(317 days)
No
The device description outlines standard electronic circuits for signal processing and display, and there is no mention of AI, ML, or related concepts in the summary.
No
The device is intended for measuring and displaying physiological parameters (SpO2 and pulse rate), not for treating, preventing, or mitigating disease.
Yes
The device is a diagnostic device because it measures physiological parameters (SpO2 and pulse rate) to assess the function of arterial hemoglobin, which can be used to identify or monitor a medical condition.
No
The device description explicitly states it is a "fingertip device" and is "composed of light signal driving circuit, preamplification circuit, low pass filtering circuit, DC bias circuit, gain control circuit, display control circuit, and main control circuit," indicating it is a hardware device with embedded software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "measuring function of arterial hemoglobin (SpO2) and pulse rate". These measurements are taken directly from the patient's finger, not from a sample of bodily fluid or tissue that is analyzed in vitro (outside the body).
- Device Description: The description details the components and function of a device that interacts directly with the patient's finger to obtain physiological measurements. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any reagents, test strips, or other elements typically associated with IVD devices that analyze samples.
IVD devices are designed to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This pulse oximeter measures physiological parameters directly from the body.
N/A
Intended Use / Indications for Use
The Fingertip Pulse Oximeter are intended for measuring function of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as not checking in home and professional caring environment. It is designed for fingers between 7mm and 25.4mm in diameter (0.28 inches to 1.0inches). And it is not intended to be used under motion or low perfusion scenarios.
Product codes
DQA
Device Description
The Fingertip Pulse Oximeter X1609P is a fingertip device, which can measure the arterial SpO2 and pulse rate value and can display the results to the user.
Moreover, the X1609P also has the function of low battery voltage indicate and automatically power off. The power source is 2xAAA batteries. Fingertip Pulse Oximeter X1609P is small in volume, light in weight and convenient in carrying. It is composed of light signal driving circuit, preamplification circuit, low pass filtering circuit, DC bias circuit, gain control circuit, display control circuit, and main control circuit.
The device is for prescription. It is neither for life-supporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger
Indicated Patient Age Range
Adults and adolescent.
Intended User / Care Setting
Home and professional caring 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 studies were conducted to verify the accuracy of proposed device. The clinical studies were conducted per following standards:
- ISO 80601-2-61: 2017 Medical Electrical Equipment Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
- Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff.
There were 13 adult volunteers to validated the accuracy of finger pulse oximeter (Model: X1906P). 5 males and 8 females (including 3 subjects with Fitzpatrick VI, 3 subjects with Fitzpatrick II and 7 with Fitzpatrick IV). The measure result between the SpO2 measured by subject device and the SaO2 measured by the blood gas analyzer, the measure result between the PR measured by subject device and the HR measured by the patient monitor were conformed with the requirements of this clinical trial and related standards. The pulse oximeter had not been found any safety issues, adverse effects and complications during the clinical trial.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Data:
- Biocompatibility testing: Conducted in accordance with ISO 10993-1. Included Cytotoxicity, Skin Sensitization, Skin Irritation. Results demonstrate biocompatibility.
- Electrical safety, Home Healthcare environment and electromagnetic compatibility (EMC): Complies with IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+A1: 2012, IEC 60601-1-11: 2015, and IEC 60601-1-2: 2014.
- Bench Testing: Complies with ISO 80601-2-61: 2017. Pulse Rate Accuracy meets requirements defined in ISO 80601-2-61, Clause 201.12.1.104.
- Software Verification and Validation Testing: Provided in accordance with FDA Guidance for software with a moderate level of concern.
Clinical test:
- Sample size: 13 adult volunteers (5 males, 8 females, including 3 Fitzpatrick VI, 3 Fitzpatrick II, 7 Fitzpatrick IV).
- Key results: The measure result between the SpO2 measured by subject device and the SaO2 measured by the blood gas analyzer, the measure result between the PR measured by subject device and the HR measured by the patient monitor were conformed with the requirements of this clinical trial and related standards. No safety issues, adverse effects, or complications were found during the clinical trial.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy of SPO2: 70% to 99% range +/- 2%; less than 70% are unspecified
Accuracy of pulse rate: +/- 3bpm
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).
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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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Mav 4, 2023
Shenzhen Changkun Technology Co., Ltd. % Reanny Wang General Manager Shenzhen Reanny Medical Devices Management Consulting.. Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen, Guangdong 518000 China
Re: K221798
Trade/Device Name: Finger Pulse Oximeter, Model: X1906P Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: May 4, 2023 Received: May 4, 2023
Dear Reanny Wang:
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 and Part 809); 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. Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia 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) K221798
Device Name Finger Pulse Oximeter, Model: X1906P
Indications for Use (Describe)
The Fingertip Pulse Oximeter are intended for measuring function of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as not checking in home and professional caring environment. It is designed for fingers between 7mm and 25.4mm in diameter (0.28 inches to 1.0inches). And it is not intended to be used under motion or low perfusion scenarios.
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 summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92.
The assigned 510(k) number is:_____K221798
1.0 Information of Submitter and Correspondent
Submitter's information:
Company Name: Shenzhen Changkun Technology Co. Ltd.
