(361 days)
No
The device description outlines a traditional pulse oximetry principle based on Lambert Beer Law and photoelectric technology, processed by electronic circuits and a microprocessor. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is intended for non-invasive spot-checking of physiological parameters (SpO2 and pulse rate) for monitoring purposes, not for treating a condition or restoring a function.
Yes
The "Intended Use / Indications for Use" section states that "The Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR)." Measuring these physiological parameters to provide information about a patient's health status constitutes a diagnostic function.
No
The device description explicitly states it is a "portable fingertip device" and describes the physical components and working principle involving light beams, sensors, electronic circuits, and a microprocessor, indicating it is a hardware device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro means "in glass"). This device is described as a "non-invasive device" that measures oxygen saturation and pulse rate by placing a finger into a clip. It does not involve collecting or analyzing any biological samples like blood, urine, or tissue.
- The working principle involves light absorption through the skin. The description explains that the device uses light beams (red and infrared) focused onto a human nail tip to measure oxygen saturation based on the absorption characteristics of hemoglobin. This is a physical measurement taken on the body, not an analysis of a sample from the body.
Therefore, this device falls under the category of a non-invasive medical device rather than an In Vitro Diagnostic.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip
Indicated Patient Age Range
Adult
Intended User / Care Setting
Home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, 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
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 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%.
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy: ± 2%: (70%~100%)
Pulse rate accuracy: ± 2 bpm
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
1
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
2
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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3
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, HeHua |
| Community, 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 Technology | |
| Co.,Ltd. | Xuzhou Yongkang Electronic | |
| Science Technology Co., Ltd. | ||
| Device | ||
| Name/Model | Fingertip Pulse Oximeter | Fingertip Pulse Oximeter |
| 510(k) Number | K163135 | K161938 |
| Product Code | DQA | DQA |
| Regulation | ||
| Number | 21CFR 870.2700 | 21CFR 870.2700 |
| Regulation Class | II | II |
4
(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
5
| 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 Pulse | |||
| Oximeter | Fingertip Pulse | ||||
| Oximeter | / | ||||
| Model | JZK-301, JZK-303, | ||||
| JZK-305, JZK-307 | |||||
| Note: The 4 models | |||||
| have the same | |||||
| technological | |||||
| characteristics, only | |||||
| in appearance have | |||||
| some different. | A300, A310, M100, | ||||
| M110, M120, M130, | |||||
| M150, M160, M170, | |||||
| M230 | |||||
| Note: A300 and | |||||
| M110 are totally | |||||
| identical model | |||||
| except for model | |||||
| name based on | |||||
| Customer's | |||||
| requirement; | |||||
| A310 and M100 are | |||||
| totally identical | |||||
| model except for | |||||
| model name based | |||||
| on Customer's | |||||
| requirement | YK-81C | / | |||
| Manufacturer | ShenZhen | ||||
| ZhengKang | |||||
| Technology Co., | |||||
| Ltd. | Shenzhen Fitfaith | ||||
| Technology Co.,Ltd. | Xuzhou | ||||
| Yongkang | |||||
| Electronic | |||||
| Science | |||||
| Technology Co., | |||||
| Ltd. | / | ||||
| 510 (k) number | Pending | K163135 | K161938 | / | |
| Regulation | |||||
| number | 21CFR 870.2700 | 21CFR 870.2700 | 21CFR 870.2700 | Same | |
| Regulation | |||||
| description | Oximeter | Oximeter | Oximeter | Same | |
| Product code | DQA | DQA | DQA | Same | |
| Class | II | II | II | Same | |
| Intended use | The subject device is | ||||
| intended for | The subject device is | ||||
| intended for | The pulse | ||||
| oximeter, | Same. | ||||
| Within | |||||
| Characteristics | Targeted device | Predicate device | Reference device | Remark | |
