(1279 days)
The Nonin Medical 3250 Finger Pulse Oximeter is a small, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of individuals who are well or poorly perfused under no motion conditions for medical use without a prescription. It is intended for spot-checking of individuals 18 years and older with finger thickness between 0.8-2.5 cm (0.3-1.0 inch). It is not intended for the diagnosis or screening of lung disease, for use in treatment decisions, and should only be used for making heathcare decisions under the advice of a healthcare provider.
Model 3250 Pulse Oximeter is a small, lightweight, portable, battery operated, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate and is intended for over-the-counter use.
The device measures the absorption caused by the pulsation of blood in the vascular bed, which 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 of the device. The LCD also provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate poor pulse quality that may affect the readings. All associated electronics and the microcontrollers are within the sensor, which is activated by inserting a patient's digit. This simple operation activates the internal circuitry automatically upon application.
The Model 3250 includes a Bluetooth radio to send real time oximeter readings to a host device. The Model 3250 features a Bluetooth LE version 4.0 radio to ease the connectivity setup configuration with options to implement secure connections for the point-to-point data connection. This oximeter uses ISP3, Nonin's core signal processing technology software.
Acceptance Criteria and Device Performance Study for Nonin OTC Pulse Oximeter Model 3250 (K211498)
The Nonin OTC Pulse Oximeter Model 3250 is intended for measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate in individuals under no motion conditions for over-the-counter medical use. The device's performance was evaluated through clinical and non-clinical testing to ensure compliance with relevant standards and demonstrate substantial equivalence to predicate and reference devices.
1. Acceptance Criteria and Reported Device Performance
The primary acceptance criteria for the pulse oximeter's accuracy is based on the ISO 80601-2-61:2017 standard, which specifies an ARMS (Accuracy Root Mean Squared) of ≤ 3.0%. The device's performance was assessed across different SaO2 ranges and skin pigmentations.
| Performance Metric | SaO2 Range | Skin Pigmentation | Acceptance Criteria (ARMS) | Reported Device Performance (ARMS) - Leeb Study | Reported Device Performance (ARMS) - UCSF Study |
|---|---|---|---|---|---|
| SpO2 Accuracy (ARMS) | 70 - 80% | Light | ≤ 3.0% | 1.8% | 1.56% (for 70-100% combined range) |
| Medium | ≤ 3.0% | 1.7% | |||
| Dark | ≤ 3.0% | 2.3% | |||
| 80 - 90% | Light | ≤ 3.0% | 1.2% | 1.86% (for 70-100% combined range) | |
| Medium | ≤ 3.0% | 2.2% | |||
| Dark | ≤ 3.0% | 1.5% | |||
| 90 - 100% | Light | ≤ 3.0% | 1.4% | 2.85% (for 70-100% combined range) | |
| Medium | ≤ 3.0% | 2.9% | |||
| Dark | ≤ 3.0% | 2.0% | |||
| 70 - 100% | Overall | ≤ 3.0% | 2.0% | 2.27% | |
| SpO2 Accuracy (BIAS) | 70 - 80% | Light | Not explicitly stated as a hard acceptance criterion in the text, but reported to show lack of significant bias. | 0.5% | 1.9% (for 70-85% light) |
| Medium | 0.9% | 1.14% (for 70-85% medium) | |||
| Dark | 2.0% | 2.57% (for 70-85% dark) | |||
| 80 - 90% | Light | 0.0% | 0.98% (for 85-100% light) | ||
| Medium | 1.1% | 0.43% (for 85-100% medium) | |||
| Dark | 0.8% | 1.08% (for 85-100% dark) | |||
| 90 - 100% | Light | 0.1% | |||
| Medium | 0.2% | ||||
| Dark | -0.2% | ||||
| 70 - 100% | Overall | 0.6% |
The reported device performance consistently falls within the 3.0% ARMS guidance, demonstrating the device meets the accuracy acceptance criteria across various SaO2 ranges and skin pigmentations. The bias values also indicate no clinically significant bias.
