(58 days)
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.
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).
Here's a summary of the acceptance criteria and the studies conducted for the snap40 system, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents performance specifications rather than explicit acceptance "criteria" in a pass/fail sense, but it does list the accuracy for each monitored parameter. The "Reported Device Performance" column reflects the accuracy achieved in the clinical studies.
| Parameter | Acceptance Criteria (from Technical Information) | Reported Device Performance (from Clinical Studies) |
|---|---|---|
| Pulse Rate | $\pm$ 3bpm | Not explicitly stated in clinical studies summary, but the device passed "Pulse Rate Testing" in accordance with ISO 80601-2-61 and FDA guidance. |
| Oxygen Saturation (SpO2) | $\pm$ 2 Digits (for range 70-100%) | $\pm$ 2 Digits across the range of 70-100% |
| Respiratory Rate | 1 breath per minute (Resolution) | $\pm$ 1 respirations per minute across a range of 6rpm to 60rpm |
| Temperature | $\pm$ 0.1°C | "Passed" in compliance with ISO 80601-2-56 |
| Movement | 10 Levels (1-10) (Classification) | Not explicitly stated in clinical studies summary, but "Passed" in relevant non-clinical testing. |
2. Sample Sizes and Data Provenance
Oxygen Saturation (SpO2) Test Set:
- Sample Size: 12 participants
- Data Provenance: The document implies these were prospectively collected in controlled desaturation studies. The country of origin is not explicitly stated but is likely the UK, where snap40 Ltd. is located.
Respiration Rate Test Set:
- Sample Size: 37 participants
- Data Provenance: The studies were conducted prospectively, with participants measured in a variety of postures. The country of origin is not explicitly stated but is likely the UK.
3. Number, Qualifications, and Adjudication of Experts for Ground Truth
- The document does not specify the number of experts used to establish ground truth for either the SpO2 or respiration rate test sets.
- The document does not specify the qualifications of these experts.
- The document does not mention any adjudication method used for establishing the ground truth.
4. Adjudication Method
As stated above, the document does not mention any adjudication method used for the test set's ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed, nor any data on how much human readers improve with AI vs. without AI assistance. The clinical studies focused on the accuracy of the device itself against established reference methods.
6. Standalone (Algorithm Only) Performance Study
Yes, standalone (algorithm only) performance studies were conducted for both SpO2 and respiration rate. The "Clinical Studies" section explicitly details these:
- SpO2: "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%."
- 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."
These are direct measurements of the device's algorithmic performance.
7. Type of Ground Truth Used
- Oxygen Saturation (SpO2): The ground truth was established using "controlled desaturation studies" in compliance with IEC80601-2-61, which typically involves comparing the device's readings against a laboratory co-oximeter or arterial blood gas analysis.
- Respiration Rate: The ground truth was established by comparing snap40 readings against "respiration rate measured via end-tidal CO2," which is a clinical standard for respiratory monitoring.
- Temperature: For the non-clinical temperature accuracy test, "compliance with ISO 80601-2-56" would imply comparison against a calibrated reference thermometer.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size used for training the device's algorithms. It only describes the clinical validation/test sets.
9. How the Ground Truth for the Training Set was Established
The document does not provide any information on how the ground truth for the training set was established, as details about the training set itself are absent.
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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.
