(210 days)
The Nonin® Model 9591Onyx® 3 Finger Pulse Oximeter is a small, lightweight, portable and reusable spot-check device indicated for use in measuring and displaying function of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. The Respiration Rate parameter provides a non-invasive measurement of respiration rate, in breaths per minute.
For %SpO2, and pulse rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, skilled nursing facilities, and home healthcare services. It is intended for adult and pediatric patients who are well or poorly perfused, with digits that are between 0.3 – 1.0 inch (0.8 –2.5 cm) thick, under non-motion conditions.
For Respiration rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, and home healthcare services. It is intended for adult who are well perfused, with digits that are between 0.3 – 1.0 inch (0.8 - 2.5 cm) thick, under non-motions. It is not intended for use in high-acuity environments, such as ICU or operating rooms where continuous monitoring is expected.
The Model 9591 Finger Pulse Oximeter is a small, lightweight, portable, reusable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. The SpO2, pulse rate, and respiration rate are displayed on the LCD display contained within the device. A color LCD provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate of poor pulse quality that may affect the readings. The Respiration Rate parameter provides a non-invasive measurement of respiration rate, in breaths per minute. It is intended for spot-checking of adult and pediatric patients who are well or poorly perfused with digits that are between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick.
This document describes the premarket notification (510(k)) for the Nonin Onyx 3, Model 9591 Finger Pulse Oximeter. The device measures functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate, and also provides a non-invasive measurement of respiration rate.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Nonin Onyx 3, Model 9591 are primarily based on demonstrating substantial equivalence to predicate devices and compliance with recognized standards such as ISO 80601-2-61:2011 for pulse oximeters. The performance values are compared against those of the predicate devices.
| Metric / Parameter | Acceptance Criteria (based on predicate/standards) | Reported Device Performance (Nonin Onyx 3, Model 9591) |
|---|---|---|
| SpO2 Accuracy (Adult/Pediatric) | ± 2 digits (± 1 ARMS) from predicate (K131021) | ± 2 digits (± 1 ARMS) |
| Low Perfusion SpO2 | ± 2 digits (± 1 ARMS) from predicate (K131021) | ± 2 digits (± 1 ARMS) |
| Pulse Rate Accuracy (Adult/Pediatric) | 20 to 250 BPM ± 3 digits from predicate (K131021) | 20 to 250 BPM ± 3 digits |
| Low Perfusion Pulse Rate | 40 to 240 BPM ± 3 digits (from predicate) | 40 to 240 BPM ± 3 digits |
| Respiration Rate Accuracy | Demonstrated through comparative study (against Capnography) | Accuracy was calculated using mean error and RMSE. Specific quantitative acceptance criteria or results are not explicitly stated in this document beyond "Pass" for "Performance" to ISO 80601-2-61. The comparison is made against the Nellcor reference device which has a range of 4 to 40 breaths/minute, and the proposed device has a range of 3 to 44 breaths/minute. |
| Electrical Safety | IEC 60601-1 | Pass |
| EMC (Immunity & Emissions) | IEC 60601-1-2 | Pass |
| Ingress Protection | ISO 80601-2-61 (IP32 for previous Nonin predicate) | IP32 (more protection than Nellcor IPX1) |
| Temperature and Humidity | IEC 60601-1 | Pass |
| Atmospheric Pressure (Altitude) | IEC 60601-1 | Pass |
| Mechanical Durability | IEC 60601-1, ISO 80601-2-61 | Pass |
| Biocompatibility | ISO 10993-1 | Pass |
2. Sample Sizes Used for the Test Set and Data Provenance
- Respiration Rate Accuracy Verification Clinical (QATR10912):
- Sample Size: A total of 30 subjects were enrolled.
- Data Provenance: Single-center, randomized study. The country of origin is not specified, but given the FDA submission, it is likely the US. The study is described as "clinical," implying a prospective data collection approach for this specific test.
- SpO2 Accuracy Testing:
- Sample Size: 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 beyond "all subjects" when referring to ARMS calculation.