2. Sample Sizes and Data Provenance
The clinical performance testing utilized data from two studies:
- Leeb Study:
- Sample Size (Test Set): 34 participants.
- Data Provenance: Not explicitly stated, but it is an "independent study." Controlled desaturation study.
- UCSF Study:
- Sample Size (Test Set): 26 participants.
- Data Provenance: Conducted at UCSF (University of California, San Francisco). Controlled desaturation study.
Both studies involved "controlled desaturation studies with arterial oxygen saturation (SaO2) plateaus between 70% and 100%," suggesting a prospective clinical study design where participants' oxygen levels were intentionally varied under medical supervision. The text emphasizes "diverse skin pigmentation" in both studies, indicating an effort to include a representative demographic.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set. For pulse oximeter accuracy studies using controlled desaturation, the ground truth for arterial oxygen saturation (SaO2) is typically established through co-oximetry measurements of arterial blood samples, which are analyzed by laboratory professionals using specialized equipment. This process does not usually involve subjective expert interpretation in the same way, for example, a radiology image would.
4. Adjudication Method
The document does not describe an adjudication method for the test set. In pulse oximetry accuracy studies, the direct comparison is between the device's SpO2 readings and the established SaO2 ground truth (from co-oximetry). There isn't typically an expert panel review or adjudication process for interpreting the ground truth data itself.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being performed for the Nonin Model 3250 or its reference device. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images. Pulse oximetry device validation focuses on the accuracy of the device's direct measurement against a physiological gold standard.
6. Standalone (Algorithm Only) Performance
The study primarily evaluates the standalone performance of the pulse oximeter device, which integrates the sensor and the algorithm. The text states: "Nonin oximeters utilize the same oximeter technology thus the accuracy of Model 3250 is identical to the results of the reference device, Model 3230" and "The optical path and algorithm for the Model 3250 is equivalent to the Model 9590." This indicates that the performance data presented directly reflects the algorithm's capability as integrated into the device, without a human-in-the-loop component for interpreting the raw signal.
7. Type of Ground Truth Used
The ground truth used for the clinical accuracy studies (Leeb and UCSF studies) was arterial oxygen saturation (SaO2) measured from arterial blood samples (co-oximetry). This is considered the gold standard for determining actual arterial oxygen saturation. The studies are described as "controlled desaturation studies," confirming the use of direct physiological measurement for ground truth.
8. Sample Size for the Training Set
The document does not provide information on the sample size for the training set. The clinical data presented is for validation (test set) of the device's accuracy. For pulse oximeters, the core signal processing technology (ISP3 for Nonin) is likely developed and refined over time using extensive proprietary datasets, but specific "training set" details for a machine learning model are not typically disclosed or relevant in the same way as for AI software devices. The statement "Nonin oximeters utilize the same oximeter technology" and "The optical path and algorithm for the Model 3250 is equivalent to the Model 9590" suggests leveraging existing, established technology rather than a newly trained AI model.
9. How Ground Truth for the Training Set Was Established
As with the training set sample size, the document does not detail how the ground truth for any presumed "training set" for the underlying "ISP3" signal processing technology software or core algorithm was established. Given the nature of pulse oximetry, it's highly probable that any developmental data would similarly rely on arterial oxygen saturation (SaO2) measured from arterial blood samples (co-oximetry), following the established methodology for validating pulse oximeter accuracy.
