Pulse Oximeter

K172141 · Shanghai Berry Electronic Tech Co., Ltd. · DQA · Apr 4, 2018 · Cardiovascular

Device Facts

• Record ID: K172141
• Device Name: Pulse Oximeter
• Applicant: Shanghai Berry Electronic Tech Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Apr 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The pulse oximeter (BM1000 & BM1000C) is designed for spot checking of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.

Device Story

Fingertip pulse oximeter (models BM1000/BM1000C) for spot-checking SpO2 and pulse rate in clinic settings. Device uses optical sensors to measure arterial hemoglobin saturation; transmits data via Bluetooth to a smartphone application. BM1000 includes plethysmogram wave display; BM1000C does not. Operated by clinicians; provides real-time SpO2 and pulse rate values, pulse bar, and history trends on mobile interface. Assists clinicians in assessing patient oxygenation status during spot checks. Benefits include non-invasive, portable, reusable monitoring of vital signs.

Clinical Evidence

Prospective clinical trial per ISO 80601-2-61 on 12 healthy adult volunteers (ages 20-41). Evaluated SpO2 accuracy during steady-state, non-motion conditions across 70-100% SaO2 range compared to arterial CO-Oximetry. Results showed Arms of 1.50 for BM1000C. No adverse effects reported. Results considered applicable to BM1000 due to identical measurement technology.

Technological Characteristics

Fingertip form factor; optical sensing principle. Powered by 3.7V rechargeable lithium battery. Connectivity via Bluetooth to smartphone app. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and ISO 80601-2-61 (pulse oximeter performance). Biocompatibility per ISO 10993-5 and ISO 10993-10. Not sterile.

Indications for Use

Indicated for adult patients in a clinic environment for spot-checking functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate. Not indicated for continuous monitoring.

Regulatory Classification

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.

Predicate Devices

• Pulse Oximeter CMS50EW (K141362)

Submission Summary (Full Text)

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April 4, 2018

Shanghai Berry Electronic Tech Co., Ltd % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-402, Building #27, No. 56, LiangXiang East Rd., FangShan District Beijing, 102401 CN

Re: K172141

Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: March 1, 2018 Received: March 5, 2018

Dear Ray 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. 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 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); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172141

Device Name Pulse Oximeter

Indications for Use (Describe)

The pulse oximeter (BM1000 & BM1000C) is designed for spot checking of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.

| Type of Use ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------|
|----------------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# Tab #3 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K172141

- 1. Date of Preparation: 03/27/2018
- 2. Sponsor Identification

Shanghai Berry Electronic Tech Co., Ltd Unit C, 1st Floor, 7th Building, No.1188 Lianhang Road, Minhang District,Shanghai, China 201112 Establishment Registration Number: 3009241523

Contact Person: Xuezhi Yin Position: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Mr. Ray Wang

#### Beijing Believe Technology Service Co., Ltd.

5-402, Building #27, YangGuang YiShang, No. 56, LiangXiang East Rd., FangShan District, BeiJing, China 102401

Tel: [phone] Fax: [phone] Email: [e-mail]

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#### 510(k) Summary

- Identification of Proposed Device 4.
Trade Name: Pulse Oximeter Common Name: Pulse Oximeter Model(s): BM1000/BM1000C

Regulatory Information Classification Name: Oximeter Classification:II Product Code:DQA Regulation Number: 21 CFR 870.2700 Review Panel:Anesthesiology;

Intended Use Statement:

The pulse oximeter (BM1000 & BM1000C) is designed for spot checking of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.

#### Device Description

The proposed device, pulse oximeter, includes two models in this application, BM1000C. The two proposed devices all are fingertip device; they are share the following same features:

- ★ Spot check and display SpO2 and PR value;
- ★ Low battery capacity indicator;
- ★ Finger off indicator;
- ★ wireless connection function

Beside the features above, the BM1000 can display Plethysmogram wave, but the BM1000C deoesn't have this function.

The pulse oximeter (BM1000 & BM1000C) is designed for spot checking of thefunctional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.

The proposed device is not provided sterile and is not a reprocessed single-use device.

- 5. Identification of Predicate Device(s)
Predicate Device :

510(k) Number: K141362 Product Name: Pulse Oximeter CMS50EW

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#### 510(k) Summary

Model Name: CMS50EW Manufacturer: Contec Medical System Co., Ltd.

- Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- IEC 60601-1:2005/A1:2012, Medical electrical equipment- Part 1: General requirements for basic safety, a. and essential performance.
- IEC 60601-1-2:2014, Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety b. And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- ISO 80601-2-61:2011,Medical electrical equipment Part 2-61: Particular requirements for basic safety C. and essential performance of pulse oximeter equipment.
- d. ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.
- ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin e. sensitization.
- Shelf Life Testing f.
- SpO2 Accuracy and Pulse Rate Accuracy Performance Testing (Test after the repeated clean & disinfection g. conditions).
- h. SpO2 Accuracy and Pulse Rate Accuracy Performance Testing (Test under the normal conditions).
- SpO2 Accuracy and Pulse Rate Accuracy Performance Testing (Test under the low perfusion conditions). i.
- SpO2 Accuracy and Pulse Rate Accuracy Performance Testing (Test under the wireless Bluetooth j. conditions without outside interference).
- SpO2 Accuracy and Pulse Rate Accuracy Performance Testing (Test under the wireless Bluetooth k. conditions with outside interference).
- Wireless coexistence testing. 1.
- FCC Part 15C Testing. m.
- Software Validation and Verification Testing. n.
- 7. Clinical Test Conclusion

The clinical trial was performed according to Clause 201.12.1.101.2 and Annex EE.2 of ISO 80601-2-61:2011 Procedure for invasive laboratory testing on healthy volunteers.

