(119 days)
The Fingertip Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate, and the device is a reusable device and intended to be used with the finger of adults or children over three years old in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.
The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2). The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery. The differences between different models only includes the color of the non-patient contacting shell part and the size. And the color display screen of BSX221/BSX223/BSX261/BSX263/BSX281/BSX283 is OLED, while that of BSX231/BSX233/BSX251/BSX253 is TFT.
The provided document describes the K202324 submission for "Fingertip Pulse Oximeter, Models BSX221, BSX223, BSX261, BSX263, BSX281, BSX283, BSX231, BSX233, BSX251, BSX253." The acceptance criteria and the study proving the device meets these criteria are detailed in the "510(k) Summary" section, particularly under "7. Predicate Device Comparison" and "8. Performance Testing."
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The regulatory document outlines the performance specifications, which serve as the acceptance criteria, and the reported performance of the proposed device.
| ITEM | Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) | Comparison Result |
|---|---|---|---|
| SpO2 Range | 0%~100% | 35%~100% | Different (Proposed device has a narrower specified range) |
| SpO2 Accuracy | 70%~100%: ±2%0% to 69%: unspecified | 70% ~79%: ±3%;80%~100%:±2%;0% to 69%: unspecified | Different (Proposed device has slightly wider acceptable accuracy for 70-79%, but the same for 80-100%) |
| SpO2 Resolution | 1% | 1% | Same |
| Pulse Rate Range | 25 bpm ~ 250 bpm | 30 bpm ~ 250 bpm | Different (Proposed device has a slightly higher minimum pulse rate) |
| Pulse Rate Accuracy | ±2 bpm | ±3 bpm | Different (Proposed device has slightly wider acceptable accuracy) |
| Pulse Rate Resolution | 1 bpm | 1 bpm | Same |
| Biocompatibility | ISO 10993-1, -5, -10 | Compliance with ISO 10993-1, -5, -10 (Cytotoxicity, Skin Sensitization, Skin Irritation tests passed) | Same |
| Electrical Safety | IEC 60601-1, IEC 60601-1-11 | Compliance with ANSI AAMI ES60601-1 and IEC 60601-1-11 | Same |
| EMC | IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Same |
| Performance (Bench) | ISO 80601-2-61 (Pulse Oximeter Equipment) | Compliance with ISO 80601-2-61:2017. Pulse Rate Accuracy meets ISO 80601-2-61, Clause 201.12.1.104. | Same |
| Software Verification and Validation | N/A (General Guidance) | Provided in accordance with FDA Guidance for software with moderate level of concern. | N/A |
| Cleaning Validation | N/A (General Guidance) | Conducted per FDA guidance, device showed no degradation after repeated cleaning/disinfection. | N/A |
| Clinical Accuracy (SpO2) | N/A (Specific guideline mentioned for evaluation) | Evaluated per Annex EE Guideline of ISO 80601-2-61:2011 | N/A |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states that "Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment."
However, the specific sample size (number of subjects/patients) used for this clinical test set, or the data provenance (country of origin, retrospective/prospective nature), is not explicitly mentioned in the provided 510(k) summary. ISO 80601-2-61:2011 Annex EE typically outlines requirements for such studies, including participant numbers, but the summary does not detail the results of the specific study performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
For pulse oximetry, the ground truth for SpO2 accuracy is typically established using a co-oximeter and arterial blood samples in a controlled desaturation study. This process usually does not involve "experts" establishing a subjective ground truth in the same way as, for example, image interpretation. Instead, it relies on objective laboratory measurements.
The document does not explicitly state the number or qualifications of "experts" involved in establishing the ground truth for the clinical accuracy testing, as the ground truth itself is derived from reference measurements (co-oximetry).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant for studies where subjective interpretation is involved, such as reading medical images, and disagreements between multiple human readers need to be resolved to establish ground truth.
