EA Stimulator is a battery powered TENS, which is used in the treatment of chronic, acute, and post-surgical pain. The device contains a printed circuit board, independent intensity controlled channels, and Microcurrent-Milliampere Switches. It also has windows, display frequency, pulse width, and time settings. The device has different stimulation frequency modes with different selected waveforms. EA Stimulator uses self adhesive electrodes and has energy saving feature that automatically turns off if the device has no activity for 5 minutes or when a treatment session is completed.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the EA Stimulator (K080221):

The provided document (K080221) is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device called the "EA Stimulator." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving de novo effectiveness through extensive clinical trials.

As such, many of the requested criteria for a clinical study proving device performance, particularly those related to AI algorithms, ground truth establishment, and multi-reader studies, are not applicable to this 510(k) submission. This is a common characteristic of TENS device submissions, which typically rely on adherence to established electrical and safety standards and comparison to a legally marketed predicate.

Here's what can be extracted and inferred from the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Electrical Safety Standards	Compliance with recognized international standards for electromedical equipment, specifically related to general safety and essential performance, and electromagnetic compatibility. This would typically cover aspects like electrical shock protection, mechanical hazards, labeling, and immunity/emissions interference.	The device conforms to applicable standards including: - EN60601-1-2:2001/A1:2006 (Electromagnetic Compatibility - EMC)- IEC 60601-1-2:2001/A1:2004 (Electromagnetic Compatibility - EMC)- IEC 60601-1 / EN60601-1 (General Requirements for Basic Safety and Essential Performance)- IEC 60601-2-10 / EN60601-2-10 (Particular Requirements for the Safety of Nerve and Muscle Stimulators - specific to TENS devices).
Substantial Equivalence to Predicate	The device must demonstrate technological characteristics, intended use, and performance that are substantially equivalent to a legally marketed predicate device. This implies that any differences do not raise new questions of safety or effectiveness. The predicate device here is ES-160 (K051020).	FDA's review determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. The technological characteristics described (battery-powered, independent intensity channels, microcurrent/milliampere switches, display, frequency modes, waveforms, self-adhesive electrodes, energy-saving feature) are implicitly deemed equivalent to the predicate.
Intended Use	The device's intended use must align with the predicate device and established uses for TENS units.	The device is designed to be used in the treatment of chronic, acute, and post-surgical pain. This matches the common indications for TENS units and is consistent across the 510(k) summary and the "Indications For Use" page.
Device Configuration/Features	The functional description and features of the device (e.g., battery power, number of channels, adjustability, display, auto-off) should be consistent with safe and effective operation for a TENS unit and comparable to the predicate.	The device is battery powered, has independent intensity controlled channels, Microcurrent-Milliampere Switches, windows, display frequency, pulse width, and time settings, different stimulation frequency modes with different selected waveforms, uses self-adhesive electrodes, and has an energy saving feature (auto-off after 5 mins inactivity or treatment completion). These features are presented to demonstrate functional equivalence and safety.

Regarding the study that proves the device meets the acceptance criteria:

The primary "study" or evidence for this 510(k) clearance is the demonstration of compliance with relevant consensus standards and substantial equivalence to a predicate device. There is no mention of a clinical performance study (e.g., randomized controlled trial on patients using the device to measure pain reduction) in this summary. For TENS devices, generally, if a device is substantially equivalent in technology and intended use to a legally marketed device and meets recognized safety standards, explicit new clinical performance data is often not required for 510(k) clearance.

Let's address the specific points based on the provided text:

A table of acceptance criteria and the reported device performance:
- (See table above) The acceptance criteria are largely based on regulatory compliance and technical standards.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. No clinical performance test set or data provenance is mentioned as this is a safety/technical standards compliance and substantial equivalence demonstration, not a clinical efficacy trial. The "tests" relate to electrical and mechanical performance in a lab setting against standards, not patient outcomes.
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):
- Not applicable / Not provided. Ground truth, in the context of clinical or diagnostic performance, is not established or discussed for this type of device submission. The "ground truth" here is compliance with technical standards as assessed by engineers/testing labs.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No adjudication method for a clinical test set is mentioned.
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:
- No. This device is a physical TENS unit, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study and AI assistance are entirely irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm-only device. It's a hardware medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the technical standards compliance, the "ground truth" is adherence to the specifications outlined in standards like IEC 60601-1 andIEC 60601-2-10, verified through engineering tests. For substantial equivalence, the "ground truth" is established by comparing the device's technological characteristics and intended use to the predicate device (ES-160, K051020) and finding no new questions of safety or effectiveness. No clinical "outcomes data" or "pathology" is mentioned.
The sample size for the training set:
- Not applicable / Not provided. There is no "training set" in the context of an AI algorithm described here. The device itself is designed and manufactured according to specifications.
How the ground truth for the training set was established:
- Not applicable / Not provided. As there's no training set for an AI algorithm, this question doesn't apply.

Summary

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K080221

SEP 0 9 2008

510 (k) SUMMARY

Submitter's Name:Address:	Helio Medical Supplies, Inc.606 Charcot AvenueSan Jose, CA 95131
Telephone:	408-433-3355
Fax:	408-433-5566
Contact person:	YUKUO HSU
Device Name:

Proprietary Name: EA Stimulator Common Name: TENS unit Classification Name: Transcutaneous Electrical Nerve Stimulator (21 CFR 882.5890, Class II)

Predicate Device Information:

Legally marketed device for substantial equivalence comparison is ES-160 (K051020)

Description of Device:

Intended use of the Device:

This device is designed to be used in the treatment of chronic, acute, and post-surgical pain. A physician can select different frequency modes, waveform modes, switch Microcurrent-Milliampere mode, and adjust the intensity to treat his/her patients.

Technological Characteristics:

EA Stimulator uses four or eight 1.5volt batteries and has a stimulation mode for the treatment.

Performance Summary:

The device conforms to applicable standards includes EN60601-1-2:2001/A1:2006. IEC 60601-1-2:2001/A1:2004, IEC 60601-1 / EN60601-1, IEC 60601-2-10 / EN60601-2-10,

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is in black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 9 2008

Helio Medical Supplies Inc. % Mr. Yukuo Hsu Quality System Manager 606 Charcot Avenue San Jose, California 95131

Re: K080221 Trade Name: EA 2/2 Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief. Regulatory Class: Class II Product Code: GZJ Dated: September 3, 2008 Received: September 4, 2008

Dear Mr. Hsu:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 -- Mr. Yukuo Hsu

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark N. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number (if known): K080221

Device Name: EA Stimulator

Indications For Use:

This device is designed to be used in the treatment of chronic, acute, and post-surgical pain.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number	K640221

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).