(68 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a guiding catheter, with no mention of AI or ML.
No
The device is a guiding catheter intended for the introduction of other devices, not for therapeutic intervention itself.
No
Explanation: The "Intended Use / Indications for Use" states that the device is "intended for the intravascular introduction of interventional/diagnostic devices." This indicates it is a tool used to facilitate diagnostic procedures, not a diagnostic device itself.
No
The device description clearly states it is a physical catheter made of nylon, stainless steel, and PTFE, and the performance studies involve physical testing of the catheter's properties.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems." This describes a device used within the body to facilitate other procedures, not a device used to test samples outside the body.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. This is consistent with an interventional/diagnostic tool used in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
In summary, the Concierge® Guiding Catheter is an invasive medical device used for guiding other instruments within the vascular system, not a device used for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The Concierge Guiding Catheter is intended for the intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The 6 French Concierge Guiding Catheter is a single lumen catheter that incorporates a nylon body reinforced with stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip. It is available in 6F size and 100cm length and in a variety of shapes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or peripheral vascular systems
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)
Performance testing of the subject 6 French Concierge Guiding Catheter was conducted based on the risk analysis and based on the requirements of the following FDA guidance document and international standards: ISO 10555-1:1995, Sterile, single-use intravascular catheters - Part 1: General requirements ISO 10555-2:1996, Sterile, single-use intravascular catheters - Part 2: Angiographic catheters ANSI/AAMI/ISO 11135-1: 2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing within a risk management process, and the FDA Modified ISO 10993 Test Profile ASTM F756-08, Standard Practice for Assessment of Hemolytic Properties of Materials ISO 10993-3 :2003, Biological Evaluation of Medical Devices Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity ISO 10993-4:2002, Biological evaluation of medical devices - Part 4: Selection of tests for interaction with blood ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-11:2006, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity ISO 2233:2000, Packaging - complete, filled transport packages and unit loads - conditioning and testing ASTM D4169-08, Standard practice for performance testing of shipping containers and systems.
Significant testing successfully completed: Design Verification (Dimensions, Air Leak, Liquid Leak, Catheter Tip Support and Attachment, Tensile, Shaft Kink, Shaft Stiffness, Ink Adherence); Biocompatibility Tests (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Genotoxicity, Hemocompatibility); Physicochemical Tests.
Key results: The results of the testing demonstrated that the subject 6 French Concierge Guiding Catheter met the pre-determined acceptance criteria applicable to the safety and efficacy of the device.
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 5
| 510(k) Summary | ||
|---|---|---|
| General | ||
| Provisions | Submitter Name: | |
| Address: | Merit Medical Systems, Inc. | |
| 1600 West Merit Parkway | ||
| South Jordan, UT 84095 | ||
| Telephone Number: | (801) 208-4196 | |
| Fax Number: | (801) 253-6932 | |
| Contact Person: | Michaela Rivkowich | |
| Date of Preparation: | April 5, 2012 | |
| Registration Number: | 1721504 | |
| Subject | ||
| Device | Trade Name: | 6 French Concierge® Guiding Catheter |
| Common/Usual Name: | Guiding Catheter | |
| Classification Name: | Percutaneous Catheter | |
| Predicate | ||
| Device | Trade Name: | Concierge® Guiding Catheter |
| Common/Usual Name: | Guiding Catheter | |
| Classification Name: | Percutaneous Catheter | |
| Premarket Notification: | K043387 | |
| Manufacturer: | Merit Medical Systems, Inc. | |
| Classification | Class II | |
| 21 CFR § 870.1250 | ||
| Cardiovascular | ||
| Intended Use | The Concierge Guiding Catheter is intended for the intravascular | |
| introduction of interventional/diagnostic devices into the coronary or | ||
| peripheral vascular systems. | ||
| Device | ||
