(2 days)
Not Found
No
The device description and intended use focus on the physical characteristics and function of a micro catheter for delivering substances. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a micro catheter intended for the infusion of therapeutic agents; it is not the therapeutic agent itself.
Yes
The device's intended use explicitly mentions the controlled selective infusion of "diagnostic materials such as contrast media."
No
The device description clearly describes physical catheters with shafts, lumens, luer adapters, and radiopaque markers, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The description clearly states that these micro catheters are intended for the controlled selective infusion of therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy. This is an invasive procedure performed inside the body.
- Lack of Diagnostic Testing: The device is used to deliver substances or visualize anatomy, not to perform diagnostic tests on biological samples.
Therefore, the function and intended use of these micro catheters fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Rebar Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.
The UltraFlow HPC Flow Directed Micro Catheter is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy. It is not intended for use in the coronary vasculature.
The Nautica Micro Catheter is intended to access peripheral and neurovasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media. Not intended for use in the coronary vasculature.
The Marathon Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
The Echelon™ Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Product codes
KRA
Device Description
The MTI/ev3 micro catheters are single-lumen, end-hole catheters designed for the sub selective infusion of physician-specified therapeutic agents such as embolization materials and diagnostic materials such as contrast media in tortuous, distal vessels. The catheters have a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheters incorporates a standard luer adapter to facilitate the attachment of accessories. The catheters have single or dual radiopaque markers at the distal end to facilitate fluoroscopic visualization. The outer surfaces of the catheters are coated to increase lubricity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro anatomy, distal vasculature of the peripheral and neuro anatomy, peripheral and neurovasculature, peripheral and neuro 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The micro catheter devices have not changed; there is no performance data included in this submission. The Instructions for Use have been revised to remove the pediatric and neonatal contraindication.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K993672, K001966, K002723, K024118, K024122, K034036, K030688, K031992, K042187, K051990
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
K093750 page 1 of 2
DEC - 9 2009
Special 510K
ev3 Micro Catheters
December 04, 2009
9
3. 510(K) SUMMARY
Applicant - Manufacturer Name and Address
Micro Therapeutics dba ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 Establishment Registration No. 2029214
Date: December 04, 2009
Contact Information
Laura Heaton Senior Regulatory Affairs Specialist Main: (949) 837-3700 Direct: (949) 680-1241 Fax: (949) 859-7228
Trade Names
Rebar™ Micro Catheter Ultraflow™ HPC Flow Directed Micro Catheter Nautica™ Micro Catheter Marathon™ Flow Directed Micro Catheter Echelon™ Micro Catheter
Device Classification & Common Name
| Product Code: | KRA, 21CFR Part 870.1210 |
|---|---|
| Classification: | Class II |
| Classification Name: | Catheter, Continuous Flush |
| Common Name: | Micro Catheter |
Predicate Devices - 510(k) References
| Rebar™-14 Micro Catheter | K993672 |
|---|---|
| Rebar™-18, Rebar™-27 Micro Catheter | K001966 |
| Rebar™-10 Micro Catheter | K002723 |
| Ultraflow™ HPC Flow Directed Micro Catheter | K024118 |
| Nautica™ Micro Catheter | K024122 |
| Marathon™ Flow Directed Micro Catheter | K034036 |
| Echelon™-14 Micro Catheter | K030688 |
| Echelon™-10 Micro Catheter | K031992 |
| Echelon™-10, Echelon™-14 Tip Shape Micro Catheter | K042187 |
| Echelon™ Micro Catheter | K051990 |
Description of the Device Subject to Premarket Notification
The MTI/ev3 micro catheters are single-lumen, end-hole catheters designed for the sub selective infusion of physician-specified therapeutic agents such as embolization materials and diagnostic materials such as contrast media in tortuous, distal vessels. The catheters have a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheters incorporates a standard luer adapter to facilitate the attachment of accessories. The catheters have single or dual radiopaque markers at the distal end to
1
December 04, 2009
facilitate fluoroscopic visualization. The outer surfaces of the catheters are coated to increase lubricity.
Indications for Use
The Rebar Micro Catheter is intended for the controlled selective infusion of physicianspecified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.
The UltraFlow HPC Flow Directed Micro Catheter is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy. It is not intended for use in the coronary vasculature.
The Nautica Micro Catheter is intended to access peripheral and neurovasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media. Not intended for use in the coronary vasculature.
The Marathon Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
The Echelon™ Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Performance Data
The micro catheter devices have not changed; there is no performance data included in this submission. The Instructions for Use have been revised to remove the pediatric and neonatal contraindication.
Substantial Equivalence
The devices have not changed and no new risks have been identified. The indications for use demonstrate the MT//ev3 Micro Catheters are substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
eV3 Inc. c/o Ms. Laura Heaton Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine. CA 92618
DEC - 9 7009
Re: K093750
Rebar™ Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II (two) Product Code: KRA Dated: December 4, 2009 Received: December 7, 2009
Dear Ms. Heaton:
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 conceming your device in the Federal Register.
3
Page 2 - Ms. Laura Heaton
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/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/ReportalProblem/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,
buna R. h. h. hner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
December 04, 2009
2. STATEMENT OF INDICATIONS FOR USE
Indications for Use
510(k) Number (if known): 长〇9 375C
Device Name: Rebar™ Micro Catheter
Indications for Use: The Rebar Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.
Prescription Use X (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
bma D. Vclmes
scular Devices
510(k) Ni
5
December 04, 2009
Indications for Use
510(k) Number (if known): 长ひ9.375C
Device Name: UltraFlow™ HPC Flow Directed Micro Catheter
Indications for Use: The UltraFlow HPC Flow Directed Micro Catheter is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy. It is not intended for use in the coronary vasculature.
Prescription Use X
(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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
6
December 04, 2009
Indications for Use
510(k) Number (if known): KO9 3750
Device Name: Nautica™ Micro Catheter
Indications for Use: The Nautica Micro Catheter is intended to access peripheral and neurovasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media. Not intended for use in the coronary vasculature.
Prescription Use _ X
(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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
7
December 04, 2009
Indications for Use
510(k) Number (if known): KO93750
Device Name: Marathon™ Micro Catheter
Indications for Use: The Marathon Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
8
December 04, 2009
(
| Indications for Use | ||
|---|---|---|
| 510(k) Number (if known): 长۵۶: 375ປ | ||
| Device Name: Echelon™ Micro Catheter | ||
| Indications for Use: The Echelon™ Micro Catheter is intended to access peripheral and neuro | ||
| vasculature for the controlled selective infusion of physician-specified therapeutic agents such | ||
| as embolization materials and of diagnostic materials such as contrast media. | ||
| Prescription Use | 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) | ||
| Page 1 of 1 | ||