(361 days)
The Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
The Oximeter is intended for spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of adult patients in the home and hospital. The oximeter features a small size, low power consumption, a convenient operation, and portability. It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement. Principle of the oximeter 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 infrared zones. 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 red and 905nm infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant data is shown on the Oximeter's display through electronic circuits and a microprocessor. The four models (JZK-301, JZK-303, JZK-305, and JZK-307) have the same intended use, working principle, characteristic, and conformance standards, only in appearance have some different (appearance design, dimension, and weight).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Targeted Device) |
|---|---|---|
| SpO2 Accuracy | $\pm$ 2% (70% - 100% SpO2), Unspecified for <70% SpO2 | $\pm$ 2% (70% - 100% SpO2), Unspecified for <70% SpO2 (determined through clinical hypoxia accuracy testing and comparison with CO-oximeter, meeting ISO 80601-2-61 criteria) |
| Pulse Rate | $\pm$ 2 bpm | $\pm$ 2 bpm (determined through clinical hypoxia accuracy testing and comparison with CO-oximeter, meeting ISO 80601-2-61 criteria) |
| Measurement Range (SpO2) | 0-100% | 45-100% (The submission states the subject device's range is within the range of the predicate, which is 0-100%. The specific reported range for the subject device is 45-100%, indicating it meets the predicate's relevant operational range.) |
| Measurement Range (Pulse Rate) | 25-250 bpm | 25-250 bpm (The submission states the subject device's range is within the range of the predicate.) |
| Electrical Safety | ANSI AAMI ES60601-1 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012; IEC 60601-1-11 Edition 2.0 2015-01; IEC 60601-1-2 Edition 4.0 2014-02; ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) | Passed all specified IEC/ANSI standards. |
| EMC Safety | IEC 60601-1-2 Edition 4.0 2014-02 | Passed IEC 60601-1-2. |
| Biocompatibility | ISO 10993-5, ISO 10993-10, ISO 10993-23 | Passed all specified ISO 10993 series tests. |
| Software | FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices" | Software verification and validation conducted. |
| Cleaning Validation | FDA "Pulse Oximeters - Premarket Notification Submissions [510(k)s] - Guidance for Industry and Food and Drug Administration Staff" | Conducted and proved device can function as intended after cleaning. |
| Operating Environment (Humidity) | 15-85%RH (non-condensing) for predicate | ≤80%RH (Similar to predicate, met IEC 60601-1 and ISO 80601-2-61) |
| Storage & Transport Environment (Humidity) | 10-95%RH for predicate | ≤93%RH (Similar to predicate, met ISO 80601-2-61) |
Please note that the acceptance criteria for SpO2 and Pulse Rate accuracy are directly stated as the target performance matching the predicate device. The narrative details how this performance was verified. Other criteria are related to compliance with recognized standards.
2. Sample Size for the Test Set and Data Provenance
- Sample Size: 12 subjects (healthy, non-smoking, light-to-dark-skinned adults).
- Data Provenance: The study was a prospective clinical hypoxia accuracy testing conducted during induced hypoxia studies in an independent research laboratory. The country of origin is not explicitly stated, but the manufacturing and submission details point to China.
3. Number of Experts and Qualifications for Ground Truth
- The document implies the use of a CO-oximeter as the control device to establish the ground truth for arterial hemoglobin oxygen (SaO2) values from blood samples. While clinical experts are involved in conducting the study and collecting samples, the direct measurement of SaO2 by a CO-oximeter serves as the objective ground truth, rather than expert interpretation.
- The qualifications of individuals operating the CO-oximeter or collecting blood samples are not specified in this summary but are implicit in conducting a clinical study according to ISO 80601-2-61.
4. Adjudication Method for the Test Set
- The ground truth for SpO2 and Pulse Rate accuracy was established by comparing the device's readings against arterial hemoglobin oxygen (SaO2) values determined from blood samples with a CO-oximeter. This is an objective measurement rather than a subjective expert adjudication process.
- The analysis of the data included Bland and Altman statistics and assessing outliers. This indicates a statistical method for evaluating agreement rather than a consensus-based adjudication from multiple human readers. Therefore, an adjudication method like 2+1 or 3+1 is not applicable here as it's not based on expert interpretation of images or other subjective data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done.
