(112 days)
Not Found
No
The summary describes a device for measuring galvanic skin response and explicitly states "Mentions AI, DNN, or ML: Not Found". The description focuses on the hardware and its function, not on any data processing or analysis that would typically involve AI/ML.
No
The device is described as a "Galvanic Skin Response Measurement Device" used for "measurement," indicating a diagnostic or measurement purpose, not therapeutic.
No
The device is a Galvanic Skin Response Measurement Device, which measures skin conductivity. The "Intended Use / Indications for Use" states "The measurement of Galvanic Skin Response," and there is no mention of the device being used to diagnose any disease or condition. The performance studies describe bench testing for equivalency, not diagnostic accuracy.
No
The device description explicitly states it consists of "electrical circuit boards encased in a plastic/metal case" and "conductive contacts," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "The measurement of Galvanic Skin Response." This is a physiological measurement taken directly from the patient's skin.
- Device Description: The device is described as a "Galvanic Skin Response Measurement Device" that is "non-invasive and comes in contact with the patient via conductive contacts." This further reinforces that it's a device interacting with the body, not a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on the analysis of such samples. IVDs are specifically designed for testing samples in vitro (outside the body).
Therefore, the ZYTO Hand Cradle, as described, is a device for measuring a physiological response in vivo (within the body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The measurement of Galvanic Skin Response; Prescription Use
Product codes (comma separated list FDA assigned to the subject device)
GZO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary
AUG 3 0 2011
Contact Details
1
| Applicant Name: | ZYTO Technologies, Inc
387 S. 520 W., Ste. 200
Lindon, UT 84042 |
|-----------------|-----------------------------------------------------------------------|
| | Phone: 801-224-7199
Fax: 801-221-4662 |
| | Contact Person: Vaughn R Cook, CEO
Email: 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 SKIN | |
| RESPONSE DEVICE | GLOBAL ENT. |
Device Description
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.
1
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:
-
- Intended Use
-
- 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.
-
- Both are designed for use with intact skin.
-
- 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing-like shapes, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
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.
3
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
4
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)
tuh
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K111.308
Page 1 of