The N9+ (OTC) device, combined with a smartphone application, is a multiple-sensor device that is intended to measure, record, and transmit the recorded data of auscultation sound of human body temperature, oxygen saturation (SpO2) and pulse rate, and images of an examined body part.

N9+ (OTC) device is intended for use by adult lay users in a non-clinical environment. Nonagon application enables counseling with the physician and transmission of the information over an IP network.

The oxygen saturation (SpO2) sensor of the device is for Rx only.

Device Description

The N9+ (OTC) (except for the oxygen saturation function), is a home use device. The device is comprised of a handheld unit that interfaces with a smartphone, a wireless otoscope kit comprised of the otoscope camera, a reusable tongue depressor and 2 reusable ear specula (adult and toddlers) and a dedicated smartphone software application that runs on the user's personal smartphone.

The system uses the smartphone's camera to record images of the patient's skin.

An API is defined to enable healthcare providers to communicate with the device. The pulse oximeter will be a prescription device in the US market.

The Device enables user's examination at home with or without the quidance of a remote physician. It also enables guidance and data examination by a remote physician over an IP network. The Smartphone Application controls the Handheld Unit and wireless otoscope functionality (besides recording images of the patient's skin) and processes and displays the collected data.

AI/ML Overview

The provided text describes the regulatory clearance of the N9+ (OTC) device and details some performance data, but it does not contain the specific information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding the acceptance criteria and the study that proves the device meets those criteria for the AI/algorithm component.

The document discusses general performance data related to biocompatibility, software validation, electrical safety, EMC, wireless quality of service, and self-selection testing. It does not provide performance metrics (like accuracy, sensitivity, specificity, AUC) for the device's functional capabilities (e.g., measuring auscultation sounds, temperature, SpO2, or image analysis).

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria for device performance as an AI/algorithm.

The document does mention software validation was conducted and the software level of concern is moderate, but it does not specify the performance metrics or studies directly related to the accuracy or effectiveness of the data collection or image acquisition beyond general compliance.

Information provided in the document that somewhat relates to the request:

Software Validation: "Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The N9+ (OTC) software level of concern is moderate." (This confirms software validation was done, but gives no specifics on acceptance criteria or performance metrics).
Self-Selection Testing: "The study enrolled 31 men and women of different ages and literacy levels. All the participants made a correct purchasing decision. The results of this self-selection study show that consumers are able to decide whether the N9+ (OTC) is right for them based on the information communicated on the outer package (box)." (This is about user understanding of the product, not the device's functional performance.)

The document does NOT include:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance for an AI/algorithm.
Number of experts used to establish ground truth or their qualifications for an AI/algorithm.
Adjudication method for the test set for an AI/algorithm.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size of human reader improvement with AI.
Standalone performance of an algorithm.
Type of ground truth used for an AI/algorithm.
Sample size for the training set for an AI/algorithm.
How the ground truth for the training set was established for an AI/algorithm.

Summary

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April 14, 2023

Nonagon Ltd. % Jonathan Kahan Partner Hogan Lovells US LPP 555 Thirteenth Street NW Washington, District of Columbia 20004

Re: K223785

Trade/Device Name: N9+ Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD, FLL, DQA, ERA, Dated: March 23, 2023 Received: March 23, 2023

Dear Jonathan Kahan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Robert T. Kazmierski -S

for

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223785

Device Name

N9+ (OTC) device

Indications for Use (Describe)

The oxygen saturation (SpO2) sensor of the device is for Rx only.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional Premarket Notification Submission - 510(k) N9+ (OTC) device 510(k) Number K223785

Date Prepared: April 13, 2023

l. SUBMITTER

Nonagon Ltd. 1 HaEshel St., Caesarea 3079830, Israel Tel: +972-(0)4- 9874202

Contact Persons

Jonathan Kahan, Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 Tel:+1 202 637 5794 jonathan.kahan@hoganlovells.com Lina Kontos, Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 Tel:+1 202 637 5713 lina.kontos@hoganlovells.com

Back-up Company Contact:

Orly Maor 25 Sirkin Street Kfar Saba 44421 Israel Tel: +972-9-7453607 oram.ma@gmail.com

DEVICE ll.

Name of Device: Common or Usual Name: Classification Name: Requlatory Class: Product Code:

N9+ (OTC) device Patient Monitor Oximeter, Clinical Electronic Thermometer, and Otoscope Class II DQD, FLL, DQA, ERA

PREDICATE DEVICE lll.

Primary predicate:

MyHomeDoc device (K202483), Requlation Number: 870.1875 Classification Product Code: DQD Subsequent Product Codes: DQA, ERA, FLL

Secondary predicates:

Tyto Care Ltd. Tyto Thermometer (OTC) cleared under K190242 Regulation Number: 21 CFR 880.2910 Product Code: FLL

TytoCare Ltd. Tyto Stethoscope (OTC) cleared under K181612 Regulation Number: 21 CFR 870.1875 Product Code: DQD

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IV. DEVICE DESCRIPTION

The system uses the smartphone's camera to record images of the patient's skin.

