(219 days)
The B40i is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The B40i is intended for use under the direct supervision of a licensed health care practitioner. The B40i is not intended for use during MRI. The B40i can be a stand-alone monitor or interfaced to other devices via a network. The B40i monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.
The proposed monitor B40i is a multi-parameter patient monitor that is developed based on the predicate Monitor B40 (K133576) platform. The proposed monitor B40i provides support for optional modules (E-Entropy module (K061907) and CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195). The proposed monitor B40i is also compatible with CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV) (K123195) but with disabled spirometry function. The proposed monitor B40i supports Airway Gas Option (N-CAiO). The proposed monitor B40i expands the impedance respiration parameter feature to cover the neonatal patient population compared to the predicate Monitor B40 (K133576). This parameter feature patient population extension to cover neonatal patient population uses Patient Data Module as predicate (K071073), which impedance respiration implementation especially concerning the algorithm used is based on the predicate Aware Transport (K042642). The proposed monitor B40i utilizes 12 inch LCD display panel and LED backlight with an integrated keypad and a pre-configuration patient parameter measurement module. The proposed monitor B40i interfaces with the optional E-MiniC (K052582) and Thermal Recorder with an extension rack. As with the predicate Monitor B40, the proposed monitor B40i includes features and subsystems that are optional or configurable. The proposed monitor B40i interfaces to a variety of existing central station systems via a cabled network interface. As with the predicate Monitor B40, the proposed monitor B40i has a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.
The provided text is a 510(k) Summary for the GE Healthcare B40i Patient Monitor. This document describes the device and its claimed substantial equivalence to predicate devices, but it does not contain a study demonstrating that the B40i device meets specific acceptance criteria based on performance data.
The document primarily focuses on:
- Device Description and Intended Use: Outlining what the B40i monitors (ECG, SpO2, NIBP, temperature, airway gases, Entropy) and for which patient populations (adult, pediatric, neonatal) and environments (hospital, intra-hospital transport).
- Comparison to Predicate Devices: A detailed table comparing the B40i to similar legally marketed devices (Monitor B40 and Patient Data Module), highlighting that most features/functions are identical or enhanced (e.g., neonatal impedance respiration expanded).
- Summary of Non-Clinical Tests: Listing the quality assurance measures and voluntary standards (IEC, AAMI, ISO) with which the device complies. This indicates that safety and performance were tested according to recognized standards.
- Statement on Clinical Tests: Explicitly stating that "No additional clinical tests were performed for proposed monitor B40i."
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them from this document. The document relies on comparison to predicate devices and compliance with standards to establish substantial equivalence, rather than presenting a novel performance study with specific acceptance criteria.
However, I can extract the acceptance criteria implied by the comparison to predicate devices and the listed standards, and present the device's reported performance as stated for the predicate devices, since the submission claims substantial equivalence and often refers to the same performance specifications.
Based on the provided K143676 510(k) Summary, here's what can be inferred and extracted, recognizing that this document does not present a new performance study with specific acceptance criteria for the B40i itself, but rather establishes equivalence to predicate devices which presumably met these criteria:
1. Table of Acceptance Criteria (Implied) and Reported Device Performance
The device claims to be substantially equivalent to its predicates, which means its performance should meet or exceed the performance of the predicate if they are identical. The acceptance criteria are typically defined by recognized international standards (e.g., AAMI, IEC, ISO) and the specifications of the predicate devices. The reported device performance for the B40i is stated as identical to the predicate device's performance for most parameters.
