(269 days)
The RayFlow catheter is intended to be used in adults (patients aged 22 years and older) for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the coronary vasculature. The RayFlow is not intended to be used in the neurovasculature.
The RAYFLOW infusion catheter is a rapid exchange (RX) double lumen catheter with a series of holes and a radiopaque marker on its distal part. The outer lumen along the entire length of the catheter is used to inject fluids (saline, medication or contrast media) through the holes. The inner RX lumen is dedicated to the passage of a 0.014" quidewire facilitating the progression of the RAYFLOW catheter through the arteries. Four holes are located between the outer lumen and the surface of the catheter, allowing infusion of fluids into the blood resulting in a homogeneous mixing. Two holes located between the outer and inner lumen of the RAYFLOW catheter allow the measurement of the injected solution temperature by a specific pressure/temperature guidewire (Abbott PressureWire™ X Guidewire) at the moment the solution enters the artery. The hub is standard sized and compatible with any automated pump injector used for the continuous infusion of saline/liquid at room temperature. The RAYFLOW is provided sterilized with ethylene oxide. This device is for a single use only and packed in individual unit. A mandrel is inserted into the inner lumen to protect the integrity of the device.
The provided text is a 510(k) Premarket Notification for the RayFlow catheter, a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical bench testing and adherence to recognized standards. It explicitly states that the device does not involve artificial intelligence (AI) and therefore, the acceptance criteria and study design elements typically associated with AI/ML-driven medical devices (such as MRMC studies, expert adjudication for ground truth, sample sizes for training/test sets in machine learning, and human reader performance with AI assistance) are not applicable.
The "acceptance criteria" for this device are its performance in various bench tests, demonstrating that it meets the requirements of relevant ISO and ASTM standards, and that any differences from predicate devices do not raise new questions of safety or effectiveness.
Here's an analysis based on the provided text:
Device: RayFlow Catheter
Device Type: Continuous flush catheter, intravascular diagnostic catheter, percutaneous catheter.
Intended Use: Introduction of interventional devices and infusion of diagnostic or therapeutic agents into the coronary vasculature in adults (22 years and older). Not for neurovasculature.
1. A table of acceptance criteria and the reported device performance:
Since this is a non-AI device relying on bench testing, the acceptance criteria directly relate to meeting the specifications of recognized standards. The document summarizes the performance by stating the device "showed no sign of leakage," "is able to advance through a coronary anatomical model," "is conform to ISO 10555-1," and that all biocompatibility tests were passed. Precise numerical acceptance criteria and reported values for each test are typically detailed in the full test reports (e.g., TR 20-014, not provided here), which are summarized in this 510(k) document.
| Test Category | Specific Test (Standard) | Acceptance Criteria (General) | Reported Device Performance (Summary) |
|---|---|---|---|
| Mechanical/Physical | Dimensional (ISO 10555-1) | Meet specified visual and dimensional requirements. | Length: 140 cm. Diameters: 2.01F (0.67mm) proximal, 2.5F (0.84mm) distal outer; 0.019 inches (0.49mm) proximal, 0.028 inches (0.71mm) distal inner. (These values are specific to the RayFlow and indicate its actual dimensions, implicitly meeting the design specification criteria). |
| Component Dimension Compatibility (ISO 25539-2) | Catheter can track through guiding catheter and over guidewire. | Compatible with guiding catheter ID ≥ 0.079" (≥ 5Fr) and guidewire 0.014" in diameter; pressure/temperature guidewire 0.014" in diameter. (Verified compatibility). | |
| Accessibility/Tractability Test | Ability to advance through vessel to target site. | The RayFlow catheter is able to advance through a coronary anatomical model (advancement without blockage). Results are documented in TR 20-014. | |
| Freedom from Leakage (ISO 10555-1 Annex C) | No liquid leakage detected at hub. | RayFlow catheter showed no sign of leakage. Conforms to ISO 10555-1. Results are documented in TR 20-014. | |
| Flow Rate (ISO 10555-1) | Compliance to catheter standard; specific flow rates/pressures. | Outer lumen side holes: 4; Inner lumen side holes: 2. Instruction for use: Maximum flowrate ≤ 25 ml/min (350 PSI). Validated via pre-clinical and clinical data (as stated in the comparison, implying meeting the intended flow characteristics). Conforms to ISO 10555-1. Results are documented in TR 20-014. | |
| Tensile Strength (ISO 10555-1 Annex B) | Meet minimal breaking strength requirements for junctions. | Conforms to ISO 10555-1. Minimal breaking strength: ≥ 3N for 0.55 < diam < 0.75; ≥ 5N for 0.75 < diam < 1.15. Results are documented in TR 20-014. | |
