ASI Plethysmogrpah Analyzer

K200567 · Arterial Stiffness, Inc. · JOM · Feb 26, 2021 · Cardiovascular

Device Facts

• Record ID: K200567
• Device Name: ASI Plethysmogrpah Analyzer
• Applicant: Arterial Stiffness, Inc.
• Product Code: JOM · Cardiovascular
• Decision Date: Feb 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2780
• Device Class: Class 2

Intended 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.

Device Story

Device measures finger pulse waveform using optoelectronic sensor (infrared LED and photodiode). LED transmits light through tissue; photodiode measures absorption changes. Signal transferred via Texas Instrument circuit board to computer. Proprietary algorithm analyzes plethysmograph data to calculate heart rate and blood circulation characteristics. Output displayed as graphic pulse waveform on computer screen. Used in clinical settings by healthcare professionals. Provides objective pulse data to assist in cardiovascular assessment.

Clinical Evidence

Clinical and non-clinical testing performed at Prism Research. Clinical studies conducted per 21 CFR Parts 812, 50, and 56. Bench testing included electrical safety evaluations. Results indicate device is as safe and effective as the predicate.

Technological Characteristics

Optoelectronic sensor (infrared LED/photodiode); FDA-approved fingertip oximeter probe; Texas Instrument circuit board; USB 3.0 powered; Windows 10 compatible software; standalone PC-based architecture.

Indications for Use

Indicated for professional use in adults (18+ years) for non-invasive measurement of pulse waveform and heart rate via photoelectric plethysmography.

Regulatory Classification

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.

Predicate Devices

• McPulse Photoelectric Plethysmograph (AKA Meridian DPA) (K023238)

Reference Devices

• Novametrix Pulse Oximeter, Model 500 (K853124)
• Nellcor Oximeter (K822909)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span style="unicode-bidi:bidi-override; direction: rtl;"> <input checked="checked" type="checkbox"/> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="unicode-bidi:bidi-override; direction: rtl;"> <input type="checkbox"/> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(K) Summary of Safety and Effectiveness

Arterial Stiffness Inc. Contact: Marshall Ring, CEO 300-136 Market Street Winnipeg, Canada R3B 0P3 Phone: [phone]

February 8, 2020 Contact: US Agent: Joseph Shaw c/o International Life Science Enterprises Inc. 1000 Westgate Drive, St Paul, MN55114 Phone: [phone] Fax: [phone] Email: [e-mail]

### 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.

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# 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<br>Analyzer 3.01 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| INDICATION OF USE | The device provides non-<br>invasive measurement of<br>pulse waveform and heart<br>rate by photoelectric<br>plethysmography | The device provides non-<br>invasive measurement of<br>pulse waveform and heart<br>rate by photoelectric<br>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<br>3.0 cable supplies up to 900<br>milliamps of power to reading<br>device |
| TYPE OF SENSOR | LED - Photodiode/finger<br>probe | LED - FDA approved<br>Oximeter. 510(k) 822909,<br>NellcorTM, (Medtronic) |
| ANATOMICAL SITE | Finger | Finger |
| RECORDER OUTPUTS | Pulse Waveform<br>Hear rate | Pulse Waveform<br>Hear rate |
| HEART RATE & DISPLAY<br>RESOLUTION | 30-230 bpm | 30-230 bpm |
| SIZE (UNIT: MM) | 305x296x92.5 mm | 80x160x40 mm (not including<br>computer) |
| WEIGHT | Approx. 5.5 kg | Approx. 0.18 kg (Not including<br>computer) |
| CONFIGURATION | Integrated unit including<br>printer, pre-programed CPU<br>and software program built in. | CPU and software included in<br>separate computer and<br>provided on disc. Operating<br>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.