(822 days)
Not Found
No
The description details standard pulse oximetry technology based on light absorption and a microprocessor calculation, with no mention of AI or ML.
No.
The device is for monitoring oxygen saturation and pulse rate, not for providing therapy or treatment.
Yes
A diagnostic device is one used to identify the nature or cause of a disease or condition. This pulse oximeter helps measure oxygen saturation and pulse rate, which are physiological parameters used by healthcare professionals to assess a patient's respiratory and cardiovascular status, contributing to the diagnosis of various conditions.
No
The device description explicitly details hardware components including a probe, electronic circuits, display, plastic enclosures, light emitting diodes, a light detector, and a microprocessor. It also mentions being powered by batteries. This indicates it is a physical device, not software-only.
Based on the provided information, 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.
- Device Function: The description clearly states the pulse oximeter is a non-invasive device that measures oxygen saturation and pulse rate by shining light through the finger. It does not analyze samples taken from the body.
- Intended Use: The intended use is for "spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients." This is a physiological measurement, not an in vitro diagnostic test.
Therefore, the device described is a medical device, but it falls under the category of non-invasive physiological monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The pulse oximeter is a non-invasive device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios. The device is reusable.
Product codes (comma separated list FDA assigned to the subject device)
DQA
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 subjected 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.OP-101 display the measuring results on 1.5' LED screen, and the backlight of the three models are red, white and green respectively. And the screen of OP-102 and OP-103 are 0.96' OLED and 1.3' OLED. Additionally, battery indicator and pulse waveform can be displayed on OP-102 and OP-103. The subjected device is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospitals and clinics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Healthcare environments / hospitals and clinics.
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 Data:
- Biocompatibility testing: Conducted in accordance with ISO 10993-1, testing included Cytotoxicity, Skin Sensitization, and Skin Irritation. Results demonstrate biological safety.
- Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012) and IEC 60601-1-2: 2014.
- Bench Testing: Complies with ISO 80601-2-61: 2017 and IEC 60601-1-11:2015 for performance effectiveness, safety, and effectiveness.
- Software Verification and Validation Testing: Documentation provided in accordance with FDA Guidance for software with a moderate level of concern. Data shows the software works as expected and performance is stable.
Clinical data:
- Study type: Randomized Clinical Study
- Sample size: 12 adult volunteers (5 males, 7 females, including 4 subjects with Fitzpatrick V, VI, and 8 subjects with Fitzpatrick I ~ Fitzpatrick IV).
- Key results: The measure result between the SpO2 measured by subject device and the SaO2 measured by the blood gas analyzer, was 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.)
- SpO2 Accuracy: 70~100%: ±2%; 0% to 69%: unspecified
- Pulse Rate Accuracy: ±3 bpm or ±1%, whichever is greater
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.
Not Found
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
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July 17, 2023
Shenzhen brav electronic technologies co., Ltd Yolanda Lan Consultant R4-5/F, Block 11, Tongfuyu Industrial District, Lezhujiao, Huangmabu. Baoan Shenzhen, GuangDong 518060 China
Re: K211143
Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: June 13, 2023 Received: June 13, 2023
Dear Yolanda Lan:
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.
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
1
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 (OS) 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,
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211143
Device Name
Pulse Oximeter(OP-101,OP-102)
Indications for Use (Describe)
The pulse oximeter is a non-invasive device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios. The device is reusable.