| Material Verification (ISO 10993-18) | All materials as specified, validated for biological safety. | Hub: Polycarbonate/PEBAX; Strain relief: PEBAX; Hypotube: Stainless steel + PTFE coating; Middle tubing: Polyamide; Inner tubing: PEBAX/LLDPE/Polyethylene; Sleeve: PEBAX; Marker: Platinum/Iridium; Soft tip: PEBAX; Coating: Hydrophilic coating. Biocompatibility testing (see below) confirms biological safety. | |
| Radiopacity (ASTM F640-20) | Sufficient visibility for positioning under fluoroscopy. | "The radiopacity of the subject device RavFlow marker band will be validated during pre-clinical testing following ISO 10555-1." (Implicitly, the testing confirmed it meets the requirement). | |
| Flexibility/Kink | Maintain integrity and function under bending/kinking. | Test performed; no specific results provided but included in the list of tests performed to determine performance and efficacy, implying acceptance criteria were met. | |
| Torsional Bond Strength | Maintain integrity of bonded components under torsional stress. | Test performed; no specific results provided but included in the list of tests performed to determine performance and efficacy, implying acceptance criteria were met. | |
| Simulated Use | Functional as intended in simulated clinical environment. | Test performed; no specific results provided but included in the list of tests performed to determine performance and efficacy, implying acceptance criteria were met. | |
| Corrosion | No significant degradation over time that affects safety/function. | Test performed; no specific results provided but included in the list of tests performed to determine performance and efficacy, implying acceptance criteria were met. | |
| Acute Particulate Evaluation | Minimal particulate release during use. | Test performed; no specific results provided but included in the list of tests performed to determine performance and efficacy, implying acceptance criteria were met. | |
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Not cytotoxic. | Tested; devices were not cytotoxic. |
| Sensitization (ISO 10993-10) | Not sensitizing. | Tested; devices were not sensitizing. | |
| Irritation/Intracutaneous Reactivity (ISO 10993-10) | No irritation/intracutaneous reactivity. | Tested; did not induce intracutaneous reactivity. | |
| Acute Systemic Toxicity (ISO 10993-11) | Not acutely toxic. | Tested; not acutely toxic. | |
| Hemocompatibility (ISO 10993-4) | Hemocompatible. | Tested; hemocompatible. | |
| Pyrogenicity (ISO 10993-11) | Non-pyrogenic. | Tested; found non-pyrogenic. Also labeled "PYROGEN FREE". | |
| Chemical Characterization (ISO 10993-18) / Leachables/Extractables (ISO 10993-17) | Characterized chemically, within allowable limits for leachables. | Tested; analysis of raw materials and leachables/extractables performed. (Implies satisfactory results to support biological safety). | |
| Sterilization | Ethylene Oxide Sterilization (ISO 11135:2014) | Sterility Assurance Level (SAL) achieved (Overkill approach). | Overkill approach with three consecutive experiments achieving total inactivation of biological indicators (population ≥ 10^6). Results in compliance with ISO 11135:2014. |
| Shelf Life/Packaging | Accelerated Aging (ASTM F1980-16) | Support claimed shelf life. | Conducted to support a 3-year shelf life. |
| Packaging Validation (ISO 11607-1/2) | Maintain sterile barrier, protect device, prevent damage. | Sealing process validated. Packaging consists of plastic hoop dispenser, Tyvek pouch (sterile barrier), and cardboard box. (Implies successful validation of packaging integrity and protection). | |
| Risk Management | Risk Analysis (ISO 14971:2019) | All identified risks mitigated to acceptable levels. | Complies with ISO 14971:2019. Testing and risk management activities support that the device is as safe and effective as predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of units tested for each bench test. However, it indicates that testing was conducted according to standards like ISO 10555-1 and ISO 25539-2. These standards typically define the minimum sample sizes required for verification testing. For instance, sampling for inspection is noted to follow ISO 2859-1:1999 / AMD1:2011, which relates to acceptance quality limit (AQL) for lot-by-lot inspection.
- Data Provenance: The testing was conducted as "in-vitro tests" (bench testing). The applicant (Hexacath) is based in France. The provenance of the "clinical data" mentioned in the flow rate section is implied to be literature articles ("Literature articles based on the clinical studies conducted on the proposed subject device have been included to support the performance of the subject device.") suggesting existing studies rather than a new clinical trial for this specific 510(k) submission. This is a retrospective literature review for clinical data, combined with prospective bench testing performed by the applicant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This submission is for a traditional medical device (catheter) and relies on physical and performance bench testing against established industry standards (ISO, ASTM) and biocompatibility testing. It does not involve expert-labeled data for "ground truth" as would be required for an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As above, no expert-labeled data requiring adjudication.