- Data Provenance: Conducted at an independent research laboratory. The country of origin is not specified, but likely the US. This also implies a prospective clinical study where arterial blood samples were taken.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test sets.
- Respiration Rate: Ground truth was established by Capnography based respiratory rate. This is an objective measurement, not directly relying on human expert interpretation for ground truth.
- SpO2 Accuracy: Ground truth was established by co-oximetry analysis of simultaneous arterial blood samples. This is a gold standard, objective measurement and does not involve human expert consensus for ground truth.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth for both Respiration Rate and SpO2 accuracy was established through objective, clinical gold standard measurements (Capnography and co-oximetry), rather than subjective expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The performance assessment focused on the device's accuracy against recognized clinical standards/predicate devices, not on how human readers' performance might improve with or without AI assistance from this device. This device is a direct measurement device (pulse oximeter), not an AI-assisted diagnostic tool for image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies described (Respiration Rate Accuracy, SpO2 Accuracy) evaluate the standalone performance of the device itself (the Model 9591 Pulse Oximeter) against established ground truth methods. It measures and displays the parameters, and its accuracy is assessed in isolation from human interpretation.
7. The Type of Ground Truth Used
- Respiration Rate: Capnography based respiratory rate. (Objective, physiological measurement)
- SpO2 Accuracy: Co-oximetry of simultaneous arterial blood samples. (Objective, laboratory gold standard)
8. The Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. For a device like a pulse oximeter that relies on physiological principles and signal processing, a distinct "training set" in the context of machine learning (where algorithms learn from large datasets) is typically not applicable in the same way as it would be for an AI-based image analysis tool. The device's algorithms are likely developed and validated through engineering design, signal processing, and testing against known physiological responses, rather than deep learning from a "training set" of patient data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as a distinct "training set" in the context of machine learning is not mentioned or implied for this device's development as described. The performance validation relies on the clinical studies mentioned above, comparing the device's output to objective physiological measurements.
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Nonin Medical, Inc. Walter Holbein Manager, RA/CA 13700 1st Avenue North Plymouth, Minnesota 55441
Re: K191403
Trade/Device Name: Nonin Onyx 3, Model 9591 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: November 20, 2019 Received: November 25, 2019
Dear Walter Holbein:
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.
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191403
Device Name Nonin Onyx 3, Model 9591
Indications for Use (Describe)
The Nonin® Model 9591Onyx® 3 Finger Pulse Oximeter is a small, lightweight, portable and reusable spot-check device indicated for use in measuring and displaying function of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. The Respiration Rate parameter provides a non-invasive measurement of respiration rate, in breaths per minute.
For %SpO2, and pulse rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, skilled nursing facilities, and home healthcare services. It is intended for adult and pediatric patients who are well or poorly perfused, with digits that are between 0.3 – 1.0 inch (0.8 –2.5 cm) thick, under non-motion conditions.
For Respiration rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, and home healthcare services. It is intended for adult who are well perfused, with digits that are between 0.3 – 1.0 inch (0.8 - 2.5 cm) thick, under non-motions. It is not intended for use in high-acuity environments, such as ICU or operating rooms where continuous monitoring is expected.
| 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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1. 510(k) Summary: K191403
| Submitter: | Nonin Medical, Inc.13700 1st Ave. NorthPlymouth, MN 55441-5443 |
|---|---|
| Contact Person: | Walter HolbeinRA/CA Manager |
| Phone: | 763-577-5504 |
| Fax: | 763-553-7807 |
| Date Prepared: | 20 May, 2019 |
| Trade Name: | Onyx® 3 Model 9591 Finger Pulse Oximeter |
| Common Name: | Finger Pulse Oximeter |
| Classification Name: | Oximeter |
| Regulation Number: | Class II, 21 CFR 870.2700 |
| Product Code, Panel: | DQA, Anesthesiology |
| Predicate Device(s): | Nonin Model 3230 Bluetooth® Smart Pulse oximeter cleared by theFDA under K131021 on 9/11/2013, and |
| Reference Device: | Nellcor™ Bedside Respiratory Patient Monitoring System(PM1000N) cleared by the FDA under K141518 on 3/5/2015. |
Device Description
The Model 9591 Finger Pulse Oximeter is a small, lightweight, portable, reusable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. The SpO2, pulse rate, and respiration rate are displayed on the LCD display contained within the device. A color LCD provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate of poor pulse quality that may affect the readings. The Respiration Rate parameter provides a non-invasive measurement of respiration rate, in breaths per minute. It is intended for spot-checking of adult and pediatric patients who are well or poorly perfused with digits that are between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick.