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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 (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
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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: +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:
| RegulationNumber | Device | DeviceClass | ProductCode | ClassificationPanel |
|---|---|---|---|---|
| 870.2300 | System, Network andCommunication,Physiological Monitors | Class 2 | MSX | Cardiovascular |
Secondary Product Codes:
| RegulationNumber | Device | DeviceClass | ProductCode | ClassificationPanel |
|---|---|---|---|---|
| 880.2910 | Thermometer, Electronic,Clinical | Class 2 | FLL | GeneralHospital |
| 870.2700 | Oximeter | Class 2 | DQA | Cardiovascular |
| 868.2375 | Monitor, BreathingFrequency | Class 2 | BZQ | Anesthesiology |
| 870.2910 | Transmitters andReceivers, PhysiologicalSignal, 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 | ProposedDevice snap40 | PrimaryPredicateIACS | Infinity CentralStation | IntelliVue CLRespiration Pod | IntelliVue GuardianSoftware |
| Common Name | System,Network andCommunication,PhysiologicalMonitors | Monitor,Physiological,Patient (WithArrhythmiaDetection orAlarms) | Monitor,Physiological,Patient (WithArrhythmiaDetection orAlarms) | Monitor, BreathingFrequency | Display, Cathode-Ray Tube |
| Device Manufacturer | snap40 Ltd | Draeger | Draeger | Philips | Philips |
| Device Classification | II | II | II | II | II |
| Primary ProductCode | MSX | MHX | MHX | BZQ | DXJ |
| Secondary ProductCode | FLL DQA BZQDRG | 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, Paediatricand Neonatal | Adult, Paediatricand Neonatal | Adult | N/A |
| Environment | Hospital | Hospital | Hospital | Hospital | Hospital |
| Intended Use/Indication for Use | snap40 isintended forreusablebedside, mobileand centralmulti-parameter,physiologicpatientmonitoring ofadult patients inenvironmentswhere patientcare is providedby trained | The IACS isintended formulti-parameter,physiologicpatientmonitoring ofadult, pediatricand neonatalpatients inenvironmentswhere patientcare isprovided by | The InfinityCentralStation(ICS) isintended for useby trainedhealthcareprofessionalsfor the purposeof centralizedmonitoring ofadult, pediatricand neonatalpatient datawithin the | The IntelliVueCLRespirationPod isindicated foruse byhealthcareprofessionalswheneverthere is aneed forintermittent orspot-checkacquisition | The IntelliVueGuardianSoftware isindicated foruse byhealthcareproviderswheneverthere is a needfor thegeneration of apatient 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 rateOxygen saturationTemperatureMovement | 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 | ProposedDevice snap40 | PrimaryPredicateIACS | Infinity CentralStation | IntelliVue CLRespiration Pod | IntelliVue GuardianSoftware |
| respiration ratein adults. | professional.The M540 isintended tomonitor onepatient at atime. | RespirationPod whenused togetherwith a patientmonitor is forintermittent orspot-checkmonitoringand recordingof, and togeneratealarms for,respirationrate and pulserate of adultpatients. | |||
| snap40 is notintended for usein high-acuityenvironments,such as ICU oroperatingrooms or foruse in the home | The M540monitors thefollowingparameters:• Heart rate• Arrhythmia(adult andpediatric only)• 12-leadanalysis• ST segmentanalysisincludingTruST® (adultand pediatriconly)• 12-lead STsegmentanalysis (adultand pediatriconly)• Apnea• Respirationrate• Invasivepressure• Non-invasivepressure• Temperature• Cardiacoutput (onlyavailable whenthe M540 isdocked in an | The IntelliVueCLRespirationPod is alsointended foracquisition ofrespirationrate and pulserate data ofadult patientsfor a clinicalinformationmanagementsystem. | |||
| snap40 is notintended for useon acutely illcardiac patientswith thepotential todevelop lifethreateningarrhythmias e.g.very fast atrialfibrillation. Forthese patients,they should bemonitored usinga device withcontinuousECG. snap40 isnot a substitutefor an ECGmonitor. | The IntellivueCLRespirationPod isintended foruse byhealthcareprofessionals.It is not | ||||
