(331 days)
The AT-102 is a 12-channel, ECG Device used for the recording, analysis and evaluation of ECG recordings. Recordings made with the AT-102 can be used as a diagnostic aid for heart function and heart conditions. The AT-102 is designed for indoor use.
The device provide an optional interface to the SP-250 for pulmonary function data.
The CARDIOVIT AT-102 is a 12-channel ECG device. It has dimensions of 380x328x100mm and weighs 5.0 kg. It operates in temperatures from +10° to 40° C and storage temperatures from -10° to +50° C, with relative humidity between 25% and 95% (non condensing). It uses Standard / Cabrera leads and has a battery capacity of 2 hours of normal use. The frequency range of the digital recorder is 0 to 150Hz. It has an Alphanumerics, LCD Display control panel and a Myogram Filter programmable at 25Hz or 35Hz. Paper speed options are 5/10/25/50mm/s direct. It uses high resolution thermal printing with 40dots per mm / 1000 dots per inch time axes at 25mm/s. It uses Thermoreactive, Z-folded, 210mm chart paper and has 6 channels for recording tracks, positioned at optimal width on 80 mm / 3.2 inch with automatic baseline adjustment. It has 6 channel representation of 12 simultaneously acquired standard leads for automatic lead programs.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the SCHILLER CARDIOVIT AT-102 device:
1. Table of Acceptance Criteria and Reported Device Performance
The submission claims substantial equivalence to the predicate device CARDIOVIT AT-1C (K953396). The acceptance criteria implicitly refer to matching or exceeding the performance of this predicate device, especially for the ECG interpretation features.
| Feature / Acceptance Criteria Category | Reported Device Performance (CARDIOVIT AT-102) | Details from Submission Regarding Performance |
|---|---|---|
| ECG Measurement | Multi-lead atlas measurement results | Performance verified by Common Standards for Quantitative Electrocardiograph (CSE), multi lead atlas measurement results. (Implies adherence to CSE standards for accuracy) |
| ECG Interpretation | Detection of acute myocardial infarction | - Performance verified by enzyme evolvement (PREMIS study)- Performance verified by Cardiologists (Boehringer Ingelheim Study) |
| Safety Standards | Complies with relevant safety standards | EN 60601-1 (Safety), EN 60601-1-2 (EMC), IEC 601-1-4 (Software Quality) |
| Physical Dimensions | 380x328x100mm | Larger than predicate (290x210x69mm), but deemed not safety relevant. |
| Weight | 5.0 kg | Heavier than predicate (2.9 kg), but deemed not safety relevant. |
| Environmental Conditions | Same as predicate | Operating temp: +10° - 40° C; Storage temp: -10° - +50° C; Relative humidity: 25% - 95% (non-condensing) |
| Leads | Standard / Cabrera | Same as predicate. |
| Battery Capacity | 2 hrs of normal use | Same as predicate. |
| Frequency Range (digital recorder) | 0 to 150Hz | Same as predicate. |
| Control Panel | Alphanumerics, LCD Display | Different from predicate (Pad keys, LED indications), but deemed not safety relevant. |
| Myogram Filter | 25Hz or 35Hz programmable | Same as predicate. |
| Paper Speed | 5/10/25/50mm/s direct | More options than predicate (5/25/50mm/s direct), but deemed not safety relevant. |
| Printing Process | High resolution thermal | Same as predicate. |
| Printing Resolution | 40dots per mm / 1000 dots per inch (amplitude axes), 25mm/s (time axes) | Same as predicate. |
| Chart Paper | Thermoreactive, Z-folded, 210mm | Wider than predicate (90mm), but deemed not safety relevant. |
| Recording Tracks | 6 channels, positioned at optimal width on 80 mm / 3.2 inch automatic baseline adjustment | More channels than predicate (3 channels), but deemed not safety relevant. |
| Automatic Lead Programs | 6 channel representation of 12 simultaneously acquired standard leads | More channels than predicate (3 channels), but deemed not safety relevant. |
2. Sample Size Used for the Test Set and Data Provenance
- ECG Measurement (CSE Study): The submission mentions "Common Standards for Quantitative Electrocardiograph (CSE) study" for ECG measurement. It does not explicitly state the sample size or data provenance (country, retrospective/prospective) for this particular study within the provided text. CSE studies are typically large, international, and prospective/retrospective collections of ECGs.