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November 13, 2024
Nonin Medical Inc. % Sheila Mena Sr Regulatory Affairs Specialist 13700 1st Ave N Plymouth, MN 55441
Re: K211498
Trade/Device Name: Nonin OTC Pulse Oximeter Model 3250 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: OLK Dated: May 21, 2024 Received: May 21, 2024
Dear Shiela Mena:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Bradley Q. Quinn -S
Bradley Ouinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K211498
Device Name
Nonin Medical 3250 Finger Pulse Oximeter
Indications for Use (Describe)
The Nonin Medical 3250 Finger Pulse Oximeter is a small, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of individuals who are well or poorly perfused under no motion conditions for medical use without a prescription. It is intended for spot-checking of individuals 18 years and older with finger thickness between 0.8-2.5 cm (0.3-1.0 inch). It is not intended for the diagnosis or screening of lung disease, for use in treatment decisions, and should only be used for making heathcare decisions under the advice of a healthcare provider.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | 区 Over-The-Counter Use (21 CFR 801 Subpart C) |
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5.0 TRADITIONAL 510(K) SUMMARY
| Submitted by: | Nonin Medical, Inc.13700 1st Ave NorthPlymouth, MN 55441 |
|---|---|
| Contact Person: | Sheila MenaSr RegulatoryAffairs Specialist13700 1st Ave NPlymouth, MN 55441 |
| Date of Summary: | October 8, 2024 |
| Device Trade Name: | Nonin Model 3250 OTC Pulse Oximeter (K211498) |
| Common or Usual Name: | Pulse Oximeter |
| Classification Name: | Oximeter |
| Class: | 2 |
| Product Code: | OLK |
| Review Panel: | Anesthesiology |
| Predicate Device(s): | Masimo MightySat OTC Medical (K214115) |
| Reference Device | Nonin's Model 3230 finger pulse oximeter (K131021) |
| Model Number(s): | 3250 |
| Device Description: | Model 3250 Pulse Oximeter is a small, lightweight, portable, battery operated, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate and is intended for over-the-counter use.The device measures the absorption caused by the pulsation of blood in the vascular bed, which 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 of the device. The LCD also provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate poor pulse quality that may affect the readings. All associated electronics and the microcontrollers are within the sensor, which is activated by inserting a patient's digit. This simple operation activates the internal circuitry automatically upon application.The Model 3250 includes a Bluetooth radio to send real time oximeter readings to a host device. The Model 3250 features a Bluetooth LE version 4.0 radio to ease the connectivity setup configuration with options to implement secure connections for the point-to-point data connection. This oximeter uses ISP3, Nonin's core signal processing technology software. |
| Indication for Use: | The Nonin Medical 3250 Finger Pulse Oximeter is a small, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of individuals who are well or poorly perfused under no motion conditions for medical use without a prescription. It is intended for spot-checking of individuals 18 years and older with finger thickness between 0.8-2.5 cm (0.3-1.0 inch). It is not intended for the diagnosis or screening of lung disease, for use in treatment decisions, and should only be used for making healthcare decisions under the advice of a healthcare provider. |
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Technological Characteristics/Substantial Equivalence Rationale:
The Model 3250 Pulse Oximeter is designed and built identical to the reference device, Model 3230 Pulse Oximeter.
- Nonin oximeters utilize the same oximeter technology thus the accuracy ● of Model 3250 is identical to the results of the reference device, Model 3230.
- Nonin oximeters use the same electro-optical sensor components, and the ●
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SpO2 algorithm of Model 3250 is identical to the reference device. Model 3230.
- The Bluetooth radio module of Model 3250 is the same technology presented in the reference device. Model 3230.
- Nonin's Model 3250 Pulse Oximeters are made from the same materials. have the same design, and the manufacturing process as the reference device.
The Model 3250 Pulse Oximeter and the reference device, Model 3230 Pulse Oximeter, have a different indication for use, intended use, and labeling.
-
. The Model 3250 Pulse Oximeter is intended for over-the-counter use.
The Model 3250 Pulse Oximeter Indications for use are similar to the predicate device, Masimo MightySat OTC Medical. -
Nonin model 3250 is equivalent to the predicate device regarding the OTC indication.
-
Nonin model 3250 is equivalent to the predicate device regarding measures, patient population age group, patient use conditions, and environmental attributes. Further specification is provided compared to the predicate and reference devices with respect to physical attributes.
-
Nonin model 3250 is similar to the predicate device regarding the device ● specifications.
Non-Clinical Performance Testing:
Nonin's Model 3250 Oximeter is supported by both laboratory and clinical hypoxia accuracy testing in order to ensure that it has appropriate performance, functional features to fully comply with ISO 80601-2-61:2017, and IEC 60601-1-11 collateral standard for home healthcare equipment.
