(268 days)
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.
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.
The provided document is a 510(k) summary for the Orion™ Micro Catheter, which is a medical device for controlled selective infusion. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data (biocompatibility, bench testing, in-vitro design validation, and shelf-life testing).
Because this is a 510(k) for a physical medical device (a catheter) and not an AI/ML-driven diagnostic or prognostic tool, the types of studies, acceptance criteria, and specific metrics (like sensitivity, specificity, AUC) typically associated with AI/ML systems or diagnostic devices are not present. The document describes engineering, material, and performance tests for the catheter.
Therefore, many of the requested fields are not applicable or cannot be extracted from this specific document.
Here's an attempt to answer based on the provided text, indicating "N/A" where the information is not present or not relevant to this type of device submission:
**1. Table of acceptance criteria and the reported device performance**
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance / Outcome |
| :------------------------------ | :---------------------------------------- | :------------------------------------------------------------------------------------ | :--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| **Biocompatibility Testing** | Cytotoxicity | Pass (implied, no specific numeric criteria provided) | Included in the submission. The "Substantial Equivalence Determination" section states the information presented shows the device is substantially equivalent, implying successful completion of these tests. |
| | Sensitization | Pass (implied) | Included in the submission. |
| | Intracutaneous | Pass (implied) | Included in the submission. |
| | Systemic Toxicity | Pass (implied) | Included in the submission. |
| | Pyrogen | Pass (implied) | Included in the submission. |
| | Coagulation UPPT | Pass (implied) | Included in the submission. |
| | Thromboresistance | Pass (implied) | Included in the submission. |
| | Complement Activation C3a and SC5b-9 Assy | Pass (implied) | Included in the submission. |
| **Bench Testing** | Aspiration Testing | Pass (implied) | Included in the submission. |
| | Catheter Particle Testing | Pass (implied) | Included in the submission. |
| | Catheter Tip Shape Retention | Pass (implied) | Included in the submission. |
| | Catheter Trackability Coating Performance | Pass (implied) | Included in the submission. |
| | Catheter Coating Integrity | Pass (implied) | Included in the submission. |
| | Dimensional Inspection | Pass (implied) | Included in the submission. |
| | Distribution Simulation | Pass (implied) | Included in the submission. |
| | DMSO Compatibility Testing | Pass (implied) | Included in the submission. |
| | Dynamic Pressure Burst Test | Pass (implied) | Included in the submission. |
| | Enterprise Stent Compatibility Testing | Pass (implied) | Included in the submission. |
| | Flow Rate Test | Pass (implied) | Included in the submission. |
| | Kink Diameter and Lumen Concentricity | Pass (implied) | Included in the submission. |
| | Static Pressure Test | Pass (implied) | Included in the submission. |
| | Tensile Strength Test | Pass (implied) | Included in the submission. |
| | Tortuous Neurovascular Model | Pass (implied) | Included in the submission. |
| **In-Vitro Design Validation Study** | Pushability | Pass (implied) | Included in the submission. |
| | Navigability | Pass (implied) | Included in the submission. |
| | Radiopacity | Pass (implied) | Included in the submission. |
| | Stent Delivery Friction | Pass (implied) | Included in the submission. |
| | Stability | Pass (implied) | Included in the submission. |
| | Ability to Cross Clot | Pass (implied) | Included in the submission. |
| **Shelf-life Testing** | 6-month Accelerated Aging | Pass (implied for demonstrating shelf-life equivalent to predicate or specified life) | Included in the submission. |
*Note: The document states "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." This implies that all listed tests were successfully completed and met appropriate acceptance criteria for substantial equivalence.*
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**2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)**
* **Sample Size:** Not explicitly stated for each test, but standard engineering and in-vitro testing often involves multiple samples. The document lists the types of tests performed.
* **Data Provenance:** The tests are non-clinical (bench, in-vitro, biocompatibility) and therefore no country of origin for human data or retrospective/prospective designation is applicable. These are laboratory-based studies.
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**3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)**
* **N/A.** This device submission for a catheter does not involve establishing ground truth from expert readings (e.g., medical images). The "ground truth" for these tests would be defined by engineering specifications, material properties, and biological compatibility standards.
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**4. Adjudication method (e.g. 2+1, 3+1, none) for the test set**
* **N/A.** Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers interpreting data (e.g., medical images). This is not relevant for the type of bench and biocompatibility testing described.
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**5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance**
* **N/A.** This is a physical medical device (catheter), not an AI/ML diagnostic system. No MRMC study was conducted or is applicable for this type of submission.
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**6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done**
* **N/A.** This is a physical medical device (catheter), not an algorithm.
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**7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)**
* For Biocompatibility, the "ground truth" is established by adherence to recognized biocompatibility standards and test protocols (e.g., ISO 10993 series).
* For Bench Testing, the "ground truth" is defined by engineering specifications, design requirements, and performance characteristics compared to predicate devices or established safety/efficacy benchmarks for similar catheters.
* For In-Vitro Design Validation, the "ground truth" is based on functional performance against established design criteria and comparison with predicate device performance in a controlled simulated environment.
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**8. The sample size for the training set**
* **N/A.** This is a physical medical device, not an AI/ML system that requires a "training set."
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**9. How the ground truth for the training set was established**
* **N/A.** As no training set is applicable, no ground truth for a training set was established.
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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 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment 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
.
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.
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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
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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
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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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§ 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).