(138 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a support catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a "support catheter" used to facilitate placement and exchange of guidewires and other interventional devices, and to provide a conduit for delivery of solutions, but it does not directly perform a therapeutic function itself.
No
The "Intended Use" section states that the device "may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents." While it can deliver diagnostic agents, its primary function as described in both "Intended Use" and "Device Description" is to provide support for guidewires and other interventional devices to access regions of the peripheral vasculature. It does not perform a diagnostic function itself, but rather aids in procedures where diagnostic agents may be delivered.
No
The device description clearly outlines a physical catheter with a lumen, hub, flexible part, and radiopaque tip, indicating it is a hardware medical device. The performance studies also focus on physical properties and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (peripheral vasculature) to facilitate the placement of other devices and deliver substances. This is an in vivo application.
- Device Description: The description details a catheter designed for insertion into blood vessels, which is consistent with an in vivo device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is used inside the body for interventional procedures.
N/A
Intended Use / Indications for Use
The speX Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
Product codes
DQY
Device Description
The speX Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral vasculature. The device is an over the wire single lumen catheter with a proximal female hub and a distal flexible part with a radiopaque tapered tip. The distal end of the catheter has a lubricious coating. The speX Support Catheter is 0.035" guidewire compatible and has working lengths of: 50cm, 90c, 135cm and 150cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic imaging
Anatomical Site
Peripheral vasculature
Indicated Patient Age Range
Not Found
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 device design was qualified through the following tests:
- Simulated Use (baseline, aged)
- Tensile Strength (baseline, aged)
- Torque (baseline, aged)
- Pressure Test (baseline, aged)
- Coating verification (baseline, aged)
- Corrosion Test (baseline, aged)
- Luer Verification (baseline, aged)
- Dimensional verification and visual inspections (baseline, aged)
- Sterilization Validation
- Biocompatibility
- Cytotoxicity
- Irritation
- Sensitization
- Materials Mediated Pyrogenicity
- Acute Systemic Tox
- Hemolysis (direct, indirect)
- PTT
- Complement Activation
- Thrombosis
The speX Support Catheter met all specified criteria and did not raise new safety or performance questions.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined human profiles facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 5, 2014
ReFlow Medical Ms. Rebecca Pine VP. Regulatory/Clinical Affairs & Quality Assurance 1003 Calle Sombra San Clemente, CA 92673
Re: K141649 Trade/Device Name: speX Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 2, 2014 Received: October 2, 2014
Dear Ms. Pine,
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
speX Support Catheter, 50cm, 300006; speX Support Catheter, 90cm, 300007; speX Support Catheter, 135cm, 300008; speX Support Catheter. 150cm. 300009
Indications for Use (Describe)
The speX Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents
Type of Use (Select one or both, as applicable)
스 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/2/Picture/15 description: The image shows the FDA logo. The logo is in a light gray color. The letters FDA are large and stylized.
Bram D. Zuckerman -S 2014.11.05 06:17:25 -05'00'
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3
510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | ReFlow Medical |
|---|---|
| DATE PREPARED: | October 1, 2014 |
| CONTACT PERSON: | Rebecca K Pine |
| ReFlow Medical | |
| 1003 Calle Sombra | |
| San Clemente, CA 92673 | |
| Phone: (760) 809.5178 | |
| TRADE NAME: | speX Support Catheter |
| COMMON NAME: | Guide Catheter |
| CLASSIFICATION NAME: | Percutaneous Catheter |
| DEVICE CLASSIFICATION: | Class 2, per 21 CFR 870.1250 |
| PRODUCT CODE | DQY |
| PREDICATE DEVICES: | Volcano Valet Microcatheter (K112035) |
| Quickcross Support Catheter (K072750) | |
| Minnie Support Catheter (K082337) |
Substantially Equivalent To:
The speX Support Catheter is substantially equivalent in intended use, principal of operation and technological characteristics to the Volcano Valet Microcatheter (K112035), QuickCross Support Catheter (K072750), and the Minnie Support Catheter (K082337).
Description of the Device Subject to Premarket Notification:
The speX Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral vasculature. The device is an over the wire single lumen catheter with a proximal female hub and a distal flexible part with a radiopaque tapered tip. The distal end of the catheter has a lubricious coating. The speX Support Catheter is 0.035" guidewire compatible and has working lengths of: 50cm, 90c, 135cm and 150cm.