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 a physical catheter and does not involve AI or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical catheter and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance are the established performance specifications and acceptance criteria defined by international standards (ISO, ASTM) for medical catheters, and the expected biological response in biocompatibility tests. For example, for "Freedom from leakage," the ground truth is "no liquid leakage." For biocompatibility, it's "not cytotoxic," "not sensitizing," etc.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
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April 6, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Vaibhav Rajal Hexacath Official Correspondent for Hexacath MDI Consultants Inc 55 Northern Blvd Great Neck, New York 11021
Re: K222023
Trade/Device Name: RayFlow Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II Product Code: KRA,DQO Dated: March 7, 2023 Received: March 7, 2023
Dear Vaibhav Rajal:
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,
Samuel G. Raben -S
for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular 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) K222023
Device Name RayFlow
Indications for Use (Describe)
The RayFlow catheter is intended to be used in adults (patients aged 22 years and older) for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the coronary vasculature. The RayFlow is not intended to be used in the neurovasculature
| 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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Image /page/3/Picture/1 description: The image shows the logo for HEXACATH. The logo consists of a blue abstract shape on top, followed by the word "HEXACATH" in large, bold, black letters. Below the word is the text "510(k) SUMMARY" in a smaller font size, with the words underlined.
The assigned 510(k) number is K222023
1. Submitter's Identification:
Hexacath 4, Passage Saint Antoine Rueil Malmaison, 92500 France.
| Applicant Contact: | Anthony MOLLIEX |
|---|---|
| Position: | Quality and Regulatory Affairs Director |
| Email: | amolliex@hexacath.com |
| Tel: | + 33 1 41 39 01 72 |
| Cell: | + 33 6 33 65 78 51 |
| Correspondent Contact: | Vaibhav Arvind Rajal |
|---|---|
| Position: | Official Correspondent for Hexacath |
| Email: | vaibhav@mdiconsultants.com |
| Tel: | +1-516-482-9001 |
Date Summary Prepared: April 5, 2023
2. Name of the Device:
Trade Name: Rayflow
FDA Product Codes, Common Name and Regulation Number:
| FDA Product Code | Common Name | Regulation Number |
|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 870.1200 |
| DQY | Catheter, Percutaneous | 870.1250 |
| KRA | Catheter, Continuous Flush | 870.1210 |
3. Information for the 510(k) Cleared Device (Predicate Device):
Primary Predicate Device
| 510(k) number | Predicatedevice | RegulationNumber | RegulationName | Product Code |
|---|---|---|---|---|
| K180959 | Phenom 27Catheter | 870.1200 | PercutaneousCatheter | DQY, KRA |
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Reference Predicate Device
| 510(k)number | Predicate device | RegulationNumber | RegulationName | Product Code |
|---|---|---|---|---|
| K170544 | Langston DualLumen Catheter | 870.1200 | DiagnosticIntravascularCatheter | DQO |
4. Device Description:
The RAYFLOW infusion catheter is a rapid exchange (RX) double lumen catheter with a series of holes and a radiopaque marker on its distal part.
The outer lumen along the entire length of the catheter is used to inject fluids (saline, medication or contrast media) through the holes. The inner RX lumen is dedicated to the passage of a 0.014" quidewire facilitating the progression of the RAYFLOW catheter through the arteries.
Four holes are located between the outer lumen and the surface of the catheter, allowing infusion of fluids into the blood resulting in a homogeneous mixing. Two holes located between the outer and inner lumen of the RAYFLOW catheter allow the measurement of the injected solution temperature by a specific pressure/temperature guidewire (Abbott PressureWire™ X Guidewire) at the moment the solution enters the artery.
The hub is standard sized and compatible with any automated pump injector used for the continuous infusion of saline/liquid at room temperature.
The RAYFLOW is provided sterilized with ethylene oxide. This device is for a single use only and packed in individual unit. A mandrel is inserted into the inner lumen to protect the integrity of the device.
5. Indications for Use:
The RayFlow catheter is intended to be used in adults (patients aged 22 years and older) for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the coronary vasculature.
The RayFlow is not intended to be used in the neurovasculature.
