The Bpump Blood Pressure Cuff, Model: BC1000, BC8000, are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to complete the measurement of blood parameters on adults.

Device Description

The proposed device, Bpump Blood Pressure Cuff, is a rectangle soft inelastic sleeve reusable with a bladder. There is a single-tube connected to the bladder and the Non Invasive Blood Pressure Monitor for inflating and deflating. The device should be connected to a Non Invasive Blood Pressure Monitor to complete the function. There are two sizes for different arm range as follows:

Model	Arm range
BC1000	22cm~~36cm (8.7in~~14.2in)
BC8000	32cm~~44cm (12.6in~~17.3in)

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Bpump Blood Pressure Cuff, based on the provided FDA 510(k) summary:

Device Name: Bpump Blood Pressure Cuff, Model: BC1000, BC8000
Submission K-Number: K151810

Table of Acceptance Criteria and Reported Device Performance

The document states that the device "met all applicable requirements of the standard" during clinical testing. The primary standard for clinical validation of automated non-invasive sphygmomanometers is ANSI/AAMI/ISO 81060-2. This standard sets out accuracy requirements for blood pressure measurement devices. While the exact numerical acceptance criteria from the standard are not explicitly listed in the provided text, the conclusion affirms compliance.

Acceptance Criteria (Based on ANSI/AAMI/ISO 81060-2) Reported Device Performance
Unspecified (Meets applicable requirements of standard for accuracy) Met all applicable requirements of the standard
Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text.
- Data Provenance: Not explicitly stated. The submitting company is from China (Shenzhen, PEOPLE'S REPUBLIC OF CHINA), but the location of the clinical test is not mentioned. The test is described as "Clinical test has been done," suggesting it was prospective but this is not explicitly stated.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For blood pressure devices, "ground truth" (reference measurements) are typically established by trained observers using a validated reference sphygmomanometer, often with specific training and certification for such measurements.
Adjudication Method for the Test Set

This information is not provided in the document.
If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI versus without AI assistance

This is not applicable. This device is a blood pressure cuff, not an AI-powered diagnostic imaging device. Therefore, an MRMC study and analysis of AI assistance effect size are not relevant to this submission.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device is a blood pressure cuff intended to be used with a "non-invasive blood pressure monitor system." The clinical validation was for the automated measurement type according to ANSI/AAMI/ISO 81060-2, which validates the device's ability to accurately measure blood pressure. This essentially represents the "standalone" performance of the cuff and the non-invasive blood pressure monitor as a system, separate from human interpretation of complex outputs.
The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For blood pressure devices, the ground truth is typically established by simultaneous or near-simultaneous measurements using a recognized reference standard sphygmomanometer (e.g., mercurial or validated aneroid device) performed by trained observers. While not explicitly detailed, compliance with ANSI/AAMI/ISO 81060-2 implies adherence to these ground truth methodologies.
The Sample Size for the Training Set

This information is not applicable. Blood pressure cuffs do not typically involve "training sets" in the machine learning sense. The device's underlying algorithm (if it uses one for interpretation of oscillometric pulses) is developed and then validated.
How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" in the context of this traditional medical device.

Acceptance Criteria (Based on ANSI/AAMI/ISO 81060-2)	Reported Device Performance
Unspecified (Meets applicable requirements of standard for accuracy)	Met all applicable requirements of the standard

Summary

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Public Health Service

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

December 17, 2015

Shenzhen Pump Medical System Co., Ltd. Ms. Migo Yang Clinical Registration Specialist 2/f, M-7 Sinosteel Building, Maqueling Estate Hi-tech Industrial Park Nanshan District, Shenzhen, 518057 CN

Re: K151810

Trade/Device Name: Bpump Blood Pressure Cuff, Model: BC1000, BC8000, Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO Dated: June 15, 2015 Received: July 2, 2015

Dear Ms. Migo Yang,

We have reviewed vour 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

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Page 2 - Ms. Migo Yang

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 vours

Mitchell Stein

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151810

Device Name

Bpump Blood Pressure Cuff, Model: BC1000, BC8000, Blood Pressure Cuff.

