(282 days)
The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients.
Respiratory rate (RR) is intended for adults only.
The Pulse Oximeter is intended for use in hospitals, hospital-type facilities and homecare environment.
The Pulse Oximeter is not intended for patients with:
- cardiopulmonary disease
- cardiac dysrhythmias, unstable patients, or patients in the ICU
- respiratory insufficiency or recovering from surgery or trauma
- morbid obesity
- severe arrhythmia
The Pulse Oximeter is not intended for patients who are:
- injured, disabled or physically deformed
- pregnant or lactating
- taking drugs that stain the blood.
The Pulse Oximeter is not designed to detect apneas.
The proposed device Fingertip Pulse Oximeter MD300CI218R is a battery powered device. It can detect and display the measured %SpO2 ,pulse rate,respiratory rate and perfusion index and will automatically power off when there is no signal for longer than 8 seconds. The proposed device is adopted colorful color OLED screen to display SpO2, PR , respiratory rate, perfusion index, and waveform which can be displayed in 2 directions. And it is designed with the battery indicator function to warn the user that the battery power mav be low.
The proposed device is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients, respiratory rate (RR) for adult in hospital-type facilities and homecare environment. And it can transmit the measurements to Smart Device installed the mobile APP via Bluetooth 4.0 to help the users to organize and track their health information.
The proposed device consists of power supply module, detector and emitter LED, signal collection and processor module, display module, Bluetooth module, user interface and button control.
The fingertip pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.
The proposed device is not for life-supporting or life-sustaining, not for implant.
The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization.
The device is for prescription.
The device does not contain drug or biological products.
The device is software-driven and the software validation is provided in software.
Here's an analysis of the acceptance criteria and study information for the Pulse Oximeter (K211400), based on the provided FDA 510(k) summary:
Acceptance Criteria and Reported Device Performance
The document describes the device performance in terms of accuracy for SpO2 and Pulse Rate (PR), and Mean Error and Root Mean Square (RMS) error for Respiratory Rate (RR).
| Performance Metric | Acceptance Criteria (from predicate) / Standards | Reported Device Performance (Proposed Device) |
|---|---|---|
| SpO2 Accuracy | 70%-100%, ±2%; 0-69% no definition | 70%-100%, ±2%; 0-69% no definition |
| PR Accuracy | 30bpm-99bpm, ±2bpm; 100bpm-250bpm, ±2% | 30bpm-99bpm, ±2bpm; 100bpm-250bpm, ±2% |
| RR Accuracy (Mean Error) | Not explicitly stated as acceptance criteria but implied by predicate: 1 RPM Mean Error (primary predicate) | ±1 rpm |
| RR Accuracy (RMS Error) | Not explicitly stated as acceptance criteria but implied by predicate: 3 RPM ARMS (primary predicate) | ≤ 2 |
| RR Measurement Range | 4-70 rpm (primary predicate) | 4-45 rpm |
Note: The reported device performance for SpO2 and PR is stated as "same as" or "similar to" the predicate devices in the comparison table, which indicates it meets the predicate's performance. For RR, a specific clinical study was performed.
Study Information
Here's an breakdown of the study information based on your requested criteria:
-
Sample size used for the test set and the data provenance:
- SpO2 Measurement: The summary states that clinical testing for SpO2 measurement was conducted as part of K181503 (secondary predicate device) and was not repeated for this submission, as there was no change in the SpO2 measurement function. The sample size and data provenance for the original SpO2 clinical test are not provided in this document.
- Respiratory Rate (RR) Measurement: A specific clinical test was performed for RR.
- Sample Size: 11 healthy adult volunteer subjects and 22 patients. (Total of 33 subjects)
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective), but it was a clinical test performed by "Choice" (Beijing Choice Electronic Technology Co., Ltd.), implying it was likely prospective for the purpose of this submission. No specific region or country is disclosed for the subjects.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For SpO2: Not applicable in this submission as the clinical test data was carried over from the predicate. Information on ground truth experts for the original predicate study is not available in this document.
- For RR: The document does not specify the number of experts used or their qualifications for establishing the ground truth for the respiratory rate during the clinical test. It only states that a "clinical test" was performed and a "clinical study report was presented in Performance Testing-Clinical Study Report."