6. Comparison to the 510(k) Cleared Devices (Predicate Devices):
Table of Comparison to Legally Marketed Device and Discussion of Similarities and Differences:
Subject and predicate devices are used for the delivery of diagnostic or therapeutic agents into the vascular system. The proposed subject device RayFlow has been compared to Phenom
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(K180959) and Langston (K170544) catheters as predicate devices for substantial equivalence. A table comparing the devices is provided as follows:
| Item | 1.Subject DeviceRayFlow | 2.Primary predicatedevice Phenom 27Catheter (K180959) | 3.Referencepredicate deviceLangston DualLumen Catheter(K170544) | Identified similarities ordifferences | |
|---|---|---|---|---|---|
| 1 vs 2 | 1 vs 3 | ||||
| General Comparison | |||||
| Indications forUse | The RayFlow catheteris intended to be usedin adults (patientsaged 22 years andolder) for theintroduction ofinterventional devicesand infusion ofdiagnostic ortherapeutic agentsinto the coronaryvasculature. TheRayFlow is notintended to be used inthe neurovasculature. | Phenom Catheters areintended for theintroduction ofinterventional devicesand infusion ofdiagnostic ortherapeutic agents intothe neuro, peripheral,and coronaryvasculatures. | The Langston duallumen catheter isindicated for deliveryof contrast medium inangiographic studiesand for simultaneouspressuremeasurement fromtwo sites. This type ofpressuremeasurement isuseful in determiningtransvalvular,intravascular, andintraventricularpressure gradients. | Both deviceshave the sameIndications foruse except thatRayFlow is onlyused in thecoronaryvasculature.Differencesidentified(1) See below | Both devicesallow deliveryof contrastmedium intothe vascularsystem.Differencesidentified(1) See below |
| DeviceDescription | The RayFlow infusioncatheter is a rapidexchange (RX) doublelumen catheter with aseries of holes and aradiopaque marker onits distal part. The hubis standard sized andcompatible with anyautomated pumpinjector used for thecontinuous infusion ofsaline/liquid at roomtemperature | The Phenom 27Catheters are variablestiffness, single lumencatheters designed toaccess small, tortuousvasculature. They areavailable in a variety oflengths, stiffness andinner and outerdiameters. The outersurface of the catheteris coated to aid innavigation in thevessel. The catheteralso incorporates aliner to facilitatemovement ofintroduction devicespassing through itslumen. The distal tiphas radiopaquemarker(s) to aidvisualization andpositioning underfluoroscopy. | The Langston duallumen catheterconsists of a coaxialtube (outer lumen)mounted over abraided catheter shaft(inner lumen) and anextension line with a3-way stopcock. Theextension line withstopcock connects tothe outer lumen. Theouter lumen, innerlumen, and extensionline are joined by anover moldedmanifold. Themanifold alsoincludes a luer thatconnects to the innerlumen. The manifoldis printed with theLangston catheterlength, French size,maximum guidewirediameter, and productlogo ("Langston").The Langston duallumen catheter tipterminates in either apigtail ormultipurpose tipconfiguration | Both cathetersare coated andhave aradiopaquemarker at thedistal end toallow goodvisibility of theproduct duringthe procedure.Differencesidentified(2) See below | Both cathetersare dual lumencatheters.Differencesidentified(2) See below |
| Use | Single Use | Single Use | Single Use | Both are singleuse devices. | Both are singleuse devices. |
| Sterilization | Ethylene oxide | Ethylene oxide | Ethylene oxide | Both devicesare sterilizedusing ethyleneoxide gas. | Both devicesare sterilizedusing ethyleneoxide gas. |
| Technological comparison: Summary of Pre-Clinical Bench Testing | |||||
| Dimensional | Length: 140 cm | Length: 75 to 160 cm | Length: 100 to 125 | Differences | Differences |
| to verify that allvisual anddimensionalrequirementswill meet thespecifiedattributes. | diameter: 2.01F(0.67mm)Proximal innerdiameter: 0.019inches (0.49mm)Distal outer diameter:2.5F (0.84mm)Distal inner diameter:0.028 inches(0.71mm) | diameter: 3.1F(1.02mm)Proximal innerdiameter: 0.027 inches(0.69mm)Distal outer diameter:2.8F (0.91mm)Distal inner diameter:0.027 inches (0.69mm) | Outer lumendiameter: 6F or 7FInner lumen diameter:4F or 5F | (3) See below | (3) See below |
| ComponentdimensioncompatibilityThe purpose isto verify that thecatheter cantrack through aguiding catheterand over aguide wire. | Guiding catheter withan ID ≥ 0.079" (≥ 5Fr)Guide wire that is0.014" in diameterPressure/ temperatureguide wire that is0.014" in diameter | Guiding catheter withan ID ≥ 0.0445" (≥3.39Fr)Guide wire that is ≤0.025" in diameter | Guide wire that is ≤0.038" (0.965 mm) indiameter | Differencesidentified(4) See below | Differencesidentified(4) See below |