- ECG Interpretation (PREMIS Study & Boehringer Ingelheim Study):
- PREMIS Study: Verified performance by "enzyme evolvement" for detection of acute myocardial infarction. No sample size, country of origin, or retrospective/prospective nature is provided in this document. The name "PREMIS" does not immediately point to a commonly known, publicly documented ECG study without further context.
- Boehringer Ingelheim Study: Verified performance by "Cardiologists." No sample size, country of origin, or retrospective/prospective nature is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- ECG Interpretation (Boehringer Ingelheim Study): Ground truth was established by "Cardiologists." The number of cardiologists and their specific qualifications (e.g., years of experience, board certification) are not specified in the provided document.
- ECG Interpretation (PREMIS Study): Ground truth was established by "enzyme evolvement." This implies a biochemical marker for myocardial damage, not expert opinion.
4. Adjudication Method for the Test Set
- For the "Cardiologists" verification in the Boehringer Ingelheim Study, the adjudication method (e.g., 2+1, 3+1, none) is not specified.
- For the PREMIS study using "enzyme evolvement," expert adjudication would not be the primary method for ground truth, but rather the enzyme levels themselves.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A formal MRMC comparative effectiveness study, where human readers' performance with and without AI assistance is measured, is not explicitly mentioned or described in the provided text. The studies appear to validate the device's algorithmic performance against established ground truths, rather than its impact on human reader performance.
6. Standalone Performance Study
- Yes, standalone performance was done for the ECG measurement (CSE study) and ECG interpretation (PREMIS study and Boehringer Ingelheim Study). These studies describe the algorithm's performance in "detection of acute myocardial infarction" and "multi lead atlas measurement results" independent of human intervention in the interpretation process.
7. Type of Ground Truth Used
- ECG Measurement: Implicitly, the ground truth for the CSE study (Common Standards for Quantitative Electrocardiograph) would be highly accurate, meticulously measured ECG parameters, often meticulously reviewed or derived from diverse, well-defined populations.
- ECG Interpretation (PREMIS Study): "Enzyme evolvement" is the stated ground truth. This refers to the presence and changes in cardiac enzymes (e.g., troponin, CK-MB) in the blood, which are objective biochemical markers for myocardial necrosis (heart attack). This is a form of outcomes data/pathological evidence at a biochemical level.
- ECG Interpretation (Boehringer Ingelheim Study): "Cardiologists" are stated as the verifier, implying expert consensus/opinion as the ground truth.
8. Sample Size for the Training Set
- The document does not specify the sample size used for the training set for any of the algorithms (ECG measurement or interpretation).
9. How the Ground Truth for the Training Set Was Established
- The document does not specify how the ground truth for the training set was established. The mentioned studies (CSE, PREMIS, Boehringer Ingelheim) appear to relate to verification or validation, rather than the initial establishment of ground truth for a training dataset.
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SCHILLER AG Allaosse 68. Postfact
MWST Nr. 212858 e mail: sales@schiller.c buving schiller 110://www.schiller.ch
2031557
p 1 of 3
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APR 1 4 2004
Food and Drug Administration Center for Devices and Radiological Health Document Control Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 USA
- of May 03
Pre-market Notification Letter, 510 (k) Notification
Dear Documentation Control Clerk:
In accordance with Section 510 (k) of the Federal Food, Drug and Cosmetic Act, and in conforniance 21 CFR 807, this pre-market notification is being submitted prior to the date when SCHILLER AG Switzerland, proposes to introduce into interstate commerce for commercial distribution of a new-dev CARDIOVIT AT-102
| 1. Trade Names: | CARDIOVIT AT-102 |
|---|---|
| ----------------- | ------------------ |
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- Common Name:
-
- Address of Manufacturing Facility:
System, ECG, Analysis Product code: 74 LOS
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SCHILLER AG, Switzerland Altgasse 68 CH-6341 Baar
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- Classification:
-
- Reason for Premarket Notification:
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ნ. Substantially Equivalent Devices:
-
- Substantial Equivalence:
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Class II
New Device
CARDIOVIT AT-1C K953396
For all technical specifications, substantial equivalence is claimed with the SCHILLER device, CARDIOVIT AT-1C (K953396)
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5K14005
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MWS1 Nr. 212858 e mail: sales@schiller.ch buying@schiller.ch http://www.schiller.ch
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Image /page/1/Picture/3 description: The image shows the word "SCHILLER" in large, bold, black letters. Below the word is a horizontal line, and below that is the word "SWITZERLAND" in smaller, sans-serif letters. The text appears to be a logo or brand name.
