(40 days)
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.
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.
This document is a 510(k) summary for the Fortrex™ 0.035" OTW PTA Balloon Catheter, which is a medical device intended to dilate stenoses in various arteries and for stent post-dilatation in the peripheral vasculature. The summary outlines the device's characteristics, its similarities to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.
Here's an analysis of the provided text in response to your questions:
1. A table of acceptance criteria and the reported device performance
The document states: "The Fortrex catheter met all acceptance criteria for the performance testing. The results from these tests demonstrate that the technological characteristics and performance criteria of the Fortrex Catheter are comparable to the predicate EverCross Catheter and that the Fortrex Catheter performs in a manner equivalent to the predicate EverCross device currently on the market."
However, specific quantitative acceptance criteria values are not provided, nor are the numerical results for each test. The table below lists the performance tests conducted, but without the specific criteria or reported performance data.
| Performance Test | Acceptance Criteria (Not specified) | Reported Device Performance (Not specified quantitatively) |
|---|---|---|
| Balloon Dimensional Verification | Met acceptance criteria | Met all acceptance criteria |
| Balloon Rated Burst Pressure | Met acceptance criteria | Met all acceptance criteria |
| Minimum Balloon Burst Strength | Met acceptance criteria | Met all acceptance criteria |
| Balloon Fatigue | Met acceptance criteria | Met all acceptance criteria |
| Balloon Compliance | Met acceptance criteria | Met all acceptance criteria |
| Catheter Dimensional Verification | Met acceptance criteria | Met all acceptance criteria |
| Inflation / Deflation Time | Met acceptance criteria | Met all acceptance criteria |
| Wire Movement | Met acceptance criteria | Met all acceptance criteria |
| Radiopacity | Met acceptance criteria | Met all acceptance criteria |
| Device Tracking | Met acceptance criteria | Met all acceptance criteria |
| Insertion Force | Met acceptance criteria | Met all acceptance criteria |
| Balloon Pull-back Force | Met acceptance criteria | Met all acceptance criteria |
| Reinsertion Force | Met acceptance criteria | Met all acceptance criteria |
| Torque Strength | Met acceptance criteria | Met all acceptance criteria |
| Tensile Strength | Met acceptance criteria | Met all acceptance criteria |
| Kink | Met acceptance criteria | Met all acceptance criteria |
| Marker Band to Balloon Body | Met acceptance criteria | Met all acceptance criteria |
| Biocompatibility (ISO 10993-1) | Met acceptance criteria | Met all acceptance criteria |
| - Cytotoxicity | Met acceptance criteria | Met all acceptance criteria |
| - Sensitization | Met acceptance criteria | Met all acceptance criteria |
| - Intracutaneous reactivity | Met acceptance criteria | Met all acceptance criteria |
| - Acute systemic toxicity | Met acceptance criteria | Met all acceptance criteria |
| - Hemolysis | Met acceptance criteria | Met all acceptance criteria |
| - Pyrogen | Met acceptance criteria | Met all acceptance criteria |
| - Complement activation | Met acceptance criteria | Met all acceptance criteria |
| - Thromboresistance | Met acceptance criteria | Met all acceptance criteria |
| - Partial thromboplastin time | Met acceptance criteria | Met all acceptance criteria |
| - Platelet/leukocyte counts | Met acceptance criteria | Met all acceptance criteria |
| - Mutagenicity | Met acceptance criteria | Met all acceptance criteria |
| - Lymphoma | Met acceptance criteria | Met all acceptance criteria |
| - Micronucleus assay | Met acceptance criteria | Met all acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists performance tests but does not specify the sample sizes used for each test. It also does not provide information on the data provenance in terms of country of origin or whether the study was retrospective or prospective. The study appears to be an internal bench testing and biocompatibility testing conducted by the manufacturer, Covidien llc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This document describes performance testing of a medical device (PTA balloon catheter), not a diagnostic algorithm that requires expert-established ground truth from medical images or clinical data. Therefore, this question is not applicable to the type of study presented here. The "ground truth" for these tests would be established by validated test methods and reference standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is bench and biocompatibility testing of a physical device, not an assessment requiring human adjudication of results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document pertains to the 510(k) clearance of a physical medical device (balloon catheter), not an AI/software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is about a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests:
- Bench Testing: The "ground truth" is established by the specifications and validated test methods for a medical device (e.g., burst pressure measured by a pressure gauge, dimensions measured by calibrated instruments).
- Biocompatibility Testing: The "ground truth" is established by the accepted standards and protocols defined in ISO 10993-1, using biological assays and analytical methods.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning study, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device study.
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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
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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
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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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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 llc4600 Nathan Lane NPlymouth, MN 55441-2651Tel: 763-398-7000Fax: 763-591-3248 |
|---|---|
| Contact Person | Rupali GuptaSenior 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 (<24 hours). The testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, complement activation, thromboresistance, partial thromboplastin time, platelet/leukocyte counts, mutagenicity, lymphoma and micronucleus assay.
The Fortrex catheter met all acceptance criteria for the performance testing. The results from these tests demonstrate that the technological characteristics and performance criteria of the Fortrex Catheter are comparable to the predicate EverCross Catheter and that the Fortrex Catheter performs in a manner equivalent to the predicate EverCross device currently on the market.
8. Conclusions
Based on the intended use, technological characteristics, safety and performance testing included in this submission, Covidien considers the proposed Fortrex Catheter to be substantially equivalent to the currently marketed EverCross™ .035" OTW PTA Dilatation Catheter (K103322, K110319) and Mustang™ Balloon Dilatation Catheter (K103751).
§ 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).