The DEEG-LITE-OXY 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).

Device Description

The DEEG-LITE-OXY system consists of (a) a laptop computer with liquid crystal display, (b) a MicroCoder which consists of State) Signa components such as: a mgil resolution Analog to Digital converter, a DSP (Digital Signal processor a safe low voltage includes supply and (d) a wearable, 32 channel EEG amplifier/recorder, and (e) an internal pulse ossimeter module supplied by Neilcor(model Mr 205). The DDLG De De oximeter module, all of the foregoing power supply. With the exception of the pulse oximeter modules income DEEC I ITE power supply. With the excopiton of unded in the predicate device DEEG-LITE.

AI/ML Overview

The provided document is a 510(k) summary for the DEEG-LITE-OXY device, which is a portable EEG recorder with an integrated pulse oximeter. The document focuses on demonstrating substantial equivalence to a predicate device (DEEG-LITE) and does not contain a detailed study proving the device meets specific acceptance criteria in the manner typically described for AI/ML devices.

Instead, the submission relies on the following:

1. Acceptance Criteria and Device Performance (Implicit - based on Substantial Equivalence):

The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device, DEEG-LITE (K972202), and that the addition of the pulse oximeter does not alter its safety or effectiveness. The device performance is affirmed by claiming identity of components and performance where relevant.

Acceptance Criteria (Implied)	Reported Device Performance
EEG Functionality: Equivalent to predicate device (DEEG-LITE).	"The DEEG-LITE-OXY electronic is identical to that of the DEEG-LITE and has been carried out with careful attention to compliance with these standards." "The resulting system [DEEG-LITE-OXY] portable and more easily set up in both the office and home environment. The performance of the DEEG-LITE-OXY remains in no way degraded by the performance of the DEEG-LITE." The device claims "equivalent noise performance of the DEEG-LITE OXY system to that of the DEEG-LITE."
Pulse Oximeter Functionality: Meets Nellcor's specifications.	"Bench test data which confirms that the internal Nellcor oximeter (equivalent to that documented in Nellcor's document for their 510(k) #K962424) meets Nellcor's specifications when installed in the DEEG-LITE-OXY electronic environment." The pulse oximeter is described as an "OEM module" from Nellcor (model N-205).
Electrical Safety: Complies with UL2601-1 and IEC601-1.	"Electrical safety for EEG monitoring equipment is well specified by the UL2601-1 and IEC601-1 and IEC601-1 standards. The design of the DEEG-LITE-OXY electronics is identical to that of the DEEG-LITE and has been carried out with careful attention to compliance with these standards."
Battery Life Impact: Not significantly affected by oximeter.	"The DEEG-LITE-OXY has increased power consumption by only 300 milliwatts per additional function; this does not significantly affect battery life."
Overall Safety and Effectiveness: Equivalent to predicate.	"It is our conclusion that the nonclinical (Bench Tests) and the substantially equivalent design of the DEEG-LITE-OXY to that of the DEEG-LITE, demonstrate that the DEEG-LITE-OXY is safe and effective and performs as well as the predicate device DEEG-LITE."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable in the context of a clinical test set. The evaluation was primarily based on nonclinical (bench tests). The pulse oximeter module itself references Nellcor's 510(k) #K962424, implying that its performance was established separately by Nellcor.
Data Provenance: The bench tests were conducted by Telefactor Corporation. The country of origin for this data is implicitly the United States, where Telefactor Corporation is located. The tests were likely prospective in nature, performed specifically for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. No clinical expert-driven ground truth establishment is described for the "test set" because no clinical trials or reader studies were performed for this submission. The "ground truth" for the EEG aspect is the established performance of the predicate DEEG-LITE, and for the oximeter, it's Nellcor's specifications documented in their respective 510(k).

4. Adjudication Method for the Test Set:

Not applicable. No human readers or adjudication processes are described for evaluating the device's performance in a clinical setting.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Because of the identical performance confirmed by the Bench Tests, clinical performance tests are deemed unnecessary." This indicates reliance on non-clinical testing and substantial equivalence rather than human performance studies.

6. Standalone (Algorithm Only) Performance:

Yes, the evaluation conducted was primarily a standalone (algorithm/device only) performance assessment through nonclinical bench tests. The device's electrical characteristics, noise performance, and adherence to established standards (for both EEG and the pulse oximeter module) were tested independently. There is no "human-in-the-loop" component to the described testing.

7. Type of Ground Truth Used:

The "ground truth" for this submission is based on:
- Predicate Device Performance: The established performance and safety of the legally marketed predicate device, DEEG-LITE (K972202).
- Manufacturer Specifications/Standards: For the integrated Nellcor pulse oximeter, its performance is compared against Nellcor's own documented specifications and its previously cleared 510(k) (K962424).
- Industry Standards: Electrical safety compliance is measured against UL2601-1 and IEC601-1 standards.

8. Sample Size for the Training Set:

Not applicable. This device is a hardware system for signal acquisition and recording, not an AI/ML algorithm that undergoes "training." Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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JUN - 9 1998

Section 2: 510(K) Summary & Certification

Image /page/0/Picture/2 description: The image shows a series of numbers and letters written in a bold, handwritten style. The characters appear to be 'K174583'. The writing is dark and stands out against the background.

2.0 Summary

This summary is submitted in accordance with the content & format requirements of section 807.92 I the CFR, by Telefactor Corporation, and is a part of the Premarket Notification 510(k) Application.

(Requirement: CFR807.92 paragraph (a))

March 04, 1998 Date: a.

