Not Found
No
The summary describes a multi-sensor device for data collection and transmission, but there is no mention of AI or ML being used for data analysis, interpretation, or any other function. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is described as measuring, recording, and transmitting data (auscultation sound, temperature, SpO2, pulse rate, images) for counseling with a physician, but not directly providing therapy. The only specific function mentioned as "Rx only" is the oxygen saturation sensor, which is a diagnostic/monitoring function, not a therapeutic one.
Yes
The device 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," which are all functions related to gathering medical data to aid in diagnosis or monitoring. The device also "enables user's examination at home with or without the guidance of a remote physician" and "guidance and data examination by a remote physician," further indicating its role in data collection for medical assessment.
No
The device description explicitly states it is comprised of a handheld unit, a wireless otoscope kit (including camera, tongue depressor, and ear specula), and a dedicated smartphone software application. It also mentions electrical safety and EMC testing, which are related to hardware components.
Based on the provided text, the N9+ (OTC) device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- N9+ Functionality: The N9+ device measures physical parameters directly from the human body (auscultation sound, temperature, oxygen saturation, pulse rate) and captures images of external body parts. It does not analyze samples taken from the body.
The device is a multi-sensor medical device intended for direct measurement and imaging of the human body, not for analyzing biological samples in vitro.
N/A
Intended Use / 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 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.
Product codes
DQD, FLL, DQA, ERA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human body
Indicated Patient Age Range
adult lay users
Intended User / Care Setting
adult lay users in a non-clinical environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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 Safety 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.
- 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
Indications for Use
510(k) Number (if known) K223785
Device Name
N9+ (OTC) device
Indications for Use (Describe)
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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
4
IV. 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.
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.
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.
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) device
K223785 | MyHomeDoc device
(N9+)
K202483 | Tyco Care Tyto
Stethoscope (OTC)
K181612 | Tyto Care Tyto
Thermometer (OTC)
K190242 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | The MyHomeDoc 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. | The Tyto
Stethoscope is an
electronic
stethoscope that
enables transmission
of auscultation sound
data, whereby a
clinician at one
location on an IP | The Tyto
Thermometer is a
non - contact clinical
infrared thermometer
intended for
intermittent
determination of
human body
temperature from the |
5
| N9+ (OTC) device
K223785 | MyHomeDoc device
(N9+)
K202483 | Tyco Care Tyto
Stethoscope (OTC)
K181612 | Tyto Care Tyto
Thermometer (OTC)
K190242 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | human body
temperature, oxygen
saturation (SpO2) and
pulse rate, and images of
an examined body part.
MyHomeDoc device is
intended for use by adult
lay users in a non-clinical
environment.
MyHomeDoc application
enables counseling with
the physician and
transmission of the
information over an IP
network. | network can listen to
the auscultation
sounds of a patient
on site or at a
different location on
the IP network with
the signal carried on
an IP connection
between the two
locations. The Tyto
Stethoscope is
intended to be used
by professional users
in a clinical
environment or by lay
users in a nonclinical
environment. The
device is for medical
diagnostics purposes
only. The device is
not intended for self-
diagnosis. | center of the
forehead on people of
all ages. The Tyto
Thermometer is
intended for use by
both adult lay users
and clinicians. It can
be used both at home
and in clinic
environments. |
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.
6
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.