(269 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the catheter, with no mention of AI or ML capabilities.
No
The device is described as an "infusion catheter" used for the introduction of interventional devices and infusion of diagnostic or therapeutic agents, not as a therapeutic device itself.
No
The device is primarily a catheter for introducing other devices and infusing agents. While it can introduce "diagnostic agents" and has features to measure "injected solution temperature" (which could be considered a diagnostic activity in some contexts), its core function is not to diagnose a condition itself but to facilitate other diagnoses or therapies. The "Intended Use" explicitly states "introduction of interventional devices and infusion of diagnostic or therapeutic agents," placing it as an accessory to diagnostic procedures rather than a diagnostic device itself.
No
The device description clearly details a physical catheter with lumens, holes, a radiopaque marker, and a hub. It also mentions bench performance testing on the physical device. This is not a software-only device.
Based on the provided information, the RayFlow catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the coronary vasculature. This is an in-vivo application, meaning it's used within the living body.
- Device Description: The description details a catheter designed for delivering substances and facilitating the passage of a guidewire within blood vessels. This is consistent with an interventional medical device used directly on a patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health. The RayFlow catheter does not perform this function.
Therefore, the RayFlow catheter is an interventional medical device, not an IVD.
N/A
Intended Use / 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.
Product codes
KRA, DQO, DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary vasculature
Indicated Patient Age Range
adults (patients aged 22 years and older)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
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)
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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 “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 "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.