(359 days)
Not Found
No
The description mentions a "proprietary algorithm" for analyzing the plethysmograph, but there is no mention of AI, ML, or any related concepts like training data or neural networks. The analysis appears to be based on traditional signal processing techniques.
No
The device is described as a measurement device for pulse waveform and heart rate, with no indication of providing any treatment or therapy.
Yes
Explanation: The device measures pulse waveform and heart rate and analyzes generated pulse waveforms to produce a plethysmograph of the patient's blood circulation, which are diagnostic measurements. Its intended use is to provide non-invasive measurement of pulse waveform and heart rate.
No
The device description explicitly mentions hardware components including an optoelectronic sensor (LED and photodiode), an FDA approved pulse oximeter fingertip probe, and a Texas Instrument designed circuit board. While it utilizes a proprietary algorithm (software), it is integrated with and dependent on these physical components for its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography. This involves placing a sensor on the finger and measuring light transmission through the tissue.
- No Sample Analysis: There is no mention of collecting or analyzing any biological samples from the patient. The measurement is performed directly on the body.
Therefore, since the device operates by non-invasively measuring physiological signals from the body rather than analyzing samples taken from the body, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography. For Professional Use only. Not for use in individuals under the age of 18 years.
Product codes (comma separated list FDA assigned to the subject device)
JOM
Device Description
The ASI Device is intended to be used to measure pulse waveform in the finger. The measurement oximeter is an optoelectronic sensor consisted of a light- emitting diode (infrared LED) and a photodiode placed on opposite side as a light receiver. The ASI System incorporates an FDA approved pulse oximeter fingertip probe. The light from the LED is transmitted through the tissue at the sensor site and a photodiode in the sensor measures the transmitted light and calculating how much light is absorbed. This device converts the changes of transmitted light from a photodiode into a waveform and displays a graphic display of the pulse waveform on computer screen. As well as the optoelectronic sensor, the system utilizes a Texas Instrument designed circuit board which in turn transfers the signal to the computer contains the downloaded ASI proprietary algorithm which analysis the generated plethysmograph. The ASI System measures and analyzes the generated pulse waveforms to produce heart rate and plethysmograph of the patient's blood circulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger
Indicated Patient Age Range
Not for use in individuals under the age of 18 years.
Intended User / Care Setting
For Professional Use only.
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)
Clinical and non-clinical tests were performed to support the determination of substantial equivalence. These tests were performed at independent CRO Prism Research at 1000 Westgate Drive, Saint Paul, Minnesota 55114. Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812- Investigational Device Exemptions, Part 50- Protection of Human Subjects and Parts 56-Instituational Review Boards. Statistical Analysis was performed by ASI Staff.
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.
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
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 26, 2021
Arterial Stiffness Inc. Nida Shoubash Partner 1000 Westgate Drive Suite 101B Saint Paul, Minnesota 55114
Re: K200567
Trade/Device Name: ASI Plethysmograph Analyzer Model 3.01 Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, Pneumatic, Or Photoelectric Plethysmographs Regulatory Class: Class II Product Code: JOM Dated: February 28, 2020 Received: March 4, 2020
Dear Nida Shoubash:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200567
Device Name ASI Plethysmograph Analyzer Model 3.01
Indications for Use (Describe) The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography.
For Professional Use only. Not for use in individuals under the age of 18 years.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) Summary of Safety and Effectiveness
Arterial Stiffness Inc. Contact: Marshall Ring, CEO 300-136 Market Street Winnipeg, Canada R3B 0P3 Phone: 204.272.2406
February 8, 2020 Contact: US Agent: Joseph Shaw c/o International Life Science Enterprises Inc. 1000 Westgate Drive, St Paul, MN55114 Phone: 651.208.9596 Fax: 651.641.2801 Email: jshaw@il-se.us
1. Identification of Device
- . Proprietary Trade Name: ASI Plethysmograph Analyzer 3.01
- Classification Name: Class II Device, Plethysmograph, Photelectric, Product Code . JOM
- . Common/Usual Name: Photoelectric Plethysmograph
2. Equivalent legally marketed devices
- This product is similar in function to the McPulse Photoelectric Plethysmograph . (AKA Meridian DPA) 510(k) No. K023238, Applicant Meridian Co. Ltd.
