(330 days)
PULSE OXIMETER SHO-3002,SHO-3006 and SHO-3008 is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult at hospital (including clinical use internist/surgery, Anesthesia etc ).It is not for continuously monitoring.
The devices consist of detector and emitter LED, CPU, display unit and power unit. The Pulse oximeter is a kind of innovated medical detection device with non-invasive and continuous features for arterial SPO2 and PR detection. The proposed device consists of photo detector and emitter, LED, CPU, data display unit and power unit. It is portable and easy to measure the SPO2 and PR value quickly and precisely. The series of pulse oximeter detect the body's oxygen saturation and pulse rate through the fingers. The device does not contain drug or biological products. The power sources of the proposed devices are 2 AAA alkaline batteries. All the proposed devices have low battery voltage indicator function, and all the proposed devices will automatically power off when there is no signal for longer than 5 seconds. The proposed devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization. The devices are for prescription. The devices do not contain drug or biological products. The Pulse oximeter SHO-3002, SHO-3006 and SHO-3008 share the same measurement principle and oximeter sensor and oxygen saturation module and power supply. The indented target population and use environment of the Pulse oximeter SHO-3002, SHO-3006 and SHO-3008 are the same. The devices are software-driven and the software validation is provided in Section of Software.
Here's an analysis of the acceptance criteria and study detailed in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate or Standard) | Reported Device Performance (SHO-3002, SHO-3006, SHO-3008) |
|---|---|---|
| SpO2 Accuracy | 70% | 70%~100%: ±2%, 0~69%: unspecified. Clinical study results: Accuracy Arms is smaller than 2%. |
| Pulse Rate Accuracy | ±2bpm (Predicate device MD300C1/MD300C2: ±2bpm (30 | ±2bpm. |
| SpO2 Display Range | Predicate device MD300C1: 0 | 35%~100%. (Slightly different from predicate but compliant with clinical application, ES60601-1 and ISO80601-2-61 requirements, and 0~69% is no definition for accuracy). |
| PR Display Range | Predicate device: 0~254 bpm. Clinical application, ES60601-1 and ISO80601-2-61 requirements. Clinical experience shows 30bpm range is sufficient. | 30bpm~250bpm. (Slightly different from predicate but compliant with clinical application, ES60601-1 and ISO80601-2-61 requirements, and clinical experience indicates this range meets application needs). |
| Measurement Wavelength (IR) | Predicate device: 940nm. Infrared spectrum area (800nm ~ 1000nm), ES 60601-1 and ISO80601-2-61 requirements. | 905nm. (A different wavelength than predicate, but within acceptable infrared spectrum area (800nm ~ 1000mm) and complies with standards). |
| Electromagnetic Compatibility (EMC) | Conformed to IEC60601-1-2. | Conformed to IEC60601-1-2. |
| Electrical Safety | Conformed to IEC60601-1. | Conformed to IEC60601-1. |
| Biocompatibility | No cytotoxic potential (In Vitro Cytotoxicity), No evidence of causing sensitization (Skin Sensitization Test), No evidence of significant irritation (Skin Irritation Test). | Results confirmed: No cytotoxic potential, No evidence of causing sensitization, No evidence of significant irritation from the test extract to rabbits. |
| Software Validation | Compliance with FDA Guidance for the content of Premarket Submissions for Software Contained in Medical Devices, Moderate Level of Concern. | Compliance with FDA Guidance for the content of Premarket Submissions for Software Contained in Medical Devices, Moderate Level of Concern. Software Validation and Verification Test performed. |
| General performance/functionality | FFC bending test, drop test, function test, Use Life Test, Storage Condition Test. | All bench tests conducted (including FFC bending test, drop test, function test) and results are provided in the performance testing section. Use Life Test and Storage Condition Test performed. Met requirements of FDA Guidance. |
Study Details:
This submission primarily refers to internal validation and clinical testing against established standards and a predicate device, rather than a large-scale, multi-center pivotal trial.
2. Sample size used for the test set and the data provenance
-
Test Set (Clinical Study for SpO2 and PR Accuracy): The document states that the clinical trial was performed "according to Annex EE.2 Procedure for invasive laboratory testing of ISO80601-2-61:2011". This annex details the use of healthy adult volunteers and a protocol for creating various SpO2 levels by controlled hypoxia.
- The exact number of subjects for the clinical test set is not explicitly stated in the provided text, but such studies as per ISO 80601-2-61 typically involve a minimum of 10 healthy subjects to obtain a sufficient number of SpO2 data points across the specified range.
