(62 days)
Not Found
No
The document describes standard signal processing and calculation of indices from arterial waveforms, with no mention of AI or ML techniques.
No.
The device is used for assessing cardiac health and measuring blood pressure parameters and indices; it does not provide therapy or treatment.
Yes
The device provides data to qualified medical personnel for the purpose of assessing the patient's cardiac health via blood pressure waveforms, measures systolic and diastolic blood pressure, pulse rate, central aortic pressure (CAP), radial augmentation index (rAl), and other indices, all of which are used to aid in the diagnosis or detection of a disease or condition.
No
The device description explicitly states that the system consists of three main elements: A-Pulse PC Software, the BPro® wrist-mounted tonometric monitor, and the BPCalibrator MC3000 oscillometric blood pressure monitor. The BPro and BPCalibrator are hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This device measures physiological signals (blood pressure waveforms) directly from the patient's radial artery using a non-invasive method (tonometry). It does not analyze blood, urine, tissue, or any other sample removed from the body.
- The intended use and device description focus on measuring and analyzing physiological signals. The system acquires and displays arterial blood pressure waveforms and derives indices from these waveforms. This is a direct measurement of a physiological process, not an analysis of a biological sample.
Therefore, the A-Pulse™ Arterial Pulse Waveform Analysis System falls under the category of a non-invasive physiological monitoring and analysis device, not an IVD.
N/A
Intended Use / Indications for Use
The A-Pulse™ Arterial Pulse Waveform Analysis System consists of A-Pulse PC Software, the BPro® Blood Pressure monitor, and the BPCalibrator Oscillometric monitor.
A-Pulse PC software is used in conjunction with the HealthSTATS BPro Blood Pressure monitor to provide data to qualified medical personnel for the purpose of assessing the patient's cardiac health via blood pressure waveforms measured at the radial artery.
Before each measurement session, the BPro wrist-mounted tonometric device is calibrated using the BPCalibrator oscillometric monitor. Once calibrated, A-Pulse PC Software is capable of acquiring and displaying arterial blood pressure waveforms from the BPro wrist device.
A-Pulse PC software is intended to measure systolic and diastolic blood pressure and pulse rate, and to utilize the radial pulse waveform to derive central aortic pressure (CAP), radial augmentation index (rAl), and a range of other indices.
A-Pulse PC Software is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse.
Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician or other licensed practitioner.
Product codes (comma separated list FDA assigned to the subject device)
74 DXN, 21 CFR § 870.1130
Device Description
HealthSTATS BPro® is a noninvasive arterial waveform analysis system system based on arterial tonometry at the radial artery of the wrist. The system consists of three main elements:
- A-Pulse PC Software for radial arterial pulse waveform analysis, a PC-. based computer program [new device].
- BPro® wrist-mounted tonometric monitor [listed device K060315]. .
- BPCalibrator MC3000 oscillometric blood pressure monitor [listed . device, K051546] for calibration of the BPro monitor ..
Once calibrated using the BPCalibrator oscillometric device, A-Pulse PC Software is capable of acquiring and displaying arterial blood pressure waveforms from the BPro wrist device.
The A-Pulse™ Arterial Pulse Waveform Analysis System measures and records radial arterial waveforms and derives two indices which are also reported by the combination of referenced predicate devices:
- Radial Augmentation Index (rAI) .
- . Central Aortic Pressure (CAP*).
The BPro monitor is applied to the wrist with a pressure transducer placed over the radial artery. The monitor has a size and weight similar to a sports type wrist watch. An embedded microcontroller supervises the actions of the monitor including scheduled measurements, on-demand measurements, and serial data communication with the host PC.
The A-Pulse PC Software measures arterial waveforms in real time, calculates blood pressure parameters and indices on selected waveforms. and stores and prints reports.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radial artery of the wrist
Indicated Patient Age Range
eighteen (18) years and older
Intended User / Care Setting
qualified medical personnel
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)
Non-Clinical Tests Submitted:
The BPro monitor devices meet applicable standards for medical device electrical safety, electromagnetic compatibility, shock and vibration, and environment (temperature and humidity).
