(98 days)
The Nonin® Model 3231 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 with digits between 0.8 - 2.5 cm (0.3 - 1.0 inch) thick.
Model 3231 Pulse oximeter is a small, lightweight, portable, 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. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. Light emitting diodes (LEDs) are contained within the device along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and pulse 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 if there is poor pulse quality that may affect the readings. All associated electronics and the microcontroller are within the sensor, which is activated by placing on a patient's digit. This simple operation activates the internal circuitry automatically upon application. The device is intended for spot-checking adult and pediatric patients who are well or poorly perfused.
The modification of the Model 3230 to the Model 3231, include the removal of Bluetooth LE 4.0 and the addition USB 2.0 for serial communication. This modification includes moving from batteries to the USB 2.0 to power the Model 3231. The oximeter circuitry, software and electro optical elements of the Model 3231 are identical to the Model 3230. There are no technological characteristic changes to the device that affect the measurement or display of SpO2 or pulse rate to the user.
Here's an analysis of the acceptance criteria and study information for the Nonin Model 3231 Finger Pulse Oximeter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Reference Standard) | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1 | Pass |
| Temperature and Humidity | IEC 60601-1, IEC 60601-1-11 | Pass |
| Cleaning | IEC 60601-1 | Pass |
| Electromagnetic Immunity and Emissions | IEC 60601-1-2 | Pass |
| USB 2.0 certification | USB 2.0 | Pass |
| Performance | ISO 80601-2-61, IEC 60601-1, IEC 60601-1-6 | Pass |
| Ingress Protection | ISO 80601-2-61, IEC 60601-1-11 | Pass |
| Mechanical Durability | ISO 80601-2-61 | Pass |
| Atmospheric Pressure | IEC 60601-1, IEC 60601-1-6 | Pass |
| Usability | IEC 60601-1-6, IEC 60601-1-11 | Pass |
| SpO2 Accuracy (Decades) | 70-80% ±2, 80-90% ±2, 90-100% ±2, 70-100% ±2 | Identical to predicate (implying met) |
| SpO2 Accuracy (General) | ±2 digits (±1 Arms) | Identical to predicate (implying met) |
| Low Perfusion SpO2 Accuracy | ±2 digits (±1 Arms) | Identical to predicate (implying met) |
| Pulse Rate Accuracy | 20 to 250 BPM ±3 digits | Identical to predicate (implying met) |
| Low Perfusion Pulse Rate Accuracy | 40 to 240 BPM ±3 digits | Identical to predicate (implying met) |
Note: For accuracy specifications, the document states "Identical" to the predicate model (Model 3230), which was cleared by FDA. This implies that the acceptance criteria for these accuracy metrics were met by the Model 3231, as it is stated to have the same performance characteristics.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "predicate laboratory and clinical hypoxia accuracy testing," but does not specify the sample size for these tests for the Model 3231 or its predicate.
The data provenance is not explicitly stated as retrospective or prospective, nor are specific countries of origin mentioned for the data. However, the testing is done to ensure compliance with international standards (e.g., IEC, ISO), suggesting a general clinical testing environment rather than a specific geographic location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth, particularly for the clinical hypoxia accuracy testing.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device is a standalone pulse oximeter, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance assessment was done. The performance testing for SpO2 and pulse rate accuracy (including under low perfusion) is a standalone evaluation of the device's measurement capabilities. The "Performance" test also indicates compliance with ISO 80601-2-61, which relates to basic safety and essential performance of pulse oximeter equipment.
7. Type of Ground Truth Used
The ground truth for pulse oximeters is typically established through:
- Clinical hypoxia studies: Involving human subjects who are induced into various levels of hypoxia, with arterial blood gas analysis (co-oximetry) serving as the reference standard for actual arterial oxygen saturation (SaO2). The oximeter's SpO2 readings are then compared against the SaO2.
- Controlled laboratory conditions: For assessing performance characteristics like signal processing, optical accuracy, and resistance to interference.
While the document generally refers to "clinical hypoxia accuracy testing," it doesn't detail the precise method of ground truth establishment beyond this. Given the device's nature, the ground truth would be from direct measurements of arterial oxygen saturation using a gold standard method.
8. Sample Size for the Training Set
The document describes the Model 3231 as having identical "oximeter circuitry, software and electro optical elements" as the predicate Model 3230. Since this is a hardware device with embedded software, rather than a machine learning algorithm that is "trained," the concept of a "training set" in the context of AI/ML is not directly applicable. The device's underlying algorithms for SpO2 calculation would have been developed and validated through extensive data, but this wouldn't be referred to as a "training set" in the typical ML sense. The provided text does not specify a training set size.
