(306 days)
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.
GENTEEL BP-100 Wrist Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure, and pulse rate(heart of an individual).
Here's a breakdown of the acceptance criteria and study information for the GENTEEL BP-100 Wrist Blood Pressure Monitor, based on the provided text:
Acceptance Criteria and Device Performance
The provided document indicates that the device's performance was evaluated against applicable standards. The general acceptance criteria are implied by conformity to these standards, rather than explicitly stated numerical thresholds in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conforms to EN-1060-3 | "the device conforms to applicable standards included EN-1060-3" |
| Conforms to ANSI/AAMI SP-10 | "the device conforms to applicable standards included ... ANSI/AAMI SP-10" |
| Conforms to IEC 60601-1-2 | "the device conforms to applicable standards included ... and IEC 60601-1-2 requirements" |
| Clinical repeatability | "The comparison study demonstrated that the clinical repeatability of GENTEEL BP-100 Wrist Blood Pressure Monitor is statistically and clinically acceptable." (No specific numerical values for repeatability are provided.) |
Study Information
The document describes a "comparison study" as the primary evidence for validating the performance of the GENTEEL BP-100 Wrist Blood Pressure Monitor.
- Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The study used an "auscultatory method" for comparison. This implies that human observers (likely trained medical professionals such as doctors or nurses) were involved in taking the blood pressure readings manually using a stethoscope and sphygmomanometer, which would serve as the ground truth.
- Number of Experts: Not specified.
- Qualifications: Not specified (e.g., "physicians with X years of experience").
- Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. The nature of the auscultatory method usually involves a single trained observer taking a reading, or potentially multiple observers with their readings averaged or adjudicated. The document does not provide these details.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This study is a direct comparison of the device against a manual (auscultatory) method, not a study of human readers assisted by AI. The device itself is a measurement tool, not an AI diagnostic aid for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The GENTEEL BP-100 Wrist Blood Pressure Monitor is a standalone device that measures blood pressure without human interpretation of its outputs. Its performance was tested by comparing its readings to those obtained via the auscultatory method.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Expert auscultatory readings. The ground truth was established by readings obtained using the "auscultatory method," which is the gold standard for non-invasive blood pressure measurement and relies on a trained human observer.
- The sample size for the training set:
- Not applicable/Not specified. The document does not describe a training set as this is not an AI/machine learning device requiring such. The comparison study is likely a validation study against an established method.
- How the ground truth for the training set was established:
- Not applicable/Not specified, as there is no described training set.
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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 similargeneral design with OMRON HEM-608 Wrist Blood PressureMonitor marketed by Omron Healthcare INC. |
| 5.0 | Device Description: | GENTEEL BP-100 Wrist Blood Pressure Monitor is designedto measure the systolic and diastolic blood pressure, and pulserate(heart of an individual). |
| 6.0 | Intended Use: | GENTEEL BP-100 Wrist Blood Pressure Monitor is intended tomeasure the systolic and diastolic blood pressure, and pulserate(heart rate) by using an inflating cuff which is wrapped aroundthe wrist. The Device is indicated for use by people over 15 age oldin home use. |
| 7.0 | Performance Summary: | In terms of operating specification, Safety & EMC requirements, thedevice conforms to applicable standards included EN-1060-3,ANSI/AAMI SP-10 and IEC 60601-1-2 requirementsA comparison study with device that use auscultatory method wasperformed to validate the performance of the GENTEEL BP-100Wrist Blood Pressure Monitor. The comparison studydemonstrated that the clinical repeatability of GENTEEL BP-100Wrist Blood Pressure Monitor is statistically and clinicallyacceptable. |
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
§ 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).