Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on electrical stimulation and does not mention any AI/ML components or functions.

Therapeutic

Yes

The device is a percutaneous electrical nerve stimulator (PENS) system indicated for symptomatic relief of chronic, intractable pain, which directly treats a medical condition.

Diagnostic

No

The device is described as a "percutaneous electrical nerve stimulator (PENS) system indicated for multiple treatments... for symptomatic relief of chronic, intractable pain." Its purpose is to deliver treatment, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components including a wearable, battery-operated device, wire assembly, stimulation needles, and zinc air batteries, which are integral to its function as a percutaneous electrical nerve stimulator.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
Device Function: The First Relief device is a percutaneous electrical nerve stimulator. It delivers electrical pulses to the ear to treat pain. This is a therapeutic device that acts directly on the patient's body.
Lack of Specimen Analysis: The description does not mention the device analyzing any biological specimens (blood, tissue, etc.). Its function is based on electrical stimulation, not laboratory testing.

Therefore, based on the provided information, the First Relief device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The First Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for multiple treatments up to 56 days for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy.

Product codes (comma separated list FDA assigned to the subject device)

NHI

Device Description

The First Relief is designed to aid in the treatment of chronic pain symptoms by the method of cranial electrical stimulation at the auricular stimulation points. The First Relief is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over seven days / 168 hours from the time of activation of the device.

The electrical pulse from the device will be delivered to the branches of cranial Nerves on the ear through a set of wire assembly and stimulation needles. Three zinc air batteries with 1.4 V each provide the required stimulation energy for 168 hours. There stimulation electrode and one ground electrode which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Ear (auricular stimulation points)

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)

This was a single centre, three arm, randomized, controlled, parallel assignment, double blinded, prospective study involving 63 patients (30 - 74 years old; mean age = 57.0 ± 9.1 years) with Type II diabetes established as per American Diabetes Association (ADA guidelines) along with a diagnosis of diabetic peripheral neuropathy made after a careful clinical examination. The inclusion criteria included being 18 to 75 years of age, known diabetes mellitus (KDM) for a duration of minimum of 5 years, and has diabetic neuropathic pain based on Toronto Expert Panel on diabetic neuropathy diagnostic criteria.

Patients in two out of the three arms received the First Relief (Group A - first treatment arm) and sham device (Group C - identical to the subject device but delivers no stimulation and acts as placebo). A third arm included the use of an already cleared FDA device (Group B - 1 Hz stimulation frequency) as the second treatment arm. The devices (treatment and sham) were applied on a bi-weekly basis for 16 weeks and the subjects visited every week either for treatment or followup/removal of the device.

The primary efficacy endpoint is pain intensity measured through Visual Analog Scale (VAS) score and the secondary efficacy endpoints are vibration perception threshold (VPT) value, insomnia severity index (ISI), overall neuropathy limitations scale (ONLS), Hamilton rating scale for anxiety - A (HAM-A). The five endpoints were measured weekly over the study period of 16 weeks. A 30day and 90-day follow-up was also part of the study design to understand the long-term impact of the treatment.

The VAS pain score analysis showed a significant reduction in the pain score in Group B from the start of the treatment to the end. This improvement persisted throughout the 90-day follow-up, suggesting that the treatment was a long term improvement in neuropathic pain and not a short term improvement. Both the treatments showed a marked improvement (3.12 and 3.15 against 1.18 for the control group).

The secondary outcome measures (VPT, Insomnia, ONLS and HAM) also showed similar improvements to the pain score, showing significant improvement in sleep and mood as the neuropathic pain decreased.

However, treatment B (First Relief device) was the more effective one at reducing the ONLS and HAM scores over the long term.