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K151810

Date Summary Prepared: Oct 16, 2015

1. Submitter's Identification:

SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. 2/F, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, 518057 Shenzhen, PEOPLE'S REPUBLIC OF CHINA

Contact: Xie Qiongyu Tel: 86-0755-26710795 Fax: 86-0755-26498210 E-mail:xieqy@bpump.com.cn

2. Device Information:

Trade Name: Bpump Blood Pressure Cuff Model No.: BC1000, BC8000 Common Name/Classification Name: Blood Pressure Cuff Product Code: DXQ Regulation Number: 21 CFR 870.1120 Regulation Class: Class II Review Panel: Cardiovascular

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3. Predicate Device:

510(k) Number: K133117 Trade Name: Andon Blood Pressure Cuff Common Name/Classification Name: Blood Pressure Cuff Product Code: DXQ Regulation Number: 21 CFR 870.1120 Regulation Class: Class II Review Panel: Cardiovascular Manufactured By: Andon Health Co., Ltd.

4. Indication for Use

5. Intended Use

6. Description of the device:

Model	Arm range
BC1000	22cm~~36cm (8.7in~~14.2in)
BC8000	32cm~~44cm (12.6in~~17.3in)

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7. Summary Comparing Technological Characteristics with Predicate Device

The proposed changes described in this submission do not affect the intended use of the device and/or alter the fundamental scientific technology of the legally marketed predicate device described in the Kl 33177.Please refer to table below for comparing result:

Technological Characteristics	Comparing Result
Intended Use	Identical
Indications For Use	Identical
Patient Population	Identical
Environment of Use	Identical
Tube Configuration	Identical
Sterility	Identical
Applicable Arm Circumference	Similar
Standards Applied	Similar

The subject device and predicate device are identical in intended use, Indications for Use, Patient Population, Environment of Use, Tube Configuration, Sterility, Standards; The subject device and predicate device are similar in Applicable Arm Circumference and Standards Applied. But the minor discrepancies mentioned above do not affect the safety or effectiveness of the subject device.

8. Discussion of non-clinical and clinical test performed

Non-clinical Tests have been done as follows:

a. Safety and performance characteristics of the test according to IEC 80601-2-30 b. Biocompatibility test performed according to ISO 10993-5 and ISO 10993-10 None of the test demonstrates that the Bpump Blood Pressure Cuff brings new questions of safety or effectiveness.

Clinical Test Concerning the Compliance of ANSI/AAMI/ISO 81060-2

Clinical test has been done in accordance with IEC 80601-2-30 and ANSI/AAMI/ISO 81060-2. and the test result shows, the device met all applicable requirements of the standard.

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9. Performance:

Guidances

There is a guidance named "Guidance for Industry: Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version I, November 19, 1998" for product code DXQ, which scope does not include any automated non-invasive blood pressure monitors whether using the oscillometric method or any other method. So, we concluded that the guidance is inapplicable to the subject device.

Standards

The Bpump Blood Pressure Cuff conforms to the following standards:

· IEC 80601-2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
· ANSI/AAMI/ISO 81060-2: Non-invasive sphygmomanometers part 2: Clinical validation of automated measurement type.
ISO 10993-1: Biological evaluation of medical devices Part I: Evaluation and testing within a risk manangement process
· ISO 10993-5: Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
· ISO 10993-10: Biological evaluation of medical devices Part I 0: Tests for irritation and skin sensitization

10. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this premarket notification, SHENZHEN PUMP MEDICAL SYSTEM concludes that the subject device, the Bpump Blood Pressure Cuff, is safe, effective and substantially equivalent to Andon Blood Pressure Cuff (K133117).

Regulation Number and Section

§ 870.1120 Blood pressure cuff.

(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).