(38 days)
No
The description focuses on electrical stimulation parameters and hardware components, with no mention of AI or ML algorithms for data analysis, pattern recognition, or adaptive stimulation.
Yes
The device is described as an aid to reduce the symptoms of opioid withdrawal, indicating it has a therapeutic effect. It administers electrical pulses to stimulate nerves, which is a therapeutic intervention.
No
The device is described as a stimulator that administers electrical pulses to reduce symptoms, not to diagnose a condition.
No
The device description clearly outlines hardware components such as batteries, wire assembly, stimulation needles, electrodes, and a physical device housing designed to be worn on the neck. It administers electrical pulses, which is a hardware function.
Based on the provided information, the Drug Relief v1 device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The definition of an IVD involves testing samples like blood, urine, tissue, etc., outside of the body to provide information about a person's health.
- The Drug Relief v1 is a therapeutic device. Its intended use is to treat symptoms of opioid withdrawal by applying electrical stimulation to nerves on the body. It does not analyze any biological samples.
The description clearly states it's a "percutaneous nerve field stimulator (PNFS) system" that delivers electrical pulses to the ear. This is a form of neuromodulation therapy, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Drug Relief v1 is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of cranial nerves V, VII, IX and X, and the occipital nerves identified by transillumination.
Product codes
PZR
Device Description
The Drug Relief v1 is designed to aid in the treatment of symptoms by the method of cranial electrical stimulation at the auricular stimulation points. The Drug Relief v1 is a wearable, batteryoperated device that is designed to administer periodical low level electrical pulses to the ear over five days / 120 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 120 hours. There are three stimulation electrode and one ground electrode which constitute of a titanium 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.
The device is rectangular in shape and designed to fit comfortably on the neck. The biocompatible adhesive ensures that the device maintains contact with the skin during normal use. The adhesive fasteners ensure that the electrode needles and the entire device stay in place in a secure manner.
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 interpulse 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination.
Indicated Patient Age Range
Adults
Intended User / Care Setting
Clinics, Hospital and Home environments. Intended to be a prescription (Rx) device for use by or on the order of a licensed healthcare practitioner.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The nonclinical testing of Drug Relief v1 device included biocompatibility testing, electrical safety (electromagnetic compatibility and safety), performance bench testing and software validation. The Drug Relief v1 device and its components are subjected to performance bench testing to validate the effectiveness of each unit. The functional test is performed for 120 hours to monitor the continuous performance. The pulse width, pulse duration, amplitude and current values are captured for the Drug Relief v1 device. The Drug Relief v1 has equivalent performance specifications when compared to the predicate device. The comparison bench testing information has been leveraged from information previously provided for the Drug Relief v1 device cleared under K211971 to establish substantial equivalence to the subject device, Drug Relief v1.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5896 Percutaneous nerve stimulator for substance use disorders.
(a)
Identification. A percutaneous nerve stimulator for substance use disorders is a device that stimulates nerves percutaneously to aid in the reduction of withdrawal symptoms associated with substance use disorders.(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 specified 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The seal features a stylized depiction of a human figure, while the text is in a clear, sans-serif font, with "FDA" in a blue square.
June 6, 2022
DyAnsys, Inc. Srini Nageshwar CEO 300 North Bayshore Boulevard San Mateo, CA 94401
Re: K221231
Trade/Device Name: Drug Relief v1 Regulation Number: 21 CFR 882.5896 Regulation Name: Percutaneous nerve stimulator for substance use disorders Regulatory Class: Class II Product Code: PZR Dated: June 1, 2022 Received: June 2, 2022
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
1
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,
for Pamela Scott 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
2
Indications for Use
510(k) Number (if known) K221231
Device Name Drug Relief v 1
Indications for Use (Describe)
The Drug Relief v1 is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of cranial nerves V, VII, IX and X, and the occipital nerves identified by transillumination.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 201 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
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 /page/3/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 a bold, sans-serif font. A registered trademark symbol is present 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: K221231
I. SUBMITTER
| Date Prepared: | May 26th 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: | Drug Relief v1 |
|---|---|
| Classification Name: | Percutaneous nerve stimulator for substance use disorder |
| (21 CFR 882.5896) | |
| Common Name: | Percutaneous nerve stimulator |
| Device Class: | Class II |
| Product Code: | PZR |
III. PREDICATE DEVICE
Model Name: Drug Relief v1 - (K211971) Manufacturer: DyAnsys Inc.,
The predicate device has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Drug Relief v1 is designed to aid in the treatment of symptoms by the method of cranial electrical stimulation at the auricular stimulation points. The Drug Relief v1 is a wearable, batteryoperated device that is designed to administer periodical low level electrical pulses to the ear over five days / 120 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 120 hours. There are three stimulation electrode and one ground electrode which constitute of a titanium 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.