The post hoc analysis of ONLS scores indicates a significant difference in the reduction of ONLS score in group B compared to group C (Adj. P-value = 0.007). By contrast, the Adj P-value is

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

December 20, 2021

DyAnsys, Inc. Srini Nageshwar CEO 300, North Bayshore Boulevard San Mateo. California 94401

Re: K212859

Trade/Device Name: First Relief Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NHI Dated: August 26, 2021 Received: September 8, 2021

Dear Srini Nageshwar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Amber Ballard, PhD Assistant Director, Neurodegenerative Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212859

Device Name First Relief

Indications for Use (Describe)

The First Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for multiple treatments up to 56 days for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a red stylized "D" shape followed by the text "DyAnsys" in black. A circled "R" symbol is located to the upper right of the text.

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87 and 21 CFR 807.92.

510(k) Number: K212859

I. SUBMITTER

Date Prepared:
Name:	DyAnsys, Inc
Address:	300, North Bayshore Boulevard,
San Mateo, CA 94401, USA
Contact Person:	Srini Nageshwar
Phone Number:	408.480.4700
Facsimile Number:	(650)-556-1621

II. DEVICE INFORMATION

Trade Name:	First Relief
Classification Name:	Percutaneous Electrical Nerve Stimulation (PENS) device
(21 CFR 882.5890)
Device Class:	Class II
Product Code:	NHI

III. PREDICATE DEVICE

Model Name: SPRINT PNS System (K202660, K181422, K170902, K161154) Manufacturer: SPR Therapeutics, Inc.

First Relief v1 (K202940) manufactured by our company has been used as reference device in this submission.

Both the predicate and reference devices have not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

The First Relief is designed to aid in the treatment of chronic pain symptoms by the method of cranial electrical stimulation at the auricular stimulation points. The First Relief is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over seven days / 168 hours from the time of activation of the device.

The electrical pulse from the device will be delivered to the branches of cranial Nerves on the ear through a set of wire assembly and stimulation needles. Three zinc air batteries with 1.4 V each provide the required stimulation energy for 168 hours. There stimulation electrode and one ground electrode which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device.

510(k) Number: K212859

Confidential

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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 to the left of the company name, "DyAnsys," which is written in black. A registered trademark symbol is located to the upper right of the company name.

This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin.

The stimulation pattern consists of rectangular pulses with differing inter-pulse intervals.

A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance

V. INDICATIONS FOR USE

The First Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for multiple treatments up to 56 days for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy.

The Indications for Use statement of First Relief is not identical to that of the predicate device; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use of symptomatic relief and management of pain through the delivery of short-term electrical stimulation.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The DyAnsys, Inc First Relief system is substantially equivalent to the legally marketed predicate device SPRINT PNS System (K202660). It was evaluated through performance and non-clinical testing.

