(44 days)
Not Found
No
The summary describes a physical medical device (a guiding catheter) and its functional performance testing. There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typically associated with AI/ML-enabled devices.
No
Explanation: The device is a guiding catheter, designed to facilitate the introduction of other therapeutic devices. It does not provide therapeutic treatment itself.
No
The device is described as a guiding catheter used to provide a pathway for therapeutic devices, not to diagnose a condition.
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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The Medtronic Launcher Guiding Catheter is a device used inside the body (in vivo) to provide a pathway for other therapeutic devices within the coronary or peripheral vascular system. It is a surgical/interventional tool, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states it's for providing a pathway for therapeutic devices, not for analyzing biological samples.
The information provided describes a medical device used for interventional procedures, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Medtronic® Launcher™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Launcher catheter is intended to be used in the coronary or peripheral vascular system.
Product codes (comma separated list FDA assigned to the subject device)
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 thin lubricious coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or peripheral vascular 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional testing consisted of hub to shaft, shaft, distal tip to shaft tensile, torque response, lumen lubricity, radiopacity, pressure shaft burst and hub leak, tip compression (softness). Results verified that the Medtronic Launcher Guiding Catheter meets all of the applicable specifications and considered an appropriate device for the intended use.
Biocompatibility tests performed per ISO10993 were chosen based on Guide Catheters categorized as external-communicating devices, circulating blood, limited exposure (≤24 hours). The following test results reports have been received and the results demonstrate that the tests were successfully performed. All materials used for the Medtronic Launcher Guiding Catheter passed the following tests: Acute Intracutaneous Reactivity, Acute Systemic Toxicity, Cytotoxicity, Hemolysis, Sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Section 9
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990)
1. Identifying Information
(a) Submitters Name:
Medtronic AVE, Inc. 37A Cherry Hill Drive Danvers, MA 01923
- Fred L. Boucher R.A.C. (b) Contact Person: (978) 777-0042
- Percutaneous Catheter (c) Classification Name: (21 CFR Part 870.1250)
- Medtronic 5F Launcher™ Guide (d) Proprietary Name: Catheter
- (e) Name of Predicate Devices Catheter
Medtronic 6F Launcher™ Guide K021256
Medtronic 5F Genius™ Guide Catheter K010579
2. 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 thin lubricious coating.
3. Intended Use
The Medtronic Launcher 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.
4. Technological Characteristics
The 5F Launcher Guide Catheters are manufactured similar to the legally marketed predicate 6F Guide Catheters.
The manufacturing processes, materials and design are substantially equivalent to the 6F Launcher Guide Catheter and 5F Genius.
1
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- Biocompatibility tests performed per ISO10993 were chosen based on Guide Catheters categorized as external-communicating devices, circulating blood, limited exposure (≤24 hours). The following test results reports have been received and the results demonstrate that the tests were successfully performed. All materials used for the Medtronic Launcher Guiding Catheter passed the following tests:
Acute Intracutaneous Reactivity Acute Systemic Toxicity Cytotoxicity Hemolysis Sensitization
- Biocompatibility tests performed per ISO10993 were chosen based on Guide Catheters categorized as external-communicating devices, circulating blood, limited exposure (≤24 hours). The following test results reports have been received and the results demonstrate that the tests were successfully performed. All materials used for the Medtronic Launcher Guiding Catheter passed the following tests:
-
Functional testing consisted of hub to shaft, shaft, distal tip to shaft tensile, torque 6. response, lumen lubricity, radiopacity, pressure shaft burst and hub leak, tip compression (softness). Results verified that the Medtronic Launcher Guiding Catheter meets all of the applicable specifications and considered an appropriate device for the intended use. Based on a comparison of the intended use, design, invitro test results and the fact that the fundamental scientific technology has not changed, the Launcher guide catheter is considered to be substantially equivalent to the following device:
- o Medtronic 6F Launcher Guiding Catheter
- Medtronic 5F Genius Guiding Catheter O
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or other bird with three curved lines representing its wings or feathers.
APR 2 4 2003
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic, Inc. Mr. Fred L. Boucher, R.A.C. Sr. Regulatory Affairs Manager 37A Cherry Hill Drive Danvers, MA 01923
Re: K030779
Trade/Device Name: 5F Launcher™ Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: April 7, 2003 Received: April 8, 2003
Dear Mr. Boucher:
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.
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
3
Page 2 - Mr. Fred L. Boucher, R.A.C.
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division 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,
N. Oele VTu
Bram D. Zuckerman, M.D.
m D. Zuckerman, M Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number:
1630779
Device Name:
Medtronic® 5F Launcher™ Guiding Catheter
Indications for Use:
The Medtronic® Launcher™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Launcher catheter is intended to be used in the coronary or peripheral vascular system.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use _ OR
N. Delette
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030779