(52 days)
No
The summary describes a physical medical device (a balloon catheter) and its performance characteristics based on bench testing and biocompatibility. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
The device is described as a "Balloon Dilatation Catheter" intended to "dilate stenoses" and for "treatment of obstructive lesions," which are therapeutic actions.
No
The device is a Rapid Exchange Balloon Dilatation Catheter intended to dilate stenoses and treat obstructive lesions, indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly describes a physical catheter with a balloon, lumens, and a lubricious coating, indicating it is a hardware device. The performance studies also focus on physical characteristics 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 in vivo (within the body) to dilate blood vessels and treat lesions. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose diseases or conditions.
- Device Description: The description details a catheter with a balloon for physical intervention within the body. This is consistent with a medical device used for treatment, not for analyzing samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter is a medical device used for therapeutic purposes in vivo, not an IVD.
N/A
Intended Use / 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. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, native or synthetic 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)
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 on the predicate RapidCross catheter and are leveraged for the modified RapidCross catheter (K123544):
• Crossing Profile
• Balloon Burst Strength
• Balloon Compliance
• Balloon OD
• Inflation/Deflation Time
• Balloon Fatigue
• Bond Tensile Strength
• Kink
• Device Tracking
• Insertion Force
• Balloon Pull-back Force
• Repeat Inflations (In Stent)
• Torque Strength
• Radiopacity
• Presence of Coating
• Coating Durability
• Particle Generation
• Pushability
• Support Wire Securement
• Tip ID / RX Port ID
• Tip / Lesion Entry Profile
• Re-Insertion Force
• Catheter Working Length
• RX Port Length
• RX Port OD
The following tests were performed on the modified RapidCross catheter:
• Balloon Burst Strength (In Stent)
The predicate RapidCross catheter was tested for biocompatibility 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).
0
Image /page/0/Picture/0 description: The image shows the logo for the company "ev3". 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 text "Your endovascular company."
K130911 p. 1 of 3
510(k) Summary
MAY 2 4 2013
RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter
| 510(k) Summary | This 510(k) summary information is submitted in accordance
with the requirements of 21 CFR §807.92. | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Applicant | ev3 Inc. | |
| Submitter | ev3 Inc.
3033 Campus Drive
Plymouth, MN 55441-2651
Tel: 763-398-7000
Fax: 763-591-3248 | |
| Contact Person | Laura J. Lind | |
| Date Prepared | May 21, 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 Code LIT) | |
| Classification Panel | Cardiovascular | |
| Predicate Devices | RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter
(K123544, cleared February 12, 2013), PowerCross™ .018
OTW PTA Dilatation Catheter (K093286, cleared November 13,
2009.) | |
| Intended 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. This device is also indicated for
stent post-dilatation in the peripheral vasculature. | |
| Device Description | 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 | |
| Performance data | 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 on the predicate RapidCross catheter and are
leveraged for the modified RapidCross catheter (K123544): | |
| | • 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 following tests were performed on the modified RapidCross
catheter: | |
| | • Balloon Burst Strength (In Stent) | |
| | hemolysis, pyrogen, complement activation, thromboresistance, partial thromboplastin time, and platelet/leukocyte count and is leveraged for the modified RapidCross catheter (K123544). | |
| | The RapidCross catheter met all acceptance criteria for the 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. | |
| Summary of
Substantial
Equivalence | The RapidCross PTA Rapid Exchange Balloon Dilatation Catheter has the following similarities to the predicate devices:
Same intended use Similar indications for use Same fundamental scientific technology Same operating principle Same technological characteristics Identical sterility assurance level and sterilization method | |
| | 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 modified RapidCross catheter indications for use are identical to the ev3 PowerCross PTA Dilation Catheter indications for use. The differences between modified and predicate RapidCross catheters do not raise new safety and effectiveness questions. | |
| Conclusion | 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 RapidCross PTA Rapid Exchange Balloon Dilatation Catheter (K123544) and the PowerCross PTA Dilatation Catheter (K093286). | |
ev3 Corporate World Headquarters / Peripheral Vascular - 3033 Campus Drive, Plymouth, MN 55441, USA - Ph +1 763 398 7000 ev3 Neurovascular • 9775 Toledo Way, Irvine, CA 92618 • Ph + 1 949 837 3700
.
1
The predicate RapidCross catheter was tested for biocompatibility per ISO 10993-1 for short duration contact with blood (