(142 days)
Not Found
No
The device description details standard pulse oximetry technology using light absorption and a microprocessor for calculation, with no mention of AI or ML algorithms.
No.
The device is used for spot-checking oxygen saturation and pulse rate, which are diagnostic measurements, not therapeutic interventions.
Yes
This device functions as a diagnostic tool by measuring and displaying physiological parameters (oxygen saturation and pulse rate) to assess a patient's health status in a healthcare environment.
No
The device description explicitly details hardware components such as a probe, electronic circuits, display, plastic enclosures, light emitting diodes, a light detector, and a microprocessor. It also mentions being powered by batteries. This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the pulse oximeter measures oxygen saturation and pulse rate by shining light through the finger and detecting the transmitted light. This is a non-invasive measurement performed on the body, not on a sample taken from the body.
- Intended Use: The intended use is for "spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients". This aligns with a non-invasive physiological monitoring device.
Therefore, the device described is a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
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.
YM101 display the measuring results on 1.5' LED screen, and the backlight of the three models are red, white and green respectively. And the screen of YM201 and YM301 are 0.96' OLED and 1.3' OLED. Additionally, battery indicator and pulse waveform can be displayed on YM201 and YM301.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger
Indicated Patient Age Range
adult patients
Intended User / Care Setting
healthcare environments.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Biocompatibility testing: Conducted in accordance with ISO 10993-1. Included Cytotoxicity, Skin Sensitization, Skin Irritation tests. Results demonstrate biocompatibility.
Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012) and IEC 60601-1-2: 2007.
Bench Testing: Complies with ISO 80601-2-61: 2011. Pulse Rate Accuracy meets requirements in ISO 80601-2-61, Clause 201.12.1.104.
Software Verification and Validation Testing: Documentation provided in accordance with FDA Guidance for software with a moderate level of concern.
Cleaning Validation: Conducted in accordance with FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". Performance shows no degradation after repeated cleaning and disinfection.
Clinical data: Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy: 70~100%: ±2%, 0% to 69%: unspecified
Pulse Rate Accuracy: ±2 bpm
Predicate Device(s)
Reference Device(s)
Not Found
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. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 18, 2019
Shenzhen Yimi Life Technology Co.,Ltd. Shande Peng General Manager 305 Tengbo Industrial Park, Changshangjiang Street, Longbei Village, Pingshan District Shenzhen, 518118 CN
Re: K191430
Trade/Device Name: Pulse Oximeter, models YM101, YM201, YM301 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: September 10, 2019 Received: September 20, 2019
Dear Shande Peng:
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.
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
1
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 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 (OS) 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 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,
for Todd Courtney Assistant Director DHT1C: Division of ENT, 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) K191430
Device Name Pulse Oximeter, models YM101, YM201, YM201, YM301
Indications for Use (Describe)
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.
| 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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510(k) Summary
K191430
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Shenzhen Yimi Life Technology Co., Ltd.
305 Tengbo Industrial Park, Changshangjiang Street, Longbei Village,
Pingshan District, 518118, Shenzhen, P.R. China
Tel.: +86 755- 86573112 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Shande Peng |
| Prepare date: | 2019-10-17 |
| 2. Device name
and classification | Device Name: Pulse Oximeter
Models: YM101, YM201, YM301
Classification Name: 21 CFR 870.2700 Oximeter
Product code: DQA
Regulatory Class: Class II |
| 3. Reason for
Submission | New Application. No prior submission associated with the current
submission. |
| 4. Predicate
Device(s) | Shenzhen IMDK Medical Technology Co., Ltd., C101H1 Pulse Oximeter /
K173123 |
| 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.
