MIDA ALGORITHM REV. B

K023414 · Ortivus AB · DYC · Dec 5, 2003 · Cardiovascular

Device Facts

• Record ID: K023414
• Device Name: MIDA ALGORITHM REV. B
• Applicant: Ortivus AB
• Product Code: DYC · Cardiovascular
• Decision Date: Dec 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2400
• Device Class: Class 2

Intended Use

For use only by a digital device to measure ST-segment shifts. Assessment of real time ST segment analysis in adult patients. The MIDA™ Algorithm Rev. B is intended for use in the hospital environment for the following patient population: Ages: 33-82 years Heights: 147 to 185cm (58 to 73 in.) Weights: 53 to 118kg (117 to 261 lbs.) Height to weight ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb) The use of EASI leads implies that the results may not be of diagnostic quality.

Device Story

MIDA™ Algorithm Rev. B is a software modification enabling vectorcardiogram analysis using 5-lead EASI electrode placement. Device processes ECG signals to calculate ST-segment shifts; provides real-time ST segment analysis for adult patients in hospital environments. Operated by clinicians via digital monitoring systems. Output assists healthcare providers in monitoring ischemia. Benefits include continuous ST-segment monitoring using reduced lead sets. EASI lead configuration noted as potentially non-diagnostic.

Clinical Evidence

Bench testing only. Performance validated by acquiring data from patients undergoing PTCA. Simultaneous recordings obtained using both Frank and EASI electrode placements. ST-segment shifts calculated for both configurations were compared to establish functionality and reliability.

Technological Characteristics

Digital algorithm; 5-lead EASI electrode input; bandwidth 0.05 to 130 Hz; input dynamic range ± 328 mV. Software-based ST-segment analysis.

Indications for Use

Indicated for real-time ST-segment shift measurement in adult patients (ages 33-82, heights 147-185cm, weights 53-118kg) in hospital settings. Note: EASI lead usage may result in non-diagnostic quality data.

Regulatory Classification

Identification

A vectorcardiograph is a device used to process the electrical signal transmitted through electrocardiograph electrodes and to produce a visual display of the magnitude and direction of the electrical signal produced by the heart.

Predicate Devices

• MIDA™ System, Models 1000/1100 (K896396)
• HP Viridia CMS (K992595)

Submission Summary (Full Text)

{0}------------------------------------------------

DEC - 5 2003

023414

# 12

## SECTION 2. GENERAL INFORMATION

### A. 510(k) SUMMARY

### Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Ortivus AB summary for the MIDA™ Algorithm Rev. B.

| SUBMITTER'S NAME: | Ortivus AB |
|---------------------|-------------------------------------------|
| ADDRESS: | Enhagsslingan 5<br>SE-187 40 Täby, Sweden |
| CONTACT PERSON: | Kenneth Eklund |
| PHONE NUMBER: | [phone] |
| FAX NUMBER: | [phone] |
| DATE OF SUBMISSION: | 7 October, 2002 |

- 1. Identification of device: Proprietary Name: MIDA™ Algorithm Rev. B Common Name: Vectorcardiograph Classification Status: Class II per regulation 870.2400 Product Codes: 74DYC
- 2. Equivalent device:

The new device that allows the MIDA™ algorithm to use vectorcardiogram from the five leads system EASI is substantially equivalent to the MIDATM System, Models 1000/1100 manufactured by Medical Graphics Corporation (K896396) and the HP Viridia CMS (K992595).

- 3. Description of the Device:
The new device is a modification that allows the MIDA™ algorithm to use vectorcardiogram from the five leads system EASI.

- 4. Indication for use:
For use only by a digital device to measure ST-segment shifts. Assessment of real time ST segment analysis in adult patients. The MIDA™ Algorithm Rev. B is intended for use in the hospital environment for the following patient population: Ages: 33-82 years Heights: 147 to 185cm (58 to 73 in.) Weights: 53 to 118kg (117 to 261 lbs.) Height to weight ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb)

The use of EASI leads implies that the results may not be of diagnostic quality.

