(252 days)
The Multi-Sensing Oximetry System when used with Model 8330AA sensor, is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), and pulse rate. The measurements may be multiple spot-checks to observe change and/or continuous monitoring. This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms.
• For %SpO2 and pulse rate, the multi-sense system is intended for use in professional healthcare facilities, mobile, and EMS settings in adult and pediatric patients (> 66 lbs/30 kg).
• For %COHb, the multi-sense system is intended for use in professional healthcare facilities in adult and pediatric patients (> 66 lbs/30 kg). This device should not be used to screen, diagnose or make treatment decisions related to suspected carbon monoxide poisoning.
Nonin Medical's Multi-Sensing Oximetry system, when used with Model 8330AA reusable finger clip sensor, is based on Nonin's SenSmart™ technology platform, displays (%COHb), pulse oxygen saturation (%SpO2), and pulse rate (PR) data transmitted from one channel of data through a direct connection of a signal processor to the monitor. The model 8330AA sensor provides real time data output of COHb, SpO2, and PR.
Here's a breakdown of the acceptance criteria and study details for the Nonin Medical Inc. Multi-Sensing Oximetry System with Model 8330AA Sensor, extracted from the provided text:
This FDA 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device. Therefore, the "acceptance criteria" discussed are largely in the context of demonstrating performance comparable to the predicate and compliance with relevant medical device standards, rather than an AI-specific set of metrics. The study described is a clinical accuracy study for a medical device (oximeter), not an AI algorithm. As such, many of the typical AI-specific sections (experts establishing ground truth, MRMC study, training set details) will not be applicable.
Acceptance Criteria and Reported Device Performance
The device's performance is primarily evaluated against its ability to accurately measure %SpO2, %COHb, and pulse rate, in comparison to a gold standard (co-oximetry) and in demonstration of equivalence to its predicate device. The Acceptance Criteria are implicitly defined by the stated accuracy specifications and the results demonstrating compliance ("Pass") with various international standards for medical electrical equipment.
Table 1: Key Performance Metrics & Compliance (Based on Text)
| Measurement/Test Category | Acceptance Criteria (Implicit from Predicate/Standard) | Reported Device Performance |
|---|---|---|
| COHb Accuracy | ISO 80601-2-61 specified accuracy (Root-mean-squared, Arms value) over specified ranges for the predicate device. | Adults, Pediatrics:• ±3 Arms (COHb range of 0-15%, SaO₂ 95-100%)• ±3 Arms (COHb range of 0-5%, SaO₂ 95-100%)• ±2 Arms (COHb range of 5-10%, SaO₂ 95-100%)• ±2 Arms (COHb range of 10-15%, SaO₂ 95-100%)(Note: These match the predicate's stated COHb accuracies, except for 0-15% range which is ±2 Arms for predicate) |
| COHb Accuracy with Elevated HHb | ISO 80601-2-61 specified accuracy (Arms value). | Adults, Pediatrics:• ±3 Arms (COHb range of 0-15%, SaO₂ 80-100%)• ±3 Arms (COHb range of 0-5%, SaO₂ 80-100%)• ±2 Arms (COHb range of 5-10%, SaO₂ 80-100%)• ±3 Arms (COHb range of 10-15%, SaO₂ 80-100%)(Matches predicate) |
| SpO2 Accuracy in Presence of COHb | ISO 80601-2-61 specified accuracy (Arms value) over specified ranges for the predicate device. | Adults, Pediatrics:• ±2 Arms (COHb range of 0-3%, SaO₂ 70-100%)• ±3 Arms (COHb range of 0-3%, SaO₂ 70-80%)• ±2 Arms (COHb range of 0-3%, SaO₂ 80-90%)• ±2 Arms (COHb range of 0-3%, SaO₂ 90-100%)(Matches predicate, except for 80-90% range which is ±3 Arms for predicate) |
| Pulse Rate Accuracy (non-motion) | ISO 80601-2-61 specified accuracy. | Adults, Pediatrics: ±3 digits (40-250 bpm) (Matches predicate) |
| Electrical Safety & EMC Test Results | Compliance with various IEC, ISO, ANSI/AAMI standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61). | Pass (for all listed tests in Table 1, page 4-5) |
| Functional Testing | Equivalency with predicate, compliance to recognized standards. | Pass (demonstrates equivalency and compliance) |
Study Details:
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The text states clinical accuracy testing for COHb and SpO2 was conducted on "healthy, male and female, non-smoking, light to dark-skinned subjects that were 18 years of age and older." The exact number of subjects is not specified in the provided text.
