(65 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.
The EnSite Velocity System consists of the following:
- Display Workstation .
- Amplifier
The provided text is a 510(k) summary for the EnSite Velocity System. It details the device's intended use and substantial equivalence to a predicate device but does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond general "bench testing" to confirm design requirements.
Therefore, I cannot fulfill your request for the specific details outlined as the information is not present in the provided document.
Here's a breakdown of why I cannot answer each point based on the given text:
- A table of acceptance criteria and the reported device performance: This information is not provided. 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," but no specific criteria or performance metrics are listed.
- Sample sized used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- 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: Not provided. This is a diagnostic mapping system, not specifically an AI-assisted diagnostic tool as described in the question.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided.
- The type of ground truth used: Not provided.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
The document's primary focus is on establishing substantial equivalence to a predicate device based on similar indications for use, fundamental scientific technology, and the outcome of general bench testing. It does not delve into detailed performance studies with specific acceptance criteria as you've requested.
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12 510(k) Summary for Public Disclosure
FEB 2 5 2010
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 Common or Usual Name
Electrophysiology Mapping System with console and catheter
12.3 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
12.4 Classification Name
DQK, Programmable diagnostic computer (21 CFR 870.1425), Class II, Circulatory Systems Device Panel
12.5 Hardware Description
The EnSite Velocity System consists of the following:
- Display Workstation .
- � Amplifier
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12.6 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.
12.7 Device Comparison to the Predicate Device
The EnSite Velocity System v. 1.3 (EnSite Derexi Module) has the same intended use and fundamental scientific technology as the predicate device. All technological characteristics of the EnSite Velocity System v. 1.3 are substantially equivalent to the predicate device.
Summary of Non-Clinical Testing 12.8
Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product.
Summary of Design Control Activities 12.9
The development of the EnSite Velocity System v.1.3 (The EnSite Derexi Module) was performed in accordance with St. Jude Medical'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.
12.10 Conclusion
The EnSite Velocity System v.1.3 (The EnSite Derexi Module) has the same indications for use, intended use and fundamental scientific technology as the predicate device. All technological characteristics of the EnSite Velocity System v. 1.3 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.
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K093942 $\frac{3}{3}$
Therefore, St. Jude Medical considers the EnSite Velocity System to be substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, depicted in a minimalist, abstract design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Regulatory Technology Services LLC. c/o Mr. Mark Job Third Party Official 1394 25th Street NW Buffalo, MN 55313
FEB 2 5 2010
Re: K093942
Trade/Device Name: EnSite Velocity System v1.3 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: January 27, 2010 Received: February 1, 2010
Dear Mr. Job:
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.
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Page 2 - Ms. Mark Job
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); medical device reporting (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/ResourcesforYou/Industry/default.htm.
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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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.
Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (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)
W.W.W.C.
510(k) Number K0823942
§ 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).