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 a 14Fr Introducer. The set also consists of a dilator, 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 or 80 cm working lengths. The device is provided sterile and is intended for single use only.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Percu-Pro™ Steerable Introducer based on the provided text:

Preamble: This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance standards. Therefore, the "acceptance criteria" are primarily related to meeting established industry standards and guidance for similar devices, and the "device performance" is reported in terms of compliance with these standards and suitability for intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion / Test Name	Reported Device Performance / Outcome
Biocompatibility & Hemocompatibility (ISO 10993)	Cytotoxicity	Demonstrated suitability for intended use
	Systemic Injection	No intracutaneous reaction observed (O indicated for pass)
	Intracutaneous Injection	No intracutaneous reaction observed (O indicated for pass)
	Sensitization Maximization	Demonstrated suitability for intended use
	Material Mediated Pyrogenicity	Demonstrated suitability for intended use
	Direct Hemolysis	Demonstrated suitability for intended use
	Partial Thromboplastin Time	Demonstrated suitability for intended use
	In Vivo Thromboresistance Study in Dog	Demonstrated suitability for intended use
	ASTM Hemolysis - Direct Contact	Demonstrated suitability for intended use
	SC5b-9 Complement Activation Assay	Demonstrated suitability for intended use
	C3a Complement Activation Assay	Demonstrated suitability for intended use
Mechanical Testing (ISO 10555 & FDA Guidance)	Visual Surface Inspection	All test results demonstrate that the properties and performance of the device are suitable for its intended use.
	Dimensional Verification	All test results demonstrate that the properties and performance of the device are suitable for its intended use.
	Corrosion Resistance	All test results demonstrate that the properties and performance of the device are suitable for its intended use.
	Tensile Break Force	All test results demonstrate that the properties and performance of the device are suitable for its intended use.
	Tip Separation Force	All test results demonstrate that the properties and performance of the device are suitable for its intended use.
	Freedom from Leakage Under Pressure	All test results demonstrate that the properties and performance of the device are suitable for its intended use.
	Air Leakage During Aspiration	All test results demonstrate that the properties and performance of the device are suitable for its intended use.
	Luer Hub Compliance	All test results demonstrate that the properties and performance of the device are suitable for its intended use.
	Flexural Fatigue Tolerance	All test results demonstrate that the properties and performance of the device are suitable for its intended use.
	In Vitro Simulated Use Studies	All test results demonstrate that the properties and performance of the device are suitable for its intended use.
	Functional Performance Testing	All test results demonstrate that the properties and performance of the device are suitable for its intended use.
	Radiopacity	All test results demonstrate that the properties and performance of the device are suitable for its intended use.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Safety and Performance Testing." This testing included Biocompatibility and Hemocompatibility testing in accordance with ISO 10993, and Mechanical testing conducted in accordance with ISO 10555 and FDA Guidance.

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

Sample Size: The document does not specify the exact sample size (number of devices or tests performed per criterion) for either the biocompatibility/hemocompatibility or mechanical testing. It lists the categories of tests conducted.
Data Provenance: The studies were conducted by Cardiosolutions Inc. as part of their 510(k) submission. The location of the testing facilities is not explicitly stated. The nature of the tests (biocompatibility and mechanical properties) indicates they are "benchtop" or "laboratory" studies, not directly involving human patients (except for the in vivo thromboresistance study in dogs, which is an animal model). These were likely prospective tests designed to evaluate the physical and biological properties of the manufactured device.

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

Not Applicable. For this type of device (intravascular catheter introducer), "ground truth" as typically defined in diagnostic AI studies (e.g., expert consensus on medical images) is not relevant. The "truth" is established by adherence to a pass/fail criterion for each technical standard or guidance document. The expertise would lie in the engineers and scientists performing and interpreting these technical tests in accordance with the specified ISO standards and FDA guidance. Their qualifications are not explicitly stated but are implicitly assumed to be appropriate for conducting such specialized testing.

4. Adjudication Method for the Test Set

Not Applicable. Similar to the point above, adjudication in the sense of resolving disagreements among human readers on a diagnosis is not relevant here. The tests likely have clear pass/fail criteria based on quantitative measurements or qualitative observations by a single or multiple trained personnel, but not in a "reader adjudication" format typically seen in clinical studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is designed to assess the performance of diagnostic systems (e.g., AI with/without human readers). This 510(k) pertains to a medical device (introducer sheath) that is not a diagnostic system. The studies described are focused on the physical and biological properties of the device itself.

