(420 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 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).
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.
Here's an analysis of the acceptance criteria and study detailed in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance document indicates that the device's performance was compared to its predicate device and to standards. For SpO2 and PR accuracy, the acceptance criteria are generally established by standards like ISO 80601-2-61.
| Feature / Metric | Acceptance Criteria (from predicate/standards) | Reported Device Performance (from studies) |
|---|---|---|
| SpO2 Display Range | 0%~100% | 0%~100% |
| SpO2 Measurement Range | 70%~100% | 70%~100% |
| SpO2 Accuracy (70%~100%) | ± 2% | 70%~100%, ± 2% (implied by meeting standards) |
| SpO2 Accuracy (0~69%) | No definition | 0~69% no definition |
| SpO2 Resolution | 1% | 1% |
| PR Display Range | 30 bpm~250 bpm | 30 bpm~250 bpm |
| PR Measurement Range | 30 bpm~250 bpm | 30 bpm~250 bpm |
| PR Accuracy (30 bpm~99 bpm) | ± 2 bpm | 30 bpm~99 bpm, ± 2 bpm (implied by meeting standards) |
| PR Accuracy (100 bpm~250 bpm) | ± 2% | 100 bpm~250 bpm, ± 2% (implied by meeting standards) |
| PR Resolution | 1 bpm | 1 bpm |
| Biocompatibility | Meet ISO 10993-1, -5, -10 | Tests confirm meeting requirements (Section 5, Analysis 9) |
| Electrical Safety | Conformed to IEC60601-1, IEC 60601-1-11 | Conformed (Section 7, Non-Clinical Test Conclusion) |
| EMC | Conformed to IEC60601-1-2 | Conformed (Section 7, Non-Clinical Test Conclusion) |
| Software Validation | Compliance with FDA Guidance for Software in Medical Devices | Compliance (Section 7, Non-Clinical Test Conclusion) |
| Operational Temp (MD300CN130) | 0℃~40℃ | 0℃~40℃ (implied by meeting standard ISO 80601-2-61) |
| Operational Temp (MD300CN356 & Predicate) | 5°C~40°C | 5°C~40°C (implied by meeting standard ISO 80601-2-61) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 11 healthy adult volunteer subjects.
- Data Provenance: The study was a prospective clinical study conducted to validate SpO2 accuracy. The country of origin is not explicitly stated, but the manufacturer is based in Beijing, China, suggesting the study likely occurred in China or an affiliated location. The subjects had "light to dark pigmentation, include male and female."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts used to establish ground truth or their qualifications. However, the ground truth was established by "arterial blood co-oximeter," which is a laboratory instrument. This implies expert handling and interpretation of the co-oximeter results, but no specific human expert qualifications are provided for the ground truth establishment itself. Clinical personnel would have been involved in drawing blood samples and operating the co-oximeter.
4. Adjudication Method for the Test Set
Not applicable. This was a quantitative measurement comparison study against a reference standard (co-oximeter), not a qualitative assessment requiring adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study focused on the standalone performance of the pulse oximeter against a clinical reference standard. It did not involve human readers interpreting results with or without AI assistance.
6. If a Standalone Study Was Done
Yes, a standalone study was done. The clinical study described in Section 7 (Clinical Test) was conducted to evaluate the SpO2 accuracy performance of the proposed pulse oximeter itself, without human-in-the-loop interaction for interpretation, other than operating the device.
7. The Type of Ground Truth Used
The ground truth used was outcomes data / reference standard measurement from an "arterial blood co-oximeter." This is considered a gold standard for measuring arterial oxygen saturation (SaO2).
8. The Sample Size for the Training Set
The document does not provide information regarding a training set or its size. As this is a traditional medical device (pulse oximeter) and not explicitly a machine learning/AI device in the context of image analysis or complex pattern recognition requiring a training set, such information would typically not be present in its 510(k) submission. Pulse oximeters operate based on established physiological principles and algorithms, rather than training on large datasets in the way modern AI models do.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set information is provided or implied for this type of device.
