ASYRA by GALLOWAY TECHNOLOGIES, LLC

The provided text is a 510(k) summary for the Asyra Galvanic Skin Response Device. This document focuses on establishing substantial equivalence to a predicate device and outlines safety features. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be stated based on the text:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document.	The document only states: "In summary the Asyra meets or exceeds all the safety requirements for a medical device in its class." and "Galloway Technologies believes the Asyra is substantially equivalent to The J & J G-25a GSR device"

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. The document does not describe a performance study with a test set. It is a 510(k) submission based on substantial equivalence and safety features, not a clinical or performance study.

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):

Not applicable. There is no mention of a test set or ground truth establishment by experts in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There is no mention of a test set or adjudication.

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:

No. This is a Galvanic Skin Response device, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is for measuring Galvanic Skin Response, which inherently involves human interaction (patient connected to electrodes). It does not appear to be an algorithm-only device in the context of advanced diagnostic interpretation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable. The document does not describe a study involving ground truth. The submission is based on substantial equivalence and safety rather than a performance study that requires ground truth.

8. The sample size for the training set:

Not applicable. The document does not describe a machine learning or algorithm-based device that would require a training set.

9. How the ground truth for the training set was established:

Not applicable. The document does not describe a machine learning or algorithm-based device that would require ground truth for a training set.

Summary

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JUN 2 4 2003

K023355 1/1

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

APPLICANT'S Galloway Technologies NAME/ADDRESS 3736 Panarama Drive Saratoga Springs, UT 84043-3247 CONTACT PERSON Joe Galloway COMMON/USUAL NAME Galvanic Skin Response Device CLASSIFICATION NAME Galvanic Skin Response Device Applied for (Owner/Operator ESTABLISHMENT # 9051656) REGISTRATION NUMBER CLASSIFICATION The Galvanic Skin Response Measurement Device is classified into class II as described in Title 21, Code of Federal Regulations 82.1540 PERFORMANCE Galloway Technologies is not STANDARD aware of any special controls or performance standards established this device under section 513 or 514. respectively, of the Food, Drug and Cosmetics Act Galloway Technologies believes the Asyra is substantially equivalent to The J & J G-25a GSR device

The Asyra has Nemours safety features imbedded in the firmware to both monitor and test it's circuitry before and after each test. We have included double fault protection for the safety of the user and all information going into the system or out of the system is handled by an isolated infrared interface. The battery charger mechanically disconnects the measurement circuit when pluging thus isolating the Stylus Probe and Hand-Mass. Plugs for the Stylus Probe and Hand-Mass are wired such that if plugged in incorrectly no reading can be taken.

In summary the Asyra meets or exceeds all the safety requirements for a medical device in its class.

SUBSTANTIAL EQUIVALENCE

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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with three lines above them representing the concept of health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2003

Mr. Joe Galloway Vice President of Compliance Galloway Technologies LLC 3736 Panarama Drive Saratoga Springs, Utah 84043

Re: K023355

Trade/Device Name: ASRYA Regulation Number: 21 CFR 882.1540 Regulation Name: Galvanic skin response measurement device Regulatory Class: II Product Code: GZO Dated: April 23, 2003 Received: May 13, 2003

Dear Mr. Galloway:

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 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.

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Page 2 - Mr. Joe Galloway

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 Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (il known): _ KO23355

Device Name: Asyra

Indications For Use:

The Anyra's intended use is for the measurement
of Galvanic Skin Response

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K023355

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801 109) ાર

Over-The-Counter Use

(Oplional Forma

Regulation Number and Section

§ 882.1540 Galvanic skin response measurement device.

(a)
Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.