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not provide information about any adjudication method used for either the SpO2 (from predicate) or the RR clinical test.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was mentioned. This device (Pulse Oximeter) is a standalone measurement device and not described as incorporating AI for human reader assistance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the device itself is a standalone measurement device (algorithm only, without human-in-the-loop assistance in the sense of AI-aided diagnosis). The clinical test for Respiratory Rate directly assessed the device's performance against a reference standard in patients.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- SpO2: The type of ground truth for SpO2 from the predicate study is not specified in this document, but typically, pulse oximeter accuracy studies use fractional arterial oxygen saturation (SaO2) measured by a co-oximeter from arterial blood samples as the gold standard.
- RR: The document does not explicitly state the specific method used to establish the ground truth for respiratory rate in the clinical study. Common ground truth methods for RR measurement include manual counting by trained personnel or capnography.
-
The sample size for the training set:
- The document does not provide any information about a "training set" or "training data" for this device. This implies that the device's algorithms were likely developed and validated internally against engineering standards and potentially historical data, rather than through a separate, explicitly described machine learning training pipeline in this regulatory submission. For traditional medical devices like this, the 'training' phase might be part of the R&D and engineering design process rather than a distinct 'training set' as understood in AI/ML contexts.
-
How the ground truth for the training set was established:
- Not applicable, as no training set information is provided.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
February 11, 2022
Beijing Choice Electronic Technology Co., Ltd. Haiying Zhao Quality Director No.9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing, 100041 China
Re: K211400
Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: February 11, 2022 Received: August 6, 2021
Dear Haiving Zhao:
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.
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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 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 Courtnev 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
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Indications for Use
510(k) Number (if known) K211400
Device Name Pulse Oximeter
Indications for Use (Describe)
The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients.
Respiratory rate (RR) is intended for adults only.
The Pulse Oximeter is intended for use in hospitals, hospital-type facilities and homecare environment.
The Pulse Oximeter is not intended for patients with:
- · cardiopulmonary disease
- · cardiac dysrhythmias, unstable patients, or patients in the ICU
- · respiratory insufficiency or recovering from surgery or trauma
- · morbid obesity
- · severe arrhythmia
The Pulse Oximeter is not intended for patients who are:
- · injured, disabled or physically deformed
- · pregnant or lactating
- · taking drugs that stain the blood.
The Pulse Oximeter is not designed to detect apneas.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Research Use (Part 21 CFR 361.2, Subpart B) |
|---|
| Same As Control Use (21 CFR 361.2, Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Section III 510(k) Summary
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.
There is no prior submission for the device.
3.1 Submitter Information
● Manufacturer Name:
Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. 2nd Floor, 3rd Floor and Room 410-412 4th Floor, No. 2 Building, No. 9 Shuangyuan Road , Shijingshan District BEIJING, 100041, P.R.China
. Contact Person:
Haiying Zhao Beijing Choice Electronic Technology Co., Ltd. North Building 3F, No. 9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing China 100041 Phone: +86-10-88204631 Fax:861088204632 Email: cc(@choicemmed.com
- Date prepared : January 6, 2022
3.2 Proposed Device Information
Device Common Name: Pulse Oximeter Device Trade/Proprietary Name: Pulse Oximeter Model: MD300CI218R Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA
Regulatory Class: Class II
Panel: Anesthesiology
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3.3 Predicate Device
| Elements | Primary Predicate Device | Secondary Predicate Device |
|---|---|---|
| 510(k) Number | K181956 | K181503 |
| Device Name | Masimo MightySat Rx FingertipPulse Oximeter | Fingertip Pulse Oximeter |
| Model | / | MD300CI218 |
| Classification Name | Oximeter | Oximeter |
| Product Code | DQA,BZQ | DQA |
| Regulation Number | 870.2700 | 870.2700 |
| Regulatory Class | Class II | Class II |
| Panel | Anesthesiology | Anesthesiology |
| Applicant | Masimo Corporation | Beijing Choice ElectronicTechnology Co., Ltd. |
| Indications for Use | The Masimo MightySat RxFingertip Pulse Oximeter isintended for hospitals,hospital-type facilities,homeenvironments, and transport.The Masimo MightySat RxFingertip Pulse Oximeter isindicated for the noninvasivespot checking of functionaloxygen saturation of arterialhemoglobin (SpO2) and pulserate (PR) for adult and pediatricpatients during both no motionand motion conditions, and forpatients who are well or poorlyperfused.The Masimo MightySat RxFingertip Pulse Oximeter isindicated for the noninvasivespot checking of respiration rate(RRn) for adult patients | The MD300CI218 is a handheldnon-invasive device intended forspot-checking of oxygensaturation of arterial hemoglobin(SpO2) and Pulse Rate of adult,adolescent, child and infantpatients in hospitals,hospital-type facilities andhomecare environment. |
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3.4 Device Description
The proposed device Fingertip Pulse Oximeter MD300CI218R is a battery powered device. It can detect and display the measured %SpO2 ,pulse rate,respiratory rate and perfusion index and will automatically power off when there is no signal for longer than 8 seconds. The proposed device is adopted colorful color OLED screen to display SpO2, PR , respiratory rate, perfusion index, and waveform which can be displayed in 2 directions. And it is designed with the battery indicator function to warn the user that the battery power mav be low.
