SleepSense sensors provide a qualitative measure of a patient's physiological parameters for recording onto an FDA-cleared data acquisition system. Their target population: Children and adult patients who are screened during sleep disorder studies. Their environment of use is usually at a sleep laboratory or sometimes at the patient's home.

Device Description

Monitoring various physiological parameters is standard practice in sleep disorder testing. Standard overnight recordings show, among others, traces of parameters like respiration movement, leg and arm movement, snoring sounds, respiration airflow and body position during sleep.

In order to record tracings showing these parameters, sensors are needed to convert the physiological parameter into an electrical signal. These sensors are very simple sensing elements like piezo-crystals that convert mechanical force or vibrations to an electrical signal. Other sensing elements may be thermocouples which generate a signal proportional to temperature, or gravity switches, that switch and electrical circuit on and off depending on their position.

In practice, these sensing elements are packaged in small, patient-friendly enclosures which are applied to the patient, and connected to the recording system via a long and flexible cable. There is no electrical contact of any kind between the sensors and the patient.

All signals received from the sensors are qualitative, and are only used to record the dynamic nature or existence of the physiological parameter recorded. A specially trained sleep technician called "scorer" reviews the overall recording in the morning following the study. The signals recorded, together with additional channels like EKG or EEG, are analyzed to arrive at a diagnosis of a sleep disorder like sleep apnea or insomnia.

AI/ML Overview

This 510(k) summary for the SleepSense Sleep Sensors outlines the device's classification, intended use, and substantial equivalence to predicate devices. However, it does not include any specific acceptance criteria or details of a study demonstrating the device meets such criteria.

The document states:

"No performance standards are specified for physiological sensors for sleep disorder testing."
The manufacturer claims substantial equivalence because they are the OEM manufacturer for the predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because this information is not present in the provided text.

Based on the provided text, I can only confirm the following:

1. A table of acceptance criteria and the reported device performance: This information is not provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
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): Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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: Not provided. The device is a sensor, not an AI system for clinicians.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's a sensor providing qualitative signals for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
8. The sample size for the training set: Not applicable, as it's a sensor without a "training set" in the context of an algorithm.
9. How the ground truth for the training set was established: Not applicable.

Summary

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510(K) SUMMARY

SleepSense Sleep Sensors 510(k) Number K_ O42253

Applicant's Name:	S.L.P Ltd.
	18 Hazfira Street
	Tel-Aviv 67779, Israel
	Tel: 972-3-537-1281
	Fax: 972-3-537-1282

Contact Person:	Noam Hadas
	S.L.P Ltd.
	18 Hazfira Street
	Tel-Aviv 67779, Israel
	Tel: 972-3-537-1281
	Fax: 972-3-537-1282

Trade Name:

SleepSense sleep disorder sensors

Classification Name:

MNR - Ventilatory effort recorder

Classification:

The FDA has classified sensors for sleep disorder sensor device as class II devices. EPM development systems have classified the predicate devices as product code BZQ (monitor, respiration frequency). SLP selected to classify these products as product code MNR (Respiration effort recorder) under the same regulation #. 868.2375. This classification is based on the fact that these products do not monitor, but only output signals which are recorded in a system.

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No monitoring takes place at all, since no indication of the patient's condition is presented to any caregiver, there is no need or intention to treat the patient, and there are no alarms or thresholds of any kind.

Predicate Device:

Device	Applicant	510(k)	Decision Date
snoring sensor	EPM development systems	K941759	11/10/1994
moving images(tm)	EPM information systems	K935518	05/17/1994
the tracker	EPM information systems	K923033	06/01/1993
easyflow(tm)	EPM information systems	K922112	12/07/1992
resp-ez(tm) respirat	EPM information systems	K903300	12/28/1990

Performance Standards:

No performance standards are specified for physiological sensors for sleep disorder testing. The SleepSense sensors are designed, and are specified to be used, only with FDA approved sleep recording systems, which are required to comply with all electrical safety requirements as specified in IEC 60601-1.

Intended Use:

Device Description:

In order to record tracings showing these parameters, sensors are needed to convert the physiological parameter into an electrical signal. These sensors are very simple sensing

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elements like piezo-crystals that convert mechanical force or vibrations to an electrical signal. Other sensing elements may be thermocouples which generate a signal proportional to temperature, or gravity switches, that switch and electrical circuit on and off depending on their position.

Substantial Equivalence:

S.L.P Ltd. claims that SleepSense sensors are the same products as the predicate devices, since S.L.P is the designer and OEM manufacturer of the sensors distributed by EPM since 1990. It is therefore obvious that they are substantially equivalent to these predicate devices cited above, without raising new safety and/or effectiveness issues.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 6 - 2004

S.L.P. Limited C/O Ms. Patricia Murphy Responsible Third Party Official KEMA Quality BV 4377 County Line Road Chalfont, Pennsylvania 18914

Re: K042253

Trade/Device Name: SleepSense Sleep Sensors Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: October 4, 2004 Received: October 4, 2004

Dear Ms. Murphy:

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. Murphy

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 (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 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 vour 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 (240) 276-0115. 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,

Chiu Lin, Ph.D.

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

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number: ____

Device Name: SleepSense sensors for sleep disorder testing

Indications for Use:

SleepSense sleep sensors provide a qualitative measure of some physiological parameters for recording onto an FDA-cleared data acquisition system. Their target population: Children and adult patients who are screened during sleep disorder studies. Their environment of use is usually at a sleep laboratory or sometimes at the patient's home.

Que Subcom

(Division Sign-Off) General Hospital, Division of Anesthesiology, C Infection Control, Dental f 510(k) Number

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510(k) Number

× Prescription Use

Over the Counter Use

(Per 21 CFR 801.109)

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).