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K Number
K170391
Device Name
ANSiStim-PP
Manufacturer
DyAnsys Inc
Date Cleared
2017-03-09

(29 days)

Product Code
BWK
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ANSiStim-PP is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Device Description
The ANSiStim®-PP is a wearable, battery-operated device that is designed to administer continuous low-level electrical pulses to the ear over four days / 96 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the stimulation point 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 96 hours. There are three Stimulation needles 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 auricular cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device is also provided with a bottom ground. There are three options available for using the ground terminal in the device. Either the ground electrode or the bottom ground can be used. Or both the ground electrode and bottom ground can be used together. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The treatment period varies based on the severity of the pain in the individual. The stimulation pattern consists of 1 Hz single pulses with square waveform. The current direction is inverted every second pulse, which is intended to avoid polarization effects. To minimize the risk of adaption or tolerance to the electrical stimulation is applied for 3 hours, followed by a pause of 3 hours. 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.
More Information

K141168

Not Found

No
The device description focuses on electrical stimulation parameters and hardware components, with no mention of AI or ML algorithms for data analysis, decision-making, or adaptive stimulation.

Yes.
The device administers continuous low-level electrical pulses to the ear for a therapeutic purpose, specifically for use in the practice of acupuncture by qualified practitioners. This direct application of energy to the body for a medical effect classifies it as a therapeutic device.

No

The device description indicates it is used to "administer continuous low-level electrical pulses to the ear" and for "stimulating the auricular cranial nerves." This describes a therapeutic, not a diagnostic, function. While a 3-pin connector allows output voltage checks, this is for device function verification, not patient diagnosis.

No

The device description clearly outlines hardware components such as batteries, wire assembly, stimulation needles, ground electrode, and a 3-pin connector, indicating it is a physical device that delivers electrical pulses.

Based on the provided information, the ANSiStim-PP is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • ANSiStim-PP Function: The ANSiStim-PP is an electro-acupuncture device that applies electrical stimulation to the ear. It does not analyze any biological specimens from the patient.
  • Intended Use: The intended use is for electro-acupuncture by qualified practitioners, which is a therapeutic intervention, not a diagnostic test.

Therefore, the ANSiStim-PP falls under the category of a therapeutic device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The ANSiStim-PP is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Product codes

BWK

Device Description

The ANSiStim®-PP is a wearable, battery-operated device that is designed to administer continuous low-level electrical pulses to the ear over four days / 96 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the stimulation point 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 96 hours. There are three Stimulation needles 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 auricular cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device is also provided with a bottom ground.

There are three options available for using the ground terminal in the device. Either the ground electrode or the bottom ground can be used. Or both the ground electrode and bottom ground can be used together.

This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The treatment period varies based on the severity of the pain in the individual.

The stimulation pattern consists of 1 Hz single pulses with square waveform. The current direction is inverted every second pulse, which is intended to avoid polarization effects. To minimize the risk of adaption or tolerance to the electrical stimulation is applied for 3 hours, followed by a pause of 3 hours.

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

ear

Indicated Patient Age Range

Adults

Intended User / Care Setting

qualified practitioners of acupuncture as determined by the states.
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)

Performance testing for 96 hours to monitor the 3 hours ON state followed by 3 hours OFF state. The pulse duration, amplitude and current values are captured for the ANSiStim®-PP device. The ANSiStim®-PP has equivalent Performance specifications when compared to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K141168

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

N/A

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 9, 2017

Dyansys Inc Srini Nageshwar CEO 300. North Bavshore Boulevard San Mateo. California 94401

Re: K170391

Trade/Device Name: ANSiStim-PP Regulatory Class: Unclassified Product Code: BWK Dated: February 4, 2017 Received: February 8, 2017

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

William J.Digitally signed by William J. Heetderks -S
Heetderks -SDN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=0010149848,
cn=William J. Heetderks -S
Date: 2017.03.09 10:27:14-05'00'
  • for Carlos L. Peña, PhD, MS 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) K170391

Device Name ANSiStim - PP

Indications for Use (Describe)