Materials utilized in skin contact surfaces were reviewed for conformance with biocompatibility requirements. The materials met the requirements.
The A-Pulse PC software was verified to requirements and validated to meet intended use. System level risk and failure mode analysis was performed and residual risks were determined to be acceptable.
Clinical Tests Submitted:
The A-Pulse Arterial Pulse Waveform Analysis System was clinically tested in comparison with the listed devices for the derivation of the indices. Test results confirm reliable indices that are consistent with the predicate device measurements within the stated accuracy claims.
Conclusions from Tests:
As described in (b)(1) and (b)(2) above, the testing demonstrates that the A-Pulse Arterial Pulse Waveform Analysis System is as safe and effective as, and functions in a manner equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K060315 HealthSTATS BPro® Ambulatory Blood Pressure Monitoring System, K012487 SphygmoCor Pulse Waveform Analysis System, K050233 Omron HEM 9000Al Non-invasive Blood Pressure Monitor with Augmentation Index
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92
| (a) | (1) | Submitted by: | HealthSTATS International Pte. Ltd.
6 New Industrial Road #04-01/02
Hoe Huat Industrial Building
Singapore 536199
NOV 1 5 2007 |
|-----|-----|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | Phone: +65-6858 3248
Fax: +65-6858 0148
E-mail: cmting@healthstats.com.sg |
| | | Contact Person: | Dr. Ting Choon Meng, M.D. |
| | | Position/Title: | CEO |
| | | Date of Preparation: | September 13, 2007 |
| | | Trade Name: | HealthSTATS A-Pulse™ Arterial Pulse
Waveform Analysis System |
| | | Common/Classification Name: | System, Measurement, Blood-pressure,
Non-invasive |
| | | Product Code: | 74 DXN, 21 CFR § 870.1130 |
| | | Class: | Class II |
| | (3) | Predicate Device(s): | |
- K060315 HealthSTATS BPro® Ambulatory Blood Pressure Monitoring System, HealthSTATS International Pte Ltd K012487 SphygmoCor Pulse Waveform Analysis System, AtCor Medical Ptv Ltd K050233 Omron HEM 9000Al Non-invasive Blood Pressure Monitor with Augmentation Index, Omron Healthcare Inc.
Reason for Submission: New Device
(4) Description of Device:
HealthSTATS BPro® is a noninvasive arterial waveform analysis system system based on arterial tonometry at the radial artery of the wrist. The system consists of three main elements:
- A-Pulse PC Software for radial arterial pulse waveform analysis, a PC-. based computer program [new device].
1
- BPro® wrist-mounted tonometric monitor [listed device K060315]. .
- BPCalibrator MC3000 oscillometric blood pressure monitor [listed . device, K051546] for calibration of the BPro monitor ..
Once calibrated using the BPCalibrator oscillometric device, A-Pulse PC Software is capable of acquiring and displaying arterial blood pressure waveforms from the BPro wrist device.
Intended use: (5)
Blood pressure is measured in millimeters of mercury (mmHg) and is represented by two values: systolic pressure and diastolic pressure. The systolic pressure represents the pressure in the blood vessels when the heart contracts (pumps), while the diastolic pressure is the pressure when the heart relaxes and blood fills the heart. The two pressures are clinically useful, however they do not fully describe the dynamics of the heart's pumping.
Arterial pulse waveform analysis can provide additional information on the condition of the heart and the arterial tree. The shape of the arterial pulse waveform can be interpreted to assist with diagnosis of specific cardiovascular conditions.
Indications for Use:
The A-Pulse™ Arterial Pulse Waveform Analysis System consists of A-Pulse PC Software, the BPro® Blood Pressure monitor, and the BPCalibrator Oscillometric monitor.
A-Pulse PC software is used in conjunction with the HealthSTATS BPro Blood Pressure monitor to provide data to qualified medical personnel for the purpose of assessing the patient's cardiac health via blood pressure waveforms measured at the radial artery.
