(104 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and Bluetooth data transmission, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is a blood pressure monitor intended for measurement and monitoring, not for providing therapy or treatment.
Yes
Explanation: The device is described as a "Digital Automatic Blood Pressure Monitor BPM20 Series" which is intended to "measure the systolic blood pressure, and pulse rate of an adult individual". Measuring these physiological parameters to provide information about the health status of an individual is a diagnostic function.
No
The device description clearly states it is a "non-invasive blood pressure measurement system" that utilizes an "inflatable cuff" and "detects your blood's movement through your brachial artery." These are hardware components essential to the device's function, even though some models have Bluetooth for data transmission to a mobile application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device function: The Digital Automatic Blood Pressure Monitor BPM20 Series measures blood pressure and pulse rate by using a cuff wrapped around the upper arm. This is a non-invasive method that does not involve analyzing samples taken from the body.
- Intended Use: The intended use clearly states it measures blood pressure and pulse rate using a non-invasive technique.
Therefore, based on the provided information, the device is a non-invasive medical device for measuring physiological parameters, not an IVD.
N/A
Intended Use / Indications for Use
Digital Automatic Blood Pressure Monitor BPM20 Series is for use by medical professional or home user. The BPM20 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm of an individual. The inflatable cuff circumference is limited to 17cm - 44cm via 3 different size of cuffs. The 3 different cuff sizes are 17 - 22cm, 22 - 32cm and 32 - 44cm. For Bluetooth capable models, the measurement result can be transmitted to pre-approved mobile devices.
Digital Automatic Blood Pressure Monitor BPM20 Scries is for use by medical professional or home user. The BPM20 Series is intended to measure the systolic blood pressure, and pulse rate of an adult individual by using a non-invasive technique, in which an inflatable culf is wrapped around the upper arm of an individual. The inflaable cuff circumference is limited to 17cm - 44cm via 3 diffs. The 3 different cuff sizes are 17 - 22cm, 22 - 32cm and 32 - 44cm. For Bluetooth capable the measurement result can be transmitted to pre-approved mobile devices.
Product codes (comma separated list FDA assigned to the subject device)
DYN, DXN
Device Description
Digital Automatic Blood Pressure Monitor BPM20 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel.
The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.
Certain models of Digital Automatic Blood Pressure Monitor BPM20 Series equipment with Bluetooth transmission function, which enable user to transfer the measurement record from the device to a mobile platform through Bluetooth. User can manage the measurement record by using the mobile application.
The table below illustrate the feature presence in Digital Automatic Blood Pressure Monitor BPM20 Series.
Digital Automatic Blood Pressure Monitor BPM20 Series is a non-invasive measuring device and utilizes the oscillometric methodology to measure the blood pressure reading. The key components of device are: a pressure sensor, a electric valve, an electronic control module, an electric pump and a Bluetooth module. The electric pump inflate (and deflate) the inflatable cuff automatically according to our designed architecture. The Bluetooth module responses to the Bluetooth Version 4.0 (BLE) connection. The predicate device adopts exactly same methodology and key components for measuring blood pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
Adult, Age 16 or above
Intended User / Care Setting
medical professional or at home (home user)
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
One hundred patients (52 males and 48 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left upper arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2009.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Test Summary
Testing to insure clinical accuracy of the device in accordance with ISO 81060-222009 as documented in Clinical Test report.
One hundred patients (52 males and 48 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left upper arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2009.
Non-Clinical Test Summary
Digital Automatic Blood Pressure Monitor BPM20 Series has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests includes the follows:
- EN 1060-1:1995+A2:2009
- EN 1060-3:1997+A2:2009
- .IEC 60601-1:2012
- EN 60601-1-2:2007
- FCC Part 15 Subpart B
- FCC Part 15 Subpart C
- ISO 10993-5:2009
- ISO 10993-10:2010
- IEC 62304:2006
- ETSI EN 301 489-1 V1.9.2 (2011-09) & ETSI EN 301 489-17 V2.2.1 (2012-09)
- ETSI EN 300 328 V1.7.1 (2006-10) & EN 62479:2010
- FDA Radio-Frequency Wireless Technology in Medical Device, Wireless coexistence
As all of the clinical and non-clinical testing performed on Digital Automatic Blood Pressure Monitor BPM20 Series are same as the predicate device. Therefore, no bench test is conducted to show the performance of Digital Automatic Blood Pressure Monitor BPM20 Series is equivalent to the predicate device.
