(640 days)
For the measurement of systolic and diastolic blood pressure and pulse rate in adult patients.
The SEIN SE-330 Wrist Blood Pressure Meter is a semi-automatic electronic device designed to measure blood pressure and pulse, and in which a compact wrist cuff is used in place of the standard wrist cuff. Inflation and deflation are accomplished through the use of a manual inflation bulb and solenoid valve respectively. Blood pressure and pulse are measured using the oscillometric method. A liquid crystal display of up to six digits is employed to record blood pressure and pulse. Power is supplied by two lithium batteries (size CR2032). Built-in memory allows the display of the previously measured blood pressure and pulse values for comparison to current measurements. An automatic power cut-off feature after one minute of non-use is built into the device to permit saving of energy. The measuring range of the device is 20-280 mmHg (pressure) and 40-200 pulses per minute with an accuracy of +3mmHg or 2% of the reading, whichever is greater, for the pressure and t5% of the reading for pulse. The dimensions of the SE-330 Blood Pressure Meter are 58 mm (W) and 70 mm (D) x 23.8 mm (H). The weight of the meter is approximately 110 g including two batteries. The wrist cuff dimensions are 314.7 mm (1) x 70 mm (w). Battery life for the device is approximately 150 measurements.
The provided text describes a 510(k) summary for a Digital Wrist Blood Pressure Meter, Model SE-330. It outlines the device's technical specifications and a study conducted for its approval. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ANSI/AAMI SP-10 1992 Guidance) | Reported Device Performance (Model SE-330) |
|---|---|
| Accuracy for Pressure | +3mmHg or 2% of the reading, whichever is greater |
| Accuracy for Pulse | +5% of the reading |
| Equivalency to cuff-stethoscope auscultatory method | Shown to be equivalent |
Note: The document states the device's measuring range is 20-280 mmHg (pressure) and 40-200 pulses per minute. While these are not explicitly termed "acceptance criteria" in the text, they define the operational limits of the device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 108 patients
- Data Provenance: The document states "A clinical trial... conducted on 108 patients," implying the data was collected prospectively for this study. The country of origin for the data is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document refers to the "cuff-stethoscope auscultatory method" as the comparator for determining blood pressure and pulse. This method typically involves trained medical professionals (e.g., doctors, nurses). However, the number of experts used to establish the ground truth for the test set and their specific qualifications (e.g., years of experience) are not specified in the provided text.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the test set. It mentions the "cuff-stethoscope auscultatory method" as the basis for comparison, which usually relies on direct measurement by a human observer. There is no mention of multiple experts or any reconciliation process (like 2+1 or 3+1).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the provided text. The study compares the device's performance against a standard manual method, not the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The study described is a standalone performance test of the device, comparing its measurements to the traditional cuff-stethoscope auscultatory method. The device itself is an "Automatic Digital Wrist Blood Pressure Meter," implying it operates without continuous human-in-the-loop adjustment for each reading, other than initial placement and activation. Therefore, this can be considered a standalone performance study for the device's measurement capabilities.
7. Type of Ground Truth Used
The type of ground truth used is the cuff-stethoscope auscultatory method for determining blood pressure and pulse. This is a clinically accepted, established method for blood pressure measurement, serving as the gold standard for comparison in this context.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. The description pertains to a clinical trial for performance evaluation against a standard, not the development or training of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, this information is not applicable or not provided in the document.
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MAY 20 1995
SEIn ELECTRONICS CO.,LTD. 133 3. PYUNGCHON DONG. ANYANG SHI, KYUNGKI DO, KORFA 11 L . ANYANG (0343) 21-3201, 21 0389 JAX (0343)21 5639
510(k) SUMMARY
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR -807.92."
"The assigned 510(k) number is: _ . "
Applicant: SEIN Electronics Co., Ltd. 133--3, Pyung Chon -- Dong, Dong An-Gu Anyang -- City, Kyungki--Do, Korea Tel: Anyang (0343) 21-3201 FAX: (0343) 21 - 5639
Brenda M. Kelly, M.D. Contact Person: Executive V.P., Medical & Regulatory Affairs The Lahr Consulting Group, Inc. One Lethbridge Plaza, Suite #4 Mahwah, N.J. 07430 Tel: (201) 529-3111 FAX: (201) 529-0059
Date August , 1997
Name of Device:
| Proprietary Name: | Digital Wrist Blood Pressure Meter, Model SE-330 |
|---|---|
| Common or Usual Name: | Digital Wrist Blood Pressure Meter |
| Classification Name: | System, Measurement, Blood Pressure,Non-Invasive, Systolic and/or Diastolic |
The Digital Wrist Blood Pressure Meter, Model SE-330, is equivalent to the OMRON compact wrist blood pressure meter, Model HEM-605.
