(212 days)
No
The description focuses on preprogrammed electrical stimulation parameters and hardware components, with no mention of adaptive algorithms, learning, or data processing beyond basic device function.
Yes.
The device is used for "auricular point nerve stimulation for pain," which indicates a therapeutic purpose.
No
The description explicitly states the device is for "stimulation of auricular point nerve stimulation for pain", indicating a therapeutic purpose rather than diagnosing a condition.
No
The device description clearly outlines physical hardware components including a battery, wires, and needle arrays, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
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 about a person's health. This testing is done outside of the body ("in vitro").
- Device Description: The EAD is an electro acupuncture device that directly stimulates nerves on the ear using needles. This is a therapeutic intervention performed on the body, not a diagnostic test performed on a sample taken from the body.
- Intended Use: The intended use is for "stimulation of auricular point nerve stimulation for pain" in the practice of acupuncture. This is a treatment for pain, not a diagnostic test to identify a disease or condition.
The device description clearly indicates it's a therapeutic device used for direct stimulation, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The EAD 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 EAD system is a battery-operated, single-use device that has a preprogrammed frequency, pulse and duration for the stimulation of auricular point nerve stimulation for pain. The device power supply connects via four (4) stainless steel wires, sheathed in a plastic over-molding, to three (3) needle arrays comprised of four (4) needles each and one (1) needle array comprised of only 1 needle.
The device is powered by one 3 Volt lithium ion battery.
The device modulates a duty cycle between 2 hours on and 2 hours at rest. The maximum performance time frame is 5 days or 120 hours (5 days X 24 hours). Weight is 4 grams including batteries. The power supply dimensions are 36 mm x 17 mm x 7 mm. The needle dimensions are 0.5 mm width x 2 mm length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
auricular point (ear)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified practitioners of acupuncture / At the clinic and at home
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)
Non-Clinical Performance Data:
- Biocompatibility Testing: Evaluation for the adhesive conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Tests included Cytotoxicity, Sensitization, and Irritation. The adhesive is considered tissue contacting for less than 30 days. Other patient contacting materials are unchanged from the P-Stim predicate device.
- Electrical Safety and Electromagnetic Compatibility (EMC): Testing conducted on the EAD device. Complies with IEC 60601-1, IEC 60601-2-10, and IEC 60601-1-2 standards.
- Software Verification and Validation Testing: Conducted and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered a "minor" level of concern.
- Sterility/Shelf Life: Sterilization Validation conducted using the VDMAX25 method according to ISO 11137-2 and ISO 11737-2. Performance and stability of packaging validated in accordance with ISO 11607-1 and Accelerated aging performed in accordance with ASTM F1980-07. Packaging qualifications according to ISO 11607-1 and machine qualifications for sealing process according to ISO 11607-2.
Key Results: The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the EAD device should perform as well as the predicate device in the specified use conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are stacked slightly on top of each other, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 2, 2014
Navigant Consulting, Inc. Colleen Hittle Managing Director 30 S. Wacker Drive, Suite 3100 Chicago, Illinois 60606
Re: K140530
Trade/Device Name: Electro Auricular Device Regulation Name: Electro Acupuncture Stimulator Regulatory Class: Unclassified Product Code: BWK Dated: August 29, 2014 Received: September 2, 2014
Dear Ms. Colleen Hittle:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) 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" (21CFR 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 yours.
Felipe Aquel -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K140530
Device Name EAD (electro auricular device)
Indications for Use (Describe)
The EAD 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Felipe Aquel Date: 2014.10.02 20:47:21 -04'00'
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3
510(k) Summary
Submitter & Contact Information
Colleen Hittle, RAC Managing Director Navigant Consulting, Inc. 30 S. Wacker Drive Suite 3100 Chicago IL 60606 Phone: (317) 228-8730 Fax: (317) 228-8701 colleen.hittle@navigant.com
Date: June 23, 2014
Manufacturer: Key Electronics 2533 Centennial Blvd Jeffersonville, IN 47130
Trade Name: EAD (electro auricular device)
Common Name: electro acupuncture device
Classification Name(s): BWK - stimulator, electro-acupuncture
Classification Number: Unclassified
Predicate Device(s)
| 510(k) Number | Device Name | Submitter Name | |
|---|---|---|---|
| Primary | K050123 | P.Stim System | Neuroscience Therapy |
| Predicate | Corporation | ||
| Reference | K091875 | E-Pulse | Medevice Corporation |
| Device |
4
Device Description
The EAD system is a battery-operated, single-use device that has a preprogrammed frequency, pulse and duration for the stimulation of auricular point nerve stimulation for pain. The device power supply connects via four (4) stainless steel wires, sheathed in a plastic over-molding, to three (3) needle arrays comprised of four (4) needles each and one (1) needle array comprised of only 1 needle.
