(207 days)
The Citizen CH-601A and CH-601B digital wrist sphygmomanometers are intended to be used for the oscillometric measurement of systolic blood pressure and pulse. They are intended to be sold over-the-counter.
The Citizen Ch-601A and CH-601B digital wrist sphygmomanometers are small handheld noninvasive blood pressure measurement systems that measure systolic and diastolic blood pressure and pulse from the user's left wrist. The units are contained in a hard plastic housing that contains a user interface panel and an adjustable wrist cuff. The user interface panel has a power switch, a start switch, and a liquid crystal display ("LCD") for displaying the systolic and diastolic blood pressure and pulse. The device measures blood pressure through the use of an automatically-inflating wrist cuff. The cuff automatically deflates during blood pressure measurement. The only difference between the CH-601A and the CH-601B is that the CH-601B has a memory function which displays the last blood pressure readout (but not the last pulse) when the system is turned on.
Here's an analysis of the provided text to extract the acceptance criteria and details of the study proving the device's performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (Citizen CH-601A/B) |
|---|---|---|
| Blood Pressure Range | 0 to 280 mm Hg | 0 to 280 mm Hg |
| Blood Pressure Accuracy | Greater of ± 3 mm Hg or ± 2% of reading | Greater of ± 3 mm Hg or ± 2% of the reading |
| Pulse Measurement Range | 40 to 200 pulses/minute | 40 to 200 pulses/minute |
| Pulse Measurement Accuracy | ± 5% of the measured pulse frequency | ± 5% of the measured pulse frequency |
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "Citizen submitted laboratory testing data to establish the accuracy of its Sphygmomanometers for comparison to the Omron predicate device." However, it does not specify the sample size used for this test set nor the provenance (e.g., country of origin, retrospective/prospective nature) of the data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not provide information regarding the number of experts used to establish ground truth or their qualifications. Blood pressure measurements are typically compared against a standard reference method (e.g., auscultatory method with a trained observer), but this detail is absent.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not mentioned. The document focuses on the device's standalone accuracy compared to a predicate device.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The document states, "Citizen submitted laboratory testing data to establish the accuracy of its Sphygmomanometers for comparison to the Omron predicate device." This indicates that the device's performance (accuracy for blood pressure and pulse) was directly measured and compared against the stated accuracy of the predicate device (Omron HEM-605).
7. Type of Ground Truth Used:
The document implies the ground truth for blood pressure and pulse accuracy was established through laboratory testing, likely by comparing the device's readings against a validated reference method (though the specific method is not detailed). It's not explicitly stated as expert consensus, pathology, or outcomes data. Given the nature of blood pressure measurement devices, the ground truth would typically be derived from a validated method of direct physiological measurement.
8. Sample Size for the Training Set:
The document does not provide any information about a training set or its sample size. This type of device (oscillometric sphygmomanometer) typically relies on established algorithms for signal processing and does not usually involve a "training set" in the machine learning sense for its core function.
9. How Ground Truth for the Training Set Was Established:
As no training set is mentioned for this device, information on how its ground truth was established is not applicable and therefore not provided in the document.
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510(k) SUMMARY
Citizen Watch Company, Ltd MAR | 3 |998 CH-601A and CH-601B Digital Wrist Sphygmomanometers
Submitter's Name, Address, Telephone Number, Contact Person and Date PREPARED
Citizen Watch Company, Ltd. Medical Device Section, NP Development Department 1-12, 6-Chome, Hon-cho Tanashi-shi, Tokyo, 188 Japan
| Contact Person: | Joseph D. Edmondson, Jr., Esq. |
|---|---|
| Yoichuro Yamaguchi, Esq. | |
| Phone: | (202) 672-5300 |
| Fax: | (202) 672-5399 |
Date Prepared:
August 15, 1997
NAME OF DEVICE
| Trade Name: | CH-601A and CH-601B Digital Wrist Sphygmomanometers |
|---|---|
| Common Name: | Wrist Sphygmomanometer (blood pressure meter) |
| Classification Name: | Noninvasive blood pressure measuring system, per 21C.F.R. § 870.1130 |
PREDICATE DEVICES
Omron HEM-605 Digital Wrist Sphygmomanometer (1)
INTENDED USE
The Citizen CH-601A and CH-601B digital wrist sphygmomanometers are intended to be used for the oscillometric measurement of systolic blood pressure and pulse. They are intended to be sold over-the-counter.
