(134 days)
Not Found
No
The description focuses on electrical stimulation parameters and hardware, with no mention of AI/ML algorithms for data analysis, pattern recognition, or adaptive stimulation.
Yes
Explanation: The device is described as an "aid to reduce the symptoms of opioid withdrawal" and "administer periodical low level electrical pulses to the ear" for cranial electrical stimulation, which directly provides a therapy to alleviate a medical condition.
No
The device is a percutaneous nerve field stimulator (PNFS) system used to reduce the symptoms of opioid withdrawal through electrical stimulation. It is a therapeutic device, not a diagnostic one. Its purpose is to treat or aid in the reduction of symptoms, not to identify or diagnose a condition.
No
The device description explicitly states it is a "wearable, battery-operated device" that administers electrical pulses through "wire assembly and stimulation needles." This indicates the presence of physical hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Drug Relief v1 Function: The Drug Relief v1 is a device that applies electrical stimulation directly to the patient's body (percutaneously) to treat symptoms. It does not analyze samples taken from the body.
The description clearly states it's a "percutaneous nerve field stimulator (PNFS) system" that applies electrical pulses to the ear. This is a form of therapy or treatment, not a diagnostic test performed on a sample.
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 (comma separated list FDA assigned to the subject device)
PZR
Device Description
The Drug Relief v1 is designed to be used as an aid to reduce opioid withdrawal symptoms by the method of cranial electrical stimulation at the auricular stimulation points. The Drug Relief v1 is a wearable, battery-operated 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 atimulation 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 and a duty cycle of 2 hours ON/1 minute OFF.
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
branches of 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Drug Relief v1 device and its components are subjected to performance testing to validate the effectiveness of each unit. The final product testing is perfy and compare the effectual output along with that of the predicate device. The functional test is performed for 120 hours to monitor the continuous performance. The pulse width, duty cycle, 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 nonclinical testing of Drug Relief v1 device included biocompatibility testing, electrical safety (electromagnetic compatibility and safety), performance bench testing and software verification and validation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 5, 2021
DyAnsys, Inc. Srini Nageshwar CEO 300, North Bayshore Boulevard San Mateo, CA 94401
Re: K211971
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: October 5, 2021 Received: October 6, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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,
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)
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 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: K211971
1. SUBMITTER
| 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 disorders |
| (21 CFR 882.5896) | |
| Classification | : Class II |
| Product Code | : PZR |
III. PREDICATE DEVICE INFORMATION
| Model Name | : Drug Relief |
|---|---|
| Manufacturer | : DyAnsys Inc., |
| K Number | : K173861 |
| Classification Name | : Percutaneous nerve stimulator for substance use disorder |
| (21 CFR 882.5896) | |
| Classification | : Class II |
| Product Code | : PZR |
IV. DEVICE DESCRIPTION
The Drug Relief v1 is designed to be used as an aid to reduce opioid withdrawal symptoms by the method of cranial electrical stimulation at the auricular stimulation points. The Drug Relief v1 is a wearable, battery-operated 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 atimulation 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.
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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 resembling an abstract letter 'A' or an arrow pointing to the right. To the right of the symbol is the company name "DyAnsys" in a bold, sans-serif font, with a registered trademark symbol '®' positioned at the upper right corner of the 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 and a duty cycle of 2 hours ON/1 minute OFF.
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 Drug Relief, the cited predicate device.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The DyAnsys, Inc Drug Relief v1 device is substantially equivalent to its own legally marketed predicate device Drug Relief (K173861). It was evaluated through performance and non-clinical testing.