Address: Room 501, Changkun Technology Building A, 12 Shijia Road, Biling Community, Biling Subdistrict, Pingshan District, Shenzhen City, Guangdong Province, 518118, P.R. China
Telephone: +86(755)-29100487 Contact Person: Wang Qingpeng General Manager Contact Title:
Contact Email: 757168025@qq.com
Submission correspondent's information:
Company Name: Shenzhen Reanny Medical Devices Management Consulting Co., Ltd
Address: Room 1407, Jingting Building, Dongzhou Community, Guangming Street,
Guangming District, Shenzhen, Guangdong Province, China
Contact person: Reanny Wang
E-Mail: Reanny@reanny.com
2.0 Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Fingertip Pulse Oximeter |
| Model: | X1906P |
| Classification name: | Oximeter |
| Review Panel: | Anesthesiology |
| Product Code: | DQA |
| Device Class: | Class II |
| Regulation Number: | 870.2700 |
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3.0 Predicate Device Information
| Sponsor: | Beijing Choice Electronic Technology Co., Ltd. |
|---|---|
| Device: | Fingertip Pulse Oximeter |
| 510(K) Number: | K160268 |
4.0 Intended Use
The Fingertip Pulse Oximeter are intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as non-invasive spot checking in home and professional caring environment. It is designed for fingers between 7mm and 25.4mm in diameter (0.28 inches to 1.0inches). And it is not intended to be used under motion or low perfusion scenarios.
5.0 Product introduction
The Fingertip Pulse Oximeter X1609P is a fingertip device, which can measure the arterial SpO2 and pulse rate value and can display the results to the user.
Moreover, the X1609P also has the function of low battery voltage indicate and automatically power off. The power source is 2xAAA batteries. Fingertip Pulse Oximeter X1609P is small in volume, light in weight and convenient in carrying. It is composed of light signal driving circuit, preamplification circuit, low pass filtering circuit, DC bias circuit, gain control circuit, display control circuit, and main control circuit.
The device is for prescription. It is neither for life-supporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterile.
The intended use, design principle, operation principle, functions, material and the applicable standards of X1609P Fingertip Pulse Oximeter are the same as the predicated device MD300CG51 Fingertip Pulse Oximeter (K160268) manufactured by Beijing Choice Electronic Technology Co., Ltd.
6.0 Summary comparing technological characteristics with predicate device
5
| Technological Characteristics | Comparison result |
|---|---|
| Indications for use | Same |
| Design principle | Same |
| Appearance | Similar |
| Patients contact materials | Same |
| Performance | Similar |
| Biocompatibility | Same |
| Mechanical and Electrical safety | Same |
| Standards met | Same |
| EMC | Same |
| Function | Similar |
7.0 Performance Summary
Performance data includes "Non-Clinical Data", brief description of which are shown as below.
Non-Clinical Testing:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Fingertip Pulse Oximeter was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The testing included the following tests, results of which demonstrate the biocompatibility of the subject device:
- Cytotoxicity
- Skin Sensitization
- Skin Irritation
Electrical safety, Home Healthcare environment and electromagnetic compatibility (EMC)
Electrical safety, Home Healthcare environment and EMC testing were conducted, and the results show that the subject device complies with the IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+A1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance, IEC 60601-1-11: 2015 Medical
6
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 and the IEC 60601-1-2: 2014 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Bench Testing
Bench testing was conducted, and the results show that the subject device complies with the ISO 80601-2-61: 2017 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of Fingertip Pulse Oximeter Equipment standard. And Pulse Rate Accuracy meets the requirements defined in ISO 80601-2-61, Clause 201.12.1.104.
Software Verification and Validation Testing
Software documentation including verification & validation was provided in accordance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern.
The above tests were selected to show substantial equivalence between the subject device and the predicate device.
Clinical test:
Clinical studies were conducted to verify the accuracy of proposed device. The clinical studies were conducted per following standards:
- ISO 80601-2-61: 2017 Medical Electrical Equipment Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
- · Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff.
There were 13 adult volunteers to validated the accuracy of finger pulse oximeter (Model: X1906P). 5 males and 8 females (including 3 subjects with Fitzpatrick VI, 3 subjects with Fitzpatrick II and 7 with Fitzpatrick IV). The measure result between the SpO2 measured by subject device and the SaO2 measured by the blood gas analyzer, the measure result between the PR measured by subject device and the HR measured by the patient monitor
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were conformed with the requirements of this clinical trial and related standards. The pulse oximeter had not been found any safety issues, adverse effects and complications during the clinical trial.
