(60 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of AI or ML.
No.
The device is a guidewire indicated for aiding in the selective placement of catheters during diagnostic and/or therapeutic procedures, not for performing the therapy itself.
Yes.
The "Intended Use / Indications for Use" section states: "The Meridian Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral, and cerebral vasculature during diagnostic and/or therapeutic procedures." This explicitly mentions diagnostic procedures.
No
The device description explicitly states it is a "stainless steel guidewire with a radiopaque, distal coil" and includes physical accessories like a torque device and introducer, indicating it is a physical medical device, not software-only.
Based on the provided information, the Meridian Guidewire is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "general intravascular use to aid in the selective placement of catheters in the peripheral, visceral, and cerebral vasculature during diagnostic and/or therapeutic procedures." This describes a device used within the body for procedural guidance, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a physical guidewire with specific material and coating properties, along with accessories for manipulation and introduction. This aligns with a medical device used in interventional procedures, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Meridian Guidewire does not fit this description.
N/A
Intended Use / Indications for Use
The Meridian Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral, and cerebral vasculature during diagnostic and/or therapeutic procedures.
Product codes
DQX
Device Description
The Meridian Guidewire is a stainless steel guidewire with a radiopaque, distal coil. The distal portion of the guidewire is hydrophilically coated. Included within the sterile pouch is a torque device to assist in guidewire manipulation and a guidewire introducer to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, visceral, and cerebral vasculature
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
Biocompatibility testing, extensive bench testing, and an in vitro design validation study were performed as well as shelf-life testing and an assessment of bioburden, pyrogen, EtO residuals, and sterility.
Key Metrics
Not Found
Predicate Device(s)
SilverSpeed Guidewire (K993257)
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
510(k) Summary
・
510(k) Summary .
JAN 2 6 2010
KO93681
| 510(k) Owner: | Micro Therapeutics dba ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration No. 2029214 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Deborah Baker-Janis
Senior Regulatory Affairs Specialist,
Regulatory Affairs
Telephone: (949) 297-9246
E-mail: dbakerjanis@ev3.net |
| Date Summary Prepared: | 25 November 2009 |
| Trade Name of Device: | Meridian Guidewire |
| Common Name of Device: | Catheter Guidewire |
| Classification of Device: | DQX, Catheter Guidewire (21 CFR 870.1330), Class II |
| Predicate Device: | SilverSpeed Guidewire (K993257) |
| Device Description: | The Meridian Guidewire is a stainless steel guidewire with a
radiopaque, distal coil. The distal portion of the guidewire is
hydrophilically coated. Included within the sterile pouch is a torque
device to assist in guidewire manipulation and a guidewire introducer to
ease the introduction of the guidewire into the catheter hub and/or
hemostasis valve. |
| Intended Use: | The Meridian Guidewire is indicated for general intravascular use to aid
in the selective placement of catheters in the peripheral, visceral, and
cerebral vasculature during diagnostic and/or therapeutic procedures. |
| Summary of Technological Characteristics: | The Meridian Guidewire and the predicate device both consist of a core
guidewire with overlying soldered distal coil. The materials and
dimensions of the Meridian Guidewire are similar to those of the
predicate device. The packaging materials and materials comprising
the accessories are identical to those of the predicate device. |
| Non-Clinical Performance Data: | Biocompatibility testing, extensive bench testing, and an in vitro design
validation study were performed as well as shelf-life testing and an
assessment of bioburden, pyrogen, EtO residuals, and sterility. |
| Conclusion: | The Meridian Guidewire is substantially equivalent to the SilverSpeed
Guidewire based on the successful completion of non-clinical testing,
identical principles of operation and indications for use, similarities in
the design, materials, and dimensions of the device, identical
accessories and final packaging, and similar design specifications. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized bird, possibly an eagle or similar avian creature, with its wings spread in a dynamic, abstract form. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and the country it represents.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JAN 2 6 2010
Micro Therapeutics, Inc. c/o Ms. Deborah Baker-Janis Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, CA 92681
Re: K093681
Trade/Device Name: Meridian Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DOX Dated: November 25, 2009 Received: November 27, 2009
Dear Ms. Baker-Janis: .
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.
2
Page 2 - Ms. Deborah Baker-Janis
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 (OS) 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 vours.
vuna R. V. Muniz
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
2. Indications for Use Statement
Indications for Use
510(k) Number (if known): KO9 368 |
Device Name: Meridian Guidewire
Indications for Use: The Meridian Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, and cerebral vasur ture during diagnostic and/or therapeutic procedures.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Dumar. Voondurmense of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices |
510(k) Number_Ko.93681
Page 1 of 1
CONFIDENTIAL
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