Before each measurement session, the BPro wrist-mounted tonometric device is calibrated using the BPCalibrator oscillometric monitor. Once calibrated, A-Pulse PC Software is capable of acquiring and displaying arterial blood pressure waveforms from the BPro wrist device.
A-Pulse PC software is intended to measure systolic and diastolic blood pressure and pulse rate, and to utilize the radial pulse waveform to derive central aortic pressure (CAP), radial augmentation index (rAl), and a range of other indices.
A-Pulse PC Software is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse.
2
Page 3 of 3
Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician or other licensed practitioner.
(6) Technological Characteristics:
The A-Pulse™ Arterial Pulse Waveform Analysis System measures and records radial arterial waveforms and derives two indices which are also reported by the combination of referenced predicate devices:
- Radial Augmentation Index (rAI) .
- . Central Aortic Pressure (CAP*).
The BPro monitor is applied to the wrist with a pressure transducer placed over the radial artery. The monitor has a size and weight similar to a sports type wrist watch. An embedded microcontroller supervises the actions of the monitor including scheduled measurements, on-demand measurements, and serial data communication with the host PC.
The A-Pulse PC Software measures arterial waveforms in real time, calculates blood pressure parameters and indices on selected waveforms. and stores and prints reports.
(b) (1) Non-Clinical Tests Submitted:
The BPro monitor devices meet applicable standards for medical device electrical safety, electromagnetic compatibility, shock and vibration, and environment (temperature and humidity).
Materials utilized in skin contact surfaces were reviewed for conformance with biocompatibility requirements. The materials met the requirements.
The A-Pulse PC software was verified to requirements and validated to meet intended use. System level risk and failure mode analysis was performed and residual risks were determined to be acceptable.
(2) Clinical Tests Submitted:
The A-Pulse Arterial Pulse Waveform Analysis System was clinically tested in comparison with the listed devices for the derivation of the indices. Test results confirm reliable indices that are consistent with the predicate device measurements within the stated accuracy claims.
(3) Conclusions from Tests:
As described in (b)(1) and (b)(2) above, the testing demonstrates that the A-Pulse Arterial Pulse Waveform Analysis System is as safe and effective as, and functions in a manner equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 5 2007
HealthSTATS International PTE, LTD c/o Mr. Stephen Gorski Imagenix Inc. S65 W35739 Piper Road Eagle, WI 53119
Re: K072593
A-Pulse Arterial Waveform Analysis System. A-Pulse System 7000. and A-Pulse Arterial Pulse PC Software, A-Pulse 7000 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: June 5, 2007 Received: September 14, 2007
Dear Mr. Gorski:
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.
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Page 2 - Mr. Stephen Gorski
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
D. Zimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K072593
HealthSTATS A-Pulse™ Arterial Pulse Waveform Analysis System Device Name:
Indications for use:
The A-Pulse™ Arterial Pulse Waveform Analysis System consists of A-Pulse PC Software, the BPro® Blood Pressure monitor, and the BPCalibrator Oscillometric monitor.
A-Pulse PC software is used in conjunction with the HealthSTATS BPro Blood Pressure monitor to provide data to qualified medical personnel for the purpose of assessing the patient's cardiac health via blood pressure waveforms measured at the radial artery.
Before each measurement session, the BPro wrist-mounted tonometric device is calibrated using the BPCalibrator oscillometric monitor. Once calibrated, A-Pulse PC Software is capable of acquiring and displaying arterial blood pressure waveforms from the BPro wrist device.
A-Pulse PC software is intended to measure systolic blood pressure and pulse rate, and to utilize the radial pulse waveform to derive central aortic pressure (CAP), radial augmentation index (rAl), and a range of other indices.
A-Pulse PC Software is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse.
Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician or other licensed practitioner.
Prescription Use × (Part 21 CFR 801 Subpart D) 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)
Bhimsimon
Division of Cardiovascular Dev 510(k) Number
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