| snap40 is notintended forSpO2monitoring inconditions ofhigh motion orlow perfusion. | |||||
| General Information | |||||
| Property | ProposedDevice snap40 | PrimaryPredicate | Infinity CentralStation | IntelliVue CLRespiration Pod | IntelliVue GuardianSoftware |
| IACSIACSconfiguration)· Arterialoxygensaturation(SpO 2)· Pulse rate· PerfusionIndex (P1)· Totalhemoglobin(SpHb) - adultand pediatriconly· Total oxygencontent (SpCO)- adult andpediatric only· Methemoglobinsaturation(SpMet)· Plethvariabilityindex (PVI)· MainstreametCO2 | intended forhome use. Itis not atherapeuticdevice.The IntelliVueCLRespirationPod is notintended foruse onpatients withextremelyhigh valuesfor respirationrate (above 60rpm).The IntelliVueCLRespirationPod is notintended foruse onacutely illcardiacpatients withthe potentialto develop lifethreateningarrhythmias,e.g. very fastatrialfibrillation orventriculartachycardia(rapidirregularpulse rate).For | ||||
| General Information | |||||
| Property | ProposedDevice snap40 | PrimaryPredicateIACS | Infinity CentralStation | IntelliVue CLRespiration Pod | IntelliVue GuardianSoftware |
| monitoring ofthesepatients, adevice forcontinuousECGmonitoring isnecessary.The IntelliVueCLRespirationPod is not asubstitute foran ECGmonitor.Warning: Donot use theCLRespirationPod onpatients withrapid,irregular heartrates greaterthan 110 bpm.Use undertheseconditionshas not beenclinicallyvalidated. | |||||
| Property | Proposed Devicesnap40 | System InformationPrimary PredicateIACS | Infinity CentralStation | IntelliVue CLRespiration Pod | IntelliVueGuardianSoftware |
| ParametersMonitored | Pulse RateOxygen SaturationRespiration RateTemperatureMovement | Heart rateArrhythmia (adult and pediatric only)12-lead analysisST segment analysis including TruSTⓇ(adult and pediatric only)12-lead ST segment analysis (adult andpediatric only)ApneaRespiration rateInvasive pressureNon-invasive pressureTemperatureCardiac output (only available when theM540 is docked in an IACS configuration)Arterial oxygen saturation (SpO 2)Pulse ratePerfusion Index (P1)Total hemoglobin (SpHb) - adult andpediatric onlyTotal oxygen content (SpCO) - adult andpediatric onlyMethemoglobin saturation (SpMet)Pleth variability index (PVI)Mainstream etCO2 | N/A | Respiration RatePulse Rate | N/A |
| Alarms | Yes | Yes | Yes | Yes | Yes |
| Energy Source | Battery | Primarily Mains + Battery Backup &For Patient Transport | Mains | Battery | Mains |
| Battery Type | Lithium Ion | Lithium Ion | N/A | Lithium Ion | N/A |
| Battery OperatingTime | 36 Hours | 3 Hours | N/A | 24 Hours | N/A |
| Battery Indicator | Via User Interface(Central/Bedside/Mobile) | Via User Interface (Bedside) | N/A | Via | On Device |
| Central Monitoring | Yes | No | Yes | N/A | Yes |
| User InterfaceDisplayable atBedside | Yes | Yes | No | N/A | No |
| Interfaces | Central/Bedside/Mobile | Bedside | Central | Via IntelliVueGuardianSoftware | Central/Mobile |
| DisplayedInformation onInterface | Vital Sign Parameters +Alarms | Vital Sign Parameters + Alarms | Vital SignParameters +Alarms | Vital SignParameters +Alarms | Vital SignParameters +Alarms |
| System Information | |||||
| Property | Proposed Devicesnap40 | Primary PredicateIACS | Infinity CentralStation | IntelliVue CLRespiration Pod | IntelliVueGuardianSoftware |
| Labelling | Comply with FDARequirement | Comply with FDA Requirement | Comply withFDARequirement | Comply with FDARequirement | Comply withFDARequirement |
| NetworkCommunication | IEEE 802.11 WiFi | IEEE 802.11 WiFi | LAN | IEEE 802.15.4 | LAN |
| Data Update Period | 30 seconds | <10 seconds | N/A | Up to 30 Seconds | N/A |
K182543 Page 3 of 14
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snap40 Ltd. Traditional 510(k)
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snap40 Ltd. Traditional 510(k)
