(31 days)
The EnSite 3000® System is indicated for patients for whom electrophysiology studies are indicated.
• When used with the EnSite® Catheter, the EnSite 3000® 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 3000® System is intended to display the position of conventional electrophysiology catheters in the heart.
The EnSite 3000® System is a computerized storage and display system for use in electrophysiology studies of the human heart. The system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter or surface electrode kit. Unlike currently available electrode recording catheters, the EnSite Catheter does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite 3000® System is a system that facilitates mapping and treatment of arrhythmias. When used with the EnSite catheter, the system is useful for treating patients with complex, non-sustained, or poorly tolerated arrhythmias that are difficult, if not impossible, to map with current mapping techniques. By visualizing the global activation pattern seen on the color-coded isopotential maps in the EnSite 3000® System, in conjunction with the reconstructed electrograms, the electrophysiologist can identify the arrhythmia source and can navigate to the defined area for therapy. When used with NavX patches, the system is useful in treating patients with simpler arrhythmias by providing non-fluoroscopic navigation and visualization of conventional EP catheters
The provided text is a 510(k) summary for the Endocardial Solutions EnSite 3000® System. It describes the device, its intended use, and states that it has "the same technological characteristics as the legally marketed predicate device."
However, this document does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria. Instead, it states that "The changes made to the EnSite 3000® System underwent a battery of bench and user tests. Device validation testing was conducted in accordance with in-house procedures."
Therefore, I cannot provide the requested information from the given text. The 510(k) summary is a declaration of substantial equivalence to a predicate device, and for such submissions, detailed performance data, especially clinical study results with specific metrics and acceptance criteria, are often not included in the publicly available summary if they are considered proprietary or have already been established for the predicate device.
Based on the provided text, the answer is: The document does not contain the specific acceptance criteria or details of a study that proves the device meets acceptance criteria.
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OCT 15 2004
K0462493
page 1 of 2
510(k) Summary for Public Disclosure
| Submitter: | Endocardial Solutions1350 Energy Lane, Suite 110St. Paul, MN 55108 USAPhone: 651-523-6900Fax: 651-644-7897 |
|---|---|
| Contact: | Karen J. McKelveyRegulatory Compliance Engineer |
| Date Prepared: | September 10, 2004 |
| Trade Name: | EnSite 3000® Systema) Model EC 1000 EnSite Multi-electrode Diagnostic Catheterb) EnSite 3000® Electrophysiology Workstationc) Model EN 0010 EnSite™ NavX Surface Electrode |
| Common name: | Electrophysiology cardiac mapping system |
| Classification Name: | a) Electrode recording catheter or electrode recording probe(21CFR 870.1220)b) Programmable diagnostic computer (21 CFR 870.1425) |
| Predicate Device: | Endocardial Solutions EnSite 3000® System510(k) No. K030129 |
| Device Description: | The EnSite 3000® System is a computerized storage and display system for use in electrophysiology studies of the human heart. The system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter or surface electrode kit.Unlike currently available electrode recording catheters, the EnSite Catheter does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite 3000® |
.
Endocardial Solutions, Inc. EnSite® System
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K040493
page 2 of 2
| System is a system that facilitates mapping and treatment ofarrhythmias. When used with the EnSite catheter, the system isuseful for treating patients with complex, non-sustained, or poorlytolerated arrhythmias that are difficult, if not impossible, to mapwith current mapping techniques. By visualizing the globalactivation pattern seen on the color-coded isopotential maps in theEnSite 3000® System, in conjunction with the reconstructedelectrograms, the electrophysiologist can identify the arrhythmiasource and can navigate to the defined area for therapy. When usedwith NavX patches, the system is useful in treating patients withsimpler arrhythmias by providing non-fluoroscopic navigation andvisualization of conventional EP catheters | |
|---|---|
| Intended use: | The EnSite 3000® System is indicated for patients for whomelectrophysiology studies are indicated. |
| • When used with the EnSite® Catheter, the EnSite 3000®System is intended to be used in the right atrium of patientswith complex arrhythmias that may be difficult to identifyusing conventional mapping systems alone.OR | |
| • When used with the EnSite NavX™ Surface Electrode Kit, theEnSite 3000® System is intended to display the position ofconventional electrophysiology catheters in the heart. | |
| TechnologicalCharacteristics: | The new device has the same technological characteristics as thelegally marketed predicate device. |
| Non-clinicalPerformance Data: | The changes made to the EnSite 3000® System underwent a batteryof bench and user tests. Device validation testing was conductedin accordance with in-house procedures. |
| Conclusion: | An evaluation of the device changes indicates that the device is assafe and effective as the previously marketed device to which it isbeing compared and does not raise any new issues of safety andeffectiveness. |
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 15 2004
Endocardial Solutions, Inc. c/o Ms. Karen J. McKelvey Regulatory Compliance Engineer 1350 Energy Lane, Suite 110 St. Paul MN 55108
Re: K042493
Trade Name: EnSite System: EnSite 3000 Electrophysiology Workstation Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: September 30, 2004 Received: October 4, 2004
Dear Ms. McKelvey:
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 - Ms. Karen J. McKelvey
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 Erth 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. product from to begin marketing your device as described in your Section 510(k) rremarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicated 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) 594-4646. 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 may be obtained from the O wision 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,
Bhiminor for
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
510(k) Number (if known):
Device Name:
Indications For Use:
The EnSite System is indicated for patients for whom electrophysiology studies are indicated in the
-
Site System is indicated for patients r, the EnSite System is intended to be used in the . When used with the EnDito' Catheter, 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 . Which used with the Diffice National electrophysiology catheters in the heart.
) Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
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)
Bhummer
28
310(k) Number
Page 1 of 1
§ 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).