Pulse Oximeter by Shanghai Berry Electronic Tech Co., Ltd

The pulse oximeter (BM1000A & BM2000A) is designed for spot checking of the pulse oxygen saturation 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, BM1000A and BM2000A. The two proposed devices all are handheld device with detachable SpO2 sensor, the BM1000A work with the SpO2 sensor BSA09001P and the BM2000A work with the SpO2 sensor BST09001S; they share the following same features:
★ Spot check and display SpO2 and PR value;
★ Low battery capacity indicator;
★ Finger off indicator;
The pulse oximeter (BM1000A & BM2000A) is designed for spot checking of the pulse oxygen saturation 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Feature	Acceptance Criteria	Reported Device Performance
SpO2 Measurement Range	0-100%	0-100%
SpO2 Accuracy	70%-100%, ±3%; Undefined for <70%	70%-100%, ±3%; Undefined for <70% (Accuracy Arms < 3%)
PR Measurement Range	25-250 bpm	25-250 bpm
PR Accuracy	±2 bpm	±2 bpm
Electrical Safety	Comply with IEC 60601-1	Complies with IEC 60601-1
EMC	Comply with IEC 60601-1-2	Complies with IEC 60601-1-2

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document states that "A total of 24 samples were obtained per subject." However, it does not explicitly state the number of subjects (healthy volunteers) involved in the clinical trial. Therefore, the exact total sample size for the test set is not provided.
Data Provenance: The data was generated prospectively during a clinical trial where "Hypoxia was induced to different levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide." The data was "recorded by Bickler-Ye lab and provided for analysis." The country of origin is not explicitly stated, but the mention of a "Bickler-Ye lab" suggests a research institution. Given the regulatory submission to the FDA (USA), it is plausible that the study was conducted within the US or under internationally recognized standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

The document describes the ground truth for SpO2 as being determined by "blood gas analysis to determine oxyhemoglobin saturation was performed on an OSM-3® multi-wavelength oximeter (Hemoximeter, Radiometer, Copenhagen)." This indicates that the ground truth was established by an instrument, not by human experts interpreting data. Therefore, the concept of "number of experts" or their "qualifications" for establishing ground truth for the test set does not directly apply in this context.

4. Adjudication Method for the Test Set

No adjudication method is mentioned. The ground truth was established by an objective instrument (OSM-3 Hemoximeter).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This study focuses on the standalone performance of the device against an established reference method (hemoximetry), not on human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The clinical trial directly compares the device's SpO2 and PR readings against a reference standard (arterial blood gas analysis via hemoximeter) without human intervention in the device's measurement process. The device's "Accuracy Arms" (likely referring to Accuracy Root Mean Square) was found to be "smaller than 3%."

7. Type of Ground Truth Used

The type of ground truth used was objective instrument data (arterial blood gas analysis to determine oxyhemoglobin saturation using an OSM-3® multi-wavelength oximeter).

8. Sample Size for the Training Set

The document does not provide information about a separate "training set" for an algorithm. This device is a pulse oximeter, and its accuracy is typically established through direct clinical measurement trials against a recognized standard (like arterial blood gas), rather than through a machine learning model that requires explicit training data. The study described is a validation study.

9. How the Ground Truth for the Training Set Was Established

As no separate training set is mentioned or implied for an algorithm in the context of this device, this question is not applicable. The device's underlying principles are based on known physiological light absorption properties of oxygenated and deoxygenated hemoglobin, and its calibration and validation are performance-based.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 13, 2015

Shanghai Berry Electronic Tech Co., Ltd % Mr. Rav Wang Official Correspondent Beijing Believe Tech. Service Co., Ltd. 1-202, Build 3, Beijing New World, No.5 Chaoyang Road Chaoyang District, Beijing, 100024 CHINA

Re: K142687 Trade/Device Name: Pulse Oximeter (BM1000A/ BM2000A) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: March 5, 2015 Received: March 12, 2015

Dear Mr. 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.