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snap40 Ltd. Traditional 510(k) For snap40 system
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snap40 Ltd. Traditional 510(k)
For snap40 system
For snap40 system
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For snap40 system
| Technical Information for Pulse Rate | ||||||
|---|---|---|---|---|---|---|
| Property | Proposed Devicesnap40 | Primary PredicateIACS | Infinity CentralStation | IntelliVue CLRespiration Pod | IntelliVue GuardianSoftware | |
| Module | snap40 Module | NellcorOxiMax | MassimoRainbowSET | N/A | Philips Module | N/A |
| Site of Sensing | Upper Arm | Finger | Finger | N/A | Left Costal Arch | N/A |
| Range | 30bpm to 240bpm | 20bpm to250 bpm | 25bpm to240 bpm | N/A | 30 to 220 bpm | N/A |
| Resolution | 1bpm | 1bpm | 1bpm | N/A | 1bpm | N/A |
| Accuracy | $\pm$ 3bpm | $\pm$ 3bpm | $\pm$ 3bpm | N/A | $\pm$ 3% or $\pm$ 1bpm(whichever isgreater) | N/A |
| Applicable Standards | Complies toISO80601-2-61 | CompliestoISO80601-2-61 | CompliestoISO80601-2-61 | N/A | Complies toISO80601-2-61 | N/A |
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snap40 Ltd. Traditional 510(k) For snap40 system
Technical Information for Oxygen Saturation Proposed Device
Primary Predicate
Infinity Central
| Property | Proposed Devicesnap40 | Primary PredicateIACS | Infinity CentralStation | IntelliVue CLRespiration Pod | IntelliVue GuardianSoftware | |
|---|---|---|---|---|---|---|
| Module | In-Built SpO2 | NellcorOxiMax | MassimoRainbowSET | N/A | N/A | N/A |
| Site of SpO2Monitoring | Upper Arm | Finger | Finger | N/A | N/A | N/A |
| Measuring Range | 0% to 100% | 0% to100% | 0% to100% | N/A | N/A | N/A |
| Range | 70-100% | 70% to100% | 70% to100% | N/A | N/A | N/A |
| Resolution | 1% | 1% | 1% | N/A | N/A | N/A |
| Accuracy | $\pm$ 2 Digits | $\pm$ 2 Digits | $\pm$ 2 Digits | N/A | N/A | N/A |
| Applicable Standards | Complies toISO80601-2-61 | CompliestoISO80601-2-61 | CompliestoISO80601-2-61 | N/A | N/A | N/A |
| Technical Information for Respiratory Rate | |||||
|---|---|---|---|---|---|
| Property | Proposed Devicesnap40 | Primary PredicateIACS | Infinity CentralStation | IntelliVue CL RespirationPod | IntelliVue GuardianSoftware |
| Method | Chest MovementDetection | ImpedancePneumography | N/A | Chest MovementDetection | N/A |
| Site of RespiratoryRate Monitoring | Upper Arm | Chest | N/A | Left Costal Arch | N/A |
| Range | 6 - 60 breaths perminute | 0 - 155 breaths perminute | N/A | 5 - 60 breaths perminute | N/A |
| Resolution | 1 breath per minute | 1 breath per minute | N/A | 1 breath per minute | N/A |
| Property | Proposed Devicesnap40 | Primary PredicateIACS | Infinity CentralStation | IntelliVue CL RespirationPod | IntelliVue GuardianSoftware |
| Method | Accelerometer &Gyroscope | N/A | N/A | Accelerometer &Gyroscope | N/A |
| Site of MovementMonitoring | Upper Arm | N/A | N/A | Left Costal Arch | N/A |
| Classification | 10 Levels - 1 (VeryLow Activity) to 10(Very High Activity) | N/A | N/A | 10 Levels - 1 (VeryLow Activity) to 10(Very High Activity) | N/A |
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For snap40 system
| Technical Information for Skin Temperature | |||||
|---|---|---|---|---|---|
| Property | Proposed Devicesnap40 | Primary PredicateIACS | Infinity CentralStation | IntelliVue CL RespirationPod | IntelliVue GuardianSoftware |
| Method | Skin Temperature viaIn-Built Thermistor | Skin Temperature viaThermistor inAccessory | N/A | N/A | N/A |
| Site of TemperatureMonitoring | Upper Arm | Selected byPhysician (Can beUpper Arm) | N/A | N/A | N/A |
| Range | 0°C to 50°C | 0°C to 50°C | N/A | N/A | N/A |
| Resolution | 0.1°C | 0.1°C | N/A | N/A | N/A |
| Accuracy | $\pm$ 0.1°C | $\pm$ 0.1°C | N/A | N/A | N/A |
| Applicable Standard | Complies toISO80601-2-56 | Complies toISO80601-2-56 | N/A | N/A | N/A |
Any technical differences have been justifically and using performance testing. These do not affect the safety or effectiveness of the proposed device.
