(282 days)
Not Found
No
The summary describes standard pulse oximetry technology and signal processing without mentioning AI or ML. The performance studies focus on traditional accuracy metrics for SpO2, PR, and RR.
No.
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate" and "is not for life-supporting or life-sustaining". This indicates it is a diagnostic or monitoring device, not one designed to provide therapy.
Yes
Explanation: The device is intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate, and Respiratory Rate, which are physiological measurements used to assess a patient's health status, thus aiding in diagnosis.
No
The device description explicitly states it is a "battery powered device" and lists hardware components such as a "power supply module, detector and emitter LED, signal collection and processor module, display module, Bluetooth module, user interface and button control." While it includes software, it is not solely software.
Based on the provided text, 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 the device is a "handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate... Respiratory rate (RR)..." It works by applying a sensor to the fingertip and using light absorption to measure these parameters.
- No Sample Analysis: The device does not analyze any samples taken from the body. It directly measures physiological parameters on the body.
Therefore, the device falls under the category of a non-invasive medical device, not an in vitro diagnostic.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip
Indicated Patient Age Range
adult, adolescent, child and infant patients (SpO2 and Pulse Rate)
adults (Respiratory Rate)
Intended User / Care Setting
hospitals, hospital-type facilities and homecare environment.
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Test for Respiratory Rate:
Sample Size: 11 healthy adult volunteer subjects and 22 patients.
Key Results: The Mean Error is ± 1 and the Root mean square error is ≤ 2.
Other Performance Tests (details not provided on specific study types or full results):
- Biocompatibility Testing (ISO 10993-1, ISO 10993-5, ISO 10993-10)
- Electrical safety and electromagnetic compatibility (EMC) (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 80601-2-61)
- 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
Software Verification and Validation Testing: Considered "Moderate" level of concern.
Wireless Testing: Testing reports from K181503 regarding FCC and wireless coexistence also apply to the proposed device.
Clinical Test for SpO2: Not repeated, as there was no change in SpO2 measurement function. Information from K181503 applies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Respiratory Rate (Clinical Study):
Mean Error: ± 1
Root mean square error: ≤ 2
SpO2 Accuracy: 70%100%, ±2%; 069% no definition
PR Accuracy: 30bpm99bpm, ±2bpm; 100bpm250bpm, ±2%
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
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 & 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.
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 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
2
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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3
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
4
3.3 Predicate Device
| Elements | Primary Predicate Device | Secondary Predicate Device |
|---|---|---|
| 510(k) Number | K181956 | K181503 |
| Device Name | Masimo MightySat Rx Fingertip | |
| Pulse 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 Electronic |
| Technology Co., Ltd. | ||
| Indications for Use | 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 adult and pediatric | ||
| patients during both no motion | ||
| and motion conditions, and for | ||
| patients who are well or poorly | ||
| perfused. | ||
| The Masimo MightySat Rx | ||
| Fingertip Pulse Oximeter is | ||
| indicated for the noninvasive | ||
| spot checking of respiration rate | ||
| (RRn) for adult patients | 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. |
5
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.
6
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 Fingertip |
| Pulse 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
7
| Premarket Notification 510(k) Submission-Section III 510(k) Summary | |
|---|---|
| --------------------------------------------------------------------- | -- |
| | 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. | | both no motion and motion
conditions, and for patients who
are well or poorly perfused.