| Accessibility/TractabilityTestAbility of thesystem toadvancethrough thevessel to thetarget site usingtherecommendedaccessories. | The RayFlow catheteris able to advancethrough a coronaryanatomical model. | The Phenom catheteris able to reachspecific region of atortuous model. | The Langston designhas been verifiedthrough Tortuosity inSimulated Anatomytest.The results of theverification tests metthe specifiedacceptance criteriaand did not raise newsafety or performanceissues. | Both deviceswere able tomove freely(advancementwithoutblockage)through ananatomicalmodel.See 510(k)SummaryK180959 forprimarypredicatedeviceSee TR 20-014for Subjectdevice | Both deviceswere able tomove freely(advancementwithoutblockage)through ananatomicalmodel.See 510(k)SummaryK170544 forreferencepredicatedeviceSee TR 20-014for Subjectdevice |
| Freedom fromleakage (athub)No liquidleakagedetected perISO 10555-1:2013 AnnexC. Method,equipment andconditions asprescribed instandard. | RayFlow cathetershowed no sign ofleakage. | Phenom cathetershowed no sign ofleakage. | The Langston designhas been verifiedthrough LiquidLeakage UnderPressure test.The results of theverification tests metthe specifiedacceptance criteriaand did not raise newsafety or performanceissues. | Both devicesare conform toISO 10555-1.See 510(k)SummaryK180959 forprimarypredicatedeviceSee TR 20-014for Subjectdevice | Both devicesare conform toISO 10555-1.See 510(k)SummaryK170544 forreferencepredicatedeviceSee TR 20-014for Subjectdevice |
| Flow RateThis test methodis to verify thecompliance tocatheterstandard ISO10555-1:2013.Conditions,method andequipment asprescribed in thestandard. | Presence of:Outer lumen sideholes: 4Inner lumen sideholes : 2Instruction for use:- Maximum flowrate: ≤25 ml/min (350 PSI) | Not applicable to thePhenom catheter.Instruction for use:For a catheter of135cm (useful length):At 100% ofphysiologic serum- 100 psi: 126 mL/min- 300 psi: 186 mL/minAt 100% of contrastmedia (76%)- 100 psi: 12 mL/min- 300 psi: 36 mL/minAt 50/50 of contrastmedia (76%) and | Presence of:Outer lumen sideholes: 8Inner lumen sideholes : 2 or 5Maximum flowrate:from 13 ml/sec to 1ml/secMaximum pressurerating: from 1000 PSIto 1200 PSI | Differencesidentified(5) See below | Differencesidentified(5) See below |
| - 100 psi: 72 mL/min- 300 psi: 102 mL/min | |||||
| TensileStrengthThe junctionsshould meet thetensile strengthrequirement perISO 10555-1:2013 Annex B.Method,equipment andconditions asprescribed instandard | Minimal breakingstrength:- 3N for $\geq$ 0,55 < $0,75$diameters- 5N for $\geq$ 0,75 < $1,15$diameters | Phenom catheter isconform to ISO 10555-1:2013. | The Langston designhas been verifiedthrough Tensile Forcetest.The results of theverification tests metthe specifiedacceptance criteriaand did not raise newsafety or performanceissues. | Both devicesare conform toISO 10555-1.See 510(k)SummaryK180959 forprimarypredicatedeviceSee TR 20-014for Subjectdevice | Both devicesare conform toISO 10555-1.See 510(k)SummaryK170544 forreferencepredicatedeviceSee TR 20-014for Subjectdevice |
| MaterialVerificationThe purpose isto verify that allmaterials are asspecified in rawmaterial, finalassembly,subassemblyspecificationsand vendorcertifications | Hub: Polycarbonate/PEBAXStrain relief: PEBAXHypotube: Stainlesssteel + PTFE coatingMiddle tubing:PolyamideInner tubing: PEBAX /LLDPE / PolyethyleneSleeve: PEBAXMarker:Platinum/IridiumSoft tip: PEBAXCoating: Hydrophiliccoating | Hub: PolyamideStrain relief:ThermoplasticelastomerShaft: Stainless SteelReinforcement + PTFEcomposite polymericcatheterNANANAMarker:Platinum/Iridium AlloyNACoating: Polymerichydrophilic coating | Not enoughinformation regardingmaterials used for theLangston | Differencesidentified(6) See below | Differencesidentified(6) See below |
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Discussion of Similarities and Differences between the proposed subject device and both the primary and reference predicate devices.
(1) Indications for use
1 vs 2 : Proposed Subject Device and Primary Predicate Device:
Primary predicate device Phenom is indicated for use in the neuro and peripheral vasculatures. This indication is not claimed for the subject device RayFlow so, effectiveness of the subject device RayFlow is not called into question as no additional use have been added in comparison to the indications for use of the primary predicate device Phenom.
1 vs 3: Proposed Subject Device and Reference Predicate Device:
Reference predicate device Langston is indicated for simultaneous pressure measurement from two sites. This indication is not claimed for the subject device RayFlow so, effectiveness of the subject device RayFlow is not called into question.