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For snap40 system
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).
Technological Characteristics:
A comparative review of the snap40 system with the predicate device found that the technology, mode of operation, and general principles for treatment with this device were substantially equivalent to the predicate device.
Non-Clinical Tests (Performance/Physical Data):
The snap40 system was evaluated for its safety and effectiveness based on the following testing:
| Test Name | Test Description | Results |
|---|---|---|
| Electrical Safety | The snap40 System was tested to confirm that itmet the applicable standards for electrical safety(IEC 60601-1) | Passed |
| EMC | The snap40 System was tested to confirm that itmet the applicable standards for electromagneticcompatibility (EMC) (IEC 60601-1-2) | Passed |
| Environment Testing | The snap40 System was tested to confirm thestorage and operating temperature ranges. | Passed |
| Alarm Testing | The snap40 System was tested to confirm that itmet the applicable standards for basic safetyand essential performance for alarm systems(IEC 60601-1-8)Alarm Function Verification Tests for eachparameter function were performed. | Passed |
| Pulse Rate TestingValidation of theaccuracy of pulse ratemonitoring | The snap40 System was tested to confirm theaccuracy of pulse rate monitoring of the systemin accordance with ISO 80601-2-61 and the FDAPulse Oximeters - Premarket NotificationSubmissions: Guidance for Industry and FDAStaff. 2007 | Passed |
| Test Name | Test Description | Results |
| Battery Testing | snap40 Wearable Device Battery Life testingwas performed to determine the battery life ofthe Wearable Device while operating in variousmodes as well as time to fully charge. | Passed |
| Usability Testing | snap40 System was assessed with regards tousability for compliance with IEC 62366 -Medical devices - Application of usabilityengineering to medical devices | Passed |
| Device Ship/TransportTesting | Ensure device, enclosed in the selected shippingcontainer, meets ASTM D4169 specifications. | Passed |
| BiocompatibilityTesting | Testing and analysis of the snap40 System hasdemonstrated compliance to ISO 10993-1:Biological evaluation of medical devices -Guidance | Passed |
| SpO2 TestingValidation of theaccuracy of SpO2monitoring | Ensure the accuracy and communication of theSpO2 functions within the snap40 system as perISO80601-2-61 and the FDA SpO2 guidance;Pulse Oximeters-Premarket NotificationSubmissions Guidance for Industry and Foodand Drug Staff, March 4, 2013 | Passed |
| Respiratory RateTesting | Ensure accuracy of snap40 respiration rate incomparison to respiration rate measured viaend-tidal CO2 in a variety of postures | Passed |
| TemperatureMeasurementAccuracy | snap40 System was tested to confirm theTemperature Measurement Accuracy of thesystem in compliance with ISO 80601-2-56 | Passed |
| Wireless RadioCommunication(Wireless CoexistenceTesting) | snap40 System was tested to ensure device cancommunicate via wireless radio in its intendedenvironment in compliance with FDA RadioFrequency Wireless Technology in MedicalDevices Guidance, issued August 2013 | Passed |
| System Verificationand Validation Testing | The system verification and validation testingwas performed to verify the software andfirmware of the snap40 System. | Passed |
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Software Verification and Validation Testing
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 software for this device was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator or a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
Animal Studies
No animal studies were conducted as part of submission to prove substantial equivalence.
Clinical Studies
Clinical studies were conducted to assess accuracy of both SpO2 and respiration rate.
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.
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.
Safety and Effectiveness/Conclusion:
Based on the information presented in these 510(k) premarket notifications the snap40 system is considered substantially equivalent. The snap40 system is substantially equivalent to the currently marketed predicate devices.
Based on testing and comparison with the predicate devices, the snap40 system indicated no adverse indications or results. It is our determination that the snap40 system performs within its design specifications and is substantially equivalent to the predicate device.
§ 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).