(133 days)
No
The description focuses on electrical stimulation parameters and hardware components, with no mention of AI/ML algorithms for data analysis, pattern recognition, or adaptive stimulation.
Yes
The device is designed to aid in the treatment of opiate withdrawal symptoms by applying electrical stimulation, which directly addresses a medical condition, making it a therapeutic device.
No
The device is described as a stimulatory system used to reduce symptoms, indicating a therapeutic rather than a diagnostic function.
No
The device description clearly outlines hardware components such as a wearable, battery-operated device, wire assembly, stimulation needles, electrodes, and a connector. It is not solely software.
Based on the provided information, 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, or tissue) to detect diseases, conditions, or infections. They are used outside the body (in vitro) to provide information about a person's health.
- Drug Relief Function: The Drug Relief device is a percutaneous nerve field stimulatory system. It works by applying electrical stimulation to specific nerves on the ear to reduce symptoms of opioid withdrawal. This is a therapeutic intervention applied to the body, not a diagnostic test performed on a sample from the body.
The description clearly outlines a device that delivers electrical pulses to the patient's ear for treatment purposes, which is the opposite of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Drug Relief is a percutaneous nerve field stimulatory (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™ is designed to aid in the treatment of opiate withdrawal symptoms by the method of electrical stimulation at the auricular stimulation points. The Drug Relief is a wearable, battery-operated device that is designed to administer periodical low-level electrical pulses to the ear over five days / 120 hours (2 hours ON/1 minute OFF) 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 provides the required stimulation energy for a maximum of 120 hours. There are three Stimulation electrodes and one ground electrode - which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device.
This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin.
The stimulation pattern consists of rectangular pulses with differing inter-pulse intervals.
A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.
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
Indicated Patient Age Range
Adults
Intended User / Care Setting
Clinics, Hospital and Home environments
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 device and its components are subjected to performance 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 predicate device. 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 device. The Drug Relief has equivalent Performance specifications when compared to the predicate device.
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.
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.
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May 2, 2018
DyAnsys, Inc. Srini Nageshwar CEO 300 North Bavshore Boulevard San Mateo, California 94401
Re: K173861
Trade/Device Name: Drug Relief Regulation Number: 21 CFR 882.5896 Regulation Name: Percutaneous Nerve Stimulator For Opiod Withdrawal Regulatory Class: Class II Product Code: PZR Dated: April 18, 2018 Received: April 20, 2018
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
William J. Heetderks -S 2018.05.02 15:36:03 -04'00'
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173861
Device Name Drug Relief
Indications for Use (Describe)
The Drug Relief is a percutaneous nerve field stimulatory (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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Image /page/3/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a stylized symbol to the left of the company name. The symbol is a combination of a greater-than sign and a curved line, with the curved line colored in red. The company name, "DyAnsys", is written in a simple, sans-serif font and is colored in black.
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: K173861
Applicant Information:
| 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 |
Device Information
| Classification | : Class II |
|---|---|
| Trade Name | : Drug Relief |
| Classification Name | : Percutaneous nerve stimulator for substance use disorder |
| Product Code | : PZR |
Predicate Device:
DEN Number: DEN170018 Model Name: NSS-2 BRIDGE Manufacturer: Innovative Health Solutions, Inc.
Device Description:
The Drug Relief™ is designed to aid in the treatment of opiate withdrawal symptoms by the method of electrical stimulation at the auricular stimulation points. The Drug Relief is a wearable, battery-operated device that is designed to administer periodical low-level electrical pulses to the ear over five days / 120 hours (2 hours ON/1 minute OFF) from the time of activation of the device.
The electrical pulse from the device will be delivered to the branches of Cranial Nerves on the ear through a set of wire assembly and Stimulation needles. Three zinc air batteries with 1.4 V each
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Image /page/4/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a stylized symbol to the left, resembling a combination of a greater-than sign and a curved line, with the right portion of the symbol colored in red. To the right of the symbol is the text "DyAnsys" in a simple, sans-serif font, with the letters in black.
provides the required stimulation energy for a maximum of 120 hours. There are three Stimulation electrodes and one ground electrode - which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device.
This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin.
The stimulation pattern consists of rectangular pulses with differing inter-pulse intervals.
A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.
Intended 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.
Comparison to Predicate Device:
The DyAnsys, Inc Drug Relief device is substantially equivalent to it's own legally marketed predicate device NSS-2 BRIDGE (DEN 170018). It was evaluated through Performance and Non-Clinical testing.
| MODEL NAME | Drug Relief
(Subject) | NSS-2 BRIDGE
(DEN 170018) |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | DyAnsys Inc | Innovative Health Solutions, Inc. |
| 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 NSS-2 BRIDGE 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 | Adults |
| SHAPE | Rectangle | Rectangle |
| DIMENSION, mm | 50237 mm | 36167 mm |
| WEIGHT, Kg | 6 gm (including battery) | 4 gm |
| DEVICE ADHESIVE | The device's foam pad is connected to the
adhesive – gel pad | Tegaderm is used to fasten the device. |
| NEEDLE DIMENSIONS, | 0.42 mm (widthlength) | 0.5mm width x 2mm length |
| mm | | |
| 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. | One stainless steel wire with four
stimulation needles and two stainless steel
wires with one stimulation needle each.