- Also, Novametrix Pulse Oximeter, Model 500, 510(k) K853124 .
3. Indications for Use (intended use):
- The device provides non-invasive measurement of pulse waveform and heart rate . by photoelectric plethysmography - For professional use only. Not for use individuals under the age of 18 years.
4. Description of the device
The ASI Device is intended to be used to measure pulse waveform in the finger. The measurement oximeter is an optoelectronic sensor consisted of a light- emitting diode (infrared LED) and a photodiode placed on opposite side as a light receiver. The ASI System incorporates an FDA approved pulse oximeter fingertip probe. The light from the LED is transmitted through the tissue at the sensor site and a photodiode in the sensor measures the transmitted light and calculating how much light is absorbed. This device converts the changes of transmitted light from a photodiode into a waveform and displays a graphic display of the pulse waveform on computer screen. As well as the optoelectronic sensor, the system utilizes a Texas Instrument designed circuit board which in turn transfers the signal to the computer contains the downloaded ASI proprietary algorithm which analysis the generated plethysmograph. The ASI System measures and analyzes the generated pulse waveforms to produce heart rate and plethysmograph of the patient's blood circulation.
4
5. Safety and Effectiveness, comparison to predicate device
The results of both bench testing and clinical trial data indicates that the new device is as safe and effective as the predicate devices.
| Feature | McPulse (Meridian DPA) | ASI Plethysmograph
Analyzer 3.01 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| INDICATION OF USE | The device provides non-
invasive measurement of
pulse waveform and heart
rate by photoelectric
plethysmography | The device provides non-
invasive measurement of
pulse waveform and heart
rate by photoelectric
plethysmography |
| MODE | Noninvasive | Noninvasive |
| PRACTITIONER USE | For professional use only | For professional use only |
| DISPLAY | Digital LCD Display | Computer LCD screen |
| POWER SOURCE | AC (100-240Vac) | USB power source, A USB
3.0 cable supplies up to 900
milliamps of power to reading
device |
| TYPE OF SENSOR | LED - Photodiode/finger
probe | LED - FDA approved
Oximeter. 510(k) 822909,
NellcorTM, (Medtronic) |
| ANATOMICAL SITE | Finger | Finger |
| RECORDER OUTPUTS | Pulse Waveform
Hear rate | Pulse Waveform
Hear rate |
| HEART RATE & DISPLAY
RESOLUTION | 30-230 bpm | 30-230 bpm |
| SIZE (UNIT: MM) | 305x296x92.5 mm | 80x160x40 mm (not including
computer) |
| WEIGHT | Approx. 5.5 kg | Approx. 0.18 kg (Not including
computer) |
| CONFIGURATION | Integrated unit including
printer, pre-programed CPU
and software program built in. | CPU and software included in
separate computer and
provided on disc. Operating
system Windows 10 |
6. Substantial Equivalence chart
7. Non-clinical and Clinical Tests
Clinical and non-clinical tests were performed to support the determination of substantial equivalence. These tests were performed at independent CRO Prism Research at 1000 Westgate Drive, Saint Paul, Minnesota 55114. Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812- Investigational Device Exemptions, Part 50- Protection of Human Subjects and Parts 56-Instituational Review Boards. Statistical Analysis was performed by ASI Staff.
8. Conclusion
After analysis the bench responses and considerations of electrical safety combined with clinical trial data it is the conclusion of Arterial Stiffness Inc., that the ASI Plethysmograph Analyzer has few technological differences and those that do exist represent little or no significance thus rendering it substantially equivalent to the predicate device.