(13 days)
It can be used as medical assistant instrument at home or in medical center for adult population for measuring systolic and diastolic blood pressure and heart rate.
The device is intended for use in only adult population, not applied to the other populations such as neonatal baby.
It can not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
BP201 Wrist Blood Pressure Monitor is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method by inflating an inflatable cuff on the wrist.
BP201 Wrist Blood Pressure Monitor uses an inflated cuff which is wrapped around the wrist .The cuff is inflated by a built-in air pump. The systolic and diastolic blood pressures are determined by Oscillometric method. The inflation rate is controlled by MCU at a constant rate 2~5mmHg/second. The user can release the cuff to stop measuring by pressing the "START/STOP" button at any time while measuring. The measuring result is displayed in LCD.
Here's an analysis of the provided text regarding the BP201 Wrist Blood Pressure Monitor, outlining the acceptance criteria and study details:
Acceptance Criteria and Device Performance for BP201 Wrist Blood Pressure Monitor
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criteria for blood pressure monitors generally revolve around accuracy standards set by organizations like ANSI/AAMI, and the provided document confirms adherence to these.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Accuracy (Clinical) | ANSI/AAMI SP10:2002 | Device complies with the standard. |
| BS EN1060-4: 2004 | Device complies with the standard. | |
| Safety | IEC60601-1:1998+A1:1991+A2:1995 | Device conforms to the standard. |
| EMC (Electromagnetic Compatibility) | IEC 60601-1-2:2001/A1:2004 | Device conforms to the standard. |
| Clinical Repeatability | Not explicitly stated as a numerical threshold, but implied by compliance with accuracy standards. | "The comparison study demonstrated that the clinical repeatability of BP201 is statistically and clinically acceptable." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample size (number of subjects/measurements) used for the clinical comparison study. It only mentions that "A comparison study with a device that uses auscultatory method used by trained observers was performed".
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the submitter's location in Shenzhen, PR China, it is probable the study was conducted there, likely as a prospective study for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The document states that the comparison study involved "trained observers" using an auscultatory method. It does not specify the number of these observers (experts).
- Qualifications of Experts: The experts are described as "trained observers" using an auscultatory method. Their specific qualifications (e.g., medical doctors, nurses, years of experience) are not detailed.
4. Adjudication Method for the Test Set
The document describes a "comparison study with a device that uses auscultatory method used by trained observers." This implies the auscultatory measurements served as the reference standard against which the BP201 was compared. It does not describe an explicit adjudication method for discrepancies between multiple readers, as the ground truth seems to have been established by the trained observers directly.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. The study described focuses on the comparison of the device against a reference method, not on human readers' improvement with or without AI assistance.
6. Standalone Performance Study (Algorithm Only)
Yes, a standalone performance study was done. The entire submission focuses on the performance of the BP201 Wrist Blood Pressure Monitor itself (the "algorithm only," in this context meaning the device's automated oscillometric measurement) compared against a recognized reference standard (auscultatory method). The device's automated measurements are validated against these established methods.
7. Type of Ground Truth Used
The type of ground truth used was expert concensus (implicitly, as "trained observers" using the "auscultatory method") measurements. The auscultatory method is a widely accepted clinical standard for blood pressure measurement, and its execution by trained observers serves as the ground truth.
8. Sample Size for the Training Set
The document does not provide information on a training set or its sample size. This is typical for medical devices that are not "AI/ML-enabled" in the modern sense but rather rely on established algorithms (like oscillometric) and hardware. Such devices are typically validated against standards rather than "trained" on data.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of an AI/ML model, there is no information on how its ground truth was established. The device utilizes an oscillometric method, which is an established principle, and its performance is assessed through clinical validation against a reference standard.
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K083043
P1/4
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. BP201 Wrist Blood Pressure Monitor Annex35 510K Summary
510(k) Summary
l . Submitter's Name: Mr. Dacheng Gong, Manager
OCT 2 7 2008
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD.
Address: Section CI-2, Fu'Hai Industrial Zone, Fu'Yong Street,
Bao'An District, Shenzhen, PR China
Phone: +86-755-27371997
Fax: +86-755-27331856
E-mail: kingyield@kingyield.com
Contact person:
Name1: Mr. Dacheng Gong,
Title: Manager
Name2: Ms. Xuecai Wang
Title; Asistant manager
Phone: +86-755-27371997
Fax: +86-755-27331856
e-mail: kingyield@kingvield.com
Date of Summary: Jan. 12 2007
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Trade Name: BP201 Wrist Blood Pressure Monitor
-
Classification Name
Non-invasive Blood Pressure Measurement System.