Digital Automatic Blood Pressure Monitor BPM20 Series has the similar intended use and same technological characteristics as the predicate device, BPM656ZB (K072137). Moreover clinical testing has demonstrated that no differences in the technological characteristics and questioning on safety or effectiveness to be raised. Thus, Digital Automatic Blood Pressure Monitor BPM20 Series is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Blood Pressure Measurement Accuracy: ± 3 mmHg or 2% of reading
Pulse Rate Measurement Accuracy: ± 5 % of the reading
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
§ 870.1130 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).
0
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
Section 7 510(k) Summary
Re: K_
CHECK ONLY ONE
风 510(k) Summary. Attached is a summary of safety and effectiveness information upon which an equivalence determination could be based.
510(k) Statement. I certify that, in my capacity as (the position held in company by person required to submit the premarket notification, preferably the official correspondent) of (company name), I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.
Ch. Fanz
Patrick Chow, General Manager (00852)-2851-6789
05th March, 2014
1
510(k) Summary
Submitter Identification 1.
| 510(k) Submitter | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
|---|---|
| Address | Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang |
| District, Shenzhen, Guang Dong, People's Republic of China | |
| Phone Number | (00852)-2851-6789 |
| Fax Number | (00852)-2851-6278 |
| Contact Person | Mr. Patrick Chow |
| Date of Submission | 05th March, 2014 |
2. Device Identification
| Trade Name | Digital Automatic Blood Pressure Monitor BPM20 Series
[Model No.: MD20xy] |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | x --- The first character (0, 1, 2, 3, 4, 5, 6, 7, 8 & 9) is for the
minor change revision of device. The mentioned "minor
change" refers to those device changes not to be affecting the
conformity test results of EMC & safety as well as device
performance, i.e. IEC 60601-1, EN 60601-1-2, ETSI EN 301
489-1 V1.92 and ETSI EN 300 328 V1.7.1. |
| | y --- The second character (0 & 1) is for the identification of
presence of DC jack. Surely, the presence of DC jack does
not affecting the conformity test results of EMC & safety as
well as device performance, i.e. IEC 60601-1, EN 60601-1-2,
ETSI EN 301 489-1 V1.92 and ETSI EN 300 328 V1.7.1. |
| Common Name | Non-invasive Blood Pressure Measurement System |
| Classification Name | Non-invasive Blood Pressure Measurement System
(CFR 870.1130, Class II, Product Code DYN) |
3. Predicate Device
ﺰ
| Predicate Device | AVITA Bluetooth Blood Pressure Monitor (Model: BPM656ZB) |
|---|---|
| Manufacturer | AVITA Corporation |
| 510(k) Number | K072137 |
2
Device Description 4.
Digital Automatic Blood Pressure Monitor BPM20 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel.
The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.
Certain models of Digital Automatic Blood Pressure Monitor BPM20 Series equipment with Bluetooth transmission function, which enable user to transfer the measurement record from the device to a mobile platform through Bluetooth. User can manage the measurement record by using the mobile application.
