The Percu-Pro™ Steerable Introducer is intended to be used for the introduction of various cardiovascular catheters into the heart, including the left side of the heart through the inter-atrial septum.

Device Description

The Cardiosolutions Percu-Pro™ Steerable Introducer is provided as a 9Fr and 14Fr Introducer. The set also consists of a dilator (14Fr only), stylet, and tear-away introducer sheath. The steerable introducer is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer provides both proximal tip and distal tip steering and is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer sheath is reinforced Pebax and the distal tip has a radiopaque marker to improve fluoroscopic visualization. The device is provided in 65 cm working lengths. The device is provided sterile and is intended for single use only. The purpose of this submission is to add an additional device diameter; 9Fr has 65 cm working lengths.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Testing	Conformity to ISO 10555 "Sterile, single-use intravascular catheters Part 1: General requirements" (as amended, 1999, 2004) and FDA Guidance on Premarket Notification 510(k) Submission for Short Term and Long Term Intravascular Catheters. This implies that the device should meet specified standards for: - Visual Surface Inspection - Dimensional Verification - Corrosion Resistance - Tensile Break Force - Tip Separation Force - Freedom from Leakage Under Pressure - Air Leakage During Aspiration - Luer Hub Compliance - Flexural Fatigue Tolerance - In Vitro Simulated Use Studies - Functional Performance Testing - Radiopacity	"All test results demonstrate that the properties and performance of the device are suitable for its intended use." (Specific quantitative results are not provided in this summary.)
Material/Biocompatibility	New device materials should be biocompatible or identical to predicate device materials.	"The materials used in the 9Fr Percu-Pro™ Steerable Introducer are identical to the 14Fr Percu-Pro™ Steerable Introducer predicate device. No additional biocompatibility is required."
Shelf Life	The device should maintain its properties and performance over its intended shelf life.	Shelf life testing was completed (specific results not provided).
Substantial Equivalence	The device must be substantially equivalent to the predicate device in terms of intended use, design, materials, technology, and function, with no new issues of safety or effectiveness.	"The 9Fr Percu-Pro™ Steerable Introducer is substantially equivalent to the predicate devices in terms of intended use, design, materials, technology, and function. There are no differences between devices which would raise new issues of safety or effectiveness."

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

The document does not provide specific sample sizes for each mechanical and functional test. It generally states that "Design verification testing performed on the 9Fr device consisted of mechanical testing conducted in accordance with..."

Sample Size: Not explicitly stated as a number of devices/units. The testing generally applies to the 9Fr device.
Data Provenance: Not applicable in the context of clinical data for AI. These are engineering/device performance tests.

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

Not applicable. This is a device performance evaluation, not an AI study requiring expert ground truth for classification.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, this is not an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

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

7. The Type of Ground Truth Used

The "ground truth" here is adherence to established engineering standards (ISO 10555) and FDA guidance for the performance of intravascular catheters. For material equivalence, the ground truth is the chemical composition of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm.

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

Not applicable. This is not an AI algorithm.

Summary

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JUL 1 9 2013

510(k) Summary

Special 510(k)

As required by section 807.92(c) _________

CompanyName	Cardiosolutions Inc.
	As required by section 807.92(c)
Address	375 West St.West Bridgewater MA 02379Phone: 781-344-0801Fax: 781-344-0803
Contact Person	Michele Lucey
Date Prepared	April 24, 2013
Trade Name	Percu-Pro™ Steerable Introducer
Common Name	Steerable Introducer
ClassificationName	Steerable Guide CatheterCatheter Introducer
Product Code	DYB, DRA
Regulation #	870.1340, 870.1280
Class	2
Panel	Cardiovascular
PredicateDevices	Percu-Pro™ Steerable Introducer K120086
DeviceDescription	The Cardiosolutions Percu-Pro™ Steerabl e Introducer is provided as a 9Frand 14FrIntroducer. The set also consists of a dilator (14Fr only), stylet, and tear-away introducersheath. The steerable introducer is designed to pro vide flexible catheter positioning i nthe cardiac anatomy. The steer able introducer provides both proximal tip and distal tipsteering and is fitted with a hem ostasis valve to minim ize blood loss duri ng catheterintroduction and/or exchange. A sideport with stopcock is provided for air or bloo daspiration, fluid infusion, blood sampling, and pressure monitoring. The i ntroducersheath is rei nforced Pebax and the distal tip has a radiopaque marker to im provefluoroscopic visualization. The device is pro vided in 65 cm working len gths. Thedevice is provided sterile and is intended for single use only.The purpose of this submission is to add an ad ditional device diameter; 9Fr has65 cm working lengths.

Intended Use	The Percu-Pro™ Steerable Introducer is intended to be used for the introdu ction ofvarious cardiovascular catheters into the heart, including the left side of the heart throughthe inter-atrial septum.
Safety andPerformanceTesting	No performance standards have been established under Section 514 of the Food, Drugand Cosmetic Act for these devices.
	The materials used in the 9Fr Percu-Pro™ Steerable Introducer are identical to the 14FrPercu-Pro™ Steerable Introducer predicate device. No additional biocompatibility isrequired.
	Design verification testing performed on the 9Fr device consisted of mechanical testingconducted in accordance with the ISO 10555 St erile, single-use intravascular cathetersPart 1: General requirem ents (as amended, 1999, 2004) and in consideration of FDAGuidance on Premarket Notification 510(k) Submission for Short Term and Long TermIntravascular Catheters. The following tests were completed:
	○ Visual Surface Inspection
	○ Dimensional Verification
	○ Corrosion Resistance
	○ Tensile Break Force
	○ Tip Separation Force
	○ Freedom from Leakage Under Pressure
	○ Air Leakage During Aspiration
	○ Luer Hub Compliance
	○ Flexural Fatigue Tolerance
	○ In Vitro Simulated Use Studies
	○ Functional Performance Testing
	○ Radiopacity
	○ Shelf Life
	A summary of the testing performed is included in the 510(k) submission. All testresults demonstrate that the properties and performance of the device are suitable for itsintended use.
SubstantialEquivalence	The 9Fr Percu-Pro™ Steerable Introducer is substantially equivalent to the predicatedevices in terms of intended use, design, materials, technology, and function. There ar eno differences between devices which would raise new issues of safety or effectiveness.

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Public Health Service

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

July 19, 2013

Cardiosolutions, Inc. c/o Michele Lucey Vice President Regulatory and Quality Compliance 375 West Street West Bridgewater, MA 02379

Re: K131332

Trade Name: Percu-ProTM Stecrable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB, DRA Dated: June 21, 2013 Received: June 26, 2013

Dear Ms. Lucey:

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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unlinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, and 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

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Page 2 - Ms. Michele Lucey

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillman

for

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

510(k) Number: K131332

Device Name: Percu-Pro™ Steerable Introducer

Indications for Use:

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.Z. Zillman

Cardiosolutions Inc.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).