(65 days)
Not Found
No
The summary describes a physical delivery catheter and its mechanical properties, with no mention of AI or ML capabilities.
No.
The device is a delivery catheter used to introduce other leads and catheters; it does not itself provide therapy.
No
Explanation: The device is described as a delivery catheter used for introducing leads and catheters for pacing or defibrillation, not for diagnosing medical conditions. Its function is interventional, not diagnostic.
No
The device description clearly outlines a physical catheter and dilator made of Polyether Block Amide and Polyethylene, with specific dimensions, a hemostatic valve, and a radiopaque tip. The performance studies also focus on physical properties and integrity of the hardware components.
Based on the provided information, the Medtronic C315 Delivery Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of pacing or defibrillator leads and catheters into the body. This is an invasive procedure performed on a living patient.
- Device Description: The description details a physical catheter and dilator designed for insertion and manipulation within the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
The C315 is a medical device used in vivo (within the body) for a procedural purpose, not for analyzing biological samples in vitro.
N/A
Intended Use / Indications for Use
The C315 is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Medtronic C315 Delivery Catheter 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Device integrity testing was performed to support the equivalency of the Medtronic C315 Delivery Catheter product family to the predicates. The following in-vitro bench tests were completed using C315 devices:
● Dimensional Measurement
● Catheter Tensile Strength
● Curve Stiffness
● Straight Shaft Distal Segment Compression
● Radiopacity
● Curve Retention
● Manual Slitting of Catheter
● Guide Catheter Leakage Test (Catheter Shaft Related)
● Guide Catheter Leakage Test (Valve Related)
● Torsional Strength
● Chemical Compatibility
● Straight Shaft Kink Resistance
● Guide Catheter Interface Testing
● Transport Simulation
● Seal Strength
● Pouch Seal Area
● Dye Penetration Test
The Medtronic C315 Delivery Catheter product family met all specified design and performance requirements.
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
CONFIDENTIAL May not be reproduced without written permission from Medironic
Parkmore Business Park West
Senior Regulatory Affairs Specialist
Parkmore Business Park West
Phone: (011-353-91) 708990
Fax: (011-353-91) 708672
July 02, 2010
Galway Ireland
Galway Ireland
Medtronic Ireland
Elaine O'Connor
Medtronic Ireland
510(k) Summary
Date Prepared:
Applicant:
Primary Correspondent:
Alternate Correspondent:
Bruce Backlund Senior Regulatory Affairs Specialist Cardiac Rhythm Disease Management 8200 Coral Sea Street MS MVS11 Mounds View MN 55112 USA Phone: (763) 526-2357 Fax: (651) 367-0603 Email: bruce.j.backlund@medtronic.com
Email: elaine.oconnor(@medtronic.com
Proprietary Name:
Medtronic C315 Delivery Catheter
Medtronic Ireland C315 Delivery Catheter Special 510(k)
K101885
SEP 0 9 2010
8
1
| Common Name: | C315 Delivery Catheter |
|---|---|
| Device Classification Name: | Catheter, Percutaneous |
| Class II, 21 CFR 870.1250 | |
| Product Code: | DQY |
| Device Description: | The Medtronic C315 Delivery Catheter 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: | The C315 is indicated for the introduction of various types of |
| pacing or defibrillator leads and catheters. This is identical to the | |
| predicate Acumen Single Lumen Delivery Sheath (510(k) cleared | |
| K080500). | |
| Substantially Equivalent | |
| Devices: | The Medtronic C315 Delivery Catheter product family uses similar |
| technology and has similar intended uses, function, materials and | |
| method of operation to the predicates Acumen Single Lumen | |
| Delivery Sheath (510(k) K080500) and Attain Command™ 6250 | |
| product family (510(k) K090659). | |
| Summary of Technological | |
| Characteristics: | The Medtronic C315 Delivery Catheter consists of a hydrophilic |
| coated inner liner to aid lubricity, and an outer jacket, with a wire | |
| braid encapsulated between the inner liner and outer layers. The | |
