(203 days)
No
The summary does not mention AI, ML, or any related concepts. The device description focuses on standard hardware components for EEG and pulse oximetry.
No
The device is intended for long-term recording of brain activity for diagnostic review, not for therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "subsequent diagnostic review" and provides "supplemental diagnostic data."
No
The device description explicitly lists multiple hardware components including a laptop computer, a MicroCoder with A/D converter and DSP, a wearable EEG amplifier/recorder, and an internal pulse oximeter module.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "long-term recording of voltages produced by the brain and measured on the scalp (EEG)" and providing "supplemental diagnostic data in the form of blood oxygen saturation (SpO2 percent)". These are measurements taken directly from the patient's body, not from a sample of biological material in vitro (outside the body).
- Device Description: The components described are for measuring electrical signals from the scalp and blood oxygen levels, which are in vivo measurements.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples like blood, urine, tissue, etc., which is the defining characteristic of an IVD.
Therefore, the DEEG-LITE-OXY is a medical device for in vivo diagnostic measurements, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
GWQ, OLV, DOA
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 lesolution Analog to Digital converter, a DSP (Digital Signal processor a safe low voltage which 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 are powered from an isolated power supply. With the exception of the pulse oximeter module, the components of the DEEG-LITE-OXY are included in the predicate device DEEG-LITE.
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
Qualified clinician
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)
(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.
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.
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
§ 882.1400 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).
0
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.
1
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.
2
- (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.
、
0
John B Chatten President Telefactor Corporation 1094 New Dehaven Street West Conshohocken, PA 19428
Date: March 06, 1998
3
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.
4
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) |