4
Image /page/4/Picture/0 description: The image shows the logo for DyAnsys, a medical device company. The logo consists of a stylized red symbol resembling a stylized letter 'A' or an abstract shape, followed by the company name "DyAnsys" in black, sans-serif font. A registered trademark symbol (®) is placed to the upper right of the company name.
The device is rectangular in shape and designed to fit comfortably on the neck. The biocompatible adhesive ensures that the device maintains contact with the skin during normal use. The adhesive fasteners ensure that the electrode needles and the entire device stay in place in a secure manner.
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 interpulse 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 Drug Relief v1 is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination.
The Indications for Use statement of Drug Relief v1 is identical to that of the predicate device.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Drug Relief v1 device has identical intended use, indications for use, population, application of the device, environment of use as that of the predicate device. The auricular stimulation device stimulates the cranial nerves for reduction of symptoms associated with opioid withdrawal and produces a therapeutic effect. The determination of substantial equivalence is based on the identical fundamental technological and operational characteristics between the subject and identified predicate device.
| MODEL NAME | Drug Relief v1
(Subject) | Drug Relief v1
(K211971 - Predicate) |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| MANUFACTURER | DyAnsys Inc. | |
| Intended Use / Indications for Use Statement | | |
| INTENDED USE | Short-term electrical stimulation therapy as an aid in
the reduction of opioid withdrawal symptoms. | |
| INDICATIONS FOR USE | The Drug Relief v1 is a percutaneous nerve field stimulator
(PNFS) system, that can be used as an aid to reduce the
symptoms of opioid withdrawal, through application to
branches of Cranial Nerves V, VII, IX and X, and the occipital
nerves identified by transillumination. | |
| PATIENT POPULATION | Adults | |
| SINGLE USE ELECTRODES | Yes | |
| DURATION OF PATIENT
CONTACT (days) | 5 | |
| TECHNOLOGICAL CHARACTERISTICS | | |
| PULSE GENERATOR | | |
| PRODUCT DIMENSION
(mm x mm x mm) | 38 * 21 * 10 | |
| MASS (g) | 8 g (including battery) | |
| PRODUCT SHAPE | Rectangle | |
| | POWER | |
| FREQUENCY (Hz) | 1 - 10 | |
| WAVEFORM | Biphasic with Rectangular Pulse | |
| BATTERY TYPE | P13 Zinc Air batteries that are non-rechargeable | |
| BATTERY CAPACITY | 310 mAh | |
| NO. x VOLTAGE (V) | 3 x 1.4 V | |
| PULSE WIDTH(ms) | 0.980 | |
| DUTY CYCLE | 2 hours ON / 1 min OFF | |
| TYPICAL BATTERY
OPERATING TIME (hours) | 120 | |
| ENVIRONMENTAL | | |
| OPERATING TEMPERATURE | 5 °C to 45 °C | |
| OPERATING HUMIDITY | 40% to 80% | |
| ENVIRONMENT OF USE | Clinics, Hospital and Home environments | |
| STERILIZATION OF
ELECTRODES | EtO Sterilization | |
| RE-USE | Single use Device | |
| SHELF LIFE | 12 months | 6 months |
| ACCESSORIES | • Drug Relief v1 device with inserted non-activated batteries.
