ENSTYLET MODELS EC0010, EC0020

K993376 · Endocardial Solutions, Inc. · DRB · Jan 5, 2000 · Cardiovascular

Device Facts

• Record ID: K993376
• Device Name: ENSTYLET MODELS EC0010, EC0020
• Applicant: Endocardial Solutions, Inc.
• Product Code: DRB · Cardiovascular
• Decision Date: Jan 5, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1380
• Device Class: Class 2

Indications for Use

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.

Device Story

EnStylet™ is a 0.027-inch diameter stainless steel wire, available in pre-formed J-shaped or straight configurations with a ball-tip. It functions as a mechanical accessory for the EnSite® EC1000 catheter during electrophysiologic mapping procedures. The device is inserted into the catheter to provide structural support, enabling precise deflection and positioning of the catheter's distal end within the heart. It is used by clinicians in a clinical setting during electrophysiologic studies. By facilitating accurate catheter placement, the device assists the physician in mapping cardiac electrical activity, which supports the diagnosis and management of cardiac arrhythmias.

Clinical Evidence

Bench testing only. Extensive in vitro testing demonstrated that the device met or exceeded all dimensional, mechanical, and functional specifications.

Technological Characteristics

0.027-inch diameter stainless steel wire; pre-formed J-shaped or straight geometry; ball-tipped design. Mechanical device used for catheter deflection and positioning. No software or energy source.

Indications for Use

Indicated for use in electrophysiologic mapping procedures to provide deflection and positioning of the distal end of the EnSite® EC1000 catheter when used with the EnSite 3000® System.

Regulatory Classification

Identification

A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.

Predicate Devices

• Intermedics Stylets Models 365-81, 365-82, 365-89, 365-90
• Pacesetter Locator Steerable Stylet Model 4036

Submission Summary (Full Text)

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K993376

## Premarket Notification (510(K)) Summary For Public Disclosure APPENDIX G:

| Submitter: | Endocardial Solutions, Inc.<br>1350 Energy Lane, Suite 110<br>St. 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, and<br>Pacesetter Locator Steerable Stylet Model 4036 |
| Description: | The EnStylet™ EC0010/20 is a pre-formed J-shaped or straight, ball-<br>tipped, 0.027-inch diameter stainless steel wire designed to be used in<br>conjunction with the EnSite® EC1000 catheter during<br>electrophysiologic mapping procedures using the EnSite 3000®<br>System. |
| Intended Use: | The EnStylet™ EC0010/20 is intended for use in conjunction with the<br>EnSite® EC1000 catheter during electrophysiologic mapping<br>procedures using the EnSite 3000® System. The EnStylet™ is<br>designed to provide deflection and positioning of the distal end of the<br>catheter. |
| Technological Characteristics: | Comparisons between the new and predicate devices shows that<br>technological characteristics (i.e. device design, materials, and<br>components) and indications for use for the EnStylet™ are equivalent<br>to the currently marketed predicate devices. |
| Non-Clinical Data: | The EnStylet™ was subjected to extensive in vitro testing<br>demonstrating that the stylet met or exceeded all dimensional,<br>mechanical, and functional specifications. The performance of the<br>EnStylet™ was found to be acceptable for its intended use. |
| Conclusion: | The EnStylet™ was found to be equivalent to technological<br>characteristics and indications for use for the predicate devices.<br>Extensive in vitro testing demonstrated the performance of the<br>EnStylet™ to be acceptable for its intended use. |

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] 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)