Telefactor Corporation Name & address of the submitter: 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

DEEG-LITE-OXY Trade Name: C.
Common Name: Portable EEG Recorder d.
Product Classification (per CDRH Database): e. Product Category: ELECTROENCEPHALOGRAPH Regulation Number: 882.1400 Medical Specialty: NE Product Code: GWQ , OLV , DOA Tier: 2 Product class: Class II Device
This device claims equivalence to: Telefactor Corporation's DEEG-LITE Portable EEGf. Recorder for which previously granted 510(k) number is: K972202
Brief functional description of the device: DEEG-LITE-OXY receives signals from an g. DITIC Tunctional desertpacer of them on the digital media for subsequent evaluation by a qualified clinician.

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Intended use for the device: h.

INDICATIONS FOR USE, previously approved for DEEG-LITE (510(k) #K972202:

DEEG-LITE is intended for use in long-term digital recording of voltages produced by the brain DEEG-LITE Is Intended for use in long term agains review with a digital workstation
and measured on the scalp (EEG) for subsequent diagnostic review with a davice and measured on the scap (DEC) Tor daoooqueen engineers on similar compatible device.

INDICATION FOR USE for DEEG-LITE-OXY (modified to include pulse-oximeter)

The DEEG-LITE-OXY is intended for use in long-term recording of voltages produced by the brain The DEEG-LITE-OX I is mended for acc in roughtan review with a digital workstation and measured on the scalp (EEG) for subsculent in the compatible device. An integrated supplied by the manufacturer (Telefactor Deckeeper) of children with the form of blood oxygen saturation (SpO2 percent).

Technological characteristics: The DEEG-LITE-OXY system consists of (a) a laptop i. Technological characterisates: The DEDS & Fro Coder which consists of the art
computer with liquid crystal display, (b) a MicroCoder which consists of State) Signa computer with liquid crystar usplays (0) a histor Oligital converter, a DSP (Digital Signal components such as: a mgil lesolution Analog to includes supply and (d) a wearable, 32 channel EEG amplifier/recorder, and (e) an internal pulse ossimeter module supplied by 32 channel EEG ampillerrecorder, and (0) an international processor a safe low voltage Neilcor(model Mr 205). The DDLG De De oximeter module, all of the foregoing
power supply. With the exception of the pulse oximeter modules income DEEC I ITE power supply. With the excopiton of unded in the predicate device DEEG-LITE.
(Requirement: CFR807.92 paragraph (b))
Brief statement of substantial equivalence to Telefactor DBEG-LITE: The DEG-LITE j. Brief statement of 'substantial equivalence to 'imeter covice powered from the a-c mains.
system is often operated with an external pulse oximeted anglog innut of the system is often operated with an external parts one-isolated analog input of the and supplying a non-Isolated analog output coupled to the foregoing configuration DEEG-LITE. The DEBO-EFTLE-OXY Is compressor have been obtained as an OEM module except that the pulse oximeler cheantly and proved digitally to the DEEG-LITEwhich can be operated from Isolated battery power also posted eliminates any possibility of OX Y recording system. Providing an intentian process used in DEEG-LITE and makes the error in the D-R-A and A-0-D communication proboth the office and home environment. The resulting system portable and more casily sol up in odal ins in no way degraded by the performance of the DECO-EFT E DEC 1000rains capacity only 300 milliwatts power addition tion does not significantly affect battery life.

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(1) Nonclinical (Bench Tests): The results of the bench tests described in volume 3, document the equivalent noise performance of the DEEG-LITE OXY system to that of the DEEGthe equiration noise ports-f of this application summarizes bench test data which confirms that the internal Nellcor oximeter (equivalent to that documented in Nellcor's document for their 510(k) #K962424) meets Nellcor's specifications when installed in the DEEG-LITE-OXY electronic environment.
(2) Clinical tests: Because of the identical performance confirmed by the Bench Tests, clinical performance tests are deemed unnecessary.
performance tools are desiffectiveness: Electrical safety for EEG monitoring equipment is well specified by the UL2601-1 and IEC601-1 and IEC601-1 standards. The design of the WEEG-LITE-OXY electronics is identical to that of the DEEG-LITE and has been carried out with careful attention to compliance with these standards.
(4) Conclusion: It is our conclusion that the nonclinical (Bench Tests) and the substantially equivalent design of the DEEG-LITE-OXY to that of the DEEG-LITE, demonstrate that the equivalent docry. of the and performs as well as the predicate device DEEG-LITE.

Certification 2.1

I certify, that to the best of my knowledge, the information provided in this summary for the I certify, that to the best of my into meagers ... ITE-OXY, is true and accurate.

、

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

Date: March 06, 1998

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with three faces in profile, representing health and well-being. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

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

Mr. James S. Bryan Telefactor Corporation 1094 New Dehaven Avenue West Conshohocken, Pennsylvania 19428

Re: K974583 Trade/Device Name: DEEG-LITE-OXY Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ, DQA Dated (Date on orig SE Itr): March 6, 1998 Received (Date on orig SE ltr): March 11, 1998

APR - 9 2012

Dear Mr. Bryan:

This letter corrects our substantially equivalent letter of June 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.

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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 (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.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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Kesia Alexander

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

for

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Page 1 of .: 1

510(k) Number (if known):____K974583

Device Name:__________________________________________________________________________________________________________________________________________________________________ DEEG-LITE-OXY

Indications For Use:

Indication for use for DEEG-LITE-OXY (modified to include pulse-oximeter)

The DEEG-LITE-OXY 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 subplied by the manufacturer (Telefactor Beekeeper) or similar compatible device. An integrated pulse oximeter provides supplemental diagnostic data in the form of blood oxygen saturation (SpQ2 percent).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K974583

Prescription Use (Per 21 CFR 801.109)	✓
OR	Over-The-Counter Use (Optional Format 1-2-96)

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).