Pulse Oximeter

• K Number: K142687
• Device Name: Pulse Oximeter
• Manufacturer: Shanghai Berry Electronic Tech Co., Ltd
• Date Cleared: 2015-04-13 ( 203 days)
• Product Code: DQA
• Regulation Number: 870.2700

Intended Use

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.

Predicate Devices

K093757

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard pulse oximetry functions and does not mention any AI/ML components or capabilities. The performance study description is also typical for a pulse oximeter and doesn't suggest AI/ML involvement.

Therapeutic

No.
The device is for "spot checking of the pulse oxygen saturation and pulse rate" which are diagnostic and monitoring functions, not therapeutic.

Diagnostic

Yes

The device, a pulse oximeter, is designed for "spot checking of the pulse oxygen saturation and pulse rate" for adult patients. This measurement provides diagnostic information about a patient's physiological state (oxygen saturation and pulse rate), indicating whether it is within normal ranges or if there are abnormalities that might require further medical attention or intervention.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "handheld device with detachable SpO2 sensor," indicating it includes physical hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside the body.
• Device Function: The description clearly states the device is a pulse oximeter designed for "spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment." This is a non-invasive measurement taken on the body (typically on a finger).
• Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient. It measures physiological parameters directly from the body.

The performance study described involves taking arterial blood samples for comparison, but this is a method used to validate the accuracy of the pulse oximeter's non-invasive measurements, not the primary function of the device itself.

Therefore, the pulse oximeter described is a non-invasive medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

DQA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult

Intended User / Care Setting

clinic environment.

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)

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%.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

SpO2 accuracy: 70%-100%, ±3%
PR accuracy: ±2 bpm

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.

K093757

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

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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol representing the human form, composed of three abstract figures facing to the right.

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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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
• 2. 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: [phone] Fax: [phone] Email: [e-mail]

• Submission Correspondent 3. Mr. Ray Wang Beijing Believe Tech. Service Co., Ltd Tel: [phone] Fax: [phone] Email: [e-mail]
• 4. 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:

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.

• Predicate Device Identification 5.
  510(k) Number:K093757 Product Name: MD300C1 Fingertip pulse oximeter Manufacturer: Beijing Choice Electronic Technology Co., Ltd

• 6. 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.

• 7. 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.

• 8. 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) 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.	Same
SpO2measurement
range	0-100%	Same
SpO2accuracy	70%-100%, ±3%; Undefined for