(303 days)
Not Found
No
The description details standard pulse oximetry technology using light absorption and a microprocessor for calculation, with no mention of AI or ML.
No
Explanation: The device is intended for spot-checking oxygen saturation and pulse rate, which are diagnostic or monitoring functions, not therapeutic. It measures parameters but does not provide therapy or treatment.
Yes
Explanation: The pulse oximeter is intended for "spot-checking oxygen saturation and pulse rate," which are physiological parameters used to assess a patient's condition and aid in the diagnosis of various medical conditions, thus making it a diagnostic device.
No
The device description explicitly states it consists of hardware components including a probe, electronic circuits, display, plastic enclosures, light emitting diodes, a light detector, and a microprocessor. It is also powered by batteries.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is a pulse oximeter that measures oxygen saturation and pulse rate by shining light through the finger. This is a non-invasive measurement taken on the body (in vivo).
- Intended Use: The intended use is for "spot-checking oxygen saturation and pulse rate" directly on the finger. This does not involve analyzing a sample taken from the body.
Therefore, based on the provided information, the device is a non-invasive medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate, and the device is a reusable device and intended to be used with the finger of adults in professional healthcare facility or home conditions when physician follow-up and operated by a physician. And it is not intended to be used under motion or low perfusion scenarios.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2). The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery.
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
professional healthcare facility or home conditions when physician follow-up and operated by a physician.
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 testing is conducted per Annex EE Guideline for evaluating and documenting SpO₂ACCURACY in human subjects of ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Biocompatibility testing: The biocompatibility evaluation for the Pulse Oximeter was conducted in accordance with the International Standard ISO 10993-1. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the testing included the following tests, results of which demonstrate the biocompatibility of the subject device: Cytotoxicity, Skin Sensitization, Skin Irritation.
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted, and the results show that the subject device complies with the IEC 60601-1:2005/ A1:2012, IEC 60601-1-11: 2015 and IEC 60601-1-2: 2014.
Bench Testing: Bench testing was conducted and the results show that the subject device complies with the ISO 80601-2-61: 2017. And Pulse Rate Accuracy meets the requirements defined in ISO 80601-2-61, Clause 201.12.1.104.
Software Verification and Validation Testing: Software documentation including verification & validation was provided in accordance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern.
Cleaning Validation: Cleaning and disinfection validation testing was conducted in accordance with FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued March 17,2015. Moreover, the performance of the subject device shows no degradation after repeated cleaning and disinfection as suggested in the manual.
Clinical data:
Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO₂ACCURACY in human subjects of ISO 80601-2-61:2011. There are 13 healthy volunteers aged between 18 - 50 years old were selected in this study, of which includes 8 females and 5 males, 3 light skin subjects and 3 dark skin subjects. The demographic statistical indicators of the subjects is show in the table below. And no adverse effects and complications happened during the clinical study.
Age (year): N=13, Average mean=30.15, Sd=11.25, Minimal=18, Maximum=50
Height (cm): N=13, Average mean=166, Sd=9.61, Minimal=150, Maximum=180
Weight (kg): N=13, Average mean=63.04, Sd=12.39, Minimal=47, Maximum=89
The arm, hand or finger moves may affect the accuracy of SpO2 measurement, while the gender, age and finger size have no effect to the accuracy of SpO2 measurement, as the skin pigmentation, in this study, the statistical shows no effect to the safe and effective performance of the oximeter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO₂ Range: 0%~100%, of which effective measurement range is 70%~100%
SpO2 Accuracy: 70% ~100%:±2%; 0% to 69%: unspecified
SpO2 Resolution: 1%
Pulse Rate Range: 30 bpm ~ 250 bpm
Pulse Rate Accuracy: ±3 bpm
Pulse Rate Resolution: 1 bpm
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 shows 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.
June 22, 2022
Huizhou Xiaoou Technology Co., Ltd. Xia Wang General Manager 3rd Floor, No.113 (Building D), Xikeng Industrial Zone Zhongkai High-tech Zone Huizhou, Guangdong 516000 China
Re: K212665
Trade/Device Name: Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number-SO711), Pulse Oximeter (SO811), Pulse Oximeter (SO911) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: May 15, 2022 Received: May 23, 2022
Dear Xia Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212665
Device Name
Pulse Oximeter, Models SO611, SO711, SO811 and SO911
Indications for Use (Describe)
The Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate, and the device is a reusable device and intended to be used with the finger of adults in professional healthcare facility or home conditions when physician follow-up and operated by a physician. And it is not intended to be used under motion or low perfusion scenarios.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter:
Contact Person: | Huizhou Xiaoou Technology Co., Ltd.
