(56 days)
Not Found
No
The 510(k) summary describes a physical medical device (a guide catheter) and does not mention any software, algorithms, or capabilities related to AI or ML. The description focuses on the physical construction and intended use of the catheter.
No
Explanation: The device description states that the guide catheters are designed to provide a pathway through which therapeutic devices are introduced, indicating it is an accessory to therapeutic devices, not a therapeutic device itself.
No
The device is described as providing a pathway for therapeutic devices, not for diagnosing conditions.
No
The device description clearly outlines physical components like an inner liner, stainless steel braid, outer shaft jacket, sleeve, marker band, and a soft distal tip, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "provide a pathway through which therapeutic devices are introduced" within the coronary or peripheral system. This describes a device used in vivo (within the body) for a therapeutic procedure, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description details the physical construction of a catheter designed to be inserted into blood vessels. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, the Medtronic Guide Catheters described are medical devices used for interventional procedures, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Medtronic Guide Catheters are intended to be used in the coronary or the peripheral system; and are designed to provide a pathway through which therapeutic devices are introduced.
Product codes
DQY
Device Description
The Medtronic Launcher Guide Catheter is constructed with an inner liner, stainless steel braid, outer shaft jacket, sleeve, marker band and a soft distal tip. The inner lumen of the Launcher Guide Catheter has a lubricious coating. The inner lumen of the Sherpa Guide Catheters is an HDPE liner.
Luer hub: The luer hub allows interfacing of the catheter with other devices.
Outer jacket: The outer jacket provides the catheter with its ability to retain its curve, and also provides support and contributes to the shaft stiffness and kink resistance.
Wire braided shaft: The wire braided shaft provides the catheter with torque response and crush resistance.
Distal segments: The distal segments allow a transition of catheter stiffness from the proximal catheter shaft to the soft distal tip.
Soft tip: The soft tip minimizes the potential for vessel trauma when the catheter is advanced in the vasculature system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or the peripheral system
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
No clinical investigation has been performed on the modified device.
Key Metrics
Not Found
Predicate Device(s)
K103386, K021256, K062420, K042489
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image contains the Medtronic logo. The logo features a stylized depiction of a person in motion, possibly representing movement or activity. Below the figure is the word "Medtronic" in a bold, sans-serif font, which is the name of the company.
OCT 22 2013
Special 510(k) Summary
| Submitter: | Medtronic Vascular
37A Cherry Hill Drive
Danvers, MA 01923-5186 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Heather Morose
Regulatory Affairs Specialist
Phone: (978) 739-3187
Fax: (978) 750-8204
Email: heather.p.morose@medtronic.com |
| Alternate Contact: | Fred Boucher
Director of Regulatory Affairs
Phone: (978) 739-3116
Fax: (978) 750-8204
Email: fed.boucher@medtronic.com |
| Date Prepared: | August 23, 2013 |
| Trade Name: | 5F Launcher® Guide Catheter
6F Launcher® Guide Catheter
SF Sherpa® Active NX Guide Catheter
6F Z4 (Sherpa) Guiding Catheter |
| Common Name: | Guiding Catheter |
| Classification Name: | Catheter, Percutaneous
21CFR 870.1250, Product Code DQY |
・
1
.
·
·
| Device | 510(k) | Clearance Date | |
|---|---|---|---|
| Predicate Devices: | 5F Launcher® | ||
| Guide Catheter | K103386 | 02/11/2011 | |
| 6F Launcher® | |||
| Guide Catheter | K021256 | 05/17/2002 | |
| 5F Sherpa® Guide | |||
| Catheter | K062420 | 09/08/2006 | |
| 6F Sherpa® (Z4) | |||
| Guiding Catheter | K042489 | 12/13/2004 | |
| Device | |||
| Description: | The Medtronic Launcher Guide Catheter is | ||
| constructed with an inner liner, stainless steel braid, | |||
| outer shaft jacket, sleeve, marker band and a soft | |||
| distal tip. The inner lumen of the Launcher Guide | |||
| Catheter has a lubricious coating. The inner lumen of | |||
| the Sherpa Guide Catheters is an HDPE liner. | |||
| Statement of Intended | |||
| Use: | The Medtronic Guide Catheter is designed to provide | ||
| a pathway through which therapeutic devices are | |||
| introduced. The guiding catheter is intended for used | |||
| in the coronary or peripheral vascular system. | |||
| Summary of | |||
| Technological | |||
| Characteristics: | The technological characteristics of the subject | ||
| medical devices 5F and 6F Launcher and Sherpa | |||
| Guide Catheters are identical to the predicate devices. | |||
| Luer hub: The luer hub allows interfacing of the | |||
| catheter with other devices. | |||
| Outer jacket: The outer jacket provides the catheter | |||
| with its ability to retain its curve, and also provides | |||
| support and contributes to the shaft stiffness and kink | |||
| resistance. | |||
| Wire braided shaft: The wire braided shaft | |||
| provides the catheter with torque response and crush | |||
| resistance. |
2
.
.
| | Distal segments: The distal segments allow a
transition of catheter stiffness from the proximal
catheter shaft to the soft distal tip. | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | i.
Soft tip: The soft tip minimizes the
potential for vessel trauma when the
catheter is advanced in the vasculature
system. | |
| Summary of Non-
clinical Data: | No new safety or effectiveness issues were raised
during the evaluation and testing. Current testing
demonstrates that the 5F and 6F Launcher and Sherpa
Guide Catheters are safe, effective and are
substantially equivalent to the predicate devices. | |
| Biocompatibility
Testing: | The current biocompatibility testing supports the
biological safety, as no new materials or processes
are being introduced into the design, and no
additional biocompatibility tests were deemed
necessary. Therefore, the modified 5F and 6F
Launcher and Sherpa Guide Catheters remain
biocompatible and compliant to ISO 10993 | |
| Summary of
Clinical Data: | No clinical investigation has been performed on the modified
device. | |
| Conclusion from
Data: | Medtronic Vascular has demonstrated that the modified 5F
and 6F Launcher and Sherpa Guide Catheters are substantially
equivalent to the predicate device. | |
67
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a bird or abstract human figure, with three curved lines forming its body and wings. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
October 22, 2013
Medtronic Inc. C/O Heather Morose Regulatory Affairs Specialist 37a Cherry Hill Drive Danvers, MA 01923 US
Re: .K 132673
Trade/Device Name: 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 5F Sherpa Guide Catheter and 6F Sherpa Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 20, 2013 Received: September 23, 2013
Dear Ms. Morose:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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 (2 l 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
4
Page 2 - Heather Morose
forth 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
M.A. Stillemann
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K132673 510(k) Number (if known): _
Device Name: Medtronic SF and 6F Launcher™ Guide Catheters and Medtronic 5F and 6F Sherpa™ Guide Catheter.
Indications for Use: The Medtronic Guide Catheters are intended to be used in the coronary or the peripheral system; and are designed to provide a pathway through which therapeutic devices are introduced.
ਨਾ Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Zillerman
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