- Data Provenance: The nature of the clinical test described (controlled hypoxia on healthy subjects) implies prospective clinical data. The country of origin is not explicitly stated, but given the manufacturer's location (Beijing, P. R. China), it is highly probable the study was conducted in China.
-
Bench Tests: The specific sample sizes for bench tests (e.g., number of devices tested for drop, bending, etc.) are not provided. These are generally internal quality and engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- For the SpO2 Accuracy clinical study, the ground truth for arterial oxygen saturation (SaO2) is established using a laboratory CO-oximeter measurement of arterial blood samples. This is considered the gold standard for SpO2 accuracy studies.
- The ground truth is not established by "experts" in the sense of clinicians making subjective assessments, but by the objective measurements from a calibrated clinical laboratory instrument. Therefore, the concept of "number of experts" and their "qualifications" for ground truth determination in this context is not directly applicable, beyond the qualified laboratory personnel operating the CO-oximeter and the clinical staff monitoring the subjects.
4. Adjudication method for the test set
- Not applicable in the traditional sense for subjective assessments. The ground truth for SpO2 accuracy is determined by the invasive and objective method of CO-oximetry. Differences or discrepancies might be resolved through standard laboratory protocols and instrument calibration checks, rather than an expert adjudication process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done or reported. This device is a Pulse Oximeter, which provides direct numerical readings (SpO2 and Pulse Rate). It is not an AI-assisted diagnostic imaging device or a system requiring human "readers" or interpretations that would typically be subject to MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance evaluation was conducted. The clinical study to determine SpO2 and Pulse Rate accuracy (Arms) in comparison to invasive CO-oximetry is a standalone performance evaluation of the device's algorithm and sensor. The device provides "spot-check" readings, meaning it operates autonomously to produce these measurements without human interpretation or adjustment influencing the output itself. The results, particularly the Arms value "smaller than 2%", refer to this standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the SpO2 accuracy clinical study, the ground truth used is invasive CO-oximetry of arterial blood samples. This is the established gold standard for determining oxygen saturation in such studies.
8. The sample size for the training set
- The document does not explicitly state a sample size for a training set. Pulse oximeters, especially those based on the Lambert-Beer Law and photoelectric principles, typically rely on established physics and pre-defined algorithms rather than machine learning models that require distinct 'training sets' in the AI sense. While there would have been internal R&D data used for algorithm development and calibration, it is not described as a formal "training set" like in typical AI/ML submissions.
9. How the ground truth for the training set was established
- Since a formal "training set" in the context of machine learning is not explicitly mentioned or implied for this device, the method for establishing its ground truth is not detailed. The device's operation is based on known physical principles and established calibration processes, rather than learning from a dataset with pre-established ground truths. Internal calibration would use reference values from other gold-standard oximetry methods or gas mixtures to ensure accuracy.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
Beijing Safe Heart Technology Ltd. Xiaoming Yang Quality Manager Room 101, Unit 6, Building NO.6 No.88 Kechuang 6th Street Beijing Economic-Technological Development Area, 101111 Cn
Re: K172616
Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: June 29, 2018 Received: June 29, 2018
Dear Xiaoming Yang:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 D. Courtney -S
Tina Kiang, Ph.D. for Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172616
Device Name PULSE OXIMETER
Indications for Use (Describe)
PULSE OXIMETER SHO-3002,SHO-3006 and SHO-3008 is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult at hospital (including clinical use internist/surgery, Anesthesia etc ).It is not for continuously monitoring.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 6 - 510(k) Summary
Date of Summary Preparation: 06/21/2018
1. Submitter's Identifications
Submitter's Name: Beijing Safe Heart Technology Ltd. Address: Room 101, Unit 6, Building NO.6, No.88 Kechuang 6th Street,Beijing Economic-Technological Development Area, 101111 Beijing, P. R. China Contact Person: Mr. Xiaoming Yang Contact Email Address: Email: QA@safeheart.com.cn Phone number: +86- 10-61253661 Fax number: +86- 10-61253660-897
2. Correspondent's Identifications
Submitter's Name: Beijing Safe Heart Technology Ltd. Address: Room 101, Unit 6, Building NO.6, No.88 Kechuang 6th Street, Beijing Economic-Technological Development Area, 101111 Beijing, P. R. China Contact Person: Mr. Xiaoming Yang Contact Email Address: Email: QA@safeheart.com.cn Phone number: +86-10-61253661 Fax number: +86-10-61253660-897 3. Name of the Device
Device Classification Name: Oximeter Product Name: Pulse Oximeter Trade Name: Pulse Oximeter Model :SHO-3002,SHO-3006,SHO-3008 Classification Panel: Cardiovascular Product Code: DQA Device Classification: Class II
4. The Predicate Devices
K130947 MD300C1.MD300C2 Fingertip pulse Oximeter 21 CFR 870.2700
5. Device Description
The devices consist of detector and emitter LED, CPU, display unit and power unit.
