(15 days)
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 wrist cuff and oscillometric method of measurement.
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.
The provided text is a 510(k) summary for the Sein Electronics Co., Ltd. Full Auto Wrist Digital Blood Pressure Monitor SE-311. This summary focuses on demonstrating substantial equivalence to a predicate device (SE-312) rather than presenting a standalone study with detailed acceptance criteria and performance data from a new clinical trial.
Therefore, much of the requested information regarding a specific study to prove the device meets acceptance criteria, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, or detailed ground truth methodologies, cannot be extracted from the provided text. The submission's primary argument for safety and effectiveness is based on the device being "safe and effective as the predicate device cited above" due to "identical" or "similar" technological characteristics.
Here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria (e.g., specific accuracy ranges for blood pressure measurements) for the SE-311 and then report the SE-311's performance against these criteria. Instead, it claims "Performance: Identical" to the predicate device (SE-312).
Here's a table based on the provided "Summary comparing technological characteristics with predicate device":
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (SE-311) |
|---|---|
| Indicatio ns for use (Identical to SE-312) | Identical |
| Target population (Identical to SE-312) | Identical |
| Design (Similar to SE-312) | Similar |
| Materials (Identical to SE-312) | Identical |
| Performance (Identical to SE-312) | Identical |
| Sterility (Not Applicable for SE-312) | Not Applicable |
| Biocompatibility (Identical to SE-312) | Identical |
| Mechanical safety (Identical to SE-312) | Identical |
| Chemical safety (Not Applicable for SE-312) | Not Applicable |
| Anatomical sites (Identical to SE-312) | Identical |
| Human factors (Similar to SE-312) | Similar |
| Energy used and/or delivered (Identical to SE-312) | Identical |
| Compatibility with environment and other devices (Identical to SE-312) | Identical |
| Where used (Identical to SE-312) | Identical |
| Standards met (Identical to SE-312) | Identical |
| Electrical safety (Identical to SE-312) | Identical |
| Thermal safety (Identical to SE-312) | Identical |
| Radiation safety (Not Applicable for SE-312) | Not Applicable |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not provided. The submission focuses on comparing technological characteristics to a predicate device, not on presenting a new clinical study with a test set of patients.
- Data provenance: Not provided, as there's no mention of a specific clinical study for the SE-311 in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. The submission does not describe a clinical study where experts established ground truth for a test set.
4. Adjudication method for the test set
- Not applicable/Not provided. No test set or adjudication method is described.
5. 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. This device is a digital blood pressure monitor, not an AI-assisted diagnostic tool. An MRMC study is not relevant here, and no such study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device performs measurements automatically using the oscillometric method. Its standalone performance is inherently what is being described as "identical" to the predicate. However, detailed results of such a standalone performance test are not provided in this summary. The user applies the cuff and initiates the measurement, but the measurement itself is automated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated for the SE-311. For blood pressure monitors, ground truth typically involves simultaneous or near-simultaneous measurements using a recognized reference standard (e.g., mercury sphygmomanometer with auscultation by trained observers) following established protocols (e.g., ISO, AAMI standards). Since the performance is claimed to be "Identical," it's implied that the predicate device (SE-312) adhered to such ground truth methods, and the SE-311 is expected to do the same.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/machine learning device that would typically have a "training set" in the context of data-driven model development.
9. How the ground truth for the training set was established
- Not applicable/Not provided, as there is no training set described for an AI/machine learning model.
{0}------------------------------------------------
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.
PAGE 9
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K042138
Page 2 of 2
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.
PAGE 10
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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.
{3}------------------------------------------------
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 (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,
Neil R. Ogden
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):
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 |
Page 1 of 1
PAGE 20
§ 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).