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| Intended Use: | Model 9591 |
|---|---|
| The Nonin® Model 9591Onyx® 3 Finger Pulse Oximeter is a small,lightweight, portable and reusable spot-check device indicated foruse in measuring and displaying functional oxygen saturation of | |
| arterial hemoglobin (%SpO2) and pulse rate of patients who are wellor poorly perfused. The Respiration Rate parameter provides a non-invasive measurement of respiration rate, in breaths per minute. | |
| For %SpO2, and pulse rate, the 9591 is intended for use in hospitals,clinics, long-term care facilities, skilled nursing facilities, and homehealthcare services. It is intended for adult and pediatric patients | |
| who are well or poorly perfused, with digits that are between 0.3 -1.0 inch (0.8 - 2.5 cm) thick, under non-motion conditions. | |
| For Respiration rate, the 9591 is intended for use in hospitals, | |
| clinics, long-term care facilities, skilled nursing facilities, and home | |
| healthcare services. It is intended for adult who are well perfused, | |
| with digits that are between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick, | |
| under non-motion conditions. It is not intended for use in high-acuity environments, such as ICU or operating rooms wherecontinuous monitoring is expected. | |
| Testing: | Nonin's Model 9591 Finger Pulse Oximeter has successfullyundergone both laboratory and clinical hypoxia accuracy testing inorder to ensure that it has appropriate performance, functionalfeatures to fully comply with ISO 80601-2-61:2011 and issubstantially equivalent to the predicate devices. |
| Functional andSafety Testing: | The results of the testing demonstrate equivalency with the predicatedevices and compliance to recognized standards. Table 1summarizes test results for the proposed devices, which met therelevant requirements of the applicable recognized standards. |
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| Test | Reference | Result |
|---|---|---|
| Electrical Safety | IEC 60601-1 | Pass |
| Temperature and Humidity | IEC 60601-1 | Pass |
| Atmospheric Pressure (Altitude) | IEC 60601-1 | Pass |
| Electromagnetic Immunity andEmissions | IEC 60601-1-2 | Pass |
| Performance | ISO 80601-2-61IEC 60601-1IEC 60601-1-6IEC 60601-1-11IEC 62304ISO 14155 | Pass |
| Ingress Protection | ISO 80601-2-61 | Pass |
| Diaphoretic related ingress | Internal performancecharacterization | Pass |
| Mechanical Durability | IEC 60601-1ISO 80601-2-61 | Pass |
| Biocompatibility | ISO 10993-1 | Pass |
Table 1
Clinical Testing: Respiratory Rate Accuracy Verification Clinical (QATR10912)
Respiratory rate accuracy testing was a comparative single-center, randomized study. The respiratory rate output of the Onyx 3 fingertip oximeter was compared to Capnography based respiratory rate. This was a minimal risk study using a non-significant risk device. A total of 30 subjects were enrolled in the study. Up to 3 subjects were enrolled per day. Subject participation lasted up to 2 hours. Demographic and anthropometric data (date of birth, gender, ethnicity, race, height, weight, skin tone and finger dimensions) were collected for all subjects. Accuracy data was calculated using both mean error and root mean square error (RMSE).
SpO2 Accuracy Testing
SpO2 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 oxygen saturation value (SpO2) of the device was compared to simultaneous arterial blood samples as assessed by co-oximetry. The accuracy of the device in comparison to the co-oximeter samples was measured over the SaO2 range of 70-100% in motion and non-motion conditions. Accuracy data was calculated using the root-mean-squared (ARMS value) for all subjects.
