The Prodigy Support Catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.

Device Description

The Prodigy Support Catheter is an over-the-wire (OTW) 2-lumen catheter with a 5 mm clastomeric balloon located near the distal tip. One lumen of the catheter is used to inflate and deflate the balloon with contrast fluid. The second lumen provides access for a guidewire. Two side legs are located at the proximal catheter end to provide access to the balloon lumen and the guidewire lumcu. A pressure relief valve is attached at the proximal end of the balloon side leg and allows for connection with an inflation device. There are two radiopaque marker bands located at each end of the balloon. The inflated balloon diameter is variable with increased pressure up to 5 mm. The Prodigy Support Catheter is packaged in a mylar/Tyvek pouch and ETO sterilized to SAL 10-6.

AI/ML Overview

The provided 510(k) summary focuses on the Prodigy Support Catheter and describes its performance based on biocompatibility and in vitro functional testing, not a clinical study involving human readers or AI. Therefore, most of the requested information regarding AI performance, human reader studies, and ground truth establishment for clinical data is not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission discusses performance tests against established standards rather than specific acceptance criteria values paired with reported performance values. It states biocompatibility and in vitro performance tests were conducted according to the requirements of Guidance for Industry and FDA Staff-Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010, and ISO10993-1:2009 for biocompatibility.

Test Category	Specific Test Conducted	Performance Evaluation Criteria (Implicit)	Reported Device Performance (Summary)
Biocompatibility	Cytotoxicity	Met requirements of ISO10993-1:2009 and FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)
	Sensitization	Met requirements of ISO10993-1:2009 and FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)
	Intracutaneous Reactivity	Met requirements of ISO10993-1:2009 and FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)
	Acute Systemic Toxicity	Met requirements of ISO10993-1:2009 and FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)
	Hemolysis	Met requirements of ISO10993-1:2009 and FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)
	Material Mediated Pyrogenicity	Met requirements of ISO10993-1:2009 and FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)
	Thombogenicity	Met requirements of ISO10993-1:2009 and FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)
	Complement Activation	Met requirements of ISO10993-1:2009 and FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)
In Vitro Performance	Dimensional Verification	Met requirements of FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)
	Balloon Preparation, Deployment and Retraction	Met requirements of FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)
	Balloon Burst Pressure	Met requirements of FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)
	Balloon Fatigue	Met requirements of FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)
	Balloon Inflation/Deflation Time	Met requirements of FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)
	Catheter Bond Strength	Met requirements of FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)
	Flexibility and Kink Test	Met requirements of FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)
	Torque Strength	Met requirements of FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)
	Radiopacity	Met requirements of FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)
	Balloon Holding Force	Met requirements of FDA Guidance for PTCA Catheters	Pass (Implied by conclusion of substantial equivalence)

Conclusion: Based on these tests, the device was deemed "substantially equivalent to the currently marketed Minnie Support Catheter, Maverick XL PTCA Catheter and NC Quantum Apex OTW PTCA Dilatation Catheter."

2. Sample Size Used for the Test Set and Data Provenance

This submission does not involve a clinical test set from human subjects or derived from existing clinical data. The "test set" consists of multiple samples of the Prodigy Support Catheter for in vitro and biocompatibility testing. The number of devices tested for each in vitro performance test or material batch for biocompatibility is not specified in the summary but would typically be dictated by the relevant standards and internal quality procedures.
Data Provenance: The origin of the data is laboratory testing (in vitro and biocompatibility) of manufactured device samples, not patient data from a specific country or retrospective/prospective studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is not a study requiring expert readers to establish ground truth for clinical data. Performance was measured against physical and chemical standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert interpretations of clinical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

Not applicable. This submission does not involve an MRMC study or AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. This is a medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by the requirements and methodologies outlined in the referenced international standards (ISO10993-1:2009) and FDA guidance documents ("Guidance for Industry and FDA Staff-Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters," September 8, 2010). This involves predefined physical, chemical, and biological endpoints.

8. The Sample Size for the Training Set

Not applicable. This device does not use a "training set" in the context of AI or machine learning. Its performance is based on direct manufacturing and laboratory testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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K130714

510(K) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR 807.92 and the requirements of the Safe Medical Device ACT (SMDA) of 1990.

1. Sponsor Name Submitter's Name: Radius Medical, LLC Address: 577 Main St, Suitc 360 Hudson, MA 01749 Phone: (978) 263-4466 Fax: (978) 263-4465 Contact Person: Richard DeMello Date of Preparation: March 7, 2013
  AUG 2 2 2013
1. Device Information

Trade Name:	Prodigy Support Catheter
Common Name:	Percutaneous catheter
Class:	II
Classification Name:	Percutaneous catheter (21 CFR 870.1250, Product Code DQY)

1. Predicate Devices
  Minnie™ Support Catheter (K082337) manufactured by Vascular Solutions, Inc.

Maverick XL PTCA Catheter (P860019/183) manufactured by Boston Scicntific.

