(420 days)
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No
The document describes a standard pulse oximeter using established signal processing techniques, with no mention of AI, ML, or related concepts in the device description, performance studies, or key metrics.
Yes
Explanation: The device is intended for "spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate," which are physiological parameters used in medical assessment and management. While it's for spot-checking rather than continuous monitoring, it provides information for medical purposes, indicating a therapeutic intent in supporting diagnosis or treatment decisions. Additionally, it is explicitly stated to be for "patients in hospital-type facilities and homecare" and is "for prescription."
Yes
The device is intended for "spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate," which are measurements used to assess a patient's physiological state and can indicate potential medical conditions, thus serving a diagnostic purpose.
No
The device description explicitly states it is a battery-powered device with hardware components including a power supply module, detector and emitter LED, signal collection and process module, display module, user interface, button control circuit, and an enclosure made of ABS and silicone gel. This indicates it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Pulse Oximeter described is a non-invasive device that measures oxygen saturation and pulse rate by shining light through the finger. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate". This is a direct measurement of physiological parameters, not an analysis of a biological sample.
Therefore, this device falls under the category of a non-invasive physiological monitoring 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 in hospital-type facilities and homecare. The device is not intended to be used under motion and low perfusion. It is designed for finger thickness between 0.8cm and 2.2cm (0.3 inches to 0.9 inches).
Product codes
DQA
Device Description
The proposed device, Pulse Oximeter, is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. It available two models, MD300CN130 and MD300CN356. The model MD300CN130 is adopted LED screen to display SpO2 and Pulse Rate (PR) value, low power indication and pulse bar, the device has 2 display modes. The model MD300CN356 using LCD screen with 7 display modes, it can display SpO2, Pulse Rate (PR), Perfusion Index (PI), waveform, battery indicator, signal indicator and pulse bar, the brightness level can be adjusted 1-10 level. The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit. The enclosure of the proposed device is made of ABS and the fingertip cushion is made of Silicone Gel. 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. The device is for prescription. The device does not contain drug or biological products.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
finger
Indicated Patient Age Range
adult, adolescent, child and infant patients
Intended User / Care Setting
hospital-type facilities and homecare
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
A clinical study was conducted per the requirement of Annex EE of ISO 80601-2-61 to validate the SpO2 accuracy of proposed pulse oximeter. The purpose of the clinical study was to evaluate the SpO2 accuracy performance of the pulse oximeter during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood co-oximeter. 11 healthy adult volunteer subjects (ages 20-42yr, with light to dark pigmentation, include male and female) were included in the study conducted to evaluate the SpO2 accuracy performance of proposed three models. Each system was evaluated during steady state/non-motion conditions with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% and 70% SaO2. Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on reference cooximeter providing functional SaO2 for the basis of the SpO2 accuracy comparison.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards and guidance:
- IEC60601-1: 2005, AMD1:2012, AMD2:2020 Medical Electrical Equipment – Part 1: General Requirements for basic safety and essential performance
- IEC60601-1-11: 2015, AMD1:2020 Medical Electrical Equipment-Part 1-11: General Requirements for basic safety and essential performance- Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC60601-1-2: 2020 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- ISO 80601-2-61:2017 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
- The Software Validation is in compliance with FDA Guidance to Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- ISO10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Clinical Study: A clinical study was conducted per the requirement of Annex EE of ISO 80601-2-61 to validate the SpO2 accuracy of proposed pulse oximeter. The purpose of the clinical study was to evaluate the SpO2 accuracy performance of the pulse oximeter during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood co-oximeter. 11 healthy adult volunteer subjects (ages 20-42yr, with light to dark pigmentation, include male and female) were included in the study conducted to evaluate the SpO2 accuracy performance of proposed three models. Each system was evaluated during steady state/non-motion conditions with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% and 70% SaO2. Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on reference cooximeter providing functional SaO2 for the basis of the SpO2 accuracy comparison. The results of the testing demonstrate that all requirements and performance specifications were satisfied and the subject device is substantially equivalent to its predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 and PR accuracy.
SpO2 accuracy: 70%100%, ± 2%99 bpm, ± 2 bpm; 100 bpm~250 bpm, ± 2%
PR Accuracy: 30 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).
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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.
March 8, 2023
Beijing Choice Electronic Technology Co., Ltd. Haiying Zhao Quality Director 2nd Floor 3rd Floor and Room 410-412 4th Floor No. 2 Building No. 9 Shuangyuan Road Shijingshan Beijing, Beijing 100041 China
Re: K220101
Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: February 21, 2023 Received: March 2, 2023
Dear Haiying 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.
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 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,
James J. Lee -S
James J. Lee, Ph.D. 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220101
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 in hospital-type facilities and homecare. The device is not intended to be used under motion and low perfusion. It is designed for finger thickness between 0.8cm and 2.2cm (0.3 inches to 0.9 inches).
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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Section II 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.
Submitter Information 1.
Manufacturer
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.
2nd Floor, 3rd Floor and Room 410-412 4th Floor, No. 9 Shuangyuan Road, Shijingshan District BEIJING, 100041, P.R. China.