| 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. | 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 and pediatric | |||||
| patients in homes | |||||
| and clinics. | YK-81C, is | ||||
| designed for spot | |||||
| checking of the | |||||
| pulse oxygen | |||||
| saturation and | |||||
| pulse | |||||
| rate for adult in | |||||
| clinic | |||||
| environment. This | |||||
| medical device | |||||
| can be reused. | |||||
| Not for | |||||
| continuously | |||||
| monitoring. | the range | ||||
| of | |||||
| predicate | |||||
| device. | |||||
| (The | |||||
| predicate | |||||
| device is | |||||
| intended | |||||
| for use by | |||||
| adult and | |||||
| pediatric | |||||
| patient, | |||||
| our | |||||
| device is | |||||
| intended | |||||
| for use by | |||||
| adult | |||||
| patient | |||||
| only. | |||||
| 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). | The Fingertip Pulse | ||||
| 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 | |||||
| and pediatric | |||||
| patients in home and | |||||
| hospital | |||||
| environments | |||||
| (including clinical | |||||
| use in internist/ | |||||
| surgery, anesthesia, | |||||
| intensive care, etc). | The pulse | ||||
| oximeter | |||||
| (YK-81C) | |||||
| is designed for | |||||
| spot checking | |||||
| of the pulse | |||||
| oxygen saturation | |||||
| and pulse rate for | |||||
| adult in | |||||
| clinic | |||||
| environment. This | |||||
| medical device | |||||
| can be reused. | |||||
| Not for | |||||
| continuously | |||||
| monitoring. | Same. | ||||
| Within | |||||
| the range | |||||
| of | |||||
| predicate | |||||
| device. | |||||
| (The | |||||
| predicate | |||||
| device is | |||||
| intended | |||||
| for use by | |||||
| adult and | |||||
| pediatric | |||||
| patient, | |||||
| our | |||||
| device is | |||||
| intended | |||||
| for use by | |||||
| adult | |||||
| patient | |||||
| only. | |||||
| Intended patient | |||||
| population | Adult | Adult & Pediatric | Adult | Same | |
| with | |||||
| Characteristics | Targeted device | Predicate device | Reference device | Remark | |
| reference | |||||
| device; | |||||
| Within | |||||
| the range | |||||
| of | |||||
| predicate | |||||
| device. | |||||
| Intended | |||||
| application site | Fingertip | Fingertip | Fingertip | Same | |
| Intended | |||||
| environments | Home & hospital | Home & hospital | Clinic | Same | |
| with | |||||
| predicate | |||||
| device | |||||
| Prescription & | |||||
| OTC | Prescription | Prescription | Prescription | Same | |
| Working | |||||
| 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 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 | 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 can be | / | Same | |||
| Characteristics | Targeted device | Predicate device | Reference device | Remark | |
| 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. | 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. | |||||
| Wavelength | Red light: | ||||
| 660nm $\pm$ 3nm | |||||
| Infrared light: | |||||
| 905nm $\pm$ 5nm | Red light: | ||||
| 660nm $\pm$ 3nm | |||||
| Infrared light: | |||||
| 905nm $\pm$ 5nm | Red light: | ||||
| 660nm | |||||
| Infrared light: | |||||
| 940nm | Same | ||||
| with | |||||
| predicate | |||||
| device | |||||
| Maximum | |||||
| optical power | 21.8 mW for red | ||||
| light (660nm) | |||||
| 5 mW for IR | |||||
| (905nm) | 1.5 mW for red light | ||||
| (660nm) | |||||
| 1.2 mW for IR | |||||
| (905nm) | 21.8 mW | Similar | |||
| Note 1 | |||||
| Contact | |||||
| material | ABS for enclosure | ||||
| silica gel for clip | ABS for enclosure | ||||
| silica gel for clip | / | Same | |||
| Internal Power | |||||
| supply | DC 3V (two AAA | ||||
| alkaline batteries) | 2*AAA 1.5v alkaline | ||||
| battery | 2 AAA alkaline | ||||
| batteries | Same | ||||
| Working | |||||
| current | Less than | ||||
| 40mA(Normal) | Less than | ||||
| 40mA(Normal) | / | Same | |||
| Resolution | SpO2: 1% | ||||
| Pulse rate: 1 bpm | SpO2: 1% | ||||
| Pulse rate: 1 bpm | SpO2: 1% | ||||
| Pulse rate: 1 bpm | Same | ||||
| Measurement | |||||
| range | SpO2: 45-100% | ||||
| Pulse rate: 25-250 | |||||
| bpm | SpO2: 0-100% | ||||
| Pulse rate: 25-250 | |||||
| bpm | SpO2: 0-100% | ||||
| Pulse rate: 30-254 | |||||
| bpm | Similar | ||||
| Note 2 | |||||
| Measurement | |||||
| accuracy | SpO2: | ||||
| $\pm$ 2%: (70%~100%) | |||||
| Unspecified for | |||||
| 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.