| MODEL NAME | Drug Relief
(K173861) | Drug Relief v1
(Subject) | JUSTIFICATION
ON SAFETY &
EFFECTIVENES
S VARIATIONS | | |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|--|--|
| MANUFACTURER | DyAnsys Inc | DyAnsys Inc | NA | | |
| INDICATIONS
FOR USE | The Drug Relief 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 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. | NA | | |
| PATIENT
POPULATION | Adults | Adults | NA | | |
| TECHNOLOGICAL CHARACTERISTICS | | | | | |
Table 6.1: Comparison of Technological Characteristics
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| PULSE GENERATOR | |||
|---|---|---|---|
| SHAPE | Rectangle | Rectangle | NA |
| PRODUCT | |||
| DIMENSION | |||
| (mm) | $50 * 23 * 7$ | $38 * 21 * 10$ | NA |
| MASS (g) | 8 (including battery) | 6 (including battery) | NA |
| PRODUCT | |||
| SHAPE | Rectangle | Rectangle | NA |
| POWER | |||
| FREQUENCY | |||
| (HZ) | 1 - 10 (Pulse with | ||
| modulating frequency) | 1 - 10 (Pulse with | ||
| modulating frequency) | NA | ||
| WAVEFORM | Rectangular Pulse | Rectangle pulse | NA |
| ENERGY | |||
| SOURCE | Battery Operated | Battery Operated | NA |
| BATTERY TYPE | P10 Zinc Air batteries | P13 Zinc Air batteries | Improved |
| specification | |||
| BATTERY | |||
| CAPACITY | |||
| (mAh) | 100 | 310 | validated by |
| electrical safety | |||
| and bench testing. | |||
| NO. * VOLTAGE | $3 * 1.4V$ | $3 * 1.4 V$ | NA |
| PULSE | |||
| WIDTH(ms) | 0.980 | 0.980 | NA |
| DUTY CYCLE | 2 hours ON / 1 min OFF | 2 hours ON/ 1 min OFF | NA |
| BATTERY | |||
| OPERATING | |||
| TIME (hours) | 120 | 120 | NA |
| ENVIRONMENTAL | |||
| OPERATING | |||
| TEMPERATURE | 5°C to 45°C | 5°C to 45°C | NA |
| OPERATING | |||
| HUMIDITY | |||
| (NON | |||
| CONDENSING) | 40% to 80% | 40% to 80% | NA |
| ENVIRONMENT | |||
| OF USE | Clinics, Hospital and Home | ||
| environments | Clinics, Hospital and Home | ||
| environments | NA | ||
| STERILIZATION | EtO Sterilization | EtO Sterilization | NA |
| RE-USE | Single use Device | Single use Device | NA |
| SHELF LIFE | 6 months | 6 months | NA |
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| System
Characteristic | Drug Relief
(K173861) | Drug Relief v1
(Subject) |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pulse Generator | | |
| Battery Type | Zinc Air Batteries, P10 | Zinc Air Batteries, P13 |
| Software
Controlled | Yes | Yes |
| Mass (g) | 6 | 8 |
| Dimensions(mm) | 50 * 23 * 7 | 38 * 21 * 10 |
| Housing Material | ABS Plastic Material | ABS Plastic Material |
| Electrode Needle Arrays | | |
| Introduction
Method | Percutaneous | Percutaneous |
| Needle Material | Titanium | Titanium |
| Number of leads | 4 (3 signal and 1 ground) | 4 (3 signal and 1 ground) |
| Electrode
Configuration | Single needle in all the 4 leads | Single needle in all the 4 leads |
| Needle
Dimensions –
Diameter (mm) x
Length (mm) | 0.4 x 2 | 0.4 x 2 |
| Surface area of
needle (cm²) | 0.0201 | 0.0201 |
| System Characteristics (Output Specs) | | |
| Max Charge
Density
( $\mu$ C / cm²)per
needle | 65.67 @ 1 kΩ
7.96 @ 10 kΩ | 67.16 @ 1 kΩ
8.01 @ 10 kΩ |
| Max Average
Power Density
(W/ cm²) | 0.346 @ 1 kΩ
0.0509 @ 10 kΩ | 0.363 @ 1 kΩ
0.0516 @ 10 kΩ |
| 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. | 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 | The ground electrode of Drug Relief
is a single isolated wire separated
from the assembly of signal wires, | The ground electrode of Drug Relief vl is a
single isolated wire separated from the
assembly of signal wires, which creates a |
| ground | which creates a closed circuit for
safe and proper functioning of the
stimulation device. | closed circuit for safe and proper
functioning of the stimulation device. |
| Wire Assembly | 4 units of wire with snap-fit ring
where 3 nos constitute a single
assembly for stimulation and the
other one separate wire will act as a
ground electrode. | 4 units of wire with snap-fit ring where 3
nos constitute a single assembly for
stimulation and the other one separate wire
will act as a ground electrode. |
| Voltage
Measurement
Feasibility | A 3-pin connector is provided to
measure the output voltage of the
device once it is activated. | A 3-pin connector is provided to measure
the output voltage of the device once it is
activated. |
Table 13.3.2 Comparison of Technical System Characteristics
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Similar to Drug Relief, 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.