- Data Provenance: The studies were "conducted at an independent research laboratory." The country of origin is not explicitly stated, but given the FDA submission, it is typically presumed to be from the US or a country with comparable regulatory and ethical standards. The studies were prospective as they involved induced conditions (COHb, hypoxia) and direct comparison to simultaneously collected arterial blood samples.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not an AI/imaging study requiring expert radiologist consensus. The ground truth for oximetry is established through objective laboratory measurements: specifically, arterial blood samples assessed by co-oximetry. Therefore, the concept of "experts establishing ground truth" in the sense of clinical interpretation (like radiologists for an AI model) is not applicable here. The "experts" would be the trained laboratory personnel performing the co-oximetry and blood sampling, whose qualifications are essential for the validity of the lab measurements.
-
Adjudication Method for the Test Set:
- Not applicable in the context of this device and study type. Ground truth for blood gas measurements is established by a direct analytical method (co-oximetry) on blood samples, not by human interpretation or consensus.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This is a medical device (oximeter) accuracy study comparing device readings to a gold standard (co-oximetry), not an AI diagnostic aid study involving human readers interpreting images.
-
If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The accuracy testing (%COHb, %SpO2, Pulse Rate) described is the direct performance of the device's sensing and processing capabilities (its "algorithm") compared to the scientifically accepted gold standard (co-oximetry). There isn't a "human-in-the-loop" aspect to the device's direct measurement of these physiological parameters.
-
The Type of Ground Truth Used:
- The ground truth used was objective laboratory measurements from arterial blood samples, specifically assessed by co-oximetry. This is a direct, quantitative biochemical measurement.
-
The Sample Size for the Training Set:
- This is not an AI/machine learning model where a distinct "training set" is typically used in the same way. The device's underlying technology (Nonin's SenSmart™ platform) is likely developed and validated through extensive internal research and development, which implicitly involves a large amount of raw data to refine the algorithms for signal processing and parameter estimation. However, the document does not specify a "training set" in the context of an AI model being submitted for pre-market review. The clinical accuracy studies described are specifically for performance validation (test set equivalent).
-
How the Ground Truth for the Training Set Was Established:
- As above, the concept of a "training set" with established ground truth as understood for AI models is not directly applicable to this type of medical device submission. The underlying principles for determining SpO2 and COHb involve spectrophotometry, which relies on known absorption characteristics of different hemoglobin species. The "ground truth" for developing such a device would be derived from fundamental physiological and optical principles, corroborated by empirical data from controlled studies using reference methods like invasive co-oximetry, but it's not described as a separate, labeled "training set" with ground truth in this document.
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May 11, 2018
Nonin Medical Inc. Kim Aves Principal Regulatory Affairs Specialist 13700 1st Avenue North Plymouth, Minnesota 55441
Re: K172625
Trade/Device Name: Multi-Sensing Oximetry System with Model 8330AA Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: April 3, 2018 Received: April 9, 2018
Dear Kim Aves:
We have reviewed vour 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.
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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Tina Kiang
s
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172625
Device Name
Multi-Sensing Oximetry System with Model 8330AA Sensor
Indications for Use (Describe)
The Multi-Sensing Oximetry System when used with Model 8330AA sensor, is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), and pulse rate. The measurements may be multiple spot-checks to observe change and/or continuous monitoring. This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms.