For a pulse oximeter's clinical accuracy study (desaturation study), the ground truth for SpO2 values is established by a reference co-oximeter and arterial blood gas analysis, which is an objective measurement without subjective interpretation or the need for adjudication among multiple human experts. Therefore, adjudication methods are not applicable in this context and are not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This device is a Fingertip Pulse Oximeter, a standalone measurement device, not an AI-assisted diagnostic tool that would involve human readers interpreting results. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not relevant to this type of device and was not performed. The submission does not mention AI assistance or human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the primary performance evaluation for a pulse oximeter is based on its standalone (algorithm only) performance. The device directly measures and displays SpO2 and pulse rate. The "Clinical data" section explicitly states that "Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011," which refers to a desaturation study where the device's readings are compared against a co-oximeter, without human intervention in the device's measurement process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical accuracy testing mentioned, the ground truth for oxygen saturation (SpO2) and pulse rate would be established using reference medical devices and laboratory analyses. Specifically, for SpO2 accuracy, this involves:
- Co-oximetry: Measuring arterial oxygen saturation (SaO2) from arterial blood samples using a laboratory co-oximeter.
- Arterial blood gas analysis: Providing other relevant blood gas parameters.
This is considered the gold standard for determining SpO2 accuracy in human subjects.
8. The sample size for the training set
The document does not mention the use of machine learning or AI models that would require a "training set" in the context of device development. The pulse oximeter operates based on established physical principles of light absorption by hemoglobin. Therefore, there is no mention of a training set in this 510(k) summary.
9. How the ground truth for the training set was established
As there is no mention of a training set for this device, the question of how its ground truth was established is not applicable.
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Shenzhen BSX Technology Electronics Co., Ltd. Fang Kai General Manager Rm301.3F 8th Building, LiHao Industrial Area, No.78 AiNan Road, Longgang Shenzhen, Guangdong 518116 China
Re: K202324
Trade/Device Name: Fingertip Pulse Oximeter, Models BSX221, BSX223, BSX261, BSX263, BSX281, BSX283, BSX231, BSX233, BSX251, BSX253
Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: November 20, 2020 Received: November 27, 2020
Dear Fang Kai:
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 mediation-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.
Todd Courtney Assistant Director DHT1C: Division of ENT, 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) K202324
Device Name
Fingertip Pulse Oximeter, Models BSX221, BSX261, BSX261, BSX283, BSX281, BSX231, BSX231, BSX253
Indications for Use (Describe)
The Fingertip Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate, and the device is a reusable device and intended to be used with the finger of adults or children over three years old in healthcare environments. 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
Prepared in accordance with the requirements of 21 CFR Part 807.92 K202324
-
- Submitter: Shenzhen BSX Technology Electronics Co., Ltd. Rm301.3F 8th Building, LiHao Industrial Area, No.78 AiNan Road, Longgang District, Shenzhen, 518116, P.R. China TEL: +86 755 28719103 Contact Person: Fang Kai Prepare date: 2020-09-12 2. Device name Device Name: Fingertip Pulse Oximeter and classification Models: BSX221, BSX223, BSX261, BSX263, BSX281, BSX283, BSX231, BSX233, BSX251, BSX253 Classification Name: 21 CFR 870.2700 Oximeter Product code: DQA Regulatory Class: Class II Class III Summary and Certification: Not applicable IVD Classification: Not applicable 3. Reason for New Application. No prior submission associated with the current Submission submission. 4. Predicate Shenzhen Yimi Life Technology Co., Ltd., YM101/YM201/YM301 Pulse Device(s) Oximeter / K191430 5. Device The oximeter consists of probe, electronic circuits, and display and plastic Description enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2). The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery. The differences between different models only includes the color of the non-patient contacting shell part and the size. And the color display screen of BSX221/BSX223/BSX261/BSX263/BSX281/BSX283 is OLED, while that of BSX231/BSX233/BSX251/BSX253 is TFT. 6. Indications for The Fingertip Pulse Oximeter is intended for spot-checking oxygen Use saturation and pulse rate, and the device is a reusable device and intended to be used with the finger of adults or children over three years old in
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healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.