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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 onewavelength of light source is 660nm, which is redlight; the other is 905nm, which is infrared-red light.Skin, bone, tissue and venous vessels normallyabsorb a constant amount of light over time. Thephoto detector in finger sensor collects and convertsthe light into electronic signal which is proportionalto the light intensity. The arteriolar bed normallypulsates and absorbs variable amounts of light duringsystole and diastole, as blood volume increases anddecreases. The ratio of light absorbed at systole anddiastole is translated into an oxygen saturationmeasurement. This measurement is referred to asSpO2. | bed. The sensor contains a dual lightsource and photo detector. The onewavelength 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 absorba constant amount of light over time. Thephoto detector in finger sensor collectsand converts the light into electronicsignal which is proportional to the lightintensity. The arteriolar bed normallypulsates and absorbs variable amounts oflight during systole and diastole, as bloodvolume increases and decreases. The ratioof light absorbed at systole and diastole istranslated into an oxygen saturationmeasurement. This measurement isreferred 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 operatedas long as 18 hours | continuously operated aslong 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 | 2*AAA alkaline batteries | 2*AAA 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%~100% | ||
| SpO2 Measurement Range | 70%~100% | 70%~100% | |||
| SpO2 Accuracy | 70% | 70% | |||
| SpO2 Resolution | 1% | 1% | |||
| PR | PR Display Range | 30 bpm~250 bpm | 30 bpm~250 bpm | ||
| PR Measurement Range | 30 bpm~250 bpm | 30 bpm~250 bpm | |||
| PR Accuracy | 30 bpm | 30 bpm | |||
| PR Resolution | 1 bpm | 1 bpm | |||
| PI | Display range | NA | 0.1%~20% | NA | |
| Measure range | NA | 0.3~20.0% | NA | ||
| Resolution | NA | 0.1% | NA | ||
| Transmitter | NA | Bluetooth Compliance: Version 4.0 | Similar, Analysis 7 | ||
| Environment | Operating Temperature | 0℃~40℃ | 5°C~40°C | Similar, Analysis 8 | |
| Storage/Transport temperature | -25℃~70℃ | -25℃~70℃ | |||
| Relative Humidity | 15%~93% no condensation in operation;<=93% no condensation in storage/transport | 15%~93% no condensation in operation;<=93% no condensation in storage/transport | |||
| Atmosphere Pressure | 70kPa~106kpa | 70kPa~106kpa | |||
| Comparison Elements | Proposed Device | Predicate Device(K181503) | Remark | ||
| MD300CN130 | MD300CN356 | ||||
| ContactingMaterial | Battery Cover | ABS | ABS | Different 9 | |
| Enclosure | ABS | ABS | |||
| Screen protectfilm | PMMA | PMMA | |||
| Power Button | Silica gel | ABS | |||
| FingertipCushion | Silica gel | Silica gel | |||
| Testing | LaboratoryTesting | The laboratory tests include SpO2 PR and PI (onlyapply for MED300CN356) accuracy Test, WeakPerfusion Test, High and Low Temperature andHumidity Test, Performance Test After Cleaning andISO 80601-2-61 | The laboratory tests include SpO2 and PRaccuracy Test, Weak Perfusion Test, Highand Low Temperature and Humidity Test,Performance Test After Cleaning and ISO80601-2-61 | Similar, Analysis 10 | |
| Electrical Safety | Conformed to IEC60601-1, IEC 60601-1-11 | Conformed to IEC60601-1, IEC 60601-1-11 | |||
| ElectromagneticCompatibility | Conformed to IEC60601-1-2 | Conformed to IEC60601-1-2 | |||
| Software | Compliance with FDA Guidance for the content ofPremarket Submissions for Software Contained inMedical Devices | Compliance with FDA Guidance for thecontent of Premarket Submissions forSoftware Contained in Medical Devices | |||
| Comparison Elements | Proposed Device | Predicate Device(K181503) | Remark | ||
| MD300CN130 | MD300CN356 | ||||
| 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 | Same |
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Analysis 1 - Intended Use
The intended use of proposed device is similar with the ntended finction and population of proposed device is the same. The intended use of proposed device provided more detailed description of the better understand for home use. This difference does not affect the substantially equivalence between proposed device on safety and effectiveness.