The purpose of the clinical trial was to evaluate the SpO2 accuracy performance of the BM1000C Fingertip Pulse Oximeter during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry.

After Institutional Review Board (IRB) approval, 12 healthy adult volunteer subjects (ages 20-41yr, 42-95kg, 155-181cm, with light to dark pigmentation) were included in the study conducted Nov. 9-10,

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#### 510(k) Summary

2013 to evaluate the SpO2 accuracy performance of proposed devices.

The system was evaluated during steady state/non-motion conditions with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% SaO2. Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison.

No adverse effects or complications occurred during the study.

The SpO2 accuracy performance results showed the fingertip pulse oximeter to have an Arms of 1.50 (BM1000C) during steady state conditions over the range of 70-100%.

Because the BM1000C and BM1000 has only difference as Plethysmogram wave display, no difference would effects the measurement accuracy, so the clinical test result of BM1000C could be consider as applicable to BM1000.

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### 8. Substantially Equivalent (SE) Comparison

## Table 7-1 Comparison of Technology Characteristics

| ITEM | Proposed Device<br>Pulse Oximeter (BM1000 & BM1000C) | Predicate Device Pulse Oximeter CMS50EW (K141362) | Remark | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-----------|
| Product Code | DQA | DQA | SE | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | SE | |
| Class | 2 | 2 | SE | |
| Intended Use | The pulse oximeter (BM1000 & BM1000C) is designed for spot checking of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring. | The Pulse Oximeter CMS50EW is a non-invasive device intended for spot-check or continuous monitoring of non-invasive oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate through the finger of adult patients in home and hospital environments (including clinical use internist/surgery,anesthesia, and intensive care settings). The device is reusable and not intended for out-of-hospital transport use. | Analysis 1 | |
| Features | BM1000 %SpO2 and PR measurement, Plethysmogram wave, Bluetooth | %SpO2 and PR measurement, Pulse bar, Pulse wave | SE | |
| | BM1000C %SpO2 and PR measurement, Bluetooth | Alarm function, Bluetooth | SE | |
| configuration | | Fingertip | Fingertip | SE |
| SpO2 measurement range | | 0%-100% | 0%-100% | SE |
| SpO2accuracy | | $±3% (70%~100%); Undefined for <70%$ | $70%~100%:±2%, 0~69%,unspecified$ | Analyse 2 |
| PR measurement range | | 25~250bpm | 30bpm~250bpm | Analyse 3 |
| PR accuracy | | $±2 bpm$ | $±2bpm or ±2% (select the larger)$ | SE |
| Power Supplier | | Two 1.5V AAA alkaline batteries | Voltage 3.7 rechargeable lithium battery | Analyse 4 |
| Wireless Connection | | Bluetooth | Bluetooth | SE |

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| The data transported via<br>wireless connection | SpO2 value, PR value and Pulse Bar | SpO2 value, PR value, Pulse Wave, Pulse Bar and Alarm<br>Set parameters | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Data received terminal | Smart Phone loaded App | PC with BT adaptor | Analyse 5 |
| Terminal Functions | SpO2 display, PR display, Pulse Bar display, data storage,<br>history data trend drawn, User Registration | SpO2 display, PR display, Pulse Wave display, Pulse Bar<br>display, alarm limits setting, data storage, history data<br>trend drawn, User information management, print report | |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Performance | Comply with ISO 80601-2-61 | Comply with ISO 80601-2-61 | SE |
| Biocompatibility | ISO10993-5&ISO10993-10 | ISO10993-5&ISO10993-10 | SE |
| Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | SE |

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#### SE Analysis :

The proposed device has same classification for use, similar technical specifications, same applied Standards with the predicate device.

The main differences are included as followings:

Analysis 1: The indication for use of proposed device, but the differences are indication reduction reduction, the proposed device does not include the indications, such as "continuous monitoring" and "home predicate device, such indications retuction do not raise different questions of safety or effectiveness, because the use environment for the use environment of the predicate device and the proposed device still maintains the core function as the oximeter, spot-check of non-invention of arterial hemoglobin (SpO2), and which has been validated by the non-clinical tests conducted.

Analyse 2: The SpO2 accuracy of proposed device. However it meets the requirements of ISO 80601-2-61, which FDA reognizes. Therefore, this difference is considered to not raise different questions of safety or effectiveness.

Analyse 3 . The PR measurement range of the is different than that of the measurement range is considered to be able to cover the general pulse rate of healthy people and patients. In a PR measurement range is clearly on the proposed labeling to remind the user. This difference is considered to not raise different questions of safety or effectiveness.

Analyse 4: Athough the Power supply specifications of of the proposed device.but both the predicate device and the proposed device have passed the IEC60601-1 standard, we believe the stirent grestions of the effectiveness and safety compared with the predicate device.

Analyse 5: The proposed device and predicate device terminal, Smart Phone VS PC, we have conducted the Wireless Coesistence Test and the results shown that the different receiver terminal will not raise different questions of the effectiveness and safety.

The proposed device and predicate device has different in wiretions, but all such functions of proposed device are covered by prodicate's, so we believe these differences will not raise different questions of the effectiveness and safety compared with the predicate device.

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### 9. Substantially Equivalent (SE) Conclusion

The clinical and non-clinical data support that the proposed device is as safe and as effective as the predicate device and does meet its design specification, and which are comparable to the predicate device. Also, the differences in the technological characteristics have been demonstrated to be substantially equivalent and thus the subject device is considered substantially equivalent to the predicate device.