| 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
| Submitter: | Shenzhen Brav electronic technologies co., Ltd |
|---|---|
| 4-5/F, Block 11, Tongfuyu Industrial District, Lezhujiao, Huangmabu, | |
| Baoan, Shenzhen,518060, China | |
| +086-18682273850 | |
| 1817914464@qq.com | |
| Contact Person: | Yolanda Lan |
| Yolanda.bleu@foxmail.com | |
| Prepare date: | 2021-09-04 |
| Device name | Device Name: Pulse Oximeter |
| and classification | Models: OP-101, OP -102 |
| Classification Name: 21 CFR 870.2700 Oximeter | |
| Product code: DQA | |
| Regulatory Class: Class II | |
| Reason for | |
| Submission | New Application. No prior submission associated with the current |
| submission. | |
| Predicate | |
| Device(s) | Shenzhen IMDK Medical Technology Co., Ltd., C101H1 Pulse Oximeter/ |
| K173123 | |
| 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 subjected 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.OP-101 display | |
| the measuring results on 1.5' LED screen, and the backlight of the three | |
| models are red, white and green respectively. And the screen of OP-102 | |
| and OP-103 are 0.96' OLED and 1.3' OLED. Additionally, battery | |
| indicator and pulse waveform can be displayed on OP-102 and OP-103. | |
| The subjected device is indicated for continuous or spot check monitoring of | |
| functional arterial oxygen saturation (SpO2) and pulse rate of adult patients | |
| in hospitals and clinics. | |
| Indications for | |
| Use | The pulse oximeter is a non-invasive device and intended for spot-checking |
| of oxygen saturation and pulse rate for use with the finger of adult patients in | |
| healthcare environments. And it is not intended to be used under motion or | |
| low perfusion scenarios. The device is reusable. |
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Predicate Device Comparison
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device.
Please refer to following table to find differences between the subject device. All the differences do not affect the basic design principle, usage, effectiveness, and safety of the subject device. And no question is raised regarding to effectiveness and safety.
| ITEM | Proposed Device Brav series Pulse Oximeter | Proposed Device Brav series Pulse Oximeter | Predicate Device K173123 |
|---|---|---|---|
| Manufacturer | Shenzhen Brav electronic technologies co., Ltd | Shenzhen Brav electronic technologies co., Ltd | Shenzhen IMDK Medical Technology Co., Ltd |
| Device Name | Pulse Oximeter | Pulse Oximeter | Pulse Oximeter |
| Models | OP-101 | OP-102 | C101H1 |
| Appearance | Image: Pulse Oximeter OP-101 | Image: Pulse Oximeter OP-102 | Image: Pulse Oximeter C101H1 |
| Indications for Use | The pulse oximeter is a non-invasive | ||
| device and intended for spot-checking | |||
| of oxygen saturation and pulse rate for | |||
| use with the finger of adult patients in | |||
| healthcare environments. And it is not | |||
| intended to be used under motion or | |||
| low perfusion scenarios. The device | |||
| reusable. | The pulse oximeter is a non-invasive | ||
| device and intended for spot-checking | |||
| of oxygen saturation and pulse rate for | |||
| use with the finger of adult patients in | |||
| healthcare environments. And it is not | |||
| intended to be used under motion or | |||
| low perfusion scenarios. The device | |||
| reusable. | Fingertip Pulse Oximeter C101H1 is a | ||
| non-invasive device intended for spot | |||
| checking of functional oxygen | |||
| saturation of arterial hemoglobin | |||
| (SpO2) and pulse rate (PR). This | |||
| portable device is indicated for use in | |||
| adult patients in hospitals. | |||
| Principle | The device displays numerical values | ||
| for functional oxygen saturation of | |||
| arterial hemoglobin (SpO2) and pulse | |||
| rate by measuring the absorption of red | |||
| and infrared (IR) light passing through | |||
| perfused tissue. Changes in the | |||
| absorption caused by the pulsation of | |||
| blood in the vascular bed are used to | |||
