Somnolyzer 24x7 is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.

This device is to be used under the supervision of a physician.

Device Description

Somnolyzer is a polysomnography scoring application that provides automated analysis of sleep, respiratory and movement information recorded during sleep studies. It processes information recorded during sleep by electrodes and sensors attached to the body. It then generates results that include quantitative sleep, breathing and motion parameters, used to evaluate sleep and respiratoryrelated disorders. Somnolyzer 24x7 scoring is applicable to adult patient populations only.

Somnolyzer 24x7 version 2.5 provides an update to the currently released Somnolyzer 24x7 (K083620), which enables Somnolyzer to score sleep recordings according to the American Academy of Sleep Medicine (AASM) Manual 2007 and 2012 editions.

AI/ML Overview

Here's an analysis of the provided information regarding the Somnolyzer 24x7, focusing on acceptance criteria and the study used to demonstrate compliance.

Based on the provided text, there is no explicit table of acceptance criteria or a detailed study description with performance metrics for the Somnolyzer 24x7. This submission (K131994) is a 510(k) for a modified device, and the primary claim is substantial equivalence to a previously cleared predicate device (Somnolyzer 24x7, K083620).

The submission relies on a non-clinical test approach, specifically focusing on verification and validation activities to ensure the modifications did not adversely affect safety and effectiveness.

Here's what can be extracted and inferred from the text regarding the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As stated, no explicit table of acceptance criteria or detailed performance metrics are provided in the document. The submission focuses on verification that the modifications performed as intended and did not impact safety and effectiveness.

The document implicitly states that "Testing confirmed that the Somnolyzer 24x7 software version 2.5 performs equivalently to the device predicate Somnolyzer 24x7 software (K083620). All tests had passing results or minor resolved defects." This implies the acceptance criteria were met, but the specific criteria and performance values are not detailed.

Inferred "Acceptance Criteria" (based on nature of submission):

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Functional Equivalence: The modified software must correctly implement the AASM 2007 and 2012 scoring rules for sleep staging and respiratory events.	The algorithms were updated to add inputs (additional EEG leads, CPAP flow sensor, pressure transducer, RIPflow). Sleep staging and respiratory event scoring rules were updated. The software confirmed to support sub-classification of hypopneas and detect Cheyne Stokes breathing patterns.
Accuracy of Automated Scoring: The automated scoring results of the modified device should be comparable to human manual scoring. (Implied for substantial equivalence to predicate)	Automated validation testing "compared the performance of human manual scoring against Somnolyzer 24x7 version 2.5 and previous versions of Somnolyzer." The testing confirmed that the device "performs equivalently to the device predicate."
Safety and Effectiveness: The modifications must not introduce new safety concerns or decrease effectiveness.	"Respironics has determined that the modifications have no impact on the safety and effectiveness of the device." "The verification and validation testing demonstrates that all new requirements have been satisfied and safety and effectiveness has not been inadvertently affected by modifications to the system."
Software Quality: The software should be free of significant defects.	"All tests had passing results or minor resolved defects."
Configuration Options: New clinician configurability features should function as intended.	Modifications were made "to provide clinician configurability of several scoring parameters, accept ECG input for signal processing... and identify and select the EMG channel with the most viable data for scoring." The verification test would have assessed these.

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

Sample Size for Test Set: Not specified. The document mentions "automated validation testing compared the performance of human manual scoring against Somnolyzer 24x7 version 2.5 and previous versions of Somnolyzer," but does not provide details on the number of cases or studies used.
Data Provenance: Not specified. The country of origin of the data (e.g., retrospective or prospective) is not mentioned.

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

Number of Experts: Not specified. The document refers to "human manual scoring" as the benchmark for automated validation testing but doesn't quantify how many human scorers were involved or how their results were consolidated.
Qualifications of Experts: Not specified. The qualifications of the "human manual scorers" are not detailed (e.g., board-certified sleep physicians, polysomnographic technologists, experience level).

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given that multiple "human manual scorers" may have been involved in establishing the benchmark (though not quantified), the method for resolving discrepancies or establishing a consensus (e.g., 2+1, 3+1) is not mentioned. It's possible a single expert's scoring was used as the ground truth if only one manual scorer was involved, or if the "previous versions of Somnolyzer" acted as a reference point.

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

No MRMC study was done or reported. The submission does not mention a comparative effectiveness study involving human readers with and without AI assistance to quantify an effect size of improvement. The testing compared the algorithm's performance to human scoring, not human performance with/without the algorithm.

6. Standalone Performance Study

Yes, a standalone algorithm performance evaluation was done. The "automated validation testing" involved comparing the performance of the Somnolyzer 24x7 version 2.5 (algorithm only) against human manual scoring. This is a standalone performance assessment for the algorithm.

7. Type of Ground Truth Used

Expert Consensus / Expert Interpretation. The "human manual scoring" served as the ground truth against which the automated scoring algorithm's performance was compared. This indicates an expert interpretation or potentially an expert consensus if multiple human scorers were used. The document does not mention pathology or outcomes data as ground truth.

8. Sample Size for the Training Set

Not applicable / Not specified. This submission is for modifications to an existing device. The training set for the original Somnolyzer 24x7 (K083620) is not discussed, and there is no indication that the modifications (which primarily involve updating algorithms to AASM rules) required a new or re-training with a distinct training set. The changes were algorithmic adjustments rather than training a new deep learning model from scratch.

