(30 days)
No
The device description and performance studies focus on the physical characteristics, materials, and mechanical performance of a micro catheter, with no mention of AI or ML capabilities.
No
The device is intended for the infusion of diagnostic and therapeutic agents, acting as a delivery tool, rather than providing therapy itself.
Yes
The device is intended for the infusion of "diagnostic agents, such as contrast media". While it is a delivery device and not a diagnostic tool itself, its intended use directly involves aiding diagnostic procedures by infusing diagnostic agents.
No
The device description clearly details a physical catheter with a lumen, radiopaque markers, hydrophilic coating, and a luer fitting. It also mentions included accessories like a steam shaping mandrel and peel away introducer sheath. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, the Reverse™ Micro Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils" within the body's vasculature. This involves direct interaction with the patient's internal systems.
- Device Description: The description details a physical catheter designed for insertion into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body to provide information for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be inserted into the body for direct diagnostic or therapeutic delivery.
N/A
Intended Use / Indications for Use
The Reverse™M Micro Catheter is intended for use in neuro, peripheral, and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.
Product codes (comma separated list FDA assigned to the subject device)
DQY, KRA, DQO
Device Description
The Reverse™ Micro Catheter is a single lumen catheter designed to be introduced over a steerable guide wire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate vessel navigation. The micro catheter incorporates a PTFE liner to facilitate movement or introduction of devices passed through its lumen. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter body also employs a hydrophilic coating to enhance lubricity and promote deliverability.
The Reverse™ Micro Catheter incorporates a standard luer fitting to facilitate the attachment of ancillary devices. The catheter and included accessories (steam shaping mandrel and peel away introducer sheath) are provided sterile, nonpyrogenic, and are intended for single use only. To accommodate physician preference and anatomical variations, the Reverse™ Micro Catheter is available in two models, Reverse 021, with a 0.021" inner diameter (ID) and, Reverse 027, with a 0.027" ID.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neuro, peripheral, and coronary 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)
Non-clinical performance evaluations, conducted through bench-top verification and validation, packaging verification, and biological safety testing, indicated that the subject device is substantially equivalent to, and at least as safe and effective as the predicate device (Reverse™ Medical Microcatheter, K130858). Modifications to the predicate device were assessed according to risk-based failure mode effects and criticality analysis (FMECA).
Bench testing included:
- surface inspection
- dimensional requirements
- lubricity/ friction
- particulates
- coating characterization
- simulated use device compatibility
- simulated use navigation and delivery
- shelf-life verification (1 year accelerated aging)
Biological Safety Testing: The device was subjected to biocompatibility tests in accordance with FDA Guidance, Use of International Standard ISO 10993-1, including:
- MEM Elution Cytotoxicity
- Guinea Pig Maximization Sensitization
- Intracutaneous Reactivity
- Acute System Injection
- Materials Mediated Rabbit Pyrogen
- Hemolysis Direct Contact
- Hemolysis Indirect Extract Method
- Complement Activation
- In vivo Thrombogenicity
- Genotoxicity, Ames Assay
- Genotoxicity, in vitro Mouse Lymphoma
- Genotoxicity, in vivo Mouse Micronucleus
- USP Physicochemical
Microbial assessments included bioburden, endotoxin, and sterility assurance, validated in accordance with ISO 11135-1.
Packaging Validation: Included Visual Inspection, Bubble Leak, and Seal Strength testing after being subjected to Ethylene Oxide sterilization (2x), environmental conditioning, and simulated shipping and distribution.
All testing passed the acceptance criteria and raised no new issues of safety or effectiveness.
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.
