(85 days)
The RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter is intended to dilate stenosis 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.
The RapidCross PTA Rapid Exchange Balloon Dilatation Catheter (RapidCross catheter) is a rapid exchange (RX) coaxial catheter compatible with 0.014" guidewires, with a distally mounted semi-compliant inflatable balloon and an atraumatic, tapered tip. The distal portion of the catheter has a lubricious coating. The manifold includes an inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon. On the 150 mm and 210 mm devices, two additional marker bands denote the middle of the balloon body. A guidewire lumen starts at a guidewire port located 35 cm from the catheter tip and extends to the distal tip. The 90 cm useable length devices have proximal depth marks printed on the proximal shaft at lengths of 55 cm and 65 cm from the distal tip while the 170 cm useable length devices have depth marks at 90 cm and 100 cm to serve as a reference during catheter insertion.
The RapidCross catheter is available in balloon sizes ranging from 2 mm to 4 mm in diameter and 20 mm to 210 mm in length; and, all sizes are compatible with 4 F sheaths.
The provided document is a 510(k) summary for the RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter. It focuses on establishing substantial equivalence to predicate devices based on bench testing and biocompatibility, rather than clinical studies with human subjects or AI-based performance metrics. Therefore, many of the requested categories are not applicable.
Here's an analysis of the available information:
Acceptance Criteria and Device Performance
The document states that "The RapidCross catheter met all acceptance criteria for the bench testing with results similar to the predicates." It also lists various bench tests performed.
| Acceptance Criteria Test | Reported Device Performance |
|---|---|
| Crossing Profile | Met acceptance criteria; similar to predicates |
| Balloon Burst Strength | Met acceptance criteria; similar to predicates |
| Balloon Compliance | Met acceptance criteria; similar to predicates |
| Balloon OD | Met acceptance criteria; similar to predicates |
| Inflation/Deflation Time | Met acceptance criteria; similar to predicates |
| Balloon Fatigue | Met acceptance criteria; similar to predicates |
| Bond Tensile Strength | Met acceptance criteria; similar to predicates |
| Kink | Met acceptance criteria; similar to predicates |
| Device Tracking | Met acceptance criteria; similar to predicates |
| Insertion Force | Met acceptance criteria; similar to predicates |
| Balloon Pull-back Force | Met acceptance criteria; similar to predicates |
| Repeat Inflations (In Stent) | Met acceptance criteria; similar to predicates |
| Torque Strength | Met acceptance criteria; similar to predicates |
| Radiopacity | Met acceptance criteria; similar to predicates |
| Presence of Coating | Met acceptance criteria; similar to predicates |
| Coating Durability | Met acceptance criteria; similar to predicates |
| Particle Generation | Met acceptance criteria; similar to predicates |
| Pushability | Met acceptance criteria; similar to predicates |
| Support Wire Securement | Met acceptance criteria; similar to predicates |
| Tip ID / RX Port ID | Met acceptance criteria; similar to predicates |
| Tip / Lesion Entry Profile | Met acceptance criteria; similar to predicates |
| Re-Insertion Force | Met acceptance criteria; similar to predicates |
| Catheter Working Length | Met acceptance criteria; similar to predicates |
| RX Port Length | Met acceptance criteria; similar to predicates |
| RX Port OD | Met acceptance criteria; similar to predicates |
| Biocompatibility (ISO 10993-1) | Met acceptance criteria for short duration contact with blood (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, complement activation, thromboresistance, partial thromboplastin time, and platelet/leukocyte count). |
Study Information:
This document describes a premarket notification for a medical device (RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter) seeking substantial equivalence. The "study" referenced is a series of non-clinical, bench-top tests and biocompatibility assessments, not a clinical trial or AI model validation study.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for each individual bench test. The number of devices tested for each parameter is not provided.
- Data Provenance: The tests were "internal Risk Analysis procedures" and "bench testing." This likely refers to in-house laboratory testing by the manufacturer (ev3 Inc. in Plymouth, MN, USA). The data is prospective in the sense that the tests were conducted specifically for this submission.
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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):
- Not Applicable. This is a physical device and the "ground truth" for its performance is determined by established engineering and materials science standards and test methods (e.g., measuring burst pressure, dimensions, tracking force). There were no human experts establishing ground truth in the context of diagnostic interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This concept is relevant for studies involving human interpretation or clinical endpoints. For bench testing of physical properties, the results are typically quantitative measurements against predefined specifications.
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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 device is a physical medical instrument (a balloon catheter), not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI-related effectiveness metrics are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. See above. There is no algorithm being tested in standalone mode.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Specifications and Biocompatibility Standards. The "ground truth" for this device's performance is its adherence to internal design specifications, industry standards for medical devices (e.g., ISO 10993-1 for biocompatibility), and comparability to legally marketed predicate devices.
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The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established:
- Not Applicable. See above.
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K1235244
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Image /page/0/Picture/1 description: The image shows the logo for ev3, a medical device company. The logo consists of the letters "ev3" in a stylized font, with three black circles above the letters. To the right of the logo is the tagline "Your endovascular company."
