The RMX is a physiological data recorder intended to collect and record data from multiple physiological channels and additional auxiliary inputs from undesignated channels. It is indicated for use by or on order of a physician. The RMX is intended for use in a supervised (hospital) or unsupervised (home) environment.

Device Description

The RMX is an ambulatory unattended recording device intended for the recording of sleep physiological data. The RMX functions exclusively as a data-recording device and is not intended to monitor Apnea or other vital signs in an intensive care unit or any other real time application. It is used by or on the order of a physician.

The RMX data recording device offers a platform for collecting multiple channels of physiological signals such as pulse rate, ECG, EEG, airflow, thoracic and abdominal respiratory effort, sounds intensity (i.e. noise due to snoring), body position and movements, leg movement, pulse oximetry or similar physiological signals. The data collection box is normally attached over the clothes of the patient's chest using the chest inductive effort sensor band made of clothing-standard woven elastic laces. The device may use its internal sensors, standard wired physiological sensors or several wireless sensors (not covered in this application) to match the specific needs of the patient.

Data collected is transferred on an SD memory card from the recorder to a PC at the physician's clinic, where it is converted into industry standard EDF format, after which it is analyzed by standard scoring software to generate a detailed final report with recommendations.

The RMX data recording device includes 3 software elements; 1) the SETUP part that runs on a PC and uploads the recorder setup parameters to the SD (secure digital) card as determined by the physician, 2) The Firmware operating the main and auxiliary CPU hardware which control the A/D conversion and storage of the data, and 3) the Post-Study Software which runs on a PC, reads the raw data file from the SD card as a single file and converts it into the industry standard EDF format suitable for input to analytical systems (see section 16 for software description).

AI/ML Overview

This document describes the RMX Physiological Data Recorder, but it does not contain a typical acceptance criteria table with performance metrics and a study comparing those metrics against predetermined thresholds. Instead, it focuses on functional testing to ensure accurate data recording.

Here's an analysis of the provided information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or performance metrics in the way a diagnostic device might (e.g., sensitivity, specificity). The "acceptance criteria" can be inferred from the "FUNCTIONAL TEST" section, which describes the device's ability to accurately record signals.

Acceptance Criteria (Inferred)	Reported Device Performance
Accurately generate an output replica in EDF format from known simulated signals injected to its inputs.	"The results of this test confirm that the RMX can accurately record multiple physiological signals, at a sufficient quality for later analysis by trained experts." (Page 3)
Confirm that the original patient details and the loaded setup data are correct.	"The test also confirms that the original patient details and the loaded set-up data are correct." (Page 3)
Match accepted non-formal industry standards (sampling rates, sampling depths, sensor types, attachment location, overall operation protocol).	"The technical specifications of the RMX were selected to match accepted non-formal standards in the industry, including sampling rates, sampling depths (# of bits per sample), sensor types and attachment location, as well as methods and overall operation protocol." (Page 3) The functional test confirmed its ability to generate an accurate output replica, implicitly meeting these standards.

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

Sample Size for Test Set: Not specified. The description of the "FUNCTIONAL TEST" implies a single setup (a single device or system under test) where simulated signals were injected. It does not mention a "test set" of patient data or a specific number of tests.
Data Provenance (country of origin, retrospective/prospective): Not applicable. The test involved "known simulated signals injected to its inputs," not real patient data.

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

Number of Experts: Not applicable. The "ground truth" for the functional test was the "known simulated signals" that were injected into the device. The output was then compared to these known signals.
Qualifications of Experts: Not applicable for establishing ground truth. The document mentions that the recorded signals are of "sufficient quality for later analysis by trained experts," but these experts are for downstream analysis, not for establishing the ground truth of the recording capability itself.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The functional test involved comparing the device's output to the "known simulated signals" (the ground truth). There's no mention of human adjudication in this technical verification process.

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

Performed? No. The RMX is described as a "physiological data recorder," not an AI-powered diagnostic tool. The document focuses on its ability to accurately record data, not on the interpretation of that data by humans or AI. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's functional validation as presented.
Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Performed? Not applicable in the context of an "algorithm only" study for diagnostic performance. The device's primary function is recording, not automated interpretation or diagnosis. The "FUNCTIONAL TEST" describes the standalone performance of the recording system (hardware and firmware) in replicating input signals.
- If "standalone performance" refers to the device's accuracy in recording data without human intervention, then the "FUNCTIONAL TEST" could be considered a form of standalone performance assessment. It confirms the device's ability to capture and store data correctly on its own.

7. Type of Ground Truth Used

Type of Ground Truth: Known simulated signals. For the functional test described, the ground truth was the precisely known electrical signals injected into the RMX device's inputs.