| Parameter / Feature | Implied Acceptance Criteria (from Predicate/Standards) | Reported Device Performance (B40i, stated as identical to predicate unless noted) |
|---|---|---|
| ECG - Arrhythmia Algorithm | Fulfils AAMI EC57-1998 standard for EKPRO V12 algorithm. | EKPRO V12 (Fulfils AAMI EC57-1998 standard), Identical |
| SpO2 Accuracy (GE Trusignal, Adult/Pediatric) | Without motion: 70-100% ±2 digits (±3 digits with ear sensor); With motion: 70-100% ±3 digits; Low perfusion: 70-100% ±3 digits. 1-69%: unspecified. | Identical |
| SpO2 Accuracy (GE Trusignal, Neonatal) | Without motion: 100-70% ±3 digits; With motion: 100-70% ±3 digits. 1-69%: unspecified. | Identical |
| Pulse Rate Accuracy (GE Trusignal, No Motion) | 30-250 bpm ±2 bpm (Adult/Pediatric/Neonatal) | Identical |
| Pulse Rate Accuracy (GE Trusignal, With Motion) | 30-250 bpm ±3 bpm (Adult/Pediatric/Neonatal) | Identical |
| Pulse Rate Accuracy (GE Trusignal, Low Perfusion) | ±5 bpm (Adult/Pediatric) | Identical |
| Invasive Blood Pressure Accuracy (Systolic, Diastolic, Mean) | ±5% or ±2mmHg (whichever is greater) | Identical |
| Invasive Blood Pressure Pulse Rate Accuracy | ±5% or ±5 bpm (whichever is greater) | Identical |
| Temperature Accuracy | ±0.1°C (Note: EN 12470-4:2000, A1:2009. Clause 6.3 b) Temperature measurement error with single use probes exceeded maximum permissible error for predicate). | Identical (Note: Same exception for single use probes as predicate). |
| Impedance Respiration Rate Accuracy | ±5% or ±5 bpm (whichever is greater) | Identical |
| NIBP Measurement Accuracy | Clinical evaluation for SuperStat (DINAMAP) K022834 algorithm to ensure compliance per applicable standards (e.g., AAMI SP10). Implicitly, the accuracy for systolic, diastolic, and mean pressures would need to fall within specified ranges for adult/pediatric/neonate populations. | Identical to predicate which uses SuperStat (DINAMAP) K022834 algorithm. Measurement ranges for systolic, diastolic, and MAP are identical to predicate for adult/pediatric/neonate. (E.g., Adult/Pediatric Systolic: 30-290 mmHg; Neonate Systolic: 30-140 mmHg) |
| Environmental & Safety Standards | Compliance with multiple IEC and ISO standards (e.g., IEC 60601-1 for basic safety, IEC 60601-1-2 for EMC, IEC 60601-2-27 for ECG, IEC 60601-2-30 for NIBP, etc.) and AAMI standards (e.g., AAMI / ANSI EC13). | The B40i was designed and tested for compliance to these listed standards. |
Regarding the study that proves the device meets the acceptance criteria:
The document explicitly states: "No additional clinical tests were performed for proposed monitor B40i."
Instead of a new performance study for the B40i, the submission relies on bench testing against voluntary standards and comparison to legally marketed predicate devices (K133576 Monitor B40 and K071073 Patient Data Module) to demonstrate substantial equivalence. The argument is that the B40i's fundamental technology, performance specifications, and intended use are sufficiently similar to (or improved upon but within the same performance envelope as) the predicate devices, which were previously cleared by the FDA.
Therefore, for questions 2-9 requiring details about a study, the direct answer based on this document is that no new clinical performance study with specific acceptance criteria for the B40i was conducted or presented. The device's performance is asserted through comparison and compliance with standards.
