K Number

Device Name

H2O

Manufacturer

GRASS-TELEFACTOR PRODUCT GROUP

Date Cleared

1998-03-09

(90 days)

Product Code

OLV DQA GWQ

Regulation Number

882.1400

Intended Use

THIS DEVICE IS INTENDED FOR USE IN LONG-TERN RECORDING OF VOLTAGES PRODUCED BY THE BRAIN AND MEASURED ON THE SCALP (EEG) FOR SUBSEQUENT DIAGNOSTIC REVIEW WITH A DIGITAL WORK-STATION SUPPLIED BY THE MANUFACTURER (TELEFACTOR BEEKEEPER) OR SIMILAR COMPATIBLE DEVICE. AN INTEGRATED PULSE OXIMETER PROVIDES SUPPLEMENTAL DIAGNOSTIC DATA IN THE FORM OF BLOOD OXYGEN SATURATION (SpO2 percent).

Device Description

The H2O system is battery powered, wearable, 32 channel EEG amplifies/recorder. The H2O system operates on a pack of eight Alkaline batteries for twelve hours or a pack of two lithium batteries for 24 hours. Unlike DEEG-LITE, the H2O recorder never operates from mains power, but only from batteries. Like DEEG-LITE, a binary, optically isolated output data stream is utilized by a notebook or desktop computer for initial setup. Unlike DEEG-LITE, all data recording in H2O is performed internally in the wearable device in a Flash-RAM for short recordings, or on an internal rotating disk for long recordings. The DEEG-LITE utilizes DSPs (Digital Signal Processors) for data manipulation and preparation. It uses a Intel-486 or Pentium processor in a notebook computer for data recording and display. H2O uses a single internal INTEL 186 processor for data manipulation and recording and an external notebook or desktop computer only for initial setup and electrode application to verify good EEG waveform at the beginning of the data recording session. To provide an added sensor modality useful in sleep recordings, the H2O incorporates a NONIN pulse oximeter board (NONIN OEM2 Pulse Oximeter Module), with a DB9 Female connector for one of the compatible NONIN finger probes.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K972202

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on hardware components, data storage, and basic signal processing (DSPs, Intel processors) for recording and initial setup. There is no mention of AI, ML, or advanced data analysis techniques.

Therapeutic

No.
The device is intended for diagnostic review of brain activity and blood oxygen saturation, not for treating any condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "INTENDED FOR USE IN LONG-TERN RECORDING OF VOLTAGES PRODUCED BY THE BRAIN AND MEASURED ON THE SCALP (EEG) FOR SUBSEQUENT DIAGNOSTIC REVIEW". It also mentions that the integrated pulse oximeter provides "SUPPLEMENTAL DIAGNOSTIC DATA".

SaMD (Software as a Medical Device)

The device description clearly outlines hardware components including a battery-powered wearable amplifier/recorder, internal Flash-RAM or rotating disk for data storage, an internal INTEL 186 processor, and an integrated pulse oximeter board. This is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use clearly states the device is for "LONG-TERN RECORDING OF VOLTAGES PRODUCED BY THE BRAIN AND MEASURED ON THE SCALP (EEG)". This is a measurement of electrical activity within the body, not an analysis of samples taken from the body (like blood, urine, or tissue).
Device Description: The description details a wearable EEG amplifier/recorder and an integrated pulse oximeter. These are devices that measure physiological signals directly from the patient.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components associated with IVD devices.

In Vitro Diagnostics (IVDs) are medical devices used to examine specimens, including blood, tissue, and urine, from the human body to help diagnose diseases or conditions. This device measures electrical signals and blood oxygen saturation directly from the patient's body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The H2O is intended primarily to be used for the long term monitoring h. of EEG of patients with suspected seizure disorders, and sleep disorders. H2O Indications For Use:
This device is intended for use in long-term recording of voltages produced by the brain and measured on the scalp (EEG) for subsequent diagnostic review with a digital workstation supplied by the manufacturer (Telefactor Beekeeper) or similar compatible device. An integrated pulse oximeter provides supplemental diagnostic data in the form of blood oxygen saturation (SpO2 percent).

