(28 days)
Phenom™ Catheters are intended for the introduction of interventional devices or diagnostic agents into the neuro, peripheral, and coronary vasculatures.
The Phenom™ Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to enhance navigation in the vessel. The Phenom™ 17, 21, and 27 Catheters have a hydrophilic coating that spans the distal 100cm. The Phenom™ Plus Catheters have a hydrophilic coating that spans the distal 90cm. The catheter also incorporates a liner to facilitate movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid visualization and positioning under fluoroscopy. The Phenom™ Catheter is packaged with a shaping mandrel and may be accompanied with a split introducer sheath.
The provided text describes the regulatory clearance for the "Phenom Catheters" and includes performance data from bench testing. However, it does not describe any study involving AI, human readers, or the establishment of ground truth for such a study. Therefore, I cannot fulfill your request for information related to AI or human-in-the-loop performance.
The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing. There is no mention of acceptance criteria or performance metrics in the context of an AI-based device, a multi-reader multi-case (MRMC) study, or standalone algorithm performance.
Here's a breakdown of the information that is present in the document, framed against your request:
1. A table of acceptance criteria and the reported device performance
The document provides a table of "Tests" with "Test Method Summary" and "Results." The "Results" column implicitly indicates that the acceptance criteria were met for each test, as it states "The Phenom™ Catheters met the acceptance criteria for..." or "acceptable friction force," "compatible for use," etc.
| Test | Acceptance Criteria (Implied by Result) | Reported Device Performance |
|---|---|---|
| Compatibility – Guide Catheter | Compatible with guide catheters in a simulated tortuous path model. | The Phenom™ Catheters are compatible for use with a guide catheter. |
| Compatibility – Guide Wire | Compatible with guide wires in a simulated tortuous path model. | The Phenom™ Catheters are compatible for use with a guide wire. |
| Compatibility – RHV | Compatible with a standard RHV. | The Phenom™ Catheters are compatible with the standard used RHV. |
| Coating Lubricity (Friction Force) | Exhibit acceptable friction force under simulated clinical conditions. | The Phenom™ Catheters exhibit acceptable friction force under simulated clinical conditions. |
| Hub Functional & Dimensional | Met the acceptance criteria for hub functional & dimensional requirements (per ISO 80369-7:2016 and ISO 80369-20: 2015). | The Phenom™ Catheters met the acceptance criteria for hub functional & dimensional requirements. |
| Torque Strength | Exhibit acceptable torsional strength integrity. | The Phenom™ Catheters exhibit acceptable torsional strength integrity. |
| Tensile | Met the acceptance criteria for tensile strength (per ISO 10555-1:2013, Annex B). | The Phenom™ Catheters met the acceptance criteria for tensile strength. |
| Air Aspiration | Met the acceptance criteria for air aspiration (per ISO 10555-1:2013). | The Phenom™ Catheters met the acceptance criteria for air aspiration. |
| Liquid Leak | Met the acceptance criteria for liquid leak (per ISO 10555-1:2013). | The Phenom™ Catheters met the acceptance criteria for liquid leak. |
| Particulate | Met the acceptance criteria for particulate (per USP <788>). | The Phenom™ Catheters met the acceptance criteria for particulate. |
| Design Validation | Met user needs and intended use(s) (per ANSI/AAMI HE75:2009/(R) 2018). | The Phenom™ Catheters met the user needs and intended use(s) for which it was designed and tested. |
| Biocompatibility Tests | ||
| Cytotoxicity – MEM Elution | Exhibited slight reactivity (Grade 1). | Non-cytotoxic |
| Sensitization – Guinea Pig Maximization | Exhibited no dermal reactions (Grade 0). | Non-sensitizer |
| Irritation – Intracutaneous Study in Rabbits | Exhibited no dermal reactions (Score 0.0). | Non-irritant |
| Acute Systemic Toxicity – Systemic Toxicity Study in Mice | Exhibited no mortality or evidence of systemic toxicity. | Non-toxic |
| Material Mediated Pyrogenicity – USP Rabbit Pyrogen Study | Exhibited no temperature rise above 0.5°C. | Non-pyrogenic |
| Hemocompatibility – Platelet and Leukocyte Counts | Platelet and leukocyte counts within average normalized and control values. | Non-activator |
| Hemocompatibility – Partial Thromboplastin Time | Clotting time within control values. | Non-activator |
| Hemocompatibility – Hemolysis Direct Contact and Extract Methods | No hemolysis and within control values. | Non-hemolytic |
| Hemocompatibility – Complement Activation | Complement activation within control values. | Non-activator |
Regarding the other points of your request, the document does not provide this information because it's for a medical device (catheter) and not an AI-based system:
- 2. Sample size used for the test set and the data provenance: Not applicable. The testing described is bench testing of physical devices, not a test set of data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for data interpretation is not relevant for this type of device submission.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is not an AI system.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for the catheter is its ability to perform according to engineering specifications and biocompatibility standards.