| Description | The 6 French Concierge Guiding Catheter is a single lumen catheter | |
| that incorporates a nylon body reinforced with stainless steel wire | ||
| braid, a PTFE lubricious inner lumen, and a soft radiopaque tip. It is | ||
| available in 6F size and 100cm length and in a variety of shapes. | ||
| Technological | ||
| Characteristics | The technological characteristics of the subject 6 French Concierge | |
| Guiding Catheter are substantially equivalent to those of the | ||
| predicate device, the Concierge Guiding Catheter, 510(k) K043387. | ||
| Safety & | ||
| Performance | ||
| Tests | No performance standards have been established under Section | |
| 514 of the Food, Drug and Cosmetic Act for these devices. | ||
| Performance testing of the subject 6 French Concierge Guiding | ||
| Catheter was conducted based on the risk analysis and based on | ||
| the requirements of the following FDA guidance document and | ||
| international standards: | ||
| ISO 10555-1:1995, Sterile, single-use intravascular catheters - | ||
| Part 1: General requirements ISO 10555-2:1996, Sterile, single-use intravascular catheters - | ||
| Part 2: Angiographic catheters ANSI/AAMI/ISO 11135-1: 2007, Sterilization of health care | ||
| products - Ethylene oxide - Part 1: Requirements for | ||
| development, validation and routine control of a sterilization | ||
| process for medical devices ISO 10993-1: 2009, Biological Evaluation of Medical Devices | ||
| Part-1: Evaluation and Testing within a risk management | ||
| process, and the FDA Modified ISO 10993 Test Profile ASTM F756-08, Standard Practice for Assessment of Hemolytic | ||
| Properties of Materials ISO 10993-3 :2003, Biological Evaluation of Medical Devices | ||
| Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive | ||
| Toxicity ISO 10993-4:2002, Biological evaluation of medical devices - | ||
| Part 4: Selection of tests for interaction with blood ISO 10993-5:2009, Biological evaluation of medical devices - | ||
| Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010, Biological evaluation of medical devices - | ||
| Part 10: Tests for irritation and skin sensitization ISO 10993-11:2006, Biological evaluation of medical devices – | ||
| Part 11: Tests for systemic toxicity ISO 2233:2000, Packaging - complete, filled transport packages | ||
| and unit loads - conditioning and testing ASTM D4169-08, Standard practice for performance testing of | ||
| shipping containers and systems The following is a list of all significant testing that was successfully | ||
| completed: | ||
| Safety & | ||
| Performance | ||
| Tests cont. | Design Verification | |
| Dimensions | ||
| Air Leak | ||
| Liquid Leak | ||
| Catheter Tip Support and Attachment | ||
| Tensile | ||
| Shaft Kink | ||
| Shaft Stiffness | ||
| Ink Adherence |
Biocompatibility Tests
Cytotoxicity
Sensitization
Irritation
Acute Systemic Toxicity
Genotoxicity
Hemocompatibility
Physicochemical Tests | |
| | Safety &
Performance
Tests cont. | The results of the testing demonstrated that the subject 6 French
Concierge Guiding Catheter met the pre-determined acceptance
criteria applicable to the safety and efficacy of the device. |
| Summary of
Substantial
Equivalence | Based on the indications for use, design, and safety and
performance testing, the subject 6 French Concierge Guiding
Catheter meets the requirements that are considered essential for its
intended use and is substantially equivalent to the predicate device,
the Concierge Guiding Catheter, manufactured by Merit Medical
Systems, Inc. | |
1
.
2
3
Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is likely part of a document or sign.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 3 2012
Merit Medical Systems, Inc. c/o Ms. Michaela Rivkowich Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095
Re: K121051
Trade/Device Name: 6 French Concierge Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: May 10, 2012 Received: May 14, 2012
Dear Ms. Rivkowich:
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
4
Page 2 - Ms. Michaela Rivkowich
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/CDRH0ffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bran D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Concierge® Guiding Catheter Section 4, Indications for Use Special Premarket Notification 510(k)
Section 4
Indications for Use K121051 . 510(k) Number (if known): Device Name: 6 French Concierge® Guiding Catheter Indications for Use: The Concierge® Guiding Catheter is intended for the intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Prescription Use _ X ____
AND/OR
Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices
21051 5 . k) Numbe