(158 days)
Not Found
No
The description focuses on traditional signal processing and calculation methods (photoelectron method, circuit design, counting frequency signals, averaging peak intervals) and does not mention AI or ML.
No.
The "Intended Use" states that the device is for "measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are diagnostic/measurement functions, not therapeutic ones.
Yes
Explanation: The device is used for measuring and displaying physiological parameters (SpO2 and pulse rate) which are used to assess the health status of a patient. While it doesn't provide a diagnosis itself, the information it provides can be used by a healthcare professional as part of a diagnostic process. The intended use for "sleep labs, long-term care, hospitals and home use" further supports its role in health assessment.
No
The device description clearly outlines hardware components, including emitting tubes (red light diodes and infrared diodes), a receiving end, and an MCU, which are integral to the device's function of measuring SpO2 and pulse rate. While software is mentioned as part of the calculation, the device is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) in vitro (outside the body).
- This device is a pulse oximeter, which is a non-invasive device that measures physiological parameters (SpO2 and pulse rate) on the human body (specifically, the finger) in vivo (within the body).
The description clearly states it's a "non-invasive device" and measures parameters "through the finger." This is the defining characteristic of a non-IVD medical device that measures physiological signals directly from the patient.
N/A
Intended Use / Indications for Use
The Pulse Oximeter is a non-invasive device indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot- check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.
Product codes (comma separated list FDA assigned to the subject device)
DOA
Device Description
The Pulse Oximeter is a lightweight, portable health finger ring oximeter for home or healthcare facilities. SpO2 measurement technology is based on the developed photoelectron method and circuit design, and Shenzhen Viatom Technology Co., Ltd. developed calculation software. The SpO2 sensor receives the optical signal from the red light and infrared light through the finger into the oximeter. Two emitting tubes (red light diodes and infrared diodes) are located on the inner right side of the sensor, and they can emit red light and infrared. The receiving end is located on the inner left side of the sensor, and it can receive the red light and infrared through the finger. The MCU receives the pulse signal, gets the frequency signal by counting, processes its digital signal, and finally gets the measured SpO2 value. The PR is calculated on average by the above peak intervals of the PR waveform.
Principles of Operation:
The pulse oxygen saturation, the percentage of HbO2 in the total Hb in the blood, namely the so-called O2 concentration in the blood, is an important bio-parameter for respiration. The intergradations of oxygen molecules in the blood and hemoglobin in erythrocytes are reversible. Hemoglobins integrated with oxygen are called HbO2, and those released O2 are called HbR. Oxyhemoqlobin and deoxyhemoglobin (HHb) absorb red Marqinally and infraredly at a specific wavelength. Thus the Marginal of the two wavelengths emitted from the SpQ2 sensor is absorbed when it passes through the finger, and approximate pulse oxygen saturation is calculated by measuring the absorption of the Marginal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger
Indicated Patient Age Range
Adults
Intended User / Care Setting
Prescription Use, sleep labs, long-term care, hospitals and home use.
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
Clinical performance was conducted per ISO 80601-2-61. The clinical validation testing of the SpO2 performance under no motion on healthy adult volunteers was 70% to 100%. The ARMS for SpO2 under no motion was 1.77%, which meets the accuracy requirement of less than or equal to 2% under no motion condition.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Study:
Safety and EMC: Tests performed according to IEC 60601-1 Edition 3.2 2020-08, IEC 60601-1-2 Edition 4.1 2020-09, and IEC 60601-1-11 Edition 2.1 2020-07.
Performance Data: Tests performed according to ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) and FDA Guidance of Non-Invasive Pulse Oximeter issued on Mar. 4, 2013.
Biocompatibility: Testing per ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), and ISO 10993-23 (Irritation).
Software Verification and Validation: Provided in compliance with FDA Guidance "The Content of the Premarket Submission for Software Contained in Medical Devices."
Clinical Study:
Study Type: Clinical validation testing of SpO2 performance under no motion.
Sample Size: Healthy adult volunteers.
Key Results: The ARMS for SpO2 under no motion was 1.77%, which meets the accuracy requirement of less than or equal to 2% under no motion condition. The result met the criteria specified in ISO 80601-2-61. No adverse effects or complications happened during the clinical study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy: 70-100%: ±2%, 0-69% not defined.
SpO2 measurement accuracy: 70%-100%: 1.77%; 90%-100%: 1.00%; 80%-90%: 1.70%; 70%-80%: 2.22%.
Pulse rate accuracy: ±2bpm or ±2% (whichever is greater).
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.
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.
Not Found
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 28, 2025
Shenzhen Viatom Technology Co., Ltd. % Charles Mack Principal Engineer IRC 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K242876
Trade/Device Name: Pulse Oximeter ( PO2, PO2A, PO2B) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: February 3, 2025 Received: February 3, 2025
Dear Charles Mack:
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.