| MODEL NAME | First Relief
(Subject) | SPRINT PNS System
(K202660 - Predicate) | First Relief v1
(K202940 - Reference) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| MANUFACTURER | DyAnsys Inc. | SPR Therapeutics | DyAnsys Inc. | |
| | Intended Use / Indications for Use Statement | | | |
| INTENDED USE | Short-term electrical
stimulation is delivered
for symptomatic relief
and management of pain | Short-term electrical
stimulation is delivered
for symptomatic relief
and management of pain | Short-term electrical
stimulation is delivered for
symptomatic relief and
management of pain | |
| INDICATIONS FOR
USE | | The SPRINT Peripheral
Nerve Stimulation
(PNS) System is | The First Relief v1 is a
percutaneous electrical nerve
field stimulator (PENFS)
system intended to be used
in patients 11-18 years of | |
| | The First Relief is a
percutaneous electrical
nerve stimulator (PENS)
system indicated for
multiple treatments up to
56 days for symptomatic
relief of chronic,
intractable pain from
diabetic peripheral
neuropathy. | indicated for up to 60
days in the back and/or
extremities for:
• Symptomatic relief of
chronic, intractable pain,
post surgical and post-
traumatic
acute pain;
• Symptomatic relief of
post-traumatic pain;
• Symptomatic relief of
post-operative pain. | age with functional
abdominal pain associated
with irritable bowel
syndrome (IBS). The First
Relief v1 is intended to be
used for 120 hours per week
up to 3 consecutive weeks,
through application to
Cranial Nerves V, VII, IX
and X, and the occipital
nerves identified by trans-
illumination, as an aid in the
reduction of pain when
combined with other
therapies for IBS. | |
| PATIENT
POPULATION | Adults | Adults | Children | |
| SINGLE USE
ELECTRODES | Yes | Yes | Yes | |
| PORTABLE
COMPONENTS | Yes | Yes | Yes | |
| DURATION OF
PATIENT CONTACT
(days) | 7 days | 60 days | 5 days | |
| NUMBER OF
TREATMENTS | 8 times | Once | 3 times | |
| MAXIMUM TOTAL
DURATION OF
THERAPY (days) | 7 x 8 = 56 days* | 60 x 1 = 60 days | 5 x 3 = 15 days | |
| * Note that the First Relief device is applied for 168 hours per week on alternative weeks for 16 consecutive
weeks resulting in 56 days / 8 weeks of treatment and 49 days / 7 weeks of no device in between. | | | | |
| TECHNOLOGICAL CHARACTERISTICS | | | | |
| PULSE GENERATOR | | | | |
| PRODUCT
DIMENSION (mm) | 50 * 23 * 7 | 62 * 37 * 14 | 50 * 23 * 7 | |
| MASS (g) | 5 (including battery) | 24 | 5 (including battery) | |
| PRODUCT SHAPE | Rectangle | Rectangle | Rectangle | |
| POWER | | | | |
| FREQUENCY (Hz) | 1 - 10 (Sweep Pattern) | 5 - 100 | 1 - 10 | |
| WAVEFORM | Biphasic with
Rectangular Pulse | Biphasic with
Rectangular Pulse | Biphasic with
Rectangular Pulse | |
| BATTERY TYPE | P10 Zinc Air batteries
that are non-rechargeable | Rechargeable Lithium
Ion Polymer cell | P10 Zinc Air batteries that
are non-rechargeable | |
| BATTERY
CAPACITY (mAh) | 100 | 240 | 100 | |
| NO. x VOLTAGE (V) | 3 x 1.4 V | 1 x UNK | 3 x 1.4 V | |
| PULSE WIDTH(ms) | 1 | 0.2 | ~1 | |
| DUTY CYCLE | 2 hours ON / 2 hours
OFF | 50 % or 100 % * | 2 hours ON / 2 hours OFF | |
| TYPICAL BATTERY
OPERATING TIME
(hours) | 168 | 12 - 24 | 120 | |
| | ENVIRONMENTAL | | | |
| OPERATING
TEMPERATURE | 5 °C to 45 °C | 5 °C to 40 °C | 5 °C to 45 °C | |
| OPERATING
HUMIDITY | 40% to 80% | 15% to 90% | 40% to 80% | |
| ENVIRONMENT OF
USE | Clinics, Hospital and
Home environments | Clinics, Hospital and
Home environments | Clinics, Hospital and Home
environments | |
| STERILIZATION OF
ELECTRODES | EtO Sterilization | EtO Sterilization | EtO Sterilization | |
| RE-USE | Single use Device | Single use Device | Single use Device | |
| SHELF LIFE | 6 months | 24 months | 6 months | |
| ACCESSORIES | - First Relief with non
activated batteries

Top Cover of First
Relief
Sterile pack of needles
for use with the First
Relief device
Adhesive to fasten the
needles
Adhesive for the First
Relief device
Instruction for use | - OnePass Introducer
MicroLead
Pulse Generator
Hand-Held Remote
Recharging base with
power supply
Mounting pad adhesive
Connectors and
Adapter
Adhesive Bandage
Instructions for use | - First Relief v1 with non
activated batteries
Top Cover of First Relief
v l
Sterile pack of needles for
use with First Relief v1
Adhesive to fasten the
needles
Adhesive for the First
Relief v1 device
Instruction for use | |
| UNK = Not able to determine from publicly available documents. FDA may have access in cleared 510(k). | | | | |

Table 6.1: Comparison of Technological Characteristics

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Image /page/5/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a red symbol resembling a stylized "greater than" sign combined with a curved line, followed by the word "DyAnsys" in black font. A registered trademark symbol is placed to the upper right of the word "DyAnsys".

