(822 days)
The pulse oximeter is a non-invasive device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios. The device is reusable.
The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2). The subjected device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery.OP-101 display the measuring results on 1.5' LED screen, and the backlight of the three models are red, white and green respectively. And the screen of OP-102 and OP-103 are 0.96' OLED and 1.3' OLED. Additionally, battery indicator and pulse waveform can be displayed on OP-102 and OP-103. The subjected device is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospitals and clinics.
This document describes the validation of a Pulse Oximeter device (models OP-101 and OP-102).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the ISO 80601-2-61:2017 standard for pulse oximeters, particularly for SpO2 accuracy.
| Metric | Acceptance Criteria (ISO 80601-2-61:2017) | Reported Device Performance (OP-101, OP-102) | Predicate Device Performance (C101H1) |
|---|---|---|---|
| SpO2 Accuracy (70-100% range) | (Not explicitly stated as a single value criterion in the provided text, but implied by adherence to ISO 80601-2-61 guideline which involves comparing device SpO2 readings to arterial oxygen saturation (SaO2) measurements obtained from a co-oximeter.) The standard requires the root mean square deviation (ARMS) between SpO2 and SaO2 to be within a specified range, and typically, individual readings within a certain accuracy range (e.g., ±2% or ±3%). | 70-100%: ±2% | 70-100%: ±3% |
| SpO2 Accuracy (0-69% range) | Unspecified per the standard's current scope for typical physiological measurements. | 0-69%: unspecified | 0-69%: unspecified |
| Pulse Rate Accuracy | Not explicitly detailed but implied that the device meets the "pre-specified criteria" of the clinical trial and related standards. | ±3 bpm or ±1%, whichever is greater | ±1 bpm or ±1%, whichever is greater |
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 | Passes Cytotoxicity, Skin Sensitization, Skin Irritation tests | Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-1-11 | Complies with IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012) and IEC 60601-1-11:2015 | Complies with IEC 60601-1 and IEC 60601-1-11 |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | Complies with IEC 60601-1-2: 2014 | Complies with IEC 60601-1-2 |
| Performance Effectiveness (General) | Compliance with ISO 80601-2-61:2017 | Complies with ISO 80601-2-61: 2017 | Complies with ISO 80601-2-61 |
| Software Verification and Validation | Adherence to FDA Guidance for content of premarket submissions for software contained in medical devices (moderate level of concern) | Software works as expected, stable performance | (Not explicitly stated for predicate in comparison table, but assumed compliance for clearance) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Data): 12 adult volunteers were used to validate the accuracy of the finger pulse oximeter (Model: OP-101).
- Data Provenance: The clinical study was conducted outside of the United States. It was a prospective, randomized clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts directly involved in establishing the ground truth measurements. However, the ground truth was established by measuring SaO2 with a blood gas analyzer, which is a standard method that implicitly relies on trained medical professionals to operate and interpret.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set in the sense of expert review of discrepancies. The accuracy validation appears to be a direct comparison between the device's SpO2 readings and the SaO2 measurements from the blood gas analyzer.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was done or reported in this document. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. For a pulse oximeter, the primary comparison is between the device's output and a gold standard physiological measurement.
6. Standalone Performance Study
Yes, a standalone performance study was done. The clinical study described involved evaluating the algorithm's performance (SpO2 and pulse rate measurements) against a recognized gold standard (blood gas analyzer) without human input / assistance in the measurement itself (beyond initial placement of the device and blood sample collection).
7. Type of Ground Truth Used
The ground truth for the clinical accuracy validation was arterial oxygen saturation (SaO2) measured by a blood gas analyzer. This is considered a gold standard for oxygen saturation in medical contexts.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its sample size. For medical devices like pulse oximeters, the development typically involves calibration data, and potentially internal validation data, but the focus of regulatory submissions is often on the performance demonstration of the final device (test set). Given the nature of a hardware-based measurement device, "training set" in the machine learning sense is less applicable here unless specific algorithms for signal processing or artifact rejection were developed with a dedicated training phase, which is not detailed.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is described for this device in the provided document, the method for establishing its ground truth is not detailed.