Here's an attempt to answer the remaining points based on the understanding that no new performance study specific to the B40i is detailed here:
- Sample size used for the test set and the data provenance: Not applicable, as no new clinical or performance test set for the B40i is described in this document. Performance claims are based on substantial equivalence to predicate devices and compliance testing to standards, but details of those predicate studies' sample sizes or data provenance are not provided here.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for performance testing would typically be established during the development and clearance of the predicate devices or through standard reference methods. This document does not detail such for the B40i.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a patient monitor, not an AI-powered diagnostic imaging device involving human reader interpretation.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document describes the device as a "multi-parameter patient monitor" which inherently has a standalone monitoring function. Performance measurements like SpO2 accuracy, NIBP accuracy, ECG arrhythmia detection (algorithms like EKPRO V12 and SuperStat DINAMAP) are implicitly standalone algorithm performances tested against specified accuracy ranges as part of standard compliance. However, details of such tests (e.g., specific test protocols, datasets) for the B40i are not provided beyond the statement of compliance to standards.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For parameters like SpO2 and NIBP, ground truth would typically be established using invasive reference methods (e.g., co-oximetry, arterial line) for physiological signals. For ECG/arrhythmia, it would involve expert review of annotated ECG waveforms, often from standard databases. The B40i relies on algorithms (EKPRO V12, SuperStat) that were validated against such ground truths during their initial development and predicate device clearances.
- The sample size for the training set: Not applicable to this FDA submission for the B40i. Training sets relate to algorithm development. The document refers to existing algorithms (e.g., EKPRO V12 for ECG, SuperStat DINAMAP for NIBP, Nellcor/Masimo for SpO2) from predicate devices or modules. Details of their training sets are not included here.
- How the ground truth for the training set was established: Not applicable, for the reasons mentioned in point 8.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2015
GE Healthcare Finland Oy % Joel Kent Regulatory Affairs Manager GE Healthcare 86 Pilgrim Road Needham, Massachusetts 02492
Re: K143676
Trade/Device Name: B40i Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm). Regulatory Class: Class II Product Code: MHX, BZO, CBO, CBR, CBS, CCK, CCL, DSK, DOA, DRT, DSB, DXN, FLL, GWQ, NHO, NHO, NHQ, NHP Dated: June 17, 2015 Received: June 23, 2015
Dear Joel Kent,
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. 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.
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
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman -S
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): K143676
Device Name: B40i
Indications for use:
The B40i is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The B40i is intended for use under the direct supervision of a licensed health care practitioner.
The B40i is not intended for use during MRI.
The B40i can be a stand-alone monitor or interfaced to other devices via a network. The B40i monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring
Esophageal/Nasopharvngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myo cardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
In accordance with 21 CFR 807.92(c) the following summary of information is provided:
Owner/Contact/Date (807.92(a)(1)):
| Date: | 19 December 2014 |
|---|---|
