(90 days)
365-81, 365-82, 365-89, 365-90, 4036
Not Found
No
The description focuses on the mechanical function of a stylet for catheter positioning and does not mention any AI/ML components or capabilities.
No
The device is described as a stylet used for positioning a catheter during electrophysiology mapping, not for delivering therapy.
No
The device is a stylet used to position a catheter during electrophysiologic mapping procedures; it does not itself perform diagnosis.
No
The device description explicitly states it is a "stainless steel wire," indicating it is a physical hardware component, not software.
Based on the provided information, the EnStylet™ EC0010/20 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for use in conjunction with a catheter during electrophysiologic mapping procedures. This is an in vivo procedure (performed within a living organism), not an in vitro procedure (performed outside of a living organism, typically in a lab setting using samples like blood or tissue).
- Device Description: The description of a stainless steel wire designed to provide deflection and positioning of a catheter further supports its use in an in vivo procedure.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, the EnStylet™ is a medical device used in an in vivo procedure, not an IVD.
N/A
Intended Use / 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.
Product codes
DRB
Device 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 in conjunction with the EnSite® EC1000 catheter during electrophysiologic mapping procedures using the EnSite 3000® System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The EnStylet™ was subjected to extensive in vitro testing demonstrating that the stylet met or exceeded all dimensional, mechanical, and functional specifications. The performance of the EnStylet™ was found to be acceptable for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Intermedics Stylets Models 365-81, 365-82, 365-89, 365-90, Pacesetter Locator Steerable Stylet Model 4036
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Premarket Notification (510(K)) Summary For Public Disclosure APPENDIX G:
| Submitter: | Endocardial Solutions, Inc.
1350 Energy Lane, Suite 110
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
Pacesetter 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 in
conjunction with the EnSite® EC1000 catheter during
electrophysiologic mapping procedures using the EnSite 3000®
System. |
| Intended 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. |
| Technological Characteristics: | Comparisons between the new and predicate devices shows that
technological characteristics (i.e. device design, materials, and
components) and indications for use for the EnStylet™ are equivalent
to the currently marketed predicate devices. |
| Non-Clinical Data: | The EnStylet™ was subjected to extensive in vitro testing
demonstrating that the stylet met or exceeded all dimensional,
mechanical, and functional specifications. The performance of the
EnStylet™ was found to be acceptable for its intended use. |
| Conclusion: | The EnStylet™ was found to be equivalent to technological
characteristics and indications for use for the predicate devices.
Extensive in vitro testing demonstrated the performance of the
EnStylet™ to be acceptable for its intended use. |
1
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.
2
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
3
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)