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July 17, 2023
Shenzhen brav electronic technologies co., Ltd Yolanda Lan Consultant R4-5/F, Block 11, Tongfuyu Industrial District, Lezhujiao, Huangmabu. Baoan Shenzhen, GuangDong 518060 China
Re: K211143
Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: June 13, 2023 Received: June 13, 2023
Dear Yolanda Lan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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 Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211143
Device Name
Pulse Oximeter(OP-101,OP-102)
Indications for Use (Describe)
The pulse oximeter is a non-invasive device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios. The device is reusable.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| Submitter: | Shenzhen Brav electronic technologies co., Ltd |
|---|---|
| 4-5/F, Block 11, Tongfuyu Industrial District, Lezhujiao, Huangmabu,Baoan, Shenzhen,518060, China+086-186822738501817914464@qq.com | |
| Contact Person: | Yolanda LanYolanda.bleu@foxmail.com |
| Prepare date: | 2021-09-04 |
| Device name | Device Name: Pulse Oximeter |
| and classification | Models: OP-101, OP -102 |
| Classification Name: 21 CFR 870.2700 Oximeter | |
| Product code: DQA | |
| Regulatory Class: Class II | |
| Reason forSubmission | New Application. No prior submission associated with the currentsubmission. |
| PredicateDevice(s) | Shenzhen IMDK Medical Technology Co., Ltd., C101H1 Pulse Oximeter/K173123 |
| DeviceDescription | The oximeter consists of probe, electronic circuits, and display and plasticenclosures. And one side of probe is designed to locate light emitting diodesand a light detector (called a photo-detector). Red and Infrared lights areshone through the tissues from one side of the probe to the other. Then partsof the light emitted absorbed by blood and tissues. The light absorbed by theblood varies with the oxygen saturation of haemoglobin. After that, thephoto-detector detects the light volume transmitted through the tissues whichdepends on blood pulse, Hereafter, the microprocessor calculates a value forthe oxygen saturation (SpO2). |
| The subjected device is a reusable device, and need to reprocess assuggested in the user manual after each use. And the device is intended tobe used on the finger, and powered by 2*1.5V AAA battery.OP-101 displaythe measuring results on 1.5' LED screen, and the backlight of the threemodels are red, white and green respectively. And the screen of OP-102and OP-103 are 0.96' OLED and 1.3' OLED. Additionally, batteryindicator and pulse waveform can be displayed on OP-102 and OP-103.The subjected device is indicated for continuous or spot check monitoring offunctional arterial oxygen saturation (SpO2) and pulse rate of adult patientsin hospitals and clinics. | |
| Indications forUse | The pulse oximeter is a non-invasive device and intended for spot-checkingof oxygen saturation and pulse rate for use with the finger of adult patients inhealthcare environments. And it is not intended to be used under motion orlow perfusion scenarios. The device is reusable. |
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Predicate Device Comparison
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device.
Please refer to following table to find differences between the subject device. All the differences do not affect the basic design principle, usage, effectiveness, and safety of the subject device. And no question is raised regarding to effectiveness and safety.
| ITEM | Proposed Device Brav series Pulse Oximeter | Proposed Device Brav series Pulse Oximeter | Predicate Device K173123 |
|---|---|---|---|
| Manufacturer | Shenzhen Brav electronic technologies co., Ltd | Shenzhen Brav electronic technologies co., Ltd | Shenzhen IMDK Medical Technology Co., Ltd |
| Device Name | Pulse Oximeter | Pulse Oximeter | Pulse Oximeter |
| Models | OP-101 | OP-102 | C101H1 |
| Appearance | Image: Pulse Oximeter OP-101 | Image: Pulse Oximeter OP-102 | Image: Pulse Oximeter C101H1 |
| Indications for Use | The pulse oximeter is a non-invasivedevice and intended for spot-checkingof oxygen saturation and pulse rate foruse with the finger of adult patients inhealthcare environments. And it is notintended to be used under motion orlow perfusion scenarios. The devicereusable. | The pulse oximeter is a non-invasivedevice and intended for spot-checkingof oxygen saturation and pulse rate foruse with the finger of adult patients inhealthcare environments. And it is notintended to be used under motion orlow perfusion scenarios. The devicereusable. | Fingertip Pulse Oximeter C101H1 is anon-invasive device intended for spotchecking of functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate (PR). Thisportable device is indicated for use inadult patients in hospitals. |
| Principle | The device displays numerical valuesfor functional oxygen saturation ofarterial hemoglobin (SpO2) and pulserate by measuring the absorption of redand infrared (IR) light passing throughperfused tissue. Changes in theabsorption caused by the pulsation ofblood in the vascular bed are used todetermine oxygen saturation and pulserate. | The device displays numerical values forfunctional oxygen saturation of arterialhemoglobin (SpO2) and pulse rate bymeasuring the absorption of red andinfrared (IR) light passing throughperfused tissue. Changes in theabsorption caused by the pulsation ofblood in the vascular bed are used todetermine oxygen saturation and pulserate. | The device displays numerical valuesfor functional oxygen saturation ofarterial hemoglobin (SpO2) and pulserate by measuring the absorption ofred and infrared (IR) light passingthrough perfused tissue. Changes inthe absorption caused by the pulsationof blood in the vascular bed are usedto determine oxygen saturation andpulse rate. |
| Intendedpatientpopulation | Adults in healthcare environments | Adults in healthcare environments | Adults in a clinic environment |
| Intendedapplicationsite | Finger | Finger | Finger |