The proposed device is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients, respiratory rate (RR) for adult in hospital-type facilities and homecare environment. And it can transmit the measurements to Smart Device installed the mobile APP via Bluetooth 4.0 to help the users to organize and track their health information.
The proposed device consists of power supply module, detector and emitter LED, signal collection and processor module, display module, Bluetooth module, user interface and button control.
The fingertip pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.
The proposed device is not for life-supporting or life-sustaining, not for implant.
The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization.
The device is for prescription.
The device does not contain drug or biological products.
The device is software-driven and the software validation is provided in software.
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3.5 Comparison list of the technological characteristics
| Comparison Elements | Proposed Device | Secondary Predicate Device | Primary Predicate Device |
|---|---|---|---|
| Product Name | Pulse Oximeter | Fingertip Pulse Oximeter | Masimo MightySat Rx FingertipPulse Oximeter |
| Model | MD300CI218R | MD300CI218 | Not Specified |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | 21 CFR 870.2700 |
| Classification | Ⅱ | Ⅱ | Ⅱ |
| Classification Name | Oximeter | Oximeter | Oximeter |
| Product Code | DQA | DQA | DQA,BZQ |
| Indications for Use | The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients.Respiratory rate (RR) is intended for adults only. | The MD300CI218 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients in hospitals, hospital-type facilities and homecare environment. | The Masimo MightySat Rx Fingertip Pulse Oximeter is intended for hospitals hospital-type facilities, home environments, and transport.The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for |
Table 3-1 Performance Specification Comparison Table between the Proposed Device and Predicate Device
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| Premarket Notification 510(k) Submission-Section III 510(k) Summary | |
|---|---|
| --------------------------------------------------------------------- | -- |
| intended for use inhospitals, hospital-typefacilities and homecareenvironment.The Pulse Oximeter is notintended for patients with:● cardiopulmonary disease● cardiac dysrhythmias,unstable patients, orpatients in the ICU● respiratory insufficiencyor recovering from surgeryor trauma● morbid obesity● severe arrhythmiaThe Pulse Oximeter is notintended for patients whoare:● injured, disabled orphysically deformed● pregnant or lactating● taking drugs that stain theblood.The Pulse Oximeter is notdesigned to detect apneas. | both no motion and motionconditions, and for patients whoare well or poorly perfused.The Masimo Mighty Sat RxFingertip Pulse Oximeter isindicated for the noninvasive spotchecking of respiration rate (RRp)for adult patients. | ||
|---|---|---|---|
| Comparison Statement | The proposed device and the primary predicate device have the same intended use expect that theproposed device can not be used in transport and poor perfused. |
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| Components | Power supply module, detector and emitter LED, signal collection and processor module, display module, Bluetooth module, user interface and button control. | Power supply module, detector and emitter LED, signal collection and process module, display module, Bluetooth module, indicator module, user interface. | It includes an OLED color display, enclosed by plastic housing and powered by two alkaline AAA batteries. |
|---|---|---|---|
| Design Principle | The fingertip pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light | The fingertip pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. | The MightySat Rx adopts Masimo SET technology which uses a two-wavelength sensor to measure the indicated parameters based on light absorption principles of oxygenated blood and deoxygenated blood which generates a photoplethysmogram. Respiration rate (RRp) measures the respiration rate by analyzing cyclic variations in the photoplethysmogram due to respiration. |