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
§ 870.1250 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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mav 31. 2017
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Eric Elliott Principal Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
Re: K171268
Trade/Device Name: Reverse Micro Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA, DQO Dated: April 28, 2017 Received: May 1, 2017
Dear Mr. Elliott:
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 of medical device
1
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Carlos L. Pena -S- ¯
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Reverse™ Micro Catheter
Indications for Use (Describe)
The Reverse™M Micro Catheter is intended for use in neuro, peripheral, and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary per 21 CFR 807.92
| Submitter's
Name and
Address | Micro Therapeutics, Inc.
d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618 U.S.A. | | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|----------------------------|
| Contact Name
and Information | Eric Elliott
Principal Regulatory Affairs Specialist
Tel: 949.297.5803
E-mail: Eric.Elliott@medtronic.com | | |
| Date Prepared | April 28, 2017 | | |
| Trade Name | Reverse™ Micro Catheter | | |
| Common Name | Catheter Percutaneous, Catheter Infusion, Catheter
Diagnostic | | |
| Classification
Name | Catheter, Percutaneous (DQY) has been classified as Class II per 21 CFR 870.1250 | | |
| | Catheter, Infusion (KRA) has been classified as Class II per 21 CFR 870.1210 | | |
| | Catheter, Intravascular Diagnostic (DQO) has been classified as Class II per 21 CFR 870.1200 | | |
| Predicate
Device | Reverse™ Medical
Microcatheter | K130858 | 11-Oct-2013 |
| Reference
Device(s) | Navien™ Intracranial Catheter
Arc™ Intracranial Catheter | K161152
K150107 | 12-Oct-2016
29-Jul-2015 |
| Description of
Device | The Reverse™ Micro Catheter is a single lumen catheter
designed to be introduced over a steerable guide wire to
access small, tortuous vasculature. The semi-rigid proximal
section transitions to a flexible distal tip to facilitate vessel
navigation. The micro catheter incorporates a PTFE liner to
facilitate movement or introduction of devices passed
through its lumen. Dual radiopaque markers at the distal end | | |
4
Device facilitate fluoroscopic visualization. The outer surface of the catheter body also employs a hydrophilic coating to enhance Description, lubricity and promote deliverability. continued The Reverse™ Micro Catheter incorporates a standard luer fitting to facilitate the attachment of ancillary devices. The catheter and included accessories (steam shaping mandrel and peel away introducer sheath) are provided sterile, nonpyrogenic, and are intended for single use only. To accommodate physician preference and anatomical variations, the Reverse™ Micro Catheter is available in two models, Reverse 021, with a 0.021" inner diameter (ID) and, Reverse 027, with a 0.027" ID. The Reverse™ Micro Catheter is intended for use in neuro, Intended peripheral, and coronary vasculature for the infusion of Use/Indications diagnostic agents, such as contrast media, and therapeutic for Use agents, such as occlusion coils.
5
Device Technology Characteristics and Comparison to Predicate Device
The Reverse™ Micro Catheter maintains the same fundamental scientific technology and operating principles as the predicate Reverse™ Medical Microcatheter (K130858). Furthermore, dimensions, materials of construction (excluding hydrophilic coating), sterilization method, and indications for use remain unchanged.
The primary difference between the subject and predicate device is the utilization of Serene® hydrophilic coating. This is the same coating as previously cleared with Medtronic's more recent intracranial support catheters, Navien™ (K161152) and Arc™ (K150107). Serene® will replace the predicate's legacy hydrophilic coating, thereby improving consistency across Medtronic Neurovascular's product portfolio and reducing manufacturing redundancy across the organization.
The only remaining design difference between subject and predicate is the elimination of yellow colorant from the split sheath introducer, an accessory packaged with the catheter. Even though the colorant is no longer utilized, the overall design and base formulation remains unchanged. With the two exceptions listed above, all raw materials utilized by the Reverse™ Micro Catheter are identical to those of the predicate (K130858).
In support of a substantial equivalence determination, Medtronic Neurovascular has compared and evaluated the design differences between the subject and predicate device.
| Technological
Characteristic | Subject Device
K171268 | Predicate Device
K130858 |
|-----------------------------------|------------------------------------------------------|-----------------------------------------|
| Inner Diameter | Reverse 021: 0.021"
Reverse 027: 0.027" | Same |
| Guidewire
Compatibility | Reverse 021: ≤ 0.018" OD
Reverse 027: ≤ 0.025" OD | Same |
| Distal Sheath
Outer Diameter | Reverse 021: 2.4 F
Reverse 027: 2.8 F | Same |
| Proximal Sheath
Outer Diameter | Reverse 021: 2.75 F
Reverse 027: 3.1 F | Same |
| Usable Length | 150 cm | Same |
| Coating | Hydrophilic Topcoat w/
Polyacrylamide Base | Hydrophilic Topcoat w/
Urethane Base |
| Peel Away
Introducer
Sheath | Yes (Colorless) | Yes (Yellow) |
Non-clinical performance evaluations, as described below, indicate that the subject device is substantially equivalent to. and at least as safe and effective as the predicate device (Reverse™ Medical Microcatheter, K130858).