{1}------------------------------------------------

- 5. Technological characteristics, comparison to predicate device The table below compares the MIDA B with the new predicate device (HP Viridia System) and the original MIDA.
2/2

| Characteristics | MIDA 1000/1100<br>(K896396) | HP Viridia CMS<br>(K992595) | MIDA Rev B<br>(K023414) |
|--------------------------------|-----------------------------|-----------------------------|--------------------------|
| Indications for Use | Monitor ischemia | Assessment of ST segment | Assessment of ST segment |
| Patient Population | | Adults | Adults |
| Intended Use<br>Environment | Hospital Environment | Hospital Environment | Hospital Environment |
| Technology | Digital | Digital | Digital |
| Number of Electrodes | 8 Electrodes | 5 Electrodes | 5 Electrodes |
| Bandwidth | 0.02 to 100 Hz | 0.05 to 130 Hz | 0.05 to 130 Hz |
| Input dynamic range | $\pm$ 320 mV | $\pm$ 500 mV | $\pm$ 328 mV |
| Storage | Store data | Doesn't store data | Doesn't store data |
| Calculated ST-VM<br>parameter | Yes | No | Yes |
| Calculated STC-VM<br>parameter | Yes | No | Yes |

### 5. Verification, validation and testing

The activities to establish the performance, functionality and reliability characteristics of the new device with respect to the predicate device. Testing involved acquirement of data for patients that was undergoing PTCA. Simultaneous recordings were obtained from the patient using electrode placement according to Frank and EASI. ST-segment shifts were calculated for both lead placements and compared.

#### 6. Conclusion

Based on the Software Test Report MIDA Algorithm Rev B. ID: P-593-062., MIDA™ calculated with both Frank electrode placement and EASI electrode placement and comparison with predicate devices, it is the conclusion of Ortivus AB that the MIDA™ algorithm Rev B is substantially equivalent with the predicate device and that there is no new concerns about safety and effectiveness.

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 5 2003

Ortivus AB c/o Mr. Kenneth Eklund Enhagsslingan 5 SE-183 25 Taby SWEDEN

Re: K023414

Trade Name: MIDA™ Algorithm Rev. B Regulation Number: 21 CFR 870.2400 Regulation Name: Vectorcardiograph Regulatory Class: Class II (two) Product Code: DYC Dated: September 9, 2003 Received: September 12, 2003

Dear Mr. Eklund:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your occurrent the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interscate for use stated in the encrosure) to regard to tegally and call be vice Americal Device Ameral Food. Drya commerce provision of May 20, 1970, the encordance with the provisions of the Federal Food. Drug, devices that have been reclaismed in accessful of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applicat and Costhelic Act (Act) that do not require approvince approvisions of the Act. The Act. The Act. The You may, merciole, market the devices, solo, exception of the samual registration, listing of general controls provisions of the free labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class II (PMA), it If your device is classified (soc above) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional bontroller Entreasger of the 21, Parts 800 to 898. In addition, FDA may be found in the Code of Feach. It geteral stogething your device in the Federal Register.

{3}------------------------------------------------

Page 2 – Mr. Kenneth Eklund

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Myra Mayer
Carolyn Coleman, MD

. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## INDICATIONS FOR USE

______________________________________________________________________________________________________________________________________________________________________________

510(k) Number: K023414

Device Name: MIDA™ Algorithm Rev. B

Indication for use: For use only by a digital device to measure ST-segment shifts.

Assessment of real time ST segment analysis in adult patients.

The MIDA™ Algorithm Rev. B is intended for use in the hospital environment for the following patient population: Ages: 33-82 years Heights: 147 to 185cm (58 to 73 in.) Weights: 53 to 118kg (117 to 261 Ibs.) Height to weight ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb)

The use of EASI leads implies that the results may not be of diagnostic quality.

Prescription Use X (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)

Mesa Meis
(Division Sign-Off)

Page I of 1

rascular Devices 510(k) Number