The Masimo Mighty Sat Rx
Fingertip Pulse Oximeter is
indicated for the noninvasive spot
checking of respiration rate (RRp)
for adult patients. |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison Statement | The proposed device and the primary predicate device have the same intended use expect that the
proposed device can not be used in transport and poor perfused. | | |
8
| 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. |
9
| 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. | |||||
| Respiration rate (RR) | |||||
| measures the respiration | |||||
| rate by analyzing cyclic | |||||
| variations in the | |||||
| photoplethysmogram due | |||||
| to respiration. | |||||
| Measurement | |||||
| Wavelength | 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 |
10
| | Power supply | 2* AAA alkaline batteries | 2* AAA alkaline batteries | 2*AAA alkaline batteries | RR
Measurement
Range | 4-45rpm | NA | 4-70 |
|--|------------------------------|-----------------------------------------------------------------|-------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------|
| | Display Data | SpO2, PR,Respiratory
Rate, Perfusion Index,pulse
waveform | SpO2, PR | SpO2, PR,Respiratory
Rate,Perfusion Index, Pleth
Variability Index | RR Accuracy | Mean Error: ±1rpm | NA | 3 RPM ARMS, 1 RPM Mean Error |
| | SpO2 Display
Range | 0100% | 0%250bpm | 25bpm100% | 0%250bpm | 30bpm100% | Perfusion Index240bpm | Transmitter | Bluetooth
Measurement
Range | 0.1%-20% | NA | 0.02%-20% |
| | SpO2
Measurement
Range | 70%100% | 70%250bpm | 25bpm100% | 70%250bpm | 30bpm100% | Perfusion Index10m | Not specified |
Resolution | 0.1% | NA | Not specified |
| | SpO2 Accuracy | 70%100%, ±2%;69% no definition | 70%
0100%, ±2%;69% no definition | 70%
0100%, ±2% | Wireless10m | 0
Transmission
Range | 0
| | SpO2
Resolution | 1% | 1% | 1% | Antenna Type | Internal | Internal | Not specified |
| | PR Display
Range | 30bpm
Version 4.0 | Compliance: Bluetooth Compliance: Version 4.0 | Not specified |
| | PR
Measurement
Range | 30bpm240bpm | Operating40°C | 5°C
Temperature | 5°C40°C | 5°C40°C |
| | PR Accuracy | 30bpm99bpm, ±2bpm;250bpm, ±2% | 30bpm
100bpm99bpm, ±2bpm;250bpm, ±2% | 3 BPM ARMS | Relative
100bpm
Humidity | 15% 93%, no106kpa | 54kPa~106kpa |
condensation in operation;
≤93% no condensation in
storage | 15% 93%, no condensation in106kpa | 70kPa
operation;
≤93% no condensation in storage | 10% to 95%, non-condensing |
| | PR Resolution | 1 BPM | 1 BPM | 1 BPM | Atmosphere
Pressure | 70kPa
Premarket Notification 510(k) Submission—Section III 510(k) Summary
11
NA
4-70
Premarket Notification 510(k) Submission-Section III 510(k) Summary
12
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. | |||
|---|---|---|---|---|
| Contacting | ||||
| Material | Battery Cover | ABS | ABS | Not specified |
| Enclosure | ||||
| Power Button | ||||
| Fingertip | ||||
| Cushion | 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 | Laboratory | |||
| Testing | 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 | |
| Electrical | ||||
| Safety | Conformed to IEC60601-1, IEC 60601-1-11 | Conformed to IEC60601-1, IEC 60601-1-11 | Conformed to IEC60601-1, IEC 60601-1-11 | |
| EMC | ||||
| Electrical Safe | ||||
| and | Electromagnetic | |||
| Compatibility | Conformed to | |||
| IEC60601-1-2 | ||||
| Conformed to FCC | ||||
| certification | Conformed to IEC60601-1-2 | |||
| Conformed to FCC certification | Conformed to IEC60601-1-2 | |||
| Conformed to FCC certification | ||||
| Software and Cybersecurity | Moderate level of concern | Moderate level of concern | Moderate level of concern | |
| Compliance with: | ||||
| FDA Guidance for the | ||||
| content of Premarket | ||||
| Submissions for Software | ||||
| Contained in Medical | ||||
| Devices and, | ||||
| FDA Guidance for Content | ||||
| of Premarket Submission | ||||
| for Management of | ||||
| Cybersecurity in Medical | ||||
| Device | Compliance with: | |||
| FDA Guidance for the content of | ||||
| Premarket Submissions for | ||||
| Software Contained in Medical | ||||
| Devices and, | ||||
| FDA Guidance for Content of | ||||
| Premarket Submission for | ||||
| Management of Cybersecurity in | ||||
| Medical Device | Compliance with: | |||
| FDA Guidance for the content of | ||||
| Premarket Submissions for | ||||
| Software Contained in Medical | ||||
| Devices and, | ||||
| FDA Guidance for Content of | ||||
| Premarket Submission for | ||||
| Management of Cybersecurity in | ||||
| Medical Device | ||||
| Risk Management in | ||||
| Compliance with | ||||
| ISO14971 | Risk Management in Compliance | |||
| with ISO14971 | Risk Management in Compliance | |||
| with ISO14971 | ||||
| Label and Labeling | Compliance with the | |||
| Guidance of pulse | ||||
| oximeter-premarket | ||||
| notification issued on | ||||
| March 4 2013 | Compliance with the Guidance of | |||
| pulse oximeter-premarket | ||||
| notification issued on | ||||
| March 4,2013 | Compliance with the Guidance of | |||
| pulse oximeter-premarket | ||||
| notification issued on | ||||
| March 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.