(212 days)
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 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.
The provided document is a 510(k) Summary for a medical device called the "Electro Auricular Device" (EAD). This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a predicate device already legally marketed. As such, it focuses on comparing the new device to existing ones rather than presenting a detailed clinical study demonstrating the device's performance against specific acceptance criteria in the way a clinical trial might for a novel device.
Therefore, much of the requested information about acceptance criteria and studies that prove the device meets them, especially regarding clinical performance, is not present in this type of regulatory submission. The document primarily focuses on non-clinical aspects to establish substantial equivalence.
Here's a breakdown of what can be extracted and what is not available from the provided text, based on your request:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document in the format requested. The document emphasizes substantial equivalence to predicate devices rather than meeting specific performance acceptance criteria for a novel clinical claim. The "Performance" row in the comparison table on page 6 describes operational characteristics (e.g., "2 hours on/2 hours off; pulses with modulating frequency (1 to 10 Hz)"), but these are not presented as acceptance criteria against which a study directly measured clinical performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document describes non-clinical testing (biocompatibility, electrical safety, EMC, software verification, sterilization, shelf life), but these do not typically involve patient "test sets" or data provenance in the way clinical studies do. No clinical performance testing with human subjects is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As no clinical test set for performance is mentioned, there is no discussion of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As no clinical test set for performance is mentioned, there is no adjudication method described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided. MRMC studies are typically used for imaging or diagnostic devices where human readers interpret results, often with AI assistance. The EAD is an electro-acupuncture device, and the document describes no such study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The EAD does not appear to be an algorithmic diagnostic device, but rather a therapeutic device, so standalone performance in the context of an algorithm is not applicable or discussed. The software verification and validation are for the device's operational control, not for a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. Similarly to question 3, there is no mention of ground truth as it pertains to clinical performance outcomes.
8. The sample size for the training set
This information is not provided. The device is an electro-acupuncture stimulator, not an AI/ML-based diagnostic device that typically employs training sets for machine learning models. The software mentioned is for device control, not for learning from data.
9. How the ground truth for the training set was established
This information is not provided. As there is no mention of a training set, there's no discussion of how ground truth for it would be established.
Summary of available information related to performance and testing from the document:
While the document does not present clinical acceptance criteria or studies in the traditional sense, it outlines non-clinical performance data to support the device's safety and substantial equivalence to predicate devices:
- Biocompatibility Testing:
- Acceptance Criteria/Goal: To show the EAD adhesive is safe for tissue contact and that other patient-contacting materials are unchanged from the predicate.
- Study/Testing Done: Conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Included tests for Cytotoxicity, Sensitization, and Irritation.
- Reported Performance: The adhesive is considered tissue contacting for less than 30 days. The other patient-contacting materials are unchanged from the P-Stim predicate device.
- Electrical Safety and Electromagnetic Compatibility (EMC) Testing:
- Acceptance Criteria/Goal: Compliance with recognized international standards for safety and EMC.
- Study/Testing Done: Testing conducted on the EAD device.
- Reported Performance: The system complies with IEC 60601-1 and IEC 60601-2-10 (safety) and IEC 60601-1-2 (EMC).
- Software Verification and Validation Testing:
- Acceptance Criteria/Goal: To ensure the software functions as intended and does not pose a significant risk.
- Study/Testing Done: Testing conducted and documentation provided as recommended by FDA guidance.
- Reported Performance: Software considered a "minor" level of concern, as failure would not directly result in serious injury or death.
- Sterility/Shelf Life:
- Acceptance Criteria/Goal: To demonstrate the device can be sterilized and maintain its integrity and performance over time.
- Study/Testing Done: Sterilization Validation using VDMAX25 method (ISO 11137-2 and ISO 11737-2). Packaging validation (ISO 11607-1), Accelerated aging (ASTM F1980-07), and machine qualifications for sealing (ISO 11607-2).
- Reported Performance: Validation conducted according to specified standards.
Conclusion stated in the document: "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." This highlights that the "performance" shown is largely about safety, functionality, and equivalence to existing devices, not a direct clinical efficacy study.
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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
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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
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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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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 |
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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
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| 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 anelectro acupuncturedevice for use in thepractice ofacupuncture byqualifiedpractitioners ofacupuncture asdetermined by thestates. | The E-Pulse is anelectro acupuncturedevice for use in thepractice ofacupuncture byqualifiedpractitioners ofacupuncture asdetermined by thestates. | The P-Stim is anelectro acupuncturedevice for use in thepractice ofacupuncture byqualifiedpractitioners ofacupuncture asdetermined by thestates. |
| Device Description | Battery powereddevice generateslow frequency andcontinual electricalpulse which aretransmitted to newendings of the ear. Itallows continuedtherapy over severaldays.The device iscontrolled by amicro processor. | Battery poweredunit designed toadminister auricularpoint nervestimulationtreatment for paintherapy over a 96-hour period viaelectrical pulsing.The device is on for3 hours and then offfor 3 hours.The device iscontrolled by amicro processor. | A micro stimulationappliance for paintherapy.The devicegenerates lowfrequency andcontinual electricalpulse which aretransmitted to newendings of the ear. Itallows continuedtherapy over severaldays.The device iscontrolled by amicro processor. |
| Target Population | Patients with acuteand chronic pain | Patients with acuteand chronic pain | Patients with acuteand chronic pain |
| Human Factors | To be applied by aqualifiedpractitioner ofacupuncture | To be applied by aqualifiedpractitioner ofacupuncture | To be applied by aqualifiedpractitioner ofacupuncture |
| Where Used | At the clinic and athome | At the clinic and athome | At the clinic and athome |
| Software Based | Yes | Yes | Yes |
| Performance | 2 hours on/2 hoursoff; pulses withmodulatingfrequency (1 to 10Hz) | 3 hours on/3 hoursoff; pulsemonophasic at 1 Hz | 3 hours on/3 hoursoff; pulsemonophasic 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.
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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.
N/A