(22 days)
To measure systolic and diastolic blood pressure and pulse rates of adults using wrist cuff and oscillometric method.
Full Auto Wrist Blood Pressure Monitor (Models BP1600, BP1650, BP1700 and BP1750) is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using wrist cuff and oscillometric method of measurement. The user interface panel of the device has power button, memory button and liquid crystal display ("LCD") for displaying systolic pressure, diastolic pressure and pulse rate. The device has memory capacity to store 10, 20, 60 and 90 most recent measurement results (respectively for BP1600, BP1650, BP1700 and BP1750). The device measures blood pressure through the use of an automatic inflating cuff. Pressurization is automatically governed. If the initial inflation pressure (180mmHg) is inadequate for measurement, i.e. Iower that the patient's systolic pressure, the pump will automatically re-pressurize to a preset level (30 mmHg) above the initial level. Symbols in the LCD indicate pressurization status at all times. The cuff automatically deflates with stepwise pressure drop of 5~6 mmHg per 2 pulses during blood pressure measurement.
This 510(k) premarket notification (K071523) by GENEXEL-SEIN, INC. for the Full Auto Wrist Digital Blood Pressure Monitor (Models BP1600, BP1650, BP1700, and BP1750) references substantial equivalence to a predicate device (K012054) rather than providing specific acceptance criteria and a standalone study for the new device. The provided text indicates that the performance of the new device is "Identical" to the predicate device. Therefore, the details about acceptance criteria, specific performance metrics, and the study proving compliance are derived from the overall claim of substantial equivalence and the listed characteristics.
Given the information provided, a direct table of acceptance criteria with reported device performance of the new device in a standalone study is not explicitly present. The submission relies on the established safety and effectiveness of the predicate device.
Here's an analysis based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the "Performance" of the new device is "Identical" to the predicate device (510(k) # K012054). Therefore, the implied acceptance criteria would be those met by the predicate device, and the reported performance is that it matches the predicate. Specific numerical criteria are not provided for the new device in isolation.
| Acceptance Criteria Category | Reported Device Performance (vs. Predicate K012054) |
|---|---|
| Performance (Accuracy of systolic, diastolic pressure, and pulse rate measurement using oscillometric method and wrist cuff) | Identical to predicate device |
| Mechanical safety | Identical to predicate device |
| Biocompatibility | Identical to predicate device |
| Electrical safety | Identical to predicate device |
| Thermal safety | Identical to predicate device |
| Design | Similar to predicate device |
| Human factors | Similar to predicate device |
| Standards Met | Identical to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a new, separate clinical study with a test set conducted for this 510(k) submission (K071523). Instead, it claims substantial equivalence based on the technological characteristics being identical or similar to the predicate device. Details on sample size or data provenance for a test set for the new device are therefore not provided. It's implied that the predicate device would have undergone such testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
As no specific test set study for K071523 is described, there's no information about the number or qualifications of experts used to establish ground truth.
4. Adjudication Method for the Test Set
Since no specific test set study for K071523 is described, there's no information about an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned for this device. Blood pressure monitors typically do not involve multi-reader multi-case studies, as their function is to provide an objective measurement.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
The document does not describe a standalone performance study for the K071523 device. The basis for clearance is substantial equivalence to a predicate device, meaning its performance characteristics are considered to be effectively the same as the predicate, which would have undergone performance validation. The device itself is an automated measurement system, so "algorithm only" performance would be synonymous with its standalone performance.
7. Type of Ground Truth Used
For blood pressure monitoring devices, the "ground truth" for accuracy studies typically involves comparison against a reference standard, such as auscultatory measurement by trained observers using a mercury sphygmomanometer or an invasive arterial line. However, the document does not specify the ground truth method for this submission, instead relying on the predicate device's validation.
8. Sample Size for the Training Set
This submission does not discuss a training set, as it is not a machine learning or AI-based device in the common sense that would require a distinct training and test set with ground truth labeling for its development. It's a medical device with an oscillometric measurement algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device does not describe a machine learning training set in the context typically seen for AI/ML devices.
