(126 days)
Horizon Cardiology ECG™ is a system for importing, storing, displaying and reviewing ECG procedures. Horizon Cardiology ECG is intended for use in the hospital environment by medical professionals.
HC ECG™ is a software application designed for use in various hospital departments, to import, display, store, analyze, distribute and process ECG procedures from resting ECG devices.
The HC ECG™ is intended to provide analysis or reanalysis of resting ECG's and to provide preliminary data for editing and confirmation by an over-reading physician. The HC ECG™ may provide a serial comparison of ECG data to facilitate the review of the patient's current ECG with previous ECG's of the same patient.
HC ECG™ is a comprehensive ECG management system for importing ECG waveform data, reviewing and performing measurements, diagnosis and comparison of ECG procedures and storing the data for future review and management.
HC ECG™ functions as a non-real time system. It receives ECG procedure files after the cessation of the ECG procedure, which can originate from any one of a variety of manufacturer's cardiographs. HC ECG™ acquires the ECG waveforms through a network connection or via a diskette, and normalizes them to a common format. If the ECG cart has made an ECG procedure analysis, HC ECG™ presents it and utilizes the Glasgow University Interpretive Algorithm to perform its own measurements, diagnosis and serial comparison without changing the raw waveform data.
The HC ECG™ graphic user interface provides tools that enable the physician to:
- edit measurements. .
- edit procedure diagnoses. .
- review numerous ECG procedures concurrently. .
- confirm ECG procedures. .
- distribute and print ECG procedure reports.
HC ECG™ complies with HL7 standards for export of reports to the Hospital Information System. HC ECG™ supports final ECG report distribution by printing, faxing, e-mailing and automatic export to other systems. The Horizon Cardiology ECG™ database complies with the requirements of HIPAA through robust password security, record access security and file allocation in a secure and managed server.
Horizon Cardiology ECG ™ allows access to ECG records from web-enabled PCs throughout a network and enables authorized clinical users to access the system from remote locations.
The provided documentation is a 510(k) summary for the Horizon Cardiology ECG™ system. It describes the device, its intended use, and indicates that it has been found substantially equivalent to predicate devices. However, the document does NOT contain information about specific acceptance criteria or a study that proves the device meets those criteria. Such detailed performance data and study results are typically found in the full 510(k) submission, which is not publicly available in this summary format.
Therefore, I cannot provide the requested information based solely on the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical performance study with acceptance criteria.
To answer your request, if the information were available, here's how it would be structured and what details would be needed:
Acceptance Criteria and Device Performance Study (Information Not Found in Provided Text)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Metric (e.g., Sensitivity, Specificity, Accuracy, Mean Absolute Error) | Target (e.g., ≥ 90%, ± 5 bpm) | Reported Device Performance | Meets Criterion? (Yes/No) |
|---|---|---|---|---|
| ECG Measurement Accuracy | QRS Duration Mean Absolute Error | < 10 ms | [Not provided in text] | [Not provided in text] |
| PR Interval Mean Absolute Error | < 10 ms | [Not provided in text] | [Not provided in text] | |
| QT Interval Mean Absolute Error | < 15 ms | [Not provided in text] | [Not provided in text] | |
| Diagnostic Agreement (e.g., with physician over-read) | Overall Agreement Rate | ≥ 80% | [Not provided in text] | [Not provided in text] |
| Specific Condition Agreement (e.g., AMI, Atrial Fibrillation) | ≥ 75% | [Not provided in text] | [Not provided in text] | |
| Serial Comparison Performance | Ability to detect significant changes | [Not provided in text] | [Not provided in text] | [Not provided in text] |
| System Reliability/Availability | Uptime Percentage | ≥ 99.5% | [Not provided in text] | [Not provided in text] |
2. Sample Size for Test Set and Data Provenance
- Sample Size: [Not provided in text]
- Data Provenance: [Not provided in text - e.g., "1000 ECGs from multiple hospitals across the US and Europe, collected retrospectively over 3 years"]
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: [Not provided in text]
- Qualifications: [Not provided in text - e.g., "Three board-certified cardiologists, each with over 15 years of experience in ECG interpretation"]
4. Adjudication Method for the Test Set
- Method: [Not provided in text - e.g., "2+1 adjudication, where if two experts agreed, that was the ground truth. If all three disagreed, they discussed and reached a consensus, or a fourth tie-breaking expert was consulted."]
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? [Not provided in text]
- Effect Size (if done): [Not provided in text - e.g., "Human readers improved diagnostic accuracy by an average of 5% with AI assistance compared to without."]
