(30 days)
Not Found
No
The description focuses on the mechanical and structural aspects of a deflectable catheter system and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is described as a "pathway" or "system" to facilitate the introduction of other diagnostic and therapeutic transvenous devices, not a therapeutic device itself.
No
Explanation: The device is described as a "deflectable catheter system" intended to provide a pathway for introducing other devices, including diagnostic and therapeutic ones, into the heart. It does not perform diagnostic functions itself.
No
The device description clearly details a physical catheter system with a handle, lumen, and radiopaque body, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "deflectable catheter system" used to "provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart." It's a tool for delivering other devices into the body, not for analyzing samples from the body.
- Intended Use: The intended use is focused on facilitating the placement of other devices within the heart and its vessels. This is an interventional procedure, not an in vitro diagnostic test.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, this device falls under the category of a medical device used for interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The deflectable catheter system is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
Product codes
74 DQY
Device Description
The Medtronic SelectSite Model C304 Deflectable Catheter System is designed to facilitate the introduction of transvenous devices within the chambers and coronary vasculature of the heart and the introduction of leads in the left heart via the coronary sinus.
The Model C304-S59 deflectable catheter has a single lumen for passage of transvenous devices with a maximum outer diameter of 5.6 French (1.9 mm) and a usable length of 30 cm.
The Model C304-L69 deflectable catheter has a single lumen for passage of transvenous devices with a maximum outer diameter of 5.6 French (1.9 mm) and a usable length of 40 cm.
The deflectable catheter features a deflecting distal section controlled by the deflectable catheter handle for placement of transvenous devices within the chambers of the heart and for coronary sinus cannulation. The body of the deflectable catheter is radiopaque for visibility on fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Chambers and coronary vasculature of the heart, coronary sinus, vessels of the left heart via the coronary sinus.
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)
In Vitro testing was performed to support substantial equivalence to the predicate device(s). The SclectSite Model C304 Deflectable Catheter System met all specified design and performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K033989 p1/2
JAN 2 2 2004
Special 510(k) 510(k) Summary of Substantial Equivalence
SelectSite™ Model C304 KXXXXXXX
510(K) SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Date Prepared: | 22 December 2003 |
|---|---|
| Submitter: | Medtronic Inc. |
| 7000 Central Avenue NE | |
| Minneapolis, MN 55432 | |
| Contact: | Kristy K. Mollner, MS, RAC |
| Sr. Regulatory Affairs Specialist | |
| Telephone: | (763) 514-4189 |
| Fax: | (763) 514-6424 |
| Email: | kristina.mollner@medtronic.com |
| Proprietary Name | Medtronic® SelectSite™ Model C304-S59 Deflectable |
| Catheter System | |
| Medtronic® SelectSite™ Model C304-L69 Deflectable | |
| Catheter System | |
| Common Name: | Catheter, Percutaneous |
| Device Classification: | Class II, 21 CFR § 870.1250 |
| Product Code: | 74 DQY |
Device Description
The Medtronic SelectSite Model C304 Deflectable Catheter System is designed to facilitate the introduction of transvenous devices within the chambers and coronary vasculature of the heart and the introduction of leads in the left heart via the coronary sinus.
The Model C304-S59 deflectable catheter has a single lumen for passage of transvenous devices with a maximum outer diameter of 5.6 French (1.9 mm) and a usable length of 30 cm.
The Model C304-L69 deflectable catheter has a single lumen for passage of transvenous devices with a maximum outer diameter of 5.6 French (1.9 mm) and a usable length of 40 cm.
Image /page/0/Picture/10 description: The image shows the Medtronic logo with the word "Confidential" to the right of it. The Medtronic logo consists of a stylized image of a person inside of a circle to the left of the word "Medtronic". The word "Medtronic" is in a bold, sans-serif font. The word "Confidential" is in a smaller, sans-serif font.
1
Special 510(k) 510(k) Summary of Substantial Equivalence SelectSite™ Model C304 KXXXXXXX
The deflectable catheter features a deflecting distal section controlled by the deflectable catheter handle for placement of transvenous devices within the chambers of the heart and for coronary sinus cannulation. The body of the deflectable catheter is radiopaque for visibility on fluoroscopy.
Indications for Use
The deflectable catheter system is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
Substantially Equivalent Devices
| Predicate Device | Manufacturer | 510(k) Number |
|---|---|---|
| Medtronic 10600 Deflectable Catheter Delivery System | Medtronic | K013517 |
| Medtronic Attain Model 6226DEF Deflectable Catheter System | Medtronic | K032312 |
| Introducer Valve Model 6228VAL | Cook Vascular Incorporated | K010128 |
| Universal Slitter Model 6228SLT | Medtronic | Class 1 device exempt from pre-market notification |
Summary of Studies
In Vitro testing was performed to support substantial equivalence to the predicate device(s). The SclectSite Model C304 Deflectable Catheter System met all specified design and performance requirements.
Biocompatibility Information
All device matcrials / components were assessed for biocompatibility consistent with ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing". All materials were found to be biocompatible and in compliance to ISO 10993-1.
Sterilization Validation
The SelectSite Model C304 Deflectable Catheter System will be sterilized using a validated 100% Ethylene Oxide (EtO) sterilization process.
Conclusion
Through the data and information presented, as well as similarities to legally marketed devices, Medtronic, Inc. considers the SelectSite Model C304-S59 and C304-L69 Deflectable Catheter Systems to be substantially equivalent to legally marketed predicate device(s).
Image /page/1/Picture/16 description: The image shows the Medtronic logo with the word "Confidential" to the right of it. The Medtronic logo consists of a stylized caduceus symbol to the left of the word "Medtronic." The word "Medtronic" is written in a bold, sans-serif font. The word "Confidential" is written in a smaller, lighter font.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2004
Medtronic, Inc c/o Ms. Kristy K. Mollner, M.S., RAC Senior Regulatory Affairs Specialist 7000 Central Avenue NE Mail Stop CW304 Minneapolis, MN 55432-3576
Re: K033989
Trade Name: Medtronic® SelectSite™ Model C304-S59 Deflectable Catheter System and Medtronic® SelectSite™ Model C304-L69 Deflectable Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: December 22, 2003 Received: December 23, 2003
Dear Ms. Mollner:
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 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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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.
3
Page 2 - Ms. Kristy K. Mollner, M.S., RAC
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 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 you desire specific advice for your device on the labeling regulation, please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification'(21 CFR Part 807.97). 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) 443-6597, or at its Internet address http://www.fda.gov/cdrh.dsmaldsmamain.html.
Sincerely vours.
Q. Melli
$\mathbb{R}$
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
SelectSite™ Model C304 KXXXXXXX
INDICATIONS FOR USE
Page I of I
510(k) Number (if known): K 0 33 19 9
Device Name:
Medtronic® SelectSite™ Model C304-S59 Deflectable Catheter System
Medtronic® SelectSite™ Model C304-L69 Deflectable Catheter System
Indications for Use: The deflectable catheter system is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over-the Counter Use
el.m.a.
(Division Sian-Off) Division of Cardiovascular Devices (Optional Format 1-2-96)
510(k) Number K033987
Image /page/4/Picture/18 description: The image shows the Medtronic logo with the word "Confidential" next to it. The Medtronic logo consists of a stylized image of a person inside of a circle. The word "Medtronic" is written in a bold, sans-serif font. The word "Confidential" is written in a smaller, sans-serif font.