- This study focused on the accuracy of the device itself against a reference standard (CO-oximeter), not on how human readers perform with or without AI assistance. The device is an oximeter, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance study was done. The entire clinical study described is about the standalone performance of the Oximeter device, without human-in-the-loop assistance for interpretation. The device itself produces the SpO2 and PR readings.
7. Type of Ground Truth Used
- The ground truth for SpO2 and Pulse Rate accuracy was outcomes data / objective measurement: arterial hemoglobin oxygen (SaO2) values determined from blood samples using a CO-oximeter.
8. Sample Size for the Training Set
- Not applicable / Not specified. This device is a pulse oximeter, which operates on established opto-electronic principles (Lambert Beer Law, Photoelectric Oxyhemoglobin Inspection Technology) rather than a machine learning or AI algorithm that typically requires a distinct training set. The clinical study performed is a validation (test set) study.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not specified. As there is no explicit training set mentioned for an AI/ML model, the establishment of ground truth for such a set is not relevant to this submission. The device's operational principles are physics-based, not data-driven in the sense of AI training.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 16, 2022
ShenZhen ZhengKang Technology Co., Ltd. % Becky Chen Registered Engineer Feiving Drug & Medical Consulting Technical Service Group Rm 218, Building 2, Yike Intelligent Innovation Park, No. 232 Kezhu Road, Huangpu Guangzhou, Guangdong 510000 China
Re: K213984
Trade/Device Name: Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: December 9, 2022 Received: December 12, 2022
Dear Becky Chen:
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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
James J. Lee -S
James J. Lee, Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthsia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213984
Device Name Oximeter (Model: JZK-301, JZK-303, JZK-305, JZK-307)
Indications for Use (Describe)
The Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510 (k) Summary
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information:
| 510(k) owner's name: | ShenZhen ZhengKang Technology Co., Ltd. |
|---|---|
| Address: | 2&3/F, Building A, No. 3 FuXing Yi Lane, HeHuaCommunity, PingHu Street, LongGang District, ShenZhen,GuangDong, China |
| Contact person: | Huayong Yang |
| Phone number: | +86-755-83260864 |
| Fax number: | +86-755-83251427 |
| Email: | 893488645@qq.com |
| Date of summary prepared: | 12/14/2022 |
| Reason for the submission: | New device, there were no prior submissions for the device. |
(2) Proprietary name of the device
| Trade name/model: | Oximeter / JZK-301, JZK-303, JZK-305, JZK-307 |
|---|---|
| Common name: | Oximeter |
| Regulation number: | 21CFR 870.2700 |
| Product code: | DQA |
| Review panel: | Anesthesiology |
| Regulation class: | Class II |
(3) Predicate device and Reference Device
| Predicate Device | Reference Device | |
|---|---|---|
| Sponsor | Shenzhen Fitfaith TechnologyCo.,Ltd. | Xuzhou Yongkang ElectronicScience Technology Co., Ltd. |
| DeviceName/Model | Fingertip Pulse Oximeter | Fingertip Pulse Oximeter |
| 510(k) Number | K163135 | K161938 |
| Product Code | DQA | DQA |
| RegulationNumber | 21CFR 870.2700 | 21CFR 870.2700 |
| Regulation Class | II | II |
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(4) Description/ Design of device:
The Oximeter is intended for spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of adult patients in the home and hospital.
The oximeter features a small size, low power consumption, a convenient operation, and portability. It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement.
Principle of the oximeter 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 infrared zones.
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 red and 905nm infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant data is shown on the Oximeter's display through electronic circuits and a microprocessor.
The four models (JZK-301, JZK-303, JZK-305, and JZK-307) have the same intended use, working principle, characteristic, and conformance standards, only in appearance have some different (appearance design, dimension, and weight).
(5) Intended use
The subject device is intended for measuring the functional oxygen saturation and pulse rate (PR) through a patient's finger. It is applicable for spot-checking SpO2 and pulse rate (PR) of adult patients in homes and clinics.
(6) Indications for Use:
The Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
(7) Contraindications
- High-frequency electrosurgical A
- A Placement of a sensor on an extremity with a blood pressure cuff arterial catheter, or intravascular line
- A The patient has hypotension severe vasoconstriction severe anemia or hypothermia.
- A The patient is in cardiac arrest or is in shock.
- A Fingernail polish or false fingernails may cause inaccurate SpO2 readings.