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Image /page/6/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a red abstract symbol on the left, followed by the text "DyAnsys" in black. A registered trademark symbol is located to the upper right of the text. The logo is simple and modern.

= Duty Cycle is mentioned as a percentage in the cleared 510(k) summary of predicate device.

System	First Relief	SPRINT PNS System	First Relief v1
510(k) Number: K212859		Confidential	Page 4 of 8

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Image /page/7/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a red symbol that looks like a stylized "A" or an arrow pointing to the right, followed by the word "DyAnsys" in black font. A registered trademark symbol is located to the upper right of the word "DyAnsys".

Characteristic	(Subject)	(K202660 - Predicate)	(K202940 - Reference)
Pulse Generator
Software
Controlled	Yes	Yes	Yes
Weight (g)	5 g	24 g	5 g
Dimensions(mm)	50 * 23 * 7 mm	62 * 37 * 14	50 * 23 * 7 mm
Housing
Material	ABS Plastic Material	UNK	ABS Plastic Material
Electrode Needle Arrays
Introduction
Method	Percutaneous	Percutaneous	Percutaneous
Tissue Contact	Skin/Tissue	Skin/Tissue	Skin/Tissue
Electrode Type	Percutaneous fine needle	Percutaneous fine wire	Percutaneous fine needle
Stimulating
Electrode
Material	Titanium	316L Stainless Steel	Titanium
Stimulating
electrode shape	Straight	Straight with tine	Straight
Electrode
Configuration	Single needle in all the 4
leads	1 pair (1 percutaneous
electrode and 1 surface
electrode)	Single needle in all the 4
leads
Number of leads	4 (3 signal and 1 ground)	1	4 (3 signal and 1 ground)
Diameter of
percutaneous
extension (mm)	0.4	0.64	0.4
Electrode Length
(mm)	2	15.2	2
Surface area of
needle (cm²)	0.0201 cm²	UNK	0.0201 cm²
Supplied Sterile	Yes	Yes	Yes
System Characteristics (Output Specs)
Pulse Duration
(ms)	1	0.2	1
Net Charge (µC /
pulse)	0 ( due to the nature of the
biphasic waveform)	0	0
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	Low levels of electrical
current are delivered by
the external stimulator
through electrodes
placed percutaneously	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.	in proximity to a target
peripheral nerve
associated with a
painful area.	target the associated cranial
and occipital nerves.
Anodes /
Cathodes please
identify the
ground	The ground electrode of
First Relief 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.	The ground electrode of
SmartPatch PNS is the
surface electrode in
contact with the
patient's skin, which
creates a closed circuit
for safe and proper
functioning of the
stimulation device
whereas the active
electrode is placed near
the target nerve.	The ground electrode of
First 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.

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Image /page/8/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a red symbol that looks like a stylized letter "A" or an abstract shape, followed by the text "DyAnsys" in black font. A circled "R" symbol, indicating a registered trademark, is positioned to the upper right of the word "DyAnsys".

Similar to SPRINT PNS system and First Relief v1, the First Relief device is intended to be a prescription (Rx) device for use by or on the order of a licensed healthcare practitioner. All the three devices are body-worn and deliver electrical stimulation therapy for symptomatic relief and management of pain. All the three devices deliver biphasic electrical stimulation waveforms hence are charge balanced due to the a positive and negative phase between active electrode(s) and the ground electrode.

The first minor technological difference lies in the placement of electrodes and the electrode configuration. The flexible SPRINT PNS percutaneous stimulation electrode passes through the skin to a depth of 2-4 cm, to a target peripheral nerve associated with a painful area, either in the lower back or extremities. In contrast, the First Relief stimulation electrodes pass through the skin to a depth of 2 mm on the ear to target the associated cranial and occipital nerves of the pain region. The ground electrode of SPRINT PNS is placed transcutaneously whereas that of First Relief is placed percutaneously similar to the stimulation electrodes. These differences do not raise any new questions on safety and effectiveness, as both designs pass through the skin and stay in place for the appropriate treatment period, and safely deliver electrical stimulation for the desired short-term period. The clinical study results along with the identical design present in the First Relief v1 device show that the device is safe to use on patients for pain management.

