(90 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 described as a percutaneous electrical nerve field stimulator (PENFS) system intended to aid in the reduction of pain for a medical condition (IBS) when used with other therapies, which falls under the definition of a therapeutic device.
No
Explanation: The device is described as a percutaneous electrical nerve field stimulator intended to reduce pain, not to diagnose a condition. Its function is therapeutic, not diagnostic.
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 device includes significant hardware components beyond just 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 examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The First Relief v1 is a percutaneous electrical nerve field stimulator (PENFS). It works by applying electrical stimulation to nerves on the ear.
- Mechanism of Action: The device directly interacts with the patient's nervous system through electrical pulses, rather than analyzing biological samples.
Therefore, the First Relief v1 falls under the category of a therapeutic or neuromodulation device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The First Relief v1 is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 11-18 years of 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 with other therapies for IBS.
Product codes (comma separated list FDA assigned to the subject device)
OHH
Device Description
The First Relief v1 is designed to aid in the reduction of pain when combined with other therapies of IBS in patients 11 - 18 years of age with Functional Pain associated with the Irritable bowel syndrome (IBS) by the method of Cranial electrical stimulation at the auricular stimulation points. The First 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 (V, VII, IX and X) 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
Cranial Nerves V, VII, IX and X, and the occipital nerves identified by trans-illumination. Application to the ear (auricular stimulation points).
Indicated Patient Age Range
11-18 years of age
Intended User / Care Setting
Not Found
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 First Relief v1 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 First Relief v1 device. The First Relief v1 has equivalent Performance specifications when compared to the predicate device.
The bench test has been performed and found that the First Relief v1 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
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
§ 876.5340 Nonimplanted nerve stimulator for functional abdominal pain relief.
(a)
Identification. A nonimplanted nerve stimulator for functional abdominal pain relief is a device that stimulates nerves remotely from the source of pain with the intent to relieve functional abdominal pain. This generic type of device does not include devices designed to relieve pelvic pain.(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 labeled shelf life.
(7) Labeling must include the following:
(i) A detailed summary of the device technical parameters;
(ii) A warning stating that the device is only for use on clean, intact skin;
(iii) Instructions for use, including placement of the device on the patient; and
(iv) A shelf life.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 29, 2020
DyAnsys, Inc. Srini Nageshwar CEO 300 North Bayshore Boulevard San Mateo. California 94401
Re: K202940
Trade/Device Name: First Relief v1 Regulation Number: 21 CFR 876.5340 Regulation Name: Non-implanted nerve stimulator for functional abdominal pain relief Regulatory Class: Class II Product Code: OHH Dated: July 5, 2020 Received: September 30, 2020
Dear Mr. Nageshwar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 (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
First Relief v 1
Indications for Use (Describe)
The First Relief v1 is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 11-18 years of 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 with other therapies for IBS.
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 stylized red symbol to the left of the company name, "DyAnsys," which is written in black. The symbol appears to be a combination of a greater-than sign and a stylized lambda symbol.
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: K202940
1. 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 |
De vice Information
Classification :Class II Trade Name :First Relief v1 Classification Name :Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome Product Code :OHHH
2. Predicate Device:
DEN Number: DEN180057 Model Name: IB - Stim Manufacturer: Innovative Health Solutions.Inc.,
3. De vice Description:
The First Relief v1 is designed to aid in the reduction of pain when combined with other therapies of IBS in patients 11 - 18 years of age with Functional Pain associated with the Irritable bowel syndrome (IBS) by the method of Cranial electrical stimulation at the auricular stimulation points. The First 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 (V, VII, IX and X) 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. 510(k) Number: K202940 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 resembling a greater-than sign combined with a lambda symbol, followed by the company name "DyAnsys" in black font. The font appears to be sans-serif and is relatively bold.