Phone: +86-10-88204631
Fax: 861088204632
Email: cc@choicemmed.com
Date prepared: November 10, 2021
2. Identification of Proposed Device
Device Common Name: Oximeter
Device Trade/Proprietary Name: Pulse Oximeter
Model: MD300CN130, MD300CN356
Classification Name: Oximeter
Regulation Number: 870.2700
Product Code: DQA
Regulatory Class: Class II
Panel: Anesthesiology
3. Device Description
The proposed device, Pulse Oximeter, is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. It available two models, MD300CN130 and MD300CN356. The model MD300CN130 is adopted LED screen to display SpO2 and Pulse Rate (PR) value, low power indication and pulse bar, the device has 2 display modes. The model MD300CN356 using LCD screen with 7 display modes, it can display SpO2, Pulse Rate (PR), Perfusion Index (PI), waveform, battery indicator, signal indicator and pulse bar, the brightness level can be adjusted
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1-10 level.
The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.
The enclosure of the proposed device is made of ABS and the fingertip cushion is made of Silicone Gel.
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.
The device is for prescription.
The device does not contain drug or biological products.
4. Identification of Predicate Device
Trade/Proprietary Name: Fingertip Pulse Oximeter
Model: MD300CI218
Common Name: Pulse Oximeter
K-number: K181503
Regulation Number: 21 CFR 870.2700
Device Class: II
Product Code: DQA
Panel: Anesthesiology
Manufactured by: Beijing Choice Electronic Technology Co., Ltd.
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ડ. Substantially Equivalent (SE) Comparison
Table 1 Comparison Table between the Proposed Device and Predicate Device
| Comparison Elements | Proposed Device | | Predicate Device
(K181503) | Remark | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | MD300CN130 | MD300CN356 | | | |
| Product Name | Pulse Oximeter | Pulse Oximeter | Fingertip Pulse Oximeter | / | |
| Model | MD300CN130 | MD300CN356 | MD300CI218 | / | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | 21 CFR 870.2700 | Same | |
| Regulatory Class | II | II | II | Same | |
| Classification Name | Oximeter | Oximeter | Oximeter | Same | |
| Product Code | DQA | DQA | DQA | Same | |
| 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 in hospitals, hospital-type facilities and homecare. The device is not intended to be used under motion and low perfusion. It is designed for finger thickness between 0.8cm and 2.2cm (0.3 inches to 0.9 inches). | | The Fingertip Pulse Oximeter 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. | Similar 1 | |
| Intended Population | Adult, adolescent, child and infant patients | | Adult, adolescent, child and infant patients | Same | |
| Components | Power supply module, detector and emitter LED, signal collection and processor module, display module, user interface and button control. | | Power supply module, detector and emitter LED, signal collection and processor module, display module, Bluetooth module, user interface and button control. | Similar, Analysis 2 | |
| Design Principle | The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains | | The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular | Same | |
| Comparison Elements | Proposed Device | | Predicate Device
(K181503) | Remark | |
| | MD300CN130 | MD300CN356 | | | |
| | 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. | | 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. | | |
| Measurement | Red | 660± 3nm | | 660± 3nm | |
| Wavelength | Infrared | 905± 10nm | | 905± 10nm | |
| Design | Display Type | LED | LCD | OLED | Different □ Analysis 3 |
| Features | Working Time | continuously operated
as long as 18 hours | continuously operated as
long as 20 hours | continuously operated as long as 18 hours | Similar □ Analysis 4 |
| | Display Mode | 2 display modes | 7 display modes | 2 display modes | Similar, Analysis 5 |
| Power supply | | 2AAA alkaline batteries | | 2AAA alkaline batteries | Same |
| Performance Data | | SpO2. PR | SpO2. PR. PI | SpO2. PR | Similar, Analysis 6 |
| Comparison Elements | Proposed Device | | Predicate Device
(K181503) | Remark | |
| | MD300CN130 | MD300CN356 | | | |
| SpO2 | SpO2 Display Range | 0%100% | 0%250 bpm | | |100% | | |250 bpm | 30 bpm
| | SpO2 Measurement Range | 70%100% | 70%250 bpm | | |100% | | |250 bpm | 30 bpm
| | SpO2 Accuracy | 70%100%, ± 2%;69% no definition | 70%
0100%, ± 2%;69% no definition | | |
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| | SpO2 Resolution | 1% | 1% | | |
| PR | PR Display Range | 30 bpm
| | PR Measurement Range | 30 bpm
| | PR Accuracy | 30 bpm99 bpm, ± 2 bpm;250 bpm, ± 2% | 30 bpm
100 bpm99 bpm, ± 2 bpm;250 bpm, ± 2% | | |
100 bpm
| | PR Resolution | 1 bpm | 1 bpm | | |
| PI | Display range | NA | 0.1%20% | NA | |20.0% | NA | |
| | Measure range | NA | 0.3
| | Resolution | NA | 0.1% | NA | |
| Transmitter | | NA | Bluetooth Compliance: Version 4.0 | | Similar, Analysis 7 |
| Environment | Operating Temperature | 0℃40℃ | 5°C40°C | | Similar, Analysis 8 |
| | Storage/Transport temperature | -25℃~70℃ | -25℃~70℃ | | |
| | Relative Humidity | 15%~93% no condensation in operation;