NC Quantum Apex OTW PTCA Dilatation Catheter (P860019/241) manufactured by Boston Scientific.

4. Device Description

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end to provide access to the balloon lumen and the guidewire lumcu. A pressure relief valve is attached at the proximal end of the balloon side leg and allows for connection with an inflation device. There are two radiopaque marker bands located at each end of the balloon. The inflated balloon diameter is variable with increased pressure up to 5 mm.

The Prodigy Support Catheter is packaged in a mylar/Tyvek pouch and ETO sterilized to SAL 10-6.

న. Intended Use
The Prodigy Support Catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.
1. Comparison of Technological Characteristics
  The Prodigy Support Catheter is similar in matcrials, function and design to predicate NC Quantum Apex OTW PTCA Dilatation Catheter (P860019/241) and the Maverick XL PTCA Catheter (P860019/183). All devices have two-lumen polymer shafts with a polymer balloon located near the tip of the catheter. One lumcn of the shaft allows for inflation of the balloon with contrast medium while the other lumen permits the guidewire to facilitate advancement of the catheter. The balloon sizes on the predicate devices range from 1.5 mm to 6 mm while the balloon on the Prodigy Support Catheter expands up to 6 mm. The Prodigy and NC Quantum Apex catheters both include side leg adaptors to provide separate access to the balloon inflation lumcn and the guidewire lumen. All catheters include two radiopaque marker bands at cither end of the balloon to aid in positioning the balloon within the patient. The NC Quantum Apcx OTW and Maverick XL catheters are used for dilating a stenotic portion of a coronary artery. The Prodigy Support Catheter is for accessing discrete regions of the arterial and or coronary vasculature and to facilitate placement and exchange of guidewires and other interventional devices. All are introduced into the body through a guidecatheter or outer sheath and are directed through the artery over a guidcwire. All devices have a balloon that is inflated at the distal end of the catheter into contact with the vessel wall. The NC Quantum Apex and Maverick balloon is used to dilate a narrowing in an artery using high pressures. The Prodigy balloon is used to anchor the catheter within the artery using low pressures. Guidewires can be placed and exchanged through the Prodigv and NC Quantum Apex OTW catheters.

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The design and function of the Prodigy Support Catheter is similar to the Minnie™ Support Catheter (K082337). Both devices utilize a polymer shaft, are introduced into the body through a guidccatheter or outer sheath and are directed . through the artery over a guidewire. Both catheters provide support for guidewires during interventional procedures and allow for exchanging of guidewires and other interventional devices. The Minnie catheter has a single lumen that accepts a guidewire. The Prodigy catheter has two lumens, one for a guidewire and one to inflate the distal balloon. Both catheters have radiopaque markers at the distal end to aid in location of the catheter tip.

1. Performance Data

Biocompatibility Testing

Biocompatibility tests were conducted on the Prodigy Support Catheter according to the requirements of Guidance for Industry and FDA Staff-Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 20102010 and ISO10993-1:2009, Biological Evaluation of Medial Devices Part-1: Evaluation and Testing. The following test were conducted:

. Cytotoxicity
. Sensitization
. Intracutaneous Reactivity
. Acute Systemic Toxicity
. Hemolysis
. Material Mediated Pyrogenicity
. Thombogenicity
. Complement Activation

In Vitro Performance Testing

In vitro performance tests were performed on the Prodigy Support Catheter according to the requirements of Guidance for Industry and FDA Staff-Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010. In-vitro performance testing conducted on the Prodigy Support Catheter included:

. Dimensional Verification
. Balloon Preparation, Deployment and Retraction
. Balloon Burst Pressure
. Balloon Fatigue

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Balloon Inflation/Deflation Time
. Catheter Bond Strength
. Flexibility and Kink Test
Torque Strength
. Radiopacity
. Balloon Holding Force

Conclusion

Based upon these biocompatibility and in vitro performance tests, the Prodigy Support Catheter has been shown to be substantially equivalent to the currently marketed Minnie Support Catheter, Maverick XL PTCA Catheter and NC Quantum Apex OTW PTCA Dilatation Catheter.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three wavy lines extending from its body.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 22, 2013

Radius Medical, LLC c/o Mr. Richard DeMello Vice President 577 Main St, Suite 360 Hudson, MA 01749

Re: K130714

Trade/Device Name: Prodigy Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DOY Dated: July 12, 2013 Received: July 18, 2013

Dear Mr. DeMello:

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

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Page 2 - Mr. Richard DeMello

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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,

M.A. Hillerman

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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510(k) Number (if known):

Device Name: Prodigy Support Catheter

Indications For Use:

X Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Zillerman

Regulation Number and Section

§ 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).