(210 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and performance studies do not indicate the use of AI/ML algorithms. The device measures physiological parameters using established optical and signal processing techniques.
No
The device is described as a "spot-check device indicated for use in measuring and displaying function of arterial hemoglobin (%SpO2) and pulse rate" and respiration rate. It monitors physiological parameters but does not provide therapy or treatment.
Yes
The device is indicated for use in measuring and displaying function of arterial hemoglobin (%SpO2), pulse rate, and respiration rate, which are measurements used to assess a patient's physiological state. These measurements provide information that aids in diagnosis and monitoring of a patient's health.
No
The device description explicitly states it is a "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." This involves hardware components (light emitters and detectors) and is not solely software.
Based on the provided information, the Nonin® Model 9591 Onyx® 3 Finger Pulse Oximeter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Nonin 9591 measures oxygen saturation (%SpO2), pulse rate, and respiration rate by shining light through the patient's finger and measuring the absorption. This is a non-invasive measurement performed on the patient's body, not on a specimen taken from the body.
- Intended Use: The intended use describes measuring and displaying physiological parameters directly from the patient.
- Device Description: The description reinforces that it measures light absorption through perfused tissue, which is a direct measurement on the patient.
Therefore, the Nonin 9591 falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
digits that are between 0.3 – 1.0 inch (0.8 –2.5 cm) thick
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
hospitals, clinics, long-term care facilities, skilled nursing facilities, and home healthcare services.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
SpO2 Accuracy Testing
Study Type: bench testing (accuracy testing)
Sample Size: Not specified, "all subjects"
Key Results: Accuracy data was calculated using the root-mean-squared (ARMS value) for all subjects. 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.
Respiratory Rate Accuracy Verification Clinical (QATR10912)
Study Type: comparative single-center, randomized study
Sample Size: 30 subjects
Key Results: The respiratory rate output of the Onyx 3 fingertip oximeter was compared to Capnography based respiratory rate. Accuracy data was calculated using both mean error and root mean square error (RMSE).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Nonin Model 3230 Bluetooth® Smart Pulse oximeter cleared by the FDA under K131021 on 9/11/2013
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Nellcor™ Bedside Respiratory Patient Monitoring System (PM1000N) cleared by the FDA under K141518 on 3/5/2015.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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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3
1. 510(k) Summary: K191403
| Submitter: | Nonin Medical, Inc.
13700 1st Ave. North
Plymouth, MN 55441-5443 |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Walter Holbein
RA/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 the
FDA 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.
4
| Intended Use: | Model 9591 |
|---|---|
| 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 functional oxygen saturation 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, 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 where | |
| continuous monitoring is expected. | |
| Testing: | Nonin's Model 9591 Finger Pulse Oximeter has successfully |
| undergone both laboratory and clinical hypoxia accuracy testing in | |
| order to ensure that it has appropriate performance, functional | |
| features to fully comply with ISO 80601-2-61:2011 and is | |
| substantially equivalent to the predicate devices. | |
| Functional and | |
| Safety Testing: | The results of the testing demonstrate equivalency with the predicate |
| devices and compliance to recognized standards. Table 1 | |
| summarizes test results for the proposed devices, which met the | |
| relevant requirements of the applicable recognized standards. |
5
| 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 and | ||
| Emissions | IEC 60601-1-2 | Pass |
| Performance | ISO 80601-2-61 | |
| IEC 60601-1 | ||
| IEC 60601-1-6 | ||
| IEC 60601-1-11 | ||
| IEC 62304 | ||
| ISO 14155 | Pass | |
| Ingress Protection | ISO 80601-2-61 | Pass |
| Diaphoretic related ingress | Internal performance | |
| characterization | Pass | |
| Mechanical Durability | IEC 60601-1 | |
| ISO 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.
6
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.
7
| Category | Identical/Similar/
Different
(rationale) | Predicate: Model 3230
(K131021, cleared 9/11/15) | Predicate: Nellcor™ Bedside
Respiratory Patient Monitoring
System
(K141518, cleared 3/5/15) | Proposed: Model 9591 | | | | | |
|----------------------------------------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------|--|-----------|--|
| | | Indications for Use | | | | | | | |
| Indications for use and
Intended Use from
Labeling | Different | The Model 3230 Finger Pulse
oximeter is a small, lightweight
portable device indicated for use
in measuring and displaying
functional oxygen saturation of
arterial hemoglobin (%SpO2) and
pulse rate of patients who are well
or poorly perfused. It is intended
for spot checking of adult and
pediatric patients on digits
between 0.3-1.0 inch (0.8-2.5
cm) thick. | The Nellcor™ Bedside
Respiratory Patient Monitoring
System is a portable pulse
oximeter intended for prescription
use only as a continuous non-
invasive monitor of arterial
oxygen saturation (SpO₂) and
pulse rate of adult, pediatric, and
neonatal patients during both no
motion and motion conditions,
and for patients who are well or
poorly perfused. The monitoring
system is intended for use in
hospitals, hospital-type facilities,
and during intra-hospital
transport. The OxiMax SPD™
Alert (SPD) feature is intended
only for facility-use care of
adults to detect patterns of
desaturation indicative of
repetitive reductions in
airflow through the upper airway
and into the lungs. | The Nonin® Model 9591 Finger
Pulse Oximeter is a small,
lightweight, portable spot-check
device indicated for use in
measuring and displaying
functional oxygen saturation 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, pulse rate, and respiration
rate the 9591 is intended for use
in professional healthcare and
home healthcare settings in 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. | | | | | |
| 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 SpO₂
with Motion | Different | NA | 70 to 100% $\pm$ 3 digits | NA | | | | | |
| | | Pulse Rate Accuracy | | | | | | | |
| Adult and Pediatric
Pulse 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 Pulse
Rate | Similar | 40 to 240 BPM $\pm$ 3 digits | 20 to 250 BPM $\pm$ 3 digits | 40 to 240 BPM $\pm$ 3 digits | | | | | |
| Adult/Pediatric Pulse
Rate with Motion | Different | NA | 48 to 127 BPM $\pm$ 5 digits | NA | | | | | |
| | | Device Specifications | | | | | | | |
| Measurement
Wavelength | 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 Temperature
Storage/Transportation
Temperature | 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/Transportation
Humidity | 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 hours
continuous | | | | | |
| Battery Life (Storage) | Different | 1 month, with batteries installed | 4 months | 1 month, with batteries installed | | | | | |
| Electrical - Type and
Degree of Protection | Identical | Type BF Internally powered | Type BF Internally powered | Type BF Internally powered | | | | | |
| Enclosure - Degree of
Ingress 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-Digit
Displays | 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.