Nonin's Model 3250 Oximeter complies with the following standards:
- ISO 10993-1:2018- Biological evaluation of medical devices Part 1: ● Evaluation and testing.
- IEC 60601-1-2:2014- Medical electrical equipment— Part 1-2: General ● requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-1-6:2013 Medical Electrical Equipment General requirements ● for basic safety and essential performance - Usability.
- . IEC 60601-1-11:2015 - Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- ISO 80601-2-61:2017 Medical electrical equipment-particular requirements ● for basic safety and essential performance of pulse oximeter equipment.
- ANSI AAMI IEC 62304:2006/A1:2016 Medical device software Software life ● cycle processes
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Clinical Data:
Performance clinical testing for pulse oximeter accuracy and usability testing participation by users is identical to the predicate device in 510(k) K131021.
To support the performance of the Model 3250, clinical data is provided as part of this submission.
The clinical performance testing included data from an independent study by Leeb and an internal study conducted at UCSF using Nonin's Model 9590. The optical path and algorithm for the Model 3250 is equivalent to the Model 9590. Therefore, the data from these two studies can be used to substantiate the Model 3250. The results support similar performance across all skin pigmentation.
In the Leeb study, there were 34 participants with diverse skin pigmentation utilizing a controlled desaturation study with arterial oxygen saturation (SaO2) plateaus between 70% and 100%. Skin pigmentation was assessed subjectively using a perceived Fitzpatrick Scale (pFP) and objectively using the individual typology angle (ITA) via spectrophotometry at nine anatomical sites.
| %SaO2 | 70 - 80% | 80 - 90% | 90 - 100% | 70 - 100% | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| SkinPigmentation | Light | Medium | Dark | Light | Medium | Dark | Light | Medium | Dark | |
| ARMS | 1.8 | 1.7 | 2.3 | 1.2 | 2.2 | 1.5 | 1.4 | 2.9 | 2 | 2 |
| BIAS | 0.5 | 0.9 | 2 | 0 | 1.1 | 0.8 | 0.1 | 0.2 | -0.2 | 0.6 |
In the UCSF study, there were 26 participants with diverse skin pigmentation utilizing a controlled desaturation study with arterial oxygen saturation (SaO2) plateaus between 70% and 100%. Skin pigmentation as assessed subjectively using both Fitzpatrick Scale and Monk Scale, and objectively using the individual typology angle (ITA) via spectrophotometry using five anatomical sites.
| %SaO2 | 70 - 80% | 80 - 90% | 90 - 100% | 70-100% |
|---|---|---|---|---|
| ARMS | 1.56 | 1.86 | 2.85 | 2.27 |
| %SaO2 | 70 - 85% | 85 - 100% | ||||
|---|---|---|---|---|---|---|
| SkinPigmentation | Light | Medium | Dark | Light | Medium | Dark |
| BIAS | 1.9 | 1.14 | 2.57 | 0.98 | 0.43 | 1.08 |
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The result of the clinical testing supports the performance of the subject device, Model 3250, across all skin pigmentation. The subject device demonstrated equitable performance for the intended user population across all skin pigmentation sub-groups and the accuracy was within 3.0% ARMS quidance, without any clinically significant bias compared to the blood reference SaO2, or between the groups.
Usability of the reference device Model 3230 is used to substantiate usability of the Model 3250 OTC. Self-selection of an OTC device is substantiated by similar indications for use to the predicate device MightySat OTC. To further support OTC use, updates were included in the 3250 OTC IFU.
Conclusion: Nonin's Model 3250 is substantially equivalent to Masimo MightySat under K214115 supports the OTC indication of the 3250 and does not raise new questions of safety and effectiveness. In addition, the reference device Nonin's Model 3230 finger pulse oximeter cleared by the FDA under K131021 on 9/11/2013, supports the indications for use and labeling for Model 3250.
§ 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).