(241 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a guidewire, with no mention of AI or ML.
No
The device is a guidewire used to facilitate the placement of catheters for therapeutic or diagnostic procedures, but it is not itself performing a therapeutic function. It is an accessory device.
No
Explanation: The device is a guidewire used to facilitate the placement of catheters. While it can be used in diagnostic procedures, its function is for guidance and placement, not for making a diagnosis itself.
No
The device description explicitly states it is a "flexible wire" and mentions "silicone or hydrophilic coating," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the placement of catheters within the coronary arteries during vascular interventional procedures. This is a procedure performed in vivo (within the living body).
- Device Description: The device is a guidewire used to guide other devices within blood vessels. This is a surgical/interventional tool, not a device used to examine specimens in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural and interventional.
N/A
Intended Use / Indications for Use
For use in vascular interventional procedures to facilitate placement of catheters within the coronary arteries.
Product codes
DQX
Device Description
The Concert Medical Conductor coronary guidewire consists of a flexible wire that is available with silicone or hydrophilic coating. The wire is intended to guide the placement of intravasculable will with compatible lumens during PTCA or other therapeutic or diagnostic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary arteries
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)
Bench tests performed in accordance with FDA's January 1995 Coronary and Cerebrovascular Guidewire Guidance included assessments of performance data. Biocompatibility testing was performed on the patient-contacting materials present in the Conductor guidewire in accordance with ISO 10993-1.
Performance data demonstrated that the Concert Medical Conductor guidewire is substantially equivalent to the predicate device and/or met pre-determined acceptance criteria. The risks associated with use of the new device were found acceptable when evaluated by FMEA.
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
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Concert Medical, LLC January 20, 2009
510(k) Premarket Notification (Traditional) Conductor Coronary Guidewire
Section 5 - 510(k) Summary
General Information
Owner's Name: Address:
Telephone Number: Fax Number: Contact Person:
Concert Medical, LLC SEP 2 5 2009 77 Accord Park Drive Norwell, MA 02061 (781) 871-7882 (781) 871-6657 Nancy Martin, VP of Operations & Regulatory Affairs
Subject Device Name: Trade Name: Common/Usual Name: Classification Name:
Conductor Coronary Guidewire Conductor Coronary Guidewire Coronary Guidewire DQX - Wire, Guide, Catheter 21 CFR 870.1330; Class II
Predicate Device Name; Trade Name: Common/Usual Name: Classification Name:
Premarket Notification:
Galeo Guidewire Galeo Guidewire Coronary Guidewire DQX - Wire, Guide, Catheter 21 CFR 870.1330; Class II K001736 (Galeo Hydro Guidewire), SE date August 2, 2000 K982272 (Galeo Guidewire), SE date January 8, 1999
Device Description
The Concert Medical Conductor coronary guidewire consists of a flexible wire that is available with silicone or hydrophilic coating. The wire is intended to guide the placement of intravasculable will with compatible lumens during PTCA or other therapeutic or diagnostic procedures.
Indications for Use
For use in vascular interventional procedures to facilitate placement of catheters within the coronary arteries.
Performance Testing
Performance data demonstrated that the Concert Medical Conductor guidewire is substantially equivalent to the predicate device and/or met pre-determined acceptance criteria. The risks associated with use of the new device were found acceptable when evaluated by FMEA.
Bench tests performed in accordance with FDA's January 1995 Coronary and Cerebrovascular Guidewire Guidance included assessments of performance data. Biocompatibility testing was performed on the patient-contacting materials present in the Conductor guidewire in accordance with ISO 10993-1.
Conclusion
The Concert Medical Conductor coronary guidewire meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness; the Conductor guidewire is substantially equivalent to the predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Concert Medical, LLC C/O Pamela Papineau, RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432
SEP 2 5 2009
Re: K090193
Trade/Device Name: Conductor Coronary Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II Product Code: DQX Dated: September 14, 2009 Received: September 16, 2009
Dear Ms. Papineau:
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 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); medical device reporting (reporting of medical
2
Page 2 - Ms. Pamela Papineau
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,
Duna R. Palmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Concert Medical, LLC January 20, 2009
Section 4 - Indications for Use Statement
510(k) Number (if known):
Device Name:
Conductor Coronary Guidewire
Indications for Use:
For use in vascular interventional procedures to facilitate placement of catheters within the coronary arteries.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over-the -Counter Use (Per 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)
vina D. Jackson
(Division Sign-Off) Division Ci Cardiovascular Devices
510(k) Number_K090193