(28 days)
The Rebar™ Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.
The Rebar" Micro Catheter is an endhole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. Single or dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated to increase lubricity.
The provided text does not describe a study involving a device that uses AI or machine learning. Instead, it describes a 510(k) premarket notification for a medical device called the "Rebar™ Micro Catheter." This submission is focused on demonstrating substantial equivalence to an existing predicate device based on material changes (e.g., to the hub material and adhesive) and associated non-clinical bench testing.
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving an AI/ML device meets them, as the provided document pertains to a traditional, non-AI medical device clearance.
The document discusses:
- Device: Rebar™ Micro Catheter (a vascular microcatheter)
- Purpose: Delivery of interventional devices or contrast media into the vasculature.
- Regulatory Pathway: 510(k) premarket notification, aiming for substantial equivalence to a previously cleared Rebar™ Micro Catheter (K093750).
- Changes: Primarily changes to the material of the catheter hub (from Polypropylene to Trogamid) and the adhesive used.
- Proof of Equivalence: Non-clinical bench testing and biocompatibility data, rather than clinical trials or AI/ML performance studies.
The acceptance criteria listed are for physical and functional properties of the catheter (e.g., hub integrity, pressurization, tensile strength) and not related to AI/ML performance metrics like accuracy, sensitivity, or specificity. There is no mention of a test set, ground truth acquisition involving experts, MRMC studies, or training sets, as these concepts are not applicable to the type of device and study described.
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February 16, 2021
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Catherine Chiou Associate Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
Re: K210114
Trade/Device Name: Rebar Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA, QJP Dated: January 15, 2021 Received: January 19, 2021
Dear Catherine Chiou:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210114
Device Name Rebar™ Micro Catheter
Indications for Use (Describe)
The Rebar™ Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.
| Type of Use (Select one or both, as applicable) |
|---|
| For activities that DO NOT MAKE claims or charges |
| For activities that MAKE claims or charges |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary [21 CFR 807.92]
K210114
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration: 2029214 |
|---|---|
| Contact Person: | Catherine ChiouAssociate Regulatory Affairs SpecialistTelephone: (562)286-3057Email: catherine.chiou@medtronic.com |
| Date SummaryPrepared: | February 15, 2021 |
|---|---|
| Trade Name of Device: | Rebar™ Micro Catheter |
| Common Name ofDevice: | Vascular Microcatheter |
| Review Panel: | Cardiovascular; Neurovascular |
| Product Code: | KRA; QJP |
| Regulation Number: | 21 CFR 870.1210; 21 CFR 870.1250 |
| Regulation Name: | Continuous Flush Catheter |
| Device Classification | Class II |
| Predicate Device: | Rebar™ Micro Catheter510(K)s: K093750 |
Predicate Device
Rebar™ Micro Catheter (K093750)
Reference Device
Marathon™ Flow Directed Micro Catheter (K202318)
Riptide™ Aspiration System (React 71 Catheter) (K182101)
Device Description
The Rebar" Micro Catheter is an endhole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. Single or dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated to increase lubricity.
Indications for Use Statement
The Rebar™ Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.
