The Embla N7000 is intended for use by a physician or trained technician for the acquisition of EEG and polysomnography (PSG) signals and transmission of these signals to a PC during neurophysiologic or sleep examinations. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments.

The use of the Embla N7000 system does not involve any patient monitoring or diagnosis.

Device Description

The Embla N7000 system is a full polysomnography system with expanded EEG capability. It is used to perform online sleep studies in the sleep lab, hospital or clinical environment under the supervision of a clinician or sleep technician. It does not do the recording, monitoring or analysis of this data.

The Embla N7000 system integrates digital technology and precision engineering into a flexible, rugged, full polysomnography system. The system itself, featuring an Ethernet network connection, is simple to assemble and the cables have been streamlined to provide a comfortable and reliable system. Meeting the most demanding clinical and research needs by offering 32 referential EEG channels, 8 bipolar channels plus an extensive set of respiratory signals, the system also includes auxiliary inputs for additional devices such as CPAP and CO2 machines.

AI/ML Overview

The provided text describes the Embla N7000 EEG Amplifier system and its substantial equivalence to a predicate device (Artisan™ Acquisition System). However, it does not contain a detailed study with specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity), sample sizes for test and training sets, information on ground truth establishment, or expert involvement as typically found in studies for AI/ML-driven medical devices.

Instead, the document focuses on regulatory compliance, technical characteristics, and a general verification and validation process for a medical device that primarily functions as an acquisition and transmission system, not an artificial intelligence for diagnosis or analysis.

Here's how the information provided maps to your request, with a clear indication of what is not present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicit in terms of performance metrics like sensitivity, specificity, accuracy, or similar for diagnostic/analytic capabilities. The document refers to compliance with safety and electrical standards and functional equivalence.	The Embla N7000 successfully acquired EEG and polysomnography (PSG) signals and transmitted them to a PC during neurophysiologic or sleep examinations.
Compliance with FDA "Electroencephalograph Devices Guidance for 510(k) Content, Draft Document, Version 1.0"	Certified to carry the CE mark (CE 0413), indicating compliance with EU Medical Device Directive 93/42/EEC.
Conformity to various specific standards (e.g., EN60601-1, EN60601-1-2, IEC 60601-2-26 for EEG, UL 2601-1, CAN/CSA C22.2 No.601.1-M90, AS/NZS 3200.1.0)	"Testing performed and the results verify that the Embla N7000 is safe and effective for its intended use." (General statement, no specifics provided).
Functional equivalence to the Artisan™ Acquisition System for amplifying and digitizing EEG and other polygraph channels and their transmission.	The amplification and data acquisition functions are similar to the Artisan™ system. The N7000 offers "expanded EEG capability" and "extended hardware possibilities of re-referencing." Software differences (microprocessor vs. PLD) were verified as meeting requirements.
Patient mains-isolation equivalent to predicate, fulfilling reinforced requirements of over 4000V manufacturing test voltage.	Met the reinforced requirements of over 4000V manufacturing test voltage, set by EN60601-1 and UL-2601.
Isolation from external devices equivalent to predicate.	Achieved in a similar way to the predicate device (special external box with AD converters and opto-couplers in predicate vs. built-in in N7000).
Communication construction equivalent to predicate.	Achieved via signal-transformer isolation and standard Ethernet communication (vs. fiber-optic and proprietary standard in predicate).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document mentions "internal verification and validation as well as external testing/validation" and "bench testing and practical testing in a simulated sleep lab setting." There's no numerical sample size provided for patients or data points.
Data Provenance: Not specified. The testing described is primarily focused on engineering verification and compliance with standards rather than clinical data testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document states the device is "intended for use by a physician or trained technician for the acquisition of EEG and polysomnography (PSG) signals" and that "It does not do the recording, monitoring or analysis of this data." This implies the analysis is done by human experts, but the experts involved in testing the device itself are not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not specified. Given the nature of the device as an acquisition system, the "ground truth" would likely relate to the fidelity and accuracy of the signal acquisition and transmission, rather than a diagnostic outcome requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This device is an EEG amplifier system for signal acquisition and transmission, not an AI or diagnostic tool that assists human readers with interpretation. Therefore, an MRMC study demonstrating improvement with AI assistance is not relevant or listed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. The Embla N7000 is explicitly stated as not performing "any patient monitoring or diagnosis." Its purpose is to acquire and transmit signals for human interpretation. It is not an algorithm-only device for analysis or diagnosis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not explicitly stated as "ground truth" in the diagnostic sense. For this type of device (signal acquisition), the "ground truth" would likely involve known, accurately generated electrical signals or physiological measurements against which the device's acquired signals are compared for accuracy, fidelity, and reliability according to engineering and safety standards.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/not specified. This device is a hardware system with embedded software, not a machine learning model that undergoes a "training" phase with a dataset in the conventional AI sense. The software development was "done according to the firmware development process at Medcare Flaga and it was verified that the software requirements are met."

9. How the ground truth for the training set was established

How Ground Truth for Training Set was Established: Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the word "Medcare" in bold black font. Above the word, there is a handwritten string of characters, "K024322". The handwritten string is oriented diagonally in the upper left corner of the image.

OCT 2 7 2003

510(k) Summary

December 19th, 2002

Submitter

Medcare Flaga Vesturhlid 7 105 Reykjavik Iceland Europe

Tel: 011 354 510 2000 Fax: 011 354 510 2010

Contact Person: Berglind Hallgrímsdóttir

e-mail: berglind@medcare.is, guality@medcare.is

Device

Trade Name: Common Name: Classification Product Code Classification Panel Embla N7000 EEG Amplifier Electroencephalograph, Class II GWQ Neurology

Substantial Equivalence

Artisan™ Acquisition System For EEG and polysmnography.

