(57 days)
No
The summary describes a device that uses established oscillometric and tonometry methods with a "Software algorithm" to derive CASP. There is no mention of AI, ML, or related concepts like training data or performance metrics typically associated with AI/ML models. The technology is based on existing predicate devices using similar principles.
No.
The device is intended to measure blood pressure and pulse rate to aid in diagnosis and treatment, not to provide therapy itself.
Yes
The device measures blood pressure and pulse rate and derives Central Aortic Systolic Pressure (CASP) and other waveform indices. These readings are "intended for use by qualified healthcare personnel as an aid to diagnosis and treatment," explicitly indicating a diagnostic purpose.
No
The device description explicitly states that the A-PULSE CASPro/CASPal Monitors are comprised of four main elements, including integrated hardware components like an oscillometric blood pressure module and a wrist sensor module, in addition to the software algorithm.
Based on the provided text, the A-PULSE CASPro/CASPal Monitors are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- A-PULSE CASPro/CASPal Function: The A-PULSE CASPro/CASPal Monitors measure blood pressure and pulse rate directly from the patient's body using non-invasive methods (cuff on the arm and tonometer on the wrist). They do not involve the collection or analysis of specimens taken from the body.
The device is a non-invasive physiological monitoring device.
N/A
Intended Use / Indications for Use
The A-PULSE CASPro/CASPal Monitors are intended to measure systolic and diastolic blood pressure and pulse rate, and to utilize the radial pulse waveform to derive central aortic systolic pressure (CASP) and other waveform indices.
Hypertension assessment is one of the primary factors in the evaluation of cardiovascular disease. Assessment of CASP may improve the stratification and management of patients with elevated cardiovascular risk.
Indications for Use:
The A-PULSE CASPro/CASPal Monitors are compact standalone monitors that combine two methods of blood pressure measurement:
- Conventional oscillometric blood pressure via a brachial cuff on the upper arm, and
- Radial arterial pulse acquisition via a wrist-mounted tonometer sensor.
The A-PULSE CASPro/CASPal Monitors first measure systolic and diastolic blood pressure and pulse rate via the oscillometric method, and then acquire the radial arterial pulse waveform to derive the Central Aortic Systolic Pressure (CASP) non-invasively.
The A-PULSE CASPro monitor has a graphical display that displays the arterial pulse waveform as well as a range of other pulse indices. The A-PULSE CASPal monitor has a numeric display. Both models have a nonvolatile memory to store and recall measurements.
Brachial Blood pressure, CASP and pulse rate readings obtained using the A-PULSE CASPro/CASPal Monitors are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.
Product codes (comma separated list FDA assigned to the subject device)
74 DXN, DXN
Device Description
HealthSTATS A-PULSE CASPro/CASPal Monitors are standalone noninvasive blood pressure monitors which are designed to measure (1) conventional oscillometric blood pressure with a brachial cuff and (2) Central Aortic Systolic Pressure (CASP) and other indices based on arterial tonometry at the radial artery of the wrist.
The CASPro/CASPal Monitors are comprised of four main elements:
- Integrated oscillometric blood pressure module for calibration . (identical to the BPCalibrator [listed device K041546]).
- . Wrist sensor module based on the technology of the BPro® monitor device [listed device K060315].
- Software algorithm for radial arterial blood pressure measurement . and calculation of CASP based on the A-PULSE PC Software [listed device K072593].
- A-PULSE CASPro®, A-PULSE CASPal® main processing unit. .
Two functionally equivalent monitors are offered in this 510(k), the A-PULSE CASPro Monitor and the A-PULSE CASPal Monitor:
- . The CASPro Monitor device is equipped with a full featured color TFT LCD panel to display blood pressure readings and radial arterial pulse waveforms. The device also has a real time calendar clock for time-stamped stored readings.
- The A-PULSE CASPal Monitor device is equipped with a simplified . monochrome LCD panel to provide numeric blood pressure readings and a pulse bar to display radial arterial pulsations.
