(69 days)
The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.
- When used with the EnSite Array™ Catheter, the EnSite System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
OR - When used with the EnSite NavX Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
When used with the v.1.5.1 MediGuide gMPS System Interface Module, the EnSite Velocity System interfaces to the MediGuide Guided Medical Positioning System II to combine and display gMPS II processed patient positioning and orientation Mapping information.
The EnSite Velocity System consists of the following:
- Display Workstation .
- Amplifier .
The provided text is a 510(k) summary for a medical device (EnSite Velocity System v.1.5.1 with MediGuide gMPS System Interface Module). It outlines the device's intended use, comparison to a predicate device, and non-clinical testing. However, it does not contain the detailed information required to describe specific acceptance criteria for performance, a comprehensive study proving those criteria, or details regarding ground truth establishment and expert involvement.
The document states:
- "Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product."
- "The full software performance benchmarks which measure map and waveform display refresh rates, data rates, and time to display a frame of map and waveforms were conducted."
- "The performance of the EnSite Velocity System was observed during verification and integrated system testing to ensure performance was not severely impacted by the integration with the gMPS II (K102905)."
While these statements indicate that testing was performed to ensure the device met certain performance expectations and safety requirements, they do not provide quantitative acceptance criteria or the study data that validates them. The document primarily focuses on establishing substantial equivalence to a predicate device through modifications and integration with another system.
Therefore, I cannot populate the requested table and answer many of the questions because the necessary details are not present in the provided text.
Here's a breakdown of what can be inferred from the text and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | Not provided |
| Inferred: Ensuring changes met design requirements and did not affect safety/effectiveness. | Inferred: Bench testing, software performance benchmarks (map/waveform refresh rates, data rates, time to display a frame), and verification/integrated system testing observed that performance was not severely impacted by integration with gMPS II. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance (country, retrospective/prospective): Not specified. The testing described is "bench testing" and "software performance benchmarks," suggesting laboratory/simulated environments rather than patient data.
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)
- Number of Experts: Not applicable/not mentioned. This type of testing appears to be functional and performance-based against specifications, not reliant on expert interpretation of ground truth in a clinical context.
- Qualifications of Experts: Not applicable/not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not 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
- MRMC Study: No, an MRMC study was not done or mentioned. This device is an electrophysiology mapping system, not an AI-assisted diagnostic imaging device that would typically involve human "readers" interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: The described "software performance benchmarks" (map and waveform display refresh rates, data rates, and time to display a frame) represent a form of standalone performance testing for the system's core functions. However, "standalone" in the context of AI often refers to an algorithm making a diagnosis without human intervention, which is not the primary function or testing focus described here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated. For bench testing and software benchmarks, the "ground truth" would likely be the defined design requirements and expected performance specifications derived from engineering principles and predicate device behavior.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document describes a traditional medical device (electrophysiology mapping system) and its software integration, not a machine learning or AI algorithm that would typically involve a "training set" in the context of AI model development.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable (see point 8).
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MAY - 5 2011
12 510(k) Summary for Public Disclosure
12.1 Submitter's Name/Contact Person
Donna R. Lunak St. Jude Medical One St. Jude Medical Drive St. Paul. MN 55117 USA
The Establishment Registration Number is 2184149.
12.2 Predicate Device
EnSite Velocity System with PRT (K101667).
12.3 Common or Usual Name
Electrophysiology Mapping System with console and catheter
12.4 Proprietary Name
EnSite Velocity System
Consisting of:
EnSite Multi-electrode Diagnostic Catheter (EnSite Array™ - Model EC1000) EnSite Electrophysiology Workstation – Model EE3000 EnSite NavX Surface Electrode Kit - Model EN0010
12.5 Classification Name
DQK, Programmable diagnostic computer (21 CFR 870.1425), Class II, Circulatory Systems Device Panel
12.6 Hardware Description
The EnSite Velocity System consists of the following:
- Display Workstation .
- Amplifier .
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12.7 Indications for Use
The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.
-
t When used with the EnSite Array™ Catheter, the EnSite System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
OR -
When used with the EnSite NavX Surface Electrode Kit, the EnSite . System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
12.8 Intended Use
When used with the EnSite Velocity System v.1.5.1 MediGuide aMPS System Interface Module, the EnSite Velocity System interfaces to the MediGuide gMPS System to combine and display SJM MediGuide gMPS System processed patient positioning and orientation information.
12.9 Device Comparison to the Predicate Device
The EnSite Velocity System v.1.5.1 has the same intended use and fundamental scientific technology as the predicate device. All technological characteristics of the EnSite Velocity System v.1.5.1 are substantially equivalent to the predicate device.
12.10 Summary of Non-Clinical Testing
Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product.
As part of the testing of EnSite Velocity System v.1.5.1, a gMPS II MediGuide emulator was used to simulate the gMPS II (K102905). The aMPS II MediGuide emulator was used to verify packets sent by the EnSite Velocity System. In addition, the emulator allowed the testing of error conditions by simulating error conditions that would typically be sent by the gMPS II (K102905). The testing included testing of the EnSite Velocity System to ensure that is handles the error conditions as expected.
The full software performance benchmarks which measure map and waveform display refresh rates, data rates, and time to display a frame of map and waveforms were conducted. The performance of the EnSite Velocity System was
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observed during verification and integrated system testing to ensure performance was not severely impacted by the integration with the gMPS II (K102905).
12.11 Summary of Design Control Activities
The development of the EnSite Velocity System v.1.5.1 was performed in accordance with SJM's Quality System requirements, and in compliance with Quality System Requlation design controls requirements documented in 21 CFR 820.30. A Declaration of Conformity with Design Controls follows in section 13.4.
12.12 Conclusion
The EnSite Velocity v.1.5.1 has the same indications for use and fundamental scientific technology as the predicate device. All technological characteristics of the EnSite Velocity System v.1.5.1 are substantially equivalent to the predicate device.
Where operational and performance differences exist between the proposed device and the predicate device, performance testing demonstrated that these differences do not adversely affect the device's safety and effectiveness.
Therefore, St. Jude Medical considers the EnSite Velocity System v.1.5.1 to be substantially equivalent to the predicate device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 5 2011
St. Jude Medical c/o Donna R. Lunak Regulatory Specialist One St. Jude Medical Drive Saint Paul MN 55117
Re: K110549
Trade/Device Name: EnSite Velocity System V.1.5.1 with MediGuide gMPS System Interface Module Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: March 29, 2011 Received: March 30, 2011
Dear Ms. Lunak:
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 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
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Page 2 – Ms. Donna Lunak
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
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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7 Indications for Use
Device Name: EnSite Velocity System
Indications for Use:
The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.
-
When used with the EnSite Array™ Catheter, the EnSite System is intended to . be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
OR -
When used with the EnSite NavX Surface Electrode Kit, the EnSite System is . intended to display the position of conventional electrophysiology (EP) catheters in the heart.
Intended Use:
When used with the v.1.5.1 MediGuide gMPS System Interface Module, the EnSite Velocity System interfaces to the MediGuide Guided Medical Positioning System II to combine and display gMPS II processed patient positioning and orientation Mapping information.
| Prescription Use(Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR Over-The-Counter Use(21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K110549 |
|---|---|
| --------------- | --------- |
§ 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).