An API is defined to enable healthcare providers to communicate with the device. The pulse oximeter will be a prescription device in the US market.

V. INDICATIONS FOR USE

The N9+ (OTC) device, combined with a smartphone application, is a multiple-sensor device that is intended to measure, record, and transmit the recorded data of auscultation sound of human body. human body temperature, oxygen saturation (SpO2) and pulse rate, and images of an examined body part.

The oxygen saturation (SpO2) sensor of the device is for Rx only.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE AND REFERENCE DEVICE

The N9+ (OTC) have the same intended use as the previously cleared device, with a modification to the indications for use to allow for OTC use (except for the pulse oximeter which remains under prescription use). The N9+ (OTC) device has substantially similar technology as the cleared N9+ and the secondary predicate devices and the minor differences do not raise new or different questions of safety or effectiveness.

N9+ (OTC) deviceK223785	MyHomeDoc device(N9+)K202483	Tyco Care TytoStethoscope (OTC)K181612	Tyto Care TytoThermometer (OTC)K190242
The N9+ (OTC) device, combined with asmartphone application, is amultiple-sensor device thatis intended to measure,record, and transmit therecorded data ofauscultation sound ofhuman body, human body	The MyHomeDoc device, combined with asmartphone application,is a multiple-sensordevice that is intended tomeasure, record, andtransmit the recordeddata of auscultationsound of human body.	The TytoStethoscope is anelectronicstethoscope thatenables transmissionof auscultation sounddata, whereby aclinician at onelocation on an IP	The TytoThermometer is anon - contact clinicalinfrared thermometerintended forintermittentdetermination ofhuman bodytemperature from the

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N9+ (OTC) deviceK223785	MyHomeDoc device(N9+)K202483	Tyco Care TytoStethoscope (OTC)K181612	Tyto Care TytoThermometer (OTC)K190242
temperature, oxygensaturation (SpO2) and pulserate, and images of anexamined body part.N9+ (OTC) device isintended for use by adult layusers in a non-clinicalenvironment. Nonagonapplication enablescounseling with thephysician and transmissionof the information over an IPnetwork.The oxygen saturation(SpO2) sensor of the deviceis for Rx only.	human bodytemperature, oxygensaturation (SpO2) andpulse rate, and images ofan examined body part.MyHomeDoc device isintended for use by adultlay users in a non-clinicalenvironment.MyHomeDoc applicationenables counseling withthe physician andtransmission of theinformation over an IPnetwork.	network can listen tothe auscultationsounds of a patienton site or at adifferent location onthe IP network withthe signal carried onan IP connectionbetween the twolocations. The TytoStethoscope isintended to be usedby professional usersin a clinicalenvironment or by layusers in a nonclinicalenvironment. Thedevice is for medicaldiagnostics purposesonly. The device isnot intended for self-diagnosis.	center of theforehead on people ofall ages. The TytoThermometer isintended for use byboth adult lay usersand clinicians. It canbe used both at homeand in clinicenvironments.

No significant changes to the technological characteristics of the device have been implemented since clearance except for a modification to the otoscope due to a change in supplier.

The N9+ (OTC) device has similar technological characteristics as the predicate device in that it is provides the same exams, used at home by the patient directly to record and wirelessly transmit the patient's data to the healthcare provider at a different location in either an online or offline mode. The secondary predicate devices provide similar functionalities as the N9+ (OTC) device and also allows for OTC use. With the subject and predicate devices, none of the systems provide any interpretation of the data.

PERFORMANCE DATA VII.

The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility testing in compliance with ISO 10993. -

Software Validation -

The N9+ (OTC) software level of concern is moderate. Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

Electrical Safely and EMC -

Electrical Safety per IEC 60601-1 and Electromagnetic compatibility (EMC) per IEC 60601-1-2 were conducted on the N9+ (OTC) device. In addition, the system complies with IEC 60601-1-11, IEC 62471, and IEC 60601-2-18.

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Wireless quality of service and coexistence testing

Testing was performed to address testing of the device in the presence of the relevant potential emitters in the intended use environment in accordance with ANSI C63.27-2017: Evaluation of wireless coexistence and FDA's Guidance "Radio frequency wireless technology in medical devices."

-Self-Selection testing

The study enrolled 31 men and women of different ages and literacy levels. All the participants made a correct purchasing decision. The results of this self-selection study show that consumers are able to decide whether the N9+ (OTC) is right for them based on the information communicated on the outer package (box).

VIII. CONCLUSIONS

The N9+ (OTC) device was determined to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.1875 Stethoscope.

(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.