THE PORTABLE ANSISCOPE

K071168 · Dyansys, Inc. · DPS · Aug 31, 2007 · Cardiovascular

Device Facts

• Record ID: K071168
• Device Name: THE PORTABLE ANSISCOPE
• Applicant: Dyansys, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Aug 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The Dy Ansys, Inc. ANSiscope™ ECG Monitoring System and accessories, is intended to acquire, analyze, display and record electrocardiographic information and to measure-heart rate variability. These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.

Device Story

Portable ANSiscope acquires raw ECG signals via 5-lead ECG; processes signals to calculate heart rate and heart rate variability (HRV) indices. Uses proprietary software based on scale covariance physics to extract beat-by-beat information from RR intervals; calculates interactivity of tool parameters from supine recordings; defines interactivity as lack of coupling between indices; outputs interactivity percentage over time. Used in clinical settings; operated by healthcare professionals. Output displayed on unit for physician review to aid in clinical assessment; device does not provide specific diagnoses.

Clinical Evidence

Bench testing only. Performance tests conducted to confirm compliance with functional requirements and specifications. No clinical study data provided.

Technological Characteristics

Portable ECG monitor with 5-lead ECG acquisition. Features computer-based user interface and data acquisition system. Proprietary software utilizes scale covariance physics for HRV analysis. Class II device (21 CFR 870.2340).

Indications for Use

Indicated for patients requiring acquisition, analysis, and recording of electrocardiographic information and heart rate variability (HRV) measurements. Not intended for any specific clinical diagnosis; clinical significance of parameters must be determined by a physician.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• The Qmed monitor one nDx (K972991)
• The D.E.Hokanson, Inc. ANS2000 (K973426)
• The Anscore System (K991831)
• The MAC 500 ECG Analysis System (K991735)

Submission Summary (Full Text)

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# 3 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of Safe Medical Devices Act (SMDA) 1990 and 21 CFR 807.92.

510(k) Number: _ K071168

## Applicant Information:

| Date Prepared: | August 8, 2007 |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Name: | DyAnsys, Inc., |
| Address: | c/o Emery & Howard,<br>577, Airport Boulevard, Suite 610,<br>Burlingame, CA 95032<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Michael A. Daniel |
| Phone Number: | Office: 925-254-5228 / Cell 415-407-0223 |
| Facsimile Number: | [phone] |

[e-mail]

#### Device Information:

| Classification: | DPS/class II/870.2340 |
|----------------------------------------|-------------------------|
| Trade Name: | The Portable ANSiscope™ |
| Common Name: | ECG Monitor |
| Classification Name:Electrocardiograph | |

## Predicate Devices:

| The Qmed monitor one nDx | K972991 |
|---------------------------------|---------|
| The D.E.Hokanson, Inc. ANS2000 | K973426 |
| The Anscore System | K991831 |
| The MAC 500 ECG Analysis System | K991735 |

#### Device Description:

The Portable ANSiscope™ is a device used for measuring heart rate variability (HRV). The device is designed to process raw ECG signals acquired from the patient in order to produce Heart Rate and other ancillary indices. The Portable ANSiscope™ includes an ECG Acquisition System that can digitize raw ECG signals, perform proprietary calculations from the HRV and then display the results utilizing a display unit.

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#### Intended Use:

The Dy Ansys, Inc. ANSiscope™ ECG Monitoring System and accessories, is intended to acquire, analyze, display and record electrocardiographic information and to measure-heart rate variability. These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.

# Comparison to Predicate Device(s):

The Portable ANSiscope™ is substantially equivalent to the following predicate devices:

| The Qmed monitor one nDx | K972991 |
|---------------------------------|---------|
| The D.E.Hokanson, Inc. ANS2000 | K973426 |
| The Anscore System | K991831 |
| The MAC 500 ECG Analysis System | K991735 |

- 1. The Portable ANSiscope™ is a portable system with a computer-based user interface and data acquisition system for testing, data collection and analysis. The device features a 5 lead ECG.
- 2. The Portable ANSiscope™ has the same intended use as the legally marketed predicate devices. The Portable ANSiscope™ is intended for use in Heart Rate Variability (HRV) measurements. . Though the measurement technology and the technological characteristics are not the same as those of the legally marketed devices, the new characteristics do not affect the safety and effectiveness.
- 3. The Portable ANSiscope™ was subjected to safety and performance tests against applicable recognized standards. Final testing for the product included various performance tests to confirm compliance with functional requirements and performance specifications.
- 4. The Portable ANSiscope utilizes proprietary software within the device based on scale covariance physics to calculate the interactivity of certain "tool parameters" from the supine recordings. The ANSiscope extracts beat-by-beat information from the RR time-intervals of the ECG. Indices are calculated giving activity-degrees of subsystems locally. The ANSiscope considers the interactivity as the lack of coupling of these indices and then defines its measurement as a percentage of interactivity over the time period considered (512 indices are required). The lack of coupling is measured by a metric between indices in the optimal phase. The obtained interactivity measurements form aggregates of values whose boundaries define groups that can aid diagnosis.

Confidential

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2007

DyAnsys, Inc. c/o Mr. Michael A. Daniel Emery & Howard 577 Airport Boulevard, Suite 610 Burlingame, CA 95032

Re: K071168

Trade/Device Name: Portable ANSiscope ECG Monitoring System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: August 29, 2007 Received: August 30, 2007

Dear Mr. Daniel:

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.

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

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Page 2 - Mr. Michael A. Daniel

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blomimo for

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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**NDS**

# 5 INDICATIONS FOR USE FORM

KOJIII68 510(k) Number (if known): _ TBD

The Portable ANSiscope™ Device Name:

## Indications for Use:

The Dy Ansys, Inc. ANSiscope™ ECG Monitoring System and accessories, is intended to acquire, analyze, display and record electrocardiographic information and to measure-heart rate variability. These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <span>X</span> </div> | OR | Over-The-Counter Use |
|--------------------------|-----------------------------|----|----------------------|
| (Per 21 CFR 801.109) | | | |
| (Optional Format 1-2-96) | | | |


(Division Sign-Off)

Division of Cardiovascular Devices

| 510(k) Number | K071168 |
|---------------|---------|
|---------------|---------|

DyAnsys, Inc

Confidential

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