(28 days)
Not Found
Not Found
No
The device description focuses on physical components and mechanical function for lead delivery, with no mention of AI/ML terms or capabilities.
No
The "Intended Use / Indications for Use" section explicitly states "This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads".
No
Explanation: The device is described as a "non-therapeutic delivery system" intended to aid in the introduction and placement of cardiac leads. Its purpose is to deliver other devices, not to diagnose conditions.
No
The device description explicitly lists multiple hardware components including catheters, dilators, slitters, valves, guidewires, needles, and syringes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "non-therapeutic delivery system intended to aid in the introduction and placement of cardiac leads." This describes a surgical or interventional tool used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The description details components like catheters, dilators, guidewires, needles, and syringes, all of which are used for accessing and navigating within the body during a procedure.
- Anatomical Site: The device is intended for use in the "right chambers of the heart, coronary sinus," which are internal anatomical locations.
- Input Imaging Modality: The mention of "Fluoroscopy" indicates the use of real-time imaging during the procedure to guide the device within the body.
In Vitro Diagnostic (IVD) devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
N/A
Intended Use / Indications for Use
SelectSite C304 Deflectable Catheter System: This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED.
C315 Delivery System: This non-therapeutic delivery system is in the introduction and placement of cardiac leads into the right chambers of the heart. The leads are implanted in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED.
Product codes (comma separated list FDA assigned to the subject device)
DOY, DQY
Device Description
SelectSite C304 Deflectable Catheter System: The SelectSite C304 Deflectable Catheter System contains 1 deflectable catheter, 1 deflectable catheter dilator, 1 universal slitter, 1 valve, 1 guidewire, 1 needle and 1 syringe. The SelectSite C304 Deflectable Catheter System is designed to access the coronary sinus and the chambers of the heart. The percutaneous needle and syringe are used to access the venous insertion site, the guidewire to access the vein. the introducer valve to reduce blood loss during the implant procedure, the deflectable catheter to introduce a transvenous device, the deflectable catheter dilator to facilitate deflectable catheter passage and the guide catheter slitter to remove the deflectable catheter. The SelectSite C304 Deflectable Catheter System is available in three models which are the C304-S59, C304-L69, and C304-XL74. All components except the deflectable catheter and dilator are identical in each model.
C315 Delivery System: The Medtronic C315 Delivery System contains one catheter and one dilator constructed of Polyether Block Amide and Polyethylene respectively. It is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. There are seven models in the Medtronic C315 Delivery Catheter product family, all of which have the same inner and outer diameter (5.4Fr and 7.0Fr respectively). The models differ in useable length, which varies from 20cm to 43cm. Proximally, the C315 is equipped with a hemostatic valve, and the distal tip is radiopaque to facilitate imaging under fluoroscopy. The C315 is designed to be slittable, thereby allowing its removal after device placement. A variety of curves are available to accommodate various anatomies and different lead locations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Heart (coronary sinus and chambers, specifically right chambers for C315 Delivery System)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The labeling modifications regarding compatible lead size to the subject device are supported through design verification activities. All design verification activities were completed successfully.
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.
