Who is the manufacturer of RayFlow?

Hexacath filed the 510(k) submission for RayFlow (K222023).

What is the FDA product code for RayFlow?

DQY. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for RayFlow?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like RayFlow?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RayFlow

K222023 · Hexacath · DQY · Apr 6, 2023 · Cardiovascular

Device Facts

Record ID	K222023
Device Name	RayFlow
Applicant	Hexacath
Product Code	DQY · Cardiovascular
Decision Date	Apr 6, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2
Attributes	Therapeutic

Intended 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

Device Story

RayFlow is a rapid exchange (RX) double-lumen infusion catheter used in coronary procedures. It features a series of distal holes for homogeneous infusion of fluids (saline, medication, contrast) and two holes for temperature measurement via an external pressure/temperature guidewire (e.g., Abbott PressureWire X). The device is operated by physicians in a clinical setting, compatible with standard automated pump injectors. The catheter is advanced over a 0.014" guidewire. By enabling precise infusion and temperature monitoring, it assists in diagnostic and therapeutic coronary interventions. It is a single-use, sterile device.

Clinical Evidence

Bench testing only. Testing included dimensional verification, flow rate, power injection, leakage, tensile strength, flexibility/kink, torsional bond strength, simulated use, radiopacity, corrosion, and acute particulate evaluation. Biocompatibility testing per ISO 10993-1 confirmed the device is non-cytotoxic, non-sensitizing, non-pyrogenic, and hemocompatible.

Technological Characteristics

Rapid exchange double-lumen catheter; 140 cm length. Materials: Polycarbonate/PEBAX hub, PEBAX strain relief, PTFE-coated stainless steel hypotube, Polyamide middle tubing, PEBAX/LLDPE/Polyethylene inner tubing, Platinum/Iridium marker. Hydrophilic coating. Sterilized via Ethylene Oxide (ISO 11135).

Indications for Use

Indicated for adults (≥22 years) for introduction of interventional devices and infusion of diagnostic/therapeutic agents into coronary vasculature. Not for neurovasculature.

Regulatory Classification

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.

Predicate Devices

Phenom 27 Catheter (K180959)

Reference Devices

Langston Dual Lumen Catheter (K170544)