| determine oxygen saturation and pulse | |||
| rate. | The device displays numerical values for | ||
| functional oxygen saturation of arterial | |||
| hemoglobin (SpO2) and pulse rate by | |||
| measuring the absorption of red and | |||
| infrared (IR) light passing through | |||
| perfused tissue. Changes in the | |||
| absorption caused by the pulsation of | |||
| blood in the vascular bed are used to | |||
| determine oxygen saturation and pulse | |||
| rate. | The device displays numerical values | ||
| for functional oxygen saturation of | |||
| arterial hemoglobin (SpO2) and pulse | |||
| rate by measuring the absorption of | |||
| red and infrared (IR) light passing | |||
| through perfused tissue. Changes in | |||
| the absorption caused by the pulsation | |||
| of blood in the vascular bed are used | |||
| to determine oxygen saturation and | |||
| pulse rate. | |||
| Intended | |||
| patient | |||
| population | Adults in healthcare environments | Adults in healthcare environments | Adults in a clinic environment |
| Intended | |||
| application | |||
| site | Finger | Finger | Finger |
| use under motion and | |||
| low perfusion | |||
| conditions | No | No | No |
| Signal | |||
| Detection | |||
| Method | Photodetector | Photodetector | Photodetector |
| Display screen | LED | OLED | OLED |
| Display content | SpO2%, | ||
| PR | |||
| battery indication | |||
| Pulse bar graph | SpO2%, | ||
| PR | |||
| battery indication | |||
| Pulse bar graph | |||
| pulse waveform | SpO2%, | ||
| PR | |||
| battery indication | |||
| Pulse bar graph | |||
| Perfusion Index | |||
| Contacting material | Shell: ABS | ||
| Clip Pad: Silicon | |||
| Button: PMMA | Shell: ABS | ||
| Clip Pad: Silicon | |||
| Button: PMMA | Shell: ABS | ||
| Clip pad: Silicon | |||
| Button: PC | |||
| SpO2 Range | 0~100% | 0~100% | 0~100% |
| SpO2 Resolution | 1% | 1% | 1% |
| SpO2 Accuracy | 70~100%: ±2% | ||
| 0% to 69%: unspecified | 70~100%: ±2% | ||
| 0% to 69%: unspecified | 70~100%: ±3% | ||
| 0% to 69%: unspecified | |||
| Pulse Rate Range | 40 bpm ~ 250 bpm | 40 bpm ~ 250 bpm | 30 bpm ~ 240 bpm |
| Pulse Rate Accuracy | ±3 bpm or ±1%, whichever is greater | ±3 bpm or ±1%, whichever is greater | ±1 bpm or ±1%, whichever is greater |
| Pulse Rate Resolution | 1 bpm | 1 bpm | 1 bpm |
| Shipped Sterile | No | No | No |
| Power source | 2*1.5V AAA alkaline battery | 2*1.5V AAA alkaline battery | 2*1.5V AAA alkaline battery |
| Storage and Transport | |||
| Environment | Temperature: -20°Cto | ||
| Atmospheric Pressure: 50 kPa | |||
| to 107.4 kPa | |||
| Relative Humidity: 10%-95% (no | |||
| condensation) | Temperature: -20°Cto | ||
| Atmospheric Pressure: 50 kPa | |||
| to 107.4 kPa | |||
| Relative Humidity: 10%-95% (no | |||
| condensation) | Temperature: -10°Cto | ||
| Atmospheric Pressure: 70 kPa to | |||
| 106 kPa | |||
| Relative Humidity: 10%-80% (no | |||
| condensation) | |||
| Operating | |||
| Environment | Temperature: 15°Cto40°C | ||
| Atmospheric Pressure: 70 kPa to 106 kPa | |||
| Relative Humidity: 15%-95% (no | |||
| condensation) | Temperature: 15°Cto40°C | ||
| Atmospheric Pressure: 70 kPa to 106 kPa | |||
| Relative Humidity: 15%-95% (no | |||
| condensation) | Temperature: 5°Cto40°C | ||
| Atmospheric Pressure: 70 kPa to 106 kPa | |||
| Relative Humidity: 15%-80% (no | |||
| condensation) | |||
| Bio-compatibility | ISO 10993-1 | ||
| ISO 109903-5 | |||
| ISO 10993-10 | ISO 10993-1 | ||
| ISO 109903-5 | |||
| ISO 10993-10 | ISO 10993-1 | ||
| ISO 109903-5 | |||
| ISO 10993-10 | |||
| Electrical Safety | IEC 60601-1 | ||
| IEC 60601-1-11 | IEC 60601-1 | ||
| IEC 60601-1-11 | IEC 60601-1 | ||
| IEC 60601-1-11 | |||
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 |
| Performance | ISO 80601-2-61 | ISO 80601-2-61 | ISO 80601-2-61 |
| Dimension | |||
| (WidthHeightDepth) | 57mm×30mm×30 mm | 57mm×30mm×30 mm | 60mm×36mm×35 mm |
| Weight | 30 days). |
And the testing included the following tests, results of which demonstrate the biological safety of the subject device: