(40 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML.
Yes
The device is intended to treat medical conditions by actively dilating stenoses and treating fistulae, which aligns with the definition of a therapeutic device.
No
The device is a balloon catheter used to dilate stenoses and for stent post-dilatation in various arteries and fistulae, indicating a therapeutic function rather than a diagnostic one.
No
The device description clearly details a physical catheter with a balloon, lumens, and radiopaque markers, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Fortrex Catheter Function: The description clearly states the Fortrex 0.035" OTW PTA Balloon Catheter is used to dilate stenoses (narrowings) in arteries and treat fistulae within the body. It's a therapeutic device used for intervention, not for analyzing samples.
The information provided describes a medical device used for a procedure performed inside the patient's body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fortrex 0.035" OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Product codes
LIT
Device Description
The Fortrex™ 0.035" PTA Balloon Catheter (Fortrex Catheter) is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi-compliant inflatable balloon and an atraumatic tapered tip. The manifold includes a lumen marked "THRU". This is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum diameter of 0.035". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the balloon with a mixture of contrast medium and saline solution. The balloon has two radiopague markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon.
The Fortrex Catheter is available with balloon diameters 4.0 mm to 12.00 mm, balloon lengths 20 mm, 40 mm, 80 mm, and 100 mm and with shaft lengths of 40 cm, 80 cm, and 135 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, popliteal, infra-popliteal, and renal arteries, arteriovenous dialysis fistulae, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
To demonstrate substantial equivalence of the proposed Fortrex Catheter to the predicate EverCross device, bench testing and biocompatibility testing was performed.
Bench testing included:
- Balloon Dimensional Verification
- Balloon Rated Burst Pressure
- Minimum Balloon Burst Strength
- Balloon Fatigue
- Balloon Compliance
- Catheter Dimensional Verification
- Inflation / Deflation Time
- Wire Movement
- Radiopacity
- Device Tracking
- Insertion Force
- Balloon Pull-back Force
- Reinsertion Force
- Torque Strength
- Tensile Strength
- Kink
- Marker Band to Balloon Body
Biocompatibility testing was performed per ISO 10993-1 for short duration contact with blood (
§ 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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2014
Covidien llc. c/o Mark Job Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K142654
Trade/Device Name: Fortrex 0.035" OTW PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: LIT Dated: September 16, 2014 Received: September 18, 2014
Dear Mr. Job:
This letter corrects our substantially equivalent letter of October 28, 2014.
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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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" (21CFR 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
Indications for Use
510(k) Number (if known)
Device Name
Fortrex™ 0.035" OTW PTA Balloon Catheter
Indications for Use (Describe)
The Fortrex 0.035" OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Type of Use (Select one or both, as applicable)
2 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)
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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510(k) Summary
Fortrex™ 0.035" OTW PTA Balloon Catheter
This 510(k) summary is being submitted in accordance with the requirements of 21 C.F.R § 807.92.
1. Submitter Information
| Applicant | Covidien llc
4600 Nathan Lane N
Plymouth, MN 55441-2651
Tel: 763-398-7000
Fax: 763-591-3248 |
|----------------|---------------------------------------------------------------------------------------------------------|
| Contact Person | Rupali Gupta
Senior Regulatory Affairs Specialist |
| Date Prepared | August 25, 2014 |
2. Subject Device
| Device Trade Name | Fortrex TM 0.035" OTW PTA Balloon Catheter |
|---|---|
| Device Common Name | PTA Dilatation Catheter |
| Classification Name | Catheter, Angioplasty, Peripheral, Transluminal (21 CFR§870.1250, Product Code LIT |
| Classification Panel | Cardiovascular |
3. Predicate Devices
| Device Trade Name | EverCross TM .035” OTW PTA Dilatation Catheter (Primary Predicate) |
|---|---|
| 510(k) Number | K103322, K110319 |
| 510(k) Clearance Date | December 06, 2010, April 14, 2011 |
| Device Trade Name | MustangTM Balloon Dilatation Catheter |
| 510(k) Number | K103751 |
| 510(k) Clearance Date | March 22, 2011 |
4. Device Description
The Fortrex™ 0.035" PTA Balloon Catheter (Fortrex Catheter) is an over the wire (OTW) 0.035"dual lumen catheter with a distally mounted semi-compliant inflatable balloon and an atraumatic tapered tip. The manifold includes a lumen marked "THRU". This is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum diameter of 0.035". The lumen marked "BALLOON" is the
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Fortrex™ 0.035" OTW PTA Balloon Catheter 510(k) Summary
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balloon inflation lumen, which is used to inflate and deflate the balloon with a mixture of contrast medium and saline solution. The balloon has two radiopague markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon.
The Fortrex Catheter is available with balloon diameters 4.0 mm to 12.00 mm, balloon lengths 20 mm, 40 mm, 80 mm, and 100 mm and with shaft lengths of 40 cm, 80 cm, and 135 cm.
5. Indications for Use
The Fortrex™ 0.035" OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Comparison of Technological Characteristics 6.
The proposed Fortrex Catheter uses very similar design and materials as the primary predicate EverCross Catheter. Modifications have been made to the proposed Fortrex device design and materials to improve performance of the balloon through higher burst pressure and improved joint strength and integrity. The Fortrex Catheter shares the following similarities to the predicate devices:
- Similar fundamental scientific technology
- . Same operating principle
- . Similar balloon lengths
- . Similar rated burst pressure
Additionally, the indications for use, device materials, and manufacturing site and methods are similar between the proposed Fortrex Catheter and the predicate EverCross Catheter.
7. Performance Testing Summary
To demonstrate substantial equivalence of the proposed Fortrex Catheter to the predicate EverCross device, bench testing and biocompatibility testing was performed. Results from these testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. Using internal Risk Analysis procedures, the following performance tests were performed:
| Balloon Dimensional Verification | Device Tracking |
|---|---|
| Balloon Rated Burst Pressure | Insertion Force |
| Minimum Balloon Burst Strength | Balloon Pull-back Force |
| Balloon Fatigue | Reinsertion Force |
| Balloon Compliance | Torque Strength |
| Catheter Dimensional Verification | Tensile Strength |
| Inflation / Deflation Time | Kink |
| Wire Movement | Marker Band to Balloon Body |
| Radiopacity |
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Fortrex™ 0.035'' OTW PTA Balloon Catheter 510(k) Summary
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The Fortrex Catheter was tested for biocompatibility per ISO 10993-1 for short duration contact with blood (