(268 days)
Not Found
No
The summary describes a physical micro catheter and its performance characteristics, with no mention of AI or ML.
No.
The device is intended for the controlled selective infusion of therapeutic agents or contrast media, meaning it delivers therapeutic substances but is not a therapeutic device itself.
No
Explanation: The device description states its purpose is for "controlled selective infusion of physician-specified therapeutic agents or contrast media." This indicates a treatment delivery function, not a diagnostic one.
No
The device description clearly details a physical catheter with specific material components (stainless steel, Pebax, Nitinol, PTFE, polymer) and features (hypotube, shaft, braid, liner, hub, marker bands). The performance studies also focus on physical characteristics and interactions (biocompatibility, bench testing, in-vitro validation, shelf-life), indicating a hardware device.
Based on the provided information, the Orion™ Micro Catheter device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the controlled selective infusion of therapeutic agents or contrast media into the vasculature. This is a direct medical intervention within the body (in vivo), not a test performed on samples taken from the body (in vitro).
- Device Description: The description details a catheter designed for physical delivery of substances into blood vessels. This aligns with an in vivo medical device, not an in vitro diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory tests. The device's function is purely for delivery.
Therefore, the Orion™ Micro Catheter is a medical device used for therapeutic or imaging purposes within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Orion™ Micro Catheter device is intended for the controlled selective infusion of physician-specified therapeutics agents or contrast media into the vasculature of the peripheral and neuro anatomy.
Product codes
KRA
Device Description
The Orion™ Micro Catheter is a .021 inch size delivery catheter. The construction consists of a proximal stainless steel hypotube for pushability, and a distal multi-durometer Pebax shaft with progressive pitch Nitinol braid reinforcement. A continuous PTFE liner provides an uninterrupted, smooth inner diameter for low friction stent delivery. The proximal hub is molded from a DMSO compatible polymer. The distal shaft incorporates 2 radiopaque marker bands to aid with stent or coil detachment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro anatomy
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)
Non-Clinical Performance Data:
Biocompatibility Testing
- Cytotoxicity
- Sensitization
- Intracutaneous
- Systemic Toxicity
- Pyrogen
- Coagulation UPPT
- Thromboresistance
- Complement Activation C3a and SC5b-9 Assy
Bench Testing
- Aspiration Testing
- Catheter Particle Testing
- Catheter Tip Shape Retention
- Catheter Trackability Coating Performance
- Catheter Coating Integrity
- Dimensional Inspection
- Distribution Simulation
- DMSO Compatibility Testing
- Dynamic Pressure Burst Test
- Enterprise Stent Compatibility Testing
- Flow Rate Test
- Kink Diameter and Lumen Concentricity
- Static Pressure Test
- Tensile Strength Test
- Tortuous Neurovascular Model
In-Vitro Design Validation Study
- Pushability
- Navigability
- Radiopacity
- Stent Delivery Friction
- Stability
- Ability to Cross Clot
Shelf-life Testing
- 6-month Accelerated Aging
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
§ 870.1210 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
1. 510(k) Summarv
The information in this 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).
| 510(k) Owner: | Micro Therapeutics d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration No. 2029214 |
| --------------- | ----------------------------------------------------------------------------------------------------------------------------- |
|---|
Contact Person: Analia Nieto Requlatory Affairs Specialist Telephone: (949) 680-1201 E-mail: anieto@ev3.net
July 31, 2012 Date Summarv Prepared:
Trade Name of Orion™ Micro Catheter Device:
Common Name Catheter, Continuous Flush of Device:
Classification of KRA, Class II Device:
Predicate Micro Therapeutics. Inc. d/b/a ev3 Neurovascular. Rebar® Device: Micro Catheter, K993672
Cordis Neurovascular, Inc., PROWLER® SELECT® Plus Infusion Catheter, K021591
The Orion™ Micro Catheter is a .021 inch size delivery Device Description: catheter. The construction consists of a proximal stainless steel hypotube for pushability, and a distal multi-durometer Pebax shaft with progressive pitch Nitinol braid reinforcement. A continuous PTFE liner provides an uninterrupted, smooth inner diameter for low friction stent delivery. The proximal hub is molded from a DMSO compatible polymer. The distal shaft incorporates 2 radiopaque marker bands to aid with stent or coil detachment.
- The Orion™ Micro Catheter device is intended for the Intended Use: controlled selective infusion of physician-specified therapeutics agents or contrast media into the vasculature of the peripheral and neuro anatomy.
AUG 1 2012
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K113289
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VII 3289 0.2222
Non-Clinical Performance Data:
Biocompatibility Testing
- Cytotoxicity .
- Sensitization .
- . Intracutaneous
- . Systemic Toxicity
- Pyrogen .
- Coagulation UPPT ●
- Thromboresistance .
- Complement Activation C3a and SC5b-9 Assy 0
Bench Testing
- Aspiration Testing ●
- . Catheter Particle Testing
- Catheter Tip Shape Retention .
- Catheter Trackability Coating Performance ●
- . Catheter Coating Integrity
- Dimensional Inspection .
- Distribution Simulation .
- DMSO Compatibility Testing .
- Dynamic Pressure Burst Test .
- Enterprise Stent Compatibility Testing .
- Flow Rate Test .
- Kink Diameter and Lumen Concentricity .
- Static Pressure Test .
- Tensile Strength Test t
- . Tortuous Neurovascular Model
In-Vitro Design Validation Study
- Pushability ●
- . Navigability
- Radiopacity ●
- . Stent Delivery Friction
- . Stability
- Ability to Cross Clot
Shelf-life Testing
- 6-month Accelerated Aging .
Substantial Equivalence Determination
The information presented in the 510k shows that the Orion™ Micro Catheter is substantially equivalent to the Rebar® Micro Catheter and PROWLER® SELECT® Plus in regards to the similar indications for use, device design, device materials, device dimensions, and materials comprising its accessories and final packaging, and design specifications.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 symbol on the right. To the left of the bird is text arranged in a circular pattern that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 1 2012
Micro Therapeutics, Inc. c/o Ms. Analia Nieto Regulatory Affairs Associate 9775 Toledo Way Irvine, CA 92618
Re: K113289
Trade/Device Name: Orion Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II Product Code: KRA Dated: July 23, 2012 Received: July 24, 2012
Dear Ms. Nieto:
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.
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 Or it Far 007); aboning (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Analia Nieto
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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Indications for Use:
510(k) Number (if known):
Device Name:
Orion™ Micro Catheter
The Orion™ Micro Catheter device is intended for the controlled selective infusion of physicianspecified therapeutics agents or contrast media into the vasculature of the peripheral and neuro anatomy.
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)
(Division Sign-Off) Division of Cardiovascular Devices 510fk) Number
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