FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311

K042138 · Sein Electronics Co., Ltd. · DXN · Aug 24, 2004 · Cardiovascular

Device Facts

• Record ID: K042138
• Device Name: FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311
• Applicant: Sein Electronics Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 24, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

This device is an over the counter device, and its intended use is to measure systolic and diastolic pressure and pulse rate of adults by the individual, in a home care environment, using wrist cuff and oscillometric method of measurement.

Device Story

Full Auto Wrist Digital Blood Pressure Monitor SE-311; oscillometric measurement via wrist cuff. User-operated in home environment; patient applies cuff and initiates sequence via power button. Device automatically controls bleed-down rate; preprogrammed system functions. Outputs systolic/diastolic pressure and pulse rate to LCD; stores 180 results for four users; data transmission to PC via RS232C. Enables patient self-monitoring of blood pressure; supports clinical decision-making through longitudinal data tracking.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on comparison of technological characteristics and performance specifications to the predicate device.

Technological Characteristics

Oscillometric blood pressure measurement system; wrist cuff; LCD interface; RS232C connectivity for PC data transfer. Preprogrammed system functions; non-invasive. Materials and design are identical to predicate SE-312.

Indications for Use

Indicated for use by adults to measure systolic and diastolic blood pressure and pulse rate in a home care environment using an oscillometric wrist cuff. No contraindications; suitable for normotensive, hypertensive, or hypotensive patients.

Regulatory Classification

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.

Predicate Devices

• Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312 (K012054)

Submission Summary (Full Text)

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AUG 2 4 2004

# 510(k) Summary

As Required by 21 section 807.92 ( c )

- Sein Electronics Co., Ltd 1- Submitter Name: #506, U-chen Factopia, 196 Manan-Gu, Anyang-city, 2- Address:
- Kyungqi-do. Korea
- (82) 31-421-0389 3- Phone:
- (82) 31-422-0821 4- Fax:
- Won-Kv Kim 5- Contact Person:
- 6- Date summary prepared: August 5, 2004
- 7 Official Correspondent: Mansour Consulting LLC
- 1308 Morningside Park Dr. Alpharetta, GA 30022 USA 8- Address:
- 770-777-4146 9- Phone:
- 678-623-3765 10- Fax:
- Jav Mansour, President 11- Contact Person:
- 12- Device Trade or Proprietary Name: Full Auto Wrist Digital Blood Pressure Monitor

SE-311.

- 13- Device Common or usual name: Digital Blood Pressure Monitor
- Non Invasive blood pressure measuring system 14- Device Classification Name:
- 15- Substantial Equivalency is claimed against the following device: Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312, manufactured
- by Sein Electronics Co., Ltd. 510k #K012054

#### 16- Description of the Device:

Full Auto Wrist Digital Blood Pressure Monitor SE-311 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 SE-311 has power button, time button, time button, user button, memory button and liquid crystal display ("LCD") for displaying systolic pressure, diastolic pressure, pulse rate, time, date and user. SE-311 has memory capacity to store the 180 most recent measurement results for four users and the function to transmit the measured data to PC through RS232C cable.

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 aqainst 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.

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K042138
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## 17- Intended use of the device: (refer to FDA form attached)

This device is an over the counter device, and its intended use is to measure systolic and l his device is an over the counter abouts by the individual, in a home care environment, using wrist cuff and 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 companson (Paragraph 14 below)

# 14- Summary comparing technological characteristics with predicate device:

Please find below a tabulated comparison supporting that this device is substantially equivalent Please in a beiow a labulated compansori support. Also, Equivalency overview chart path is to other medical devices in commercial disclibed. Association Associate 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 |
| Thermal safety | Identical |
| Radiation safety | Not Applicable |

Refer to the submission for more details.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### AUG 2 4 2004

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

Re: K042138

Trade Name: Full Auto Wrist Digital Blood Pressure Monitor SE-311 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: August 05, 2004 Received: August 09, 2004

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.

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Page 2 - Jay Mansour, MSQA, BE, LA, RAC

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 [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 Division 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/dsma/dsmamain.html

Sincerely yours,

Neil R. Ogden

Bram D. Zuckerman. 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: Full Auto Wrist Digital Blood Pressure Monitor SE-311

Indications For Use:

This device is an over the counter device, and is indicated for use to measure systolic and diastolic pressure and pulse rate of adults by the indivated for use to headler and using arm cuff and oscillometric method of measurement.

Prescription Use (Part 21 CFR 801 Subpart D)

1 - 1 - 1 - 1 - 1 -

(k) Number_

AND/OR

Over-The-Counter Use (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) | |
|--------------------------------------------------------|--|
|--------------------------------------------------------|--|

| sion Sign-Off) | sion of Cardiovascular Devices | |
|----------------|--------------------------------|--|
| (k) Number | K042138 | |

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