(57 days)
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and mentions no features or components related to AI or ML. The technology described is conventional for this type of device.
No.
The device is a blood pressure monitor intended to measure blood pressure and pulse rate, not to provide therapy or treatment. The "Intended Use" section explicitly states it is "not intended to be diagnostic device."
No
The "Intended Use / Indications for Use" section explicitly states "Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor are not intended to be diagnostic device."
No
The device description explicitly states it consists of a "Main Control Unit, LCD and attachments" and is a "battery driven automatic non-invasive Blood Pressure Monitor" with inflatable cuffs. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, the Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor are not intended to be diagnostic device." While this doesn't directly say "not an IVD," it strongly indicates it's not for diagnostic purposes, which is a key characteristic of IVDs.
- Nature of Measurement: The device measures blood pressure and pulse rate, which are physiological parameters obtained in vivo (from the living body), not in vitro (outside the body, typically from biological samples like blood or urine).
- Lack of Biological Sample Analysis: The description focuses on the mechanical process of cuff inflation and deflation and the oscillometric technique, not on the analysis of any biological samples.
Therefore, based on the information provided, this device is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor are non-invasive blood measurement system intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments.
The Fudakang BT series Blood Pressure Monitors are of Bluetooth transmission function, which enable user to transfer the measurement record from the device to a mobile phone or PC through Bluetooth.
Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor are not intended to be diagnostic device.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
Fudakang Blood Pressure Monitor is battery driven automatic non-invasive Blood Pressure Monitor.
It consists of the Main Control Unit, LCD and attachments. The device can automatically complete the inflation, deflation and BP measurement, which intended to measure the diastolic, systolic blood pressures and pulse rate for an adult individual via the oscillometric technique.
Fudakang Blood Pressure Monitor includes two types of automatic non-invasive Blood Pressure Monitor, Arm Automatic Blood Pressure Monitor and Wrist Fully Automatic Blood Pressure Monitor. The Arm Blood Pressure Monitor utilizes an inflatable cuff that is wrapped around the upper arm; the cuff circumference is limited to 22cm-30cm (8.66 in - 11.8 in). The Wrist Blood Pressure Monitor utilizes an inflatable cuff wrapped around the wrist, the cuff circumference is limited to 13.5cm- 19.5cm (5.31in -7.67 in).
The BT series Blood Pressure Monitors are of Bluetooth transmission function, which enable user to transfer the measurement record from the device to a mobile phone or PC through Bluetooth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper arm; wrist
Indicated Patient Age Range
Adult
Intended User / Care Setting
Hospitals, hospital-type facilities and home environments.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Test Summary: One hundred and twenty three patients (65 males and 58 females) participate in the clinical study. Same arm simultaneous method was adopted during the clinical testing for arm type blood pressure monitor and Same arm sequential method was used in the course of the clinical study for wrist type blood pressure monitor. The manual Mercury Sphygmomanometer was used as a reference device for the both clinical testing. All the subjects are volunteer to take part in the clinical study. The results showed the accuracy of the blood pressure monitor made by Fudakang Industrial Co., Ltd. is within acceptable scope specified in ISO 81060-2.
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
§ 870.1130 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
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three overlapping profiles of human faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2015
Fudakang Industrial Co., Ltd c/o Mr. Field Fu Senior Regulatory Specialist 4th Floor, Jinhui Building Nanhai Blvd, Nanshan District Shenzhen, 518100 CN
Re: K150430
Trade/Device Name: Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 31, 2014 Received: February 19, 2015
Dear Mr. Field Fu,
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
Page 2 - Mr. Field Fu
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 yours.
Muda Yellm
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: K150430
Device Name: System, measurement, blood-pressure, non-invasive
Model:
- Arm Blood Pressure Monitor や Models: FT-C21Y, FT-C22Y, FT-C23Y, FT-C24Y, FT-C11B, FT-C12B, FT-C21Y-V, FT-C22Y-V, FTC-23Y-V, FT-C24Y-V, FT-C11B-V, FT-C12B-V, FT-C11B-UR and FT-C11B-BT.
- や Wrist Blood Pressure Monitor Models: FT-B11W, FT-B12W, FT-B13W, FT-B14W, FTB21Y, FT-B22Y, FT-B11W-V. FT-B12W-V. FT-B13W-V. FT-B14W-V. FT-B21Y-V. FT-B22Y-V, FT-B13W-UR and FT-B13W-BT.
Indications for Use:
Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor are non-invasive blood measurement system intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments.
The Fudakang BT series Blood Pressure Monitors are of Bluetooth transmission function, which enable user to transfer the measurement record from the device to a mobile phone or PC through Bluetooth.
Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor are not intended to be diagnostic device.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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SECTION 05 510(K) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR§807.92
| The assigned 510(k) number is: | (applicant leave blank) |
|---|---|
| Submission Date: | Sep 28, 2014 |
| Submitter: | Fudakang Industrial Co., Ltd |
| Address: No.8 Yinghe Road, Yuanjiangyuan Management | |
| Zone, Changping Town, Dongguan, Guangdong, China. | |
| Submitter Contact: | Shenzhen Joyantech Consulting Co., Ltd. |
| 2032#, International Mayor Communication Center, Shizhou | |
| zhong Road 55#, Nanshan District, Shenzhen, China. | |
| Contact person: Mr. Field.Fu | |
| E-Mail: cefda13485@163.com | |
| Image: [logo] | |
| Manufacturing Site: | Fudakang Industrial Co., Ltd |
| Address: No.8 Yinghe Road, Yuanjiangyuan Management | |
| Zone, Changping Town, Dongguan, Guangdong, China. | |
| Common Name: | Non-invasive Sphygmomanometer |
| Trade Name & Models of | |
| the device: | ◇ Arm Blood Pressure Monitor |
| Models: FT-C21Y, FT-C22Y, FT-C23Y, FT-C24Y, FT-C11B, FT-C12B, | |
| FT-C21Y-V, FT-C22Y-V, FTC-23Y-V, FT-C24Y-V, FT-C11B-V, | |
| FT-C12B-V, FT-C11B-UR and FT-C11B-BT. | |
| ◇ Wrist Blood Pressure Monitor | |
| Models: FT-B11W, FT-B12W, FT-B13W, FT-B14W, FTB21Y, | |
| FT-B22Y, FT-B11W-V, FT-B12W-V, FT-B13W-V, FT-B14W-V, | |
| FT-B21Y-V, FT-B22Y-V, FT-B13W-UR and FT-B13W-BT | |
| Classification Name: | System, measurement, blood-pressure, non-invasive |
| Regulation: | 21 CFR § 870.1130; |
| Product Code: | DXN |
| Device Class: | II |
| Predicate Devices: | ◇ QardioArm, model A 100 (K140067) |
| ◇ Wrist Measurement Electronic Blood Pressure | |
| Monitor, Models: KD-791, KD-792, KD-793, KD-795, | |
| KD-796, KD-797, KD-798 (K070826) |
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Intended Use/Indications for use:
Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor are non-invasive blood measurement system intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospital-type facilities and home environments. The Fudakang BT series Blood Pressure Monitors are of Bluetooth transmission function, which enable user to transfer the measurement record from the device to a mobile phone or PC through Bluetooth.
Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor are not intended to be diagnostic device.
Device Description:
Fudakang Blood Pressure Monitor is battery driven automatic non-invasive Blood Pressure Monitor.
It consists of the Main Control Unit, LCD and attachments. The device can automatically complete the inflation, deflation and BP measurement, which intended to measure the diastolic, systolic blood pressures and pulse rate for an adult individual via the oscillometric technique.
Fudakang Blood Pressure Monitor includes two types of automatic non-invasive Blood Pressure Monitor, Arm Automatic Blood Pressure Monitor and Wrist Fully Automatic Blood Pressure Monitor. The Arm Blood Pressure Monitor utilizes an inflatable cuff that is wrapped around the upper arm; the cuff circumference is limited to 22cm-30cm (8.66 in - 11.8 in). The Wrist Blood Pressure Monitor utilizes an inflatable cuff wrapped around the wrist, the cuff circumference is limited to 13.5cm- 19.5cm (5.31in -7.67 in).
The BT series Blood Pressure Monitors are of Bluetooth transmission function, which enable user to transfer the measurement record from the device to a mobile phone or PC through Bluetooth.
Clinical and Non-clinical Tests
Clinical Test Summary 1)
One hundred and twenty three patients (65 males and 58 females) participate in the clinical study. Same arm simultaneous method was adopted during the clinical testing for arm type blood pressure monitor and Same arm sequential method was used in the course of the clinical study for wrist type blood pressure monitor. The manual Mercury Sphygmomanometer was used as a reference device for the both clinical testing. All the subjects are volunteer to take part in the clinical study. The results showed the accuracy of the blood pressure monitor made by Fudakang Industrial Co., Ltd. is within acceptable scope specified in ISO 81060-2.
Non-Clinical Test Summary 2)
Several non-clinical tests were performed on Fudakang Arm type and Wrist type Blood Pressure Monitor Series Models, the results showed that all requirements were met. The tests includes the follows:
- Electrical safety, EMC, FCC, Wireless coexistence and Home healthcare environment test reports
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- � IEC 60601-1: 2005.1: 2006+CORR. 2:2007+AM1:2012
- ◆ IEC 60601-1-2: 2007
- � CFR 47 FCC PART 15 (SUBPART B and C 2013)
- � 47 CFR Part 1.1307(2013)
- � 47 CFR Part 2.1093(2013)
- � EN 300328 v1.8.1
- � IEC 60601-1-11 Edition 1.0 2010-04
- Performance
- � IEC 80601-2-30:2009+A1:2013
- . Biocompatibility
- � ISO 10993-5:2009
- � ISO 10993-10:2002/Amd.1:2006.
Summary of the Substantially Equivalent
The Fudakang Noninvasive blood pressure monitor is substantially equivalent to the Blood Pressure Monitor (K140067) and the Noninvasive blood pressure measurement systems (K070826).