| Model | Blood Pressure
Measurement | Pulse Rate
Measurement | WHO | IHB | LCD Type | Backlight | DC
Jack | BLE | Memory |
|--------|-------------------------------|---------------------------|-----|-----|-----------------------|-----------|------------|-----|---------|
| MD2000 | ✓ | ✓ | LED | ✓ | Positive Reflective | X | ✓ | X | 4 × 120 |
| MD2010 | ✓ | ✓ | LED | ✓ | Positive Transmissive | Blue | ✓ | X | 4 × 240 |
| MD2020 | ✓ | ✓ | LED | ✓ | Positive Transmissive | White | ✓ | 4.0 | 4 × 240 |
| MD2030 | ✓ | ✓ | ✓ | ✓ | Positive Transmissive | Blue | ✓ | 4.0 | 4 × 240 |
| MD2040 | ✓ | ✓ | ✓ | ✓ | Positive Reflective | X | ✓ | X | 4 × 240 |
| MD2050 | ✓ | ✓ | ✓ | ✓ | Positive Transmissive | Blue | ✓ | X | 4 × 240 |
| MD2060 | ✓ | ✓ | ✓ | ✓ | Positive Transmissive | White | ✓ | 4.0 | 4 × 240 |
| MD2070 | ✓ | ✓ | LED | ✓ | Positive Transmissive | Blue | ✓ | 4.0 | 4 × 240 |
| MD2080 | ✓ | ✓ | LED | ✓ | Negative Transmissive | White | ✓ | 4.0 | 4 × 240 |
| MD2090 | ✓ | ✓ | LED | ✓ | Negative Transmissive | White | ✓ | X | 4 × 240 |
| MD2001 | ✓ | ✓ | LED | ✓ | Positive Reflective | X | X | X | 4 × 120 |
| MD2011 | ✓ | ✓ | LED | ✓ | Positive Transmissive | Blue | X | X | 4 × 240 |
| MD2021 | ✓ | ✓ | LED | ✓ | Positive Transmissive | White | X | 4.0 | 4 × 240 |
| MD2031 | ✓ | ✓ | ✓ | ✓ | Positive Transmissive | Blue | X | 4.0 | 4 × 240 |
| MD2041 | ✓ | ✓ | ✓ | ✓ | Positive Reflective | X | X | X | 4 × 120 |
| MD2051 | ✓ | ✓ | ✓ | ✓ | Positive Transmissive | Blue | X | X | 4 × 240 |
| MD2061 | ✓ | ✓ | ✓ | ✓ | Positive Transmissive | White | X | 4.0 | 4 × 240 |
| MD2071 | ✓ | ✓ | LED | ✓ | Positive Transmissive | Blue | X | 4.0 | 4 × 240 |
The table below illustrate the feature presence in Digital Automatic Blood Pressure Monitor BPM20 Series.
3
5. Indication for Use
Digital Automatic Blood Pressure Monitor BPM20 Series is for use by medical professional or home user. The BPM20 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm of an individual. The inflatable cuff circumference is limited to 17cm - 44cm via 3 different size of cuffs. The 3 different cuff sizes are 17 - 22cm, 22 - 32cm and 32 - 44cm. For Bluetooth capable models, the measurement result can be transmitted to pre-approved mobile devices.
6. Comparison of Technological Characteristics between New Device and Predicate Devices
Digital Automatic Blood Pressure Monitor BPM20 Series is compared to the predicate device, BPM656ZB (K072137) in the device comparison table below.
| Comparison between Digital Automatic Blood Pressure Monitor BPM20 Series and predicate device | |||
|---|---|---|---|
| Item | Predicate Device (K072137) | Digital Automatic Blood Pressure | |
| Monitor BPM20 Series | Comment | ||
| Indication for | |||
| Use | The device is arm type Blood Pressure | ||
| Monitor that applies oscillometric method | |||
| to measure human Systolic, Diastolic | |||
| blood pressure and heart rate. The | |||
| measurement results are displayed on the | |||
| LCD and transmitted to Bluetooth enabled | |||
| devices, such as a PC, a PDA or a printer. | |||
| The device is designed for adult. | Digital Automatic Blood Pressure Monitor | ||
| BPM20 Series is for use by medical | |||
| professional or home user. The BPM20 | |||
| Series is intended to measure the systolic | |||
| and diastolic blood pressure, and pulse | |||
| rate of an adult individual by using a | |||
| non-invasive technique, in which an | |||
| inflatable cuff is wrapped around the | |||
| upper arm of an individual. The inflatable | |||
| cuff circumference is limited to 17cm - | |||
| 44cm via 3 different size of cuffs. The 3 | |||
| different cuff sizes are 17 - 22cm, | |||
| 22 - 32cm and 32 - 44cm. For | |||
| Bluetooth capable models, the | |||
| measurement result can be transmitted to | |||