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Technical Comparison with Predicate Device:
A comparison of the Rebar™ Micro Catheter to the predicate device is provided in the table below:
| Attribute | Predicate: Rebar™ Micro Catheter(K093750) | Subject: Rebar™Micro Catheter |
|---|---|---|
| Indication for Use(IFU) Statement | The Rebar Micro Catheter is intended for the controlledselective infusion of physician-specified therapeuticagents or contrast media into the vasculature of theperipheral and neuro anatomy. | The Rebar MicroCatheter is intendedfor the delivery ofinterventional devicesor contrast media intothe vasculature of theperipheral and neuroanatomy. |
| Principles ofOperations | The Rebar™ Micro Catheter is inserted within a guidecatheter that has already been advanced to the desiredlocation. The user connects a hemostatic side armadapter to the guide catheter to prevent backflow ofblood during insertion of the micro catheter. The useralso connects a one-way stopcock to the hemostaticside arm adapter to continuously flush the guidecatheter with saline. The outer surface of the cathetermust be hydrated, and the catheter lumen must beflushed with heparinized saline by attaching a salinefilled syringed to the catheter hub.The user selects an appropriate steerable guidewire,inserts it into the hub of the micro catheter andadvances the guidewire in the lumen. The stopcock isclosed, and the hemostatic valve loosened. Theguidewire and micro catheter are introduced as a unitthrough the hemostatic port of the hemostatic sidearmadapter into the lumen of the guiding catheter. Theguidewire/catheter assembly is advanced to the distaltip of the guiding catheter or until the desired site hasbeen reached. The valve around the micro catheter istightened enough to prevent backflow but allowingsome movement through the valve by the microcatheter. The stopcock is then opened. When ready toinfuse, the user withdraws the guidewire completelyfrom the micro catheter. A syringe with the desiredinfusate is connected to the hub of the micro catheter.The user infuses the site as required and then removesand discards the micro catheter. | Same |
| Proximal Tubing | Pebax with stainless steel helical coil | Same |
| Distal Tubing | Adhesive, UV Cure | Same |
| Adhesive | Adhesive, Loctite | Dymax UV Adhesive |
| Attribute | Predicate: Rebar™ Micro Catheter(K093750) | Subject: Rebar™Micro Catheter |
| Strain Relief | Inner: ElvaxOuter: Dynaflex | Same |
| Inner lining | PTFE | Same |
| Outer Coating | Pebax | Same |
| Hub Resin | Polypropylene | Trogamid |
| Marker Bands | Platinum-Iridium Alloy | Same |
| Usable Length | Rebar™ 18:105-5081-130: 130 cm105-5081-153: 153 cm105-5083-153: 153 cmRebar™ 27:105-5082-130: 130 cm105-5082-145: 145 cm | Same |
| Proximal Section OD(hub) | Rebar™ 18:2.7F – 0.035" MaximumRebar™ 27:2.8F – 0.043" Maximum | Same |
| Distal Section OD (attip) | Rebar™ 18:2.4F – 0.037" MaximumRebar™ 27:2.8F – 0.043" Maximum | Same |
| Distal Section ID (attip) | Rebar™ 18:0.020" MinimumRebar™ 27:0.026" Minimum | Same |
| Carton | Natural, PTFE Tubing | Same |
| Pouch | High-Density Polyethylene (HDPE) | Same |
| Shelf Life | 2 years | Same |
| Sterilization | Ethylene Oxide (EO) | Same |
| Use | Single Use | Same |
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Performance Data- Bench
The following non-clinical bench testing was performed to evaluate the performance of the Rebar™ Micro Catheter. The passing results of the testing demonstrated that the changes do not raise new questions of safety and effectiveness, supporting the substantial equivalence to the predicate device.