YM101 display the measuring results on 1.5' LED screen, and the backlight
of the three models are red, white and green respectively. And the screen of
YM201 and YM301 are 0.96' OLED and 1.3' OLED. Additionally, battery
indicator and pulse waveform can be displayed on YM201 and YM301. |
| 6. 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. |
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7. Predicate Device Comparison
Please refer to following table to find differences between the subject device and predicate device.
| ITEM | Proposed Device
YM series Pulse Oximeter | Predicate Device
C101H1/K173123 | Compariso
n Result |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Manufacture | Shenzhen Yimi
Life Technology Co., Ltd. | Shenzhen Med-link
Electronics Tech Co., Ltd. | Different |
| Indications for
Use | The pulse oximeter is
intended for measure
oxygen saturation and pulse
rate of adult patients in
healthcare environments. | Fingertip Pulse Oximeter
C101H1 is a non-invasive
device intended for spot
checking of functional oxygen
saturation of arterial
hemoglobin (SpO2) and pulse
rate (PR). This portable
device is indicated for use
in adult patients in hospitals. | Different |
| Operational Specifications | | | |
| Intended patient
population | Adult | Adult | Same |
| Intended
application site | Finger | Finger | Same |
| use under motion
and low perfusion
conditions | No | No | Same |
| Measurement
Principles | 2-wavelength Relative
Optical Absorption | 2-wavelength Relative
Optical Absorption | Same |
| Signal Detection
Method | Photodetector | Photodetector | Same |
| SpO2 Range | 0100% | 0100% | Same |
| SpO2 Resolution | 1% | 1% | Same |
| SpO2 Accuracy | 70100%: ±2%100%: ±3%
0% to 69%: unspecified | 70
0% to 69%: unspecified | Different |
| Pulse Rate
Range | 25 bpm ~ 250 bpm | 30 bpm ~ 240 bpm | Different |
| Pulse Rate
Accuracy | ±2 bpm | ±1 bpm or ±1%, whichever is
greater | |
| Pulse
Rate Resolution | 1 bpm | 1 bpm | Same |
| Shipped Sterile | No | No | Same |
| Power suppler | 21.5V AAA alkaline battery | 21.5V AAA alkaline battery | Same |
| Storage and
Transport
Environment | Temperature: -20°C to 60°C
Atmospheric Pressure: 50
kPa to 107.4 kPa
Relative Humidity:
10%-95% (no
condensation) | Temperature: -10°C to 40°C
Atmospheric Pressure: 70
kPa to 106 kPa
Relative Humidity: 10%-80%
(no condensation) | Different |
| Table 1 Comparison between main predicate C101H1 and the subject device | ||
|---|---|---|
5
| Operating
Environment | Temperature: 15℃to 40℃
Atmospheric Pressure: 70 kPa to 106 kPa
Relative Humidity:
15%-95% (no
condensation) | Temperature: 5℃to 40℃
Atmospheric Pressure: 70 kPa to 106 kPa
Relative Humidity: 15%-80%
(no condensation) | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------|
| Compliance Standards | | | |
| Bio-compatibility | ISO 10993-1
ISO 109903-5
ISO 10993-10 | ISO 10993-1
ISO 109903-5
ISO 10993-10 | Same |
| Electrical Safety | IEC 60601-1
IEC 60601-1-11 | IEC 60601-1
IEC 60601-1-11 | |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | |
| Performance | ISO 80601-2-61 | ISO 80601-2-61 | |
| Physical Specifications | | | |
| Dimension
(WidthHeightDe
pth) | 57mm×30mm×30 mm | 60mm×35mm×35 mm | Different |
As seen in the comparison tables, the subject and predicate devices have same design principle, similar design features and performance specifications. The different technological characteristics between the subject and predicate devices will not raise different questions of safety or effectiveness.
8. Performance Testing
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
Non-Clinical Testing:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Pulse Oximeter was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. 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+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012) Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2007 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC.
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Bench Testing
Bench testing was conducted, and the results show that the subject device complies with the ISO 80601-2-61: 2011 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of Pulse Oximeter Equipment standard. 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 quidance "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 SpO2 ACCURACY 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.
9. Conclusion
Verification and validation testing was conducted on the subject device Pulse Oximeter and all testing passed pre-specified criteria. This premarket notification submission demonstrates that the subject device is substantially equivalent to the predicate device.