| distal tip is radiopaque to facilitate imaging under fluoroscopy and | |
| the hub at the proximal end of the shaft consists of an integrated | |
| valve and flushing side port. The catheter is packaged with a | |
| dilator. The technological characteristics of the Medtronic C315 | |
| Delivery Catheter are identical to the predicate Acumen Single | |
| Lumen Delivery Sheath (510(k) K080500). | |
| Summary of Studies: | Device integrity testing was performed to support the equivalency of the Medtronic C315 Delivery Catheter product family to the predicates. The following in-vitro bench tests were completed using C315 devices: |
| ● Dimensional Measurement | |
| ● Catheter Tensile Strength | |
| ● Curve Stiffness | |
| ● Straight Shaft Distal Segment Compression | |
| ● Radiopacity | |
| ● Curve Retention | |
| ● Manual Slitting of Catheter | |
| ● Guide Catheter Leakage Test (Catheter Shaft Related) | |
| ● Guide Catheter Leakage Test (Valve Related) | |
| ● Torsional Strength | |
| ● Chemical Compatibility | |
| ● Straight Shaft Kink Resistance | |
| ● Guide Catheter Interface Testing | |
| ● Transport Simulation | |
| ● Seal Strength | |
| ● Pouch Seal Area | |
| ● Dye Penetration Test | |
| The Medtronic C315 Delivery Catheter product family met all specified design and performance requirements. | |
| Summary of Clinical Data: | No clinical investigation has been performed for this device. |
.
·
Medtronic Ireland C315 Delivery Catheter
Special 510(k)
u
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ﻟﻠﻘﺎﻧﻮﻥ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
MedIronic Ireland
C315 Delivery Catheter
Special 510(k)
·
.
.
.
3
The testing which supports the biocompatibility of the Medtronic Biocompatibility C315 Delivery Catheter product family is consistent with Information: International Standard ISO10993-1:2009 "Biological Evaluation of Medical devices- Part 1: Evaluation and Testing." When classified according to this standard, the catheter and dilator included in the Medtronic C315 Delivery Catheter product family are categorized as external communicating devices with limited exposure i.e. whose contact with circulating blood is ≤ 24 hours. The following Biocompatibility tests were performed: Cytotoxicity Using ISO Elution Method . ASTM Hemolysis Study . Material Mediated Pyrogen t ISO Maximization Sensitization Study . ISO Intracutaneous Study . ISO Systemic Toxicity Study . C3a and SC5b-9 Complement Activation Assay Study . Physicochemical Tests for Plastic . ASTM Partial Thromboplastin Time Study (PTT) . In Vivo Thromboresistance Study in the Dog, Jugular Vein . The biocompatibility evaluation completed verifies that the Medtronic C315 Delivery Catheter product family is biocompatible. The Medtronic C315 Delivery Catheter product family will be Sterilization Validation: The Meditorne CSTS Donvery Casinory Casine (EtO) sterilization nrocess. Through the data and information presented, Medtronic Ireland Conclusion: I hrough the data and information product family to considers the modifications to the predicate devices.
Medtronic Ireland C315 Delivery Catheter Special 510(k)
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtronic, Inc. c/o Ms. Elaine O'Connor Primary Regulatory Affairs Specialist Medtronic Ireland Parkmore Business Park West Galway Ireland
SEP 0 9 2010
Re: K101885
Trade/Device Name: Medtronic C315 Delivery Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY Dated: August 19, 2010 Received: August 23, 2010
Dear Ms. O'Connor:
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.
5
Page 2 - Ms. O'Connor
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Bram, Zuckerman, MD Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
CONFIDENTIAL
May not be reproduced without written permission from Medtronic
7
| Indication for Use | K101885 |
|---|---|
| 510(k) Number (if known): | K101885 |
| SEP 09 2010 | |
| Device Name: | Medtronic C315 Delivery Catheter |
| Indications for Use: | The C315 is indicated for the introduction of various types of pacing or defibrillator leads and catheters. |
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)
W.M.P
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K106885
Medtronic Ireland C315 Delivery Catheter Special 510{k}