7. Predicate Device Comparison
Please refer to following table to find differences between the subject device and predicate device.
| ITEM | Predicate DeviceYM 101/YM201/YM301Pulse OximeterK191430 | Proposed DeviceBSX221, BSX223, BSX261,BSX263, BSX281, BSX283,BSX231, BSX233, BSX251,BSX253 | ComparisonResult |
|---|---|---|---|
| Manufacture | Shenzhen YimiLife Technology Co., Ltd. | Shenzhen BSX TechnologyElectronics Co., Ltd. | --- |
| Indications forUse | The pulse oximeter isintended for measure oxygensaturation and pulse rate ofadult patients in healthcareenvironments. | The Fingertip Pulse Oximeteris intended for measureoxygen saturation and pulserate of adults or children overthree years old. | Different |
| Intended patientpopulation | Adult | Adult or children over threeyears old | Different |
| Contraindications | Not intended to be used undermotion or low perfusionscenarios. | Not intended to be used undermotion or low perfusionscenarios. | Same |
| Operational Specifications | |||
| Intendedapplication site | Finger | Finger | Same |
| MeasurementPrinciples | 2-wavelength RelativeOptical Absorption | 2-wavelength RelativeOptical Absorption | Same |
| Signal DetectionMethod | Photodetector | Photodetector | Same |
| Display content | SpO2%, PR, battery indicator,Pulse ratebar graph, pulse waveform | SpO2%, PR, battery indicator,Pulse ratebar graph, pulse waveform | Same |
| SpO2 Range | 0%~100% | 35%~100% | Different |
| SpO2 Accuracy | 70~100%: ±2%0% to 69%: unspecified | 70% ~79%: ±3%;80%~100%:±2%;0% to 69%: unspecified | Different |
| SpO2 Resolution | 1% | 1% | Same |
| Pulse RateRange | 25 bpm ~ 250 bpm | 30 bpm ~ 250 bpm | Different |
| Pulse RateAccuracy | ±2 bpm | ±3 bpm | Different |
| PulseRate Resolution | 1 bpm | 1 bpm | Same |
| Data Memory | Not available | 20 sets | Different |
| Shipped Sterile | No | No | Same |
| Power supplier | 2*1.5V AAA alkaline battery | 2*1.5V AAA alkaline battery | Same |
| Safetyclassification | |||
| Class IIa, Internally powered,Type BF applied part, IP22 | Class IIa, Internally powered,Type BF applied part, IP22 | Same | |
| Storage andTransportEnvironment | Temperature: -20°C to 60°CAtmospheric Pressure: 50 kPa to 107.4 kPaRelative Humidity: 10%-95% (no condensation) | Temperature: -20°Cto 55°CAtmospheric Pressure: 70 kPa to 106 kPaRelative Humidity: <93% (no condensation) | Different |
| OperatingEnvironment | Temperature: 15°Cto 40°CAtmospheric Pressure: 70 kPa to 106 kPaRelative Humidity: 15%-95% (no condensation) | Temperature: 10°Cto 40°CAtmospheric Pressure: 70 kPa to 106 kPaRelative Humidity: 30%-75% (no condensation) | |
| Compliance Standards | |||
| Bio-compatibility | ISO 10993-1ISO 10993-5ISO 10993-10 | ISO 10993-1ISO 10993-5ISO 10993-10 | Same |
| Electrical Safety | IEC 60601-1IEC 60601-1-11 | AAMI/ANSI EC 60601-1IEC 60601-1-11 | |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | |
| Performance | ISO 80601-2-61 | ISO 80601-2-61 |
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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.
8. Performance Testing
Performance data includes "Non-Clinical Data" and "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 worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the testing included the following tests, results of which demonstrate the biocompatibility of the subject device:
- Cytotoxicity
- Skin Sensitization
- Skin Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted, and the results show that the subject device complies with the ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) for safety and the IEC 60601-1-2: 2007 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests standard for EMC.
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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 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.
Cleaning Validation
Cleaning and disinfection validation testing was conducted in accordance with FDA quidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued March 17,2015. Moreover, the performance of the subject device shows no degradation after repeated cleaning and disinfection as suggested in the manual.
Clinical data:
Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
9. Conclusion
Verification and validation testing was conducted on the subject device Fingertip Pulse Oximeter and all testing passed pre-specified criteria. The subject device and the predicate device has the same intended use, and the difference in technological features do not raise different questions of safety and effectiveness. This premarket notification submission demonstrates that the 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).