Integra® Jarit® Heparin Cannulas, Injectors, and Needles are used in conjunction with various syringe sizes (not supplied by Integra®) for flushing, irrigation and solution injection into a vessel or cavity during vascular, bypass or other cardiovascular surgical procedures.

Device Description

Integra® Jarit® Heparin Cannulas, Injectors, and Needles are manual, stainless steel catheter cannulas provided in various sizes, shapes, and lengths for use during cardiovascular surgical procedures such as coronary artery bypass surgery. The cannulas are intended to be connected to a syringe filled with heparinized saline to confirm there is no leakage as well as ensure patency of harvested and/or grafted veins. The syringes are not being supplied with the cannulas nor are the syringes offered by Integra; therefore they are not part of this submission. These reusable devices are packaged non-sterile and are steam sterilizable.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Integra® Jarit® Heparin Cannulas, Injectors, and Needles:

Context: The provided text is a 510(k) Summary for a medical device seeking substantial equivalence to predicate devices, not an AI/ML medical device. Therefore, many of the typical acceptance criteria and study components associated with AI devices (like ground truth, expert consensus, MRMC studies, training/test sets, etc.) are not applicable here. This document focuses on demonstrating physical and material properties, and reusability.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Standard/Test)	Reported Device Performance
Cleaning Validation	Manual Cleaning Validation (Protein Analyses) per AAMI TIR30:2003	Pass
	Mechanical Cleaning Validation (Protein Analyses) per AAMI TIR30:2003	Pass
Sterilization Validation	Pre-Vacuum (wrapped) Steam Sterilization Validation per ANSI/AAMI ST79:2010 & A1:2010 and ANSI/AAMI/ISO 14937:2009 at 270°F (132°C) with an Exposure Time of 4 minutes and Drying Time of 30 minutes	Pass
Material/Durability Testing	Repeated Autoclave Testing, Boiling Water Testing, Copper Sulfate Corrosion Testing and Thermal Testing per ISO 13402:1995 and ASTM F 1089-02	Pass
Mechanical Strength	Laser Weld Joint Mechanical Strength Testing	Pass
	Brazed Joint Mechanical Strength Testing	Pass
Biocompatibility	Use of recognized biocompatible materials (304 and 303 Stainless Steel) per ASTM F899-11 and ISO 7153-1, with a long history of safe and effective use.	Not performed (deemed unnecessary based on material properties and history)

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

Sample Size for Test Set: Not explicitly stated. The tests conducted are typically on a sample of the devices designed to be representative of production, but the specific number is not disclosed in this summary.
Data Provenance: The tests are controlled bench tests performed on the physical devices manufactured by Integra York PA, Inc. The data is prospective for the purpose of this submission; it's generated specifically to demonstrate compliance for the 510(k). Country of origin for data generation is not specified beyond "Integra York PA, Inc." (USA).

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

This question is not directly applicable to this type of device submission. The "ground truth" for these tests is established by recognized industry standards (e.g., AAMI, ASTM, ISO) and the scientific principles behind them (e.g., measuring protein residue, assessing material integrity, verifying sterilization efficacy). These standards themselves are developed by committees of experts, but specific individual experts are not cited for establishing the ground truth for this particular test of this device.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human interpretation or consensus. The tests performed yield objective, measurable results (e.g., "Pass" or "Fail" based on whether predefined thresholds from the standards are met).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a manual surgical instrument, not an AI/ML-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., Algorithm-Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical, manual surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used is defined by adherence to established national and international performance standards and test methods (e.g., ANSI/AAMI ST79, ASTM TIR 30, ISO 13402, ASTM F1089-02, ISO 7153-1). These standards specify acceptable levels for cleanliness, sterilization, corrosion resistance, and mechanical strength. In the case of biocompatibility, the ground truth is based on the recognized biocompatibility profiles of the specified stainless steel materials as per relevant material standards (ASTM F899-11 and ISO 7153-1) and their long history of safe use in medical devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.

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

Not applicable, as there is no training set for this type of device.