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Summary of Substantial Equivalence:
The Model 9591 Onyx® 3 Finger Pulse Oximeter has the following similarities to its respective predicate Nonin device:
- Similar SpO2 and Pulse Rate ranges ●
- . Identical SpO2 and Low Perfusion SpO2 accuracy specifications
- Identical critical optics technology
- Perform equivalently to the similar specifications
The following lists the differences and the rationale for those differences between the proposed device and the predicate devices:
- Indications for Use: the proposed and predicate Nonin devices have identical Indications for Use and identical patient population, with the exception of the respiratory rate feature in the proposed device. The Nellcor device is a tabletop device with the additions of an alarm feature and expanded patient population, which Nonin is not seeking claims for.
- Respiratory Rate: the Nonin predicate device does not have the respiratory rate feature. The Nonin proposed device and the Nellcor predicate have similar respiratory rate ranges.
- SpO2 accuracy with Motion: Nonin is not seeking motion claims similar to the predicate Nellcor device.
- Pulse accuracy with Motion: Nonin is not seeking motion claims similar to the predicate Nellcor device.
- Enclosure Ingress Protection: the proposed and predicate ● Nonin devices are identical and offer more ingress protection than the Nellcor device.
- Battery Input: the proposed and predicate Nonin devices are identical. The Nellcor device is a tabletop-type device with a rechargeable battery (Li-Ion battery). The Nonin devices do not use rechargeable batteries.
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| Category | Identical/Similar/Different(rationale) | Predicate: Model 3230(K131021, cleared 9/11/15) | Predicate: Nellcor™ BedsideRespiratory Patient MonitoringSystem(K141518, cleared 3/5/15) | Proposed: Model 9591 | |||||
|---|---|---|---|---|---|---|---|---|---|
| Indications for Use | |||||||||
| Indications for use andIntended Use fromLabeling | Different | The Model 3230 Finger Pulseoximeter is a small, lightweightportable device indicated for usein measuring and displayingfunctional oxygen saturation ofarterial hemoglobin (%SpO2) andpulse rate of patients who are wellor poorly perfused. It is intendedfor spot checking of adult andpediatric patients on digitsbetween 0.3-1.0 inch (0.8-2.5cm) thick. | The Nellcor™ BedsideRespiratory Patient MonitoringSystem is a portable pulseoximeter intended for prescriptionuse only as a continuous non-invasive monitor of arterialoxygen saturation (SpO₂) andpulse rate of adult, pediatric, andneonatal patients during both nomotion and motion conditions,and for patients who are well orpoorly perfused. The monitoringsystem is intended for use inhospitals, hospital-type facilities,and during intra-hospitaltransport. The OxiMax SPD™Alert (SPD) feature is intendedonly for facility-use care ofadults to detect patterns ofdesaturation indicative ofrepetitive reductions inairflow through the upper airwayand into the lungs. | The Nonin® Model 9591 FingerPulse Oximeter is a small,lightweight, portable spot-checkdevice indicated for use inmeasuring and displayingfunctional oxygen saturation ofarterial hemoglobin (%SpO2) andpulse rate of patients who are wellor poorly perfused. TheRespiration Rate parameterprovides a non-invasivemeasurement of respiration rate,in breaths per minute. For %SpO2, pulse rate, and respirationrate the 9591 is intended for usein professional healthcare andhome healthcare settings in adultand pediatric patients who arewell or poorly perfused, withdigits that are between 0.3-1.0inch (0.8-2.5 cm) thick. | |||||
| SpO₂ Range | Similar | 0% to 100% SpO₂ | 1% to 100% SpO₂ | 0% to 100% SpO₂ | |||||