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Page 2 - Mr. Ray Wang

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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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Exhibit #2 Indications for Use

510(k) Number: K142687 Device Name: Pulse Oximeter (BM1000A/ BM2000A)

Indications for Use:

ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D) □OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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Exhibit #3 510(k) Summary

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

The assigned 510(k) Number: __

1. Date of Preparation: Sept. 11, 2014
1. Sponsor

Shanghai Berry Electronic Tech Co., Ltd Unit C, 1st Floor, 7th Building, No.1188 Lianhang Road, Minhang District, Shanghai, P.R.China

Establishment Registration Number: Pending

Contact Person: Xuezhi Yin Position: General Manager Tel: +86-21-5853 1958 Fax: +86-21-5853 0468 Email: berrymedical@hotmail.com

Submission Correspondent 3. Mr. Ray Wang Beijing Believe Tech. Service Co., Ltd Tel: +86-21-50313932 Fax: +86-21-68093116 Email: ray.wang@believe-med.com
1. Proposed Device Identification

Proposed Device Name: Pulse Oximeter Proposed Device Model: BM1000A/ BM2000A Device Common Name: Pulse Oximeter

Classification: 2 Product Code: DQA Regulation Number: 21 CFR 870.2700 Review Panel: Anesthesiology

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Intended Use Statement:

Predicate Device Identification 5.
510(k) Number:K093757 Product Name: MD300C1 Fingertip pulse oximeter Manufacturer: Beijing Choice Electronic Technology Co., Ltd
1. Device Description
  The proposed device, pulse oximeter, includes two models in this application, BM1000A and BM2000A. The two proposed devices all are handheld device with detachable SpO2 sensor, the BM1000A work with the SpO2 sensor BSA09001P and the BM2000A work with the SpO2 sensor BST09001S; they share the following same features:
★ Spot check and display SpO2 and PR value;
★ Low battery capacity indicator;
★ Finger off indicator;

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

1. Non-Clinical Test Conclusion
  Bench 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 60601-1:2012, Medical electrical equipment- Part 1: General requirements for basic safety, and essential performance.

IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

ISO 80601-2-61:2011,Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

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

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sensitization.

1. Clinical Trial 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.

A radial arterial cannula was placed in either the left or right wrist of each subject. Blood gas analysis to determine oxyhemoglobin saturation was performed on an OSM-3® multi-wavelength oximeter (Hemoximeter, Radiometer, Copenhagen). No subject was anemic (Hemoglobin _ 10gm dl-1). Each subject had control data taken at the beginning of each experiment, with two control blood samples drawn while breathing room air. Hypoxia was induced to different levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide. Oxyhemoglobin saturation was reduced to a series of targets and stabilized at the plateau value. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds. Two arterial blood samples were then obtained, approximately 30 seconds apart. A total of 24 samples were obtained per subject. Data were recorded by Bickler-Ye lab and provided for analysis.

It can be determined from the result of the clinical study that the accuracy Arms of the proposed device is smaller than 3%.

Table III-1 Substantially Equivalent Comparison
ITEM	Proposed Device	Predicate Device MD300C1 Fingertip pulse oximeter (K093757)
Product Code	DQA	Same
Regulation No.	21 CFR 870.2700	Same
Class	2	Same
Intended Use	The pulse oximeter (BM1000A & BM2000A) isdesigned for spot checking of the pulse oxygensaturation and pulse rate for adult in clinicenvironment. This medical device can be reused.Not for continuously monitoring.	Same
SpO2measurementrange	0-100%	Same
SpO2accuracy	70%-100%, ±3%; Undefined for <70%	Same
PR measurementrange	25-250 bpm	Similar
PR accuracy	±2 bpm	Same
Power Supplier	BM1000A: 2AA Batteries	Similar

1. Substantially Equivalent

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		BM2000A: Li ion battery
Technical Characteristics	Device Form	Handheld Pulse Oximeter with separate sensor	Similar
	Sensor type	BM1000A: wrap typeBM2000A: Fingertip type	Similar
	Display Information	SpO2 measurement dataPR measurement dataBattery and finger off indicatorSpO2/PR alarm setting (BM1000A only)	Same
	Electrical Safety	Comply with IEC 60601-1	Same
	EMC	Comply with IEC 60601-1-2	Same

Difference in SpO2 accuracy, PR measurement range and Power supplier between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.

There are several different in Technical Characteristics between the proposed and predicate device:

The proposed device has different device form with the predicate device, but all proposed a. devices have same measurement principle with predicate device, and all proposed devices meet the requirements of ISO 80601-2-61. Therefore, this difference is considered to have no effect on effectiveness and safety.
The proposed device has different sensor type with the predicate device, but all sensors have b. same measurement principle with predicate device, and all sensors meet the requirements of ISO 80601-2-61. Therefore, this difference is considered to have no effect on effectiveness and safety.

The proposed device, Pulse Oximeter (BM1000A & BM2000A), is determined to be Substantially Equivalent (SE) to the predicate device, MD300C1 Fingertip pulse oximeter (K093757).

Regulation Number and Section

§ 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).