Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard physiological monitoring parameters and a software platform for data presentation and alarming.

Therapeutic

No
The device is described as a monitoring device that measures various physiological parameters and provides alarms. It does not perform any therapeutic intervention or treatment.

Diagnostic

No

The device is a patient monitor that measures and continuously tracks physiological parameters (e.g., pulse rate, oxygen saturation, temperature, movement, respiration rate) to provide real-time data and alarms for patient care. It is not intended to provide a diagnosis of a disease or condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that snap40 "consists of a single monitoring device worn on the upper arm, a software platform... and a user interface". This indicates the presence of a physical hardware component (the monitoring device worn on the arm) in addition to the software.

IVD (In Vitro Diagnostic)

Based on the provided information, the snap40 device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the human body. This typically involves blood, urine, tissue, or other bodily fluids.
snap40 is a patient monitoring device. It measures physiological parameters directly from the patient's body (pulse rate, oxygen saturation, temperature, movement, respiration rate) using sensors applied externally.

The description clearly states that snap40 is intended for "physiologic patient monitoring" and measures parameters like pulse rate, oxygen saturation, temperature, movement, and respiration rate. These are all measurements taken on the patient, not from a sample of the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

snap40 is intended for reusable bedside, mobile and central multi-parameter, continuous and intermittent physiologic patient monitoring of adult patients in environments where patient care is provided by trained healthcare professionals.

snap40 is intended to provide visual and audible physiologic multi-parameter alarms.

snap40 is intended for temperature monitoring temperature at the upper arm is clinically indicated.

snap40 continuously monitors the following parameters in adults:

· Pulse rate
· Oxygen saturation
· Temperature
· Movement

snap40 is intended for intermittent or spot-check monitoring of respiration rate.

snap40 is not intended for use in high-acuity environments, such as ICU or operating rooms or for use in the home

snap40 is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. snap40 is not a substitute for an ECG monitor.

snap40 is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

Product codes (comma separated list FDA assigned to the subject device)

MSX, DQA, BZQ, FLL, DRG

Device Description

snap40 consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station.

snap40 is intended to continuously monitor adult patient vital signs in non-critical areas of the hospital, mainly general medical/surgical units, across pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). snap40 is intended for intermittent or spot-checking monitoring of respiration rate (RESP).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Upper Arm (for device placement, temperature monitoring, SpO2 monitoring, site of respiratory rate monitoring, and movement monitoring)

Indicated Patient Age Range

Adult

Intended User / Care Setting

Trained healthcare professionals / Hospital (non-critical areas, mainly general medical/surgical units)

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

Oxygen Saturation: controlled desaturation studies were conducted in compliance with IEC80601-2-61 across 12 participants. This testing was not conducted in the presence of motion or low perfusion.
Respiration Rate: snap40 was compared to respiration rate measured by end-tidal CO2. This was conducted on 37 participants in a variety of postures.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Test Name: SpO2 Testing Validation of the accuracy of SpO2 monitoring
Test Description: Ensure the accuracy and communication of the SpO2 functions within the snap40 system as per ISO80601-2-61 and the FDA SpO2 guidance; Pulse Oximeters-Premarket Notification Submissions Guidance for Industry and Food and Drug Staff, March 4, 2013
Results: Passed
Clinical Study: To assess oxygen saturation, controlled desaturation studies were conducted in compliance with IEC80601-2-61 across 12 participants. This testing demonstrated accuracy of +/- 2 digits across the range of 70-100%. This testing was not conducted in the presence of motion or low perfusion.

Test Name: Respiratory Rate Testing
Test Description: Ensure accuracy of snap40 respiration rate in comparison to respiration rate measured via end-tidal CO2 in a variety of postures
Results: Passed
Clinical Study: To assess respiration rate, snap40 was compared to respiration rate measured by end-tidal CO2. This was conducted on 37 participants in a variety of postures. This testing demonstrated accuracy of +/- 1 respirations per minute across a range of 6rpm to 60rpm.

Test Name: Pulse Rate Testing Validation of the accuracy of pulse rate monitoring
Test Description: The snap40 System was tested to confirm the accuracy of pulse rate monitoring of the system in accordance with ISO 80601-2-61 and the FDA Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and FDA Staff. 2007
Results: Passed

Test Name: Temperature Measurement Accuracy
Test Description: snap40 System was tested to confirm the Temperature Measurement Accuracy of the system in compliance with ISO 80601-2-56
Results: Passed

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Oxygen Saturation (SpO2): Accuracy of +/- 2 Digits across the range of 70-100%
Respiration Rate: Accuracy of +/- 1 respirations per minute across a range of 6rpm to 60rpm.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K113798, K151860, K132320, K161767

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 14, 2018

snap40 Ltd Edwin Lindsay QA/RA Manager 24 Forth Street Edinburgh, EH1 3LH Gb

Re: K182543

Trade/Device Name: Wearable Device; Cradle; Small Strap, Medium Strap, Large Strap; Multiple Device Charger; Hospital Starter Package Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX, DQA, BZQ, FLL, DRG Dated: September 17, 2018 Received: September 20, 2018