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 8, 2022
Medtronic Sarah Meyer Senior Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112
Re: K223178
Trade/Device Name: SelectSite C304 Deflectable Catheter System, C315 Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: October 10, 2022 Received: October 11, 2022
Dear Sarah Meyer:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Hetal B. Patel -S
Hetal Odobasic Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223178
Device Name C315 Delivery System
Indications for Use (Describe)
This non-therapeutic delivery system is in the introduction and placement of cardiac leads into the night chambers of the heart. The leads are implanted in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K223178
Device Name
SelectSite C304 Deflectable Catheter System
Indications for Use (Describe)
This non-therapeutic delivery system is in the introduction and placement of cardiac leads in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ✖ Prescription Use (Part 21 CFR 801 Subpart D) | ❍ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
| Date Prepared: | October 10, 2022 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Medtronic Cardiac Rhythm Management | |
| 8200 Coral Sea Street N.E. | |
| Mounds View, MN 55112 | |
| Establishment Registration Number: 218220 | |
| Contact Person: | Sarah Meyer |
| Sr. Principal Regulatory Affairs Specialist | |
| Medtronic Cardiac Rhythm Management | |
| 8200 Coral Sea Street N.E. | |
| Mounds View, MN 55112 | |
| Phone: 763.526.2350 | |
| Fax: 651-367-0603 | |
| Email: sarah.meyer@medtronic.com |
General Information
| Trade Name: | SelectSite C304 Deflectable Catheter System
C315 Delivery System |
|--------------------------------------------------------------------------|---------------------------------------------------------------------|
| Common Name: | Catheter delivery system |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | DQY |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
| Predicate Device:
(SelectSite C304
Deflectable
Catheter System) | SelectSite C304 Deflectable Catheter System |
| Predicate Device: | C315 Delivery Catheter |
(C315 Delivery
C315 Delivery Catheter
System)
C313 Delivery Catheter
Device Description
SelectSite C304 Deflectable Catheter System
The SelectSite C304 Deflectable Catheter System contains 1 deflectable catheter, 1 deflectable catheter dilator, 1 universal slitter, 1 valve, 1 guidewire, 1 needle and 1 syringe. The SelectSite
5
C304 Deflectable Catheter System is designed to access the coronary sinus and the chambers of the heart. The percutaneous needle and syringe are used to access the venous insertion site, the guidewire to access the vein. the introducer valve to reduce blood loss during the implant procedure, the deflectable catheter to introduce a transvenous device, the deflectable catheter dilator to facilitate deflectable catheter passage and the guide catheter slitter to remove the deflectable catheter. The SelectSite C304 Deflectable Catheter System is available in three models which are the C304-S59, C304-L69, and C304-XL74. All components except the deflectable catheter and dilator are identical in each model.
C315 Deliverv System
The Medtronic C315 Delivery System contains one catheter and one dilator constructed of Polyether Block Amide and Polyethylene respectively. It is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. There are seven models in the Medtronic C315 Delivery Catheter product family, all of which have the same inner and outer diameter (5.4Fr and 7.0Fr respectively). The models differ in useable length, which varies from 20cm to 43cm. Proximally, the C315 is equipped with a hemostatic valve, and the distal tip is radiopaque to facilitate imaging under fluoroscopy. The C315 is designed to be slittable, thereby allowing its removal after device placement. A variety of curves are available to accommodate various anatomies and different lead locations.
Indications for Use
SelectSite C304 Deflectable Catheter System
This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED.
C315 Delivery System
This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads into the right chambers of the heart. The leads are implanted in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED.
Technological Characteristics
The technology of the subject devices is identical to the respective predicates. Compared to the predicate devices, the subject devices have updated instructions for use (IFU) to indicate a larger compatible lead size. There are no changes to the design, physical characteristics, materials, packaging, or sterilization presented in this subject devices have similar indications for use to the respective predicate devices. The intended use of the catheters, to introduce transvenous devices to the heart, remains the same.
When compared to the predicate devices, the subject SelectSite C304 Deflectable Catheter System and subject C315 Delivery System presented in this submission have the same:
6
- Intended use
- Operating principle
- Design features
- Device functionality
- Biological safety
- Packaging materials ●
- Shelf life
The subject SelectSite C304 Deflectable Catheter System and C315 Delivery System devices differ from the respective predicates in that the subject devices have updated instructions for use (IFU) to indicate a larger compatible lead size.
Substantial Equivalence and Summary of Studies
The labeling modifications regarding compatible lead size to the subject device are supported through design verification activities. All design verification activities were completed successfully. The subject devices are substantially equivalent to the specified predicate devices based on comparisons of the intended use, device functionality, and technological characteristics.
Conclusion
The results of the verification testing met the specified acceptance criteria and did not raise new or different questions of safety or effectiveness. Therefore, the labeling modifications for the C315 Delivery System and SelectSite C304 Deflectable Catheter System described in this submission result in a device that is substantially equivalent to the respective predicates.