(243 days)
Not Found
No
The description focuses on the mechanical function of the device (scoring plaque) and mentions only bench testing and animal/cadaveric/clinical evaluations, with no indication of AI/ML components or data analysis beyond standard performance metrics.
Yes.
The device is used to facilitate dilation of stenoses in arteries and treat obstructive or synthetic arteriovenous dialysis fistulae, which are therapeutic interventions.
No
The device is described as a scoring catheter used to facilitate dilation of stenoses and treat fistulae, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines a physical catheter with scoring elements, an atraumatic tip, and a radiopaque marker band, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The FLEX Scoring Catheter is a physical device used inside the body (in vivo) during a medical procedure (percutaneous transluminal angioplasty). It directly interacts with the patient's anatomy (arteries and fistulae) to facilitate dilation of stenoses.
- Intended Use: The intended use clearly describes a therapeutic intervention within the body, not the analysis of specimens.
The device description and intended use are consistent with a surgical or interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FLEX Scoring Catheter is indicated for use with percutaneous transluminal angioplasty (PTA) catheters to facilitate dilation of stenoses in the femoral and poplited arteries and treatment of obstructive or synthetic arteriovenous dialysis fistulae.
Product codes
PNO
Device Description
The FLEXTM Scoring Catheter is a sterile, single use, disposable device designed to facilitate the dilation of stenoses. The device has a working length of 120cm and is comprised of three scoring elements at the distal end. The distal end also contains an atraumatic tip and radiopaque maker band to aid in proper placement of the catheter. When the device is unsheathed the scoring elements are expanded to contact the plaque. The device scores the plaque as it is retracted. Once the desired plaque is scored the device is exchanged for a PTA balloon.
The device is compatible with0.18" guidewires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral and poplited arteries, obstructive or synthetic arteriovenous dialysis fistulae
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
To verify that the device design meets its functional and performance requirements, representative samples of the device underwent bench testing. Testing included: General Requirements for Intravascular Catheters - ISO 10555-1 Biocompatibility Testing - ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Sterilization Validation Testing - ISO-11135-1 Sterilization of Health Care Products. Ethylene Oxide Sterilization Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices Simulated Use Testing In Vivo GLP animal testing, cadaveric studies, and clinical evaluations were also performed and demonstrated the FLEX device meets user needs and intended use.
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 logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three heads in profile, representing health, humans, and services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 25,2016
VentureMed Group Ms. Tiffini Diage, MPH Regulatory Affairs Consultant 5855 Monroe St, Suite 220 A Sylvania, OH 43560
Re: K152789
Trade/Device Name: Flex Scoring Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: April 21, 2016 Received: April 25, 2016
Dear Ms. Diage,
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,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152789
Device Name FLEX Scoring Catheter
Indications for Use (Describe)
The FLEX Scoring Catheter is indicated for use with percutaneous transluminal angioplasty (PTA) catheters to facilitate dilation of stenoses in the femoral and poplited arteries and treatment of obstructive or synthetic arteriovenous dialysis fistulae.
Type of Use (Select one or both, as applicable)
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)
3
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."
4
510(k) Summary
| Submitter: | VentureMed Group, Ltd
5855 Monroe St, Suite 200
Sylvania, OH 43560 | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tiffini Diage
Regulatory Affairs Consultant
Phone: 707.799.6732
E-mail: tdiage@raechelon.com | |
| Date Prepared: | 5/17/2016 | |
| Trade Name: | FLEXTM Scoring Catheter | |
| Common Name: | Percutaneous Catheter | |
| Classification: | Class II | |
| Product Code: | PNO - 21 CFR 870.1250 | |
| Predicate Device(s): | The subject device is equivalent to the following devices:
K113103 - SplitWire Percutaneous Transluminal Angioplasty Scoring Device | |
| Device Description: | The FLEXTM Scoring Catheter is a sterile, single use, disposable device designed to facilitate the dilation of stenoses. The device has a working length of 120cm and is comprised of three scoring elements at the distal end. The distal end also contains an atraumatic tip and radiopaque maker band to aid in proper placement of the catheter. When the device is unsheathed the scoring elements are expanded to contact the plaque. The device scores the plaque as it is retracted. Once the desired plaque is scored the device is exchanged for a PTA balloon.
The device is compatible with0.18" guidewires. | |
| Technical Comparison Table | | |
| | FLEX TM Scoring Catheter
(Subject Device) | SplitWire Percutaneous
Transluminal Angioplasty
Scoring Device
(Predicate Device) |
| 510(k) Number | K152789 | K113103 |
| Decision Date | | |
| Manufacturer | VentureMed Group Ltd | Rex Medical |
| Classification | Class II | Class II |
| Regulation | 21 CFR 870.1250 | 21 CFR 870.1250 |
| Indications for Use | indicated for use with percutaneous
transluminal angioplasty (PTA)
catheters to facilitate dilation of
stenoses in the femoral and
popliteal arteries and treatment of
obstructive lesions of native or
synthetic arteriovenous dialysis
fistulae. | indicated for use with percutaneous
transluminal angioplasty (PTA)
catheters to facilitate dilation of
stenosis in the iliac, femoral, ilio-
femoral, popliteal, infra-popliteal,
and renal arteries and treatment of
obstructive lesions of native or
synthetic arteriovenous dialysis
fistulae. |
| Intended Use | Same | To facilitate the dilation of stenotic
vessels |
| Overall Device Length | 120cm | 90cm, 180cm, 260cm |
| Balloon Compatibility | Not applicable – device not in
vessel at same time as balloon | 20 – 80mm |
| Integrated Balloon | No | No |
| Visibility | Radiopaque markerband at distal
tip | Radiopaque coil at distal tip, plus 2
markerbands for balloon placement |
| Expansion Mechanism | Operator expanded | Balloon expanded |
| Scoring Member | 3 | 1 |
| Scoring Member Height | 0.010" | 0.014" |
| Scoring Member
Expanded Size | 5 mm | Dependent on inflated balloon
diameter |
| Scoring Member Depth
Control | Yes | No |
| Deflection | Yes