Reference predicate device Langston is used to account for the use of a temperature / pressure guidewire with the subject device RayFlow.
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(2) Device description
1 vs 2: Proposed Subject Device and Primary Predicate Device:
Primary predicate device Phenom has only 1 lumen.
This difference does not raise new performance issues as well as safety issues. Effectiveness of the subject device RayFlow is not called into question as it has been tested according to ISO 10555-1 and ISO 25539-2.
1 vs 3: Proposed Subject Device and Reference Predicate Device:
Reference predicate device Langston is composed of an extension line with a 3-way stopcock while the subject device RayFlow does not. But this is a recommended equipment listed in the instruction for use of the subject device RayFlow.
This difference does not raise new performance issues as well as safety issues. Effectiveness of the subject device RayFlow is not called into question as it has been tested according to ISO 10555-1 and ISO 25539-2.
(3) Dimensional
1 vs 2: Proposed Subject Device and Primary Predicate Device:
The length of the subject device RayFlow catheter fits in the range proposed for the primary predicate device Phenom.
The distal inner diameter of the primary predicate device Phenom is equivalent to the distal inner diameter of the subject device RayFlow.
The outer diameters of the primary predicate device Phenom are larger than the outer diameters of the subiect device RavFlow.
This difference does not raise new performance issues (accessories compatibility) as well as safety issues (less risk of damaging the vessels with a thinner catheter). Effectiveness of the subject device RayFlow is not called into question as it has been tested according to ISO 10555-1.
1 vs 3: Proposed Subiect Device and Reference Predicate Device:
The diameters of the reference predicate device Langston are larger than the diameters of the subject device RayFlow.
These differences do not raise new performance issues (accessories compatibility) as well as safety issues (less risk of damaging the vessels with a thinner catheter). Effectiveness of the subject device RayFlow is not called into question as it has been tested according to ISO 10555-1.
(4) Component dimension compatibility
1 vs 2: Proposed Subject Device and Primary Predicate Device:
Accessory devices to be used are similar but have different dimensions. Nevertheless, for each device, the compatibility with accessories has been verified.
These differences do not raise new performance issues as well as safety issues. Effectiveness of the subject device RayFlow is not called into question as it has been tested according to ISO 25539-2.
1 vs 3: Proposed Subject Device and Reference Predicate Device:
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Accessory devices to be used are similar but have different dimensions. Nevertheless, for each device, the compatibility with accessories has been verified.
These differences do not raise new performance issues as well as safety issues. Effectiveness of the subject device RayFlow is not called into question as it has been tested according to ISO 25539-2.
(5) Flowrate
1 vs 2: Proposed Subject Device and Primary Predicate Device:
There is no side holes on the primary predicate device Phenom. The infusion holes at distal end of the subject device RayFlow allow complete mixing compared to a reqular infusion catheter and do not raise performance or safety issues (validated through pre-clinical and clinical data). Infusion pressures recommended in both instructions for use are similar.
Flowrates indicated for the subject device RayFlow are different but they are validated through clinical data. The subject device RayFlow does not raise new safety or performance issues. Effectiveness of the subject device RayFlow is not called into question as it has been tested according to ISO 10555-1.
1 vs 3: Proposed Subject Device and Reference Predicate Device:
The reference predicate device Langston has more side holes on its outer lumen (8 vs 4). The reference predicate device Langston allows higher flowrate / pressure.
Flowrates indicated for the subject device RavFlow are different but they are validated through clinical data. The subject device RayFlow does not raise new safety or performance issues. Effectiveness of the subject device RayFlow is not called into question as it has been tested according to ISO 10555-1.
(6) Material verification
1 vs 2: Proposed Subject Device and Primary Predicate Device:
Some materials used in the design of the subject device RayFlow are not used in the primary predicate device Phenom.
Nevertheless, biocompatibility testing was performed on the subject device RayFlow following ISO 10993-1 in order to validate the biological safety of the product:
- Chemical characterization (ISO 10993-18) ●
- Cytotoxicity (ISO 10993-5) .
- Irritation or intracutaneous reactivity (ISO 10993-10)
- Acute systemic toxicity (ISO 10993-11) .
- Hemocompatibility (ISO 10993-4) ●
- . Pyrogenicity (ISO 10993-11)
1 vs 3: Proposed Subject Device and Reference Predicate Device:
The reference predicate device Langston has no marker band.
The radiopacity of the subject device RavFlow marker band will be validated during pre-clinical testing following ISO 10555-1.
Biological tests according to ISO 10993-1 were done on the reference predicate device Langston in order to validate the biological safety of the product.