- 8. The sample size for the training set: Not applicable. This is not an AI model requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the regulatory clearance of a physical medical device (catheter) based on non-clinical performance and biocompatibility testing, not an AI software/device.
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February 25, 2021
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Prerana Gurubasavaraj Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
Re: K210230
Trade/Device Name: Phenom Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA, QJP Dated: January 27, 2021 Received: January 28, 2021
Dear Prerana Gurubasavaraj:
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.
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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-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 medical devices and radiation-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) K210230
Device Name Phenom™ Catheters
Indications for Use (Describe)
Phenom™ Catheters are intended for the introduction of interventional devices or diagnostic agents into the neuro, peripheral, and coronary vasculatures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K210230
510(k) Summary
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration: 2029214 |
|---|---|
| Contact Person: | Prerana GurubasavarajSpecialist, Regulatory AffairsTelephone: (949) 297-5804Email: prerana.gurubasavaraj@medtronic.com |
| Date SummaryPrepared: | February 24, 2021 |
| Trade Name ofDevice: | Phenom™ Catheters |
| Device ClassificationName: | Catheter, Percutaneous |
| Regulation MedicalSpecialty: | Cardiovascular |
| 510(k) Review Panel: | Cardiovascular |
| Classification ProductCode: | DQY |
| Subsequent ProductCode: | KRA, QJP |
| Regulation Number: | 870.1250870.1210 |
| RegulationDescription: | Percutaneous catheterContinuous flush catheter |
| Device Classification: | Class II |
| Predicate Device: | Phenom™ 17 Catheter, Phenom™ 21 Catheter, Phenom™ 27Catheter, Phenom™ Plus Catheter510(k): K151638Phenom™ 27 Catheter510(k): K180959 |
| Reference Device: | React™ 68 Catheter510(k): K180715Navien™ Intracranial Support Catheter |
Device Description:
The Phenom™ Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to enhance navigation in the vessel. The Phenom™ 17, 21, and 27 Catheters have a hydrophilic coating that spans the distal 100cm. The Phenom™ Plus Catheters have a hydrophilic coating that spans the distal 90cm. The catheter also incorporates a liner to facilitate movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid visualization and positioning under fluoroscopy. The Phenom™ Catheter is packaged with a shaping mandrel and may be accompanied with a split introducer sheath.
