(97 days)
The Pulse Oximeter FS20P is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adolescent, child and infant patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
The Pulse Oximeter FS20C and FS10C is a handheld non-invasive device intended for spotchecking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
The subject device Pulse Oximeter is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. The device is normally applied to infants, children, adolescents and adult in hospitals, hospital-type facilities and homecare.
The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter LED, signal collection and process module (MCU), OLED/LED display screen, user interface and button control circuit.
The document provided is a 510(k) Premarket Notification from the FDA for a Pulse Oximeter. It describes the device, its intended use, and a comparison to a predicate device, including non-clinical and clinical data.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Acceptance Criteria Table and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| SpO2 Accuracy (for FS20P model)Measurement Accuracy: 70%~100%: ±2% (Implied from "Accuracy: 70% | FS20P Pulse Oximeter:ARMS (Accuracy Root Mean Square) of 1.70% over the range of 70-100%. This value 1.70% is less than or equal to the implied acceptance criteria of ±2% as defined by the predicate device and the new device's listed specification for accuracy. |
| SpO2 Accuracy (for FS20C model)Measurement Accuracy: 70%~100%: ±2% (Implied from "Accuracy: 70% | FS20C Pulse Oximeter:ARMS (Accuracy Root Mean Square) of 1.71% over the range of 70-100%. This value 1.71% is less than or equal to the implied acceptance criteria of ±2% as defined by the predicate device and the new device's listed specification for accuracy. |
| BiocompatibilityMust conform to the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1. | The biocompatibility evaluation for the Pulse Oximeter was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". (Statement of compliance, not a numerical performance metric). |
| Bench Testing / Electrical SafetyConform to specified IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-61). | The Pulse Oximeter has been tested according to the following standards:- IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012- IEC 60601-1-2:2014- IEC 60601-1-11 Edition 2.0 2015-01- ISO 80601-2-61: 2017(Statement of compliance, not a numerical performance metric, beyond the clinical accuracy which is detailed elsewhere). Electrical safety explicitly stated: "Conformed to IEC60601-1, IEC 60601-1-11". |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- FS20P: 10 healthy female adult volunteer subjects.
- FS20C: 13 healthy adult volunteer subjects.
- Data Provenance: The studies involved volunteer subjects, implying prospective data collection. The document does not specify the country of origin of the study data, but the submitting company is based in China, so it is highly likely the studies were conducted there. The subject skin tones (Fitzpatrick 1-6) suggest a diverse population, but this is a characteristic, not a location.
3. Number of Experts and Qualifications for Ground Truth
- The document describes a clinical study for SpO2 accuracy compared to arterial blood CO-Oximetry. This is a direct physiological measurement, implying that no human expert adjudication was used to establish the ground truth for SpO2. The CO-Oximeter itself is the "expert" or gold standard.
- Therefore, the concept of "number of experts" for ground truth establishment, as typically applied to image-based diagnostic AI, is not directly applicable here.
4. Adjudication Method for the Test Set
- None, as the ground truth was established by direct physiological measurement using a CO-Oximeter, which is considered a gold standard for SpO2. No human adjudication process (like 2+1 or 3+1) was necessary or mentioned for the SpO2 values.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI devices where human readers interpret medical images with and without AI assistance.
- For a pulse oximeter, the device directly measures physiological parameters (SpO2 and PR). The clinical study focused on validating the device's accuracy against a gold standard (arterial blood CO-Oximetry), not on improving human reader performance.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance study was done. The clinical studies directly measured the device's (i.e., the pulse oximeter's algorithm/measurement system) SpO2 accuracy (ARMS) against a gold standard (arterial blood CO-Oximetry). The reported ARMS values (1.70% for FS20P and 1.71% for FS20C) are metrics of the device's standalone performance.
7. Type of Ground Truth Used
- The ground truth used was outcomes data / physiological measurement, specifically arterial blood CO-Oximetry. This method provides a direct, highly accurate measurement of arterial oxygen saturation, serving as the gold standard for SpO2.
8. Sample Size for the Training Set
- The document does not specify a separate training set or its sample size. For a traditional medical device like a pulse oximeter, particularly one based on well-established principles of optical measurement, there isn't typically an "AI training set" in the sense of machine learning. The device's calibration and design would be based on engineering principles and potentially internal validation data, but not typically a labeled "training set" like an AI performs. The studies described are for validation/testing the accuracy of the final device.
9. How Ground Truth for the Training Set Was Established
- This question is not applicable as there is no mention of an "AI training set" or a separate training set in the context of this device's submission. The described clinical studies are for performance validation (test set), not for training an algorithm.
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January 2, 2025
Hunan Accurate Bio-Medical Technology Co., Ltd. % Jie Yang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China
Re: K243049
Trade/Device Name: Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: September 27, 2024 Received: December 6, 2024
Dear Jie Yang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep 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
Submission Number (if known)
K243049
Device Name
Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)
Indications for Use (Describe)
The Pulse Oximeter FS20P is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adolescent, child and infant patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
The Pulse Oximeter FS20C and FS10C is a handheld non-invasive device intended for spotchecking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
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
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2024/09/27
1. Submission sponsor
Name: Hunan Accurate Bio-Medical Technology Co., Ltd. Address: Accurate Industrial Park, No.108, Zhixian Road, Xuelian Community, Xueshi Street of Yuelu District, 410208 Changsha, Hunan Province, PEOPLE'S REPUBLIC OF China Contact person: Zhang Li Title: General Manager E-mail: regulation@accbiomed.com Tel: +86 731-8559853
2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China
Contact person: Yang Jie
E-mail: yangjie(@chonconn.com
Tel: +86-755 33941160
| Trade/Device Name | Pulse Oximeter |
|---|---|
| Model | FS20P, FS20C,FS10C |
| Common Name | Fingertip Pulse Oximeter |
| Regulatory Class | Class II |
| Classification | 21CFR 870.2700 / Oximeter / DQA |
| Submission type | Traditional 510(K) |
Subiect Device Information 3.