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
4. Intended Use :
The First Relief v1 is a Percutaneous Electric Nerve Field Stimulator (PENFS) system intended to be used in patients 11 -18 years of 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 branches of cranial nerves V, VII, IX and X and the occipital nerves identified by transillumination as an aid in the reduction of pain when combined with other therapies for IBS.
5. Comparison to Predicate Device:
The DyAnsys .Inc., First Relief v1 is substantially equivalent to legally marketed predicate device IB-Stim (DEN180057). It was evaluated through Non-Clinical testing.
| MODEL NAME | Drug Relief
(K173841) | First Relief v1
(Subject) | IB-Stim
(DEN180057) | | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| MANUFACTURER | DyAnsys.Inc., | DyAnsys.Inc., | Innovative Health Solutions. Inc., | | |
| 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,
VI, IX and X, and the occipital
nerves identified by
transillumination. | The First Relief v 1 is a Percutaneous
Electrical Nerve Field Stimulator
(PENFS) systemintended to be used
in patients 11-18 years of age with
functional abdominal pain
associated with the irritable bowel
syndrome (IBS). The First Relief v 1
is intended to be used for 120 hours
per week up to 3 consecutive weeks,
through application to branches of
Cranial nerves V, VI, IX and X the
occipital nerves identified by
transillumination as an aid in the
reduction of pain when combined
with other therapies for IBS. | The IB-Stim is a percutaneous
Electrical Nerve Field Stimulator
(PENFS) systemintended to be used
in patients 11-18 years of age with
functional abdominal pain associated
with the irritable bowel syndrome
(IBS). The IB-Stim is intended to be
used for 120 hours per week up to 3
consecutive weeks, through
application to branches of Cranial
Nerves V, VI, IX and X and the
occipital nerves identified by
transillumination as an aid in the
reduction of pain when combined with
other therapies for IBS. | | |
| PATIENT
POPULATION | Adults | Child | Child | | |
| | TECHNOLOGICAL CHARACTERISTICS | | | | |
| SHAPE | Rectangle | Rectangle | Rectangle | | |
| PRODUCT
DIMENSION, mm | 50237 mm | 50237 mm | 36167 mm | | |
| WEIGHT, Kg | 6 gm (including battery) | 6 gm (including battery) | 5 gm | | |
| NEEDLE
DIMENSIONS, mm | 0.42 mm (widthlength) | 0.42 mm (widthlength) | 0.52 mm (widthlength) | | |
| Wire Assembly | 4 units of wire with snap-fit
ring, where 3 nos constitute a | 4 units of wire with snap-fit ring,
where 3 nos constitute a single | Four stainless steel wire with four
stimulation needles each. There are 3 | | |
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Image /page/5/Picture/0 description: The image contains the logo for DyAnsys. The logo consists of a stylized "A" in red, with a black greater-than sign to the left of it. To the right of the logo is the company name, "DyAnsys," in black sans-serif font.
