(198 days)
Not Found
No
The document describes a standard digital blood pressure monitor and does not mention any AI or ML capabilities. The performance studies focus on electrical safety and accuracy against established standards, not on algorithmic performance.
No
A therapeutic device is used to treat a disease or condition. This device is a blood pressure monitor, which is used for measurement and monitoring, not for treatment.
Yes
Explanation: The device is intended to "measure the systolic and diastolic blood pressure, and pulse rate (heart rate)", which are diagnostic measurements of a patient's physiological state.
No
The device description explicitly states it uses an "inflating cuff" and has an "LCD DISPLAY," indicating physical hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The FB-100U Series Digital Blood Pressure Monitor measures blood pressure and pulse rate by using a cuff wrapped around the upper arm. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
- Intended Use: The intended use clearly states it measures blood pressure and pulse rate using an inflating cuff on the upper arm.
Therefore, based on the provided information, the device is a non-invasive medical device for measuring physiological parameters, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
FB-100U Series DIGITAL Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm.
The device is indicated for use by people over 15 years old in home use.
Product codes
DXN
Device Description
FB-100U Series DIGITAL Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure, and pulse rate(heart of an individual). All values can be read out in one LCD DISPLAY. Measurement position is on adult arm only.
FB-100U Series DIGITAL Blood Pressure Monitor meets the requirements specified in ANSI/AAMI SP-10 - Manual, electronic, or automated sphygmomanometers. Full responsibility for the conformance of this product to standard is assumed by FEGO Precision Industrial Co., Ltd.
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
over 15 years old
Intended User / Care Setting
home use.
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)
In terms of operating specification, Safety & EMC requirements, the Performance device conforms to applicable standards included ANSI/AAMI SP-10, IEC 60601-1 and IEC 60601-1-2 requirements.
bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(K) SUMMARY
AUG - 8 2007
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
| 1. Submitter's Name: | FEGO Precision Industrial Co., Ltd. |
|---|---|
| Address: | 947 Lin-Sen Rd., Wu-Fong, Taichung County., 413 Taiwan, R.O.C. |
| Phone: | +886-4-23391802 |
| Fax: | +886-4-23399374 |
| Contact: | Mr. Bruce Chang / General Manager |
| 2. Device Name : | |
| Trade Name: | FB-100U Series DIGITAL Blood Pressure Monitor |
| (Model No.: FB-1XYU, XY=00 ~ 99 represent type of case housing ) | |
| Common Name: | Non-Invasive Blood Pressure Monitor |
| Classification name | System , Measurement , Blood-Pressure , Non-Invasive |
| 3. DEVICE CLASS | FB-100U Series DIGITAL Blood Pressure Monitor have been classified as |
| Regulatory Class: II | |
| Panel: 74 | |
| Product Code: DXN | |
| Regulation Number: 2ICFR 870.1130 | |
| 4. Predicate Device: | The predicate device is the Rossmax Automatic Blood Pressure |
| Monitor(K021225) marketed by ROSSMAX INTERNATIONAL LTD. | |
| 5. Device Description: | FB-100U Series DIGITAL Blood Pressure Monitor is designed to |
| measure the systolic and diastolic blood pressure, and pulse rate(heart | |
| of an individual). All values can be read out in one LCD DISPLAY. | |
| Measurement position is on adult arm only. | |
| FB-100U Series DIGITAL Blood Pressure Monitor meets the | |
| requirements specified in ANSI/AAMI SP-10 - Manual, electronic, or | |
| automated sphygmomanometers. Full responsibility for the | |
| conformance of this product to standard is assumed by FEGO Precision | |
| Industrial Co., Ltd. |
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FB-100U Series DIGITAL Blood Pressure Monitor is intended to 6. Intended Use: measure the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm.
The device is indicated for use by people over 15 years old in home use. -
In terms of operating specification, Safety & EMC requirements, the 7. Performance device conforms to applicable standards included ANSI/AAMI SP-10, Summary: IEC 60601-1 and IEC 60601-1-2 requirements.
8. Conclusions:
FB-100U Series DIGITAL Blood Pressure Monitor has the same intended use and similar technological characteristics as the Rossmax Automatic Blood Pressure Monitor(K021225) marketed by ROSSMAX INTERNATIONAL LTD. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, FB-100U Series DIGITAL Blood Pressure Monitor is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three overlapping, curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2007
Fego Precision Industrial Co. Ltd. c/o Ms. Jennifer Reich Harvest Consulting Corp. 2904 N. Boldt Drive Flagstaff, AZ 86001
Re: K070209
Trade/Device Name: FB-100U Series Digital 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: July 17, 2007 Received: July 19, 2007
Dear Ms. Reich:
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. Ilsting 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.
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Page 2 - Ms. Jennifer Reich
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); 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 entitled, "Misbranding by reference to premarket 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,
B. Gemmer 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):_____________________________________________________________________________________________________________________________________________________
Device Name: FB-100U Series Digital Blood Pressure Monitor FEGO Precision Industrial Co., Ltd.
Indications For Use:
FB-100U Series Digital Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm.
The device is indicated for use by people over 15 years old in home use.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use V (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)
Blumuna
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