Pulse Oximeter

{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) | | |-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 10px;"> X </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 10px;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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<br>( L x W x H ) | 57mm x 31. 5mm x 30.<br>5mm | 57mm x 31. 5mm x<br>30. 5mm | 57mm x 31. 5mm x 30.<br>5mm | | Appearances and color | Different | Different | Different | | Structure and composition | The proposed device<br>consists of photo<br>detector and emitter<br>LED, CPU, data<br>display unit and power<br>unit. | The proposed device<br>consists of photo<br>detector and emitter<br>LED, CPU, data<br>display unit and<br>power unit. | The proposed device<br>consists of photo<br>detector and emitter<br>LED, CPU, data display<br>unit and power unit. | | Operating style | Fingertip | Fingertip | Fingertip | | Accessories | 1. One lanyard<br>2. Two batteries<br>3. One user's manual | 1. One lanyard<br>2. Two batteries<br>3. One user's manual | 1. One lanyard<br>2. Two batteries<br>3. 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<br>SHO-3002,SHO-3006 and<br>SHO-3008 is a portable<br>non-invasive, spot-check, oxygen<br>saturation of arterial hemoglobin<br>(SpO2) and pulse rate of adult at<br>hospital (including clinical use<br>internist/surgery, Anesthesia<br>etc). It is not for continuously | The Fingertip Pulse<br>Oximeter MD300C series,<br>are portable, non-invasive<br>devices intended for spot<br>checking of arterial<br>hemoglobin oxygen<br>saturation(SPO2) and pulse<br>rate of adult and pediatric<br>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<br>wavelength of<br>IR led is<br>different.<br>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<br>0~100%: MD300C2 | Same | | Spo2 Accuracy | | 70%~100%: ±2%, 0~69% is no definition | | MD300C1: 70~99% is ±2%, 0~69% is no definition<br>MD300C2: 70~100% is ±2%, 0~69% is no definition | The Spo2 Display Range is different.<br>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.<br>SE Note 3 | | PR Accuracy | | ±2bpm | | ±2bpm(30~99bpm) and 2%(100~235bpm) | Same | | PR resolution | | 1 bpm |…