(18 days)
Not Found
No
The description details a standard kiosk for measuring vital signs using established methods (oscillometric for blood pressure) and does not mention any AI/ML components or capabilities.
No.
The device measures vital signs (blood pressure, pulse, weight) but does not treat, cure, mitigate, or prevent disease. It is explicitly stated that it is not a diagnostic device.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not intended to be a diagnostic device; it only provides data on blood pressure, heart rate and weight and users are advised to consult a physician."
No
The device description explicitly details hardware components such as a cuff mechanism, push buttons, displays, and a weight measurement system, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the CSI Model 5K Managed Health System Kiosk is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states, "It is not intended to be a diagnostic device; it only provides data on blood pressure, heart rate and weight and users are advised to consult a physician." IVD devices are specifically intended for the diagnosis of diseases or other conditions.
- Device Description: The device measures physiological parameters (blood pressure, pulse, weight) directly from the user's body. IVD devices typically analyze samples taken from the body (like blood, urine, tissue).
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples.
Therefore, the CSI Model 5K Managed Health System Kiosk is a medical device that measures vital signs and weight, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CSI Model 5K Managed Health System Kiosk is intended for use by the general public to measure blood pressure, pulse and weight. It is not intended to be a diagnostic device; it only provides data on blood pressure, heart rate and weight and users are advised to consult a physician.
Product codes
DXN
Device Description
The CSI Model 5K Managed Health System Kiosk provides an unsupervised means for measuring and tracking an individual's blood pressure (both systolic and diastolic) and pulse rate. The kiosk can typically be installed in retail establishments and drug stores and may or may not be part of the pharmacy.
The device has push buttons for user interface. Such buttons include "Start" button to start the test after the user has inserted the arm into the cuff mechanism, a "Release" button to deflate the cuff mechanism in the event of an emergency, a "Weight" button to start the process of measuring the weight of the user. The output of the machine includes displays to indicate the blood pressure (systolic and diastolic), heart rate and weight.
To start the process, the user inserts her arm into the cuff and The machine then proceeds to inflate the cuff and pushes a button. measure the blood pressure using oscillometric method. Once measured, the blood pressure (both systolic and diastolic) and the heart rate are output to the display mounted on the front of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
General public / retail establishments and drug stores
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)
The CSI Model 5K Managed Health System Kiosk has been subjected to clinical evaluation and bench testing and meets the requirements of The device also meets the IEC 60601-1 AAMI/ANSI SP10:2002. standard for Medical Electrical Equipment - General requirements for safety and 60601-2-30 standard for Medical Electrical Equipment Part 2 Particular Requirements for Safety and 60601-1-2 General Requirements for Safety, Electromagnetic Compatibility,
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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510(k) Summary
(per 21 CFR 807.92)
I. Applicant NOV 1 7 2009
(093389 $1/2
Computerized Screening, Inc. 9550 Gateway Drive Reno, NV 89521 USA
Contact:
Sam Kumar Vice President of Manufacturing Operations Tel: (775) 359-1191 Fax: (775) 359-7879 Email: skumar@computerizedscreening.com
II. Device Name
Trade Name: CSI Model 5K Managed Health System Kiosk Common Name: Automated noninvasive blood pressure monitor Classification Name: Noninvasive blood pressure measurement system
Classification Number: 870.1130 Product Code: DXN Classification: Class II
III. Predicate Devices
K063137: PharmaSmart, Model PS-1000/PS-1500/PS-2000 K040562: HealthGuard International, Lifeclinic 2400
IV. Intended use of the Device
The CSI Model 5K Managed Health System Kiosk is intended for use by the general public to measure blood pressure, pulse and weight. It is not intended to be a diagnostic device; it only provides data on blood pressure, heart rate and weight and users are advised to consult a physician.
V. Description of the Device
The CSI Model 5K Managed Health System Kiosk provides an unsupervised means for measuring and tracking an individual's blood pressure (both systolic and diastolic) and pulse rate. The kiosk can typically be installed in retail establishments and drug stores and may or may not be part of the pharmacy.
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The device has push buttons for user interface. Such buttons include "Start" button to start the test after the user has inserted the arm into the cuff mechanism, a "Release" button to deflate the cuff mechanism in the event of an emergency, a "Weight" button to start the process of measuring the weight of the user. The output of the machine includes displays to indicate the blood pressure (systolic and diastolic), heart rate and weight.
To start the process, the user inserts her arm into the cuff and The machine then proceeds to inflate the cuff and pushes a button. measure the blood pressure using oscillometric method. Once measured, the blood pressure (both systolic and diastolic) and the heart rate are output to the display mounted on the front of the device.
VI. Technical Characteristics
The CSI Model 5K Managed Health System Kiosk measures systolic and diastolic arterial blood pressure using an inflatable cuff mechanism that is placed around the user's arm. The cuff is then inflated before it is gradually deflated through a series of controlled deflation steps (oscillometric method).
VI. Testing
CSI Model 5K Managed Health System Kiosk has been subjected to clinical evaluation and bench testing and meets the requirements of The device also meets the IEC 60601-1 AAMI/ANSI SP10:2002. standard for Medical Electrical Equipment - General requirements for safety and 60601-2-30 standard for Medical Electrical Equipment Part 2 Particular Requirements for Safety and 60601-1-2 General Requirements for Safety, Electromagnetic Compatibility,
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three intertwined figures forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Computerized Screening, Inc. c/o Mr. Morten Christensen Staff Engineer, Reviewer Underwriters Laboratories, Inc. 455 E. Trimble Road, San Jose, CA 95131
NOV 1 7 2009
Re: K093389
Trade/Device Name: CSI Model 5K Managed Health System Kiosk Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: September 10, 2009 Received: October 30, 2009
Dear Mr. Christensen:
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 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 - Mr. Morten Christensen
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
W. M. P.
Bram D. Zuckerman, M.D. 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: _CSI Model 5K Managed Health System Kiosk
Indications for Use:
The CSI Model 5K Managed Health System Kiosk is intended for use by the general public to measure blood pressure, pulse and weight. It is not intended to be a diagnostic device; it only provides data on blood pressure, heart rate and weight and users are advised to consult a physician.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M.S.A.
Division Sian-Off) Division of Cardiovascular Devices
5.10(k) Number K093282
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