Product codes (comma separated list FDA assigned to the subject device)

GWQ, OLV, DQA

Device Description

H2O receives signals from an EEG Amplifier, formats g & records them on the digital media for subsequent evaluation by a qualified clinician.
The H2O system is battery powered, wearable, 32 channel EEG i. amplifies/recorder. The H2O system operates on a pack of eight Alkaline batteries for twelve hours or a pack of two lithium batteries for 24 hours. Unlike DEEG-LITE, the H2O recorder never operates from mains power, but only from batteries. Like DEEG-LITE, a binary, optically isolated output data stream is utilized by a notebook or desktop computer for initial setup. Unlike DEEG-LITE, all data recording in H2O is performed internally in the wearable device in a Flash-RAM for short recordings, or on an internal rotating disk for long recordings. The DEEG-LITE utilizes DSPs (Digital Signal Processors) for data manipulation and preparation. It uses a Intel-486 or Pentium processor in a notebook computer for data recording and display. H2O uses a single internal INTEL 186 processor for data manipulation and recording and an external notebook or desktop computer only for initial setup and electrode application to verify good EEG waveform at the beginning of the data recording session. To provide an added sensor modality useful in sleep recordings, the H2O incorporates a NONIN pulse oximeter board (NONIN OEM2 Pulse Oximeter Module), with a DB9 Female connector for one of the compatible NONIN finger probes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Scalp (EEG)

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)

Nonclinical (Bench Tests): The results of the Bench Tests described in Volume 3 of the original premarket 510(k) application # K974587, document the equivalent noise performance of the DEEG-LITE system.
Clinical Tests: Because of the identical performance confirmed by Bench Tests, clinical performance tests are deemed unnecessary.
Summary of Safety & Effectiveness: Electrical safety for EEG monitoring equipment is well specified by the UL2601-1 and IEC601-1 General Safety Standards for Medical Devices. The design of the electronics for both the predicate device DEEG-LITE, and the new device H2O have been carried out with careful attention to compliance with these standards.
Conclusion: It is our conclusion that the nonclinical (Bench Tests) demonstrate that the device is safe, effective and performs as well as the predicate device.

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.

K972202

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

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).

Summary

Section 2: 510(K) Summary & Certification

2.0 Summary

×974587 MAR - 9 1998

This summary is submitted in accordance with the content and format requirements as stated in section This Sullinary is submitted in accordance was a part of the Premarket Notification 510(k) Application for their new device H2O.

Requirement: CFR807.92 paragraph (a)

a. Date: March 03, 1998
Name & address of the submitter :

Telefactor Corporation 1094 New Dehaven Street West Conshohocken, PA 19428

Establishment registration number: 2523420 b.

Contact person:	James S. Bryan
	Chief Engineer
	Tel: (610) 825-4555
	FAX: (610) 941-0348

Trade Name: H2O C.
Common Name: Portable EEG Recorder તે.
Product Classification (per CDRH Database): e. Product Category: ELECTROENCEPHALOGRAPH Regulation Number: 882.1400 Medical Specialty: NE Product Code: GWQ / Ol-V Tier: 2 Product class: Class II Device
f. This device claims equivalence to: Telefactor Corporation's "DEEG-LITE" EEG-Recorder for which previously granted 510(k) number is: #K972202
Brief functional description of the device: H2O receives signals from an EEG Amplifier, formats g & records them on the digital media for subsequent evaluation by a qualified clinician.
Intended use for the device: The H2O is intended primarily to be used for the long term monitoring h. of EEG of patients with suspected seizure disorders, and sleep disorders. H2O Indications For Use:

This device is intended for use in long-term recording of voltages produced by the brain and measured on the scalp (EEG) for subsequent diagnostic review with a digital workstation supplied by the manufacturer (Telefactor Beekeeper) or similar compatible device. An integrated pulse oximeter provides supplemental diagnostic data in the form of blood oxygen saturation (SpO2 percent).

