(74 days)
The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients. The information consists of measurements, text, and digitized waveforms. The MUSE Cardiology Information System provides the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison. The MUSE Cardiology Information System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or facility providing patient care. The MUSE Cardiology Information System is not intended for primary monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison.
The MUSE Cardiology Information System is a network PC-based system comprised of a client workstation/server configuration that manages adult and pediatric diagnostic cardiology data by providing centralized storage and ready access to a wide range of data/reports (e.g. Resting ECG, Stress, Holter, HiRes) from GE and non-GE diagnostic and monitoring equipment.
The device provides the ability
To review and edit stored data consisting of measurements, text, and digitized waveforms on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison.
To generate formatted management reports, ad-hoc database search reports and clinical patient reports on selected stored data.
This modification will provide the capability to generate median waveforms and ECG measurements from 12-lead ECG data received in a GE specified XML format. Other added functionality includes an additional QTc calculation method, a refined tool (Interval Editor) to manually measure, review, and document ECG waveform parameters, and workflow enhancements.
The provided document, K072502, a Special 510(k) Premarket Notification for the GE Healthcare MUSE Cardiology Information System, focuses on demonstrating substantial equivalence to a predicate device (K050614) after a modification. This type of submission typically emphasizes non-clinical testing and conformity to standards rather than detailed clinical study data with specific acceptance criteria for performance metrics.
Based on the provided text, the document states: "Based on the results of the performed testing it is concluded that the MUSE Cardiology Information System with the modifications subject to this submission is substantially equivalent to and is as safe, as effective, and performs as well as the currently marketed predicate device cleared in K050614."
This indicates that the "acceptance criteria" for this specific submission is primarily demonstration of substantial equivalence through non-clinical testing and adherence to quality assurance measures, rather than meeting specific quantifiable performance thresholds for clinical accuracy or efficacy.
Therefore, a table of acceptance criteria and reported device performance in the clinical sense is not explicitly provided in this document as it would be in an original 510(k) or PMA that introduces a novel analytical capability. The focus is on the impact of the modification to an already cleared device.
However, I can extract information related to the "study" (testing) that proves the device meets the implicit criterion of substantial equivalence.
1. A table of acceptance criteria and the reported device performance
As noted above, explicit quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy for a specific disease detection) and corresponding reported performance are not provided in this 510(k) summary. The acceptance criterion for this modification is largely qualitative: proving the modified device is as safe, effective, and performs as well as the predicate.
The document lists the following quality assurance measures and performance testing as the "study" demonstrating this:
| Acceptance Criteria (Implicit for Substantial Equivalence of Modification) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Compliance with voluntary standards | Complies with voluntary standards detailed in Section 3.2 |
| Demonstrated safety and effectiveness equivalent to predicate device | Concluded to be as safe, as effective, and performs as well as the currently marketed predicate device (K050614) |
| Proper functioning of new capabilities (e.g., XML format, QTc calculation) | Functionality implemented and tested (implied by "Integration Testing (System verification)", "Final acceptance testing (Validation)", "Performance testing") |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical testing (risk analysis, requirements reviews, design reviews, integration testing, final acceptance testing, performance testing). It does not mention a clinical test set or sample size in the context of clinical performance evaluation. Therefore, information regarding data provenance (country of origin, retrospective/prospective) for a clinical test set is also not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Given that no clinical test set is described, there is no mention of experts used to establish ground truth for such a set in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since no clinical test set is described, no adjudication method for a clinical test set is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was mentioned or performed according to this document. The submission is for a modification of an existing system, not the introduction of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe the evaluation of a standalone algorithm's performance in the context of clinical diagnostic accuracy. The testing mentioned (integration, acceptance, performance testing) refers to the functionality of the system modifications, not a new diagnostic algorithm. The device itself is described as an "ECG Analysis Computer," implying an algorithm component, but its standalone diagnostic performance is not the subject of the testing reported here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the focus on non-clinical testing for system modifications, no specific type of clinical ground truth (like expert consensus, pathology, or outcomes data) is mentioned as being used for performance evaluation in this document.
