(306 days)
"Not Applicable"
Not Found
No
The document describes a standard blood pressure monitor using an inflating cuff and LCD display, with no mention of AI, ML, image processing, or data training/testing sets typically associated with AI/ML devices.
No
The device is a blood pressure monitor, which measures physiological parameters but does not provide therapy or treatment.
Yes
The device "provide Systolic, Diastolic blood pressure and pulse rate(heart rate) measurements," which are used by healthcare professionals to diagnose conditions like hypertension (high blood pressure).
No
The device description explicitly states it uses an "inflating cuff which is wrapped around the wrist" and has an "LCD Panel," indicating it includes hardware components for measurement and display.
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 (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside the body (in vitro).
- Device Function: The description clearly states the device is noninvasive and measures blood pressure and pulse rate by using a cuff wrapped around the wrist. This is a direct measurement of physiological parameters within the body, not an analysis of a specimen taken from the body.
The device described is a non-invasive physiological monitoring device, specifically a blood pressure monitor.
N/A
Intended Use / Indications for Use
GENTEEL BP-100 Wrist 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 wrist. The Device is indicated for use by people over 15 age old in home use.
The device is noninvasive and provide Systolic, Diastolic blood pressure and pulse rate(heart rate) mesurements by using an inflating cuff which is wrapped around the wrist. All values can be read out in one LCD Panel. The Device is indicated for use by people over 15 age old in home use.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
GENTEEL BP-100 Wrist Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure, and pulse rate(heart of an individual).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
over 15 age old
Intended User / Care Setting
home use.
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)
In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included EN-1060-3, ANSI/AAMI SP-10 and IEC 60601-1-2 requirements
A comparison study with device that use auscultatory method was performed to validate the performance of the GENTEEL BP-100 Wrist Blood Pressure Monitor. The comparison study demonstrated that the clinical repeatability of GENTEEL BP-100 Wrist Blood Pressure Monitor is statistically and clinically acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
OMRON HEM-608 Wrist Blood Pressure Monitor, OMRON HEM-600 Wrist Blood Pressure Monitor
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
K022926 S-10 K summ with the requirements of SMDA and 21 CFR §807.92
.IIIN = 6 2003
| 1.0 | Submitter's Name: | GENTEEL TECHNOLOGY CO., LTD. |
|---|---|---|
| Address: | 3F, No. 23, Sec. 2, Chung-Hsiao E. Rd., Taipei, Taiwan, R.O.C. | |
| Phone: | 001-886-2-23917311 | |
| Fax: | 001-886-2-23916335 | |
| Contact: | Mr. Deng-Jeng Chou, President | |
| 2.0 Device Name: | GENTEEL BP-100 Wrist Blood Pressure Monitor | |
| 3.0 | Classification: | Class II |
| 4.0 | Predicate Device: | GENTEEL BP-100 Wrist Blood Pressure Monitor has similar |
| general design with OMRON HEM-608 Wrist Blood Pressure | ||
| Monitor marketed by Omron Healthcare INC. | ||
| 5.0 | Device Description: | GENTEEL BP-100 Wrist Blood Pressure Monitor is designed |
| to measure the systolic and diastolic blood pressure, and pulse | ||
| rate(heart of an individual). | ||
| 6.0 | Intended Use: | GENTEEL BP-100 Wrist 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 wrist. The Device is indicated for use by people over 15 age old | ||
| in home use. | ||
| 7.0 | Performance Summary: | In terms of operating specification, Safety & EMC requirements, the |
| device conforms to applicable standards included EN-1060-3, | ||
| ANSI/AAMI SP-10 and IEC 60601-1-2 requirements | ||
| A comparison study with device that use auscultatory method was | ||
| performed to validate the performance of the GENTEEL BP-100 | ||
| Wrist Blood Pressure Monitor. The comparison study | ||
| demonstrated that the clinical repeatability of GENTEEL BP-100 | ||
| Wrist Blood Pressure Monitor is statistically and clinically | ||
| acceptable. |
8. Conclusions:
The GENTEEL BP-100 Wrist Blood Pressure Monitor have the same intended use and similar technological characteristics as OMRON HEM-600 Wrist Blood Pressure Monitor marketed by Omron Healthcare INC.. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the GENTEEL BP-100 Wrist Blood Pressure Monitor is substantially equivalent to the predicate devices.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a cascading manner. The profiles are connected by flowing lines, creating a sense of unity and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 2003
Genteel Technology Co., Ltd. c/o Ms. Jennifer Reich Harvest Consulting Corp. 3892 South America West Trail Flagstaff, AZ 86001
K022926 Re:
Trade Name: Genteel Wrist Digital Blood Pressure Monitor Model No. BP-100 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: March 11, 2003 Received: March 17, 2003
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, 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
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Page 2 - Ms. Jennifer Reich
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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
DaLatTe
ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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NUMBER (IF KNOWN): 510 (k)
GENTEEL BP-100 Wrist Blood Pressure Monitor DEVICE NAME: genteel technology co., Ltd.
INDICATIONS FOR USE:
The device is noninvasive and provide Systolic, Diastolic blood pressure and pulse rate(heart rate) mesurements by using an inflating cuff which is wrapped around the wrist. All values can be read out in one LCD Panel. The Device is indicated for use by people over 15 age old in home use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation Over-The-Counter OR Prescription Use (Optional Format) (Per 21 CFR 801.109)
510(k) Number K022926