• Cover of the Drug Relief v1
• Sterile pack of needles for use with the Drug Relief v1
• Adhesive to fasten the needles
• Adhesive for the Drug Relief v1 device.
• Instructions for Use | |
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 stylized "greater than" symbol followed by the text "DyAnsys" in black. A registered trademark symbol is located to the upper right of the text.
To summarize, the energy source in the form of P13 batteries, device design (form factor), material type, chemical composition of all the components are unchanged and remain identical to those of the predicate device.
6
Image /page/6/Picture/0 description: The image shows the logo for DyAnsys, a medical device company. The logo consists of a stylized red and black symbol resembling an abstract letter 'D' or a stylized nerve, followed by the company name "DyAnsys" in a bold, sans-serif font. A registered trademark symbol is placed to the upper right of the company name.
| Table 6.2: Comparison of System Characteristics | |||
|---|---|---|---|
| Characteristic | Drug Relief v1 | Drug |
| System Characteristic | Drug Relief v1
(Subject) | Drug Relief v1
(K211971 - Predicate) |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Pulse Generator | | |
| Software Controlled | Yes | |
| Mass (g) | 8 g | |
| Dimensions(mm) | 38 * 21 * 10 | |
| Housing Material | ABS Plastic Material | |
| Electrode Needle Arrays | | |
| Introduction Method | Percutaneous | |
| Tissue Contact | Skin/Tissue | |
| Electrode Configuration | Single needle in all the 4 leads | |
| Electrode Type | Percutaneous fine needle | |
| Number of leads | 4 (3 signal and 1 ground) | |
| Needle Dimensions
(mm x mm) | 0.4 x 2 (diameter x length) | |
| Surface area of
needle (cm²) | 0.0201 cm² | |
| Supplied Sterile | Yes | |
| System Characteristics (Output Specs) | | |
| Max Charge Density
(µC / cm²) per needle | 67.16 @ 1 kΩ
8.01 @ 10 kΩ | |
| Max Average
Power Density (W/ cm²) | 0.363 @ 1 kΩ
0.0516 @ 10 kΩ | |
| Net Charge (microcoulomb
(µC) per pulse; | 0 (Due to biphasic nature of the waveform) | |
| Where and how it is used | Low levels of electrical current are delivered by the external
stimulator through electrodes placed percutaneously on the ear to
target the associated cranial and occipital nerves. | |
| Anodes / Cathodes please
identify the ground | The ground electrode of Drug Relief v1 is a single isolated wire
separated from the assembly of signal wires, which creates a closed
circuit for safe and proper functioning of the stimulation device. | |
Identical to the predicate, the Drug Relief v1 device is intended to be a prescription (Rx) device for use by or on the order of a licensed healthcare practitioner. Both devices are body-worn, have identical indications for use and deliver electrical stimulation therapy as an aid in the reduction of opioid withdrawal symptoms. Both 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.
7
2 DyAnsys®
The only difference lies in the increase in shelf life from 6 to 12 months for the subject device compared to the predicate. This difference does not impact substantial equivalence in terms of safety and effectiveness of the Drug Relief v1 device as shown by sterilization and non-clinical performance testing.
VII. Performance Data
The nonclinical testing of Drug Relief v1 device included biocompatibility testing, electrical safety (electromagnetic compatibility and safety), performance bench testing and software validation.
The Drug Relief v1 device and its components are subjected to performance bench testing to validate the effectiveness of each unit. The functional test is performed for 120 hours to monitor the continuous performance. The pulse width, pulse duration, amplitude and current values are captured for the Drug Relief v1 device. The Drug Relief v1 has equivalent performance specifications when compared to the predicate device.
The comparison bench testing information has been leveraged from information previously provided for the Drug Relief v1 device cleared under K211971 to establish substantial equivalence to the subject device, Drug Relief v1.
VIII. Conclusion
The results of the non-clinical tests have demonstrated that the Drug Relief v1 is as safe, as effective and performs as well as the legally marketed predicate device, and has no new intended use, thus rendering it substantially equivalent to the predicate device, Drug Relief v1 (K211971).