Related Devices

K062877 — TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230 · Vascular Solutions, Inc. · Jan 18, 2007
K081147 — ISOFLOW INFUSION CATHETER · Vascular Designs, Inc. · May 29, 2009
K970401 — MEDI-DYNE GUIDING CATHETER · Medi-Dyne, Inc. · Aug 1, 1997
K033540 — TRANSXCHANGE SUPPORT CATHETER · Medtronic Vascular · May 25, 2004
K200317 — Support Catheter · Qxmedical, LLC · May 14, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 | Predicate device | Regulation Number | Regulation Name | Product Code | |---------------|-----------------------|----------------------|--------------------------|--------------| | K180959 | Phenom 27 Catheter | 870.1200 | Percutaneous Catheter | DQY, KRA | {4}------------------------------------------------ Reference Predicate Device | 510(k) number | Predicate device | Regulation Number | Regulation Name | Product Code | |------------------|---------------------------------|----------------------|-----------------------------------------|--------------| | K170544 | Langston Dual Lumen Catheter | 870.1200 | Diagnostic Intravascular Catheter | 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 {5}------------------------------------------------ (K180959) and Langston (K170544) catheters as predicate devices for substantial equivalence. A table comparing the devices is provided as follows: | Item | 1.Subject Device RayFlow | 2.Primary predicate device Phenom 27 Catheter (K180959) | 3.Reference predicate device Langston Dual Lumen Catheter (K170544) | Identified similarities or differences | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | 1 vs 2 | 1 vs 3 | | General Comparison | | | | | | | 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. | Phenom Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures. | The Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular, and intraventricular pressure gradients. | Both devices have the same Indications for use except that RayFlow is only used in the coronary vasculature. Differences identified (1) See below | Both devices allow delivery of contrast medium into the vascular system. Differences identified (1) See below | | 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 hub is standard sized and compatible with any automated pump injector used for the continuous infusion of saline/liquid at room temperature | The Phenom 27 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 aid in navigation in the vessel. 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 Langston dual lumen catheter consists of a coaxial tube (outer lumen) mounted over a braided catheter shaft (inner lumen) and an extension line with a 3-way stopcock. The extension line with stopcock connects to the outer lumen. The outer lumen, inner lumen, and extension line are joined by an over molded manifold. The manifold also includes a luer that connects to the inner lumen. The manifold is printed with the Langston catheter length, French size, maximum guidewire diameter, and product logo ("Langston"). The Langston dual lumen catheter tip terminates in either a pigtail or multipurpose tip configuration | Both catheters are coated and have a radiopaque marker at the distal end to allow good visibility of the product during the procedure. Differences identified (2) See below | Both catheters are dual lumen catheters. Differences identified (2) See below | | Use | Single Use | Single Use | Single Use | Both are single use devices. | Both are single use devices. | | Sterilization | Ethylene oxide | Ethylene oxide | Ethylene oxide | Both devices are sterilized using ethylene oxide gas. | Both devices are sterilized using ethylene oxide 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 all visual and dimensional requirements will meet the specified attributes. | diameter: 2.01F (0.67mm) Proximal inner diameter: 0.019 inches (0.49mm) Distal outer diameter: 2.5F (0.84mm) Distal inner diameter: 0.028 inches (0.71mm) | diameter: 3.1F (1.02mm) Proximal inner diameter: 0.027 inches (0.69mm) Distal outer diameter: 2.8F (0.91mm) Distal inner diameter: 0.027 inches (0.69mm) | Outer lumen diameter: 6F or 7F Inner lumen diameter: 4F or 5F | (3) See below | (3) See below | | Component dimension compatibility The purpose is to verify that the catheter can track through a guiding catheter and over a guide wire. | Guiding catheter with an ID ≥ 0.079" (≥ 5Fr) Guide wire that is 0.014" in diameter Pressure/ temperature guide wire that is 0.014" in diameter | Guiding catheter with an ID ≥ 0.0445" (≥ 3.39Fr) Guide wire that is ≤ 0.025" in diameter | Guide wire that is ≤ 0.038" (0.965 mm) in diameter | Differences identified (4) See below | Differences identified (4) See below | | Accessibility/ Tractability Test Ability of the system to advance through the vessel to the target site using the recommended accessories. | The RayFlow catheter is able to advance through a coronary anatomical model. | The Phenom catheter is able to reach specific region of a tortuous model. | The Langston design has been verified through Tortuosity in Simulated Anatomy test. The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. | Both devices were able to move freely (advancement without blockage) through an anatomical model. See 510(k) Summary K180959 for primary predicate device See TR 20-014 for Subject device | Both devices were able to move freely (advancement without blockage) through an anatomical model. See 510(k) Summary K170544 for reference predicate device See TR 20-014 for Subject device | | Freedom from leakage (at hub) No liquid leakage detected per ISO 10555- 1:2013 Annex C. Method, equipment and conditions as prescribed in standard. | RayFlow catheter showed no sign of leakage. | Phenom catheter showed no sign of leakage. | The Langston design has been verified through Liquid Leakage