| Submitter: | GE Healthcare Finland OyKuortaneenkatu 2,00510 HelsinkiFinlandPhone: +358-40-539 7764 |
| Primary Contact Person: | Joel KentManager, Quality and Regulatory AffairsGE Medical Systems Information Technologies, Inc.Telephone: +1 617 851 0943Fax at +1 781 433-1344E-mail: joel.kent@med.ge.com |
| Secondary Contact Person: | Anssi RuokonenRegulatory Affairs LeaderGE Healthcare Finland OyKuortaneenkatu 2,00510 HelsinkiFinlandPhone: +358-10-394 3686E-mail: anssi.ruokonen@med.ge.com |
Device names (807.92(a)(2)):
Trade Name: B40i Common/Usual Name: Multi-parameter patient monitor
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| Classification Names: | 21 CFR 870.1025 Arrhythmia detector and alarm (includingST-segment measurement and alarm) |
|---|---|
| Classification ProductCode: | MHX |
| Subsequent Product Codes | BZQ CBQ CBR CBS CCKCCL DQA DRT DSB DSK DXNFLL GWQ NHO NHP NHQ |
| Predicate Device(s)(807.92(a)(3): | K133576 Monitor B40K071073 Patient Data Module |
| Device Description(807.92(a)(4)): | The proposed monitor B40i is a multi-parameter patient monitorthat is developed based on the predicate Monitor B40 (K133576)platform. The proposed monitor B40i provides support foroptional modules (E-Entropy module (K061907) andCARESCAPE Respiratory modules (E-sCO and E-sCAiO)(K123195). The proposed monitor B40i is also compatible withCARESCAPE Respiratory modules (E-sCOV and E-sCAiOV)(K123195) but with disabled spirometry function. The proposedmonitor B40i supports Airway Gas Option (N-CAiO). Theproposed monitor B40i expands the impedance respirationparameter feature to cover the neonatal patient populationcompared to the predicate Monitor B40 (K133576). Thisparameter feature patient population extension to cover neonatalpatient population uses Patient Data Module as predicate(K071073), which impedance respiration implementationespecially concerning the algorithm used is based on the predicateAware Transport (K042642). The proposed monitor B40i utilizes12 inch LCD display panel and LED backlight with an integratedkeypad and a pre-configuration patient parameter measurementmodule. The proposed monitor B40i interfaces with the optionalE-MiniC (K052582) and Thermal Recorder with an extensionrack. As with the predicate Monitor B40, the proposed monitorB40i includes features and subsystems that are optional orconfigurable. The proposed monitor B40i interfaces to a varietyof existing central station systems via a cabled network interface.As with the predicate Monitor B40, the proposed monitor B40ihas a mounting plate on the bottom of the monitor. The monitorcan be mounted in a variety of ways (e.g. shelf, countertop, table,wall, pole, or head/foot board) using existing mountingaccessories. |
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| Intended Use (807.92(a)(5)): | The B40i is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. |
|---|---|
| The B40i is intended for use under the direct supervision of a licensed health care practitioner. | |
| The B40i is not intended for use during MRI. | |
| The B40i can be a stand-alone monitor or interfaced to other devices via a network. | |
| The B40i monitors and displays: | |
| ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring. | |
| Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy. | |
| Technology (807.92(a)(6)): | The proposed monitor B40i is a modified system based on the predicate Monitor B40 (K133576). In addition to the labeling differences with the predicate Monitor B40 (K133576), the proposed monitor B40i also expands the impedance respiration parameter feature to cover the neonatal patient population compared to the predicate Monitor B40 (K133576). Patient Data Module (K071073) is the predicate, which impedance respiration implementation especially concerning the algorithm used is based on the predicate Aware Transport (K042642). The fundamental technology of the proposed monitor B40i is the same as the predicate devices. The proposed monitor B40i is as safe and effective as the predicate devices as summarized in the comparison table below. |