There is one ground wire with one needle. |
| WIRE ASSEMBLY TYPE | Wire assembly, without stimulation needles
soldered with the pulse generator. | Wire assembly is connected with the
stimulation needles as one end and has the
facility to connect with the pulse generator. It
is sterilized and packed separately. |
| VOLTAGE
MEASUREMENT
FEASIVLITY | A 3-pin connector provided to measure the
output voltage of the device once it is
activated. | Not feasible.
There is no provision to measure the voltage.
Hence not feasible. |
| POWER: | | |
| FREQUENCY | Pulses with modulating frequency (1 Hz - 10
Hz) | Pulses with modulating frequency (1 Hz - 10
Hz) |
| WAVEFORM | Rectangular pulse | Rectangular pulse |
| (ENERGY SOURCE)
BATTERY OPERATION | Yes | Yes |
| BATTERY TYPE | Zinc Air batteries, P10 | Lithium ion battery, CR1220 |
| BATTERY CAPACITY | 100 mAh | 40 mAh |
| NO. / VOLTAGE | 31.4 V | 13 V |
| PULSE WIDTH | 0.980mSec | 0.980mSec |
| OPERATING TIME,
HOURS | 120 hrs (5 days), 2 Hours ON (Periodically) | 120 hrs (5 days), 2 Hours ON (Periodically) |
| ENVIRONMENTAL | | |
| OPERATING
TEMPERATURE | 5°C to 45°C | 5°C to 30°C |
| OPERATING
HUMIDITY (NON
CONDENSING) | 40% to 80% | 40% to 60% |
| ENVIRONMENT OF
USE | Clinics, Hospital and Home environments | Clinics, Hospital and Home environments |
| STERILIZATION | EtO Sterilization | Irradiation (Gamma) |
| RE-USE | Single use Device | Single use Device |
| SHELF LIFE | 6 Months | 12 months |
| PLANNING &
PURCHASE | | |
| WARRANTY | NA | NA |
| Battery Type and Voltage (V) | Zinc Air batteries, P10 | Lithium ion battery, CR1220 |
| Voltage Controlled? | Yes | Yes |
| Software Controlled? | Yes | Yes |
| Weight (grams) | 6 g | 4 g |
| Dimensions (mm) | 50237 mm | 36167 mm |
| Electrode Needle Arrays | | |
| Number of leads | 4 | 4 |
| Lead type | 1 Single needle in all the 4 leads | One stainless steel wire with four
stimulation needles and two stainless
steel wires with one stimulation needle
each. There is one ground wire with
one needle. |
| Dimensions of each needle (width
and length in mm) | 0.4 mm width x 2 mm length | 0.5 mm width x 2 mm length |
| Surface Area of needle (cm2) | 0.0201 cm² | 0.0276 cm² |
| Needle Material | Titanium | Titanium |
| System Characteristics (Output Specs) | | |
| Max Charge Density
(microcoulomb/cm2) Per needle | 65.67 @ 1K ohm
7.96 @ 10K ohm | 48.91 @ 1K ohm
5.79 @ 10K ohm |
| Max Average Power Density (W/cm2) | 0.346 @ 1K ohm
0.0509 @ 10K ohm | 0.2645 @ 1K ohm
0.0371 @ 10K ohm |
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Image /page/5/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, which is written in black. The symbol appears to be a combination of a greater-than sign and a stylized letter A.
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Image /page/6/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a stylized red symbol resembling a greater-than sign combined with a curved line, followed by the company name "DyAnsys" in black sans-serif font. The symbol is positioned to the left of the company name.
Pulse Generator
These differences do not affect the safety and effectiveness of the device.
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Image /page/7/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a stylized red and black symbol to the left of the company name, "DyAnsys," which is written in a simple, sans-serif font. The symbol appears to be an abstract representation of a waveform or signal, with a portion of it colored red. The overall design is clean and modern, conveying a sense of technology and innovation.
Performance Testing Summary
The Drug Relief device and its components are subjected to performance 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 predicate device. 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 device. The Drug Relief has equivalent Performance specifications when compared to the predicate device.
All the hardware components, form factors, material for sterilization and patient contacting materials of the Drug Relief are similar to the 510(K) cleared device ANSiStim-PP (K170391).
Compliance with Standards
The ANSiStim complies with the following standards
-
- IEC 60601-1 2. IEC 60601-1-2 3. ISO 10993-1 4. ISO 10993-5 5. ISO 10993-6 6. ISO 10993-7 7. ISO 10993-10 8. ISO 10993-11 9. ISO 11135
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 process the biological indicators are used to ensure the desired sterility assurance level. These BIs 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 in-line with standards requirement. All Sterilization testing was performed in accordance with ISO 11135:2014-Sterilization of healthcare productsethylene oxide, ISO 11140-1:2005/(R) 2010 Sterilization of healthcare products- chemical indicators, ISO 10993-7:2008/(R) 2012 Biological evaluation of medical devicesethylene 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
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Of Healthcare Products-Biological Indicators- Part2: Biological Indicators for ethylene oxide Sterilization Processes.
9. Non-Clinical Testing Summary
The bench test has been performed and found that the Drug Relief met all the requirements specifications and standards requirements. The testings includes the following:
-
- MEE testing as per IEC 60601-1
-
- EMI/EMC testing as per IEC 60601-1-2
-
- Biocompatibility testing as per ISO 10993
-
- Performance testing
10. Conclusion
Hence it is concluded that by demonstrating the Performance testing and with the Indications For Use, Environment for Use, Biocompatibility and compliance with the same harmonized standards, the product Drug Relief is substantially equivalent to the predicate device NSS-2 BRIDGE.