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Indication for Use Statement:
Phenom™ Catheters are intended for the introduction of interventional devices or diagnostic agents into the neuro, peripheral, and coronary vasculatures.
| Legally Marketed Predicate Devices(K151638 & K180959) | Phenom™Catheters | ||||
|---|---|---|---|---|---|
| Indication for UseStatement | The Phenom™ Catheters are intended for the introduction ofinterventional devices and infusion of diagnostic or therapeuticagents into the neuro, peripheral, and coronary vasculatures. | Phenom™Catheters areintended for theintroduction ofinterventionaldevices ordiagnosticagents into theneuro,peripheral, andcoronaryvasculatures. | |||
| Dimensions | Phenom™ 17(K151638) | Phenom™ 21(K151638) | Phenom™ 27(K180959) | Phenom™ Plus(K151638) | |
| Proximal/DistalOuter Diameter(OD) | 2.2 F / 1.8 F | 2.6 F / 2.3 F | 3.1 F / 2.8 F | 4.7 F / 4.2 F | Same |
| InternalDiameter (ID) | 0.017" | 0.021" | 0.027" | 0.0445" | Same |
| Min. GuidingCatheter ID | ≥ 0.035" | ≥ 0.038" | ≥ 0.0445" | ≥ 0.070 | Same |
| Max. GuidewireOD | ≤ 0.014" | ≤ 0.018" | ≤ 0.025" | ≤ 0.041 | Same |
| Effective Length(cm) | 75 - 170 | 75 - 170 | 75 - 160 | 75 - 150 | Phenom 17:150Phenom 21:150, 160Phenom 27:150, 160Phenom Plus:120 |
| Distal segmentlength (cm) | 6 - 20 | 6 - 20 | 6 - 20 | 6 - 20 | Same |
| Inner Lumen | Inner lumen lined with lubricious PTFE to facilitate movement ofguidewires and other devices. | Same | |||
| No. of lumens | Single lumen | Same | |||
| Shaft | Progressively softer from proximal end to distal tip | Same | |||
| Method ofdelivery/tracking | Coaxial tracking over steerable guidewire | Same | |||
| Shaft Materials | PTFE and Pebax | Same | |||
| Shaftreinforcement | Metallic (Stainless Steel) reinforced | Same | |||
| Inner Liner | PTFE liner | Same | |||
| Tip Markers | 1 or 2 | 1 or 2 | 1 | 1 | Same |
| Tip Shaping | Steam shapeable straight tip;Pre-shaped 45°, 90° and J | Steam shapeable tip | Steam shapeable tip | Same | |
| Coating | Hydrophilic coating | ||||
| Packaging | |||||
| Pouch Material | PET/Tyvek | NYLON/Tyvek | |||
| Pouch Dimensions | 11" X 12" (Hoop configuration)11" X 13.75" (Tray configuration) | 13" X 10.94" | |||
| Carton | Cardboard, Solid Bleach Sulfate | Same | |||
| Accessories | |||||
| Shaping Mandrel | Yes | Same | |||
| Split IntroducerSheath(Phenom™ 17) | No | Yes | |||
| Sterilization | |||||
| Method | Ethylene Oxide (EO) | Same | |||
| Stability | |||||
| Shelf Life | 36 Months | 12 Months |
Device Comparison:
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Performance Data – Bench:
The following non-clinical bench testing was performed to evaluate the performance of the Phenom™ Catheters. 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 devices.