9. How Ground Truth for the Training Set Was Established

Not applicable / Not specified. Similar to the above, as this is a modification submission focused on rule implementation rather than re-training a new model, the establishment of ground truth for a training set is not discussed. For the original predicate device, it is presumed to have been established through expert manual scoring in accordance with relevant sleep scoring guidelines at that time.

Summary

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K131994

Somnolyzer 24x7

510(K) SUMMARY

Official Contact	Daniela AizpitarteRegulatory Affairs EngineerRespironics Inc.1740 Golden Mile HighwayMonroeville, PA 15146daniela.aizpitarte@philips.com
	724-387-7954 t	OCT 17 2013
Date of Preparation	June 27, 2013
Classification Reference	21 CFR 868.2375
Product Code	MNR—Ventilatory Effort Recorder
Common/Usual Name	Sleep Analysis System
Proprietary Name	Somnolyzer 24x7
Predicate Device(s)	Somnolyzer 24x7 (K083620)
Reason for submission	Modified Device

Substantial Equivalence

The modified device has the following similarities to the previously cleared predicate device:

□ Same intended use.
D Same operating principle.
O Same technology.

Design verification tests were performed on Somnolyzer 24x7 as a result of the product requirements. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this substantially equivalent to the predicate device.

. .

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The modified device complies with the applicable standards referenced in the Guidance for FDA Reviewers and Industry "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices," May 2005.

Indications for Use

Somnolyzer 24x7 is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.

This device is to be used under the supervision of a physician.

The indications for use remain unchanged from K083620.

Device Description

Somnolyzer is a polysomnography scoring application that provides automated analysis of sleep, respiratory and movement information recorded during sleep studies. It processes information recorded during sleep by electrodes and sensors attached to the body. It then generates results that include quantitative sieep, breathing and motion parameters, used to evaluate sleep and respiratoryrelated disorders. Somnolyzer 24x7 scoring is applicable to adult patient populations only.

Description of Modifications.

The fundamental scientific technology of Somnolyzer 24x7 is unchanged from the predicate device (K083620). Respironics has made the following changes to the previously cleared Somnolyzer 24x7 to be considered for this submission:

Modifications to accommodate the AASM rules up to the 2012 edition: .
To accommodate the American Academy of Sleep Medicine (AASM) scoring rules, various algorithms in the Somnolyzer 24x7 software were updated to add inputs. The use of additional EEG leads in the AASM recommended EEG montage were built into the software for detecting

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sleep staging and arousals. A CPAP flow sensor and pressure transducer air flow channel were added as valid inputs into the software. In sleep studies where the primary air flow channels are absent or have produced unreliable data, the respiratory effort belt signal can now be used to derive an air flow signal, known as RIPflow was added as an optional flow channel in the AASM 2012 manual.

Sleep staging and respiratory event scoring rules were also updated to incorporate new rules with the AASM 2012 edition. Somnolyzer has the ability to support the sub-classification of hypopneas, as well as detect Cheyne Stokes breathing patterns.

. Other improvements:

In addition to the AASM updates, Somnolyzer 24x7 was modified to provide clinician configurability of several scoring parameters, accept ECG input for signal processing (allow for removal of ECG electrical interference in the EEGIEOG/EMG data, use the ECG signal in respiratory event detection as part of the scoring consideration for hypopneas), and identify and select the EMG channel with the most viable data for scoring.

Non-Clinical Tests

Verification activities were performed to verify that the software modifications performed as intended and did not affect safety and effectiveness. Two types of testing were conducted: verification tests and automated validation tests. The verification testing involved verifying the results from the autoscoring algorithms. The automated validation testing compared the performance of human manual scoring against Somnolyzer 24x7 version 2.5 and previous versions of Somnolyzer. Testing included software code reviews, bench verification testing and user manual inspection. The verification and validation testing demonstrates that all new requirements have been satisfied and safety and effectiveness has not been inadvertently affected by modifications to the system.

Testing confirmed that the Somnolyzer 24x7 software version 2.5 performs equivalently to the device predicate Somnolyzer 24x7 software (K083620). All tests had passing results or minor resolved defects.

Clinical Tests

Clinical tests were not required to demonstrate the safety and effectiveness of Somnolyzer 24x7. Product functionality has been adequately assessed by non-clinical tests.

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Conclusion

Somnolyzer 24x7 software has passed all of the aforementioned non-clinical tests and required no clinical tests in order to demonstrate safety or effectiveness. It is therefore concluded that Somnolyzer 24x7 is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

October 17, 2013

Public Health Service

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

Respironics, Inc. Daniela Aizpitarte Regulatory Affairs Engineer 1740 Golden Mile Highway Monroeville, PA 15146

Re: K131994

Trade/Device Name: Somnolyzer 24x7 Regulation Number: 21 CFR 868.2375 Regulation Name: Ventilatory Effort Recorder Regulatory Class: Class II Product Code: MNR Dated: September 6, 2013 Received: September 9, 2013

Dear Ms. Aizpitarte:

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 Eederal Register.

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.

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Page 2 - Daniela Aizpitarte

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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/McdicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.ida.gov/MedicalDevices/Safety/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours, Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID FOR Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Traditional 510(k) Tab 4 - Indications for Use Statement

K13, 1994/
Somnolyzer 24x7

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

Somnolyzer 24x7 is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.

Somnolyzer 24x7 is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.

This device is to be used under the supervision of a physician.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

K131994

Anva C. Harry -5 16 23 25 1 1 = 0 1 1 = 0 1 1 1 5 5 80

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).