8.0 Comparison to predicate device
The subject device X1906P Fingertip Pulse Oximeter is substantially equivalent to MD300CG51 Fingertip Pulse Oximeter whose 510(k) number is K160268.
| Elements of
| Comparison | Subject Device | Predicate Device | Judgment |
|---|---|---|---|
| Company | Shenzhen Changkun | ||
| Technology Co. Ltd. | Beijing Choice Electronic | ||
| Technology Co., Ltd. | -- | ||
| Device Name | Fingertip Pulse Oximeter | Fingertip Pulse Oximeter | -- |
| Model | X1906P | MD300CG51 | -- |
| 510(k) Number | Pending | K160268 | -- |
| Product code | DQA | DQA | Same |
| Intended patient | |||
| population | Adult and Children | Adult, adolescent, child | |
| and infant patient | Same, | ||
| within the | |||
| range of | |||
| predicate | |||
| device | |||
| Intended | |||
| application site | Finger | Finger | Same |
| Intended use | The Fingertip Pulse | ||
| Oximeter are intended for | |||
| measuring functional | |||
| oxygen saturation of | |||
| arterial hemoglobin (SpO2) | |||
| and pulse rate for both | |||
| adults and adolescent as | |||
| non-invasive spot checking | |||
| in home and professional | |||
| caring environment. It is | |||
| designed for fingers | |||
| between 7mm and 25.4mm | The Fingertip Pulse | ||
| Oximeter MD300CG11/ | |||
| D300CG51 is a portable, | |||
| non-invasive device | |||
| intended for spot checking | |||
| of oxygen saturation of | |||
| arterial hemoglobin (SpO2) | |||
| and pulse rate of adult, | |||
| adolescent, child and infant | |||
| patient with the fingers | |||
| between 0.9 - 2.2 m (0.4 - | |||
| 0.9 inch) thick in hospital. | Same, the | ||
| description | |||
| is | |||
| difference | |||
| and the | |||
| finger thick | |||
| range have | |||
| been | |||
| evaluated | |||
| in clinical | |||
| trial | |||
| according | |||
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Judgment |
| in diameter (0.28 inches to | |||
| 1.0inches). And it is not | |||
| intended to be used under | |||
| motion or low perfusion | |||
| scenarios. | to ISO | ||
| 80601-2- |
-
|
| Presentation or
OTC | Presentation | Presentation | Same |
| Measurement
range of SPO2 | 099% | 099% | Same |
| Accuracy of SPO2 | 70% to 99% range $\pm$ 2%;
less than 70% are
unspecified | 70%-99%, $\pm$ 2%;
Less than 70% no
definition | Same |
| Resolution of
SPO2 | 1% | 1% | Same |
| Transducer of
SPO2 | Dual-wavelength LED
sensor | Dual-wavelength LED
sensor | Same |
| Measurement
wavelength of
SPO2 | Red light:660nm,
Infrared light: 940nm | Red light: 660nm,
Infrared light: 940nm | Same |
| Measurement
range of pulse rate | 30-250bpm | 30-235bpm | Similar |
| Accuracy of pulse
rate | $\pm$ 3bpm | 30-99bpm, $\pm$ 2bpm; 100-
235bpm, $\pm$ 2% | Similar |
| Resolution of
pulse rate | 1 bpm | 1 bpm | Same |
| Pulse intensity of
pulse rate | Bar graph indicator | Bar graph indicator | Same |
| 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 | | Same |
| Elements of
Comparison | Subject Device | Predicate Device | Judgment |
| | Oxyhemoglobin Inspection Technology is adopted in
accordance with Capacity Pulse Scanning and
Recording Technology, so that two beams of different
wavelength of lightscan 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. | | |
| Power source | Internal powered
equipment
DC3V, 2 x AAA batteries | Internal powered
equipment
1 AAA-size alkaline battery | Same |
| Dimensions | 60mm×35mm×37mm | Unknown | / |
| Weight | About 56g (including 2
AAA alkaline batteries) | Unknown | / |
| Classification | Internally powered
equipment, type BF
applied part | Internally powered
equipment, type BF
applied part | Same |
| Grade of
waterproof | IP22 | IPX2 | Same |
| Material of pulse
oximeter | ABS and silicone rubber | ABS and Silicone gel | Same |
| Performance | Compliance with ISO
80601-2-61 | Compliance with ISO
80601-2-61 | Same |
| Biocompatibility | All the patient contacting
materials are compliance
with ISO 10993-1/-5/-10 | All the patient contacting
materials are compliance
with ISO 10993-1/-5/-10 | Same |
| Electrical Safety | Compliance with IEC
60601-1 | Compliance with IEC
60601-1 | Same |
| Safety of home
healthcare | Compliance with IEC
60601-1-11 | Compliance with IEC
60601-1-11 | Same |
| Elements of
Comparison | Subject Device | Predicate Device | Judgment |
| environment | | | |
| EMC | Compliance with IEC
60601-1-2 | Compliance with IEC
60601-1-2 | Same |
8
9
10
As seen in the comparison tables, the subject and predicate devices have same design principle, similar design features and performance specifications. The different technological characteristics between the subject and predicate devices will not raise different questions of safety or effectiveness
9. Conclusion
The Fingertip Pulse Oximeter is monitoring the patient's SpO2 and pulse rate in non-invasive, timely and convenient. Non-clinical testing and clinical testing were conducted on the subject device and all testing passed pre-specified criteria. The risks of Finger Pulse Oximeter also have been evaluated according to ISO 14971, the overall residual risk and side effect are acceptable, the benefit is greater than risk and hazard. Which demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed device predicate. The subject device is substantially equivalent to the predicate device.
10. Summary prepared date
May 4, 2023