Technological characteristics: The H2O system is battery powered, wearable, 32 channel EEG i. amplifies/recorder. The H2O system operates on a pack of eight Alkaline batteries for twelve hours or a pack of two lithium batteries for 24 hours. Unlike DEEG-LITE, the H2O recorder never operates from mains power, but only from batteries. Like DEEG-LITE, a binary, optically isolated output data stream is utilized by a notebook or desktop computer for initial setup. Unlike DEEG-LITE, all data recording in H2O is performed internally in the wearable device in a Flash-RAM for short recordings, or on an internal rotating disk for long recordings. The DEEG-LITE utilizes DSPs (Digital Signal Processors) for data manipulation and preparation. It uses a Intel-486 or Pentium processor in a notebook computer for data recording and display. H2O uses a single internal INTEL 186 processor for data manipulation and recording and an external notebook or desktop computer only for initial setup and electrode application to verify good EEG waveform at the beginning of the data recording session. To provide an added sensor modality useful in sleep recordings, the H2O incorporates a NONIN pulse oximeter board (NONIN OEM2 Pulse Oximeter Module), with a DB9 Female connector for one of the compatible NONIN finger probes.

(Requirement: CFR807.92 paragraph (b))

Brief statement of substantial equivalence to Telefactor DEEG-LITE: The H2O System has j. recording performance identical to the Telefactor DEEG-LITE System. The wearable amplifiers although of a different design, have equal or better signal to noise ratio, equal digital resolution, and identical sample rates. The inclusion of an internal pulse oximeter parallels the frequent use of an external pulse oximeter with the DEEG-LITE instrument.
- (1) Nonclinical (Bench Tests): The results of the Bench Tests described in Volume 3 of the original premarket 510(k) application # K974587, document the equivalent noise performance of the DEEG-LITE system.
- (2) Clinical Tests: Because of the identical performance confirmed by Bench Tests, clinical performance tests are deemed unnecessary.
- (3) Summary of Safety & Effectiveness: Electrical safety for EEG monitoring equipment is well specified by the UL2601-1 and IEC601-1 General Safety Standards for Medical Devices. The design of the electronics for both the predicate device DEEG-LITE, and the new device H2O have been carried out with careful attention to compliance with these standards.
- (4) Conclusion: It is our conclusion that the nonclinical (Bench Tests) demonstrate that the device is safe, effective and performs as well as the predicate device.

2.1 Certification

I certify, that to the best of my knowledge, the information provided indias summary for the Premarket Notification 510(k) for the H2O, is true and accurate.

Signed

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............................

John B. Chatten President Telefactor Corporation 1094 New Dehaven Street West Conshohocken, PA 19428

Date: March 03, 1998

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Mr. James S. Bryan Chief Engineer Telefactor Corporation 1094 New DeHaven Street West Conshohocken, Pennsylvania 19428

Re: K974587

Trade/Device Name: H20 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ, DQA Dated (Date on orig SE Itr): December 4, 1997 Received (Date on orig SE Itr): December 9, 1997 APR - 9 2012

Dear Mr. Bryan:

This letter corrects our substantially equivalent letter of March 9, 1998.

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.

Page 2 - Mr. James S. Bryan

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 of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/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/ReportaProblem/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,

Image /page/3/Picture/6 description: The image shows a stylized handwritten word "for". The "f" is written in a cursive style with a large loop extending below the baseline and a smaller loop at the top. The letters "o" and "r" are connected and smaller in size, sitting atop the "f". The writing appears to be done with a pen or marker, and the overall impression is that of a signature or a quick note.

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

I । Page of

K974587 510 (k) NUMBER (IF KNOWN) :

H20 DEVICE NAME:

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter-Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K974587