MSAS PROFESSIONAL

• K Number: K993824
• Device Name: MSAS PROFESSIONAL
• Manufacturer: BIOMERIDIAN, INT.
• Date Cleared: 2000-01-20 ( 69 days)
• Product Code: GZO
• Regulation Number: 882.1540

Intended Use

The MSA-21 intended use is for the measurement of Galvanic Skin Response

Device Description

Not Found

Predicate Devices

J&J G-25a GSR, Global Corp.'s C-29

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of these technologies.

Therapeutic

No.
The device's sole stated intended use is for the measurement of Galvanic Skin Response, which is a diagnostic or monitoring function, not a therapeutic one.

Diagnostic

Yes
The device is intended for the "measurement of Galvanic Skin Response," which is a physiological measurement often used as an indicator in diagnostic contexts. Its inclusion of predicate devices also suggests a medical or diagnostic purpose.

SaMD (Software as a Medical Device)

Unknown

The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the MSA-21 is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "for the measurement of Galvanic Skin Response." This is a physiological measurement taken directly from the body, not a test performed on a sample (like blood, urine, or tissue) outside of the body.
• Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples.
  • Detecting or measuring substances in samples.
  • Providing information for diagnosis, monitoring, or screening based on sample analysis.

IVDs are specifically designed to perform tests on samples taken from the body to provide information about a person's health status. The MSA-21 measures a physiological response on the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The MSA-21 intended use is for the measurement of Galvanic Skin Respons

Product codes

GZO

Device Description

Not Found

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)

The MSA-21 has undergone an extensive battery of tests to insure safety. The unit design was safety intense from the outset. Small details such as using a 3 pin mini Din connector for the electrode and a 7 pin mini Din connector for the probe so they could not be inserted into the wrong plug are just one example. This quest for safety included all MSA-21 accessories. BioMeridian, Inc. also submitted the MSA-21 to Intertek Testing Services for test and evaluation. The MSA-21 fully passed the following test:

Medical Electrical Equipment (see attachment # 3)
a) UL 2601-1
b) CSA C22.2 No 601.1
Medical Electrical Equipment, Part 1: General Requirements for Safety (see attachment # 4)
a) EN60601-1
b) IEC 601-1

Emissions and Immunity Testing (see attachment # 5)
a) EN60601-1-2:1993
In summary the MSA-21 meets or exceeds all the safety requirements for a medical device in its class. Our dedication to safety is evidenced in the many extra steps we have taken to insure a safe product. Also the MSA-21 has met all the requirements and has received a registered CE mark.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

J&J G-25a GSR, Global Corp.'s C-29

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

K 993824

Image /page/0/Picture/2 description: The image is a logo for "The Human Calibration Company BioMeridian". The logo features a geometric design in the center, surrounded by the text "The Human Calibration Company" in a circular arrangement. Below the geometric design, the word "BioMeridian" is written in a bold font.

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

APPLICANT'S NAME/ADDRESS

Contact Person

COMMON/USUAL NAME:

CLASSIFICATION NAME:

ESTABLISHMENT REGISTRATION NUMBER:

CLASSIFICATION:

PERFORMANCE STANDARD:

BioMeridian, Inc. Draper, Utah 84020 12411South 265 West Suite F

Joe Galloway

Galvanic Skin Response Device

Galvanic Skin Response Device

1723429

The Galvanic Skin Response Measurement Device is classified into class II as described in Title 21, code of Federal Regulation 82.1540.

BioMeridian Inc. is not aware of any special controls or performance standards established for this device under sections 513 or 514, respectively, of the Food, Drug and Cosmetics Act.

SUBSTANTIAL EQUIVALENCE:

BioMeridian, Inc. believes the MAS-21 is substantially equivalent to the J&J G-25a GSR, and Global Corp.'s C-29

CORPORATE OFFICES

TRAINING AND EDUCATION

(801) 501-

• [phone]
  BioMeridian International, Inc.