6. Standalone (Algorithm Only) Performance Study
- Was it done? The text mentions the system "utilizes the Glasgow University Interpretive Algorithm to perform its own measurements, diagnosis and serial comparison," suggesting standalone algorithmic performance. However, specific performance metrics for this standalone algorithm are not provided in the text.
7. Type of Ground Truth Used
- Type: [Not provided in text - e.g., "Expert Consensus" for ECG interpretations, "Pathology reports" for certain diagnoses, or "Outcomes data" for clinical relevance.] Given the nature of an ECG system, expert consensus by cardiologists is highly probable.
8. Sample Size for the Training Set
- Sample Size: [Not provided in text]
9. How Ground Truth for the Training Set Was Established
- Method: [Not provided in text - e.g., "Ground truth for the training set was established through expert consensus of two independent cardiologists, with a third cardiologist resolving discrepancies."]
In summary, the provided 510(k) summary (K061905) for Horizon Cardiology ECG™ serves as a regulatory document for market clearance based on substantial equivalence to existing devices. It does not include the detailed technical or clinical study results with acceptance criteria and specific performance metrics that would typically be part of a full regulatory submission or a scientific publication.
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Chapter 2 - 510(k) Summary
NOV - 8 2006
Chapter 2 contains summary information, which is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807,92.
Submitter
Medcon, a McKesson Company 3 Tevuot Ha'aretz Street Tel Aviv 69546 Israel Tel: +972 3 648 7702 Fax: +972 3 647 8593
Predicate Device(s)
Horizon Cardiology ECG is substantially equivalent to a combination of the following predicate devices
- Pyramis™ ECG Management system (K032038) .
- Ascentia HeartStation™ (K050858) .
- Infinity MegaCare™, manufactured by Siemens Medical Solutions (K031970) .
Name of the Device
Horizon Cardiology ECG™ (HC ECG™ for brevity)
Description of the Device
HC ECG™ is a comprehensive ECG management system for importing ECG waveform data, reviewing and performing measurements, diagnosis and comparison of ECG procedures and storing the data for future review and management.
HC ECG™ functions as a non-real time system. It receives ECG procedure files after the cessation of the ECG procedure, which can originate from any one of a variety of manufacturer's cardiographs. HC ECG™ acquires the ECG waveforms through a network connection or via a diskette, and normalizes them to a common format. If the ECG cart has made an ECG procedure analysis, HC ECG™ presents it and utilizes the Glasgow University Interpretive Algorithm to perform its own measurements, diagnosis and serial comparison without changing the raw waveform data.
October 2006
Honzon Cardiology ECG ™ - Premarket Notification 510(K) Release 1.0
Chapter 2 -1
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The HC ECG™ graphic user interface provides tools that enable the physician to:
- edit measurements. .
- edit procedure diagnoses. .
- review numerous ECG procedures concurrently. .
- confirm ECG procedures. .
- distribute and print ECG procedure reports. �
HC ECG™ complies with HL7 standards for export of reports to the Hospital Information System. HC ECG™ supports final ECG report distribution by printing, faxing, e-mailing and automatic export to other systems. The Horizon Cardiology ECG™ database complies with the requirements of HIPAA through robust password security, record access security and file allocation in a secure and managed server.
Horizon Cardiology ECG ™ allows access to ECG records from web-enabled PCs throughout a network and enables authorized clinical users to access the system from remote locations.
Intended Use
HC ECG™ is a software application designed for use in various hospital departments, to import, display, store, analyze, distribute and process ECG procedures from resting ECG devices.
The HC ECG™ is intended to provide analysis or reanalysis of resting ECG's and to provide preliminary data for editing and confirmation by an over-reading physician. The HC ECG™ may provide a serial comparison of ECG data to facilitate the review of the patient's current ECG with previous ECG's of the same patient.
Horizon Cardiology ECG ™ - Premarket Notification 510(k) Release 1.0
October 2006
061905
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medcon Ltd. c/o Jonathan S. Kahan Partner Hogan & Hartson L.L.P. 555 13th Street Washington D.C. 20004
NOV - 8 2006
Re. K061905
Trade Name: Horizon Cardiology ECG Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II Product Code: DOK Dated: October 10, 2006 Received: October 11, 2006
Dear Mr. Kahan:
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. Jonathan Kahan
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 240-276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Horizon Cardiology ECGTM
Indications for Use:
Horizon Cardiology ECG™ is a system for importing, storing, displaying and reviewing ECG procedures. Horizon Cardiology ECG is intended for use in the hospital environment by medical professionals.
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K061905 |
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).