Dear Edwin Lindsay:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Arielle Drummond -S

For

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K182543

Device Name snap40 System

Indications for Use (Describe)

snap40 is intended for reusable bedside, mobile and central multi-parameter, continuous and intermittent physiologic patient monitoring of adult patients in environments where patient care is provided by trained healthcare professionals.

snap40 is intended to provide visual and audible physiologic multi-parameter alarms.

snap40 is intended for temperature monitoring temperature at the upper arm is clinically indicated.

snap40 continuously monitors the following parameters in adults:

· Pulse rate
· Oxygen saturation
· Temperature
· Movement

snap40 is intended for intermittent or spot-check monitoring of respiration rate.

snap40 is not intended for use in high-acuity environments, such as ICU or operating rooms or for use in the home

snap40 is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. snap40 is not a substitute for an ECG monitor.

snap40 is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

Type of Use (Select one or both, as applicable)

|X 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

For snap40 system

510(k) Summary

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

Submitter's Name:

snap40 Ltd

Submitter's Address:

24 Forth Street, Edinburgh EH1 3LH United Kingdom

Telephone: +44 (0) 131 560 1137

Establishment Registration Number:

Still to be established

Contact Person:

Edwin Lindsay

Telephone +44 (0) 7917134922

Date Prepared:

4th September 2018

Below summaries the Device Classification Information regarding the snap40 System:

Primary Product Code:

| Regulation
Number | Device | Device
Class | Product
Code | Classification
Panel |
|----------------------|-----------------------------------------------------------------|-----------------|-----------------|-------------------------|
| 870.2300 | System, Network and
Communication,
Physiological Monitors | Class 2 | MSX | Cardiovascular |

Secondary Product Codes:

| Regulation
Number | Device | Device
Class | Product
Code | Classification
Panel |
|----------------------|------------------------------------------------------------------------|-----------------|-----------------|-------------------------|
| 880.2910 | Thermometer, Electronic,
Clinical | Class 2 | FLL | General
Hospital |
| 870.2700 | Oximeter | Class 2 | DQA | Cardiovascular |
| 868.2375 | Monitor, Breathing
Frequency | Class 2 | BZQ | Anesthesiology |
| 870.2910 | Transmitters and
Receivers, Physiological
Signal, Radiofrequency | Class 2 | DRG | Cardiovascular |

4

For snap40 system

Device Trade Name:

snap40 system

Device Common Name:

snap40 system

Intended/ Indications Use:

snap40 is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in environments where patient care is provided by trained healthcare professionals.

snap40 is intended to provide visual and audible physiologic multi-parameter alarms.

snap40 is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated.

snap40 is intended for continuous monitoring of the following parameters in adults:

Pulse rate
. Oxygen saturation
Temperature ●
Movement ●

snap40 is intended for intermittent or spot-check monitoring of respiration rate in adults.

snap40 is not intended for use in high-acuity environments, such as ICU or operating rooms or for use in the home

snap40 is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. snap40 is not a substitute for an ECG monitor.

snap40 is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

5

snap40 Ltd. Traditional 510(k) For snap40 system

Summary of Substantial Equivalence:

The following predicate devices have been that the snap40 system can claim equivalence with and these are detailed below