9. How the Ground Truth for the Training Set Was Established
As explained above, the concept of a "training set" for a traditional medical device like a pulse oximeter (which predates widespread AI/ML application) isn't directly applicable. The embedded algorithms would have been developed based on scientific principles of spectrophotometry and validated against gold standard measurements (e.g., co-oximetry in clinical hypoxia studies), but this process isn't typically described as establishing "ground truth for a training set." The document does not provide this information directly.
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JUL 07 2014
2. 510(k) Summary
| Submitter: | Nonin Medical, Inc.13700 1st Ave. NorthPlymouth, MN 55441-5443 |
|---|---|
| Phone:Fax: | 763-553-9968763-553-7807 |
| Contact Person: | Brodie PedersenSenior Regulatory Engineer |
| Date Prepared: | June 19, 2014 |
| Trade Name: | Model 3231 |
| Classification Nameand Number: | Pulse OximeterClass II, 21 CFR 870.2700 |
| Product Code: | DQA |
| Predicate Device(s): | Nonin's Model 3231 finger pulse oximeter is substantially equivalent to theModel 3230 Finger Pulse oximeter cleared by the FDA under K131021 on9/11/2013. |
| Indications for Use: | Model 3231The Nonin® Model 3231 Finger Pulse Oximeter is a small, lightweight, portabledevice indicated for use in measuring and displaying functional oxygensaturation of arterial hemoglobin (%SpO2) and pulse rate of patients who arewell or poorly perfused. It is intended for spot-checking of adult and pediatricpatients with digits between 0.8 - 2.5 cm (0.3 - 1.0 inch) thick. |
| Device Description: | Model 3231 Pulse oximeter is a small, lightweight, portable, digit pulse oximeterthat displays numerical values for functional oxygen saturation of arterialhemoglobin (SpO2) and pulse rate by measuring the absorption of red andinfrared (IR) light passing through perfused tissue. Changes in the absorptioncaused by the pulsation of blood in the vascular bed are used to determineoxygen saturation and pulse rate. Light emitting diodes (LEDs) are containedwithin the device along with the photo detector, which is on the opposite sideof the probe from the LEDs. The SpO2 and pulse rate are displayed on the LCDdisplay contained within the device. A color LCD provides a visual indication ofthe pulse signal, while blinking at the corresponding pulse rate. The display willindicate if there is poor pulse quality that may affect the readings. All associatedelectronics and the microcontroller are within the sensor, which is activated by |
13700 1st Aveitue North, Plymouth, MN 55441-5443 USA / Phone +1763.553.9968 800.356.8874 / Fax +1763.553.7807 / www.nonin.com
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placing on a patient's digit. This simple operation activates the internal circuitry automatically upon application. The device is intended for spot-checking adult and pediatric patients who are well or poorly perfused.
Page 2 of 4
The modification of the Model 3230 to the Model 3231, include the removal of Bluetooth LE 4.0 and the addition USB 2.0 for serial communication. This modification includes moving from batteries to the USB 2.0 to power the Model 3231. The oximeter circuitry, software and electro optical elements of the Model 3231 are identical to the Model 3230. There are no technological characteristic changes to the device that affect the measurement or display of SpO2 or pulse rate to the user.
Technological Characteristics Comparison:
| Characteristic | Identical/Different | Model 3230 | Model 3231 |
|---|---|---|---|
| INDICATIONS FOR USE | Identical exceptModel Number | The Nonin® Model 3230Finger Pulse Oximeter is asmall, lightweight, portabledevice indicated for use inmeasuring and displayingfunctional oxygensaturation of arterialhemoglobin (%SpO2) andpulse rate of patients whoare well or poorly perfused.It is intended for spot-checking of adult andpediatric patients with digitsbetween 0.8 - 2.5 cm (0.3 -1.0 inch) thick. | The Nonin® Model 3231Finger Pulse Oximeter is asmall, lightweight, portabledevice indicated for use inmeasuring and displayingfunctional oxygensaturation of arterial .hemoglobin (%SpO2) andpulse rate of patients whoare well or poorly perfused.It is intended for spot-checking of adult andpediatric patients with digitsbetween 0.8 - 2.5 cm (0.3 -1.0 inch) thick. |
| SYSTEM CONFIGURATIONS | |||
| Parts and Accessories | |||
| Power input | Different | LR03 AAA batteries(2) | USB 2.0 |
| Operator's instructions | Identical | Paper | Paper |
| OVERALL SPECIFICATIONS | |||
| SpO2 Range | Identical | 0% to 100% SpO2 | 0% to 100% SpO2 |