The ANSiStim-PP is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

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 stylized red symbol resembling an arrow or a stylized letter 'A' on the left, followed by the word "DyAnsys" in black, sans-serif font. The logo is simple and modern, with a clear contrast between the red symbol and the black 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:

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

Device Information

Classification:Unclassified
Trade Name:ANSiStim®-PP
Common Name:Electro-acupuncture device
Classification Name:Stimulator, Electro-acupuncture
Product Code:BWK

2. Predicate Device:

K Number: K141168 Model Name: ANSiStim Manufacturer: DyAnsys Inc.,

3. Device Description:

The ANSiStim®-PP is a wearable, battery-operated device that is designed to administer continuous low-level electrical pulses to the ear over four days / 96 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the stimulation point 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 96 hours. There are three Stimulation needles 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 auricular cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device is also provided with a bottom ground.

There are three options available for using the ground terminal in the device. Either the ground electrode or the bottom ground can be used. Or both the ground electrode and bottom ground can be used together.

This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The treatment period varies based on the severity of the pain in the

510(k) Number:

Confidential

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Image /page/4/Picture/0 description: The image contains 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 letters closely spaced.

individual.

The stimulation pattern consists of 1 Hz single pulses with square waveform. The current direction is inverted every second pulse, which is intended to avoid polarization effects. To minimize the risk of adaption or tolerance to the electrical stimulation is applied for 3 hours, followed by a pause of 3 hours.

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 ANSiStim®-PP is as an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

5. Comparison to Predicate Device:

The DyAnsys, Inc ANSiStim®-PP device is substantially equivalent to it's own legally marketed predicate device ANSiStim(K141168). It was evaluated through Performance and Non-Clinical testing.

| MODEL NAME | ANSiStim®
(K141168) | ANSiStim®-PP
(Subject) | JUSTIFICATION ON
SAFETY &
EFFECTIVENESS
VARIATIONS |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| MANUFACTURER | DyAnsys Inc | DyAnsys Inc | NA |
| INTENDED USE | The ANSiStim® is as an electro-
acupuncture device for use in the
practice of acupuncture by
qualified practitioners of
acupuncture as determined by the
states. | The ANSiStim® is as an electro-
acupuncture device for use in the
practice of acupuncture by qualified
practitioners of acupuncture as
determined by the states. | NA |
| PATIENT POPULATION | Adults | Adults | NA |
| SHAPE | Oval | Rectangle | NA |
| DIMENSION, mm | 63288 mm | 47221 mm | NA |
| WEIGHT, Kg | 5 gm (including battery) | 5 gm (including battery) | NA |
| NEEDLE DIMENSIONS,
mm | 0.42 mm (widthlength) | 0.42 mm (widthlength) | NA |
| WIRE ASSEMBLY | 3 nos of Molded SS wire with
snap-fit ring constitute a single
assembly | 4 nos of Molded SS wire with snap-fit
ring.
Where 3 nos constitute a single
assembly for Stimulation and the
other one separate SS wire will act as
a ground electrode. | NA |
| GROUND TERMINAL | Bottom Ground | Either of these two or both can be
used as a ground terminal.