| Bench Testing | Test Method Summary | Results Summary |
|---|---|---|
| Safety Visual Inspection | Safety Visual Inspection: External surface ofcatheter should be free from process andsurface defects and extraneous matter. | The Rebar™ Micro Cathetermet the acceptance criteriafor visual inspection. |
| Bench Testing | Test Method Summary | Results Summary |
| Catheter Hub Integrity A | Catheter Hub Integrity A: Catheter hubtransition section shall be approximately 6°angle and length ≥ 0.5" | The Rebar™ Micro Cathetermet the acceptance criteriafor Catheter Hub Integrity A. |
| Catheter Hub Integrity B | Catheter Hub Integrity B: Catheter shall bemade of a clear thermal plastic materialwithout internal ledges and voids | The Rebar™ Micro Cathetermet the acceptance criteriafor Catheter Hub Integrity B. |
| Catheter Hub Integrity C | Catheter Hub Integrity C: Per ISO 80369-7:2018, the hub must meet ISO gaugingrequirement of 6% luer taper | The Rebar™ Micro Cathetermet the acceptance criteriafor Catheter Hub Integrity C. |
| Catheter Hub Integrity D(Liquid Leak) | Catheter Hub Integrity D (Liquid Leak): TheRebar™ Micro Catheter was evaluated perISO 10555-1: 2013 Annex C | The Rebar™ Micro Cathetermet the acceptance criteriafor Catheter Hub Integrity D(Liquid Leak). |
| Catheter Hub Integrity E (AirAspiration) | Catheter Hub Integrity E (Air Aspiration): TheRebar™ Micro Catheter was evaluated perISO 10555-1: 2013 Annex D | The Rebar™ Micro Cathetermet the acceptance criteriafor Catheter Hub Integrity E(Air Aspiration). |
| Catheter Pressurization(Dynamic Burst) | Catheter Pressurization Dynamic Burst:Catheter shall withstand adynamic pressure of ≥ 700 psi withoutrupturing/leaking | The Rebar™ Micro Cathetermet the acceptance criteriafor Catheter Pressurization(Dynamic Burst). |
| Catheter Pressurization(Static Burst) | Catheter Pressurization Static Burst:Catheter shall withstand a static pressure of ≥400 psi without rupturing/leaking | The Rebar™ Micro Cathetermet the acceptance criteriafor Catheter Pressurization(Static Burst). |
| ISO 80369-7:2016Dimensional Testing | ISO 80369-7:2018 Dimensional Testing: TheRebar™ Micro Catheter was evaluated perISO 80369-7:2016 | The Rebar™ Micro Cathetermet the acceptance criteriafor ISO 80369-7:2016Dimensional Testing. |
| ISO 80369-7:2016Performance Testing | ISO 80369-7:2018 Performance Testing: TheRebar™ Micro Catheter was evaluated perISO 80369-7:2016 | The Rebar™ Micro Cathetermet the acceptance criteriafor ISO 80369-7:2016Performance Testing. |
| Bench Testing | Test Method Summary | Results Summary |
| Tensile Strength | Tensile Strength: The Rebar™ Micro Catheterwas evaluated per ISO 10555-1: 2013 | The Rebar™ Micro Cathetermet the acceptance criteriafor Tensile Strength. |
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Biocompatibility
Biocompatibility test results for subject Rebar Micro Catheter will be leveraged and adopted for the design change to the hub. The new hub material is Trogamid, which is found within other cleared Medtronic Neurovascular product lines, and is considered indirect patient contact. Biocompatibility data can be leveraged per ISO 10993-1 from the React™ 71 Catheter (K182101), as the modified hub has the same nature and duration of contact, has similar geometry, and is identical in formulation, processing, and sterilization. Slight dimensional changes that were made to the inside of the hub, outside of the hub, and luer thread are minor and do not impact biocompatibility data. Additionally, the new UV adhesive included in the manufacturing process for the hub is nonpatient contacting, thereby not impacting biocompatibility results of subject Rebar™ Micro Catheter. Both materials were found to be non-hemolytic and non-cytotoxic per Marathon™ Flow Directed Micro Catheter (K202318).
Performance Data- Animal:
Animal testing was not included in the subject submission. The differences in technological characteristics do not raise new questions of safety and effectiveness as demonstrated through non-clinical bench testing using wellestablished scientific methods.
Performance Data - Clinical:
Clinical testing was not included in the subject submission. The differences in technological characteristics do not raise new questions of safety and effectiveness as demonstrated through non-clinical bench testing using wellestablished scientific methods.
Conclusion
The differences in technological characteristics do not raise new questions of safety and effectiveness as demonstrated through non-clinical bench testing using well-established scientific methods. The information provided in this submission supports the proposal of substantial equivalence for the Rebar™ Micro Catheter.
§ 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).