1
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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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-regulatory
2
assistance/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 Quinn 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
Enclosure
3
Indications for Use
510(k) Number (if known) K242876
Device Name Pulse Oximeter
Indications for Use (Describe)
The Pulse Oximeter is a non-invasive device indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot- check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.
| 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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4
510(k) SUMMARY K242876
| Preparation Date: | February 27, 2025 |
|---|---|
| Manufacturer's Name and Address: | Shenzhen Viatom Technology Co., Ltd. |
| 501, Building B, Ganghongji High-Tech | |
| Intelligent Industrial Park, No.1008 | |
| Songbai Road, Xili Street, Nanshan | |
| District, Shenzhen Guangdong, China | |
| 518055 | |
| Tel:+86-755-86638929 | |
| Corresponding Official: | Charles Mack |
| Telephone Number: | 931-625-4938 |
| Email Address: | charliemack@irc-us.com |
| Trade Name: | Pulse Oximeter |
| Model: PO2, PO2A, PO2B | |
| Common Name(s): | Oximeter |
| Regulation Name(s): | Oximeter |
| Regulation Number(s): | 21CFR870.2700 |
| Primary Product Code: | DQA |
| Device Class: | Class II |
| Predicate Device: | K191088 |
| Device Name: | Checkme O2 Pulse Oximeter |
| Common Name(s): | Oximeter |
| Regulation Name(s): | Oximeter |
| Regulation Number(s): | 21CFR870.2700 |
| Primary Product Code: | DQA |
| Device Class: | Class II |
5
Device Description:
The Pulse Oximeter is a lightweight, portable health finger ring oximeter for home or healthcare facilities. SpO2 measurement technology is based on the developed photoelectron method and circuit design, and Shenzhen Viatom Technology Co., Ltd. developed calculation software. The SpO2 sensor receives the optical signal from the red light and infrared light through the finger into the oximeter. Two emitting tubes (red light diodes and infrared diodes) are located on the inner right side of the sensor, and they can emit red light and infrared. The receiving end is located on the inner left side of the sensor, and it can receive the red light and infrared through the finger. The MCU receives the pulse signal, gets the frequency signal by counting, processes its digital signal, and finally gets the measured SpO2 value. The PR is calculated on average by the above peak intervals of the PR waveform.
Principles of Operation:
The pulse oxygen saturation, the percentage of HbO2 in the total Hb in the blood, namely the so-called O2 concentration in the blood, is an important bio-parameter for respiration. The intergradations of oxygen molecules in the blood and hemoglobin in erythrocytes are reversible. Hemoglobins integrated with oxygen are called HbO2, and those released O2 are called HbR. Oxyhemoqlobin and deoxyhemoglobin (HHb) absorb red Marqinally and infraredly at a specific wavelength. Thus the Marginal of the two wavelengths emitted from the SpQ2 sensor is absorbed when it passes through the finger, and approximate pulse oxygen saturation is calculated by measuring the absorption of the Marginal.
Indications for Use
The Pulse Oximeter is a non-invasive device indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate for adult patients. It is intended for spot-check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.
6
| Characteristics | Subject Device | Predicate Device | Remark for
design changes |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Device Name | Pulse Oximeter | Checkme O2 Pulse Oximeter | - |
| Model | PO2, PO2A, PO2B | Oxiband | - |
| Manufacturer | Shenzhen Viatom Technology Co., Ltd. | Shenzhen Viatom Technology Co.,
Ltd. | - |
| 510(K)
Number | Pending | K191088 | - |
| CFR | 21 CFR 870.2700 | 21 CFR 870.2700 | Same |
| Product code | DQA | DQA | Same |
| Classification | 2 | 2 | Same |
| Classification
Name(s) | Oximeter | Oximeter | Same |
| Indication for Use | The Pulse Oximeter is a non- invasive
device indicated for use in measuring,
displaying, storing, and transmitting
functional oxygen saturation of arterial
hemoglobin (SpO2) and pulse rate for
adult patients. It is intended for spot-
check and/or continuous data collection,
and not for continuous monitoring. It can
be used in sleep labs, long-term care,
hospital and home use. | The Oxiband Pulse Oximeter is a wrist
pulse oximeter indicated for use in
measuring, displaying, storing, and
transmitting functional oxygen
saturation of arterial hemoglobin
(SpO2) and pulse rate for adult
patients. It is intended for spot-check
and/or continuous data collection, and
not continuous monitoring. It can be
used in sleep labs, long-term care,
hospital and home use. | Same |
| Work mode | Spot-check and continuous data
collection of oxygen saturation of arterial
hemoglobin(SpO2) and
Pulse Rate. The device is not used for
continuous monitoring. | Spot-check and continuous data
Collection of oxygen saturation of
arterial hemoglobin(SpO2) and Pulse
Rate. The device is not used for
continuous monitoring. | Same |
| Rx or OTC | Rx | Rx | Same |
| Patient type | Adults | Adults | Same |
| Intended
application site | Finger | Finger | Same |
| Design Principle | The device 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. | The device 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. | Same |