| Test | Test Method Summary | Results |
|---|---|---|
| Performance | ||
| Compatibility – Guide Catheter | The Phenom™ Catheters wereevaluated for compatibility withguide catheters in a simulatedtortuous path model. | The Phenom™ Catheters arecompatible for use with a guidecatheter. |
| Compatibility – Guide Wire | The Phenom™ Catheters wereevaluated for compatibility withguide wires in a simulatedtortuous path model. | The Phenom™ Catheters arecompatible for use with a guidewire. |
| Compatibility – RHV | The Phenom™ Catheters wereevaluated for compatibility witha standard RHV. | The Phenom™ Catheters arecompatible with the standardused RHV. |
| Coating Lubricity (FrictionForce) | The Phenom™ Catheters wereevaluated for coating lubricityunder simulated clinicalconditions. | The Phenom™ Catheters exhibitacceptable friction force undersimulated clinical conditions. |
| Hub Functional & Dimensional | The Phenom™ Catheters wereevaluated per ISO 80369-7:2016 and ISO 80369-20:2015. | The Phenom™ Catheters metthe acceptance criteria for hubfunctional & dimensionalrequirements. |
| Torque Strength | The Phenom™ Catheters wereevaluated for torsional strengthintegrity during use in asimulated path model. | The Phenom™ Catheters exhibitacceptable torsional strengthintegrity. |
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| Test | Test Method Summary | Results |
|---|---|---|
| Tensile | The Phenom™ Catheters were evaluated per ISO 10555-1:2013, Annex B. | The Phenom™ Catheters met the acceptance criteria for tensile strength. |
| Air Aspiration | The Phenom™ Catheters were evaluated per ISO 10555-1:2013 | The Phenom™ Catheters met the acceptance criteria for air aspiration. |
| Liquid Leak | The Phenom™ Catheters were evaluated per ISO 10555-1:2013 | The Phenom™ Catheters met the acceptance criteria for liquid leak. |
| Particulate | The Phenom™ Catheters were evaluated per USP <788>. | The Phenom™ Catheters met the acceptance criteria for particulate. |
| Design Validation | The Phenom™ Catheters were evaluated per ANSI/AAMI HE75:2009/(R) 2018 | The Phenom™ Catheters met the user needs and intended use(s) for which it was designed and tested. |
Biocompatibility:
Biocompatibility was conducted for the Phenom™ Catheters. The Phenom™ Catheters are categorized as a limited exposure (< 24 hours), external communicating devices contacting circulating blood. The following biocompatibility endpoint testing was conducted for the Phenom™ Catheters:
| Test | Test Method Summary | Results |
|---|---|---|
| Cytotoxicity – MEM Elution | Cell culture treated with test sample exhibited slight reactivity (Grade 1). | Non-cytotoxic |
| Sensitization – Guinea Pig Maximization | Animals treated with test sample exhibited no dermal reactions (Grade 0). | Non-sensitizer |
| Irritation – Intracutaneous Study in Rabbits | Animals treated with test sample exhibited no dermal reactions (Score 0.0). | Non-irritant |
| Acute Systemic Toxicity –Systemic Toxicity Study in Mice | Animals treated with test sample exhibited no mortality or evidence of systemic toxicity. | Non-toxic |
| Material Mediated Pyrogenicity –USP Rabbit Pyrogen Study | Individual animals treated with test sample exhibited no temperature rise above 0.5°C. | Non-pyrogenic |
| Hemocompatibility – Plateletand Leukocyte Counts | Blood treated with the test sample exhibited platelet and leukocyte counts within the average normalized values and control values. | Non-activator |
| Hemocompatibility – PartialThromboplastin Time | Blood treated with the test article exhibited clotting time within the control values. | Non-activator |
| Hemocompatibility – HemolysisDirect Contact and Extract Methods | Blood treated with the test sample directly and indirectly exhibited no hemolysis and was within the control values. | Non-hemolytic |
| Hemocompatibility –Complement Activation | Normal human serum treated with the test sample exhibited complement activation within the control values. | Non-activator |
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Performance Data - Animal:
No animal testing was conducted. The differences in technological characteristics do not raise new questions of safety and effectiveness as demonstrated through non-clinical bench testing using wellestablished acceptable scientific methods.
Performance Data - Clinical:
No clinical testing was conducted. The differences in technological characteristics do not raise new questions of safety and effectiveness as demonstrated through non-clinical bench testing using wellestablished acceptable scientific methods.
Conclusion:
There is no change to the Intended Use for the Phenom™ Catheters in comparison to the legally marketed predicate device. In addition, the differences in technological characteristics do not raise new questions of safety and effectiveness as demonstrated through non-clinical bench testing using well-established acceptable scientific methods. The information provided in this submission supports a determination of substantial equivalence for the Phenom™ Catheters.
§ 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).