The Pulse oximeter is a kind of innovated medical detection device with non-invasive and continuous features for arterial SPO2 and PR detection. The proposed device consists of photo detector and emitter, LED, CPU, data display unit and power unit. It is portable and easy to measure the SPO2 and PR value quickly and precisely.
The series of pulse oximeter detect the body's oxygen saturation and pulse rate through the fingers. The device does not contain drug or biological products.
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The power sources of the proposed devices are 2 AAA alkaline batteries. All the proposed devices have low battery voltage indicator function, and all the proposed devices will automatically power off when there is no signal for longer than 5 seconds.
The proposed devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization. The devices are for prescription. The devices do not contain drug or biological products.
The Pulse oximeter SHO-3002, SHO-3006 and SHO-3008 share the same measurement principle and oximeter sensor and oxygen saturation module and power supply. The indented target population and use environment of the Pulse oximeter SHO-3002, SHO-3006 and SHO-3008 are the same.
The devices are software-driven and the software validation is provided in Section of Software.
6. Principle of operation and mechanism of action of the device
The device works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The wavelength of one light source is 660mm, which is red light; the other is 905nm, which is infrared light.
A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in glow and near-infrared zones.
Operation principle of the instrument: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights can be focused onto a human nail tip through a clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the oximeter's display through process in electronic circuits and microprocessor.
7. Intended Use of Device
PULSE OXIMETER SHO-3002, SHO-3006 and SHO-3008 is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult at hospital (including clinical use internist/surgery, Anesthesia etc). It is not for continuously monitoring.
8. Summary of Substantial Equivalence
Table 1: The difference between SHO-3002, SHO-3006 and SHO-3008.
| SHO-3002 | SHO-3006 | SHO-3008 | ||
|---|---|---|---|---|
| Display | Spo2 | 35%~100% | 35%~100% | 35%~100% |
| Range | PR | 30bpm~250bpm | 30bpm~250bpm | 30bpm~250bpm |
| Measurement | Spo2 | 35%~100% | 35%~100% | 35%~100% |
| Range | PR | 30bpm~250bpm | 30bpm~250bpm | 30bpm~250bpm |
| Accuracy | Spo2 | 70%~100%: ±2%, | 70%~100%: ±2%, | 70%~100%: ±2%, |
| 0~69%:unspecified | 0~69%:unspecified | 0~69%:unspecified | ||
| PR | ±2bpm | ±2bpm | ±2bpm | |
| Resolution | Spo2 | 1% | 1% | 1% |
| PR | 1 bpm | 1 bpm | 1 bpm |
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| Display Screen | OLED | OLED | OLED |
|---|---|---|---|
| Pulse waveform display | Y | Y | Y |
| Four direction display | Y | Y | Y |
| Dimension( L x W x H ) | 57mm x 31. 5mm x 30.5mm | 57mm x 31. 5mm x30. 5mm | 57mm x 31. 5mm x 30.5mm |
| Appearances and color | Different | Different | Different |
| Structure and composition | The proposed deviceconsists of photodetector and emitterLED, CPU, datadisplay unit and powerunit. | The proposed deviceconsists of photodetector and emitterLED, CPU, datadisplay unit andpower unit. | The proposed deviceconsists of photodetector and emitterLED, CPU, data displayunit and power unit. |
| Operating style | Fingertip | Fingertip | Fingertip |
| Accessories | 1. One lanyard2. Two batteries3. One user's manual | 1. One lanyard2. Two batteries3. One user's manual | 1. One lanyard2. Two batteries3. One user's manual |
Beijing Safe Heart Technology Ltd.