Regulation Number: 21 CFR 870.1130
Class: II
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Product Code: DXN
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Classification Panel: Cardiovascular
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Predicate Device: IEM-609N Digital Blood Pressure Monitor with Intelligence marketed by Omron Healthcare INC.
K 042505 (Predicate)
7. Device Description:
BP201 Wrist Blood Pressure Monitor is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method by inflating an inflatable cuff on the wrist.
The Intended use:
BP201 Wrist Blood Pressure Monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method.
The device is intended for using in only adult population, not applied to the other populations such as neonatal baby.
It can not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
8. Performance and Technological Characteristics :
8.1 Performance Summary
In terms of operating specification, Safety & EMC requirements, the
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SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. BP201 Wrist Blood Pressure Monitor Annex35 510K Summary
device conform to applicable standards including ANSI/AAMI SP10:2002, BS EN1060-4: 2004, IEC60601-1:1998+A1:1991+A2:1995 IEC 60601-1-2:2001/A1:2004. A comparison study with a device that uses auscultatory method used by trained observers was performed to validate the performance of BP201. The comparison study demonstrated that the clinical repeatability of BP201 is statistically and clinically acceptable.
8.2 Technological Characteristics
BP201 Wrist Blood Pressure Monitor uses an inflated cuff which is wrapped around the wrist .The cuff is inflated by a built-in air pump. The systolic and diastolic blood pressures are determined by Oscillometric method. The inflation rate is controlled by MCU at a constant rate 2~5mmHg/second. The user can release the cuff to stop measuring by pressing the "START/STOP" button at any time while measuring. The measuring result is displayed in LCD.
9. Substantial equivalence discussion
9.1. About the non-clinical tests
BP201 Digital Wrist Blood Pressure Monitor has the same intended use, the same technological characteristics as the predicate device HEM-609N, such as Measurement localization, Measuring parameters, Measurement range, Measurement Accuracy, Inflation, Deflation, Measurable
4
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circumference of wrist, Power source, Battery life, Operate environment, Preservation environment.
The main differences are the physical size, shape and weight, and there is no any new issue of safety and effectiveness.
So the non-clinical performance information demonstrates the equivalence of the non-clinical performance.
In a word, BP201 is equivalent to the predicate device for the non-clinical performance.
9.2. About the clinical tests
The device complies with the ANSI/AAMI SP10:2002 standard and BS EN1060-4: 2004 in its entirety. Thus BP201 & the predicate device HEM-609N are substantially equivalent.
10. Conclusion
BP201 Wrist Blood Pressure Monitor has the same intended use, the same technological characteristics as the predicate devicc HEM-609N Moreover, non-clinical testing & clinical testing contained in this submission demonstrated that any difference in their technological characteristics does not raise any new issues of safety and effectiveness. In a word, BP201 is substantial equivalent to the predicate device HEM-609N
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 2008
Shenzhen Kingyield Technology Co., Ltd. c/o TUV Rheinland of North America, Inc. Mr. Tamas Borsai Division Manager, Medical Division 12 Commerce Rd. Newton, CT 06470
Re: K083043
Trade/Device Name: BP201 Wrist Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 10, 2008 Received: October 14, 2008
Dear Mr. Borsai:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 - Mr. Tamas Borsai
all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entifled, "Misbranding by reference to promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
R. Wachner
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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SHENZHEN KINGY(ELD TECHNOLOGY CO., LTD. BP201 Wrist Blood Pressure Monitor Anne37 Indication for Use Statement
Indications for Use Statement
510(k) Number (if known): K083043
Device Name: BP201 Wrist Blood Pressure Monitor
Indications For Use:
It can be used as medical assistant instrument at home or in medical center for adult population for measuring systolic and diastolic blood pressure and heart rate.
The device is intended for use in only adult population, not applied to the other populations such as neonatal baby.
It can not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uma R. Schmer
(Division Sign-Off)
Division of Cardiovascular Devices
KOB3043 510(k) Number
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).