(8) Materials
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| Test Article Name | Body Contact Category | Contact Duration |
|---|---|---|
| Oximeter | Surface skin contact | Prolonged (>24h to 30d) |
We have tested the oximeters and obtained the Biocompatibility test reports. For details, please refer to "Biocompatibility Discussion".
| Characteristics | Targeted device | Predicate device | Reference device | Remark | |
|---|---|---|---|---|---|
| Trade name | Oximeter | Fingertip PulseOximeter | Fingertip PulseOximeter | / | |
| Model | JZK-301, JZK-303,JZK-305, JZK-307Note: The 4 modelshave the sametechnologicalcharacteristics, onlyin appearance havesome different. | A300, A310, M100,M110, M120, M130,M150, M160, M170,M230Note: A300 andM110 are totallyidentical modelexcept for modelname based onCustomer'srequirement;A310 and M100 aretotally identicalmodel except formodel name basedon Customer'srequirement | YK-81C | / | |
| Manufacturer | ShenZhenZhengKangTechnology Co.,Ltd. | Shenzhen FitfaithTechnology Co.,Ltd. | XuzhouYongkangElectronicScienceTechnology Co.,Ltd. | / | |
| 510 (k) number | Pending | K163135 | K161938 | / | |
| Regulationnumber | 21CFR 870.2700 | 21CFR 870.2700 | 21CFR 870.2700 | Same | |
| Regulationdescription | Oximeter | Oximeter | Oximeter | Same | |
| Product code | DQA | DQA | DQA | Same | |
| Class | II | II | II | Same | |
| Intended use | The subject device isintended for | The subject device isintended for | The pulseoximeter, | Same.Within | |
| Characteristics | Targeted device | Predicate device | Reference device | Remark | |
| measuring thefunctional oxygensaturation and pulserate (PR) through apatient's finger. It isapplicable forspot-checking SpO2and pulse rate (PR)of adult patients inhomes and clinics. | measuring thefunctional oxygensaturation and pulserate (PR) through apatient's finger. It isapplicable forspot-checking SpO2and pulse rate (PR)of adult and pediatricpatients in homesand clinics. | YK-81C, isdesigned for spotchecking of thepulse oxygensaturation andpulserate for adult inclinicenvironment. Thismedical devicecan be reused.Not forcontinuouslymonitoring. | the rangeofpredicatedevice.(Thepredicatedevice isintendedfor use byadult andpediatricpatient,ourdevice isintendedfor use byadultpatientonly. | ||
| Indications foruse | The Oximeter isnon-invasive deviceintended forspot-checking offunctional oxygensaturation of arterialhemoglobin (SpO2)and pulse rate (PR).The portablefingertip device isindicated for adultpatients in home andhospitalenvironments(including clinicaluse in internist/surgery, anesthesia,intensive care, etc). | The Fingertip PulseOximeter isnon-invasive deviceintended forspot-checking offunctional oxygensaturation of arterialhemoglobin (SpO2)and pulse rate (PR).The portablefingertip device isindicated for adultand pediatricpatients in home andhospitalenvironments(including clinicaluse in internist/surgery, anesthesia,intensive care, etc). | The pulseoximeter(YK-81C)is designed forspot checkingof the pulseoxygen saturationand pulse rate foradult inclinicenvironment. Thismedical devicecan be reused.Not forcontinuouslymonitoring. | Same.Withinthe rangeofpredicatedevice.(Thepredicatedevice isintendedfor use byadult andpediatricpatient,ourdevice isintendedfor use byadultpatientonly. | |
| Intended patientpopulation | Adult | Adult & Pediatric | Adult | Samewith | |
| Characteristics | Targeted device | Predicate device | Reference device | Remark | |
| referencedevice;Withinthe rangeofpredicatedevice. | |||||
| Intendedapplication site | Fingertip | Fingertip | Fingertip | Same | |
| Intendedenvironments | Home & hospital | Home & hospital | Clinic | Samewithpredicatedevice | |
| Prescription &OTC | Prescription | Prescription | Prescription | Same | |
