Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package

K182543 · Snap40, Ltd. · MSX · Nov 14, 2018 · Cardiovascular

Device Facts

• Record ID: K182543
• Device Name: Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package
• Applicant: Snap40, Ltd.
• Product Code: MSX · Cardiovascular
• Decision Date: Nov 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended 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.

Device Story

Wearable device worn on upper arm; monitors pulse rate, SpO2, temperature, and movement continuously; respiration rate intermittently. Inputs: photoplethysmography (SpO2/pulse), thermistor (temperature), accelerometer/gyroscope (movement/respiration). Data transmitted via WiFi to software platform; provides visual/audible alarms on mobile devices and central station. Used in general medical/surgical hospital units by trained healthcare professionals. Output: vital sign parameters and alarms. Benefits: enables remote/centralized monitoring of patient status in non-critical areas; facilitates timely clinical intervention. Not for high-acuity settings or home use; not a substitute for ECG.

Clinical Evidence

Clinical studies conducted on human subjects. SpO2 accuracy validated in controlled desaturation study (n=12) per IEC 80601-2-61, demonstrating +/- 2 digits accuracy (70-100% range). Respiration rate accuracy validated against end-tidal CO2 (n=37) across various postures, demonstrating +/- 1 breath per minute accuracy (6-60 rpm range).

Technological Characteristics

Wearable upper-arm monitor; Lithium-ion battery (36-hour life); WiFi (IEEE 802.11) connectivity. Sensing: In-built thermistor (temp), accelerometer/gyroscope (movement/respiration), SpO2 sensor. Standards: IEC 60601-1 (electrical), IEC 60601-1-2 (EMC), IEC 60601-1-8 (alarms), ISO 80601-2-61 (SpO2), ISO 80601-2-56 (temp), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for adult patients in hospital environments requiring continuous monitoring of pulse rate, SpO2, temperature, and movement, or intermittent/spot-check monitoring of respiration rate. Contraindicated for high-acuity environments (ICU, OR), home use, acutely ill cardiac patients prone to life-threatening arrhythmias (e.g., fast atrial fibrillation), and SpO2 monitoring during high motion or low perfusion.

Regulatory Classification

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.

Predicate Devices

• Infinity Acute Care System (IACS) (K113798)
• Infinity Central Station (K151860)
• IntelliVue CL Respiration Pod (K132320)
• IntelliVue Guardian Software (K161767)

Submission Summary (Full Text)

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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.

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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/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 ([e-mail]) or phone [phone] 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

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### 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)

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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: [phone]

### Establishment Registration Number:

Still to be established

### Contact Person:

Edwin Lindsay

Telephone [phone]

### Date Prepared:

4th September 2018

Below summaries the Device Classification Information regarding the snap40 System:

### Primary Product Code:

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

### Secondary Product Codes:

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

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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.