8. Sample Size for the Training Set

Sample Size: Not applicable. The RMX is a physiological data recorder, not a machine learning model that requires a training set. Its functionality is based on hardware design and firmware logic, not learned patterns from data.

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

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

Summary

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K080375

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SEP - 2 -2008

RMX 510(k) Submission

SECTION 5 - 510 (K) SUMMARY

5.1 510(K) SUMMARY

A 510(k) Summary is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990. This 510(k) Summary meets the requirements identified in 21 C.R.F. 807.92.

RMX Physiological Data Recorder

Date of Preparation	Aug 26, 2008
Applicant's Name	S.L.P Ltd.
	62 Anilevitch StreetTel-Aviv 67060. IsraelTel: 972-3-537-1281Fax: 972-3-537-1282
Establishment Reg. number	9614500
Contact Person	N. Hadas, CTO (see footer for contact details)
Trade Name	RMX
Common Name	Physiological Data Recorder
Classification Name	Ventilatory Effort Recorder
Classification Reg. number	21 CFR 868.2375
Regulatory Status	Class II
Product Code	MNR
Classification panel	Anesthesiology

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5.2 DEVICE DESCRIPTION

5.3 INTENDED USE

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SUBSTANTIAL EQUIVALENCE 5.4

S.L.P Ltd. believes that the RMX is substantially equivalent to the following predicate devices without raising any new safety and/or effectiveness issues:

1. Portable sleep data recorder, Pro-tech services Inc., WA, USA, cleared under K033402.
1. DeVilbiss Sleep Recorder,DeVilbiss, PA USA, cleared under K012437.
1. SleepSense Sleep Sensors, S.L.P. LTD., IL, K042253
1. SPO, Pulse Oximeter, SPO LTD., IL, K040178

Detailed description of the predicate devices is provided in Section 12 of this application.

5.5 TECHNOLOGICAL PROPERTIES

The RMX is a basic physiological signal recorder. Similar to the predicate devices, the RMX uses a set of standard internal and/or external physiological sensors to collect and record multiple physiological parameters such as respiration, movement or sound. All signals are channeled to the main unit recorder which contains a digitizer and a processor to store them on a solid-state memory card.

The predicate devices are identical to the RMX in that they contain similar functional modules, which perform the same functions.

The sensors integrated in the RMX device, or connected externally to the system are based on sensor technology developed by SLP over the last 15 years of making standard sleep lab sensors, and are covered by 510K K042253. The SPO ltd. oximeter used in the system is covered by 510K K040178. Additional sensors or devices such as the pressure cannula are covered by their respective FDA 510K approvals.

Therefore, in design and functionality aspects, the RMX does not raise any new questions of safety or effectiveness. Any minor differences in the design and operational method (intended to help the user perform the recording successfully) between the RMX and its predicate devices do not raise any safety or effectiveness issues.

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RMX 510(k) Submission

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ડ.6 FUNCTIONAL TEST

The technical specifications of the RMX were selected to match accepted non-formal standards in the industry, including sampling rates, sampling depths (# of bits per sample), sensor types and attachment location, as well as methods and overall operation protocol. Due to the sole function as a data recorder, validation encompassed a single setup in which the complete RMX device (software and hardware) was tested for its ability to generate, from known simulated signals injected to its inputs, an accurate output replica in a file in EDF format. The test also confirms that the original patient details and the loaded set-up data are correct.

The results of this test confirm that the RMX can accurately record multiple physiological signals, at a sufficient quality for later analysis by trained experts.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2008

S.L.P. Limited C/O Mr. J. G. van Vugt Responsible Third Party Official KEMA Quality B.V. 4377 County Line Road Chalfont, Pennsylvania 18914

Re: K080375

Trade/Device Name: RMX Physiological Data Recorder Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: August 15, 2008 Received: August 18, 2008

Dear Mr. van Vugt:

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. van Vugt

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 regaricies. You must comply with all the Act's requirements, including, but not limited to registers. and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing proctice 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. This letter will allow you to begin marketing your device as of ancibed in your Section 510(k) premarket notification. The FDA finding of substantial aquivalence 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

TK Samuel S-Sled, mr for "

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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SECTION 4- INDICATIONS FOR USE STATEMENT

(For 510k Substantially Equivalent Determination)

510(k) Number (if known): K080375

Device Name: RMX Physiological Data Recorder

Indications for Use:

Prescription Use __X (Part 21 CFR 801 Subpart D)

AND/ OR

Over the Counter Use (Part 21 CFR 801 Subpart C)

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

510(k) Number: K080375

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).