| Workingprinciple | A mathematicalformula isestablished makinguse of Lambert BeerLaw according toSpectrumAbsorptionCharacteristics ofReductivehemoglobin (RHb)and Oxyhemoglobin(HbO2) in red andnear-infrared zones.Operation principleof the instrument:PhotoelectricOxyhemoglobinInspectionTechnology isadopted inaccordance withCapacity PulseScanning andRecordingTechnology, so thattwo beams ofdifferent wavelength | A mathematicalformula isestablished makinguse of Lambert BeerLaw according toSpectrum AbsorptionCharacteristics ofReductivehemoglobin (RHb)and Oxyhemoglobin(HbO2) in red andnear-infrared zones.Operation principleof the instrument:PhotoelectricOxyhemoglobinInspectionTechnology isadopted inaccordance withCapacity PulseScanning andRecordingTechnology, so thattwo beams ofdifferent wavelengthof lights can be | / | Same | |
| Characteristics | Targeted device | Predicate device | Reference device | Remark | |
| of lights can befocused onto ahuman nail tipthrough a clampingfinger-type sensor. Ameasured signalobtained by aphotosensitiveelement, will beshown on theOximeter's displaythrough process inelectronic circuitsand microprocessor. | focused onto ahuman nail tipthrough a clampingfinger-type sensor. Ameasured signalobtained by aphotosensitiveelement, will beshown on theOximeter's displaythrough process inelectronic circuitsand microprocessor. | ||||
| Wavelength | Red light:660nm $\pm$ 3nmInfrared light:905nm $\pm$ 5nm | Red light:660nm $\pm$ 3nmInfrared light:905nm $\pm$ 5nm | Red light:660nmInfrared light:940nm | Samewithpredicatedevice | |
| Maximumoptical power | 21.8 mW for redlight (660nm)5 mW for IR(905nm) | 1.5 mW for red light(660nm)1.2 mW for IR(905nm) | 21.8 mW | SimilarNote 1 | |
| Contactmaterial | ABS for enclosuresilica gel for clip | ABS for enclosuresilica gel for clip | / | Same | |
| Internal Powersupply | DC 3V (two AAAalkaline batteries) | 2*AAA 1.5v alkalinebattery | 2 AAA alkalinebatteries | Same | |
| Workingcurrent | Less than40mA(Normal) | Less than40mA(Normal) | / | Same | |
| Resolution | SpO2: 1%Pulse rate: 1 bpm | SpO2: 1%Pulse rate: 1 bpm | SpO2: 1%Pulse rate: 1 bpm | Same | |
| Measurementrange | SpO2: 45-100%Pulse rate: 25-250bpm | SpO2: 0-100%Pulse rate: 25-250bpm | SpO2: 0-100%Pulse rate: 30-254bpm | SimilarNote 2 | |
| Measurementaccuracy | SpO2:$\pm$ 2%: (70%~100%)Unspecified for<70% | SpO2:$\pm$ 2%:(70%~100%)Unspecified:(0%~69%) | SpO2:$\pm$ 3%:(70%~100%)Unspecified:(0%~69%) | Samewithpredicatedevice | |
| Pulse rate: $\pm$ 2 bpm | Pulse rate: $\pm$ 2 bpm | Pulse rate: $\pm$ 2bpm | |||
| Operatingenvironment | Temperature:5℃~40℃ | Temperature:5℃~40℃ | / | SimilarNote 3 | |
| Characteristics | Targeted device | Predicate device | Reference device | Remark | |
| Humidity:≤80%RH | Humidity:15~85%RH(non-condensing) | ||||
| Storage andtransportenvironment | Temperature:-20°C~+55°C;Humidity:≤93%RH | Temperature:-20°C~+55°C;Humidity:10~95%RH | / | SimilarNote 4 | |
| Tests | IEC 60601-1 test;IEC 60601-1-2 test;IEC 60601-1-11 test;ISO 80601-2-61 test;ISO 10993-5 test;ISO 10993-10 test;ISO 10993-23 test;Cleaning validation;Clinical accuracytest | IEC 60601-1 test;IEC 60601-1-2 test;IEC 60601-1-11 test;ISO 80601-2-61 test;ISO 10993-5 test;ISO 10993-10 test;Cleaning validation;Clinical accuracytest | IEC 60601-1 test;IEC 60601-1-2 test;IEC 60601-1-11 test;ISO 80601-2-61test;ISO 10993-5 test;ISO 10993-10 test;Cleaningvalidation;Clinical accuracytest | Same |
(9) Technological characteristics and substantial equivalence:
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Comparison in details:
Note 1:
The value of the maximum optical power of subject device is between predicate device and the reference device. The higher the optical power, the light and the better the accuracy. This value is small and does not affect safety. The subject device met the requirements of ISO 80601-2-61. Such a difference does not raise new questions of safety and effectiveness.
