SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100

K052108 · Sein Electronics Co., Ltd. · NBW · Dec 7, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052108
• Device Name: SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100
• Applicant: Sein Electronics Co., Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 7, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The BGP-100 blood glucose and blood pressure measurement system consists of a meter with wrist cuff and test strips. The system is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (in Vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates. Also the system measures systolic and diastolic blood pressure and pulse rate from adult’s wrist in the home care environment. The device employs a wrist cuff and oscillometric method of measurement.

Device Story

Combined blood glucose meter and oscillometric blood pressure monitor; unit uses test strips for glucose and wrist cuff for BP. Glucose measurement: capillary blood sample applied to strip; electrochemical glucose oxidase reaction; meter measures current; converts to concentration. BP measurement: cuff detects pressure changes; converts to electrical signals; calculates systolic/diastolic pressure and pulse rate. Used in home or clinical settings; operated by patients or healthcare professionals. Results stored in memory for tracking. Output displayed on screen; aids clinical decision-making regarding diabetes and hypertension management.

Clinical Evidence

Two clinical studies performed. Lay-user study (n=110) and professional POC study (n=110) compared BGP-100 to YSI 2300 reference method. Lay-user results showed 95% of results in Clarke Error Grid Zone A and 5% in Zone B. Professional results showed 99.1% in Zone A and 0.9% in Zone B. Additional POC site studies (n=50 per site) showed high correlation (r=0.991-0.995). Analytical performance included precision (CV < 10%), linearity (20-600 mg/dL), and interference testing for endogenous/exogenous compounds.

Technological Characteristics

Integrated device with glucose oxidase-based test strips and oscillometric wrist cuff. Features LCD display, memory storage (150 glucose, 60 pressure readings), and automatic pump control. Powered by internal electronics. No specific material standards or software architecture details provided.

Indications for Use

Indicated for use by persons with diabetes mellitus (home/OTC) or healthcare professionals (clinical settings) to monitor glucose effectiveness. Also indicated for adult blood pressure and pulse rate measurement in home care. Contraindicated for use on neonates.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Clever Chek TD-3213 (k042795)
• One Touch Ultra Blood Glucose monitoring system (k002134)
• Blood pressure Monitor, Model SE-311 (k042138)

Submission Summary (Full Text)

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DEC 7 2005

K052/08

# 510(k) Summary

As Required by 21 section 807.92 ( c )

- Sein Electronics Co., Ltd 1 - Submitter Name: 133-3. Pyungchon-dong, Anyang-city, Kyunggi-do, Korea 2- Address: (82) 31-421-0389 3- Phone: [phone]- Fax: 5- Contact Person: Tae voung Choi August 1, 2005 6- Date summary prepared: Mansour Consulting LLC 7 - Official Correspondent: 1308 Morningside Park Dr. Alpharetta, GA 30022 USA 8- Address: 770-777-4146 9- Phone: [phone]- Fax: Jay Mansour, President 11- Contact Person: 12- Device Trade or Proprietary Name: BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 Blood Glucose Monitor, Blood glucose test strips, quality 13- Device Common or usual name: control material, and Blood Pressure Monitor 14- Device Classification Name: System, test, blood glucose, over the counter Glucose oxidase, glucose Single (specified) analyte controls System, measurement, blood-pressure, non-invasive 15- Substantial Equivalency is claimed against the following device: Blood Pressure Monitor, Model SE-311, manufactured by Sein Electronics Co., Ltd. 510k #K042138 Clever Chek TD-3213, 510k# K042795
One Touch Ultra Blood Glucose monitoring system, 510k #K002134

#### 16- Description of the Device:

BGP-100 Sein Blood Glucose & Pressure Monitor system BGP-100 combines the function of a blood glucose monitoring system and a blood pressure meter in one unit. Supplies with the meter are test strips, lancets, lancing device, storage case and control solution. The blood glucose monitoring system is turned on by strip insertion; Once the user confirms that the numerical code on the display, and strip bottle all match, a test strip is inserted into the meter and glucose testing can proceed. The user then supplies finger-tip blood or control solution to the strip and the meter starts the measurement, which is completed in 5 seconds. Sein Electronics Co., Ltd has provided instructions and illustrations explaining, that the blood drop will be pulled into the strip sample entry by capillary action until meter beeps and the result will be show on liquid crystal display ("LCD") after 5 seconds. Results are automatically stored in the meter's memory for tracking purposes. The capacity of memory is 150 blood glucose values and average value of past 14 days or 30days. Control Solution is sold separately from the kit. BGP-100 adopts the wrist type cuff for blood pressure meter part. The cuff and control unit are combined into a single wrist-mounted assembly. The user interface panel has power switch, mode switch, memory switch, for blood pressure meter part and LCD for displaying the systolic blood pressure, diastolic blood pressure, pulse rate, date and time. This device has the memory function that permits memory and display of the 60 most recent measurement results. User should wrap the pressure cuff around the wrist with the palm facing up and pushes the "Power" button. The cuff will be full with appropriate air pressure automatically. Pressurization is automatically governed. If the initial inflation pressure (180mmHg) is inadequate for measurement, i.e. lower that the patient's systolic pressure, the pump will automatically repressurize to a preset level (30 mmHg) above the initial level. Symbols in the LCD indicate pressurization status at all times. The air of cuff is automatically deflated during blood pressure measurement. 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.

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## 17- Intended use of the device: (refer to FDA form attached)

The BGP-100 blood glucose and blood pressure measurement system consists of a meter with rric DOF Too brood groot of the system is intended for use in the quantitative measurement of whice our and toot othpost the fingertip. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates. Also the system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillometric method of measurement.

#### 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 # K042138 | 510k # K042795 and 002134 |
|--------------------------------------------------------|-------------------|---------------------------|
| TECHNOLOGICAL<br>CHARACTERISTICS | Comparison result | |
| Indications for use | | Identical |
| Target population | | Identical |
| Design | | |
| Materials | | |
| Performance | | |
| Sterility | | |
| Biocompatibility | | |
| Mechanical safety | | |
| Chemical safety | | |
| Anatomical sites | | |
| Human factors | IDENTICAL | SIMILAR |
| Energy used and/or<br>delivered | | |
| Compatibility with<br>environment and other<br>devices | | |
| Where used | | |
| Standards met | | |
| Electrical safety | | |
| Thermal safety | | |
| Radiation safety | | |

Refer to the submission for more details.

Page 14

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

2005 DEC 7

Sein Electronics Co., Ltd. c/o Mr. Jay Mansour, MSQA, BE, LA, RAC President Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, GA 30022

Re: k052108

Trade/Device Name: Blood Glucose and Blood Pressure Monitor System, Model BGP-100 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX, DXN Dated: October 26, 2005 Received: October 31, 2005

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow your to begin inding of substantial equivalence of your device to a legally promative nevice results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 I vision of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Guti

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K052108

Device Name: Blood Glucose and Blood Pressure Monitor System, Model BGP-100

Indications For Use:

The BGP-100 blood glucose and blood pressure measurement system consists of a meter with wrist cuff and test strips. The system is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates.

Also the system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillometric method of measurement.

Prescription Use (Part 21 CFR 801 Subpart D) ANDIOR

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)

Carol C. Benson
Division Sign-Off

office of in vitro Diagnostic Device Evaluation and Safety

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