4. Predicate Device
Manufacturer: Beijing Choice Electronic Technology Co., Ltd. Device name: Pulse Oximeter, Model: MD300C19 510(K) Number: K230172
5. Device Description
The subject device Pulse Oximeter is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. The
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device is normally applied to infants, children, adolescents and adult in hospitals, hospital-type facilities and homecare.
The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter LED, signal collection and process module (MCU), OLED/LED display screen, user interface and button control circuit.
6. Intended use & Indication for use
The Pulse Oximeter FS20P is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adolescent, child and infant patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
The Pulse Oximeter FS20C and FS10C is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult patients in hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
| ITEM | Proposed DevicePulse OximeterModel: FS20P,FS20C,FS10C | Predicate DevicePulse OximeterModel: MD300C19K230172 | Comparison Result |
|---|---|---|---|
| Manufacture | Hunan Accurate Bio-MedicalTechnology Co., Ltd. | Beijing Choice ElectronicTechnology Co., Ltd. | Same |
| Indications for Use | The Pulse Oximeter FS20P isa handheld non-invasivedevice intended for spot-checking of oxygen saturationof arterial hemoglobin(SpO2) and Pulse Rate ofadolescent, child and infantpatients in hospitals, hospital-type facilities andhomecare. The device is notintended for continuousmonitoring, use duringmotion or use with lowperfusion. The device is | The Pulse Oximeter is ahandheld non-invasive deviceintended for spot-checking ofoxygen saturation of arterialhemoglobin (SpO2) and PulseRate of adult, adolescent childand infant patients in hospitals,hospital-type facilities andhomecare. The device is notintended for continuousmonitoring, use during motionor use with low perfusion. Thedevice is intended for reuse. | Same |
| intended for reuse. Thedevice is wearing onfingertips while using.The Pulse Oximeter FS20Cand FS10C is a handheld non-invasive device intended forspot-checking of oxygensaturation of arterialhemoglobin (SpO2) and PulseRate of adult patients inhospitals, hospital-typefacilities and homecare. Thedevice is not intended forcontinuous monitoring, useduring motion or use withlow perfusion. The device isintended for reuse. Thedevice is wearing onfingertips while using. | The device is wearing onfingertips while using. | ||
| Population | FS20C and FS10C: adultFS20P: adolescent, child andinfant patients. | adult, adolescent, child andinfant patients | Similar |
| Components | Power supply module,detector and emitter LED,signal collection andprocessor module, displaymodule, user interface andbutton control. | Power supply module, detectorand emitter LED, signalcollection and processormodule, display module, userinterface and button control. | Same |
| Type of SpO2Sensor | Transmittance Optical Sensor | Transmittance Optical Sensor | Same |
| ApplicationSite | Finger | Finger | Same |
| Measurement | Red (660 nm)Infrared (905 nm) | Red (660 nm)Infrared (905 nm) | Same |
| Display Type | OLED or LED | LED | Similar |
| PowerSupply | 2*AAA alkaline batteries | 2*AAA alkaline batteries | Same |
| Display Data | SPO2 , PR | SPO2 , PR | Same |
| SPO2 | FS20C,FS20P:SpO2 Display Range:0% | SpO2 Display Range:0%~100%Measurement range:70%~100%Accuracy: 70% | Similar |
| PR | PR Display Range25 | PR Display Range0 | Similar |
| EnvironmentRequirements | Operating Temperature:5~40°CAmbient Humidity:10% | Operating Temperature:0~40°CAmbient Humidity: 15% | Similar |
| ContactingMaterial | Enclosure/Battery cover/Button: ABSLens: PCFingertip cushion: Silica gel | Enclosure/Battery cover: ABSLens: PMMAButton/Fingertip cushion:Silica gel pad | Similar |
| ElectricalSafety | Conformed to IEC60601-1,IEC 60601-1-11 | Conformed to IEC60601-1,IEC 60601-1-11 | Same |
7. Comparison to the Predicate Device
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8. Non-clinical Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Pulse Oximeter was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Bench testing
The Pulse Oximeter has been tested according to the following standards:
- 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 60601-1-2:2014. Medical electrical equipment- Part 1-2: General requirements for basic . safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests
- . IEC 60601-1-11 Edition 2.0 2015-01Medical 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
- ISO 80601-2-61: 2017 Medical Electrical Equipment Part 2-61: Particular Requirements for . Basic Safety and Essential Performance of Pulse Oximeter Equipment.
Clinical data
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
After Institutional Review Board (IRB) approval, 10 healthy female adult volunteer subjects (ages 22-30yr with skin tones of Fitzpatrick 1-6) were included in the study to evaluate the SpO2 accuracy performance of the FS20P Pulse Oximeter during stationary (non-motion) conditions over a wide range of arterial blood
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oxygen saturation levels as compared to arterial blood CO-Oximetry.
The SpO2 accuracy performance results showed FS20P Pulse Oximeter to have an ARMS of 1.70% during steady state conditions over the range of 70-100%.
After Institutional Review Board (IRB) approval, 13 healthy adult volunteer subjects (ages 22-30yr with skin tones of Fitzpatrick 1-6) were included in the study to evaluate the SpO2 accuracy performance of the FS20C Pulse Oximeter during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry.
The SpO2 accuracy performance results showed FS20C Pulse Oximeter to have an ARMS of 1.71% during steady state conditions over the range of 70-100%.
9. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the 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).