The ZYTO Hand Cradle is a Galvanic Skin Response Measurement Device. The device is designed, owned, manufactured, and distributed by ZYTO Technologies, Inc. The device consists of electrical circuit boards encased in a plastic/metal case. The device is non-invasive and comes in contact with the patient via conductive contacts (the equivalent of a stylus and hand-mass) incorporated into one piece, using the same functionality as the predicate device. The device connects to a computer to supply data to an operator.

AI/ML Overview

The provided 510(k) summary for the ZYTO Hand Cradle describes performance testing conducted for substantial equivalence, but it does not provide specific acceptance criteria or a study demonstrating the device meets those criteria in the way typically expected for clinical performance evaluation (e.g., accuracy, sensitivity, specificity against a clinical gold standard).

Instead, the documentation focuses on bench testing for equivalency to a predicate device and electrical safety/EMC standards compliance.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Bench Test Equivalence (Galvanic Skin Response Measurement)	- Resistors of varying values placed across polarities of both devices.
(Not explicitly stated as a numerical threshold,	- Resultant reading noted.
but implied to be "substantially the same" as predicate)	- Data plotted graphically.
	- Responses were "substantially the same" as the predicate device.
Electrical Safety and EMC Standards	- Device met all testing requirements of EN60601-1-2 and EN55011 CLASS B PCC Part 15B.

2. Sample size used for the test set and the data provenance

Bench Test: No specific number of "samples" (in terms of resistor values or repetitions) is stated, nor is the data provenance (e.g., country, retrospective/prospective) relevant for this type of test.
Electrical Safety/EMC: Typically, one or a few units of the device are tested in a controlled laboratory environment. Data provenance is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" for the bench test was the known values of the resistors and the performance of the predicate device. For electrical safety, the ground truth is defined by the technical standards. No human expert consensus was involved in establishing ground truth for these tests.

4. Adjudication method for the test set

Not applicable. There was no human judgment or adjudication process described for these engineering/bench tests.

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 MRMC study was performed. The device is a measurement tool, not an AI-assisted diagnostic output for human readers.

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

The device itself is a standalone measurement instrument. The "Non-clinical Testing" section describes its standalone performance against a predicate and against electrical safety standards. There is no "algorithm" in the sense of a complex AI for diagnostic interpretation. It is a direct physiological measurement device.

7. The type of ground truth used

Bench Test: The ground truth was the known resistance values of the resistors used for testing and the measured output of a legally marketed predicate device (K943101 - GLOBAL ENT. GALVANIC SKIN RESPONSE DEVICE).
Electrical Safety/EMC: The ground truth was the requirements and limits defined by international standards EN60601-1-2 and EN55011 CLASS B PCC Part 15B.

8. The sample size for the training set

Not applicable. This device is a measurement device and does not describe any machine learning or AI components that would require a "training set."

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

Not applicable, as no training set was used.

Summary of the "Study" and Evidence Provided:

The "study" demonstrating the device meets acceptance criteria consists of:

Bench Testing for Performance Equivalence: Conducted by ZYTO Technologies, Inc. This involved comparing the ZYTO Hand Cradle's readings of various resistors against those obtained from a predicate device. The conclusion was that the responses were "substantially the same."
Independent Third-Party Electrical Safety and EMC Testing: Performed by SDP Engineering in December 2010. This validated the device's compliance with EN60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests) and EN55011 CLASS B PCC Part 15B (Limits and methods of measurement of radio disturbance characteristics of industrial, scientific and medical (ISM) radio-frequency equipment / FCC Part 15B, which governs electromagnetic compatibility). The device "met all testing requirements."

Conclusion:

The ZYTO Hand Cradle's 510(k) submission primarily relies on demonstrating substantial equivalence through engineering bench tests measuring its performance against a predicate device and adherence to electrical safety and electromagnetic compatibility standards. It explicitly focuses on the device's ability to measure Galvanic Skin Response, which is its stated intended use. The provided documentation does not detail a clinical study with patients, expert adjudication, or AI performance metrics, as these are not relevant for the type of device and the pathway used for its clearance.

Summary

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K111308

510(k) Summary

AUG 3 0 2011

Contact Details

Applicant Name:	ZYTO Technologies, Inc387 S. 520 W., Ste. 200Lindon, UT 84042
	Phone: 801-224-7199Fax: 801-221-4662
	Contact Person: Vaughn R Cook, CEOEmail: DrCook@ZYTO.com
Date Prepared:	July 13, 2011

Device Name

Trade Name: ZYTO Hand Cradle
Galvanic Skin Response Measurement Device Common Name:

Classification Name: GZO

Legally Marketed Predicate Device(s)

510(k) Number	Product Code	Trade Name	Applicant
K943101	GZO	GALVANIC SKINRESPONSE DEVICE	GLOBAL ENT.

Device Description

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Intended Use/Indications for use

The measurement of Galvanic Skin Response; Prescription Use

Substantial Equivalence Comparison

The ZYTO Hand Cradle is substantially equivalent to the predicate device for the following reasons:

1. Intended Use
1. Technological Characteristics:
- a. Voltage used to collect the measurement (when duty cycle is considered).
- b. Measurement ranges and the responses within those ranges.
- c. Both designed for use at multiple sampling locations on the skin. (Predicate device requires operator moving stylus between sampling locations: ZYTO Hand Cradle samples five separate locations without operator manipulation.)
- d. Both interface to a computer for display of data.
1. Both are designed for use with intact skin.
1. Performance data is equivalent.

Non-clinical Testing

Bench tests were conducted using the predicate device and the ZYTO Hand Cradle to determine performance equivalency. Resistors of varying values were placed across the opposite polarities on each device and the resultant reading was noted. Data was then plotted graphically and the responses were substantially the same. These test results are included with this summary.

In December 2010 ZYTO retained SDP Engineering in Lake Forest, CA to conduct independent third party tests in accordance with EN60601-1-2 and EN55011 CLASS B PCC Part 15B. The complete report from SDP Engineering is included in the submission. The submission device (ZYTO Hand Cradle) met all testing requirements.

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

ZYTO Technologies, Inc. c/o Vaughn R. Cook, OMD CEO 387 S. 520 W., Suite 200 Lindon, UT 84042

AUG 3 0 2011

Re: K111308

Trade/Device Name: ZYTO Hand Cradle Regulation Number: 21 CFR 882.1540 Regulation Name: Galvanic Skin Response Measurement Device Regulatory Class: Class II Product Code: GZO Dated: July 14, 2011 Received: July 15, 2011

Dear Dr. Cook:

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.

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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 forth in 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 go to http://www.fdagov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,

Robert Murphy

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K111308

Device Name:

ZYTO Hand Cradle

Indications For Use:

The measurement of Galvanic Skin Response

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K111.308

Page 1 of

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.