(168 days)
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No
The description focuses solely on the physical characteristics and function of a blood pressure cuff, with no mention of AI or ML algorithms for data processing or interpretation. The performance studies are standard tests for blood pressure cuffs.
No.
The device is used to measure blood parameters, which is a diagnostic function, not a therapeutic one.
No
This device is a blood pressure cuff, which is an accessory to a non-invasive blood pressure monitor. While it helps in the measurement of blood parameters, it does not independently diagnose conditions. Its function is to facilitate the measurement, not to interpret the data for diagnostic purposes.
No
The device description clearly states it is a physical blood pressure cuff, a "rectangle soft inelastic sleeve reusable with a bladder," and a "single-tube connected to the bladder." This is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Bpump Blood Pressure Cuff is a physical component that is wrapped around the upper arm to facilitate the measurement of blood pressure. It works by applying pressure to the arm and is used on the body, not for testing samples taken from the body.
- Intended Use: The intended use clearly states it's for "completing the measurement of blood parameters on adults" by being "wrapped on the upper arm." This describes a non-invasive, external measurement process.
- Device Description: The description details a physical cuff with a bladder and tube, designed to be connected to a blood pressure monitor. This aligns with a physical medical device used externally.
The device is a component of a non-invasive blood pressure monitoring system, which is a medical device used for physiological measurement on the body, not for in vitro testing of biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXO, DXQ
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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
upper arm
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
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 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 870.1120 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).
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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)
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.
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
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
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.
5. Intended Use
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.
6. Description of the device:
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 |
| BC8000 | 32cm |
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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).