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| intensity. The arteriolar bed | |||||
|---|---|---|---|---|---|
| normally pulsates and | |||||
| absorbs variable amounts | |||||
| of light during systole and | |||||
| diastole, as blood volume | |||||
| increases and decreases. | |||||
| The ratio of light absorbed | |||||
| at systole and diastole is | |||||
| translated into an oxygen | |||||
| saturation measurement.This measurement isreferred to as SpO2. | |||||
| Respiration rate (RR) | |||||
| measures the respirationrate by analyzing cyclicvariations in thephotoplethysmogram dueto respiration. | |||||
| MeasurementWavelength | Red | 660±3nm | 660±3nm | Not Specified | |
| Infrared | 905 ± 10nm | 905 ± 10nm | Not Specified | ||
| Comparison Statement | The proposed device and the primary predicate device have the same design principle.It has identical measurement wavalength as the second predicate device. | ||||
| Display Type | OLED | OLED | OLED | ||
| User Interface | 2 display directions | 2 display directions | 2 display directions |
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| Power supply | 2* AAA alkaline batteries | 2* AAA alkaline batteries | 2*AAA alkaline batteries | RRMeasurementRange | 4-45rpm | NA | 4-70 | |
|---|---|---|---|---|---|---|---|---|
| Display Data | SpO2, PR,RespiratoryRate, Perfusion Index,pulsewaveform | SpO2, PR | SpO2, PR,RespiratoryRate,Perfusion Index, PlethVariability Index | RR Accuracy | Mean Error: ±1rpm | NA | 3 RPM ARMS, 1 RPM Mean Error | |
| SpO2 DisplayRange | 0~100% | 0%~100% | 0%~100% | Perfusion IndexMeasurementRange | 0.1%-20% | NA | 0.02%-20% | |
| SpO2MeasurementRange | 70%~100% | 70%~100% | 70%~100% | Perfusion IndexResolution | 0.1% | NA | Not specified | |
| SpO2 Accuracy | 70% | 70% | 70%~100%, ±2% | WirelessTransmissionRange | 0~10m | 0~10m | Not specified | |
| SpO2Resolution | 1% | 1% | 1% | Antenna Type | Internal | Internal | Not specified | |
| PR DisplayRange | 30bpm~250bpm | 30bpm~250bpm | 25bpm~240bpm | Transmitter | BluetoothVersion 4.0 | Compliance: Bluetooth Compliance: Version 4.0 | Not specified | |
| PRMeasurementRange | 30bpm~250bpm | 30bpm~250bpm | 25bpm~240bpm | OperatingTemperature | 5°C~40°C | 5°C~40°C | 5°C~40°C | |
| PR Accuracy | 30bpm | 30bpm | 3 BPM ARMS | RelativeHumidity | 15% ~93%, nocondensation in operation;≤93% no condensation instorage | 15% ~93%, no condensation inoperation;≤93% no condensation in storage | 10% to 95%, non-condensing | |
| PR Resolution | 1 BPM | 1 BPM | 1 BPM | AtmospherePressure | 70kPa~106kpa | 70kPa~106kpa | 54kPa~106kpa |
Premarket Notification 510(k) Submission—Section III 510(k) Summary
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NA
4-70
Premarket Notification 510(k) Submission-Section III 510(k) Summary
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Premarket Notification 510(k) Submission—Section III 510(k) Summary
| Comparison Statement | The Proposed device has similar product specification as the primary predicate device . The proposed device and the secondary predicate device have identical product specification except that the proposed device can measure PI and RR. | |||
|---|---|---|---|---|
| ContactingMaterial | Battery Cover | ABS | ABS | Not specified |
| Enclosure | ||||
| Power Button | ||||
| FingertipCushion | Silicone Gel | Silicone Gel | Not specified | |
| Comparison Statement | The contacting materials of the proposed device are same to those of the secondary predicate device. | |||
| Performance Testing | LaboratoryTesting | The laboratory tests include SpO2 and PR accuracy Test, Weak Perfusion Test, High and Low Temperature and Humidity Test, Performance Test After Cleaning and ISO80601-2-61 | The laboratory tests include SpO2 and PR accuracy Test, Weak Perfusion Test, High and Low Temperature and Humidity Test, Performance Test After Cleaning and ISO80601-2-61 | Mechanical and environmental testing, Performance Test After Cleaning and ISO80601-2-61 |