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| Feature/Function | Current Device/Systemthe legally marketedpredicate Monitor B40V2.1(K133576) | Proposed Device/SystemNameproposed Monitor B40i | ChangeExplanation/Notes |
|---|---|---|---|
| Intended Use description to include: | |||
| Claims/ features | The Monitor B40 is a portablemulti-parameter unit to be usedfor monitoring and recording of,and to generate alarms for,multiple physiologicalparameters of adult, pediatric,and neonatal patients in ahospital environment and duringintra-hospital transport.The Monitor B40 is intended foruse under the direct supervisionof a licensed health carepractitioner.The Monitor B40 is not intendedfor use during MRI.The Monitor B40 can be astand-alone monitor orinterfaced to other devices via anetwork.The Monitor B40 monitors anddisplays: ECG (including STsegment, arrhythmia detection),invasive blood pressure,heart/pulse rate, oscillometricnon-invasive blood pressure(systolic, diastolic and meanarterial pressure), functionaloxygen saturation (SpO2) andpulse rate via continuousmonitoring (including monitoringduring conditions of clinicalpatient motion or low perfusion),temperature with a reusable ordisposable electronicthermometer for continualmonitoring.Esophageal/Nasopharyngeal/Tympanic/Rectal/B ladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature,impedance respiration,respiration rate, airway gases(C02, 02, N20, anestheticagents, anesthetic agentidentification and respiratoryrate) and Entropy. | The B40i is a portable multi-parameter unit to be used formonitoring and recording of, andto generate alarms for, multiplephysiological parameters ofadult, pediatric, and neonatalpatients in a hospitalenvironment and during intra-hospital transport.The B40i is intended for useunder the direct supervision of alicensed health care practitioner.The B40i is not intended for useduring MRI.The B40i can be a stand-alonemonitor or interfaced to otherdevices via a network.The B40i monitors and displays:ECG (including ST segment,arrhythmia detection), invasiveblood pressure, heart/pulse rate,oscillometric non-invasive bloodpressure (systolic, diastolic andmean arterial pressure),functional oxygen saturation(SpO2) and pulse rate viacontinuous monitoring (includingmonitoring during conditions ofclinical patient motion or lowperfusion), temperature with areusable or disposableelectronic thermometer forcontinual monitoringEsophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature,impedance respiration,respiration rate, airway gases(CO2, O2, N2O, anestheticagents, anesthetic agentidentification and respiratoryrate) and Entropy. | Identical (only thename of the monitor isdifferent) |
| PatientPopulation | Adult, pediatric and neonate | Adult, pediatric and neonate | Identical |
| Environment ofUse | hospital environment and duringintra-hospital transport | hospital environment and duringintra-hospital transport | Identical |
| Hardware: | |||
| Software Media | Embedded | Embedded | Identical |
| Battery Type | Lithium-Ion | Lithium-Ion | Identical |
| Battery run in time | >=2:15typical monitor configuration:- ECG, NIBP cycle time 5min,SpO2, 2x INVP, 2x Tempand continuous CO2 use- Ambient temperature 25 °C- Display brightness 70% | >=2:15typical monitor configuration:- ECG, NIBP cycle time 5min,SpO2, 2x INVP, 2x Temp andcontinuous CO2 use- Ambient temperature 25 °C- Display brightness 70% | Identical |
| Operating Systems Infrastructure Software: | |||
| Operating System | Linux | Linux | Identical |
| Networking | |||
| NetworkingInterface | LAN | LAN | Identical |
| User Interface | |||
| Front Key Pad | 18 hard keys with Trim Knob,and 1 power On/Standby | 18 hard keys with Trim Knob,and 1 power On/Standby | Identical |
| Display: | |||