510(k) Summary
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FEB 1 2 2013
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| FEB 1 2 20RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter | |
|---|---|
| 510(k) Summary | This 510(k) summary information is submitted in accordancewith the requirements of 21 C.F.R §807.92. |
| Applicant | ev3 Inc. |
| Submitter | ev3 Inc.3033 Campus DrivePlymouth, MN 55441-2651 |
| Contact Person | Laura J. Lind |
| Date Prepared | February 6, 2013 |
| Device Trade Name | RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter |
| Device Common Name | PTA Dilatation Catheter |
| Classification Name | Catheter, Angioplasty, Peripheral, Transluminal(21 CFR 870.1250, Product Codes LIT, DQY) |
| Classification Panel | Cardiovascular |
| Predicate Devices | NanoCross™ .014 OTW PTA Dilatation Catheter (K082854,K090849), PowerCross™ .018 OTW PTA Dilatation Catheter(K093286), Sterling™ Monorail™ PTA Balloon DilatationCatheter (K053118), and Advance® 14LP Low Profile PTABalloon Dilatation Catheters (K090822). |
| Intended use | The RapidCross™ PTA Rapid Exchange Balloon DilatationCatheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for thetreatment of obstructive lesions of native or syntheticarteriovenous dialysis fistulae. |
| Device Description | The RapidCross PTA Rapid Exchange Balloon DilatationCatheter (RapidCross catheter) is a rapid exchange (RX) coaxialcatheter compatible with 0.014" guidewires, with a distallymounted semi-compliant inflatable balloon and an atraumatic,tapered tip. The distal portion of the catheter has a lubriciouscoating. The manifold includes an inflation lumen, which is usedto inflate and deflate the dilatation balloon with a mixture of |
| Tel: 763-398-7000Fax: 763-591-3248 |
ev3 Corporate World Headquarters / Peripheral Vascular - 3053 Campus Dive, Flynnesh, MN 55441, USA - Ph - 1763 398 7050
ev3 Neurovascular • 9775 Tolodo V/ay, Irvine, CA 92618 • Ph • 1 949 837 3700
.
ev3 Europe / International Headquarters • 108/108 ₪e La Reètie. 75008 Paris, Firaco • Ph +33 156 89 59 1 3
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contrast medium and saline solution. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon. On the 150 mm and 210 mm devices, two additional marker bands denote the middle of the balloon body. A guidewire lumen starts at a guidewire port located 35 cm from the catheter tip and extends to the distal tip. The 90 cm useable length devices have proximal depth marks printed on the proximal shaft at lengths of 55 cm and 65 cm from the distal tip while the 170 cm useable length devices have depth marks at 90 cm and 100 cm to serve as a reference during catheter insertion.
The RapidCross catheter is available in balloon sizes ranging from 2 mm to 4 mm in diameter and 20 mm to 210 mm in length; and, all sizes are compatible with 4 F sheaths.
Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. Results from this 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 tests were performed:
| • Crossing Profile | • Radiopacity |
|---|---|
| • Balloon Burst Strength | • Presence of Coating |
| • Balloon Compliance | • Coating Durability |
| • Balloon OD | • Particle Generation |
| • Inflation/Deflation Time | • Pushability |
| • Balloon Fatigue | • Support Wire Securement |
| • Bond Tensile Strength | • Tip ID / RX Port ID |
| • Kink | • Tip / Lesion Entry Profile |
| • Device Tracking | • Re-Insertion Force |
| • Insertion Force | • Catheter Working Length |
| • Balloon Pull-back Force | • RX Port Length |
| • Repeat Inflations (In Stent) | • RX Port OD |
| • Torque Strength |
The device was tested for biocompatibility per ISO 10993-1 for <24 hours). The testing 1, intracutaneous reactivity, , pyrogen, complement tial thromboplastin time, and platelet/leukocyte count.
The RapidCross catheter met all acceptance criteria for the
| short duration contact with blood |
|---|
| included cytotoxicity, sensitization |
| acute systemic toxicity, hemolysis |
| activation, thromboresistance, part |
| platelet/leukocyte count |
Performance data
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bench testing with results similar to the predicates. Based on the bench test results, comparison to legally marketed predicates, and non-clinical test results, the RapidCross catheter is determined to perform as safely and effectively as the predicates for its intended use.
The RapidCross PTA Rapid Exchange Balloon Dilatation Catheter has the following similarities to the predicate devices:
- Same intended use (all predicates) ●
- Same indications for use (NanoCross PTA Dilatation . Catheter)
- Similar fundamental scientific technology (all predicates) .
- Similar operating principle (all predicates) .
- Similar technological characteristics .
- Same sterility assurance level and sterilization method . (NanoCross)
All devices are compatible with 0.014" wires and 4F sheaths. All devices have similar construction and principles of operation. All devices are used by the physician in a similar manner typical of PTA balloon catheters.
The RapidCross catheter and the predicates have the same intended use - all devices are intended to treat peripheral arteries. All devices are intended to treat the same target population. The manner in accessing and treating lesions is similar for the devices.
The RapidCross catheter indications for use are the same as the ev3 NanoCross PTA Dilation Catheter indications for use. The minimal differences between RapidCross and indications for use of the other predicates do not raise new safety and effectiveness questions.
Based on the intended use, technological characteristics, and results from safety and performance testing, the RapidCross PTA Rapid Exchange Balloon Dilatation Catheter is considered substantially equivalent to the legally marketed predicate devices NanoCross .014 OTW PTA Balloon Dilatation Cathetat (K082854, K090849), PowerCross PTA Dilatation Catheter (K093286) Sterling Monorail PTA Balloon Dilatation Catheter (K053118), and Advanced LP Dilatation Catheter (K090822).
Summary of Substantial Equivalence
Conclusion
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem is a symbol of an eagle with outstretched wings, representing protection and care, which is a common symbol used by the HHS.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002
FEB 1 2 2013
ev3 Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K123544
Trade/Device Name: RapidCross PTA Rapid Exchange Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: January 23, 2013 Received: January 24, 2013
Dear Mr. Job:
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
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Matthew G. Hillebrenner
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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Page 1 of 1
Indications for Use Statement
510(k) Number (if known): K123544
Device Name: RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter
Indications for Use:
The RapidCross™ PTA Rapid Exchange Balloon Dilatation 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Hillel
(Division Sign-Off) Division of Cardiovascular Devices
K123544 510(k) Number
§ 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).