Indication for Use:
The speX Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and
4
provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
Technological Characteristics:
The speX Support Catheter has similar physical and technical characteristics to the predicate device. All devices are highly flexible with a stabilizing radiopaque distal tip. In the case of the speX Support Catheter and the Volcano Catheter, both tips are shapeable. All devices utilize a luer hub handle. All devices are fabricated from medical-grade polymers with varying stiffness shafts. All devices are provided sterile and are intended for single-use. A summary of the similarities and differences between the speX Support Catheter and the identified predicates are shown in the table below:
| | speX Support
Catheter | QuickCross
Support Catheter
(K072750) | Valet Mirocatheter
(K112035) | Minnie Support
Catheter
(K082337) |
|----------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Function | Support catheter | Support catheter | Support catheter | Support catheter |
| Principle of
Operation | Controlled penetration
to create a channel
across the occlusion | Controlled
penetration to create
a channel across the
occlusion | Controlled
penetration to create a
channel across the
occlusion | Controlled
penetration to create a
channel across the
occlusion |
| Anatomical
Site | Peripheral | Peripheral
Coronary | Peripheral
Coronary | Peripheral
Coronary |
| Delivery to
Site | Percutaneous access;
over the wire | Percutaneous access;
over the wire | Percutaneous access;
over the wire | Percutaneous access;
over the wire |
| Visualization | Radiographic imaging | Radiographic
imaging | Radiographic imaging | Radiographic imaging |
| Flexibility | Highly flexible | Highly flexible | Highly flexible | Highly flexible |
| Working
length | 50cm
90cm
135cm
150cm | 65cm-150cm | 100cm-150cm | 90cm-150cm |
| Crossing
Mechanism | Distal Tip;
Radiopaque;
tapered | Distal Tip;
Radiopaque marker
Tapered | Distal Tip;
Radiopaque
tapered | Distal Tip;
Radiopaque
tapered |
| Crossing
method | Forward (advancement)
penetration of tapered
tip | Forward
(advancement)
penetration of
tapered tip | Forward
(advancement)
penetration of tapered
tip | Forward
(advancement)
penetration of tapered
tip |
| Use interface | Luer as handle | Luer as handle | Luer as handle | Luer as handle |
| Luer
connector | Yes | Yes | Yes | Yes |
| Manually
operated | Yes | Yes | Yes | Yes |
| Tip Material | Polymer | Polymer | Polymer | Polymer |
| Distal Tip OD | .022" | 0.02" - 0.041" | 0.02" | .0205"-0.0415" |
| Shapeable tip | Yes | No, available in
straight or angled | Yes | No, available straight |
| Catheter
Material | Polymer;
varying stiffness shaft;
braid reinforced; PTFE
lining | Polymer:
varying stiffness
shaft: stainless steel
braid (some models); | Polymer; varying
stiffness shaft, metal
braid | Polymer; metal braid
incorporated into
shaft |
| Hydrophilic
coating | Yes, distal 40cm | Yes | Yes, distal 30cm | Yes, distal 40cm |
| | speX Support
Catheter | QuickCross
Support Catheter
(K072750) | Valet Mirocatheter
(K112035) | Minnie Support
Catheter
(K082337) |
| Catheter OD | 4.6F | 3.0-4.8F | 1.8-3.5F | 2.9-4.8F |
| Single use | Yes | Yes | Yes | Yes |
| Guidewire
compatibility | 0.035" | 0.014" -0.035" | 0.014" -0.035" | 0.014" -0.035" |
| Targeted
injection | Yes- saline solutions,
diagnostic/therapeutic
agents | Yes- saline solutions,
diagnostic agents | Yes- saline solutions,
contrast agents | Yes- saline solutions,
diagnostic/therapeutic
agents |
5
Performance Data:
All necessary testing has been performed for the speX Support Catheter to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices.
The device design was qualified through the following tests:
- Simulated Use (baseline, aged) ●
- Tensile Strength (baseline, aged) ●
- Torque (baseline, aged) ●
- Pressure Test (baseline, aged)
- Coating verification (baseline, aged)
- Corrosion Test (baseline, aged)
- Luer Verification (baseline, aged)
- Dimensional verification and visual inspections (baseline, aged) ●
- Sterilization Validation ●
- Biocompatibility ●
- Cytotoxicity .
- l Irritation
- Sensitization
- Materials Mediated Pyrogenicity
- I Acute Systemic Tox
- Hemolysis (direct, indirect)
- PTT
- Complement Activation
- I Thrombosis
The speX Support Catheter met all specified criteria and did not raise new safety or performance questions.
Basis for Determination of Substantial Equivalence:
The data and information presented in this submission and the similarities and differences between the subject and predicate devices support a determination of substantial equivalence.. The speX Support Catheter is determined by ReFlow Medical, to be substantially equivalent to the identified predicate devices.