| use under motion andlow perfusionconditions | No | No | No |
| SignalDetectionMethod | Photodetector | Photodetector | Photodetector |
| Display screen | LED | OLED | OLED |
| Display content | SpO2%,PRbattery indicationPulse bar graph | SpO2%,PRbattery indicationPulse bar graphpulse waveform | SpO2%,PRbattery indicationPulse bar graphPerfusion Index |
| Contacting material | Shell: ABSClip Pad: SiliconButton: PMMA | Shell: ABSClip Pad: SiliconButton: PMMA | Shell: ABSClip pad: SiliconButton: PC |
| SpO2 Range | 0~100% | 0~100% | 0~100% |
| SpO2 Resolution | 1% | 1% | 1% |
| SpO2 Accuracy | 70~100%: ±2%0% to 69%: unspecified | 70~100%: ±2%0% to 69%: unspecified | 70~100%: ±3%0% to 69%: unspecified |
| Pulse Rate Range | 40 bpm ~ 250 bpm | 40 bpm ~ 250 bpm | 30 bpm ~ 240 bpm |
| Pulse Rate Accuracy | ±3 bpm or ±1%, whichever is greater | ±3 bpm or ±1%, whichever is greater | ±1 bpm or ±1%, whichever is greater |
| Pulse Rate Resolution | 1 bpm | 1 bpm | 1 bpm |
| Shipped Sterile | No | No | No |
| Power source | 2*1.5V AAA alkaline battery | 2*1.5V AAA alkaline battery | 2*1.5V AAA alkaline battery |
| Storage and TransportEnvironment | Temperature: -20°CtoAtmospheric Pressure: 50 kPato 107.4 kPaRelative Humidity: 10%-95% (nocondensation) | Temperature: -20°CtoAtmospheric Pressure: 50 kPato 107.4 kPaRelative Humidity: 10%-95% (nocondensation) | Temperature: -10°CtoAtmospheric Pressure: 70 kPa to106 kPaRelative Humidity: 10%-80% (nocondensation) |
| OperatingEnvironment | Temperature: 15°Cto40°CAtmospheric Pressure: 70 kPa to 106 kPaRelative Humidity: 15%-95% (nocondensation) | Temperature: 15°Cto40°CAtmospheric Pressure: 70 kPa to 106 kPaRelative Humidity: 15%-95% (nocondensation) | Temperature: 5°Cto40°CAtmospheric Pressure: 70 kPa to 106 kPaRelative Humidity: 15%-80% (nocondensation) |
| Bio-compatibility | ISO 10993-1ISO 109903-5ISO 10993-10 | ISO 10993-1ISO 109903-5ISO 10993-10 | ISO 10993-1ISO 109903-5ISO 10993-10 |
| Electrical Safety | IEC 60601-1IEC 60601-1-11 | IEC 60601-1IEC 60601-1-11 | IEC 60601-1IEC 60601-1-11 |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 |
| Performance | ISO 80601-2-61 | ISO 80601-2-61 | ISO 80601-2-61 |
| Dimension(WidthHeightDepth) | 57mm×30mm×30 mm | 57mm×30mm×30 mm | 60mm×36mm×35 mm |
| Weight | <28 g (without the batteries) | <28 g (without the batteries) | 51g |
Table 1 Comparison between main predicate C101H1 and the subject device
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Shenzhen Brav electronic technologies co., Ltd
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In conclusion, the differences in technological characteristics do not raise new questions of safety and effectiveness.
Performance Summary
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
Non-Clinical Testing:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Pulse Oximeter was conducted in accordance withthe International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of permanent (>30 days).
And the testing included the following tests, results of which demonstrate the biological safety of the subject device:
- < Cytotoxicity
- � Skin Sensitization
- � Skin Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted, and the results show that the subject device complies with the IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012) Medical
electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2014 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC. So the Pulse Oximeter would be safe and effective during the intended application scenarios.
Bench Testing
Bench testing was conducted and the results show that the subject device complies with the ISO 80601-2-61: 2017 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of Pulse Oximeter Equipment standard for performance effectiveness, IEC 60601-1-11:2015 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, which can future demonstrate the safety and effectiveness of the subject device.
Software Verification and Validation Testing
Software documentation including verification & validation was provided in accordance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern. And data shows thesoftware work as expected to make sure the performance stable when operated as suggested by the manufacturer.
The above tests were selected to show substantial equivalence between the subject device and the predicate device.
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Clinical data:
Randomized Clinical Study is conducted outside of United States per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2017 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment and Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff.
There were 12 adult volunteers to validated the accuracy of finger pulse oximeter (Model: OP-101). 5 males and 7 females (including 4 subjects with Fitzpatrick V, VI, 8 subjects with Fitzpatrick I ~ Fitzpatrick IV). The measure result between the SpO2 measured by subject device and the SaO2 measured by the blood gas analyzer, was conformed with the requirements of this clinical trial and related standards. The pulse oximeter had not been found any safety issues, adverse effects and complications during the clinical trial.
Summary
Based on the non-clinical performance and clinical data as documented in the device development, the subject devices were found to have a safety and effectiveness profile that is equal to the predicate device.
Conclusion
The Pulse Oximeter is monitoring the patient's SpO2 and pulse rate in non-invasive and convenient. Non-clinical testing and clinical testing were conducted on the subject device and all testing passed pre-specified criteria. The risks of Pulse Oximeter also have been evaluated according to ISO 14971, the overall residual risk and side effect are acceptable, the benefit is greater than risk and hazard. Which demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed device predicate. The subject device is substantially equivalent to the 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).