3rd Floor, No.113(Building D), Xikeng Industrial Zone, Zhongkai High-tech Zone,
Huizhou, Guangdong, Shenzhen, 516000, P.R. China
TEL: +86 752-3302188
Xia Wang |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepare date: | 2022-04-30 |
| 2. Device name and
classification | Device Name: Pulse Oximeter
Models: SO611, SO711, SO811 and SO911
Classification Name: 21 CFR 870.2700 Oximeter
Product code: DQA
Regulatory Class: Class II
Class III Summary and Certification: Not applicable
IVD Classification: Not applicable |
| 3. Reason for
Submission | New Application. No prior submission associated with the current submission. |
| 4. Predicate
Device(s) | Shenzhen Yimi Life Technology Co., Ltd., YM101/YM201/YM301 Pulse Oximeter /
K191430. No recall or medical device report have been happened to the predicate
device. |
| 5. Device Description | The oximeter consists of probe, electronic circuits, and display and plastic
enclosures. And one side of probe is designed to locate light emitting diodes and a
light detector (called a photo-detector). Red and Infrared lights are shone through
the tissues from one side of the probe to the other. Then parts of the light emitted
absorbed by blood and tissues. The light absorbed by the blood varies with the
oxygen saturation of haemoglobin. After that, the photo-detector detects the light
volume transmitted through the tissues which depends on blood pulse, Hereafter,
the microprocessor calculates a value for the oxygen saturation (SpO2).
The subject device is a reusable device, and need to reprocess as suggested in the
user manual after each use. And the device is intended to be used on the finger,
and powered by 2*1.5V AAA battery. |
| 6. Indications for Use | All the four models included in this submission, which share the same
appearance&size, intended use, performance and similar operation. The
differences between all the models is the sound beep and displayed font colors.
Sound beep is available for SO811 only, not available for other devices. Regarding
the displayed font colors, SO611 and SO711 can show fonts in blue or yellow
respectively without multiple colors, while SO811 and SO911 can show the fonts in
green/yellow/blue three colors. And the sound beep difference is realized by
removing the component buzzer, and the font color difference is realized by minor
differentiate the software. Therefore, it can be concluded that all the models share
the similar hardware and software in this submission.
The Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate
and the device is a reusable device and intended to be used with the finger of
adults in professional healthcare facility or home conditions when physician
follow-up and operated by a physician. And it is not intended to be used under
motion or low perfusion scenarios. |
4
7. Predicate Device Comparison
Please refer to following table to find differences between the subject device and predicate device.
| ITEM | Predicate Device
YM 101/YM201/YM301 Pulse
Oximeter
K191430 | Proposed Device
Pulse Oximeter SO611/SO711/
SO811/SO911 | Comparison
Result |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacture | Shenzhen Yimi Life Technology
Co., Ltd. | Huizhou Xiaoou Technology Co.,
Ltd. | --- |
| Indications for Use | The pulse oximeter is a reusable
device and intended for
spot-checking of oxygen
saturation and pulse rate for use
with the finger of adult patients
in healthcare environments. And
it is not intended to be used
under motion or low perfusion
scenarios. | The Pulse Oximeter is intended for
spot-checking oxygen saturation
and pulse rate, and the device is a
reusable device and intended to be
used with the finger of adults in
professional healthcare facility or
home conditions when physician
follow-up and operated by a
physician. And it is not intended to
be used under motion or low
perfusion scenarios. | Different |
| Intended patient
population | Adult | Adult | |
| Contraindications | Not intended to be used under
motion or low perfusion
scenarios. | Not intended to be used under
motion or low perfusion scenarios. | Same |
| Operational Specifications | | | |
| Intended
application site | Finger | Finger | Same |
| Measurement
Principles | 2-wavelength Relative
Optical Absorption | 2-wavelength Relative
Optical Absorption | Same |
| Signal Detection
Method | Photodetector | Photodetector | Same |
| Display content | SpO2%, PR, battery indicator,
Pulse rate
bar graph, pulse waveform | SpO2%, PR, battery indicator, Pulse
rate
bar graph, pulse waveform | Same |
| SpO₂ Range | 0%~100%, of which effective
measurement range is
70%~100% | 0%~100%, of which effective
measurement range is 70%100% | Same |100%: ±2%
| SpO2 Accuracy | 70
0% to 69%: unspecified | 70% ~100%:±2%;
0% to 69%: unspecified | |
| SpO2 Resolution | 1% | 1% | Same |
| Pulse Rate Range | 25 bpm ~ 250 bpm | 30 bpm ~ 250 bpm | Different |
| Pulse Rate
Accuracy | ±2 bpm | ±3 bpm | |
| Pulse
Rate Resolution | 1 bpm | 1 bpm | Same |
| Data Memory | Not available | Not available | Same |
| Shipped Sterile | No | No | Same |
| Power suppler | 21.5V AAA alkaline battery | 21.5V AAA alkaline battery | Same |
| Safety classification | Class IIa, Internally powered,
Type BF applied part, IP22 | Class IIa, Internally powered, Type BF applied part, IP22 | Same |
| Storage and
Transport
Environment | Temperature: -20°C to 60°C
Atmospheric Pressure: 50 kPa to
I07.4 kPa
Relative Humidity: 10%-95% (no
condensation) | Temperature: -10°Cto 40°C
Atmospheric Pressure: 50 kPa to
106 kPa
Relative Humidity: