(126 days)
Not Found
No
The description details standard pulse oximetry technology based on light absorption and signal processing, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
Explanation: The device is intended for spot-checking of oxygen saturation and pulse rate, which are diagnostic measurements, not for providing therapy or treatment. The device description also explicitly states it is "not for life-supporting or life-sustaining."
Yes
The device is intended for "spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate," which are physiological parameters used to assess a patient's health status. While it's non-invasive and not for life-supporting use, collecting such data constitutes a diagnostic function.
No
The device description clearly outlines hardware components such as a battery, detector and emitter LED, signal collection and processor module, display module, and Bluetooth module. While it is software-driven, it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- Device Function: The Fingertip Pulse Oximeter MD300CI218 is a non-invasive device that measures oxygen saturation and pulse rate directly from the patient's fingertip using light absorption. It does not involve the collection or analysis of specimens taken from the body.
Therefore, while it is a medical device used for monitoring physiological parameters, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Fingertip Pulse Oximeter MD300CI218 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients in hospital-type facilities and homecare environment.
Product codes
DQA
Device Description
The proposed device Fingertip Pulse Oximeter MD300CI218 is a battery powered device. It can detect and display the measured %SpO2 and pulse rate value and will automatically power off when there is no signal for longer than 8 seconds. The proposed device is adopted colorful color OLED screen to display SpO2, PR and waveform which can be displayed in 2 directions. And it is designed with the battery indicator function to warn the user that the battery power may be low.
The proposed device is normally applied to adult, adolescent, child and infant patients in hospitals, hospital facilities and homecare environment. And it can transmit the measurements to Smart Device installed the mobile APP via Bluetooth 4.0 to help the users to organize and track their health information.
The proposed device consists of power supply module, detector and emitter LED, signal collection and processor module, display module, Bluetooth module, user interface and button control.
The fingertip pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally 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 amounts 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.
The proposed device is not for life-supporting or life-sustaining, not for implant.
The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization.
The device is for prescription.
The device does not contain drug or biological products.
The device is software-driven and the software validation is provided in software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip / Nail Tip
Indicated Patient Age Range
adult, adolescent, child and infant patients
Intended User / Care Setting
hospital-type facilities and homecare environment.
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
Clinical study of MD300C1218 following testing described in clause 201.12.1 of ISO 80601-2-61:2011 Medical electrical equipment- Part 2-61 Particular requirements for basic safety and essential performance of pulse oximeter equipment.
The study was conducted Mar.9-11,2018 in the Yue Bei people's Hospital, cardiovascular medicine.
12 healthy adult subjects (7 females, 5 males) aged 18 to 45 years, with weights ranging from 42 to 83kg and heights ranging from 153 to 179cm.
Skin tones included: 4 subjects with very dark pigmentation, 1 subject with very light pigmentation, remaining subjects with light skin tones of China origins.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Study
Sample Size: 12 healthy adult subjects
Key Results: The SpO2 accuracy performance results showed the MD300CI218 Fingertip Pulse Oximeter to have an Arms of 1.66 during steady state conditions over the range of 70-100%.
Conclusion: The results of the study provide supporting evidence that the pulse oximeter MD300CI218 Fingertip Pulse Oximeter was compliance to the accuracy specification claimed by the manufacturer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy: 70%100%, ±2%; 069% no definition
PR Accuracy: 30bpm99bpm, ±2bpm; 100bpm250bpm, ±2%
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
Beijing Choice Electronic Technology Co., Ltd. Haiying Zhao Quality Director No.9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing, 100041 China
Re: K181503
Trade/Device Name: Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: September 4, 2018 Received: September 4, 2018
Dear Haiying Zhao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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
Section II Indications for Use Statement
Indications for Use
510(k) Number (if known): K181503
Device Name: _Fingertip Pulse Oximeter MD300CI218
Indications for Use:
The Fingertip Pulse Oximeter MD300CI218 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients in hospital-type facilities and homecare environment.
| Prescription Use √ | AND/OR | Over-The-Counter Use |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
(1) OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Section III 510(k) Summary
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.
There is no prior submission for the device.
3.1 Submitter Information
● Manufacturer Name:
Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. Room 4104, No. A12 Yuquan Road Haidian District 100143 Beijing, P.R.China
. Contact Person:
Lei Chen Beijing Choice Electronic Technology Co., Ltd. North Building 3F, No. 9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing China 100041 Phone: +86-10-88798300 Ext 6020 Fax:215-4052545 Email: cc@choicemmed.com
- . Date prepared: June 04, 2018
3.2 Proposed Device Information
Device Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300CI218 Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA
Class: II
Panel: Anesthesiology
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3.3 Predicate Device
510(k) Number: K142888 Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300C318T2 Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700
Device Class: II
Panel: Anesthesiology
Manufacturer: Beijing Choice Electronic Technology Co., Ltd.
Intended Use: The MD300C318T2 is intended for spot checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate. It is intended for adult, adolescent, child and infant users in hospitals, hospital facilities and home healthcare environments.
3.4 Device Description
The proposed device Fingertip Pulse Oximeter MD300CI218 is a battery powered device. It can detect and display the measured %SpO2 and pulse rate value and will automatically power off when there is no signal for longer than 8 seconds. The proposed device is adopted colorful color OLED screen to display SpO2, PR and waveform which can be displayed in 2 directions. And it is designed with the battery indicator function to warn the user that the battery power may be low.
The proposed device is normally applied to adult, adolescent, child and infant patients in hospitals, hospital facilities and homecare environment. And it can transmit the measurements to Smart Device installed the mobile APP via Bluetooth 4.0 to help the users to organize and track their health information.
The proposed device consists of power supply module, detector and emitter LED, signal collection and processor module, display module, Bluetooth module, user interface and button control.
The fingertip pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally 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 amounts 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
5
oxygen saturation measurement. This measurement is referred to as SpO2.
The proposed device is not for life-supporting or life-sustaining, not for implant.
The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization.
The device is for prescription.
The device does not contain drug or biological products.
The device is software-driven and the software validation is provided in software.
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3.5 Comparison list of the technological characteristics
| Comparison Elements | Proposed Device | Predicate Device | |
|---|---|---|---|
| Product Name | Fingertip Pulse Oximeter | Fingertip Pulse Oximeter | |
| Model | MD300CI218 | MD300C318T2 | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | |
| Classification | II | II | |
| Classification Name | Oximeter | Oximeter | |
| Product Code | DQA | DQA | |
| Indications for Use | The MD300CI218 is a handheld non-invasive | ||
| device intended for spot-checking of oxygen | |||
| saturation of arterial hemoglobin (SpO2) and | |||
| Pulse Rate of adult, adolescent, child and | |||
| infant | |||
| patients in hospitals, hospital-type | |||
| facilities and homecare environment. | The MD300C318T2 is intended for spot- | ||
| checking in measuring and displaying | |||
| functional arterial hemoglobin (SpO2) and | |||
| pulse rate. It is intended for adult, adolescent, | |||
| child and infant users in hospitals, hospital | |||
| facilities and home healthcare environments. | |||
| Comparison Statement | The proposed device and the predicated device have the same intended use and | ||
| classification | |||
| Components | Power supply module, detector and emitter | ||
| LED, signal collection and processor module, | |||
| display module, | |||
| Bluetooth | |||
| module, | |||
| user | |||
| interface and button control. | Power supply module, detector and emitter | ||
| LED, signal collection and process module, | |||
| display module, Bluetooth module, indicator | |||
| module, user interface. | |||
| Design Principle | The fingertip pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally 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 amounts 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. | Principle of the oximeter is as follows: A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in red 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 (660nm glow and 940nm near infrared light) 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. | |
| Measurement | Red | 660±3nm | 660nm |
| Wavelength | Infrared | 905±10nm | 940nm |
| Comparison Statement | The proposed device and the predicate device have the same design principle and similar measurement wavelength. The only difference is the wavelength of the infrared LED emitter, and we can verify that which will not effect the essential performance of the proposed device. | ||
| Display Type | OLED | OLED | |
| User Interface | 2 display directions | 2 display directions | |
| Power supply | 2*AAA alkaline batteries | 2*AAA alkaline batteries | |
| Display Data | SpO2, PR | SpO2, PR | |
| SpO2 Display Range | 0~100% | 0%~100% | |
| SpO2 Measurement Range | 70%~100% | 70%~100% | |
| SpO2 Accuracy | 70%~100%, ±2%; | ||
| 0~69% no definition | 70%~100%, ±2%; | ||
| 0~69% no definition | |||
| SpO2 Resolution | 1% | 1% | |
| PR Display Range | 30bpm~250bpm | 0bpm~235bpm | |
| PR Measurement Range | 30bpm~250bpm | 30bpm~235bpm | |
| PR Accuracy | 30bpm~99bpm, ±2bpm; | ||
| 100bpm~250bpm, ±2% | 30bpm~99bpm, ±2bpm; | ||
| 100bpm~235bpm, ±2% | |||
| PR Resolution | 1% | 1% | |
| Wireless Transmission Range | 0~10m | 0~10m | |
| Antenna Type | Internal | Internal | |
| Transmitter | Bluetooth Compliance: Version 4.0 | Bluetooth Compliance: Version 2.1 |
Table 3-1 Performance Specification Comparison Table between the Proposed Device and Predicate Device
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8
9
| Premarket Notification 510(k) Submission-Section III 510(k) Summary |
|---|
| --------------------------------------------------------------------- |
| Operating
| Temperature | 5°C~40°C | 5°C~40°C | |
|---|---|---|---|
| Relative Humidity | 15% ~93%, no condensation in operation; | ||
| ≤93% no condensation in storage | 15% ~93%, no condensation in operation; | ||
| ≤93% no condensation in storage | |||
| Atmosphere | |||
| Pressure | 70kPa~106kpa | 86kPa~106kpa | |
| Comparison Statement | The proposed device has similar product specification as predicate device. | ||
| Contacting | |||
| Material | Battery Cover | ||
| Enclosure | |||
| Power Button | ABS | ||
| ABS | |||
| Fingertip Cushion | Medical Silicone Gel | ||
| Medical Silicone Gel | |||
| Comparison Statement | |||
| Performance Testing | The contacting materials of the proposed device are same to those of the predicate device. | ||
| Laboratory Testing | The laboratory tests include SpO2 and PR | ||
| accuracy Test, Weak Perfusion Test, High and | |||
| Low Temperature and Humidity Test, | |||
| Performance Test After Cleaning and | |||
| ISO80601-2-61 | |||
| The laboratory tests include SpO2 and PR | |||
| accuracy Test, Weak Perfusion Test, High and | |||
| Low Temperature and Humidity Test, | |||
| Performance Test After Cleaning and | |||
| ISO80601-2-61 | |||
| Electrical Safety | Conformed to IEC60601-1, IEC 60601-1-11 | ||
| Conformed to IEC60601-1, IEC 60601-1-11 | |||
| EMC and Electrical Safety | Electromagnetic Compatibility | Conformed to IEC60601-1-2 | |
| Conformed to FCC certification | Conformed to IEC60601-1-2 | ||
| Conformed to FCC certification | |||
| Software and Cybersecurity | Moderate level of concern | Moderate level of concern | |
| Compliance with: | |||
| FDA Guidance for the content of Premarket | |||
| Submissions for Software Contained in | |||
| Medical Devices and, | |||
| FDA Guidance for Content of Premarket | |||
| Submission for Management of Cybersecurity | |||
| in Medical Device | |||
| Risk Management in Compliance with | |||
| ISO14971:2007 | Compliance with FDA Guidance for the | ||
| content of Premarket Submissions for | |||
| Software Contained in Medical Devices | |||
| Risk Management in Compliance with | |||
| ISO14971:2007 | |||
| Label and Labeling | Compliance with the Guidance of pulse | ||
| oximeter-premarket notification issued on | |||
| March 4.2013 | Compliance with the Guidance of pulse | ||
| oximeter-premarket notification issued on | |||
| March 4.2013 |
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3.6 Intended use
The Fingertip Pulse Oximeter MD300Cl218 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients in hospital-type facilities and homecare environment.
3.7 Testing
The Fingertip Pulse Oximeter MD300CI218 was supported by both laboratory and clinical accuracy testing in order to ensure that they were appropriate performance and functional features to fully comply with recognized standards and is substantially equivalent to the predicate device.
Non-clinical Test
The Fingertip Pulse Oximeter MD300CI218 is designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
IEC60601-1:2005+A1:2012 Medical Electrical Equipment-Part 1: General Requirements for Safety.
IEC 60601-1-11:2010 Medical Electrical Equipment Part 1-11: General requirements for basic safety and essential performance-Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
IEC60601-1-2:2014 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic disturbances - Requirements and tests.
ISO 80601-2-61:2011 Medical Electrical Equipment- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
We have also conducted other performance test including SpO2 and PR Accuracy Test, Device Output Time and Finger Out Time Test. Device Response Time Test. Weak Perfusion Test, High and Low Temperature & Humidity Test Per Guidance for Industry and FDA Staff: Pulse Oximeter-Premarket Notification submission [510(k)s].
The Software Validation is in compliance with FDA Guidance to Compliance with FDA
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The list of non-clinical test performed on the proposed devices.
No. Test Name
12
| 1 | System Performance Test |
|---|---|
| 2 | Performance Test according to ISO 80601-2-61 |
| 3 | Electromagnetic Compatibility Test According to IEC 60601-1-2 |
| 4 | Electrical Safety Test According to IEC 60601-1 |
| 5 | Used in the home healthcare environment test according to IEC 60601-1-11 |
| 6 | Bluetooth Wireless Test according to FCC Part 15B and Part 15C |
| 7 | wireless coexistence testing |
The test results indicate that the effectiveness of the proposed device is identical to that of the predicate device.
Clinical Test
The clinical study of MD300C1218 was conducted following the testing described in clause 201.12.1 of ISO 80601-2-61:2011 Medical electrical equipment- Part 2-61 Particular requirements for basic safety and essential performance of pulse oximeter equipment.
The Clinical Study of MD300CI218 was conducted Mar.9-11,2018 in the Yue Bei people's Hospital, cardiovascular medicine in accordance with the study procedure. There were no deviations from the study procedure. Institutional Review Board(IRB) approval was obtained for testing through the Yue Bei People's Hostiptal-IRB. 12 healthy adult subjects, gave their informed consent and were studied. The clinical study report was presented in Performance Testing-Clinical Study Report.
Subjects information:
There were no adverse events during the study. The subject demographics included a total of 12 healthy adult volunteer subjects, 7 females and 5 males. The ages ranged from 18 to 45years. The subject weights ranged from 42 to 83kg. The subject Height ranged from 153 to 179cm. The Skin tones included in the study were as follows: 4 subjects with very dark pigmentation, 1 subject with very light pigmentation. The remaining subjects with light skin tones of China origins.
Results:
The SpO2 accuracy performance results showed the MD300CI218 Fingertip Pulse Oximeter to have an Arms of 1.66 during steady state conditions over the range of 70-100% .
Conclusion:
The results of the study provide supporting evidence that the pulse oximeter MD300CI218 Fingertip Pulse Oximeter was compliance to the accuracy specification claimed by the manufacturer.
The clinical statement was presented in Performance Testing-Clinical Statement.
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3.8 Determination of substantial equivalence
The proposed device of Fingertip Pulse Oximeter MD300CI218 has the same classification information, same intended use, same design principle, similar product design and specifications, same performance effectiveness as the predicated device. The main difference is the wavelength of the infrared LED emitter, and we can verify that which will not affect the essential performance of the proposed device. So the proposed devices are Substantially Equivalent (SE) to the predicate device which is US legally market device.