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

Not Applicable. This device is a physical medical instrument, not a software algorithm or AI. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on defined scientific and engineering standards and specifications. This includes:
- ISO 10993 series: For biocompatibility and hemocompatibility, which sets criteria for acceptable biological response.
- ISO 10555 series: For sterile, single-use intravascular catheters, which defines mechanical requirements.
- FDA Guidance: On Premarket Notification 510(k) Submission for Short Term and Long Term Intravascular Catheters, which provides additional criteria.
- For the in vivo dog study mentioned, the ground truth would be the observed biological response to the device in the animal model, interpreted against established safety benchmarks for thrombus formation.

8. The Sample Size for the Training Set

Not Applicable. This is a hardware medical device, not an AI or machine learning algorithm that requires a "training set." The device is manufactured according to a design, and then tested for compliance with established standards.

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

Not Applicable. As there is no training set for this hardware device, the concept of establishing ground truth for it does not apply.

Summary

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APR 2 4 2012 11-120084

P. 1 of 2

510(k) Summary

As required by section 807.92(c) _____________________________________________________________________________________________________________________________________________

As required by section 807.92(c)
Company Name	Cardiosolutions Inc.
Address	375 West St.West Bridgewater MA 02379Phone: 781-344-0801Fax: 781-344-0803
Contact Person	Michele Lucey
Date Prepared	April 24, 2012
Trade Name	Percu-Pro™ Steerable Introducer
Common Name	Steerable Introducer
ClassificationName	Steerable Guide Catheter
Product Code	DRA, DYB
Regulation #	21 CFR 870.1280
Class	2
Panel	Cardiovascular
PredicateDevices	St. Jude Medical, Diag Division, Inc., Agilis™ Steerable Catheter Introducer, K042623Evalve Inc., Steerable Guide Catheter, K100789
DeviceDescription	The Cardiosolutions Percu-Pro™ Steerable Introducer is a 14Fr Introducer. The set also consists of a dilator, 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 or 80 cm working lengths. The device is provided sterile and is intended for single use only.
Intended Use	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.
Safety andPerformanceTesting	No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices, However, testing was conducted in accordance with protocols based on the requirements of industry standards and guidance

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documents.

Safety and performance testing included:

Biocompatibilty and Hemocompatibility testing in accordance with ISO 10993 were conducted. Results demonstrate that the device is suitable for its intended use. The assessments performed include:

Cytotoxicity

Systemic Injection O
No intracutaneous reaction observed Intracutaneous Injection 0
Sensitization Maximization O
Material Mediated Pyrogenicity 0
Direct Hemolysis O
Partial Thromboplastin Time 0
In Vivo Thromboresistance Study in Dog* O
ASTM Hemolysis- Direct Contact O
SC5b-9 Complement Activation Assay O
C3a Complement Activation Assay O

Mechanical testing was conducted in accordance with the ISO 10555 Sterile, single-use intravascular catheters Part 1: General requirements (as amended, 1999, 2004) and in consideration of FDA Guidance on Premarket Notification 510(k) Submission for Short Term and Long Term Intravascular Catheters. The following tests were completed:

Visual Surface Inspection 0
Dimensional Verification o
Corrosion Resistance O
Tensile Break Force O
Tip Separation Force O
Freedom from Leakage Under Pressure O
Air Leakage During Aspiration 0
O Luer Hub Compliance
Flexural Fatigue Tolerance 0
In Vitro Simulated Use Studies ্
O Functional Performance Testing
Radiopacity O

All test results demonstrate that the properties and performance of the device are suitable for its intended use.

The Percu-Pro™ Steerable Introducer is substantially equivalent to the predicate Substantial Equivalence 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.

Public Health Service

APR 2 4 2012

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

Cardiosolutions. Inc. c/o Ms. Michele Lucey Vice President, Regulatory Affairs & Quality Assurance 375 West Street West Bridgewater, MA 02379

Re: K120086

Trade/Device Name: Percu Pro Steerable Introducer Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Guide Catheter Regulatory Class: Class II Product Code: DRA. DYB Dated: March 9, 2012 Received: March 12, 2012

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. 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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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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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,

M.A. Killen

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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K120086

INDICATIONS FOR USE

510(k) Number (if known): K120086

Device Name: Percu-Pro™ Steerable Introducer

Indications for Use:

Prescription Use __ X__

Over-The_Counter Use

(PLEASE DO NOTR WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

AND/OR

M. J. Hillen

n Sian-Off n of Cardiovascular Devices

510(k) Number K120086

Regulation Number and Section

§ 870.1280 Steerable catheter.

(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).