The operation sequence of both A-PULSE CASPro and CASPal Monitors is the same and both devices use identical hardware and software alqorithms to measure and report conventional systolic and diastolic blood pressure readings (BP), Central Aortic Systolic Pressure (CASP), and pulse rate (PR).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brachial, Wrist (radial artery)
Indicated Patient Age Range
eighteen (18) years and older
Intended User / Care Setting
qualified healthcare 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)
The A-PULSE CASPro/CASPal Monitors were clinically tested in comparison with listed devices for the measurement of central aortic systolic pressure (CASP). Test results demonstrate CASP measurements that are consistent with the predicate devices within the stated accuracy claims.
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.
K072593, K060315, K051546, K012487
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).
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JUN - 8 2010
/0/002
Page 1 of 4
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 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------|
| | Phone: +65-6858 3248
Fax: +65-6858 0148 |
| | E-mail: cmting@healthstats.com.sg |
| Contact Person: | Dr. Choon Meng TING |
| Position/Title: | Chairman/CEO |
| Date of Preparation: | August 1, 2009 |
| Trade Name: | HealthSTATS A-PULSE CASPro/CASPal
Monitors |
| Common/Classification Name: | System, Measurement, Blood-pressure,
Non-invasive |
| Product Code: | 74 DXN, 21 CFR § 870.1130 |
| Class: | Class II |
(3) Predicate Device(s):
| K072593 | HealthSTATS A-Pulse® Arterial Pulse Waveform Analysis
System, HealthSTATS International Pte Ltd |
|---------|-----------------------------------------------------------------------------------------------------|
| K060315 | HealthSTATS BPro® Ambulatory Blood Pressure Monitoring
System, HealthSTATS International Pte Ltd |
| K051546 | HealthSTATS BPCalibrator MC300/MC3100 Blood Pressure
Monitor, HealthSTATS International Pte Ltd |
| K012487 | SphygmoCor Pulse Waveform Analysis System, AtCor
Medical Pty Ltd |
| Reason for Submission: | New Device |
|---|---|
| ------------------------ | ------------ |
(4) Description of Device:HealthSTATS A-PULSE CASPro/CASPal Monitors are standalone noninvasive blood pressure monitors which are designed to measure (1) conventional oscillometric blood pressure with a brachial cuff and (2)
1
Central Aortic Systolic Pressure (CASP) and other indices based on arterial tonometry at the radial artery of the wrist.
The CASPro/CASPal Monitors are comprised of four main elements:
- Integrated oscillometric blood pressure module for calibration . (identical to the BPCalibrator [listed device K041546]).
- . Wrist sensor module based on the technology of the BPro® monitor device [listed device K060315].
- Software algorithm for radial arterial blood pressure measurement . and calculation of CASP based on the A-PULSE PC Software [listed device K072593].
- A-PULSE CASPro®, A-PULSE CASPal® main processing unit. .
- (5) Intended use:
The A-PULSE CASPro/CASPal Monitors are intended to measure systolic and diastolic blood pressure and pulse rate, and to utilize the radial pulse waveform to derive central aortic systolic pressure (CASP) and other waveform indices.
Cardiovascular disease remains among the leading causes of death worldwide. Hypertension assessment is one of the primary factors in the evaluation of cardiovascular disease. Assessment of CASP may improve the stratification and management of patients with elevated cardiovascular risk.
Indications for Use:
The A-PULSE CASPro/CASPal Monitors are compact standalone monitors that combine two methods of blood pressure measurement:
- . Conventional oscillometric blood pressure via a brachial cuff on the upper arm, and
- Radial arterial pulse acquisition via a wrist-mounted tonometer . sensor.
The A-PULSE CASPro/CASPal Monitors first measure systolic and diastolic blood pressure and pulse rate via the oscillometric method, and then acquire the radial arterial pulse waveform to derive the Central Aortic Systolic Pressure (CASP) non-invasively.
