTERISTICS | | | | | | PULSE GENERATOR | | | | | | PRODUCT<br>DIMENSION (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 with<br>Rectangular Pulse | Biphasic with<br>Rectangular Pulse | Biphasic with<br>Rectangular Pulse | | | BATTERY TYPE | P10 Zinc Air batteries<br>that are non-rechargeable | Rechargeable Lithium<br>Ion Polymer cell | P10 Zinc Air batteries that<br>are non-rechargeable | | | BATTERY<br>CAPACITY (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 hours<br>OFF | 50 % or 100 % * | 2 hours ON / 2 hours OFF | | | TYPICAL BATTERY<br>OPERATING TIME<br>(hours) | 168 | 12 - 24 | 120 | | | | ENVIRONMENTAL | | | | | OPERATING<br>TEMPERATURE | 5 °C to 45 °C | 5 °C to 40 °C | 5 °C to 45 °C | | | OPERATING<br>HUMIDITY | 40% to 80% | 15% to 90% | 40% to 80% | | | ENVIRONMENT OF<br>USE | Clinics, Hospital and<br>Home environments | Clinics, Hospital and<br>Home environments | Clinics, Hospital and Home<br>environments | | | STERILIZATION OF<br>ELECTRODES | 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 non<br>activated batteries<br>- Top Cover of First<br>Relief<br>- Sterile pack of needles<br>for use with the First<br>Relief device<br>- Adhesive to fasten the<br>needles<br>- Adhesive for the First<br>Relief device<br>- Instruction for use | - OnePass Introducer<br>- MicroLead<br>- Pulse Generator<br>- Hand-Held Remote<br>- Recharging base with<br>power supply<br>- Mounting pad adhesive<br>- Connectors and<br>Adapter<br>- Adhesive Bandage<br>- Instructions for use | - First Relief v1 with non<br>activated batteries<br>- Top Cover of First Relief<br>v l<br>- Sterile pack of needles for<br>use with First Relief v1<br>- Adhesive to fasten the<br>needles<br>- Adhesive for the First<br>Relief v1 device<br>- 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 {5}------------------------------------------------ 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". {6}------------------------------------------------ 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 | {7}------------------------------------------------ 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 | | | | | Software<br>Controlled | Yes | Yes | Yes | | Weight (g) | 5 g | 24 g | 5 g | | Dimensions(mm) | 50 * 23 * 7 mm | 62 * 37 * 14 | 50 * 23 * 7 mm | | Housing<br>Material | ABS Plastic Material | UNK | ABS Plastic Material | | Electrode Needle Arrays | | | | | Introduction<br>Method | Percutaneous | Percutaneous | Percutaneous | | Tissue Contact | Skin/Tissue | Skin/Tissue | Skin/Tissue | | Electrode Type | Percutaneous fine needle | Percutaneous fine wire | Percutaneous fine needle | | Stimulating<br>Electrode<br>Material | Titanium | 316L Stainless Steel | Titanium | | Stimulating<br>electrode shape | Straight | Straight with tine | Straight | | Electrode<br>Configuration | Single needle in all the 4<br>leads | 1 pair (1 percutaneous<br>electrode and 1 surface<br>electrode) | Single needle in all the 4<br>leads | | Number of leads | 4 (3 signal and 1 ground) | 1 | 4 (3 signal and 1 ground) | | Diameter of<br>percutaneous<br>extension (mm) | 0.4 | 0.64 | 0.4 | | Electrode Length<br>(mm) | 2 | 15.2 | 2 | | Surface area of<br>needle (cm²) | 0.0201 cm² | UNK | 0.0201 cm² | | Supplied Sterile | Yes | Yes | Yes | | System Characteristics (Output Specs) | | | | | Pulse Duration<br>(ms) | 1 | 0.2 | 1 | | Net Charge (µC /<br>pulse) | 0 ( due to the nature of the<br>biphasic waveform) | 0 | 0 | | Where and how<br>it is used | Low levels of electrical<br>current are delivered by the<br>external stimulator through<br>electrodes placed<br>percutaneously on the ear to | Low levels of electrical<br>current are delivered by<br>the external stimulator<br>through electrodes<br>placed percutaneously | Low levels of electrical<br>current are delivered by the<br>external stimulator through<br>electrodes placed<br>percutaneously on the ear to | | | target the associated cranial<br>and occipital nerves. | in proximity to a target<br>peripheral nerve<br>associated with a<br>painful area. | target the associated cranial<br>and occipital nerves. | | Anodes /<br>Cathodes please<br>identify the<br>ground | The ground electrode of<br>First Relief is a single<br>isolated wire separated from<br>the assembly of signal wires,<br>which creates a closed<br>circuit for safe and proper<br>functioning of the<br>stimulation device. | The ground electrode of<br>SmartPatch PNS is the<br>surface electrode in<br>contact with the<br>patient's skin, which<br>creates a closed circuit<br>for safe and proper<br>functioning of the<br>stimulation device<br>whereas the active<br>electrode is placed near<br>the target nerve. | The ground electrode of<br>First Relief v1 is a single<br>isolated wire separated<br>from the assembly of signal<br>wires, which creates a<br>closed circuit for safe and<br>proper functioning of the<br>stimulation device. | {8}------------------------------------------------ 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. {9}------------------------------------------------ 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…