| Size | 12.1-inch | 12.1-inch | Identical |
| Types | TFT LCD | TFT LCD | Identical |
| Number ofWaveform traces | Up to 6 | Up to 6 | Identical |
| Alarms: | |||
| Classification | Three levels - Red, Yellow,Cyan | Three levels - Red, Yellow,Cyan | Identical |
| Notification | Audible and visual | Audible and visual | Identical |
| Trending: | |||
| Types of trenddata | Graphic, numeric data | Graphic, numeric data | Identical |
| Storage | Up to 72 hours | Up to 72 hours | Identical |
| Snapshots: | |||
| Snapshots | A snapshot is a frozen frame ofpreconfigured waveforms ortrendssaved in the monitor memory oftime. Snapshots can containwaveform clips and graphictrends. | A snapshot is a frozen frame ofpreconfigured waveforms ortrendssaved in the monitor memory oftime. Snapshots can containwaveform clips and graphictrends. | Identical |
| Printing: | |||
| Printers Supported | Local Thermal Array Recorder,Network laser printer,Strip chart recorder at theCentral Station. | Local Thermal Array Recorder,Network laser printer,Strip chart recorder at theCentral Station. | Identical |
| Measurementtechnique | Body surface electrical potential | Body surface electrical potential | Identical |
| Leads Available | 3-leads, 5-leads | 3-leads, 5-leads | Identical |
| Severe arrhythmiaanalysis | AsystoleBradycardiaTachycardiaVentricular fibrillationVentricular tachycardia | AsystoleBradycardiaTachycardiaVentricular fibrillationVentricular tachycardia | Identical |
| Arrhythmiaalgorithm | EKPRO V12Fulfils AAMI EC57-1998standard | EKPRO V12Fulfils AAMI EC57-1998standard | Identical |
| Monitored Parameter: SpO2 | |||
| MeasurementTechnique | GE SpO2Nellcor OxiMax SpO2(Nell1-S OEM board)Masimo SET Radical SpO2(MS-2011 OEM board) | GE SpO2Nellcor OxiMax SpO2(Nell1-S OEM board)Masimo SET Radical SpO2(MS-2011 OEM board) | Identical |
| MeasurementRange | GE: 1 to 100%Masimo: 1 to 100%Nellcor: 1 to 100% | GE:1 to 100%Masimo: 1 to 100%Nellcor: 1 to 100% | Identical |
| Accuracy | GE Trusingal SpO2:Adult/Pediatric:Without motion: 70 to 100% $\pm$ 2digits ( $\pm$ 3 digits with ear sensor)With motion: 70 to 100% $\pm$ 3digitsLow perfusion : 70 to 100% $\pm$ 3digits1 to 69%: unspecifiedNeonatal:without motion: 100 to 70% $\pm$ 3digitswith motion: 100 to 70% $\pm$ 3digits1 to 69%: unspecifiedNellcor:Adult: 70 to 100% $\pm$ 2 digitsNeonate: 70 to 100% $\pm$ 3 digitsLow Perfusion: 70 to 100% $\pm$ 2digitsMasimo:Without Motion - Adult/Pediatric:70 to 100% $\pm$ 2 digitsWithout Motion - Neonate: 70 to100% $\pm$ 3 digitsWith Motion -Adult/Pediatric/Neonate: 70 to100% $\pm$ 3 digitsLow Perfusion 70 to 100% $\pm$ 2digits 0 to 69% unspecified | GE Trusingal SpO2:Adult/Pediatric:Without motion: 70 to 100% $\pm$ 2digits ( $\pm$ 3 digits with ear sensor)With motion: 70 to 100% $\pm$ 3digitsLow perfusion : 70 to 100% $\pm$ 3digits1 to 69%: unspecifiedNeonatal:without motion: 100 to 70% $\pm$ 3digitswith motion: 100 to 70% $\pm$ 3digits1 to 69%: unspecifiedNellcor:Adult: 70 to 100% $\pm$ 2 digitsNeonate: 70 to 100% $\pm$ 3 digitsLow Perfusion: 70 to 100% $\pm$ 2digitsMasimo:Without Motion - Adult/Pediatric:70 to 100% $\pm$ 2 digitsWithout Motion - Neonate: 70 to100% $\pm$ 3 digitsWith Motion -Adult/Pediatric/Neonate: 70 to100% $\pm$ 3 digitsLow Perfusion 70 to 100% $\pm$ 2digits 0 to 69% unspecified | Identical |
| Pulse Rate | GE Trusingal SpO2 : | GE Trusingal SpO2 : | Identical |
| Detection | 30- 250 bpm | 30- 250 bpm | |
| Without motion: 30- 250 bpm ±2 bpm (Adult/Pediatric/Neonatal) | Without motion: 30- 250 bpm ± 2bpm (Adult/Pediatric/Neonatal) | ||
| With motion: 30- 250 bpm ± 3bpm | With motion: 30- 250 bpm ± 3bpm | ||
| (Adult/Pediatric/Neonatal) | (Adult/Pediatric/Neonatal) | ||
| Low Perfusion: ±5 bpm(Adult/Pediatric) | Low Perfusion: ±5 bpm(Adult/Pediatric) | ||
| Nellcor: | Nellcor: | ||
| 20 to 250 beats/min ±3 digits | 20 to 250 beats/min ±3 digits | ||
| Low Perfusion 20 to 250beats/min ±3 digits | Low Perfusion 20 to 250beats/min ±3 digits | ||
