(1279 days)
Nonin's Model 3230 finger pulse oximeter (K131021)
No
The description focuses on traditional pulse oximetry technology using LEDs, photodetectors, and signal processing (ISP3). There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is used for measuring and displaying oxygen saturation and pulse rate, which is a diagnostic function, not a therapeutic one. The description explicitly states it is "not intended for the diagnosis or screening of lung disease, for use in treatment decisions."
No
The "Intended Use" section explicitly states, "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." This indicates that while it measures physiological parameters, its output is not for direct diagnostic purposes.
No
The device description explicitly states it is a "small, lightweight, portable, battery operated, digit pulse oximeter" and mentions hardware components like "Light emitting diodes (LEDs)", "photo detector", "LCD display", and "internal circuitry". While it includes software ("ISP3, Nonin's core signal processing technology software") and Bluetooth connectivity, it is fundamentally a hardware device with integrated software.
Based on the provided text, the Nonin Medical 3250 Finger Pulse Oximeter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Nonin 3250 measures functional oxygen saturation and pulse rate by shining light through a finger and detecting the absorption. This is a non-invasive measurement performed on the body, not on a sample taken from the body.
- Intended Use: The intended use clearly states it's for measuring and displaying %SpO2 and pulse rate of individuals. It does not mention analyzing biological samples.
Therefore, the Nonin Medical 3250 Finger Pulse Oximeter is a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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 heathcare decisions under the advice of a healthcare provider.
Product codes
OLK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger
Indicated Patient Age Range
18 years and older
Intended User / Care Setting
medical use without a prescription.
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
Not Found
Summary of Performance Studies
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.
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.
Leeb study:
Sample size: 34 participants with diverse skin pigmentation.
Protocol: 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.
Key results (ARMS between %SaO2 70-100%): Light skin: 1.8; Medium skin: 1.7; Dark skin: 2.3. Overall ARMS: 2. Bias (between %SaO2 70-100%): 0.6.
UCSF study:
Sample size: 26 participants with diverse skin pigmentation.
Protocol: Controlled desaturation study with arterial oxygen saturation (SaO2) plateaus between 70% and 100%. Skin pigmentation was assessed subjectively using both Fitzpatrick Scale and Monk Scale, and objectively using the individual typology angle (ITA) via spectrophotometry using five anatomical sites.
Key results (ARMS for 70-100% SaO2): 2.27.
Bias (between %SaO2 70-85%): Light skin: 1.9; Medium skin: 1.14; Dark skin: 2.57.
Bias (between %SaO2 85-100%): Light skin: 0.98; Medium skin: 0.43; Dark skin: 1.08.
Overall conclusion: 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.
Key Metrics
Not Found
Predicate Device(s)
Masimo MightySat OTC Medical (K214115)
Reference Device(s)
Nonin's Model 3230 finger pulse oximeter (K131021)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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).
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
5.0 TRADITIONAL 510(K) SUMMARY
| Submitted by: | Nonin Medical, Inc.
13700 1st Ave North
Plymouth, MN 55441 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sheila Mena
Sr Regulatory
Affairs Specialist
13700 1st Ave N
Plymouth, 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. |
4
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 ●
5
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
6
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% | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Skin | ||||||||||
| Pigmentation | 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% | ||||
|---|---|---|---|---|---|---|
| Skin | ||||||
| Pigmentation | Light | Medium | Dark | Light | Medium | Dark |
| BIAS | 1.9 | 1.14 | 2.57 | 0.98 | 0.43 | 1.08 |
7
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.