The two minor technological difference are 1) the inclusion of an advanced micro-controller to replace the older version and 2) upgrading the battery to a P13 zinc air battery. To accommodate the changes, the design of the PCB has been modified. These differences do not impact substantial equivalence in terms of safety and effectiveness of the Drug Relief v1 as shown by the electrical safety and non-clinical performance test reports.
The technical system characteristics and essential electrical safety parameters are identical or near identical as noted in Table 13.3.2. The minor technological differences do not impact the electrical safety parameters in a significant manner. Note that electrical safety parameters includes the actual electrical output delivered by the subject and predicate devices. The actual electrical output is near identical as mentioned in the technical sections of this submission hence the subsequent effectiveness remains equivalent to that of the predicate device.
VII. PERFORMANCE DATA
The Drug Relief v1 device and its components are subjected to performance testing to validate the effectiveness of each unit. The final product testing is perfy and compare the effectual output along with that of the predicate device. The functional test is performed for 120 hours to monitor the continuous performance. The pulse width, duty cycle, 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 nonclinical testing of Drug Relief v1 device included biocompatibility testing, electrical safety (electromagnetic compatibility and safety), performance bench testing and software verification and validation.
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VIII. STERILIZATION TESTING SUMMARY
The needle package was subjected to Bio-burden test. The needle packs are exposed to EtO Sterilization to curtail the presence of microorganisms and to achieve the defined sterility assurance level (SAL). During the sterilization validation process the biological indicators are used to ensure the desired sterility assurance level. These Bls were placed at the appropriate location, where the sterilizing conditions are the most difficult to achieve. These needle packages carry a chemical indicator on the rear side which indicates the exposure to EtO. The sterility test performed on the needles indicates that there is no turbidity. The residual risk report carried out on the sterilized needle packs evidenced that the results are inline with standards requirement. All sterilization testing was performed in accordance with ISO 11135:2014-Sterilization of healthcare products- ethylene oxide, ISO 11140-1:2005/(R) 2010 Sterilization of healthcare products- chemical indicators, ISO 10993-7:2008/(R) 2012 Biological evaluation of medical devices- ethylene oxide sterilization residuals, ISO 11737-1:2006/(R) 2011 Sterilization of medical devices- Microbiological methods-Part 1: Determination of a population of microorganisms on products, ISO 11737-2: 2009 Sterilization of medical devices- Microbiological methods- Part2: Tests of Sterility performed in the definition, validation and maintenance of a Sterilization process and ISO 11138-2:2006/(R) 2010-Sterilization Of Healthcare Products-Biological Indicators- Part2: Biological Indicators for ethylene oxide Sterilization Processes.
IX. CONCLUSION
Drug Relief v1 has been shown to be substantially equivalent to the identified predicate device based on identical device classification, intended use, indications for use statement, basic operating principles and near identical electrical safety parameters. The minor technological differences do not impact the electrical safety parameters and subsequent effectiveness of the device.
Hence it is concluded that by demonstrating the performance testing and with the indications for use. environment for use, compliance with the appropriate safety standards, the product Drug Relief v1 is substantially equivalent to the predicate device that was cleared by FDA - Drug Relief (K173861).