| Masimo | Masimo | ||
| Without Motion | Without Motion | ||
| 25 to 240 beats/min ±3 digits, | 25 to 240 beats/min ±3 digits, | ||
| With Motion | With Motion | ||
| normal physiologic range 25 to240 beats/min ±5 digits | normal physiologic range 25 to240 beats/min ±5 digits | ||
| Monitored Parameter: Invasive Blood Pressure | |||
| Measurementtechnique | Bridge type defibrillator prooftransducers | Bridge type defibrillator prooftransducers | Identical |
| Measurementrange | -40 ... 320mmHg | -40 ... 320mmHg | Identical |
| Accuracy ofsystolic, diastolic,and meanpressures | ±5% or ±2mmHg (whichever isgreater) | ±5% or ±2mmHg (whichever isgreater) | Identical |
| Pulse rate range | 30 ... 250 bpm | 30 ... 250 bpm | Identical |
| Pulse rateaccuracy | ± 5% or ± 5 bpm, whichever isgreater | ± 5% or ± 5 bpm, whichever isgreater | Identical |
| Monitored Parameter: Temperature | |||
| Temperaturerange | 10 ... 45°C | 10 ... 45°C | Identical |
| Accuracy | ± 0.1°C | ± 0.1°C | Identical |
| Measurement | Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/skin/Airway/Room/Myocardial/Core/Surface | Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/skin/Airway/Room/Myocardial/Core/Surface. | Identical |
| Measurementtechnique | Thermally sensitive resistor | Thermally sensitive resistor | Identical |
| Monitored Parameter: CO2 | |||
| Measurement | S/5TM Single-width Airway | S/5TM Single-width Airway | Identical |
| Technique | Module, E-miniC (K052582). | Module, E-miniC (K052582). | |
| Measurement | Side stream, FiCO2 and EtCO2values, respiration rate (RR) | Side stream, FiCO2 and EtCO2values, respiration rate (RR) | Identical |
| Monitored Parameter: Full Gas | |||
| Measurementtechnique | Non-dispersive infraredabsorption, paramagneticdifferential oxygenmeasurement | Non-dispersive infraredabsorption, paramagneticdifferential oxygen measurement | Identical |
| MeasurementModule Support | CARESCAPE Respirationmodule(K123195) ( E-sCO,E-sCAIO, and compatible with E-sCOV and E-sCAIOV butdisabled spirometry function) | CARESCAPE Respirationmodule(K123195) ( E-sCO,E-sCAIO, and compatible with E-sCOV and E-sCAIOV butdisabled spirometry function) | Identical |
| Airway Gas Option (N-CAIO) | Measurement parameter:C - EtCO2, FiCO2 , and N2OAi - Anesthetic agents w/identification and agent mixturedetection0 - FiO2, EtO2 and FiO2/EtO2difference | Measurement parameter:C - EtCO2, FiCO2 , and N2OAi - Anesthetic agents w/identification and agent mixturedetectionO - FiO2, EtO2 and FiO2/EtO2difference | Identical |
| Monitored Parameter: Entropy | |||
| Measurement | RE value, SE value, BSR value | RE value, SE value, BSR value | Identical |
| Measurementtechnique | Entropy monitoring is basedon acquisition and processingof raw EEG and FEMG signalsusing the Entropy algorithm. | Entropy monitoring is basedon acquisition and processingof raw EEG and FEMG signalsusing the Entropy algorithm. | Identical |
| Monitored Parameter: Non-Invasive Blood Pressure | |||
| MeasurementTechnique | Oscillometric with step deflation | Oscillometric with step deflation | Identical |
| AlgorithmSelection | SuperStat (DINAMAP) K022834 | SuperStat (DINAMAP) K022834 | Identical |
| DisplayedParameters | Systolic, diastolic, and meanpressures, auto cycle time andthe time since the lastdetermination(when manualmode) , and cuff/hose type,inflation cuff pressure(Whenmeasurement start) | Systolic, diastolic, and meanpressures, auto cycle time andthe time since the lastdetermination(when manualmode) , and cuff/hose type,inflation cuff pressure(Whenmeasurement start) | Identical |
| MeasurementRanges | Systolic:30 to 290 mmHg(adult/pediatric)30 to 140 mmHg (neonate)Map:20 to 260 mmHg(adult/pediatric)20 to 125 mmHg (neonate)Diastolic:10 to 220 mmHg(adult/pediatric)10 to 110 mmHg (neonate) | Systolic:30 to 290 mmHg (adult/pediatric)30 to 140 mmHg (neonate)Map:20 to 260 mmHg (adult/pediatric)20 to 125 mmHg (neonate)Diastolic:10 to 220 mmHg (adult/pediatric)10 to 110 mmHg (neonate) | Identical |
