(114 days)
No
The 510(k) summary describes a physical guiding catheter and its mechanical properties, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is a guiding catheter used to facilitate the introduction of other diagnostic or therapeutic devices, not a therapeutic device itself.
No
The device is a guiding catheter used to facilitate the introduction of other diagnostic or therapeutic devices, rather than performing a diagnostic function itself.
No
The device description clearly describes a physical catheter system comprised of an outer and inner catheter, which are hardware components. The performance studies also focus on physical properties and performance of the catheter.
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 Chaperon Guiding Catheter is for "general intravascular use, including the neuro and peripheral vasculature" and to "facilitate introduction of diagnostic or therapeutic devices." This describes a device used within the body to access and deliver other devices, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description details a catheter system designed to advance devices through the vasculature. This aligns with an interventional or access device, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
In summary, the Chaperon Guiding Catheter is a medical device used for accessing and navigating within the body's vascular system, which is not the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Chaperon Guiding Catheter is intended for general intravascular use, including the neuro and peripheral vasculature. Chaperon Guiding Catheter can be used to facilitate introduction of diagnostic or therapeutic devices. Chaperon Guiding Catheter is not intended for use in coronary arteries.
Product codes
DQY
Device Description
The Chaperon Guiding Catheter system is designed to advance interventional and diagnostic devices through the vasculature. The device is intended for general intravascular use, including the neuro and peripheral vasculature. The Chaperon Guiding Catheter is a two-catheter system comprised of the outer catheter and the inner catheter. The Chaperon Guiding Catheter system can be used individually with 0.035 in or a 0.038 in guidewire or together with the Inner Catheter to access the desired anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro and peripheral 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
Bench Testing: Surface Contamination & Tip Configuration, Dimensional Inspection & Physical Attributes, Tensile Strength, Hub Attachment Strength, Tip Attachment Strength, Freedom from Leakage - Fluid & Air, Leak Test (High Static Pressure), Hub Gauging, Separation Force, Stress Cracking, Screwing Torque, Ease of Assembly, Resistance to Overriding, Flow Rate, Radio-Detectability, Catheter Burst & Leakage, Stiffness & Kink Resistance, Durability & Lubricity & Fatigue. All met established criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MicroVention Inc.
Trade Name:
Generic Name:
Classification:
Submitted By:
| 510(k) Summary | K082385 |
|---|---|
| Chaperon Guiding Catheter System | |
| Percutaneous Catheter | |
| Class II, 21 CFR 870.1250 | DEC 11 2008 |
75 Columbia Aliso Viejo, California U.S.A. Florin Truuvert Contact:
MicroVention, Inc
Predicate Device:
| Number | Description | Predicate For | Clearance Date |
|---|---|---|---|
| K070970 | Penumbra Inc., | ||
| Neuron Intracranial | |||
| Access System | Chaperon Guiding | ||
| Catheter System | August 17, | ||
| 2007 |
Device Description
The Chaperon Guiding Catheter system is designed to advance interventional and diagnostic devices through the vasculature. The device is intended for general intravascular use, including the neuro and peripheral vasculature. The Chaperon Guiding Catheter is a two-catheter system comprised of the outer catheter and the inner catheter. The Chaperon Guiding Catheter system can be used individually with 0.035 in or a 0.038 in guidewire or together with the Inner Catheter to access the desired anatomy.
Indication For Use
Chaperon Guiding Catheter is intended for general intravascular use, including the neuro and peripheral vasculature. Chaperon Guiding Catheter can be used to facilitate introduction of diagnostic or therapeutic devices. Chaperon Guiding Catheter is not intended for use in coronary arteries.
1
Verification and Test Summary Table
| Bench Testing | Result |
|---|---|
| Surface Contamination & Tip Configuration | Met established criteria |
| Dimensional Inspection & Physical Attributes | Met established criteria |
| Tensile Strength | Met established criteria |
| Hub Attachment Strength | Met established criteria |
| Tip Attachment Strength | Met established criteria |
| Freedom from Leakage - Fluid & Air | Met established criteria |
| Leak Test (High Static Pressure) | Met established criteria |
| Hub Gauging | Met established criteria |
| Separation Force | Met established criteria |
| Stress Cracking | Met established criteria |
| Screwing Torque | Met established criteria |
| Ease of Assembly | Met established criteria |
| Resistance to Overriding | Met established criteria |
| Flow Rate | Met established criteria |
| Radio-Detectability | Met established criteria |
| Catheter Burst & Leakage | Met established criteria |
| Stiffness & Kink Resistance | Met established criteria |
| Durability & Lubricity & Fatigue | Met established criteria |
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and equivalency of the Chaperon Guiding Catheter System compared with the predicate device Penumbra Neuron Intracranial Access System (K070970).
The devices,
- Have the same intended use, .
- Use the same operating principle, .
- Incorporate the same basic design, .
- Use similar construction and material, .
- Are packaged and sterilized using same processes. .
In summary, the Chaperon Guiding Catheter System described in this submission is, in our opinion, substantially equivalent to the predicate device.
2
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 16 2008
Microvention, Inc. c/o Mark Job Reviewer Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K082385
Trade/Device Name: Chaperon Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: November 11, 2008 Received: November 12, 2008
Dear Mr. Job:
This letter corrects our substantially equivalent letter of December 11, 2008.
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 (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.
3
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); 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 continue 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Radiological Health
D. Vahner
Image /page/3/Picture/6 description: The image contains a handwritten symbol or signature. It appears to be a stylized letter or a unique mark, possibly representing initials or a personal identifier. The symbol is composed of curved and straight lines, with a flowing, calligraphic quality. The overall impression is that of a deliberate and artistic design.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Chaperon Guiding Catheter System
Indications for Use:
Chaperon Guiding Catheter is intended for general intravascular use, including the neuro and peripheral vasculature. Chaperon Guiding Catheter can be used to facilitate introduction of diagnostic or therapeutic devices. Chaperon Guiding Catheter is not intended for use in coronary arteries.
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 OF NEBDED)
.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K062385 |
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