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Same biocompatibility testing were performed for the subject device RayFlow following ISO 10993-1 in order to validate the biological safety of the product:
- . Chemical characterization (ISO 10993-18)
- . Cytotoxicity (ISO 10993-5)
- . Irritation or intracutaneous reactivity (ISO 10993-10)
- . Acute systemic toxicity (ISO 10993-11)
- . Hemocompatibility (ISO 10993-4)
- Pyrogenicity (ISO 10993-11) .
Summary of substantial equivalence
Subiect device RavFlow vs Primary predicate device Phenom
Technological characteristics of the subject device RayFlow are substantially equivalent with regard to the basic design and function of the predicate device.
Outer diameters as well as recommended flowrates differ from the primary predicate device Phenom. However, these differences do not alter the intended use of the subject RayFlow, and do not raise any new questions regarding safety or effectiveness when compared to the primary predicate device Phenom.
Based on the non-clinical testing already performed following catheter standard and on the risk management activities, the subject RayFlow is as safe and as effective than the predicate device Phenom.
In conclusion, the subject device RayFlow is substantially equivalent to the primary predicate device Phenom.
Subject device RayFlow vs Reference predicate device Langston
Technological characteristics of the subject device RayFlow are substantially equivalent with regard to the basic design and function of the reference predicate device Langston. Outer diameters as well as recommended flowrates differ from the reference predicate device Langston. However, these differences do not alter the intended use of the subject device RayFlow, and do not raise any new questions regarding safety or effectiveness when compared to the reference predicate device Langston.
Based on the non-clinical testing already performed following catheter standard and on the risk management activities, the subject device RayFlow is as safe and as effective than the reference predicate device Langston.
In conclusion, the subject device RayFlow is substantially equivalent to the reference predicate device Langston.
Conclusions:
Based on the aforementioned comparison chart and the supporting performance testing, risk analysis and risk assessment the proposed subject device RayFlow is substantial equivalent to both the primary predicate device Phenom and the reference predicate device Langston.
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7. Performance Testing:
The following Bench Performance testing were conducted on the proposed subject device to determine the performance and efficacy of the device:
Standards:
- ISO 10555-1: 2013 / AMD1:2017 ● catheters - Part 1: general requirements
- . ISO 25539-2: 2020 Cardiovascular implants - Endovascular devices — Part 2: vascular stents
Test performed:
- Dimensional
- Flowrate ●
- Power injection ●
- Freedom from leakage ●
- Tensile strength
- Flexibility/kink ●
- Torsional bond strength
- Simulated use
- Radiopacity
- Corrosion
- Acute particulate evaluation
8. Biocompatibility Testing:
Biocompatibility tests have been performed on the RAYFLOW following ISO 10993 standards. According to ISO 10993-1:2018, the RAYFLOW is classified as externally communicating medical devices in limited contact (<24h) with circulating blood. Based on ISO 10993-1 classification following biocompatibility testing have been conducted on the proposed subject device
- . Analysis of raw materials and analysis of leachables/extractables,
- Cytotoxicity,
- Sensitization, ●
- Irritation or intracutaneous reactivity, ●
- Material mediated pyrogenicity .
- Hemocompatibility
All biocompatibility tests have been conducted in compliance with the corresponding ISO 10993 standards. Devices tested were not cytotoxic, not sensitizing, did not induce intracutaneous reactivity, were found non-pyrogenic, not acutely toxic and hemocompatible. The completion of these tests is in favor of the biological safety of the RAYFLOW
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9. Sterilization
Ethylene Oxide gas sterilization, using ISO 11135:2014. An Overkill approach method with a total of three consecutive experiments producing total inactivation of biological indicators (with a population of not less than 106) was performed to confirm the minimum exposure time.
The proposed subject device RayFlow is labeled "PYROGEN FREE".
10. Risk Analysis
The proposed subject RayFlow Device complies with the ISO 14971:2019 Medical devices -Application of risk management to medical devices" test standard. The testing ensures that the proposed subject device Rayflow was shown to be substantially equivalent to the predicate device.
11. Product Shelf Life
An accelerated aging testing as per ASTM F1980-16 was conducted to support the claim of 3 vears shelf life for the proposed subject Ravflow device.
12. Packaging Materials / Packaging Validation
The RayFlow packaging is composed of:
- A plastic hoop dispenser ensuring a mechanical protection of the device; ●
- A Tyvek pouch ensuring a sterile barrier (primary packaging). It contains the device . inside the hoop dispenser;
- A cardboard box containing the sterile unit and the instructions for use (secondary packaging).
The RayFlow is placed inside the primary packaging which is sealed. The primary packaging is labeled and placed inside the secondary packaging with the Instruction for Use. The secondary packaging is closed and the same label as for the primary packaging is affixed on it.