The A-PULSE CASPro monitor has a graphical display that displays the arterial pulse waveform as well as a range of other pulse indices. The A-PULSE CASPal monitor has a numeric display. Both models have a nonvolatile memory to store and recall measurements.
2
Page 3 of 4
Brachial Blood pressure, CASP and pulse rate readings obtained using the A-PULSE CASPro/CASPal Monitors are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.
The A-PULSE CASPro/CASPal Monitors are 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.
(6) Technological Characteristics: .
Two functionally equivalent monitors are offered in this 510(k), the A-PULSE CASPro Monitor and the A-PULSE CASPal Monitor:
- . The CASPro Monitor device is equipped with a full featured color TFT LCD panel to display blood pressure readings and radial arterial pulse waveforms. The device also has a real time calendar clock for time-stamped stored readings.
- The A-PULSE CASPal Monitor device is equipped with a simplified . monochrome LCD panel to provide numeric blood pressure readings and a pulse bar to display radial arterial pulsations.
The operation sequence of both A-PULSE CASPro and CASPal Monitors is the same and both devices use identical hardware and software alqorithms to measure and report conventional systolic and diastolic blood pressure readings (BP), Central Aortic Systolic Pressure (CASP), and pulse rate (PR).
(b) (1) Non-Clinical Tests Submitted:
The A-PULSE CASPro/CASPal Monitor has been tested to meet applicable standards for medical device electrical safety, electromagnetic compatibility, shock and vibration, and environment (temperature and humidity), as well as specific compliance requirements for blood pressure monitors.
Materials utilized in skin contact surfaces were reviewed for conformance with biocompatibility requirements. The materials met the requirements.
The embedded software of the A-PULSE CASPro/CASPal Monitors has been verified to requirements and validated to meet intended use. System level risk, hazard, and failure mode analysis has been performed and residual risks were determined to be acceptable.
3
(2) Clinical Tests Submitted:
The A-PULSE CASPro/CASPal Monitors were clinically tested in comparison with listed devices for the measurement of central aortic systolic pressure (CASP). Test results demonstrate CASP measurements that are consistent with the predicate devices 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 CASPro/CASPal Monitors are as safe and effective as, and function in a manner equivalent to the predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, depicted in a minimalist, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JUN - 8 2010
HealthSTATS International Pte., Ltd., c/o Mr. Stephen Gorski Imagenix. Inc. S65 W35739 Piper Road Eagle, WI 53119
Re: K101002
Trade/Device Name: A-PULSE CASPro® and A-PULSE CASPal® Monitors Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: March 5, 2010 Received: April 12, 2010
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 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.
5
Page 2 - Mr. Stephan 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); 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/CDRH0ffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
| 510(k) Number (if known): | K 10/0022 |
|---|---|
| --------------------------- | ----------- |
Device Name: HealthSTATS A-PULSE CASPro/CASPal Monitors
Indications for use:
The A-PULSE CASPro/CASPal Monitors are compact standalone monitors that combine two methods of blood pressure measurement:
- Conventional oscillometric blood pressure via a brachial cuff on the upper arm, and ●
- Radial arterial pulse acquisition via a wrist-mounted tonometer sensor. .
The A-PULSE CASPro/CASPal Monitors first measure systolic and diastolic blood pressure and pulse rate via the oscillometric method, and then acquire the radial arterial pulse waveform to derive the Central Aortic Systolic Pressure (CASP) non-invasively.
The A-PULSE CASPro monitor has a graphical display that displays the arterial pulse waveform as well as a range of other pulse indices. The A-PULSE CASPal monitor has a numeric display. Both models have a non-volatile memory to store and recall measurements.
Brachial Blood pressure, CASP and pulse rate readings obtained using the A-PULSE CASPro/CASPal Monitors are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.
The A-PULSE CASPro/CASPal Monitors are 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) | X |
|---|---|
| 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)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | Page 1 of 1 |
| 510(k) Number | K10002 |
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