6
Non-Clinical Performance Data
Modifications to the predicate device were assessed according to risk-based failure mode effects and criticality analysis (FMECA), ensuring that the appropriate verification and validation activities were conducted. Determination of substantial equivalence is based on this assessment of nonclinical verification and validation testing.
Non-clinical data includes bench-top verification and validation, packaging verification, and biological safety.
Bench Testing:
Bench testing was performed to evaluate physical integrity. functionality, and overall performance of the catheter relative to the design modifications introduced by the subject device. Comprehensive verification and validation activities were successfully completed; raising no new issues of safety or effectiveness. All testing passed the acceptance criteria. Performance testing encompassed:
- surface inspection
- dimensional requirements .
- lubricity/ friction .
- particulates
- coating characterization ●
- . simulated use device compatibility
- simulated use navigation and delivery .
- shelf-life verification (1 year accelerated aging) .
Biological Safety Testing:
The Reverse™ Micro Catheter was subiected to a series of biocompatibility tests in accordance with FDA Guidance, Use of International Standard ISO 10993-1.
- MEM Elution Cytotoxicity ●
- Guinea Piq Maximization Sensitization .
- Intracutaneous Reactivity ●
- Acute System Injection ●
- Materials Mediated Rabbit Pvrogen ●
- Hemolysis Direct Contact
- Hemolysis Indirect Extract Method
- Complement Activation
- In vivo Thrombogenicity
- Genotoxicity, Ames Assay ●
- Genotoxicity, in vitro Mouse Lymphoma ●
- Genotoxicity, in vivo Mouse Micronucleus ●
- . USP Physicochemical
Testing demonstrated that the Reverse™ Micro Catheter finished device, accessories, and packaging materials have no residual risk of biological hazards; and are therefore considered biocompatible for their intended use.
7
| Non-Clinical
Performance
Data, continued | Microbial assessments included bioburden, endotoxin, and
sterility assurance. Sterilization has been validated and is
controlled in accordance with ISO 11135-1, Medical Devices –
Validation and Routine Control of Ethylene Oxide Sterilization and
designed to provide a minimum SAL of 10-6. Validation was
conducted using the overkill approach in accordance with ISO
11135-1 Annex B (normative), Conservative determination of lethal
rate of the sterilization process – Overkill approach. The validated
cycle was adopted for the Reverse™ Microcatheter based on
fractional results determined from EO comparative resistance
testing. |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Packaging Validation: |
| | Visual Inspection, Bubble Leak, and Seal Strength testing
was used to evaluate integrity of the packaging configuration.
Testing was leveraged from representative product using
identical packaging materials after being subjected to
Ethylene Oxide sterilization (2x), environmental conditioning,
and simulated shipping and distribution. |
| | Conclusion: |
| | Non-clinical performance evaluations, as described above,
indicate that the subject device is substantially equivalent to,
and at least as safe and effective as the predicate device,
(Reverse™ Medical Microcatheter, K130858). |
| Clinical
Performance
Data | Not applicable; determination of substantial equivalence is
based on an assessment of non-clinical performance data. |
| Conclusion | With respect to the predicate, design modifications
incorporated by subject device do not alter the fundamental
scientific technology or the indications for use. Based on
failure mode effects and criticality analysis (FMECA),
comprehensive verification and validation activities were
successfully completed; raising no new issues of safety or
effectiveness. |
| | Non-clinical performance data supports a determination that
the subject device, Reverse™ Micro Catheter, is
substantially equivalent to the predicate device (Reverse™
Medical Microcatheter, K130858); and that it is at least as
safe and effective for its intended use. |