The intended use
Analysis 2 - Components
The components of proposed device are similar with does not have the Bluetooth module. The Bluetooth module that does not affect other function of device. In addition of proposed device have been verification and the results ould meet the requirement of IEC 60601-1-11, IEC60601-1-2 and ISO 80601-2-61, Submissions for Software Contained in Medical Devices. Therefore, this difference does not affect substantially equivalence between proposed device on safety and effectiveness.
Analysis 3 - Display Type
The proposed device has the different display type with the mode MD300CN 30 of proposed device is configurated with the LED display, the mode MD300CN356 are configurated with the predicate device is using the OLED display. The varies display type is due to different marked strategy. In addition, the final products have validation and the result could meet the requirement of IEC 60601-1-11, IEC60601-1-2 and ISO 80601-2-61. Therefore, this diffect substantially equivalence between proposed device and predicate device on safety and effectiveness.
Analysis 4 - Working Time
The working time of proposed device is different from the streent hardware and software design of each model. However, the final products have been verification and the result could meet the requirement of IEC 60601-1-11, IEC60601-1-2 and ISO 8001-2
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- Therefore, this difference does not affect substantially equivalence between proposed device on safety and effectiveness.
Analysis 5 - Display Mode
The display mode of the proposed device is different from the varies display modes more choices for consumer. The display mode is depended on the display type and embedded software. However, the final products have been verification and the requrenent of ISO 80001-2-61. In addition, the embeded software could meet the requirements of Software Contained in Medical Devices. This difference does not affect substantially equivalence between proposed device on safety and effectiveness.
Analysis 6 - Performance Data
The mode MD300CN130 of proposed device can measure that is same with the predicate device. Meanwhile, the mode MD300CN356 has on more PI performance data compare with the parameters of SpO2 and PR for proposed device are totally same with the predicate device. The PI finction had been ver ISO 80601-2-61 and the result could meet the requirement. Therefore, this difference does not affect substantially equivalence between proposed device and predicate device on safectiveness.
Analysis 7 - Transmitter
The proposed device does not have the Bluetont from predicate device. The Bluetooth is the independent function module, it will not affect other functions. In addition, the embeded software could meet the requirements of Submissions for Software Contained in Medical Devices. Therefore, this difference does not affect substantially equivalence between proposed device and predicate device on safectiveness.
Analysis 8 - Environment
The Operaing Temperature of proposed device and other environment requirements are same. The lover Imit operating temperature of proposed device is 0°C which the peating temperature of proposed device has been verification according to standard ISO 80601-2-61. All the results candard requirements. Therefore, this difference does not affect substantially equivalence between proposed device and predicate device on safety and effectiveness.
Different 9 - Contacting Material
The contact materials of proposed device are different with the contact materials of the proposed device have been done the biocompatibility test per ISO 1099-1 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process and the results
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can meet the standard requirements. Therefore does not affect substantially equivalence between proposed device and predicate device on safety and effectiveness.
Analysis 10 – Testing
The mode MD300CN356 have one more PI function compare with the predicate device. The PI function had been verified through the bench test per ISO 80601-2-61. The test result can meet the standard. Therefore, this difference does not affect the substantially equivalence between the proposed device and predicate device on safety and effectiveness.
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Intended Use 6.
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 fingers between 0.8cm and 2.2cm (0.3 inches to 0.9 inches).
7. Test Summary
Non-Clinical Test Conclusion
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 Test
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.
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Conclusion 8.
The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
§ 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).