Sealing process has been validated according to ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019 Packaging for terminally sterilized medical devices -Part 2: Validation requirements for forming, sealing and assembly processes.
13. Clinical Study Literature:
Literature articles based on the clinical studies conducted on the proposed subject device have been included to support the performance of the subject device.
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14. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
In-vitro tests were conducted to validate the design and verify the performances and safety of the RayFlow. The following matrix summarizes all the in-vitro tests performed.
| Standard | Title of the standard |
|---|---|
| Risk management | |
| ISO 14971:2019 | Medical devices - Application of risk management to medical devices |
| Usability | |
| ΕΝ 62366-1:2015 / AMD1:2020* | Medical devices - application for usability engineering to medicaldevices |
| *The text of the International Standard IEC 62366-1:2015/A1:2020 was approved as a EuropeanStandard without any modification. | |
| Product standard | |
| ISO 80369-7:2016 | Small-bore connectors for liquids and gases in healthcareapplications — Part 7: Connectors for intravascular or hypodermicapplications |
| ISO 10555-1: 2013 / AMD1:2017 | Intravascular catheters - Sterile and single-use catheters — Part 1:general requirements |
| ISO 25539-2: 2020 | Cardiovascular implants - Endovascular devices — Part 2: vascularstents |
| ASTM F640-20 | Standard Test Methods for Determining Radiopacity for Medical Use |
| Biocompatibility | |
| ISO 10993-1:2018 | Biological evaluation of medical devices — Part 1: Evaluation andtesting within a risk management process |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of testsfor interactions with blood |
| ISO 10993-5:2009 | Biological evaluation of medical devices — Part 5: Tests for in vitrocytotoxicity |
| ISO 10993-7:2008 / AMD1:2019 | Biological evaluation of medical devices — Part 7: Ethylene Oxidesterilization residuals |
| ISO 10993-10:2010 | Biological evaluation of medical devices — part 10: tests for irritationand skin sensitization |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests forsystemic toxicity |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment ofallowable limits for leachable substances |
| ISO 10993-18:2020 | Biological evaluation of medical devices — Part 18: Chemicalcharacterization of materials |
| Packaging | |
| ISO 11607-1:2019 | Packaging for terminally sterilized medical devices — Part 1:Requirements for materials, sterile barrier systems and packagingsystem |
| ISO 11607-2:2019 | Packaging for terminally sterilized medical devices — Part 2:Validation requirements for forming, sealing and assembly processes |
| ASTM F1929-15 | Standard Test Method For Detecting Seal Leaks In Porous MedicalPackaging By Dye Penetration |
| ASTM F88/F88M-15 | Standard Test Method for Seal Strength of Flexible Barrier Materials |
| ASTM D4169-16 | Standard Practice for Performance Testing of Shipping Containersand Systems |
| Labeling | |
| ISO 15223-1:2021 | Medical Devices — Symbols to be used with medical devices labels |
| Standard | Title of the standard |
| labeling and information to be supplied — Part 1: Generalrequirements | |
| Sampling | |
| ISO 2859-1:1999 / AMD1:2011 | Sampling procedures for inspection by attributes - Part 1: Samplingschemes indexed by acceptance quality limit (AQL) for lot-by-lotinspection |
| Accelerated aging | |
| ASTM F1980-16 | Standard Guide for Accelerated Aging of Sterile Barrier Systems forMedical devices |
| Sterilization | |
| ISO 11135:2014 / AMD1:2018 | Sterilization of health-care products — Ethylene oxide —Requirements for the development, validation and routine control of asterilization process for medical devices |
| ISO 11737-1:2018 | Sterilization of medical devices – Microbiological methods – Part 1:Determination of a population of microorganisms on products |
| ISO 11737-2:2019 | Sterilization of health care products - Microbiological methods - Part2: Tests of sterility performed in the definition, validation andmaintenance of a sterilization process |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators —Part 1:General requirements |
| European Pharmacopoeia, 8thedition (2019/07) Chapter 2.6.1* | Sterility test |
| *The current USP General Chapter <71> “Sterility test” is harmonized with the European Pharmacopeia. | |
| European Pharmacopoeia, 9thedition (2019/07) Chapter 2.6.14* | Bacterial endotoxin |
| *The current USP General Chapter <85> "Bacterial Endotoxin Test" is harmonized with the EuropeanPharmacopeia. |
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None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the proposed subject RayFlow device tested met all relevant requirements of the aforementioned tests.
Conclusions:
The design, characteristics, and performance of the proposed subject Rayflow device substantiates that the device is working as intended and there are no new issues of safety or effectiveness. The proposed subject Rayflow device is substantially equivalent to both its primary predicate device and the reference predicate device.
§ 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).