(18 days)
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.
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 pushes a button. The machine then proceeds to inflate the cuff and 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.
This looks like a 510(k) summary for a medical device called the CSI Model 5K Managed Health System Kiosk, which is an automated noninvasive blood pressure monitor. However, the provided text does not contain a detailed study report with specific acceptance criteria, device performance, sample sizes, or ground truth information in the format requested.
The document discusses that the device has been "subjected to clinical evaluation and bench testing" and "meets the requirements of AAMI/ANSI SP10:2002," along with other IEC standards. AAMI/ANSI SP10:2002 is a standard that outlines requirements for automated sphygmomanometers, including accuracy specifications. Therefore, the acceptance criteria are implicitly those defined by AAMI/ANSI SP10:2002.
Since the detailed study information is missing, I cannot fill in most of the requested table and sections. I will indicate where the information is not provided in the document.
Here's an attempt to answer based only on the provided text, with clear indications of missing information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from AAMI/ANSI SP10:2002) | Reported Device Performance |
|---|---|---|
| Blood Pressure Accuracy | Mean Difference: ≤ ±5 mmHg | Not specified in provided text; device "meets the requirements of AAMI/ANSI SP10:2002" |
| Standard Deviation | ≤ 8 mmHg | Not specified in provided text; device "meets the requirements of AAMI/ANSI SP10:2002" |
| Pulse Rate Accuracy | Not explicitly stated in AAMI/ANSI SP10 for automated devices, but typically within ±5% or 5 bpm. | Not specified in provided text; device "meets the requirements of AAMI/ANSI SP10:2002" |
| IEC 60601-1 (Safety) | Compliance with general safety requirements for medical electrical equipment. | Device "meets the requirements of IEC 60601-1" |
| IEC 60601-2-30 (Safety) | Compliance with particular safety requirements for automated non-invasive sphygmomanometers. | Device "meets the requirements of ... 60601-2-30" |
| IEC 60601-1-2 (EMC) | Compliance with general requirements for safety, electromagnetic compatibility. | Device "meets the requirements of ... 60601-1-2" |
Explanation of AAMI/ANSI SP10:2002 (Implicit Acceptance Criteria):
The AAMI/ANSI SP10:2002 standard for automated sphygmomanometers typically requires the following for blood pressure accuracy validation in clinical studies:
- Mean Difference (Device vs. Reference): The mean difference between the test device readings and reference (auscultatory) readings should be within ±5 mmHg.
- Standard Deviation (Difference): The standard deviation of the differences should be 8 mmHg or less.
- A minimum of 85 subjects is usually recommended for the validation study, balanced across age and blood pressure ranges.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The text only states "CSI Model 5K Managed Health System Kiosk has been subjected to clinical evaluation and bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For blood pressure device validation, the "experts" typically refer to trained observers using a reference auscultatory method (e.g., two trained observers blinded to each other's readings, using a mercury sphygmomanometer or validated equivalent).
4. Adjudication method for the test set
- Adjudication Method: Not specified. For blood pressure device validation, and specifically for ground truth establishment, the method often involves two trained observers taking readings and a third adjudicator if their readings differ significantly. This is typically part of the AAMI/ANSI SP10 validation protocol, but the specifics are not in the provided text.
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
- MRMC Study: No, this is not applicable. The device is an automated blood pressure monitor, not an AI-assisted diagnostic imaging or interpretation system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the entire device (CSI Model 5K Kiosk) operates as a standalone system. Its performance, as implicitly indicated by "meets the requirements of AAMI/ANSI SP10:2002," refers to its automated measurement capability without human intervention for the measurement itself.
7. The type of ground truth used
- Type of Ground Truth: For blood pressure measurement device validation according to standards like AAMI/ANSI SP10, the ground truth is typically established by simultaneous or
sequential auscultatory measurements performed by trained observers using a calibrated reference sphygmomanometer (e.g., mercury sphygmomanometer).
8. The sample size for the training set
- Training Set Sample Size: Not applicable/Not specified. For a purely oscillometric blood pressure device, the "training set" doesn't typically exist in the same way it would for a machine learning model. The device's algorithm is based on physiological principles and calibrated, rather than "trained" on a large dataset in the AI sense. If there was an internal dataset used during algorithm development, it is not mentioned.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable/Not specified, for the reasons mentioned above.
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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
Page 1 of 1
Back to the Indications for Use Page
§ 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).