(119 days)
Not Found
No
The description details standard pulse oximetry technology using light absorption and a microprocessor for calculation, with no mention of AI or ML algorithms.
No
The device is described as being "intended for spot-checking oxygen saturation and pulse rate," which are diagnostic measurements rather than therapeutic interventions.
Yes
The device is described as being for "spot-checking oxygen saturation and pulse rate," which are physiological parameters used to assess a patient's health status and can aid in diagnosis.
No
The device description explicitly states it consists of hardware components such as a probe, electronic circuits, display, plastic enclosures, light emitting diodes, a light detector, and a microprocessor. It is also powered by batteries.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description clearly states the device is a "Fingertip Pulse Oximeter" that measures "oxygen saturation and pulse rate" by shining light through the finger. This is a non-invasive measurement taken on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for "spot-checking oxygen saturation and pulse rate" using the finger. This aligns with a physiological measurement device, not an IVD.
Therefore, the device described is a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DOA
Device Description
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.
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 or children over three years old
Intended User / Care Setting
healthcare environments.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Biocompatibility testing: Conducted in accordance with ISO 10993-1. Included Cytotoxicity, Skin Sensitization, Skin Irritation tests. Results demonstrated biocompatibility.
Electrical safety and electromagnetic compatibility (EMC): Testing conducted, results show compliance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 for safety and IEC 60601-1-2: 2007 for EMC.
Bench Testing: Conducted, results show compliance 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: Documentation provided in accordance with FDA Guidance for software with a moderate level of concern.
Cleaning Validation: Testing conducted in accordance with FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued March 17,2015. Performance showed no degradation after repeated cleaning and disinfection.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy: 70% ~79%: ±3%; 80%~100%:±2%; 0% to 69%: unspecified
Pulse Rate Accuracy: ±3 bpm
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).
0
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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.
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 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
2
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
4
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 Device
YM 101/YM201/YM301
Pulse Oximeter
K191430 | Proposed Device
BSX221, BSX223, BSX261,
BSX263, BSX281, BSX283,
BSX231, BSX233, BSX251,
BSX253 | Comparison
Result |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacture | Shenzhen Yimi
Life Technology Co., Ltd. | Shenzhen BSX Technology
Electronics Co., Ltd. | --- |
| Indications for
Use | The pulse oximeter is
intended for measure oxygen
saturation and pulse rate of
adult patients in healthcare
environments. | The Fingertip Pulse Oximeter
is intended for measure
oxygen saturation and pulse
rate of adults or children over
three years old. | Different |
| Intended patient
population | Adult | Adult or children over three
years old | Different |
| Contraindications | Not intended to be used under
motion or low perfusion
scenarios. | Not intended to be used under
motion or low perfusion
scenarios. | Same |
| Operational Specifications | | | |
| Intended
application site | Finger | Finger | Same |
| Measurement
Principles | 2-wavelength Relative
Optical Absorption | 2-wavelength Relative
Optical Absorption | Same |
| Signal Detection
Method | Photodetector | Photodetector | Same |
| Display content | SpO2%, PR, battery indicator,
Pulse rate
bar graph, pulse waveform | SpO2%, PR, battery indicator,
Pulse rate
bar graph, pulse waveform | Same |
| SpO2 Range | 0%~100% | 35%100% | Different |100%: ±2%
| SpO2 Accuracy | 70
0% to 69%: unspecified | 70% ~79%: ±3%;
80%~100%:±2%;
0% to 69%: unspecified | Different |
| SpO2 Resolution | 1% | 1% | Same |
| Pulse Rate
Range | 25 bpm ~ 250 bpm | 30 bpm ~ 250 bpm | Different |
| Pulse Rate
Accuracy | ±2 bpm | ±3 bpm | Different |
| Pulse
Rate Resolution | 1 bpm | 1 bpm | Same |
| Data Memory | Not available | 20 sets | Different |
| Shipped Sterile | No | No | Same |
| Power supplier | 21.5V AAA alkaline battery | 21.5V AAA alkaline battery | Same |
| Safety
classification | | | |
| | Class IIa, Internally powered,
Type BF applied part, IP22 | Class IIa, Internally powered,
Type BF applied part, IP22 | Same |
| Storage and
Transport
Environment | Temperature: -20°C to 60°C
Atmospheric Pressure: 50 kPa to 107.4 kPa
Relative Humidity: 10%-95% (no condensation) | Temperature: -20°Cto 55°C
Atmospheric Pressure: 70 kPa to 106 kPa
Relative Humidity: