(115 days)
Not Found
No
The document describes a physical medical device (microcatheter) and its components, without mentioning any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on physical properties and equivalence to a predicate device.
Yes
The "Intended Use / Indications for Use" explicitly states that the device is intended to assist in the delivery of "therapeutic agents such as occlusion coils."
No
The device is intended to assist in the delivery of diagnostic agents, but it is not itself a diagnostic device. It is a microcatheter designed for agent delivery, not for diagnosing conditions.
No
The device description clearly outlines physical components like a flexible shaft, distal tip, luer hub, and hydrophilic coating, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to deliver diagnostic and therapeutic agents into the body (peripheral, coronary, and neuro vasculature). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description details a catheter designed for insertion into blood vessels. This is consistent with a medical device used for delivery, not for analyzing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device is a medical device used for interventional procedures within the body.
N/A
Intended Use / Indications for Use
The Micrus Courier microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents such as occlusion coils, into peripheral, coronary, and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQO
Device Description
The Micrus Microcatheters consist of 4 major components:
- A flexible shaft with a lubricious liner extruded from Teflon. The shaft is reinforced with stainless steel (coiled distally and braided proximally). The outer shaft jacket is made from Pebax and nylon Grilamid L25).
- An atraumatic distal flexible tip containing two radiopaque marker bands. The marker bands are useful in tracking catheter tip position and during placement of detachable embolic coils.
- A standard luer hub insert, which is molded onto the flexible shaft.
- A hydrophilic coating (Hydromer), which covers the distal 100 centimeters of the Microcatheters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary, 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)
Not Found
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
Safety and Efficacy Summary ll.
A. Contact Information
K.016
Margaret Webber Director, Regulatory and Clinical Affairs Micrus Endovascular Corporation 610 Palomar Avenue Sunnyvale, CA 94085
B. Device Name
Micrus Microcatheters, Courier," 165, 170, 190, & 210 Device: Catheter, Intravascular, Diagnostic Regulation Number: 870.1200 Product Code: DQO Device Class: 2
C. Predicate Device(s)
| Number | Description | Clearance Date |
|---|---|---|
| K032624 | Micrus Microcatheter, Concourse-14 | Sept 10, 2003 |
D. Device Description
The Micrus Microcatheters consist of 4 major components:
- 트 A flexible shaft with a lubricious liner extruded from Teflon. The shaft is reinforced with stainless steel (coiled distally and braided proximally). The outer shaft jacket is made from Pebax and nylon Grilamid L25).
- 트 An atraumatic distal flexible tip containing two radiopaque marker bands. The marker bands are useful in tracking catheter tip position and during placement of detachable embolic coils.
- l A standard luer hub insert, which is molded onto the flexible shaft.
- l A hydrophilic coating (Hydromer), which covers the distal 100 centimeters of the Microcatheters.
E. Intended Use
The Micrus Courier Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents such as occlusion coils, into peripheral, coronary, and neuro vasculature.
1
F. Intended Use Predicate Device (per products' Instructions for Use)
The Micrus Microcatheter, Concourse-14 is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents such as occlusion coils, into peripheral, coronary, and neuro vasculature.
2
Micrus Endovascular Corporation
.
| G. Technological (Physical and Mechanical) Characteristics as Compared to Predicate | |||
|---|---|---|---|
| Characteristic | Predicate: Micrus Concourse-14 | Micrus Courier 165, 170, 190, & 210 | Equivalence |
| Shaft Materials | Pebax with PTFE liner | Pebax and nylon with PTFE liner | Substantially equivalent |
| Shaft Design | Flexible single lumen shaft. The catheter shaft is made from Pebax with a PTFE liner. The distal flexible tip is atraumatic with 2 radiopaque markers. | Flexible single lumen shaft. The catheter shaft is made from Pebax & nylon with a PTFE liner. The distal flexible tip is atraumatic with 2 radiopaque markers. | Substantially equivalent |
| Distal Shaft Length | |||
| (dry & hydrated states) | 20 to 25 cm | 30 to 35 cm | Substantially equivalent |
| Proximal ID/OD | |||
| (dry & hydrated states) | ID: 0.0165" – 175" |
OD: 0.031" (2.4 French) | Inner diameters are within specifications:
Courier 165 ID is .0165" minimum
Courier 170 ID is 0.0170" minimum
Courier 190 ID is 0.0190" minimum
Courier 210 ID is 0.0210" minimum
Outer diameters are within specifications:
Courier 165 OD is 0.033" max. (2.3 Fr.)
Courier 170 OD is 0.034" max. (2.4 Fr.)
Courier 190 OD is 0.042" max. (3.0 Fr.)
Courier 210 OD is 0.042" max. (3.0 Fr.) | Substantially equivalent |
| Distal ID/OD
(Dimensions unchanged in
dry & hydrated states) | ID: 0.0165"
OD: 0.025" (1.9 French) | Inner diameters are within specifications:
Courier 165 ID is .0165" minimum
Courier 170 ID is 0.0170" minimum
Courier 190 ID is 0.0190" minimum
Courier 210 ID is 0.0210" minimum
Outer diameters are within specifications:
Courier 165 OD is 0.023" max. (1.7 Fr.)
Courier 170 OD is 0.024" max. (1.8 Fr.)
Courier 190 OD is 0.032" max. (2.5 Fr.)
Courier 210 OD is 0.032" max. (2.5 Fr.) | Substantially equivalent |
. $ C rı 1 iaal /Dhara т. て
3
Micrus Endovascular Corporation
、
| Shaft Marker | Tip Markers | Coating | Effective Length
(dry & hydrated states) | MicroCoil Compatibility | New feature. |
|----------------------------------------------------|-------------------------------------------------|----------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| No shaft marker | Two radiopaque marker bands, spaced 3 cm apart. | Hydrophilic coating. | 150 cm (59") | Coils:
Compatible with 10-System embolic coils.
Wires:
Compatible with 0.010" and 0.014" guide wires. | Substantially
equivalent |
| Shaft marker located at 90 cm from the distal tip. | Two radiopaque marker bands, spaced 3 cm apart. | Hydrophilic coating. | 150 cm (59") | Coils:
Courier 165 & 170 are compatible with 10-System embolic coils; Courier 190 & 210 are compatible with 18-System coils.
Wires:
Courier 165 & 170 are compatible with 0.010" and 0.014" guide wires; Courier 190 & 210 are compatible with 0.014" and 0.018" guide wires. | Substantially
equivalent |
4
Micrus Endovascular Corporat
H.
Dicusson of Non-Clinical Tests and Concludes were based upon the intended use of the dovin
the performal tots performed on the Microcations of SC Sterlits, included and reall
The following table outlines the important device characteristics and the non-clinical test data generated:
| Test or
Comparison | Concourse-14 | Courier 165, 170, 190, & 210 | Substantial
Equivalence |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Tensile strength
and tip attachment
strength | The shaft to hub junction has a minimum
tensile strength of 1.12 lb (5 Newtons).
All transition junctions of the shaft have a
minimum tensile strength of 0.67 lb (3
Newtons). | The shaft to hub junction has a minimum
tensile strength of 1.12 lb (5 Newtons). All
transition junctions of the shaft have a
minimum tensile strength of 0.67 lb (3
Newtons). | Substantially
Equivalent |
| Flexibility/Stiffness | Demonstrates adequate flexibility to bend
easily when under pressure, such as that
exerted by vessel tortuosity. | As compared to the predicate,
demonstrates adequate flexibility to bend
easily when under pressure, such as that
exerted by vessel tortuosity. | Substantially
Equivalent |
| Burst Pressure | Demonstrates a burst strength greater than
300 PSI. | Demonstrates a burst strength greater than
300 PSI. | Substantially
Equivalent |
| Biocompatibility | Materials in the microcatheter
successfully pass all biocompatibility
testing per ISO 10993-1. | Materials in the microcatheter successfully
pass all biocompatibility testing per ISO
10993-1. | Substantially
Equivalent |
| Air leakage at hub | No air leakage during testing with
negative pressure applied to the catheter
hub per ISO 10555-1. | No air leakage during testing with negative
pressure applied to the catheter hub per
ISO 10555-1. | Substantially
Equivalent |
| Liquid leakage | Demonstrates there is no liquid leakage
during testing at 46.4 PSI (maintained for
30 seconds) per ISO 10555-1. | Demonstrates there is no liquid leakage
during testing at 46.4 PSI (maintained for
30 seconds) per ISO 10555-1. | Substantially
Equivalent |
| Fatigue tolerance
and catheter
material integrity | | Catheter advanced and retracted 20 times
in a tortuous arterial model with a 150-
micron filter in a distal location. No
catheter particulate or debris resulted from
the rigorous stress placed upon the
catheter during advancement and
retraction | Substantially
Equivalent |
| Chemical
Integrity/Corrosion
Resistance | Demonstrates corrosion resistance per
ISO 10555-1 in saline solution and boiling
distilled water. | No change to the design of the Courier
microcatheters affected corrosion
resistance. | Substantially
Equivalent |
| Material Used | Pebax shaft. PTFE liner. Hydrophilic
coating. All materials are biocompatible. | Pebax shaft. PTFE liner. Hydrophilic
coating. All materials are biocompatible. | Substantially
Equivalent |
| Labeling | Label content complies with regulatory
requirements of all markets where the
product is sold. Product labels contain at
least 2 removable stickers, which specify
the catalog number, lot number and
product name. | Label content complies with regulatory
requirements of all markets where the
product is sold. Product labels contain at
least 2 removable stickers, which specify
the catalog number, lot number and
product name. | Substantially
Equivalent |
| Proximal shaft kink
radius | Demonstrates a minimum kink resistant
radius | Demonstrates a minimum kink resistant
radius of 0.325" in the proximal shaft. | Substantially
Equivalent |
| Distal shaft kink
radius | Demonstrates a minimum kink resistant
radius of 0.07" in the distal shaft. | Demonstrates a minimum kink resistant
radius of 0.07" in the distal shaft. | Substantially
Equivalent |
| Tracking force | Demonstrates the microcatheter is able to
track through a tortuous path. | Demonstrates the microcatheter is able to
track through a tortuous path with less or
equal force (friction) than the predicate | Substantially
Equivalent |
| | | | |
| Tip shape retention | Demonstrates the Microcatheter maintains
its tip shape when subjected to 3 hours of
soaking in a 37°C. bath. | Demonstrates the Microcatheter maintains
its tip shape when subjected to 3 hours of
soaking in a 37°C. bath. | Substantially
Equivalent |
| Packaging Integrity | Tyvek Pouch. | Tyvek Pouch. | Equivalent |
| | Sterile and non-pyrogenic in unopened
packaging that is designed to maintain
sterility unless the primary product pouch
has been opened or damaged. | Sterile and non-pyrogenic in unopened
packaging that is designed to maintain
sterility unless the primary product pouch
has been opened or damaged. | |
| | Packaging qualified to prevent microbial
recontamination for a minimum of 3-yrs. | The Courier microcatheters use the same
packaging as is used for the Concourse
microcatheter. The package integrity has
been qualified to prevent microbial
recontamination for a minimum of 3-yrs. | |
| Shipping/transit
testing | Demonstrates the microcatheter
successfully withstands the domestic and
international distribution environment, per
ISO 10555-1. | Demonstrates the microcatheter
successfully withstands the domestic and
international distribution environment, per
ISO 10555-1. | Substantially
Equivalent |
| Sterility | Sterilized using EtO with a sterility
assurance level of 10-6 | Sterilized using EtO with a sterility
assurance level of 10-6 | Substantially
Equivalent |
| | The above non-clinical testing has demonstrated the substantially equivalent performance of the Microcatheters | | |
5
Micrus Endovascular Corporation
.
.
.
.
6
The above non-clinical testing has demonstrated the substantially equivalent performance of the Micrus Microcatheters,
"Courier," with the predicate "Concourse" Microcatheter.
41 41
1.1 1
1
The above non-climical testing has and and and and seriormance of the Micrus Micrus Microcalleres,
"Courier," with the produce" Microcaties:
The catheres are single lumen cat
Micrus Endovascular Corporatic
7
I. 510(k) Summary of Safety and Efficacy
Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Micrus Corporation, it is concluded that the "Courier" Microcatheters are substantially equivalent to the "Concourse-14" in safety and effectiveness.
Ray Mabus
Margaret Webber Director, Regulatory and Clinical Affairs Micrus Endovascular Corporation January 9, 2006
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
12 2006 MAY
Micrus Endovascular Corporation c/o Ms. Margaret Webber Director, Regulatory and Clinical Affairs 821 Fox Lane San Jose. CA 95131
K060116 Re:
Micrus Courier Microcatheters Regulation Number: 21 CFR 870.1200 Regulation Name: Catheter Intravascular, Diagnostic Regulatory Class: II Product Code: DQO Dated: March 31, 2006 Received: April 4, 2006
Dear Ms. Webber:
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 such 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.
9
Page 2 - Ms. Margaret Webber
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. Voelmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
Indications for Use
510(k) Number (if known): _ |