8. The sample size for the training set
The document describes non-clinical testing for a system modification. There is no mention of a "training set" in the context of machine learning or algorithm development.
9. How the ground truth for the training set was established
As no training set is mentioned (see point 8), there is no information on how its ground truth would have been established.
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K072502
Special 510(k) Premarket Notification Special 510(K) Tremantet Notification
GE Healthcare – MUSE Cardiology Information System
September 4, 2007
NOV 1 9 2007
Attachment B
| Submitter: | GE Medical Systems Information Technologies9900 Innovation DriveWauwatosa, WI 53226 |
|---|---|
| Contact Person: | Patricia TaigeSr. Regulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: (414) 721-3222Fax: (414) 721-3899 |
| Date Prepared | September 4, 2007 |
| Device Names: | Proprietary Name: MUSE Cardiology Information SystemCommon/Usual Name: ECG Analysis ComputerClassification Name: Programmable Diagnostic Computer (21 CFR 870.1425 - Product Code DQK) |
| Predicate Device: | MUSE Cardiovascular Information System (K050614) |
| Device Description: | The MUSE Cardiology Information System is a network PC-based system comprised of a client workstation/server configuration that manages adult and pediatric diagnostic cardiology data by providing centralized storage and ready access to a wide range of data/reports (e.g. Resting ECG, Stress, Holter, HiRes) from GE and non-GE diagnostic and monitoring equipment.The device provides the ability To review and edit stored data consisting of measurements, text, and digitized waveforms on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison.To generate formatted management reports, ad-hoc database search reports and clinical patient reports on selected stored data. This modification will provide the capability to generate median waveforms and ECG measurements from 12-lead ECG data received in a GE specified XML format. Other added functionality includes an additional QTc calculation method, a refined tool (Interval Editor) to manually measure, review, and document ECG waveform parameters, and workflow enhancements. |
| Indications for Use: | The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients. The information consists of measurements, text, and digitized waveforms. The MUSE Cardiology Information System provides the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison. The MUSE Cardiology Information System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or facility providing patient care.The MUSE Cardiology Information System is not intended for primary monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison. |
| Technology: | The proposed MUSE Cardiology Information System employs the same functional scientific technology as the predicate device MUSE Cardiovascular Information System (K050614). |
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KC72502
Special 510(k) Premarket Notification GE Healthcare - MUSE Cardiology Information System September 4, 2007
| Test Summary: | Non-clinical Tests: The MUSE Cardiology Information System complies with thevoluntary standards as detailed in Section 3.2 of thissubmission. The following quality assurance measureswere applied to the development of the device modificationsubject to this submission: | |
|---|---|---|
| • Risk Analysis | ||
| • Requirements Reviews | ||
| • Design Reviews |
- Design Reviews
- Integration Testing (System verification)
- Final acceptance testing (Validation) ●
- Performance testing .
None required Clinical Tests:
Conclusion:
Based on the results of the performed testing it is concluded that the MUSE Cardiology Information System with the modifications subject to this submission is substantially equivalent to and is as safe, as effective, and performs as well as the currently marketed predicate device cleared in K050614.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three human figures in its body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2007
GE Medical Systems Information Technologies c/o Patricia Taige Sr. Regulatory Affairs Specialist 9900 Innovation Dr. Wauwatosa, WI 53226
Re: K072502
Trade/Device Name: Muse Cardiology Information System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: October 16, 2007 Received: October 17, 2007
Dear Ms. Taige:
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
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Page 2 - Ms. Patricia Taige
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 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,
M. A. Hillebenne
- 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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Special 510(k) Premarket Notification GE Healthcare - MUSE Cardiology Information System September 4, 2007
Attachment E
Indications for Use
510(k) Number (if known): K072502 Device Name: __ MUSE Cardiology Information System Indications for Use:
The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients. The information consists of measurements, text, and digitized waveforms. The MUSE Cardiology Information System provides the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison. The MUSE Cardiology Information System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or facility providing patient care. The MUSE Cardiology Information System is not intended for primary monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. L. Hillebrenner
(Division Sian-Off) Division of Cardiovascular Devices
510(k) Number_Ko72502
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§ 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).