Summary

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K131446

510(k) Summary

Submitted by:	Integra York PA, Inc.589 Davies DriveYork, PA 17402 USA
	OCT 2 8 2013
Contact Person:	Stephanie SheesleySr. Regulatory Affairs ManagerIntegra York PA, Inc.589 Davies Drive, York, PA 17402 USAPhone: (717) 717-840-3522Facsimile: (717) 840-9347
Date Prepared:	August 15, 2013
Device Trade Name:	Integra® Jarit® DeBakey Heparin Cannula, Integra® Jarit® StoneyHeparin Injector, and Integra® Jarit® Heparin Flushing Needle
Device Common Name:	Cardiovascular cannulas, injectors, and needles
Part Numbers:	310-379, 310-382, 310-383, 310-384
Classification Name:	Cannula, Catheter
Device Class:	Class II
Product Code:	DQR
CFR Classification:	21 CFR 870.1300

Device Description:

Indications For Use:

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Predicate Devices:

510(k) #	Device	Manufacturer
Preamendment	DeBakey Heparin Cannula	Pilling Co.
Preamendment	Stoney Heparin Injector	Pilling Co.
Preamendment	Heparin Flushing Needle	V. Mueller
K030788	DeBakey Vessel Dilator	Geister Medizintechnik GmbH

There are no differences in technology, materials, intended use, or design between the subject devices and the above predicates.

Performance Standards:

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, the Integrato Cannulas, Injectors, and Needles conform to the following standards:

ANSI/AAMI ST79:2010 & A1:2010 Comprehensive guide to steam sterilization . and sterility assurance in health care facilities
· ANSI/AAMI/ISO 14937:2009 Sterilization of health care products-General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process
ASTM TIR 30:2003 A Compendium of processes, materials, test methods, and . acceptance criteria for cleaning reusable medical devices
ASTM F 1089-02 Standard test method for corrosion of surgical instruments
0 ISO 13402:1995 Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure
. ISO 7153-1:2001 Surgical instruments- Metallic Materials- Part 1: Stainless Steel
. ASTM F899-11 Standard Specification for Wrought Stainless Steels for Surgical Instruments

Non-Clinical Tests Submitted:

Testing Performed	Results
Manual Cleaning Validation (Protein Analyses) per AAMI TIR30:2003.	Pass
Mechanical Cleaning Validation (Protein Analyses) per AAMI TIR30:2003.	Pass
Pre-Vacuum (wrapped) Steam Sterilization Validation per ANSI/AAMI ST79:2010& A1:2010 and ANSI/AAMI/ISO 14937:2009 at 270°F (132°C) with an ExposureTime of 4 minutes and Drying Time of 30 minutes	Pass
Repeated Autoclave Testing, Boiling Water Testing, Copper Sulfate CorrosionTesting and Thermal Testing per ISO 13402:1995 and ASTM F 1089-02.	Pass
Mechanical Strength Testing - Laser Weld Joint	Pass
Mechanical Strength Testing - Brazed Joint	Pass

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Integra® Jarit® Heparin Cannulas, Injectors, and Needles

No biocompatibility testing was performed on the proposed devices as the 304 and 303 Stainless Steel Materials are recognized biocompatible materials per ASTM F899-11 and ISO 7153-1 and have a long history of safe and effective use as shown in the predicate devices.

Conclusions drawn from Non-Clinical Data:

All necessary testing has been performed on the Integra® Jarit® Heparin Cannulas, Injectors, and Needles and the results support the conclusion that the subject devices are substantially equivalent to the legally marketed predicate devices based on intended use, materials, technology, and design and as such, do not raise any concerns of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized emblem with three curved lines, resembling a human figure, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the emblem. The emblem is black, and the text is also black.

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

October 28, 2013

Integra Lifesciences Corporation c/o Stephanie Sheesley Sr. Regulatory Affairs Manager Integra York PA, Inc. 589 Davies Drive York, PA 17402

Re: K131446

Trade/Device Name: Integra® Jarit® DeBakey Heparin Cannula, Integra® Jarit® Stoney Heparin Injector, and Integra® Jarit® Heparin Flushing Needle

Regulation Number: 21 CFR 870.1300 Regulation Name: Cannula Catheter Regulatory Class: Class II Product Code: DQR Dated: August 28, 2013 Received: August 29, 2013

Dear Ms. Sheesley:

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

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Page 2 - Stephanie Sheesley

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Ellison

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

Enclosure

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Indications For Use

510(k) Number (if known):

K131466

Device Name: Integra® Jarit® Heparin Cannulas, Injectors, and Needles

Indications for Use:

Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use (Part 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. Hillerman

Regulation Number and Section

§ 870.1300 Catheter cannula.

(a)
Identification. A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.(b)
Classification. Class II (performance standards).