· For %SpO2 and pulse rate, the multi-sense system is intended for use in professional healthcare facilities, mobile, and EMS settings in adult and pediatric patients (> 66 lbs/30 kg).
· For %COHb, the multi-sense system is intended for use in professional healthcare facilities in adult and pediatric patients (> 66 lbs/30 kg). This device should not be used to screen, diagnose or make treatment decisions related to suspected carbon monoxide poisoning.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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5. "510(k) Summary" as required by section 807.92(c)
| Submitter: | Nonin Medical, Inc.13700 1st Ave. NorthPlymouth, MN 55441-5443 |
|---|---|
| Phone: | 763 577 3196 |
| Fax: | 763 553 7807 |
| Contact Person: | Kim E. AvesPrincipal Regulatory Affairs Specialist |
| Date Prepared: | 10 May, 2018 |
| Trade Names: | Multi-Sensing Oximetry System with Model 8330AA Sensor |
| Common Name: | Oximeter |
| Classification Name: | Oximeter |
| Regulation Number: | Class II, 21 CFR 870.2700 (Oximeter) |
| Product Code, Panel: | DQA, Anesthesiology |
| Predicate Device(s): | Model X-100C System with Model 8300AA Sensor (K160231) |
| The Model 8300AA reusable finger clip sensor is intended for noninvasivemeasuring of functional oxygen saturation of arterial hemoglobin(%SpO2), carboxyhemoglobin saturation (%COHb), and pulse rate ofadult and pediatric patients (> 66 lbs / 30 kg). The measurements may bemultiple spot-checks to observe change and/or continuous monitoring. Itis intended for use in Emergency Medical Service (EMS), hospitals,medical facilities, and mobile environments. This device is not meant forsole use in clinical decision making; it must be used in conjunction withadditional methods of assessing clinical signs and symptoms. | |
| Device Description: | Nonin Medical's Multi-Sensing Oximetry system, when used with Model8330AA reusable finger clip sensor, is based on Nonin's SenSmart™technology platform, displays (%COHb), pulse oxygen saturation (%SpO2),and pulse rate (PR) data transmitted from one channel of data through adirect connection of a signal processor to the monitor. The model8330AA sensor provides real time data output of COHb, SpO2, and PR. |
| Intended Use: | Multi-Sensing Oximetry System with 8330AA Sensor |
| The Multi-Sensing Oximetry System when used with Model 8330AAsensor, is intended for noninvasive measuring of functional oxygensaturation of arterial hemoglobin ( $%SpO2$ ), carboxyhemoglobinsaturation ( $%COHb$ ), and pulse rate. The measurements may be multiplespot-checks to observe change and/or continuous monitoring. Thisdevice is not meant for sole use in clinical decision making; it must beused in conjunction with additional methods of assessing clinical signsand symptoms. | |
| • For $%SpO2$ and pulse rate, the multi-sense system is intended for usein professional healthcare facilities, mobile, and EMS settings in adult andpediatric patients (> 66 lbs/30 kg). | |
| • For $%COHb$ , the multi-sense system is intended for use in professionalhealthcare facilities in adult and pediatric patients (> 66 lbs/30 kg). Thisdevice should not be used to screen, diagnose or make treatmentdecisions related to suspected carbon monoxide poisoning. | |
| Testing: | The Nonin Model 8330AA sensor when used with Multi-SensingOximetry System is supported by electrical safety testing,electromagnetic compatibility, device performance, and clinical testingto ensure appropriate functionality and to demonstrate substantialequivalence to the predicate devices. |
| Functional Testing: | The results of the testing demonstrate equivalency with the predicatedevices and compliance to current recognized standards. Table 1summarizes test results for the proposed devices, which met the relevant |