The second minor difference is in the duration of patient contact where the SPRINT PNS system is applied for up to 60 days whereas that of the First Relief system is 7 days. This difference does not raise any new questions on safety and effectiveness.

Results from the clinical study have demonstrated the safety of the therapy and there were no serious adverse events observed during the study and the follow-up period.

Along with results from clinical study, performance bench testing has been performed to establish substantial equivalence of First Relief to the cited predicate device. The reference device has been utilized in comparison bench testing to denote the equivalent output characteristics. Hence, evaluation of the effect of the technological differences supports the finding of substantial equivalence.

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Image /page/9/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a stylized red symbol resembling an arrow or checkmark, followed by the text "DyAnsys" in black. A circled "R" symbol, indicating a registered trademark, is positioned to the upper right of the text.

VII. Performance Data

The nonclinical testing of First Relief device included biocompatibility testing, electrical safety (electromagnetic compatibility and safety), performance bench testing and software validation.

The First Relief device and its components are subjected to performance bench testing to validate the effectiveness of each unit. The final product testing is performed to verify and compare the effectual output along with that of the reference device. The functional test is performed for 168 hours to monitor the continuous performance. The pulse duration, amplitude and current values are captured for the First Relief device. The First Relief has equivalent performance specifications when compared to the predicate and reference devices.

Clinical testing results presented with this submission have demonstrated the safety of the therapy. No serious adverse events were observed during the study as the subsequent follow-up period.

VIII. Summary of Clinical Information

This was a single centre, three arm, randomized, controlled, parallel assignment, double blinded, prospective study involving 63 patients (30 - 74 years old; mean age = 57.0 ± 9.1 years) with Type II diabetes established as per American Diabetes Association (ADA guidelines) along with a diagnosis of diabetic peripheral neuropathy made after a careful clinical examination. The inclusion criteria included being 18 to 75 years of age, known diabetes mellitus (KDM) for a duration of minimum of 5 years, and has diabetic neuropathic pain based on Toronto Expert Panel on diabetic neuropathy diagnostic criteria.

Patients in two out of the three arms received the First Relief (Group A - first treatment arm) and sham device (Group C - identical to the subject device but delivers no stimulation and acts as placebo). A third arm included the use of an already cleared FDA device (Group B - 1 Hz stimulation frequency) as the second treatment arm. The devices (treatment and sham) were applied on a bi-weekly basis for 16 weeks and the subjects visited every week either for treatment or followup/removal of the device.

The primary efficacy endpoint is pain intensity measured through Visual Analog Scale (VAS) score and the secondary efficacy endpoints are vibration perception threshold (VPT) value, insomnia severity index (ISI), overall neuropathy limitations scale (ONLS), Hamilton rating scale for anxiety - A (HAM-A). The five endpoints were measured weekly over the study period of 16 weeks. A 30day and 90-day follow-up was also part of the study design to understand the long-term impact of the treatment.

The VAS pain score analysis showed a significant reduction in the pain score in Group B from the start of the treatment to the end. This improvement persisted throughout the 90-day follow-up, suggesting that the treatment was a long term improvement in neuropathic pain and not a short term improvement. Both the treatments showed a marked improvement (3.12 and 3.15 against 1.18 for the control group).

The secondary outcome measures (VPT, Insomnia, ONLS and HAM) also showed similar improvements to the pain score, showing significant improvement in sleep and mood as the neuropathic pain decreased.

510(k) Number: K212859

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However, treatment B (First Relief device) was the more effective one at reducing the ONLS and HAM scores over the long term.

The post hoc analysis of ONLS scores indicates a significant difference in the reduction of ONLS score in group B compared to group C (Adj. P-value = 0.007). By contrast, the Adj P-value is