| pre-approved mobile devices. | Similar | ||
| Measurement | |||
| Method | Non-invasive, Oscillometric | Non-invasive, Oscillometric | Identical |
| Patient | |||
| Population | Adult | Age 16 or above | Equivalent |
| Blood Pressure | |||
| Measurement | |||
| Range | Cuff Pressure: 30 - 280 mmHg | Cuff Pressure: 0 - 300 mmHg | |
| Systolic Pressure: 50 - 250 mmHg | |||
| Diastolic Pressure: 30 - 200 mmHg | Similar | ||
| Number of User | 2 independent users | 4 independent users | Similar, |
| improved | |||
| specification | |||
| Memory Space | 2 users × 60 memory space | 4 users × 120 memory space; or | |
| 4 users × 240 memory space | |||
| (Depends on models identification) | Similar, | ||
| improved | |||
| specification | |||
| Comparison between Digital Automatic Blood Pressure Monitor BPM20 Series and predicate device | |||
| Item | Predicate Device (K072137) | Digital Automatic Blood Pressure | |
| Monitor BPM20 Series | Comment | ||
| Resolution of | |||
| Measurement | 1 mmHg | 1 mmHg | Identical |
| Blood Pressure | |||
| Measurement | |||
| Accuracy | $\pm$ 3 mmHg | $\pm$ 3 mmHg or 2% of reading | Equivalent |
| Pulse Rate | |||
| Measurement | |||
| Range | 40 - 199 beats/min | 30 - 180 beats/min | Similar |
| Pulse Rate | |||
| Measurement | |||
| Accuracy | $\pm$ 4 % of the reading | $\pm$ 5 % of the reading | Similar |
| Operation | |||
| Temperature | +5 to +40 °C | +5 to +40 °C | Identical |
| Operation | |||
| Humidity | 15-93% R.H. max | 15-93% R.H. max | Identical |
| Storage | |||
| Temperature | -25 to 70 °C | -25 to 70 °C | Identical |
| Storage | |||
| Humidity | Up to 95% R.H. max | Up to 95% R.H. max | Identical |
| Operation, | |||
| Storage and | |||
| Transportation | |||
| Atmospheric | |||
| Pressure | 700hPa - 1060hPa | 700hPa-1060hPa | Identical |
| Display Type | LCD | LCD | Identical |
| Power Source | 4 × 1.5 V AA-batteries; and/or | ||
| AC adaptor (6V/600mA) | 4 × 1.5 V AA-batteries; and/or | ||
| AC adaptor (6V/600mA) | Equivalent | ||
| Pressurization | |||
| Mode | Automatic Inflation | Automatic Inflation | Identical |
| Deflation Mode | Automatic Exhaust/ Deflation | Automatic Exhaust/ Deflation | Identical |
| Bluetooth | |||
| function | Bluetooth 4.0 (2402Hz-2480Hz) | Bluetooth 4.0 (2402Hz - 2480Hz) | Identical |
| Cuff Size | 23-33cm | 17-22cm, 22-32cm, 32-44cm | Similar |
| Applicable | |||
| Standard | ◇ EN 1060-1 | ||
| ◇ EN 1060-3 | |||
| ◇ ANSI/ AAMI SP-10 | |||
| ◇ IEC 60601-1 | |||
| ◇ IEC 60601-1-2 | ◇ EN 1060-1:1995+A2:2009 | ||
| ◇ EN 1060-3:1997+A2:2009 | |||
| ◇ IEC 60601-1:2012 | |||
| ◇ EN 60601-1-2:2007 | |||
| ◇ FCC Part 15 Subpart B | |||
| ◇ FCC Part 15 Subpart C | |||
| ◇ ISO 10993-5:2009 | |||
| ◇ ISO 10993-10:2010 | |||
| ◇ IEC 62304:2006 | |||
| ◇ IEC 81060-2:2009 | |||
| ◇ ETSI EN 301 489-1 V1.9.2 | |||
| (2011-09) & ETSI EN 301 489-17 | |||
| V2.2.1 (2012-09) | |||
| ◇ ETSI EN 300 328 V1.7.1 (2006-10) | |||
| & EN 62479:2010 | |||
| ◇ FDA Radio-Frequency Wireless | |||
| Technology in Medical Device, | Equivalent |
4
510(k) PREMARKET NOTIFICATION
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
Digital Automatic Blood Pressure Monitor BPM20 Series is a non-invasive measuring device and utilizes the oscillometric methodology to measure the blood pressure reading. The key
5
510(k) PREMARKET NOTIFICATION
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
components of device are: a pressure sensor, a electric valve, an electronic control module, an electric pump and a Bluetooth module. The electric pump inflate (and deflate) the inflatable cuff automatically according to our designed architecture. The Bluetooth module responses to the Bluetooth Version 4.0 (BLE) connection. The predicate device adopts exactly same methodology and key components for measuring blood pressure.