| Feature/Function | Current Device/Systemthe legally marketedpredicate Monitor B40V2.1(K133576) | Proposed Device/SystemNameproposed Monitor B40i | ChangeExplanation/Notes |
| Monitored Parameter: Impedance Respiration on adult and pediatric patient populations | |||
| MeasurementTechnique | Impedance variation detection.Excitation frequency 31.25 kHz | Impedance variation detection.Excitation frequency 31.25 kHz | Identical |
| DisplayedParameters | RESP rate | RESP rate | Identical |
| Measurementrange | 4 - 120 breaths/minute | 4-120 breaths/minute | Identical |
| Measurement | +-5% or +-5 bpm, whichever isgreater | +-5% or +-5 bpm, whichever isgreater | Identical |
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Summary of Non-Clinical Tests:
Determination of Substantial Equivalence (807.92(b)(1):
The CARESCAPE Monitor B40i and its applications comply with voluntary standards as detailed below. The following quality assurance measures were applied in the development of the system:
- Risk Analysis
- Requirements Reviews
- · Design Reviews
- · Testing on unit level (Module verification)
- · Integration testing (System verification)
- · Final acceptance testing (Validation)
- · Performance testing (Verification)
- · Safety testing (Verification)
The CARESCAPE Monitor B40i was designed and tested for compliance to the following standards:
-
- IEC 60601-1: 1988+A1: 1991+A2: 1995 Medical electrical equipment - Part 1: General requirements for safety
-
- IEC60601-1-2: 2007 Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
-
- IEC60601-1-4: 2000 Medical electrical equipment Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
-
- IEC60601-1-8: 2006 Medical electrical equipment Part 1-8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
-
- IEC 60601-2-27:2005- Medical Electrical Equipment-Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment, except for the clause 50.102.8 a). Frequency response
-
- IEC 60601-2-30:1999, Medical electrical equipment Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
-
- IEC 60601-2-34:2000, Medical electrical equipment Part 2-34: Particular requirements for the safety, including
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essential performance, of invasive blood pressure monitoring equipment
-
- IEC 60601-2-49:2001, Medical electrical equipment Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
-
- AAMI / ANSI EC13:2002/(R)2007 Cardiac devices, heart rate meters, and alarms
-
- AAMI SP10:2002+A1:2003+R:2008 +A2:2006 +R:2008 Manual, electronic, or automated sphygmomanometers
-
- EN 12470-4:2000, A1:2009, Clinical Thermometers Part 4: Performance of Electrical Thermometers for Continuous Measurement. Except for the clause 6.3 b) Temperature measurement error with single use probes exceeded maximum permissible error.
-
- ISO 21647:2004 + C1:2005. Medical electrical equipment -Particular requirements for the basic safety and essential performance of respiratory gas monitors
-
- ISO9919:2005, Medical electrical equipment Particular requirements for the safety and essential performance of pulse oximeter equipment for medical use
-
- IEC 62304:2006, Medical devices Medical device software - Software life cycle processes
-
- IEC 60601-2-26:2002. Medical electrical equipment Part 2-26: Particular requirements for the safety of electroencephalographs.
-
- IEC 62366:2007. Medical devices Application of usability engineering to medical devices
| Clinical (807.92(b)(2)): | Summary of Clinical Tests: |
|---|---|
| No additional clinical tests were performed for proposed monitorB40i | |
| Conclusion (807.92(b)(3)): GE Healthcare considers the proposed monitor B40i to be as safe |
- C as effective, and performance is substantially equivalent to the predicate devices.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.