  1. Bottom Ground | NA |
    | | | 2. Ground Electrode | |
    | CONNECTOR | No | A 3-pin connector is used to check the
    output voltage of the ANSiStim®-PP
    once it is activated and before
    applying it to the patient. | Any voltage measuring
    device with appropriate
    regulatory compliance
    alone can be used. |
    | POWER: | | | |
    | FREQUENCY | 1Hz | 1 Hz | NA |
    | CURRENT | ~1mA | ~1mA | NA |
    | WAVEFORM | Square Pulse | Square Pulse | NA |
    | (ENERGY SOURCE)
    BATTERY OPERATION | Yes | Yes | NA |
    | BATTERY TYPE | Zinc Air batteries, AC A10 | Zinc Air batteries, P10 | NA |
    | BATTERY CAPACITY | 100 mAh | 100 mAh | NA |
    | NO. / VOLTAGE | 31.4V | 31.4 V | NA |
    | DUTY CYCLE | 3 hours ON/ 3 hours OFF | 3 hours ON/ 3 hours OFF | NA |
    | OPERATING TIME, HOURS | 96 h | 96 h | NA |
    | ENVIRONMENTAL | | | |
    | OPERATING
    TEMPERATURE | 5°C to 45°C | 5°C to 45°C | NA |
    | OPERATING HUMIDITY
    (NON CONDENSING) | 40% to 80% | 40% to 80% | NA |
    | ENVIRONMENT OF USE | Clinics, Hospital and Home
    environments | Clinics, Hospital and Home
    environments | NA |
    | STERILIZATION | EtO Sterilization | EtO Sterilization | NA |
    | RE-USE | Single use Device | Single use Device | NA |
    | PACKAGE | The ANSiStim device and its
    accessories are packed in a blister.
    This is then placed in a carton
    box. Each carton box has ten
    device. | Same | NA |
    | ACCESSORIES
    PLANNING & PURCHASE | ANSiStim® device with inserted non-activated batteries. Cover of the ANSiStim® Sterile pack of Needles for use with the ANSiStim®. Adhesive to fasten the needles. Adhesive for the ANSiStim® device. Alcohol Swab Instructions for Use | ANSiStim®-PP device with inserted non-activated batteries. Cover of the ANSiStim®-PP Sterile pack of Needles for use with the ANSiStim®-PP. Adhesive to fasten the needles. Adhesive for the ANSiStim®-PP device. Alcohol Swab Instructions for Use | NA |
    | WARRANTY | NA | NA | Since it is a single use
    device. |

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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 resembling an arrow or a stylized 'A', followed by the word 'DyAnsys' in a simple, sans-serif font. The text is in black, providing a strong contrast against the white background.

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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 an arrow pointing to the right, followed by the company name "DyAnsys" in black font. The font appears to be sans-serif and the overall design is clean and modern.

Difference Between the Legally Marketed Predicate Device:

  • . Difference in Components
      1. The micro-controller which is used to control the electrical stimulation pulse has been changed from that of used in the predicate device.
      1. The energy source (battery) has been replaced by its equivalent to that of the predicate device.
      1. An additional ground terminal is provided.
      1. A 3-pin connector is provided additionally, which is used to check the voltage of the device.

These differences does not affect the safety and effectiveness of the device.

6. Performance Testing Summary

The ANSiStim®-PP 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 96 hours to monitor the 3 hours ON state followed by 3 hours OFF state. The pulse duration, amplitude and current values are captured for the ANSiStim®-PP device. The ANSiStim®-PP has equivalent Performance specifications when compared to the predicate device.

All the patient contacting materials of the ANSiStim® -PP are similar to the predicate device.

7. Compliance with Standards

The ANSiStim complies with the following standards

    1. 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

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

510(k) Number:

Confidential

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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 an arrow or a stylized letter. The overall design is clean and modern.

needle packs evidenced that the results are inline with standards requirement. All Sterilization testing was performed in accordance with ISO 11135:2014-Sterilization of healthcare products- ethylene oxide, ISO 11140-1:2005/(R) 2010 Sterilization of healthcare products- chemical indicators, ISO 10993-7:2008/(R) 2012 Biological evaluation of medical devices- ethylene oxide sterilization residuals, ISO 11737-1:2006/(R) 2011 Sterilization of medical devices- Microbiological methods-Part 1: Determination of a population of microorganisms on products, ISO 11737-2: 2009 Sterilization of medical devices- Microbiological methods- Part2: Tests of Sterility performed in the definition, validation and maintenance of a Sterilization process and ISO 11138-2:2006/(R) 2010-Sterilization Of Healthcare Products-Biological Indicators- Part2: Biological Indicators for ethylene oxide Sterilization Processes.

8. Non-Clinical Testing Summarv

The bench test has been performed and found that the ANSiStim®PP met all the requirements specifications and standards requirements. The testings includes the following:

    1. MEE testing as per IEC 60601-1
    1. EMI/EMC testing as per IEC 60601-1-2
    1. Biocompatibility testing as per ISO 10993
    1. Performance testing

9. 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 ANSiStim®-PP is substantially equivalent to the predicate device that was cleared under K141168.