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### 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<br>Device snap40 | Primary<br>Predicate<br>IACS | Infinity Central<br>Station | IntelliVue CL<br>Respiration Pod | IntelliVue Guardian<br>Software |
| Common Name | System,<br>Network and<br>Communication,<br>Physiological<br>Monitors | Monitor,<br>Physiological,<br>Patient (With<br>Arrhythmia<br>Detection or<br>Alarms) | Monitor,<br>Physiological,<br>Patient (With<br>Arrhythmia<br>Detection or<br>Alarms) | Monitor, Breathing<br>Frequency | Display, Cathode-<br>Ray Tube |
| Device Manufacturer | snap40 Ltd | Draeger | Draeger | Philips | Philips |
| Device Classification | II | II | II | II | II |
| Primary Product<br>Code | MSX | MHX | MHX | BZQ | DXJ |
| Secondary Product<br>Code | FLL DQA BZQ<br>DRG | MSX, DRT, DQA,<br>BZQ, FLL, DSK,<br>FLS, MLD, DXN,<br>CCK | - | DRG MSX | DQK NSX OUG |
| 510k Numbers | N/A | K113798 | K151860 | K132320 | K161767 |
| Target Population | Adult | Adult, Paediatric<br>and Neonatal | Adult, Paediatric<br>and Neonatal | Adult | N/A |
| Environment | Hospital | Hospital | Hospital | Hospital | Hospital |
| Intended Use/<br>Indication for Use | snap40 is<br>intended for<br>reusable<br>bedside, mobile<br>and central<br>multi-parameter,<br>physiologic<br>patient<br>monitoring of<br>adult patients in<br>environments<br>where patient<br>care is provided<br>by trained | The IACS is<br>intended for<br>multi-<br>parameter,<br>physiologic<br>patient<br>monitoring of<br>adult, pediatric<br>and neonatal<br>patients in<br>environments<br>where patient<br>care is<br>provided by | The Infinity<br>CentralStation<br>(ICS) is<br>intended for use<br>by trained<br>healthcare<br>professionals<br>for the purpose<br>of centralized<br>monitoring of<br>adult, pediatric<br>and neonatal<br>patient data<br>within the | The IntelliVue<br>CL<br>Respiration<br>Pod is<br>indicated for<br>use by<br>healthcare<br>professionals<br>whenever<br>there is a<br>need for<br>intermittent or<br>spot-check<br>acquisition | The IntelliVue<br>GuardianSoftw<br>are is<br>indicated for<br>use by<br>healthcare<br>providers<br>whenever<br>there is a need<br>for the<br>generation of a<br>patient record.<br>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:<br>Pulse rate<br>Oxygen saturation<br>Temperature<br>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<br>Device snap40 | Primary<br>Predicate<br>IACS | Infinity Central<br>Station | IntelliVue CL<br>Respiration Pod | IntelliVue Guardian<br>Software |
| | respiration rate<br>in adults. | professional.<br>The M540 is<br>intended to<br>monitor one<br>patient at a<br>time. | | Respiration<br>Pod when<br>used together<br>with a patient<br>monitor is for<br>intermittent or<br>spot-check<br>monitoring<br>and recording<br>of, and to<br>generate<br>alarms for,<br>respiration<br>rate and pulse<br>rate of adult<br>patients. | |
| | snap40 is not<br>intended for use<br>in high-acuity<br>environments,<br>such as ICU or<br>operating<br>rooms or for<br>use in the home | The M540<br>monitors the<br>following<br>parameters:<br>• Heart rate<br>• Arrhythmia<br>(adult and<br>pediatric only)<br>• 12-lead<br>analysis<br>• ST segment<br>analysis<br>including<br>TruST® (adult<br>and pediatric<br>only)<br>• 12-lead ST<br>segment<br>analysis (adult<br>and pediatric<br>only)<br>• Apnea<br>• Respiration<br>rate<br>• Invasive<br>pressure<br>• Non-invasive<br>pressure<br>• Temperature<br>• Cardiac<br>output (only<br>available when<br>the M540 is<br>docked in an | | The IntelliVue<br>CL<br>Respiration<br>Pod is also<br>intended for<br>acquisition of<br>respiration<br>rate and pulse<br>rate data of<br>adult patients<br>for a clinical<br>information<br>management<br>system. | |
| | snap40 is not<br>intended for use<br>on acutely ill<br>cardiac patients<br>with the<br>potential to<br>develop life<br>threatening<br>arrhythmias e.g.<br>very fast atrial<br>fibrillation. For<br>these patients,<br>they should be<br>monitored using<br>a device with<br>continuous<br>ECG. snap40 is<br>not a substitute<br>for an ECG<br>monitor. | | | The Intellivue<br>CL<br>Respiration<br>Pod is<br>intended for<br>use by<br>healthcare<br>professionals.<br>It is not | |
| | snap40 is not<br>intended for<br>SpO2<br>monitoring in<br>conditions of<br>high motion or<br>low perfusion. | | | | |
| General Information | | | | | |
| Property | Proposed<br>Device snap40 | Primary<br>Predicate | Infinity Central<br>Station | IntelliVue CL<br>Respiration Pod | IntelliVue Guardian<br>Software |
| | | IACS<br>IACS<br>configuration)<br>· Arterial<br>oxygen<br>saturation<br>(SpO 2)<br>· Pulse rate<br>· Perfusion<br>Index (P1)<br>· Total<br>hemoglobin<br>(SpHb) - adult<br>and pediatric<br>only<br>· Total oxygen<br>content (SpCO)<br>- adult and<br>pediatric only<br>· Methemoglobin<br>saturation<br>(SpMet)<br>· Pleth<br>variability<br>index (PVI)<br>· Mainstream<br>etCO2 | | intended for<br>home use. It<br>is not a<br>therapeutic<br>device.<br><br>The IntelliVue<br>CL<br>Respiration<br>Pod is not<br>intended for<br>use on<br>patients with<br>extremely<br>high values<br>for respiration<br>rate (above 60<br>rpm).<br><br>The IntelliVue<br>CL<br>Respiration<br>Pod is not<br>intended for<br>use on<br>acutely ill<br>cardiac<br>patients with<br>the potential<br>to develop life<br>threatening<br>arrhythmias,<br>e.g. very fast<br>atrial<br>fibrillation or<br>ventricular<br>tachycardia<br>(rapid<br>irregular<br>pulse rate).<br>For | |
| General Information | | | | | |
| Property | Proposed<br>Device snap40 | Primary<br>Predicate<br>IACS | Infinity Central<br>Station | IntelliVue CL<br>Respiration Pod | IntelliVue Guardian<br>Software |
| | |…