Table 2 : The difference between Proposed Device and Predicate Device
| Comparison Elements | Proposed Device | Predicate Device | Comparison | ||
|---|---|---|---|---|---|
| Device Name | Pulse oximeter | Fingertip pulse Oximeter (K130947) | Similar | ||
| Model | SHO-3002,SHO-3006 and SHO-3008 | MD300C1,MD300C2 | ----- | ||
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | Same | ||
| Classification | II | II | Same | ||
| Classification Name | Oximeter | Oximeter | Same | ||
| Product Code | DQA | DQA | Same | ||
| Indications for Use | PULSE OXIMETERSHO-3002,SHO-3006 andSHO-3008 is a portablenon-invasive, spot-check, oxygensaturation of arterial hemoglobin(SpO2) and pulse rate of adult athospital (including clinical useinternist/surgery, Anesthesiaetc). It is not for continuously | The Fingertip PulseOximeter MD300C series,are portable, non-invasivedevices intended for spotchecking of arterialhemoglobin oxygensaturation(SPO2) and pulserate of adult and pediatricpatient at hospital (including | Similar | ||
| monitoring. | clinical use in | ||||
| internist/surgery, Anesthesia, | |||||
| and intensive care units). | |||||
| Comparison Statement | The proposed devices have the same indications for use and classification. | ||||
| Detector and emitter LED, | Similar | ||||
| Components | The applicant device consists of | signal amplify unit, CPU, data display unit and power unit. | |||
| photo detector and emitter LED, CPU, data display unit and power unit. | |||||
| Design Principle | A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in glow and near-infrared zones. Operation principle of the instrument: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights can be focused onto a human nail tip through a clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the Oximeter's display through process in electronic circuits and microprocessor shown on the Oximeter's display through electronic circuits and a microprocessor. | 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 amount 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. | Similar | ||
| Measurement | Red | 660nm | 660nm | Same | |
| Wavelength | Infrared | 905nm | 940nm | Thewavelength ofIR led isdifferent.SE Note 1 | |
| Comparision Statement | The proposed devices have the same design principle and similar components. | ||||
| Display Type | OLED | LED:MD300C1 | Same | ||
| Working time | Work about 30 hours continuously. | OLED:MD300C2 | Work for 30 hours continuously | Same | |
| Power Supply | 2 * AAA | 2 * AAA | Same | ||
| Display Data | SPO2, PR | SPO2, PR | Same | ||
| Spo2 Display Range | 35%~100% | 0 | Same | ||
| Spo2 Accuracy | 70% | MD300C1: 70 | The Spo2 Display Range is different.SE Note 2 | ||
| Spo2 resolution | 1% | 1% | Same | ||
| PR display range | 30~250bpm | 0~254 bpm | The PR range of the predicate device is bigger.SE Note 3 | ||
| PR Accuracy | ±2bpm | ±2bpm(30 | Same | ||
| PR resolution | 1 bpm | 1 bpm | Same | ||
| Operating temperature | +5°~+40°C | +5°~+40°C | Same | ||
| Relative humidity | 15%~90% (Operating),15%~93% (Storage) | ≤80%(Operating)≤93%( storage) | Similar | ||
| Atmosphere pressure | 860hPa~1060hPa (Operating)500hPa-1060hPa (Storage ) | 86~106 kPa | Similar | ||
| Pulse Beep | Not Available | Not Available | Same | ||
| Comparison Statement | The applicant device has similar device specifications as the predicate device. | ||||
| Contacting | Battery cover | ABS | ABS | Same | |
| Material | FingertipCushion | Medical Silica gel | Medical Silica gel | Same | |
| Enclosure | ABS | ABS | Same | ||
| Comparsion Statement | The contacting materials of applicant device are same as to the predicate device. | ||||
| PerformanceTesting | Bench Test | The bench test include SpO2accuracy test, pulse rate test, FFCbending test, drop test, function testand test according toISO80601-2-61.All the bench testresults are provide in performanceTesting-Bench | Meet the requirements of FDA Guidance. | Similar |
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Beijing Safe Heart Technology Ltd.
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Beijing Safe Heart Technology Ltd.