{0}------------------------------------------------
510(k) Summary As Required by 21 section 807.92 ( c )
| 1- Applicant Name: | GENEXEL-SEIN, INC (FORMERLY SEIN ELECTRONICS) |
|---|---|
| 2- Address: | NamGyeong Building, 111, Yangjae 1-dong, Seocho-gu,Seoul, 137-891, Korea |
| 3- Phone: | (82) 2-575-1141 |
| 4- Fax: | (82) 2-575-1688 |
| 5- Contact Person: | Jea Woo Han |
| 6- Date summary prepared: | May 30, 2007 |
| 7- Official Correspondent: | Mansour Consulting LLC |
| 8- Address: | 845 Aronson Lake Court. Roswell, GA 30075 USA |
| 9- Phone: | 678-908-8180 |
| 10- Fax: | 678-623-3765 |
| 11- Contact Person: | Jay Mansour, President |
| 12- Device Trade or Proprietary Name: | Full Auto Wrist Digital Blood Pressure MonitorBP1600, BP1650, BP1700 AND BP1750 |
| 13- Device Common or usual name: | Digital Blood Pressure Monitor |
| 14- Device Classification Name: | Non Invasive blood pressure measuring system |
| 15- Substantial Equivalency is claimed against the following device: | Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312, manufacturedby Sein Electronics Co., Ltd. (now Genexel-Sein) 510k #K012054 |
16- Description of the Device:
Full Auto Wrist Blood Pressure Monitor (Models BP1600, BP1650, BP1700 and BP1750) is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using wrist cuff and oscillometric method of measurement.
There are no contraindications; the subject device may be employed in the care of normotensive, hypertensive, or hypotensive patents.
The user interface panel of the device has power button, memory button and liquid crystal display ("LCD") for displaying systolic pressure, diastolic pressure and pulse rate. The device has memory capacity to store 10, 20, 60 and 90 most recent measurement results (respectively for BP1600, BP1650, BP1700 and BP1750)
The device measures blood pressure through the use of an automatic inflating cuff. Pressurization is automatically governed. If the initial inflation pressure (180mmHg) is inadequate for measurement, i.e. Iower that the patient's systolic pressure, the pump will automatically re-pressurize to a preset level (30 mmHg) above the initial level. Symbols in the LCD indicate pressurization status at all times. The cuff automatically deflates with stepwise pressure drop of 5~6 mmHg per 2 pulses during blood pressure measurement.
{1}------------------------------------------------
The patient is responsible for applying the cuff, for initiating the measurements sequence by pressuring the "Power" button, and for recording results. The patient cannot alter bleed-down rate.
All system functions are preprogrammed. The user is cautioned in the instruction manual against attempting any programming or other modification.
No special training beyond basic ability to follow instruction is required. Since the products are designed for home use, detailed instructions on avoidance of practices that adversely affect the accuracy of measurements are included in the instruction manual.
17- Intended use of the device: (refer to FDA form attached)
To measure systolic and diastolic pressure and pulse rate of adults using wrist cuff and oscillometric method.
18- Safety and Effectiveness of the device:
This device is safe and effective as the predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
14- Summary comparing technological characteristics with predicate device:
Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is SUBSTANTIALLY EQUIVALENT to the predicate device. Refer to the explanations/details within the main submission.
| FDA file reference number | 510k # K012054 |
|---|---|
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Identical |
| Performance | Identical |
| Sterility | Not Applicable |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Not Applicable |
| Anatomical sites | Identical |
| Human factors | Similar |
| Energy used and/or delivered | Identical |
| Compatibility with environment and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
⑪
page 2 of 3
{2}------------------------------------------------
| Thermal safety | Identical |
|---|---|
| Radiation safety | Not Applicable |
| A LINE AL A LINE AL AND ALL AND AND AND AND AND A | Status and States of Children Comments of Children |
Refer to the submission for more details.
:
12
Page 3 OF 3
{3}------------------------------------------------
Public Health Service
Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, stacked one behind the other, representing the department's focus on people and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 26 2007
GENEXEL-SEIN, INC. c/o Jay Mansour, MSQA, BE, LA, RAC Mansour Consulting, LLC 845 Aronson Lake Court Roswell, Georgia 30075
Re: K071523
Trade/Device Name: Full Auto Wrist Digital Blood Pressure Monitor, Models BP1600, BP1650, BP1700, and BP1750 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 30, 2007 Received: June 4, 2007
Dear Mr. Mansour:
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.
{4}------------------------------------------------
Page 2 - Mr. Jay Mansour
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. Yummuma for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
K071523 510(k) Number (if known):
Device Name: Full Auto Wrist Blood Pressure Monitor, models BP1600, BP1650, BP1700 and BP1750
Indications For Use:
To measure systolic and diastolic blood pressure and pulse rates of adults using wrist cuff and oscillometric method.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Blumima
Page 1 of _
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K071523
§ 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).