The device is powered by one 3 Volt lithium ion battery.
The device modulates a duty cycle between 2 hours on and 2 hours at rest. The maximum performance time frame is 5 days or 120 hours (5 days X 24 hours). Weight is 4 grams including batteries. The power supply dimensions are 36 mm x 17 mm x 7 mm. The needle dimensions are 0.5 mm width x 2 mm length.
Intended Use(s)
The EAD is an electro acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Technological Characteristics
Appliance: Electro-acupuncture Device Type description: EAD Power supply: 1 x 3V battery (Type CR1220 Lithium) Output: (Load impedance range 1k-10kQ) max. 3.2V, Impulse interval 1000ms, impulse width 1ms, 'ims I bipolar), max possible total duration of treatment 5x 24 hours Protection level: IP20 Type: B Duty type: approx. 2h duty I 2h at rest (periodic duty) Weight incl. battery: 4g Dimensions: 36 x 16 x 7 mm Needle Dimensions: 0.5 mm width x 2 mm length
5
| Device Name | EAD | E-Pulse
(Reference Device) | P.Stim System
(Primary Predicate) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 501(k) Number | This Submission | K091875 | K050123 |
| Indication for Use | The EAD is an
electro acupuncture
device for use in the
practice of
acupuncture by
qualified
practitioners of
acupuncture as
determined by the
states. | The E-Pulse is an
electro acupuncture
device for use in the
practice of
acupuncture by
qualified
practitioners of
acupuncture as
determined by the
states. | The P-Stim is an
electro acupuncture
device for use in the
practice of
acupuncture by
qualified
practitioners of
acupuncture as
determined by the
states. |
| Device Description | Battery powered
device generates
low frequency and
continual electrical
pulse which are
transmitted to new
endings of the ear. It
allows continued
therapy over several
days.
The device is
controlled by a
micro processor. | Battery powered
unit designed to
administer auricular
point nerve
stimulation
treatment for pain
therapy over a 96-
hour period via
electrical pulsing.
The device is on for
3 hours and then off
for 3 hours.
The device is
controlled by a
micro processor. | A micro stimulation
appliance for pain
therapy.
The device
generates low
frequency and
continual electrical
pulse which are
transmitted to new
endings of the ear. It
allows continued
therapy over several
days.
The device is
controlled by a
micro processor. |
| Target Population | Patients with acute
and chronic pain | Patients with acute
and chronic pain | Patients with acute
and chronic pain |
| Human Factors | To be applied by a
qualified
practitioner of
acupuncture | To be applied by a
qualified
practitioner of
acupuncture | To be applied by a
qualified
practitioner of
acupuncture |
| Where Used | At the clinic and at
home | At the clinic and at
home | At the clinic and at
home |
| Software Based | Yes | Yes | Yes |
| Performance | 2 hours on/2 hours
off; pulses with
modulating
frequency (1 to 10
Hz) | 3 hours on/3 hours
off; pulse
monophasic at 1 Hz | 3 hours on/3 hours
off; pulse
monophasic at 1 Hz |
| Power Source | Lithium ion battery | Zinc air battery | Zinc air battery |
| Duration | Up to 120 hours | 96 hours | 96 hours |
Comparison Table: Applicant Device vs. Predicate Devices
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| Generator | Attached behind patient ear | Attached behind patient ear | Attached behind patient ear |
|---|---|---|---|
| Leads | Four electrode needle leads | Three leads that can attach to needles | Three leads that can attach to needles |
| Needles | Titanium straight shaft | Titanium hook shaft | Titanium straight shaft |
| Shape | Elliptical | Round | Elliptical |
Non-Clinical Performance Data
Biocompatibility Testing
The biocompatibility evaluation for the adhesive for the EAD device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, " May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- . Cytotoxicity
- Sensitization
- Irritation
The EAD adhesive is considered tissue contacting for a duration of less than 30 days. The other patient contacting materials contained in the subject device are unchanged from the P-Stim predicate device.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the EAD device. The system complies with the IEC 60601-1 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern, since a failure or latent flaw in the software could not directly result in serious injury or death to the patient or operator.
Sterility/Shelf Life
Sterilization Validation was conducted on the EAD device needles and wiring harness using the VDMAX25 method according to ISO 11137-2 and ISO 11737-2. Performance and stability of the EAD packaging was validated in accordance with ISO 11607-1 and Accelerated aging of the EAD was performed in accordance with ASTM F1980-07. Packaging qualifications are according to ISO 11607-1 and machine qualifications for the sealing process are according to ISO 11607-2.
7
Conclusion
The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the EAD device should perform as well as the predicate device in the specified use conditions.