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| Table 1 | ||
|---|---|---|
| Test | Reference | Results |
| Strain Relief Pull Strength | Internal | Pass |
| Operating Temp & Humidity | IEC 60601-1:2005 Sub-Clause 7.9.3.1,EN1789:2007 Sub-clause 6.3.2IEC 60601-1-11:2010 Sub-clause 4.2.2. | Pass |
| Thermal Shock | IEC 60601-1-11:2010 Sub-clause 4.2.3 | Pass |
| Drop & Swing(Free Fall) | IEC 60601-1:2005 Sub-clauses 15.3.4.1 and 15.3.4.2ISO 80601-2-61:2011 Sub-Clause 201.15.3.5.101.2IEC 60601-1-11:2010 Sub-clause 10.1.3IEC 60601-1-12:2014 Sub-clause 10.1.3EN 1789:2007 Sub-clause 6.4.2 | Pass |
| ESU Interference | ANSI/AAMI EC 13:2002/(R) 2007 | Pass |
| Defib Proof | IEC 60601-1:2005 Clause 8.5.5 | Pass |
| Storage & Transport Tempo & Humidity | IEC 60601-1-11:2010 Sub-clause 4.2.1 & 4.2.2IEC 60601-1-12 Sub-clause 4.2.1 & 4.2.2IEC60601-1:2005/Al:2012 Sub-clause 7.9.3.1 | Pass |
| Dielectric Strength, Patient LeakageCurrent, Pre-conditioning | IEC 60601-1:2005 Sub-clause 5.7, 6.3 8.7 & 8.8.3 | Pass |
| Excessive Temp | IEC 60601-1:2005 Sub-clause 11.1.2 | Pass |
| Hyperbaric Pressure | Internal | Pass |
requirements of the applicable recognized standards.
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| Sensor Image SW V&V | FDA 938:2002IEC 62304:2008 | Pass |
|---|---|---|
| CoHb Clinical Study | ISO 14155ISO 80601-2-61 (REF) | Pass |
| SpO2 Clinical Study | ISO 14155ISO 80601-2-61 (REF) | Pass |
| Pulse Rate Testing | ISO 80601-2-61 (REF) | Pass |
Accuracy (clinical) testing:
COHb Accuracy Testing
COHb accuracy testing was conducted at an independent research laboratory on healthy, male and female, non-smoking, light to darkskinned subjects that were 18 years of age and older.
The measured carboxyhemoglobin value (%COHb) of the sensors was compared to simultaneous arterial blood samples as assessed by cooximetry. The accuracy of the sensors in comparison to the co-oximeter samples was measured over the COHb range of 0-15% with 95 - 100% SaO2. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical Equipment-Particular requirements for basic safety and essential performance of pulse oximeter equipment.
COHb Accuracy Testing with Elevated HHb (Deoxyhemoglobin)
COHb accuracy testing was conducted at an independent research laboratory on healthy, male and female, non-smoking, light to darkskinned subjects that were 18 years of age and older.
The measured carboxyhemoglobin value (%COHb) of the sensors was compared to simultaneous arterial blood samples as assessed by cooximetry. The accuracy of the sensors in comparison to the co-oximeter samples was measured over the COHb range of 0-15% with 80 - 100% SaO2. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical Equipment-Particular requirements for basic safety and essential performance of pulse oximeter equipment.
SpO2 Accuracy Testing in Presence of COHb
During no-motion conditions at an independent research laboratory, SpO2 accuracy testing in the presence of COHb was conducted during induced hypoxia studies on healthy, male and female, non-smoking, lightto dark-skinned subjects that were 18 years of age and older.
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| The measured arterial hemoglobin saturation value (SpO₂) of the sensors |
|---|
| was compared to arterial hemoglobin oxygen (SaO₂) value, determined |
| from blood samples with a laboratory co-oximeter. |
The accuracy of the sensors in comparison to the co-oximeter samples was measured over the SpO₂ range of 70-100%, range 0-3% COHb and 80 – 100%, range 0 – 15% COHb. Testing was also conducted over the SpO₂ range of 70-100%.
Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical Equipment— Particular requirements for basic safety and essential performance of pulse oximeter equipment.
Testing conclusion: The proposed Model 8330AA Sensor meets all acceptance criteria. Based on test results, analysis and comparison to the legally marketed predicates, the Model 8330AA when used with Nonin Medical's Multi-Sensing Oximetry System is substantially equivalent to the predicate device for its intended use.
| Summary ofSubstantialEquivalence: | The Model 8330AA Sensor has the following similarities to the predicate devices:• Similar indications for use - different wording, same indications• Similar intended use environments• Identical patient population• Same primary mode of operation• Performs equivalently to the similar specificationsA comparison table is on the following pages. |
|---|---|
| Conclusion: | The proposed system is substantially equivalent to the predicate |
system.
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Page 5 of 8
K172625 Comparison of Proposed Multi-Sensing Oximetry System with Model 8330AA Sensor to Predicate, Model X-100C CO-Met Oximetry System with Model 8300AA
| CATEGORY | Identical/Similar/Different | Model X-100C CO-Met Oximetry SystemMulti-Sensing Oximetry SystemWith Model 8330AA Sensor (Proposed) | Model X-100C SystemWith Model 8300AA Sensor (Predicate) |
|---|---|---|---|
| Indications for Use | |||
| System | Similar – Theindicationsare differentlyworded forclarification ofintended useenvironments.The subjectdevice alsodoes not haveMetHbfunctionality. | The Multi-Sensing Oximetry System with the Model 8330AAreusable finger clip sensor is intended for noninvasive measuringof functional oxygen saturation of arterial hemoglobin (%SpO2),carboxyhemoglobin saturation (%COHb), and pulse rate. Themeasurements may be multiple spot-checks to observe changeand/or continuous monitoring. This device is not meant for soleuse in clinical decision making; it must be used in conjunctionwith additional methods of assessing clinical signs andsymptoms.• For %SpO2 and pulse rate, the 8330AA is intended for use inprofessional healthcare facilities, mobile, and EMS settings inadult and pediatric patients (> 66 lbs/30 kg).• For %COHb, the 8330AA is intended for use in professionalhealthcare facilities settings in adult and pediatric patients (> 66lbs/30 kg). This device should not be used to screen, diagnose ormake treatment decisions related to suspected carbon monoxidepoisoning.Rxonly CAUTION: Federal law (USA) restricts this device to saleby or on the order of a licensed practitioner. | Nonin's X-100C System is indicated for noninvasive spot-checking and/or continuous monitoring ofCarboxyhemoglobin (COHb), Methemoglobin (MetHb),functional oxygen saturation of arterial hemoglobin (SpO2)and pulse rate of adult and pediatric patients using the8300AA sensor.The X-100C System is indicated for use by trained personnelin clinical and non-clinical settings, including EmergencyMedical Service (EMS), hospitals, medical facilities, mobileenvironments, and home healthcare.Rxonly CAUTION: Federal law (USA) restricts this device tosale by or on the order of a licensed practitioner. |
