(38 days)
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 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 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.
The provided text describes the regulatory clearance of the "Drug Relief v1" device (K221231) by DyAnsys, Inc. It explicitly states that the device is substantially equivalent to a previously cleared predicate device, also named "Drug Relief v1" (K211971). The document primarily focuses on demonstrating this substantial equivalence rather than presenting an independent clinical study to prove the device meets specific performance criteria against a predefined ground truth in a clinical setting.
Therefore, many of the requested items related to clinical study design, expert involvement, and statistical measures of performance (like effect size with AI assistance) are not directly applicable or available in this regulatory submission. The "acceptance criteria" discussed are largely in the context of demonstrating equivalence to the predicate and safety/performance through non-clinical testing.
Here's an attempt to answer the questions based solely on the provided text, noting where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria and corresponding reported device performance against a clinical ground truth for the subject device (K221231). Instead, it focuses on demonstrating that the subject device has "equivalent performance specifications" and "identical fundamental technological and operational characteristics" to the predicate device (K211971). The "Performance Data" section discusses non-clinical testing.
Acceptance Criteria (Implicit - related to predicate equivalence and non-clinical performance):
| Acceptance Criteria (Implicit) | Reported Device Performance (K221231) |
|---|---|
| Intended Use / Indications for Use: Identical to predicate | Identical to predicate: "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." |
| Technological Characteristics: Equivalent to predicate | "identical intended use, indications for use, population, application of the device, environment of use" to predicate |
| Product Dimensions (mm x mm x mm): 38 * 21 * 10 | 38 * 21 * 10 |
| Mass (g): 8g (including battery) | 8g (including battery) |
| Frequency (Hz): 1 - 10 | 1 - 10 |
| Waveform: Biphasic with Rectangular Pulse | Biphasic with Rectangular Pulse |
| Battery Type: P13 Zinc Air batteries, non-rechargeable | P13 Zinc Air batteries, non-rechargeable |
| Battery Capacity: 310 mAh | 310 mAh |
| No. x Voltage (V): 3 x 1.4 V | 3 x 1.4 V |
| Pulse Width (ms): 0.980 | 0.980 |
| Duty Cycle: 2 hours ON / 1 min OFF | 2 hours ON / 1 min OFF |
| Typical Battery Operating Time (hours): 120 | 120 |
| Operating Temperature: 5 °C to 45 °C | 5 °C to 45 °C |
| Operating Humidity: 40% to 80% | 40% to 80% |
| Environmental Use: Clinics, Hospital, Home | Clinics, Hospital, Home |
| Sterilization of Electrodes: EtO Sterilization | EtO Sterilization |
| Re-use: Single use Device | Single use Device |
| Max Charge Density (µC / cm²) per needle: 67.16 @ 1 kΩ, 8.01 @ 10 kΩ | 67.16 @ 1 kΩ, 8.01 @ 10 kΩ |
| Max Average Power Density (W / cm²): 0.363 @ 1 kΩ, 0.0516 @ 10 kΩ | 0.363 @ 1 kΩ, 0.0516 @ 10 kΩ |
| Net Charge (µC per pulse): 0 (biphasic) | 0 (Due to biphasic nature of the waveform) |
| Software Controlled: Yes | Yes |
| Shelf Life: Increased from 6 months (predicate) to 12 months | 12 months (demonstrated through sterilization and non-clinical performance testing) |
| Biocompatibility: Pass | Subjected to biocompatibility testing (implied pass for clearance) |
| Electrical Safety (EMC and safety): Pass | Subjected to electrical safety (electromagnetic compatibility and safety) testing (implied pass for clearance) |
| Performance Bench Testing (120 hours continuous performance): Pass for pulse width, pulse duration, amplitude, current values | Functional test performed for 120 hours to monitor continuous performance. Captured pulse width, pulse duration, amplitude, and current values. Performance equivalent to predicate. |
| Software Validation: Pass | Subjected to software validation (implied pass for clearance) |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical test set with human subjects or patient data. The "test set" discussed refers to non-clinical bench testing.
- Sample size: Not specified for individual bench tests, but implies a sufficient number of devices were tested for validation.
- Data provenance: Non-clinical bench testing data, likely conducted by DyAnsys, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no clinical test set requiring expert ground truth establishment for diagnostic performance.
4. Adjudication method for the test set
Not applicable. No clinical test set and no expert adjudication were described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a nerve stimulator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a nerve stimulator, not an algorithm. Its function is direct stimulation.
7. The type of ground truth used
For the non-clinical performance data, the "ground truth" was likely defined by engineering specifications and direct measurements against those specifications (e.g., measuring actual pulse width against the specified 0.980 ms). For establishing substantial equivalence, the "ground truth" was the characteristics, intended use, and indications for use of the predicate device (K211971).
8. The sample size for the training set
Not applicable. There is no mention of a training set for an algorithm in this submission.
9. How the ground truth for the training set was established
Not applicable. No training set was described.
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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
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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
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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)
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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.
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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 inthe 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 thesymptoms of opioid withdrawal, through application tobranches of Cranial Nerves V, VII, IX and X, and the occipitalnerves identified by transillumination. | |
| PATIENT POPULATION | Adults | |
| SINGLE USE ELECTRODES | Yes | |
| DURATION OF PATIENTCONTACT (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 BATTERYOPERATING 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 OFELECTRODES | 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
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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.
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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 ofneedle (cm²) | 0.0201 cm² | |
| Supplied Sterile | Yes | |
| System Characteristics (Output Specs) | ||
| Max Charge Density(µC / cm²) per needle | 67.16 @ 1 kΩ8.01 @ 10 kΩ | |
| Max AveragePower Density (W/ cm²) | 0.363 @ 1 kΩ0.0516 @ 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 externalstimulator through electrodes placed percutaneously on the ear totarget the associated cranial and occipital nerves. | |
| Anodes / Cathodes pleaseidentify the ground | The ground electrode of Drug Relief v1 is a single isolated wireseparated from the assembly of signal wires, which creates a closedcircuit 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.
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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).
§ 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.