| Pulse Rate Range | Identical | 18-321 BPM | 18-321 BPM |
| Accuracy | |||
| Decades | Identical | Decade OxygenSaturation (Arms)70-80% ±280 - 90% ±290 - 100% ±270-100% ±2 | Decade OxygenSaturation (Arms)70-80% ±280 – 90% ±290 - 100% ±270 - 100% ±2 |
13700 1st Avenue North, Plymouth, MN 55441-5443 USA
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Phone +1 763.553.9968 800.356.8874 /
Fax +1 763 553.7807
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| CC | A 42 " | |
|---|---|---|
| PORTO0 | 014 |
| Characteristic | Identical/Different | Model 3230 | Model 3231 |
|---|---|---|---|
| SpO2 | Identical | ±2 digits (± 1 Arms) | ±2 digits (± 1 Arms) |
| Low Perfusion SpO2 | Identical | ±2 digits (± 1 Arms) | ±2 digits (± 1 Arms) |
| Pulse Rate | Identical | 20 to 250 BPM ±3 digits | 20 to 250 BPM ±3 digits |
| Low Perfusion Pulse Rate | Identical | 40 to 240 BPM ±3 digits | 40 to 240 BPM ±3 digits |
| Displays | |||
| 7-Segment 3-Digit Displays | Identical | Multi-pixel 3-Digit Displays | Multi-pixel 3-Digit Displays |
| Pulse Strength | Identical | LCD, readings or dashes givetwo levels of pulse qualityindication | LCD, readings or dashes givetwo levels of pulse qualityindication |
| Connectivity | Different | Bluetooth SMART | USB 2.0 |
| Package | Identical | Box | Box |
Testing:
. . . . .
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Nonin's Model 3231 Pulse Oximeter is supported by predicate laboratory and clinical hypoxia accuracy testing in order to ensure that it has appropriate performance and functional features to fully comply with recognized standards and guidance documents and is substantially equivalent to the predicate device except these features specific to the modifications.
13700 1st Avenue North, Plymouth, MN 55441-5443 USA
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Functional and Safety Testing:
Laboratory testing included: software verification, safety testing for electrical, mechanical, biocompatibility analysis, ingress protection, electromagnetic compatibility, device performance, usability evaluation, certification and mechanical durability have been performed to demonstrate equivalency with the predicates. As shown in the table below the device met the relevant requirements of the applicable recognized standards and guidance.
Page 4
| Test | Reference | Result |
|---|---|---|
| Electrical Safety | IEC 60601-1 | Pass |
| Temperature and Humidity | IEC 60601-1IEC 60601-1-11 | Pass |
| Cleaning | IEC 60601-1 | Pass |
| Electromagnetic Immunity andEmissions | IEC 60601-1-2 | Pass |
| USB 2.0 certification | USB 2.0 | Pass |
| Performance | ISO 80601-2-61IEC 60601-1IEC 60601-1-6 | Pass |
| Ingress Protection | ISO 80601-2-61IEC 60601-1-11 | Pass |
| Mechanical Durability | ISO 80601-2-61 | Pass |
| Atmospheric Pressure | IEC 60601-1IEC 60601-1-6 | Pass |
| Usability | IEC 60601-1-6IEC 60601-1-11 | Pass |
Conclusion:
Nonin's Model 3231 is substantially equivalent to the Model 3230 Bluetooth® Smart Pulse oximeter cleared by the FDA under K131021 on 9/11/2013, · manufactured by Nonin Medical, Inc. The concurrent shared design elements and positive results of testing, lead.to the conclusion that the indications for use and labeling are substantially equivalent to the predicate device and do not raise new questions of safety and effectiveness.
13700 1st Avenue North, Plymouth, MN 55441-5443 USA
Phone +1 763.553.9968 8800.356.8874
Fax +1 763 553.7807
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2014
Nonin Medical, Inc. Mr. Brodie Pedersen Senior Regulatory Engineer 13700 1st Ave. North Plymouth, MN 55441-5443
Re: K140785
Trade/Device Name: Nonin Model 3231 Finger Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 22, 2014 Received: April 23, 2014
Dear Mr. Pedersen:
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.
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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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
MarySTBmer-S
Erin I. Keith, M.S. 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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1. Indications for Use Statement
510(K) Number:
Device Name:
Nonin Medical, Inc. Model 3231
Indications for Use:
Model 3231
The Nonin® Model 3231 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 with digits between 0.8 - 2.5 cm (0.3 - 1.0 inch) thick.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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13700 1st Avenue North, Plymouth, MN 55441-5443 USA / Phone +1763.553.9568 800.356.8874 / Fax +1 763.553.7807 www.nonin.com
§ 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).