| Oxygen SaturationRange (%SpO2) | Identical | 0-100% | 0-100% |
| CarboxyhemoglobinSaturation Range | Identical | 0-99% (%COHb) | 0-99% (%SpCO) |
| MethemoglobinSaturation Range | Different –Subjectdevices doesnot includeMetHbmeasurement | N/A | 0-99.9% (%SpMet) |
| Pulse Rate DisplayRange | Identical | 18-321 beats per minute (bpm) | 18-321 beats per minute (bpm) |
| K172625Page 6 of 8 | |||
| CATEGORY | Identical/Similar/Different | Multi-Sensing Oximetry SystemWith Model 8330AA Sensor (Proposed) | Model X-100C SystemWith Model 8300AA Sensor (Predicate) |
| Accuracy | |||
| Oxygen Saturation(%SpO₂) non-motion | Identical | Refer to Oxygen Saturation (SpO₂) with elevatedCarboxyhemoglobin and Oxygen Saturation (SpO₂) | Refer to Oxygen Saturation (SpO2) with elevatedCarboxyhemoglobin and Oxygen Saturation (SpO2) withelevated Methemoglobin |
| CarboxyhemoglobinAccuracy | Similar | Adults, Pediatrics• ±3 Arms (COHb range of 0-15%, SaO₂ 95-100%)• ±3 Arms (COHb range of 0-5%, SaO₂ 95-100%)• ±2 Arms (COHb range of 5-10%, SaO₂ 95-100%)• ±2 Arms (COHb range of 10-15%, SaO₂ 95-100%) | Adults, Pediatrics• ±2 Arms (COHb range of 0-15%, SaO₂ 95-100%)• ±3 Arms (COHb range of 0-5%, SaO₂ 95-100%)• ±2 Arms (COHb range of 5-10%, SaO₂ 95-100%)• ±2 Arms (COHb range of 10-15%, SaO₂ 95-100%) |
| CarboxyhemoglobinAccuracy withelevated HHb | Similar | Adults, Pediatrics• ±3 Arms (COHb range of 0-15%, SaO₂ 80-100%)• ±3 Arms (COHb range of 0-5%, SaO₂ 80-100%)• ±2 Arms (COHb range of 5-10%, SaO₂ 80-100%)• ±3 Arms (COHb range of 10-15%, SaO₂ 80-100%) | Adults, Pediatrics• ±3 Arms (COHb range of 0-15%, SaO₂ 80-100%)• ±3 Arms (COHb range of 0-5%, SaO₂ 80-100%)• ±2 Arms (COHb range of 5-10%, SaO₂ 80-100%)• ±3 Arms (COHb range of 10-15%, SaO₂ 80-100%) |
| Oxygen Saturation(SpO₂) with elevatedCarboxyhemoglobin | Similar | Adults, Pediatrics• ±2 Arms (COHb range of 0-3%, SaO₂ 70-100%)• ±3 Arms (COHb range of 0-3%, SaO₂ 70-80%)• ±2 Arms (COHb range of 0-3%, SaO₂ 80-90%)• ±2 Arms (COHb range of 0-3%, SaO₂ 90-100%) | Adults, Pediatrics• ±2 Arms (COHb range of 0-3%, SaO₂ 70-100%)• ±2 Arms (COHb range of 0-3%, SaO₂ 70-80%)• ±3 Arms (COHb range of 0-3%, SaO₂ 80-90%)• ±2 Arms (COHb range of 0-3%, SaO₂ 90-100%) |
| Pulse Rate Accuracy | |||
| Pulse Rate Accuracynon-motion | Identical | Adults, Pediatrics: ±3 digits (40-250 bpm) | Adults, Pediatrics: ±3 digits (40-250 bpm) |
| Electrical | |||
| Standalone• AC PowerRequirements• Powerconsumption• Fuses | Identical | 100-240 VAC, 50-60 Hz | 100-240 VAC, 50-60 Hz |
| Batteries• Type• Capacity• Charging Time | Identical | 7.2 volt Li-ion battery pack, 2.4 Ah when charged6 hours¹2.5 hours | 7.2 volt Li-ion battery pack, 2.4 Ah when charged6 hours¹2.5 hours |
| K172625Page 7 of 8 | |||
| CATEGORY | Identical/Similar/Different | Multi-Sensing Oximetry SystemWith Model 8330AA Sensor (Proposed) | Model X-100C SystemWith Model 8300AA Sensor (Predicate) |
| Environmental | |||
| OperatingTemperature | Identical | 32 °F to 104 °F (0 °C to 40 °C) | 32 °F to 104 °F (0 °C to 40 °C) |
| Storage/TransportTemperature | Identical | -22 °F to 158 °F (-30 °C to 70 °C) | -22 °F to 158 °F (-30 °C to 70 °C) |