Clinical and Non-clinical Tests 7.
Clinical Test Summary
Testing to insure clinical accuracy of the device in accordance with ISO 81060-222009 as documented in Clinical Test report.
One hundred patients (52 males and 48 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left upper arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2009.
Non-Clinical Test Summary
Digital Automatic Blood Pressure Monitor BPM20 Series has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests includes the follows:
- � EN 1060-1:1995+A2:2009
- � EN 1060-3:1997+A2:2009
- � .IEC 60601-1:2012
- EN 60601-1-2:2007 �
- � FCC Part 15 Subpart B
- � FCC Part 15 Subpart C
- ゃ ISO 10993-5:2009
- ISO 10993-10:2010 �
- � IEC 62304:2006
- ETSI EN 301 489-1 V1.9.2 (2011-09) & ETSI EN 301 489-17 V2.2.1 (2012-09) �
- � ETSI EN 300 328 V1.7.1 (2006-10) & EN 62479:2010
- FDA Radio-Frequency Wireless Technology in Medical Device, Wireless coexistence �
As all of the clinical and non-clinical testing performed on Digital Automatic Blood Pressure
Digital Automatic Blood Pressure Monitor BPM20 Series
6
510(k) PREMARKET NOTIFICATION
Monitor BPM20 Series are same as the predicate device. Therefore, no bench test is conducted to show the performance of Digital Automatic Blood Pressure Monitor BPM20 Series is equivalent to the predicate device.
Conclusion 8.
Digital Automatic Blood Pressure Monitor BPM20 Series has the similar intended use and same technological characteristics as the predicate device, BPM656ZB (K072137). Moreover clinical testing has demonstrated that no differences in the technological characteristics and questioning on safety or effectiveness to be raised. Thus, Digital Automatic Blood Pressure Monitor BPM20 Series is substantially equivalent to the predicate device.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three curved lines that resemble a bird or a stylized human figure. The image is in black and white and appears to be a scan or photocopy due to its slightly grainy texture. The seal is likely used to represent the U.S. Department of Health and Human Services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 18, 2014
Grandway Technology (Shenzhen) Limited Patrick Chow General Manager Zhu Keng Industrial Zone Ping Shan, Long Gang District Shenshen, Guang Dong, 518118 CH
Re: K140583
Trade/Device Name: Digital Automatic Blood Pressure Monitor BPM20 Series Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 9, 2014 Received: May 12, 2014
Dear Patrick Chow,
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.
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 device
8
Page 2 - Patrick Chow
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/8/Picture/7 description: The image shows a logo with the letters FDA. The letters are stylized and overlapping. The logo appears to be a black and white image. The image is somewhat distorted.
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
9
K140583 p.1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K 140583
Device Name
Digital Automatic Blood Pressure Monitor BPM20 Scries
Indications for Use (Describe)
Digital Automatic Blood Pressure Monitor BPM20 Scrics is for use by medical professional or home user. The BPM20 Series is intended to measure the systolic blood pressure, and pulse rate of an adult individual by using a non-invasive technique, in which an inflatable culf is wrapped around the upper arm of an individual. The inflaable cuff circumference is limited to 17cm - 44cm via 3 diffs. The 3 different cuff sizes are 17 - 22cm, 22 - 32cm and 32 - 44cm. For Bluetooth capable the measurement result can be transmitted to pre-approved mobile devices.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpan D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,
SE ST PHONE OF FOR FDAUSE ONLY MOSE ONLY MOSE ONLY MASSE ONLY MANAGE ONLY WANT Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Date: 2014.06.18
08:17:21 -04'00'
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)