Under Pressure test. The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. | Both devices are conform to ISO 10555-1. See 510(k) Summary K180959 for primary predicate device See TR 20-014 for Subject device | Both devices are conform to ISO 10555-1. See 510(k) Summary K170544 for reference predicate device See TR 20-014 for Subject device | | Flow Rate This test method is to verify the compliance to catheter standard ISO 10555-1:2013. Conditions, method and equipment as prescribed in the standard. | Presence of: Outer lumen side holes: 4 Inner lumen side holes : 2 Instruction for use: - Maximum flowrate: ≤ 25 ml/min (350 PSI) | Not applicable to the Phenom catheter. Instruction for use: For a catheter of 135cm (useful length): At 100% of physiologic serum - 100 psi: 126 mL/min - 300 psi: 186 mL/min At 100% of contrast media (76%) - 100 psi: 12 mL/min - 300 psi: 36 mL/min At 50/50 of contrast media (76%) and | Presence of: Outer lumen side holes: 8 Inner lumen side holes : 2 or 5 Maximum flowrate: from 13 ml/sec to 1 ml/sec Maximum pressure rating: from 1000 PSI to 1200 PSI | Differences identified (5) See below | Differences identified (5) See below | | | | - 100 psi: 72 mL/min - 300 psi: 102 mL/min | | | | | Tensile Strength The junctions should meet the tensile strength requirement per ISO 10555- 1:2013 Annex B. Method, equipment and conditions as prescribed in standard | Minimal breaking strength: - 3N for $\geq$ 0,55 < $0,75$ diameters - 5N for $\geq$ 0,75 < $1,15$ diameters | Phenom catheter is conform to ISO 10555- 1:2013. | The Langston design has been verified through Tensile Force test. The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. | Both devices are conform to ISO 10555-1. See 510(k) Summary K180959 for primary predicate device See TR 20-014 for Subject device | Both devices are conform to ISO 10555-1. See 510(k) Summary K170544 for reference predicate device See TR 20-014 for Subject device | | Material Verification The purpose is to verify that all materials are as specified in raw material, final assembly, subassembly specifications and vendor certifications | 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 | Hub: Polyamide Strain relief: Thermoplastic elastomer Shaft: Stainless Steel Reinforcement + PTFE composite polymeric catheter NA NA NA Marker: Platinum/Iridium Alloy NA Coating: Polymeric hydrophilic coating | Not enough information regarding materials used for the Langston | Differences identified (6) See below | Differences identified (6) See below | {6}------------------------------------------------ {7}------------------------------------------------ #### 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. {8}------------------------------------------------ ## (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: {9}------------------------------------------------ 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. {10}------------------------------------------------ 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. {11}------------------------------------------------ ## 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 {12}------------------------------------------------ # 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. {13}------------------------------------------------ ## 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 medical devices | | | *The text of the International Standard IEC 62366-1:2015/A1:2020 was approved as a European Standard without any modification. | | Product standard | | | ISO 80369-7:2016 | Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications | | 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: vascular stents | | 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 and testing within a risk management process | | ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood | | ISO 10993-5:2009 | Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | | ISO 10993-7:2008 / AMD1:2019 | Biological evaluation of medical devices — Part 7: Ethylene Oxide sterilization residuals | | ISO 10993-10:2010 | Biological evaluation of medical devices — part 10: tests for irritation and skin sensitization | | ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | | ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances | | ISO 10993-18:2020 | Biological evaluation of medical devices — Part 18: Chemical characterization of materials | | Packaging | | | ISO 11607-1:2019 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging system | | 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 Medical Packaging 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 Containers and 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: General requirements | | Sampling | | | ISO 2859-1:1999 / AMD1:2011 | Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection | | Accelerated aging | | | ASTM F1980-16 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical devices | | Sterilization | | | ISO 11135:2014 / AMD1:2018 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization 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 - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | | ISO 11138-1:2017 | Sterilization of health care products — Biological indicators —Part 1: General requirements | | European Pharmacopoeia, 8th edition (2019/07) Chapter 2.6.1* | Sterility test | | *The current USP General Chapter <71> “Sterility test” is harmonized with the European Pharmacopeia. | | | European Pharmacopoeia, 9th edition (2019/07) Chapter 2.6.14* | Bacterial endotoxin | | *The current USP General Chapter <85> "Bacterial Endotoxin Test" is harmonized with the European Pharmacopeia. | | {14}------------------------------------------------ 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.

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