CUSTOMER SUPPORT (801) 501

• [phone]

13526 South 110 West

WWW.BIOMERIDIAN.COM · GENERAL INFORMATION [e-mail]

• THAINING AND EDUCATION
• [e-mail] JUSTOMER SUPPORT [e-mail]

Draper, Utah 84020 ાં તિપ

BIOMERIDIAN INTERNATIONAL, INC s a wholly owned subsidiary of

• Magellan Technology, Inc. (OTC: MGL MAGELLAN PHONE
• [phone]
• [phone]
• MAGFILLAN SHARFHOI DER BELATIONS [e-mail]

1

Image /page/1/Picture/0 description: The image is a logo for "The Human Calibration Company BioMeridian". The logo features a geometric design in the center, resembling interlocking shapes. The text "THE HUMAN CALIBRATION COMPANY" is arranged in a circular fashion around the geometric design. Below the design, the word "BioMeridian" is written in a larger, bold font.

The MSA-21 has undergone an extensive battery of tests to insure safety. The unit design was safety intense from the outset. Small details such as using a 3 pin mini Din connector for the electrode and a 7 pin mini Din connector for the probe so they could not be inserted into the wrong plug are just one example. This quest for safety included all MSA-21 accessories. BioMeridian, Inc. also submitted the MSA-21 to Intertek Testing Services for test and evaluation. The MSA-21 fully passed the following test:

Medical Electrical Equipment (see attachment # 3)

a) UL 2601-1

• b) CSA C22.2 No 601.1
  Medical Electrical Equipment, Part 1: General Requirements for Safety (see attachment # 4)

• a) EN60601-1

• b) IEC 601-1

Emissions and Immunity Testing (see attachment # 5)

a) EN60601-1-2:1993

In summary the MSA-21 meets or exceeds all the safety requirements for a medical device in its class. Our dedication to safety is evidenced in the many extra steps we have taken to insure a safe product. Also the MSA-21 has met all the requirements and has received a registered CE mark.

CORPORATE OFFICES
• TOLL-FREE PHONE	[phone]
• TELEPHONE	[phone]
• CORPORATE FAX	[phone]
• SALES FAX	[phone]

TRAINING AND EDUCATION
• TOLL-FREE PHONE	[phone]
• TELEPHONE	[phone]
• FAX	[phone]

BioMeridian International, Inc.

CUSTOMER SUPPORT
• TOLL-FREE PHONE	[phone]
• TELEPHONE	[phone]
• FAX	[phone]

13526 South 110 West

WWW.BIOMERIDIAN.COM
• GENERAL INFORMATION	[e-mail]
• TRAINING AND EDUCATION	[e-mail]
• CUSTOMER SUPPORT	[e-mail]

Draper, Utah 84020 USA

BIOMERIDIAN INTERNATIONAL, INC
	is a wholly owned subsidiary of
	Magellan Technology, Inc. (OTC: MGLN)
• MAGELLAN PHONE	[phone]
• MAGELLAN FAX	[phone]
• MAGELLAN SHAREHOLDER RELATIONS	[e-mail]

2

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

Public Health Service

JAN 20 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joe Galloway Vice President of Compliance Biomeridian, Inc. 12411 South 265 West Suite F Draper, Utah 84020

K993824 Re: Trade Name: MSA-21 Regulatory Class: II Product Code: GZO Dated: December 21, 1999

Received: December 21, 1999

Dear Mr. Galloway:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

3

Page 2 - Mr. Joe Galloway

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Styt Rhode

James E. Dillard III
Acting Director
Division of General

Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K 993824 510 (k) Number. 25;cm イ ﺘﺮ

Device Name. M SA-21 (Meridian Stress Assessment)

Indications for Use. The MSA-21 intended use is for the measurement of Galvanic Skin Respons

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stupt Rhordu

Division of General Restorative Devices 953824 510(k) Number

Prescription Use _

OR

Over- The Counter Use

(Per 21 CFR 801.109)