The SEIN SE-330 Wrist Blood Pressure Meter is a semi-automatic electronic device designed to measure blood pressure and pulse, and in which a compact wrist cuff is used in place of the standard wrist cuff.
Inflation and deflation are accomplished through the use of a manual inflation bulb and solenoid valve respectively.
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510(k) SUMMARY Page Two --
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Blood pressure and pulse are measured using the oscillometric method.
A liquid crystal display of up to six digits is employed to record blood pressure and pulse.
Power is supplied by two lithium batteries (size CR2032)
Built--in memory allows the display of the previously measured blood pressure and pulse values for comparison to current measurements.
An automatic power cut-off feature after one minute of non-use is built into the device to permit savinq of energy.
The measuring range of the device is 20-280 mmHg (pressure) and 40-200 pulses per minute with an accuracy of +3mmHg or 2% of the reading, whichever is greater, for the pressure and t5% of the reading for pulse.
The dimensions of the SE-330 Blood Pressure Meter are 58 mm (W) and 70 mm (D) x 23.8 mm (H). The weight of the meter is approximately 110 g including two batteries.
The wrist cuff dimensions are 314.7 mm (1) x 70 mm (w).
Battery life for the device is approximately 150 measurements.
A clinical trial based on the ANSI/AAMI SP-10 1992 Guidance Document for Electronic or Automatic Sphygmomanometers and conducted on 108 patients shows the SE-330 Wrist Blood Pressure Meter to be equivalent to the cuff-stethoscope auscultatory method for determining blood pressure and pulse.
The SEIN SE-330 and OMRON HEM 605 blood pressure meters are similar in that they employ the oscillometric method of measuring, use batteries as their power source, have liquid crystal display of the measurements, and have similar measuring ranges and accuracy. Both devices employ a compact wrist cuff.
Both devices exhibit automatic cut-off power when the instruments are not in use.
Operating and storage environment requirements also are similar.
Differences between the two devices include the following:
The SE-330 uses 2 Lithium batteries, Type CR2032, whereas the HEM-605 uses 2 Alkaline batteries, Type LR03.
The SE-330 has built-in memory enabling display of the previously measured value as well as current measurements. The HEM-605 does not have this feature.
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510(k) SUMMARY Page Three …
In the SE-330 deflation is controlled by a solenoid valve which keeps velocity constant; the HEM-605 employs a constant release valve system.
Differences between the SE-330 and HEM-605 also include manua1 repressurization in the SE-330 and automatic repressurization in the HEM--605 .
In addition, the weights and dimensions of the two devices are somewhat different.
August 13, 1997
Tae Young Choi, President
, #
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 1999
Brenda M. Kelly, M.D. Executive Vice President, Medical and Regulatory Affairs The LAHR Consulting Group, Inc. One Lethbridge Plaza Mahwah, NJ 07430-2113
Re: K973078 Automatic Digital Wrist Blood Pressure Meter Model SE-330 Requlatory Class: II (Two) Product Code: 74 DPW Dated: March 8, 1999 Received: March 11 1999
Dear Dr. Kelly:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further regulatory action. announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Brenda M. Kelly, M.D.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas Flanagan Carlson
Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K923078
Device Name: Automatic Digital Wrist Blood Pressure Meter - Model SE-330
Indications For Use: For the measurement of systo1ic and diastolic blood
s of the measurements on adult patients. canons For Osc. For the meaborement.
pressure and pulse rate in adult patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bure L. Campbell
Division of Curdlovascular, Respiratory, and Neurological Devices 510(k) Number.
Prescription Use (Per 21 CFR 801.109)
ે જિલ્લાઓ પૈકીના એક એવા ગામનાં એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેત
Over-The-Counter Use_x
(Üpılonal Format 1-2-96)
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).