DEVICE DESCRIPTION
The Citizen Ch-601A and CH-601B digital wrist sphygmomanometers are small handheld noninvasive blood pressure measurement systems that measure systolic and diastolic blood pressure and pulse from the user's left wrist. The units are contained in a hard plastic housing that contains a user interface panel and an adjustable wrist cuff. The user interface panel has a power switch, a start switch, and a liquid crystal display ("LCD") for displaying the systolic and diastolic blood pressure and pulse.
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The device measures blood pressure through the use of an automatically-inflating wrist cuff. The cuff automatically deflates during blood pressure measurement. The only difference between the CH-601A and the CH-601B is that the CH-601B has a memory function which displays the last blood pressure readout (but not the last pulse) when the system is turned on.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Both the Citizen Sphygmomanometers and the Omron predicate device measure the diastolic and systolic blood pressure from the left wrist using oscillometric methods. Both systems are microcomputer controlled, digital, auto-inflate, wrist sphygmomanometers. The Omron predicate device does not have any more memory function.
Like the Omron predicate, the Citizen sphygmomanometers display systolic and diastolic pressure ranges from 0 and 280 mm Hg. Both devices have a blood pressure measurement accuracy of the greater of + 3mm Hg or + 2% of the reading. The pulse measurement range of the Citizen devices and the Omron predicate are also the same, from 40 to 200 pulses/minute. The accuracy of the pulse measurements for both the Citizen devices and the Omron predicate are also the same, from 40 to 200 pulses/minute. The accuracy of the pulse measurements for both the Citizen sphygmomanometers and the Omron predicate device are ± 5% of the measured pulse frequency. Citizen submitted laboratory testing data to establish the accuracy of its Sphygmomanometers for comparison to the Omron predicate device.
Both the Citizen and the Omron devices utilize an auto-inflate wrist cuff system for blood pressure measurement. The Citizen and Omron devices are designed to measure blood pressure and pulse from the left wrist. The wrist cuff for both systems is designed to accommodate wrists with a circumference of between 135 mm and 195 mm. The wrist cuff on the Citizen device and the predicate device are both adjusted by velcro. Inflation of the wrist cuff for the Citizen devices and the Omron predicate are accomplished with an electric pump and pressure is released during deflation by an automatic air-release valve.
The Citizen devices, like the Omron predicate, have a "POWER" switch, a "START" switch, and an LCD display. The operating environment for the Citizen sphygmomanometers and the Omron predicate are also the same: 50°F and 104°F and 30% to 85% relative humidity. Although the Citizen devices use two "LR03" size batteries, the Omron predicate device uses 2 "AAA" batteries. Any minor differences in the appearance, technology, or manufacture of the Citizen devices and the predicate device do not raise any new questions of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Citizen Watch Co., Ltd. c/o Mr. Joseph D. Edmondson, Jr. Foley & Lardner 3000 K Street, N.W. Suite 500 Washington, DC 20007
MAR 13 1998
Re : K973061 CH-601A and CH-601B Digital Wrist Sphygmomanometer Regulatory Class: II (Two) Product Code: DXN Dated: December 12, 1997 December 15, 1997 Received:
Dear Mr. Edmondson:
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 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 - Mr. Joseph D. Edmondson, Jr.
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 requlation (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" (21 CFR 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/dsmamain.html."
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
The Citizen CH-601A and CH-601B digital wrist sphygmomanometers are intended to be used for oscillometric measurement of systolic and diastolice blood pressure and pulse and are intended to be sold over-the-counter.
J. Gere & Komperly
(Division Sign-Division of Cardiovas and Neurological De 510(k) Num
§ 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).