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| Beijing Safe Heart Technology Ltd. | |||
|---|---|---|---|
| Clinical Test | Conformed to ISO80601-2-61 | Conformed to ISO 9919 | Similar | ||
|---|---|---|---|---|---|
| ElectromagneticCompatibilitySafety | ElectricalSafety | Conformed to IEC60601-1.The test results are provided inElectromagnetic Compatibility andElectrical Safety. | Conformed toIEC60601-1 | Same | |
| ElectromagneticCompatibility | Conformed to IEC60601-1-2.The test results are provided inElectromagnetic Compatibility andElectrical Safety. | Conformed toIEC60601-1-2 | Same | ||
| Software | Moderate level of ConcernCompliance with FDA Guidance forthe content of Premarket Submissionsfor Software Contained in MedicalDevices. | Moderate level ofConcernCompliance with FDAGuidance for the contentof PremarketSubmissions for SoftwareContained in MedicalDevices. | Same | ||
| Biocompatibility | MedicalSilica gel | In VitroCytotoxicity | No cytotoxicpotentialIn VitroCytotoxicity | Nocytotoxicpotential | Same |
| Skin Irritation Test | No evidence ofcausingsensitizationSkinIrritationTest | No evidenceof causingsensitization | Same | ||
| Skin SensitizationTest | No evidence ofsignificantirritation fromthe test extractto rabbitsSkinSensitization Test | No evidenceofsignificantirritationfrom thetest extractto rabbits | Same | ||
| Label and Labeling | Compliance with FDA guidance | Compliance with FDAguidance | Similar |
9. Substantial Equivalence:
SE Note 1:
The degree of light absorption and the degree of light scattering of blood are mainly related to the content of oxygenated hemoglobin, which is feasible in the infrared spectrum area (800nm ~ 1000nm). Although the "Measurement Wavelength" of the subject device is slightly different from the predicate device ,all devices comply with infrared spectrum area (800nm ~ 1000mm), ES 60601-1 and ISO80601-2-61 requirements. These differences do not raise different questions of safety and effectiveness. SE Note 2:
When the human blood oxygen saturation value less than 60%, the non-invasive blood oxygen error will be
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relatively large. So, non-invasive blood oxygen products will be specified in the Spo2 Accuracy measurement, 0 ~ 69% interval is not definition. Although the "Spo2 Display Range" of the subject device is slightly different from the predicate devices comply with clinical application, ES60601-1 and ISO80601-2-61 requirements. These differences do not raise different questions of safety and effectiveness.
SE Note 3:
Clinical experience show that range of the pulse rate interval 30bpm, has been able to meet the clinical application. Although the "PR Display Range" of the subject device is slightly different from the predicate device ,all devices comply with clinical application, ES60601-1 and ISO80601-2-61 requirements. These differences do not raise different questions of safety and effectiveness.
According to the non-clinical and clinical test results, the proposed devices are as safe, as effective and perform as well as the predicate device. So, the proposed devices are Substantially Equivalent (SE) to the predicate device which is US legally market device.
10. Non-Clinical Tests Performed:
The following testing was performed on the Pulse Oximeter SHO-3002, SHO-3006 and SHO-3008 in accordance with the requirements of the design control regulations and established quality assurance procedures.
a. ES60601-1:2005(R) 2012, Medical electrical equipment-Part 1: General requirements for basic safety, and essential performance.
b. IEC60601-1-2:2014, Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility-Requirements and tests.
c. ISO80601-2-61:2011, Medical electrical equipment-Part 2-6 1: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
d. ISO10993-1:2009, Biological evaluation of medical devices -Part 1:Evaluation and testing within a risk management process
e. ISO 10993-5:2009, Biological evaluation of medical devices - PartS5: Tests for In Vitro cytotoxicity.
f. ISO10993-10:2010, Biological evaluation of medical devices-Part10: Tests for irritation and skin sensitization
g. Software Validation and Verification Test.
h. Use Life Test.
i. SpO2 Accuracy and Pulse Rate Accuracy Test (Test after the repeated clean & disinfection conditions).
j. SpO2 Accuracy and Pulse Rate Accuracy Test (Test under the normal conditions).
k. SpO2 Accuracy and Pulse Rate Accuracy Test (Test under the low perfusion conditions).
- Storage Condition Test
11. Summary of the biocompatibility tests performed on the device.
Direct contacting the skin components included Plastic Shell (ABS Novodur HD M203FC ) and color additives (BASF K7090, BASF L0080) , Silica gel pad (Medical grade silica gel HCRU4470) and color additives (SUNWELL SILICONES P801. Plastic Shell included ABS and color additives, Silica gel pad included medical grade silica gel and color additives were tested together. Because the material only contact with the user's intact skin within 24 hours, so according to ISO 10993-1:2009, the In Vitro Cytotoxicity Test, Skin Sensitization Test and Skin Irritation Test have been performed.
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12. Clinical Trial Conclusion
The Pulse Oximeter SHO-3002, SHO-3006 and SHO-3008 share the same pulse oximeter sensor, algorithm and oxygen saturation module. So, we considered a clinical test of one of the proposed devices could cover that of other devices. The clinical test of other proposed devices can be exempted. And we conducted clinical test for one of the proposed devices, and the model is SHO-3002.
The clinical trial was performed according to Annex EE.2 Procedure for invasive laboratory testing of ISO80601-2-61:2011, Medical electrical equipment-Part 2-6 1: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
It can be determined from the result of the clinical study that the accuracy Arms of the proposed device is smaller than 2%.
13. Substantially Equivalent Conclusion
The proposed device Pulse Oximeter SHO-3002, SHO-3008 are determined to be Substantially Equivalent (SE) to the predicate device, Fingertip Pulse Oximeter (K130947) MD300C1, MD300C2.
§ 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).