(330 days)
Not Found
No
The description focuses on standard pulse oximetry technology (photo detector, emitter, CPU) and does not mention any AI/ML components or algorithms. The performance studies are based on standard clinical trial procedures for pulse oximeters, not AI/ML model validation.
Yes
The device is described as a "medical detection device" and is used in a "hospital" setting for "oxygen saturation of arterial hemoglobin (SpO2) and pulse rate" measurement, which are diagnostic indicators used in healthcare.
Yes
Explanation: The device measures oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, which provides physiological data used to assess a patient's condition and help in the diagnosis of various medical issues.
No
The device description explicitly states it consists of hardware components such as a detector and emitter LED, CPU, display unit, and power unit, in addition to being software-driven.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Pulse Oximeter SHO-3002, SHO-3006, and SHO-3008 are "portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult". It measures these parameters through the fingertip, which is a non-invasive method.
- No Sample Analysis: The device does not analyze any samples taken from the body. It uses light to measure oxygen saturation and pulse rate directly through the skin.
Therefore, since the device does not perform tests on samples taken from the body, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
DQA
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nail tip, fingers
Indicated Patient Age Range
adult
Intended User / Care Setting
hospital (including clinical use internist/surgery, Anesthesia etc)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
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%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: SpO2 70%100%: ±2%, 069%:unspecified; PR ±2bpm (all models: SHO-3002, SHO-3006, SHO-3008).
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).
0
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);
1
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
2
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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3
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.
4
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 |
5
| 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 x |
- 5mm | 57mm x 31. 5mm x 30.
5mm |
| Appearances and color | Different | Different | Different |
| Structure and composition | The proposed device
consists of photo
detector and emitter
LED, CPU, data
display unit and power
unit. | The proposed device
consists of photo
detector and emitter
LED, CPU, data
display unit and
power unit. | The proposed device
consists of photo
detector and emitter
LED, CPU, data display
unit and power unit. |
| Operating style | Fingertip | Fingertip | Fingertip |
| Accessories | 1. One lanyard - Two batteries
- One user's manual | 1. One lanyard
- Two batteries
- One user's manual | 1. One lanyard
- Two batteries
- 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 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 | The Fingertip Pulse | ||||
| Oximeter MD300C series, | |||||
| are portable, non-invasive | |||||
| devices intended for spot | |||||
| checking of arterial | |||||
| hemoglobin oxygen | |||||
| saturation(SPO2) and pulse | |||||
| rate of adult and pediatric | |||||
| patient 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 | The | |
| wavelength of | |||||
| IR led is | |||||
| different. | |||||
| 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% | 0~99%: MD300C1 | |||
| 0~100%: MD300C2 | Same | ||||
| Spo2 Accuracy | 70% | MD300C1: 70 | |||
| MD300C2: 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 | Fingertip | ||||
| Cushion | 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. | ||||
| Performance | |||||
| Testing | Bench Test | The bench test include SpO2 | |||
| accuracy test, pulse rate test, FFC | |||||
| bending test, drop test, function test | |||||
| and test according to | |||||
| ISO80601-2-61.All the bench test | |||||
| results are provide in performance | |||||
| Testing-Bench | Meet the requirements of FDA Guidance. | Similar |
6
Beijing Safe Heart Technology Ltd.
7
Beijing Safe Heart Technology Ltd.
8
| Beijing Safe Heart Technology Ltd. | |||
|---|---|---|---|
| Clinical Test | Conformed to ISO80601-2-61 | Conformed to ISO 9919 | Similar | ||
|---|---|---|---|---|---|
| Electromagnetic | |||||
| Compatibility | |||||
| Safety | Electrical | ||||
| Safety | Conformed to IEC60601-1. | ||||
| The test results are provided in | |||||
| Electromagnetic Compatibility and | |||||
| Electrical Safety. | Conformed to | ||||
| IEC60601-1 | Same | ||||
| Electromagnetic | |||||
| Compatibility | Conformed to IEC60601-1-2. | ||||
| The test results are provided in | |||||
| Electromagnetic Compatibility and | |||||
| Electrical Safety. | Conformed to | ||||
| IEC60601-1-2 | Same | ||||
| Software | Moderate level of Concern |
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. | Same | |
| Biocompatibility | Medical
Silica gel | In Vitro
Cytotoxicity | No cytotoxic
potential
In Vitro
Cytotoxici
ty | No
cytotoxic
potential | Same |
| | | Skin Irritation Test | No evidence of
causing
sensitization
Skin
Irritation
Test | No evidence
of causing
sensitization | Same |
| | | Skin Sensitization
Test | No evidence of
significant
irritation from
the test extract
to rabbits
Skin
Sensitizati
on Test | No evidence
of
significant
irritation
from the
test extract
to rabbits | Same |
| | Label and Labeling | Compliance with FDA guidance | Compliance with FDA
guidance | 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
9
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.
10
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.