General Comparison

General Information
Property	Proposed
Device snap40	Primary
Predicate
IACS	Infinity Central
Station	IntelliVue CL
Respiration Pod	IntelliVue Guardian
Software
Common Name	System,
Network and
Communication,
Physiological
Monitors	Monitor,
Physiological,
Patient (With
Arrhythmia
Detection or
Alarms)	Monitor,
Physiological,
Patient (With
Arrhythmia
Detection or
Alarms)	Monitor, Breathing
Frequency	Display, Cathode-
Ray Tube
Device Manufacturer	snap40 Ltd	Draeger	Draeger	Philips	Philips
Device Classification	II	II	II	II	II
Primary Product
Code	MSX	MHX	MHX	BZQ	DXJ
Secondary Product
Code	FLL DQA BZQ
DRG	MSX, DRT, DQA,
BZQ, FLL, DSK,
FLS, MLD, DXN,
CCK	-	DRG MSX	DQK NSX OUG
510k Numbers	N/A	K113798	K151860	K132320	K161767
Target Population	Adult	Adult, Paediatric
and Neonatal	Adult, Paediatric
and Neonatal	Adult	N/A
Environment	Hospital	Hospital	Hospital	Hospital	Hospital
Intended Use/
Indication for Use	snap40 is
intended for
reusable
bedside, mobile
and central
multi-parameter,
physiologic
patient
monitoring of
adult patients in
environments
where patient
care is provided
by trained	The IACS is
intended for
multi-
parameter,
physiologic
patient
monitoring of
adult, pediatric
and neonatal
patients in
environments
where patient
care is
provided by	The Infinity
CentralStation
(ICS) is
intended for use
by trained
healthcare
professionals
for the purpose
of centralized
monitoring of
adult, pediatric
and neonatal
patient data
within the	The IntelliVue
CL
Respiration
Pod is
indicated for
use by
healthcare
professionals
whenever
there is a
need for
intermittent or
spot-check
acquisition	The IntelliVue
GuardianSoftw
are is
indicated for
use by
healthcare
providers
whenever
there is a need
for the
generation of a
patient record.
The IntelliVue
General Information
Property	Proposed Device snap40	Primary Predicate IACS	Infinity Central Station	IntelliVue CL Respiration Pod	IntelliVue Guardian Software
	healthcare professionals.	trained healthcare professionals.	hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation. Infinity CentralStation with Rest ECG is intended for the production and interpretation of diagnostic electrocardiograms for adult and pediatric patients when connected to a monitor with diagnostic 12-Lead ECG monitoring enabled.	and monitoring of physiological patient parameters respiration rate and pulse rate wirelessly in specific hospital areas. The IntelliVue CL Respiration Pod is mainly indicated for use in general medical and surgery wards and in waiting areas of emergency rooms. It is not indicated for use in hospital areas in which continuous patient monitoring is needed, such as intensive care units or operating rooms. The intended use of the IntelliVue Cl	GuardianSoftw are is intended for use in the collection, storage and management of data from Philips specified Measurements and Philips Patient Monitors that are connected through networks.
	snap40 is intended to provide visual and audible physiologic multi-parameter alarms.	The IACS obtains the physiologic, multi- parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network.
	snap40 is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated.
	snap40 is intended for continuous monitoring of the following parameters in adults:
Pulse rate
Oxygen saturation
Temperature
Movement	The Infinity M540 is intended for the monitoring of multi- parameter, physiological patient information obtained from connected hardware in environments where patient care is provided by trained healthcare
	snap40 is intended for intermittent or spot-check monitoring of
General Information
Property	Proposed
Device snap40	Primary
Predicate
IACS	Infinity Central
Station	IntelliVue CL
Respiration Pod	IntelliVue Guardian
Software
	respiration rate
in adults.	professional.
The M540 is
intended to
monitor one
patient at a
time.		Respiration
Pod when
used together
with a patient
monitor is for
intermittent or
spot-check
monitoring
and recording
of, and to
generate
alarms for,
respiration
rate and pulse
rate of adult
patients.
	snap40 is not
intended for use
in high-acuity
environments,
such as ICU or
operating
rooms or for
use in the home	The M540
monitors the
following
parameters:
• Heart rate
• Arrhythmia
(adult and
pediatric only)
• 12-lead
analysis
• ST segment
analysis
including
TruST® (adult
and pediatric
only)
• 12-lead ST
segment
analysis (adult
and pediatric
only)
• Apnea
• Respiration
rate
• Invasive
pressure
• Non-invasive
pressure
• Temperature
• Cardiac
output (only
available when
the M540 is
docked in an		The IntelliVue
CL
Respiration
Pod is also
intended for
acquisition of
respiration
rate and pulse
rate data of
adult patients
for a clinical
information
management
system.
	snap40 is not
intended for use
on acutely ill
cardiac patients
with the
potential to
develop life
threatening
arrhythmias e.g.
very fast atrial
fibrillation. For
these patients,
they should be
monitored using
a device with
continuous
ECG. snap40 is
not a substitute
for an ECG
monitor.			The Intellivue
CL
Respiration
Pod is
intended for
use by
healthcare
professionals.
It is not
	snap40 is not
intended for
SpO2
monitoring in
conditions of
high motion or
low perfusion.
General Information
Property	Proposed
Device snap40	Primary
Predicate	Infinity Central
Station	IntelliVue CL
Respiration Pod	IntelliVue Guardian
Software
		IACS
IACS
configuration)
· Arterial
oxygen
saturation
(SpO 2)
· Pulse rate
· Perfusion
Index (P1)
· Total
hemoglobin
(SpHb) - adult
and pediatric
only
· Total oxygen
content (SpCO)

adult and
pediatric only
· Methemoglobin
saturation
(SpMet)
· Pleth
variability
index (PVI)
· Mainstream
etCO2 | | intended for
home use. It
is not a
therapeutic
device.

The IntelliVue
CL
Respiration
Pod is not
intended for
use on
patients with
extremely
high values
for respiration
rate (above 60
rpm).

The IntelliVue
CL
Respiration
Pod is not
intended for
use on
acutely ill
cardiac
patients with
the potential
to develop life
threatening
arrhythmias,
e.g. very fast
atrial
fibrillation or
ventricular
tachycardia
(rapid
irregular
pulse rate).
For | |
| General Information | | | | | |
| Property | Proposed
Device snap40 | Primary
Predicate
IACS | Infinity Central
Station | IntelliVue CL
Respiration Pod | IntelliVue Guardian
Software |
| | | | | monitoring of
these
patients, a
device for
continuous
ECG
monitoring is
necessary.
The IntelliVue
CL
Respiration
Pod is not a
substitute for
an ECG
monitor.