(420 days)
Not Found
No
The summary describes an algorithm for calculating ST-segment shifts using vectorcardiogram data and compares it to a predicate device. There is no mention of AI, ML, or related concepts, nor is there a description of training or test sets typically associated with ML development.
No.
The device is intended to measure ST-segment shifts as an assessment tool, not to provide therapy or treatment.
No
The "Intended Use" section explicitly states, "The use of EASI leads implies that the results may not be of diagnostic quality." This indicates that the device's output is not intended for diagnostic purposes.
Yes
The device description explicitly states that the new device is a modification that allows the MIDA™ algorithm to use vectorcardiogram from a five-lead system. This focuses on the algorithm (software) and its input data processing, without mentioning any new hardware components being part of the device itself. The testing also focuses on comparing the algorithm's output with different lead placements, further indicating the device is the software algorithm.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "measure ST-segment shifts" and "Assessment of real time ST segment analysis in adult patients." This involves analyzing electrical signals from the heart, which are physiological measurements from within the body, not tests performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is an algorithm that uses vectorcardiogram data from leads placed on the body. This is a form of physiological monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components associated with in vitro diagnostics.
In summary, the device analyzes electrical signals from the patient's body, which falls under the category of physiological monitoring or diagnostic devices, but not in vitro diagnostics.
N/A
Intended Use / Indications 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.
Product codes
74DYC, DYC
Device Description
The new device is a modification that allows the MIDA™ algorithm to use vectorcardiogram from the five leads system EASI.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
33-82 years
Intended User / Care Setting
Hospital Environment
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2400 Vectorcardiograph.
(a)
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.(b)
Classification. Class II (performance standards).
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 |
| SE-187 40 Täby, Sweden | |
| CONTACT PERSON: | Kenneth Eklund |
| PHONE NUMBER: | +46-8-446 45 35 |
| FAX NUMBER: | +46-8-446 45 19 |
| DATE OF SUBMISSION: | 7 October, 2002 |
-
- Identification of device: Proprietary Name: MIDA™ Algorithm Rev. B Common Name: Vectorcardiograph Classification Status: Class II per regulation 870.2400 Product Codes: 74DYC
-
- 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).
-
- Description of the Device:
The new device is a modification that allows the MIDA™ algorithm to use vectorcardiogram from the five leads system EASI.
- Description of the Device:
-
- 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)
- Indication for use:
The use of EASI leads implies that the results may not be of diagnostic quality.
1
-
- 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
- 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.
| Characteristics | MIDA 1000/1100
(K896396) | HP Viridia CMS
(K992595) | MIDA Rev B
(K023414) |
|--------------------------------|-----------------------------|-----------------------------|--------------------------|
| Indications for Use | Monitor ischemia | Assessment of ST segment | Assessment of ST segment |
| Patient Population | | Adults | Adults |
| Intended Use
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
parameter | Yes | No | Yes |
| Calculated STC-VM
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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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