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- ECG measurement:
-
- ECG interpretation:
Safety Standards:
Common Standards for Quantitative Electrocardiograph (CSE), multi lead atlas measurement results
CSE study
Detection of acute myocardial infarcation
- a) performance verified by enzyme evolvement (PREMIS study)
- performance verified by Cardiologists b) (Boehringer Ingelheim Study)
EN 60601-1 (Safety), EN 60601-1-2 (EMC), IEC 601-1-4 (Software Quality)
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- Table of Comparison to Legally Marketed Device(s): (Predicate device CARDIOVIT AT-1C (K953396)
| AT-1C K953396 | CARDIOVIT AT-102 | |
|---|---|---|
| Dimensions: | 290x210x69mm | 380x328x100mm |
| Weight: | 2.9 kg | 5.0 kg |
| Environmental Conditions: | ||
| Operating temperature | +10° - 40° C | same |
| Storage temperature | -10° - +50° C | same |
| Relative humidity | 25% - 95%(non condensing) | same |
| Leads: | Standard / Cabrera | same |
| Battery capacity: | 2 hrs of normal use | same |
| Frequency range of digital recorder: | 0 to 150Hz | same |
| Control panel | Pad keys, LED indications | Alphanumerics, LCD Display |
| Myogram Filter | 25Hz or 35Hz programmable | same |
| Paper speed | 5/25/50mm/s (direct) | 5/10/25/50mm/s direct |
| Printing process | High resolution thermal | same |
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K031557 p 30f3
| inch(amplitude axes)40dots per mm / 1000dots per inch time axes,25mm/s | ||
|---|---|---|
| Chart paper | Thermoreactive, Z-folded, 90mm | Thermoreactive, Z-folded,210mm |
| Recording tracks | 3 channels, positionedat optimal with on 80mm / 3.2 inchautomatic baselineadjustment | 6 channels, positioned atoptimal with on 80 mm /3.2 inch automaticbaseline adjustment |
| Automatic lead programs | 3 channelrepresentation of 12simultaneouslyacquired standardleads | 6 channel representationof 12 simultaneouslyacquired standard leads |
Discusson of Differences:
None of the above differences (1, 2 or 3) can be considered as safety relevant differences. We consider the submitted device to be as safe and effective as the Predicate (CARDIOVIT AT-1C) device.
M. Bu, Fe
Markus Buetler
14.05.03
(Date)
/
(Date)
lead
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2004
SCHILLER AG c/o Mr. Markus Buetler Quality Assurance and Regulatory Affairs Manager Altgasse 68, Postfach CH-6341 Baar SWITZERLAND
Re: K031557
Trade Name: CARDIOVIT AT-102 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: DPS Dated: March 19, 2004 Received: March 23, 2004
Dear Mr. Buetler:
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.
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Page 2 - Mr. Markus Buetler
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 (OS) 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) 594-4648. 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,
Dma R. lochner
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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K031557 p L at L
U.S. Food and Drug Administ
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CENTER FOR DEVICES AND RADIOLOGICAL I
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Indications for Use
510(k) Number (if known): K031557__
Device Name: Cardiovit_AT=102 /P8000Power__
Indications for Use:
The AT-102 is a 12-channel, ECG Device used for the recording, analysis and evaluation of ECG recordings. Recordings made with the AT-102 can be used as a diagnostic aid for heart function and heart conditions. The AT-102 is designed for indoor use.
The device provide an optional interface to the SP-250 for pulmonary function data.
SCHILLER AG
Altgasse, 68
CH-6341 Baar/Switzerland
469
Prescription Use × (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Lachine A
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K031557
§ 870.2340 Electrocardiograph.
(a)
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.(b)
Classification. Class II (performance standards).