| | single assembly for stimulation
and the other one separate wire
will act as a ground electrode. | assembly for stimulation and the
other one separate wire will act as a
ground electrode. | stimulation wires with 4 array of
needles each and 1 ground wire with 1
needle. |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| WIRE ASSEMBLY
TYPE | Wire assembly without
stimulation needles is soldered
with the pulse generator | Wire assembly without stimulation
needles is soldered with the pulse
generator | Wire assembly is connected with the
stimulation needles at one end and has
the facility to connect with the pulse
generator. It is sterilized and packed
separately. |
| 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 | Not Feasible |
| POWER: | | | |
| FREQUENCY | 1 Hz to 10 Hz | 1 Hz to 10 Hz | 1 Hz to 10 Hz |
| DUTY CYCLE | 2 Hours ON/1 minute OFF | 2 Hours ON/2 Hours OFF | 2 Hours ON/2 Hours Off |
| OPERATING TIME,
HOURS | 120 hours (5 days) | 120 hours (5 days) | 120 hours (5 days) |
| WAVEFORM | Rectangle pulse | Rectangle Pulse | Rectangle Pulse |
| (ENERGY
SOURCE)
BATTERY
OPERATION | Yes | Yes | Yes |
| BATTERY TYPE | Zinc Air, Battery P10 | Zinc Air Battery P10 | Lithium ion battery, CR1225 |
| BATTERY
CAPACITY | 100 mAh | 100 mAh | 50 mAh |
| VOLTAGE | $31.4V$ | $31.4V$ | $1*3V$ |
| PULSE WIDTH | 0.980 ms | 0.980 ms | 0.980 ms |
| ENVIRONMENT | | | |
| OPERATING
TEMPERATURE | 5 °C to 45 °C | 5 °C to 45 °C | 5 °C to 45 °C |
| OPERATING
HUMIDITY | 40% to 80% | 40% to 80% | 20% to 80% |
| ENVIRONMENT
OF USE | Clinics, Hospital, Home
environments | Clinics, Hospital, Home
environments | Clinics, Hospital, Home environments |
| STERILIZAITON | EtO Sterilization | EtO Sterilization | Irradiation (Gamma) |
| RE-USE | Single Use device | Single Use Device | Single Use Device |
| SHELF LIFE | 6 Months | 6 Months | 12 Months |
| PACKAGE | The drug relief device and its
accessories are packed in a
blister. This is then placed in a
carton box. Each carton boxhas
five device | The First Relief v 1 device and its
accessories are packed in a blister.
This is then placed in a carton box
Each carton boxhas multiple
devices | The IB-Stim and its accessories
packed in a blister |
| ACCESSORIES | -Drug Relief with the non
activated batteries
- Cover of the Drug Relief
- Sterile pack of needles for use
with the Drug Relief - Adhesive to fasten the needles | First Relief v1 with the non
activated batteries - Cover of the First Relief v 1
- Sterile pack of needles for use with
the First Relief v 1 - Adhesive to fasten the needles | - The IB-Stim device with inserted
batteries - Cover of the IB-Stim
- Sterile pack of Needles for use with
the IB-Stim - Tegaderm has been used to fasten |
| | - Adhesive for the Drug Relief
device - Instruction for use | - Adhesive for the First Relief v 1
device - Instruction for use | the device
- Alcohol Swab
-Instruction for use |
| PLANNING & PURCHASE | | | |
| WARRANTY | NA | NA | NA |
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Image /page/6/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a stylized symbol to the left, resembling an abstract letter 'A' with a combination of black and red lines. To the right of the symbol is the company name, 'DyAnsys', written in a clear, sans-serif font, with the letters in black.
Difference Between the Legally Marketed Predicate Device:
- Difference in Components ●
- The energy source (battery) has been replaced with higher capacity for more effective treatment
-
- Device adhesive has been replaced with a biocompatible, stretchable adhesive exclusively used for wearables and the EtO sterilization has been made used for needles.
These differences does not affect the safety and effectiveness of the device.
- Device adhesive has been replaced with a biocompatible, stretchable adhesive exclusively used for wearables and the EtO sterilization has been made used for needles.
6. Performance Testing Summary
The First Relief v1 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 First Relief v1 device. The First Relief v1 has equivalent Performance specifications when compared to the predicate device.
The form factors, material for sterilization and some patient contacting materials of the First Relief v1 are similar to the 510(K) cleared device Drug Relief (K173861).
7. Compliance with Standards
The First Relief v1 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
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Image /page/7/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a stylized red symbol resembling an arrow or a stylized letter 'A' on the left, followed by the text "DyAnsys" in black. The text is in a simple, sans-serif font, with the 'D' and 'A' capitalized and the rest of the letters in lowercase.
8. 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 Sterlization 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.
9. Non-Clinical Testing Summary
The bench test has been performed and found that the First Relief v1 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 First Relief v1 is substantially equivalent to the predicate device IB-Stim (DEN180057) that was cleared by FDA.