| Pulse Rate Range | Similar | 18-321 BPM | 20 to 250 BPM | 18-321 BPM | |||||
| Respiration Rate | Different | NA | 4 to 40 breaths/minute | 3 to 44 breaths/minute | |||||
| SpO₂ Accuracy | |||||||||
| Adult /Pediatric SpO₂ | Identical | $\pm$ 2 digits ( $\pm$ 1 Arms) | 70 to 100% $\pm$ 2 digits | $\pm$ 2 digits ( $\pm$ 1 Arms) | |||||
| Low Perfusion SpO₂ | Identical | $\pm$ 2 digits ( $\pm$ 1 Arms) | 70 to 100% $\pm$ 2 digits | $\pm$ 2 digits ( $\pm$ 1 Arms) | |||||
| Adult /Pediatric SpO₂with Motion | Different | NA | 70 to 100% $\pm$ 3 digits | NA | |||||
| Pulse Rate Accuracy | |||||||||
| Adult and PediatricPulse Rate | Identical | 20 to 250 BPM $\pm$ 3 digits | 20 to 250 BPM $\pm$ 3 digits | 20 to 250 BPM $\pm$ 3 digits | |||||
| Low Perfusion PulseRate | Similar | 40 to 240 BPM $\pm$ 3 digits | 20 to 250 BPM $\pm$ 3 digits | 40 to 240 BPM $\pm$ 3 digits | |||||
| Adult/Pediatric PulseRate with Motion | Different | NA | 48 to 127 BPM $\pm$ 5 digits | NA | |||||
| Device Specifications | |||||||||
| MeasurementWavelength | Identical | 660 and 910 nanometers | 660 and 900 nanometers | 660 and 910 nanometers | |||||
| Operating Altitude | Similar | Up to 13,123 feet | -1,000 ft. to 15,000 ft. | Up to 13,123 feet | |||||
| Operating TemperatureStorage/TransportationTemperature | Similar | -5° to +40°C | 5° to +40°C | -5° to +40°C | |||||
| Operating Humidity | Similar | -40° to +70°C | -20° to +70°C | -40° to +70°C | |||||
| Storage/TransportationHumidity | Similar | 10 - 95% non-condensing | 15 - 95% non-condensing | 10 - 95% non-condensing | |||||
| Power Requirements | Similar | 3 volts DC | 7.2 volts DC | 3 volts DC | |||||
| Battery Life(Operating) | Similar | 2200 Spot Checks | 6 hours | 2000 Spot checks 25 hourscontinuous | |||||
| Battery Life (Storage) | Different | 1 month, with batteries installed | 4 months | 1 month, with batteries installed | |||||
| Electrical - Type andDegree of Protection | Identical | Type BF Internally powered | Type BF Internally powered | Type BF Internally powered | |||||
| Enclosure - Degree ofIngress Protection | Different | IP32 | IPX1 | IP32 | |||||
| Modes of Operation | Similar | Spot-check | Continuous | Spot-check | |||||
| Battery Input | Different | Two 1.5 volt AAA-size batteries | 30 VAC maximum | Two 1.5 volt AAA-size batteries | |||||
| 7-Segment 3-DigitDisplays | Identical | Multi-pixel 3-Digit Displays(color LCD) | Not specified | Multi-pixel 3-Digit Displays(color LCD) | |||||
| Pulse Strength Indicator | Identical | Color LCD | Not specified | Color LCD | |||||
| Sensor Fault Indicator | Identical | Poor signal symbol followed by dashes | Not specified | Poor signal symbol followed by dashes | |||||
| Low Battery Indicator | Similar | Battery Icon | Battery Icon; alarm sounds at 14% | Battery Icon | |||||
| Bluetooth® Radio | Identical | Bluetooth Module 4.0 | Not specified | Bluetooth Module 4.0 | |||||
| Materials, Direct Patient Contact | |||||||||
| Enclosure | Identical | Polycarbonate (PC)/Polyester | Not specified | Polycarbonate (PC)/Polyester | |||||
| Finger Pads | Identical | Thermoplastic Elastomer (TPE) | Not specified | Thermoplastic Elastomer (TPE) | |||||
| Battery Door | Identical | Polycarbonate (PC) | Not specified | Polycarbonate (PC) |
Conclusion:
Based on the results of the above referenced testing, the same critical optics technology and risk management assessment, Nonin Medical has determined that the proposed Model 9591 Finger Pulse Oximeter is substantially equivalent to the Model 3230 finger pulse oximeter cleared by the FDA under K131021 on 9/11/2013, manufactured by Nonin Medical, Inc, without raising different questions of safety and effectiveness.
§ 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).