Note 2:
The measurement range of subject device is within the measurement range of predicate device. The subject device met the requirements of IEC 60601-1 and ISO 80601-2-61. Such a difference does not raise new questions of safety and effectiveness.
Note 3:
The humidity under operating environment of subject device and predicate device are similar. The subject device met the requirements of IEC 60601-1 and ISO 80601-2-61. Such a difference does not raise new questions of safety and effectiveness.
Note 4:
The humidity under storage & transport environment of subject device and predicate device are similar. The subject device met the requirements of ISO 80601-2-61. Such a difference does not raise new questions of safety and effectiveness.
Comparison analysis conclusion:
The subject device has the same technological characteristics as the predicate device. Only their appearance, maximum optical power (Note 1), measurement range (Note 2),
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operating environment (Note 3), storage and transport environment (Note 4) are a little bit different. However, the minor differences do not raise safety and effectiveness questions.
(8) Nonclinical and Clinical Tests: Non-clinical Tests:
The following performance data have been conducted to verify that the Oximeter meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the targeted device complies with the following standards:
Biocompatibility Testing:
The biocompatibility evaluation for the oximeter was conducted in accordance with the FDA's Biocompatibility Guidance "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process'" and per recommendations from the following standards:
- A ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity
- A ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
-
ISO 10993-23, Biological Evaluation Of Medical Devices - Part 23: Tests For Irritation
The oximeter has passed the Biocompatibility tests.
Electrical and EMC Safety:
The electrical safety and EMC safety testing was performed to, and passed, the following standards:
- ANSI AAMI ES60601-1 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A A2:2010/(R)2012 (Consolidated Text), Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-11 Edition 2.0 2015-01, Medical electrical equipment -- Part 1-11: A 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
-
IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral standard: Electromagnetic disturbances - Requirements and tests
- A ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02), Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
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Software:
We have conducted Software verification and validation according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices".
Clean Validation:
We have conducted clean validation according to the requirements of the FDA "Pulse Oximeters - Premarket Notification Submissions [510(k)s] - Guidance for Industry and Food and Drug Administration Staff" to prove that the device can continue to perform as intended after cleaning in accordance with the specific cleaning method.
Clinical Test:
Clinical testing according to ISO 80601-2-61: 2011 has also been performed on the device. Clinical hypoxia accuracy testing was conducted during induced hypoxia studies on healthy, non-smoking, light-to-dark-skinned subjects in an independent research laboratory during non-motion/static conditions. The device is not intended for SpO2 monitoring in conditions of motion or low perfusion. The measured arterial hemoglobin saturation value (SpO2) of the subject device was compared with arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter (control device). The accuracy of the subject device is in comparison with the control device over the SpO2 range of 70~100%.
Data was calculated and analyzed using the mean bias (B), root-mean-square (Arms), PRECISION (standard deviation of the residuals (sres) for all subjects, per ISO 80601-2-61, the result showed that the error is far less than the scope specified in the ISO 80601-2-61;
Besides, the Agreement between methods of measurement with multiple observations for both all subjects pooled and individual test subjects were analyzed with the Bland and Altman statistics, the analysis demonstrated that the vast majority of data is within ±95% limit of agreement, the data points beyond or below this scope were regarded as outliers. The outliers only occurred occasionally and after being analyzed, it was determined that the outliers do not raise performance concerns regarding the accuracy and precision of the device.
During the clinical study, 12 subjects were enrolled, who are healthy, nonsmoking, competent adults, between 18-50 years of age, and they were provided EC (Ethics Committee)-approved informed consent as documented on an informed consent form. No case was lost in this trial.
The trial completed 12 cases, on which 300 data sets were collected, of which 289 were valid. 11 data sets were excluded. The result met the criteria specified in the ISO 80601-2-61; In addition, there were no reported adverse effects during these investigations.
Summary:
Based on the above nonclinical and clinical tests as documented in this application, the Oximeter was found to have a safety and effectiveness profile that is similar to the predicate device.
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(9) Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the Oximeter is to be concluded substantial equivalent to its predicate device.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).