(228 days)
Not Found
No
The description mentions "fuzzy logic function," which is a form of computational intelligence but not typically classified as AI/ML in the context of modern machine learning algorithms. There are no mentions of AI, ML, DNN, or training/test sets.
No
The device is indicated for measurement of blood pressure and pulse rate, not for treating any condition.
No
Explanation: While the device measures physiological parameters (blood pressure and pulse rate), its stated purpose is for measurement and monitoring, not for diagnosing a condition or disease. It provides data that a healthcare professional might use for diagnosis, but the device itself does not perform the diagnostic function.
No
The device description explicitly mentions physical components like an arm cuff, user interface panel with switches and LCD, and an automatic inflating cuff, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device measures blood pressure and pulse rate using an arm cuff and the oscillometric method. This is a non-invasive measurement taken directly from the body, not a test performed on a sample in vitro (in glass or outside the body).
Therefore, this device falls under the category of a non-invasive medical device for monitoring physiological parameters.
N/A
Intended Use / Indications for Use
SE-7070 is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using arm cuff and oscillometric method of measurement.
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 individual, in a home care environment, using arm cuff and oscillometric method of measurement
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
SE-7070 is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using arm 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 has a power switch, a mode switch, a memory switch and a liquid crystal display ("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 58 most recent measurement results.
The device measures blood pressure through the use of a automatic inflating cuff. Pressurization is automatically governed. The device has fuzzy logic function that establishes automatically initial inflation pressure according to blood pressures of patients. The cuff automatically deflates during blood pressure measurement.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
The device has fuzzy logic function that establishes automatically initial inflation pressure according to blood pressures of patients.
Input Imaging Modality
Not Found
Anatomical Site
arm
Indicated Patient Age Range
adults
Intended User / Care Setting
individual, in a home care environment
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)
Not Found
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.
510k # K003282
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
MAY - 7 2004
K032927
p1/2
510(k) Summary As Required by 21 section 807.92 ( c )
-
1-Submitter Name: Sein Electronics Co., Ltd
2-Address: Room #506, Youcheon Factopia, #196, Anyang 7-dong, Manan-Gu, Anyang-city, Kyunggi-do, Korea -
3-Phone: (82) 31-467-2188
-
4-Fax: (82) 31-467-2107
5-Contact Person: Won-Ky Kim
- 6-Date summary prepared: September 9", 2003
- 7-Device Trade or Proprietary Name: Full Auto Arm Digital Blood Pressure Monitor, Model SE-7070
- 8-Device Common or usual name: Blood pressure monitor
9-Device Classification Name: Non Invasive blood pressure measuring system
- 10-Substantial Equivalency is claimed against the following device: Full Auto Blood Pressure Monitor, Model SE-7700H, manufactured by Sein Electronics Co., Ltd.
11-Description of the Device:
SE-7070 is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using arm 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 has a power switch, a mode switch, a memory switch and a liquid crystal display ("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 58 most recent measurement results.
The device measures blood pressure through the use of a automatic inflating cuff. Pressurization is automatically governed. The device has fuzzy logic function that establishes automatically initial inflation pressure according to blood pressures of patients. The cuff automatically deflates during blood pressure measurement.
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.
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1
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.
12-Intended use of the device:
SE-7070 is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using arm cuff and oscillometric method of measurement.
13-Safety and Effectiveness of the device:
This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
14-Summary comparing technological characteristics with other 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 SIMILAR to the predicate device.
| FDA file reference number | 510k # K003282 |
|---|---|
| Attachments inside notification submission file | 510k summary print out |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical, except that the end |
| user is the individual at home, | |
| not medical practitioner | |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Similar |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Not Applicable |
| Anatomical sites | Identical |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other devices | Similar |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | Similar |
| Thermal safety | Similar |
| Radiation safety | Similar |
REFER TO MAIN SUBMISSION FOR COMPLETE DETAILS.
2
Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2004
Sein Electronics Co., Ltd. c/o Jay Mansour Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, GA 30022
Re: K032927
Trade Name: Full Auto Arm Digital Blood Pressure Monitor, Model SE-7070 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: April 04, 2004 Received: April 12, 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.
Please be advised that FDA is 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
3
Page 2 - Mr. Jay Mansour
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) 594-4648. 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,
Meftaxmiya
Bram D. Zuckerman Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K032927
Device Name: FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-7070
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 individual, in a home care environment, using arm cuff and oscillometric method of measurement
Prescription Use (Part 21 CFR 801 Subpart D) 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)
Me Jak Mayer
sign-on
Joe Davisson
810(k) Number K032927
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