| LED
wavelength | Red=660 nm
Infrared=940 nm | Red=660 nm
Infrared=940 nm | Same |
| Sensor type | Integrated SpO2 sensor | External detachable SpO2 sensor | Similar
refer to Note 1 |
| Characteristics | Subject Device | Predicate Device | Remark for
design changes |
| SpO2
display range | 0%-100% | 0%-100% | Same |
| SpO2 accuracy | 70-100%:±2%
0-69% not defined | 70-100%:±2%
0-69% not defined | Same |
| SpO2
measurement
accuracy | 70%-100%: 1.77%
90%-100%: 1.00%
80%-90%: 1.70%
70%-80%: 2.22%
*Measured values are from a controlled
lab study in healthy volunteers. | 70%-100%: 1.866%
70%-80%: unknown
80%-90%: unknown
90%-100%: unknown | Similar |
| SpO2
resolution | 1% | 1% | Same |
| Pulse rate
measurement
range | 30 bpm250 bpm | 30 bpm250 bpm | Same |
| Pulse rate
accuracy | ±2bpm or ±2% (whichever is greater) | ±2bpm or ±2% (whichever is greater) | Same |
| Pulse rate
resolution | ±2bpm or ±2% (whichever is greater) | ±2bpm or ±2% (whichever is greater) | Same |
| Type, Degree of
protection against
electric shock | Internal electric power supply; Type BF
applied parts. | Internal electric power supply;
Type BF applied parts. | Same |
| Power supply | Lithium rechargeable battery | Lithium rechargeable battery | Same |
| Display screen | OLED | OLED | Same |
| Wireless | Bluetooth | Bluetooth | Same |
| Storage data | Yes | Yes | Same |
| Physical dimension
(mm) | 38mm (L)×29mm (W)×18mm (H) | 44mm (L) × 25mm (W) × 15mm
(H) | Similar
refer to Note 2 |
| Contacting duration | Less than 24h | Less than 24h | Same |
| Contacting Material | Fingertip pad: Silica Gel
Enclosure: PC | Fingertip pad: Silica Gel
Enclosure: PC | Same |
| Contacting type | Skin surface- contacting | Skin surface- contacting | Same |
| Software Level of
concern | Moderate | Moderate | Same |
| Operating
Temperature | 540 °C | 540 °C | Same |
| Storage/ Transport
temperature | -2570°C | -2570°C | Same |
| Relative humidity | 10%95% | 10%106KPa | Same |95% | Same |106KPa | 70KPa
| Atmospheric
pressure | 70KPa
| Performance and
Clinical Study | Comply with ISO 80601-2-61. | Comply with ISO 80601-2-61. | Same |
| Electrical Safety | Comply with IEC 60601-1 and IEC
60601-1-11. | Comply with IEC 60601-1
and IEC 60601-1-11. | Same |
| Electromagnetic
Compatibility | Comply with IEC 60601-1-2. | Comply with IEC 60601-1-2. | Same |
| Biocompatibility of
patient contact
parts | Comply with ISO 10993-1, ISO
10993-5, ISO 10993-10 and ISO
10993-23 | Comply with ISO
10993-1, ISO 10993-
5 and ISO 10993-10. | Same |
7
8
Note 1:
The subject device is the design changes version of the predicate device we cleared in K191088. The main change is that the subject device uses the integrated SpO2 sensor, unlike the predicate, which uses external detachable SpO2 sensors with external cable. Both sensors have the same ring type on the finger, and there are no changes in electrooptical components (LED), emission power, finger-pad size, etc. The subject device conforms to the same performance standards requirements of IEC 60601-1. IEC 60601-1-11. and ISO 80601-2-61 as a predicate. Thus, this difference does not raise new questions of safety and effectiveness.
Note 2:
Although the subject device's size is shorter, narrower, and higher than the predicate device's, it still conforms to the same performance requirement. Thus, this difference does not raise new questions of safety and effectiveness.
Test Summary:
To establish substantial equivalence to the identified predicate devices, we performed the test below on the subject devices: Pulse Oximeters, Models PO2, PO2A, and PO2B. The testing results proved that the devices comply with the requirements of applicable standards and are substantially equivalent to the predicate devices.
Non-Clinical Study:
Safety and EMC
To verify the basic safety and essential performance of the PO2 Pulse Oximeter. PO2. PO2A, PO2B, we performed the tests noted below:
IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION 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
Performance Data:
ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
FDA Guidance of Non-Invasive Pulse Oximeter issued on Mar. 4, 2013
9
Biocompatibility
The subject device is classified as a surface device that contacts the skin for prolonged use due to the potential for cumulative use. Testing was conducted per the ISO standards below:
Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Irritation (ISO 10993-23)
Software Verification and Validation
Software verification and validation were provided in compliance with FDA Guidance "The Content of the Premarket Submission for Software Contained in Medical Devices." The verifications and validations demonstrate that the subject device works functionally.
Clinical
Clinical performance was conducted per ISO 80601-2-61. The clinical validation testing of the SpO2 performance under no motion on healthy adult volunteers was 70% to 100%. The ARMS for SpO2 under no motion was 1.77%, which meets the accuracy requirement of less than or equal to 2% under no motion condition. The result met the criteria specified in ISO 80601-2-61. In addition, no adverse effects or complications happened during the clinical study.
Conclusion:
Per the Federal Food, Druq, and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, the subject device is as safe and effective as and substantially equivalent to the predicate devices described herein.