Airsep Corporation

290 Creekside Drive Buffalo, NY 14228

510(k) Number K992283

Description of the Device

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Medcare

Intended Use of the device

The use of the Embla N7000 system does not involve any patient monitoring or diagnosis.

Technological Charaterics

Both Artisan and Embla N7000 are used for amplifying EEG and sleep signals in clinical and research laboratories. Both are designed for collection and transmission of sleep data to a personal computer. Both systems are only acquisition systems from amplifying and digitizing EEG and other polygraph channels and their transmission to a PC.

The amplification and data acquisition functions are similar for both systems. The main difference is the extended hardware possibilities of re-referencing in the Embla N7000. Also the Embla N7000 is controlled by software that is stored in internal Flash memory and runs on internal microprocessors. Artisans programs are also stored in internal Flash memory and run on a PLD (Programmable Logic Device). The difference between a microprocessor and a PLD is mainly how the commands are processed in each device. The software for PLDs sets up the configuration of the PLDs electronics to make it perform certain logical operations. The software for microprocessors performs the same logical operations by a sequence of instructions executed in the processors CPU. The software development was done according to the firmware development process at Medcare Flaga and it was verified that the software requirements are met. The software level of concern for both products was minor.

The patient mains-isolation is equivalent for the two devices. The N7000 has internal mains isolation transformer to power the device. The Artisan is powered from external mains transformer that provides the same isolation. In both cases the mains isolation fulfills the reinforced requirements of over 4000V manufacturing test voltage, set by the EN60601-1 and UL-2601.

The isolation from external devices is done in similar way in both devices. In Artisan, a special external box containing AD converters and opto-couplers are used to isolate the signals, but in N7000 the similar converters and opto-couplers are built in the device.

The construction of the communication is also equivalent. Artisan uses fiber-optic cable for the isolation, using a proprietary communication standard for the point to point communications with the PC. The N7000 uses a signal-transformer to isolate the communications and communicates over standard Ethernet with the PC.

Test

The Embla N7000 has been tested and verified in various phases, the testing included design review, internal verification and validation as well as external testing/validation. The design was verified throughout the design process. Internal validation included bench testing and practical testing in a simulated sleep lab setting. Hazard analysis was done and appropriate measures were implemented and their effectiveness was verified. External test house, SEMKO, was used to confirm compliance to EMC requirements and standards for electrical safety including UL2601.

Testing performed and the results verify that the Embla N7000 is safe and effective for its intended use.

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Medcare

Compliance with guidelines and standards

Embla N/S7000 complies with the FDA "Electroencephalograph Devices Guidance for 510(k) Content, Draft Document, Version 1.0"

Embla N/S7000 is certified to carry the CE mark (CE 0413). The CE mark is a declaration that Embla N7000 is in compliance with the directive set forth by the European Union for medical devices.

Embla N/S7000 is manufactured by Medcare Flaga and the system conforms to the following standards and requlations:

Class IIa, Medical Device Directive (MDD), Annex V, "EC Directive" 93/42/EEC

EN60601-1:1990 with A1 and A12:1993, A2:1995 and A13:1996. (IEC 60601-1, 2nd ed., 1988 with A1,1991 and A2, 1995) : MEDICAL ELECTRICAL EQUIPMENT -PART 1: GENERAL REQUIREMENTS FOR SAFETY

EN60601-1-2:2001 MEDICAL ELECTRICAL EQUIPMENT -PART 1: GENERAL REQUIREMENTS FOR SAFETY - 2. COLLATERAL STANDARD: ELECTROMAGNETIC COMPATIBILITY -REQUIREMENTS AND TESTS

EN 61000-3-2:1995 and A14:2000. ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-2: LIMITS - LIMITS FOR HARMONIC CURRENTS EMISSIONS (EQUIPMENT INPUT CURRENT UP TO AND INCLUDING16 A PER PHASE)

EN 61000-3-3:1995, ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-3: LIMITS -LIMITATION OF VOLTAGE FLUCTUATIONS AND FLICKER IN LOW-VOLTAGE SUPPLY SYSTEMS FOR EQUIPMENT WITH RATED VOLTAGE UP TO 16 A

EN865:1997 PULSE OXIMETERS - PARTICULAR REQUIREMENTS

IEC 60601-2-25:1993 PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROCARDIOGRAPHS

60601-2-26:1994 PARTICULAR FOR IEC REQUIREMENTS THE SAFETY OF ELECTROENCEPHALOGRAPHS

IEC-60601-2-40:1998 PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT

EN60601-1-4 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY - 4. COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS

UL 2601-1: MEDICAL ELECTRICAL EQUIPMENT, PART 1:GENERAL REQUIREMENTS FOR SAFETY, 2nd ed. 1997

CAN/CSA C22.2 No.601.1-M90 MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR SAFETY

AS/NZS 3200.1.0: 1998 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - PARENT STANDARD

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the wings and body of the bird.

Public Health Service

OCT 27 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kumar Kulkarni Medcare Flaga c/o RTS, Incorporated 46 Loch Haven Lane Battle Creek, MI 49015

Re: K024322

Trade/Device Name: Embla N7000 Regulation Number: 21 CFR 868.2375 Regulation Name: Ventilatory Effort Recorder Regulatory Class: II Product Code: MNR Dated: July 27, 2003 Received: July 31, 2003

Dear Mr. Kulkarni:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Kumar Kulkarni

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Joflis
Chiu Lin, Ph.D.

fer

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

(Optional Format 3-10-98)

Applicant: Medare Flaga

510(k) Number (if known): K024322

Device Name: Embla N7000

Indications For Use:

The use of the Embla N7000 system does not involve any patient monitoring or diagnosis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Q. Patricku 10/24/03

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Numb

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).