| Operating Humidity | Identical | 15% to 93%, noncondensing | 15% to 93%, noncondensing |
| Storage/TransportHumidity | Identical | Up to 93%, noncondensing | Up to 93%, noncondensing |
| Operating Altitude | Identical | 0 to 4,000 meters (0 to 13,124 feet) | 0 to 4,000 meters (0 to 13,124 feet) |
| Physical | |||
| Characteristics | |||
| Dimensions | Identical | Multi-Sensing Monitor• 305 mm W x 180 mm H x 130 mm D (12.0" W x 7.2" H x5.0" D)X-100SPMM• 21.4 mm H x 21.7 mm W x 72.7 mm L (including strainrelief) with 0.75 m cable(0.84" H x 0.85" W x 3.1" L (including strain relief) with2.5 ft cable) | X-100MM• 305 mm W x 180 mm H x 130 mm D (12.0" W x 7.2"H x 5.0" D)X-100SPMM• 21.4 mm H x 21.7 mm W x 72.7 mm L (includingstrain relief) with 0.75 m cable(0.84" H x 0.85" W x 3.1" L (including strain relief)with 2.5 ft cable) |
| Weight | Identical | Multi-Sensing Monitor• Approximately 900 grams (2 pounds)X-100SPMM• 40 grams (1.4 ounces) | X-100MM• Approximately 900 grams (2 pounds)X-100SPMM• 40 grams (1.4 ounces) |
| Trending | Identical | Not specified | Not specified |
| Memory | Identical | Minimum of 280 hours | Minimum of 280 hours |
| SpO₂ Averaging | Identical | 6 seconds | 6 seconds |
| Display/Indicators | Identical | %SpO₂, %COHb, pulse rate, pleth waveform, alarm status, statusmessages, sensor fault, poor signal indicator, signal processorcommunication error, visual alarm indicator, alarm silence,Bluetooth, battery indicator and date and time. | %SpO₂, %COHb, %MetHb, pulse rate, pleth waveform, alarmstatus, status messages, sensor fault, poor signal indicator,signal processor communication error, visual alarm indicator,alarm silence, Bluetooth, battery indicator and date andtime. |
| Display Update Rate | Identical | 2-5 seconds, typically < 2 seconds | 2-5 seconds, typically < 2 seconds |
| Response Time | Identical | <10 second delay | <10 second delay |
| Display color | Identical | Black | Black |
| K172625 | Page 8 of 8 | ||
| CATEGORY | Identical/Similar/Different | Multi-Sensing Oximetry SystemWith Model 8330AA Sensor (Proposed) | Model X-100C SystemWith Model 8300AA Sensor (Predicate) |
| Display Type | Identical | Backlit LCD | Backlit LCD |
| Pixels | Identical | 800 x 600 | 800 x 600 |
| Output Interface | Identical | BluetoothSerial RS-232Nurse Call/Analog Output | BluetoothSerial RS-232Nurse Call/Analog Output |
| Compliance | |||
| EMC Compliance | Identical | IEC 60601-1-2, Class B | EN60601-1-2, Class B |
| EquipmentClassification | Identical | IEC 60601-1 /CAN/CSA-C22.2 No. 601.1 / UL 60601-1, | IEC 60601-1 /CAN/CSA-C22.2 No. 601.1 / UL 60601-1, |
| Type of Protection | Identical | Internally powered (on battery power). Class II with AC adapter. | Internally powered (on battery power). Class II with ACadapter. |
| Degree ofProtection | Identical | Patient Cable: Type BF-Applied Part | Patient Cable: Type BF-Applied Part |
| Mode of Operation | Identical | Continuous | Continuous |
| Enclosure Degree ofIngress Protection | Identical | IP32 | IP32 |
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1 Fully charged battery and screen at default brightness
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§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).