(90 days)
The EnStylet™ EC0010/20 is intended for use in conjunction with the EnSite® EC1000 catheter during electrophysiologic mapping procedures using the EnSite 3000® System. The EnStylet™ is designed to provide deflection and positioning of the distal end of the catheter.
The EnStylet™ EC0010/20 is a pre-formed J-shaped or straight, ball-tipped, 0.027-inch diameter stainless steel wire designed to be used in conjunction with the EnSite® EC1000 catheter during electrophysiologic mapping procedures using the EnSite 3000® System.
The provided document is a 510(k) summary for the EnStylet™ Model EC0010/20, a catheter stylet. It focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and in vitro testing. Therefore, much of the requested information regarding clinical studies, expert-established ground truth, and AI-related evaluations is not applicable or not provided in this regulatory submission for a medical device of this type.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Testing | Dimensional specifications | Met or exceeded |
| Non-Clinical Testing | Mechanical specifications | Met or exceeded |
| Non-Clinical Testing | Functional specifications | Met or exceeded |
| Overall Performance | Acceptable for intended use | Found to be acceptable |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "extensive in vitro testing" was performed, but no specific number of units or test runs is provided.
- Data Provenance: Not applicable. The data is from in vitro (bench) testing, not human subjects or real-world use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. The "ground truth" for in vitro testing of a physical device like a stylet is typically based on engineering specifications, material properties, and functional requirements, rather than expert clinical consensus or pathology of medical images/data. The testing would compare the device's physical and functional attributes against predefined engineering standards.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or clinical outcomes where there might be disagreement among evaluators. For in vitro engineering tests, results are generally objective and measured against established specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. This is not an AI-enabled device or an diagnostic imaging product where MRMC studies are typically conducted. The device is a physical tool (catheter stylet) used in conjunction with other medical systems, not a standalone diagnostic or interpretative tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No. This is not an algorithm or AI system. It is a physical medical device.
7. The Type of Ground Truth Used
- Engineering Specifications and Functional Requirements: The ground truth for this device's performance is based on its ability to meet predetermined dimensional, mechanical, and functional specifications established during the device's design and engineering phases. This would involve objective measurements (e.g., tensile strength, flexibility, dimensions) and functional tests (e.g., ability to deflect a catheter).
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
Summary of Device Performance and Equivalence Claim:
The EnStylet™ Model EC0010/20 demonstrated substantial equivalence to predicate devices (Intermedics Stylets and Pacesetter Locator Steerable Stylet) based on:
- Similar technological characteristics (device design, materials, components).
- Similar indications for use.
- "Extensive in vitro testing" which showed the stylet "met or exceeded all dimensional, mechanical, and functional specifications" and its performance was "acceptable for its intended use."
The device is a Class II medical device, and its 510(k) clearance was based on these non-clinical, in vitro testing results demonstrating equivalence.
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Premarket Notification (510(K)) Summary For Public Disclosure APPENDIX G:
| Submitter: | Endocardial Solutions, Inc.1350 Energy Lane, Suite 110St. Paul, MN 55108 |
|---|---|
| Contact: | James W. Bullock, President and Chief Executive Officer |
| Date Prepared: | October 4, 1999 |
| Trade Name: | EnSylet™ Model EC0010/20 |
| Common Name: | Stylet, Catheter Stylet |
| Equivalence to: | Intermedics Stylets Models 365-81, 365-82, 365-89, 365-90, andPacesetter Locator Steerable Stylet Model 4036 |
| Description: | The EnStylet™ EC0010/20 is a pre-formed J-shaped or straight, ball-tipped, 0.027-inch diameter stainless steel wire designed to be used inconjunction with the EnSite® EC1000 catheter duringelectrophysiologic mapping procedures using the EnSite 3000®System. |
| Intended Use: | The EnStylet™ EC0010/20 is intended for use in conjunction with theEnSite® EC1000 catheter during electrophysiologic mappingprocedures using the EnSite 3000® System. The EnStylet™ isdesigned to provide deflection and positioning of the distal end of thecatheter. |
| Technological Characteristics: | Comparisons between the new and predicate devices shows thattechnological characteristics (i.e. device design, materials, andcomponents) and indications for use for the EnStylet™ are equivalentto the currently marketed predicate devices. |
| Non-Clinical Data: | The EnStylet™ was subjected to extensive in vitro testingdemonstrating that the stylet met or exceeded all dimensional,mechanical, and functional specifications. The performance of theEnStylet™ was found to be acceptable for its intended use. |
| Conclusion: | The EnStylet™ was found to be equivalent to technologicalcharacteristics and indications for use for the predicate devices.Extensive in vitro testing demonstrated the performance of theEnStylet™ to be acceptable for its intended use. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 5 2000
James W. Bullock President and Chief Executive Officer Endocardial Solutions 1350 Energy Lane Suite 110 55108-5254 Saint Paul, MN
Re: K993376 EnSylet™ Model EC0010/20 Regulatory Class: II (two) Product Code: DRB Dated: October 4, 1999 Received: October 7, 1999
Dear Mr. Bullock:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. James W. Bullock
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
a Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE 9.0
The EnStyler™ EC0010/20 is intended for use in conjunction with the EnStyle® EC1000 The Lifetyler - LC0010/2013 is mended for about of confess using the EnSite 3000® System. The Callieler during ciccrophysionelis mapping probables assigned.
EnStylet™ is designed to provide deflection and positioning of the distal end of the catheter.
Dea Ve Mille
Div and Neurolo 510(k) Number
Prescription Use X
(Per 21 CFR 801.109)
§ 870.1380 Catheter stylet.
(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).