| ElectricalSafety | Conformed to IEC60601-1, IEC 60601-1-11 | Conformed to IEC60601-1, IEC 60601-1-11 | Conformed to IEC60601-1, IEC 60601-1-11 | |
| EMCElectrical Safeand | ElectromagneticCompatibility | Conformed toIEC60601-1-2Conformed to FCCcertification | Conformed to IEC60601-1-2Conformed to FCC certification | Conformed to IEC60601-1-2Conformed to FCC certification |
| Software and Cybersecurity | Moderate level of concern | Moderate level of concern | Moderate level of concern | |
| Compliance with:FDA Guidance for thecontent of PremarketSubmissions for SoftwareContained in MedicalDevices and,FDA Guidance for Contentof Premarket Submissionfor Management ofCybersecurity in MedicalDevice | Compliance with:FDA Guidance for the content ofPremarket Submissions forSoftware Contained in MedicalDevices and,FDA Guidance for Content ofPremarket Submission forManagement of Cybersecurity inMedical Device | Compliance with:FDA Guidance for the content ofPremarket Submissions forSoftware Contained in MedicalDevices and,FDA Guidance for Content ofPremarket Submission forManagement of Cybersecurity inMedical Device | ||
| Risk Management inCompliance withISO14971 | Risk Management in Compliancewith ISO14971 | Risk Management in Compliancewith ISO14971 | ||
| Label and Labeling | Compliance with theGuidance of pulseoximeter-premarketnotification issued onMarch 4 2013 | Compliance with the Guidance ofpulse oximeter-premarketnotification issued onMarch 4,2013 | Compliance with the Guidance ofpulse oximeter-premarketnotification issued onMarch 4,2013 |
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Premarket Notification 510(k) Submission—Section III 510(k) Summary
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3.6 Intended use
The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients, respiratory rate (RR) for adult in hospitals, hospital-type facilities and homecare environment.
3.7 Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility testing of the patient contacted materials used in the proposed device have been conducted according to the requirement of ISO 10993-1, ISO 10993-5, ISO 10993-10.
Electrical safety and electromagnetic compatibility (EMC)
We have conducted IEC 60601-1,IEC 60601-1-11,IEC 60601-1-2,ISO 80601-2-61 test for the proposed device.
We have also conducted other performance test including SpO2 Accuracy Test, PR Accuracy Test, Reperatory Rate Test , Perfusion Index Test Device, Output Time and Finger Out Time Test, Device Response Time Test, , High and Low Temperature & Humidity Test Per Guidance for Industry and FDA Staff: Pulse Oximeter-Premarket Notification submission [510(k)s].
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
Wireless Testing
The hardare of the proposed device is same to those of the secondary predicate device
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which was cleared in October 11.2018 by FDA. So testing reports performed and submitted with K181503 with repect to FCC and wireless coexistence also apply to the proposed device.
Clinical Test
In K181503, Choice include the clinical test of the secondary predicate device for the SpO2 measurement. Because there was no change in SpO2 measurement function of the device as part of this submission, the clinical study for SpO2 was not repeated.
For this submission to add the Respiratory Rate.Choice performed clinical test to validate the performance of Respiratory Rate. Choice conduted the clinial test on 11 heathy adult volunteer subjects and 22 patient. There were no adverse events during the study. The results of clinical study of respiratory rate is that the Mean Error is ± 1 and the Root mean square error is ≤ 2. The clinical study report was presented in Performance Testing-Clinical Study Report.
3.8 Conclusion
The proposed device has the same classification information, same intended use, similar design principle as the primary predicated device. The hardware of the proposed device is same as the secondary predicate device . The results of the testing demonstrate that all requirements and performance specifications were satisfied and the subject device is substantially equivalent to its predicate.
§ 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).