XCath (model 2064-XC) is intended to be inserted into the HQS Introducer (model 2064-HQS) to establish multiple and simultaneous conduits through the same vascular access (previously established by the HQS introducer).

The whole XCath / HQS allows insertion of several endovascular devices at the same time while minimizing blood loss associated with such insertions.

Device Description

The XCath (model 2064-XC) consists of a multiple ways access (2, 3 or 4 ways) adapted to the HQS Introducer (K113849) to optimize the sealing when several vascular tools up to 9,3F need to be introduced through the same vascular access.

The device features include (1) a flexible multilumen body, with 2, 3 or 4 channels compatible with the open valve of HQS Introducer; (2) a base with 2, 3 or 4 valves, (3) Extension line for each valve with stopcock and Luer Lock connection.

Once the XCath is connected to the HQS Introducer, the device can accommodate vascular tools up to 9,3 French (3,1mm). The XCath (accessory) is fixed in proximal position of the HQS introducer body and allows the simultaneous insertion of several vascular tools.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Device Performance
Biocompatibility: In accordance with ISO 10993-1 for external communicating devices, direct circulating blood path, duration ≤ 24 hours.	Biocompatibility testing has concluded that the device does not introduce significant questions of safety and is substantially equivalent to the predicate.
Material/Design Equivalence: Substantially equivalent to predicate device in Indications for Use, Materials and design.	Safety and performance testing concluded that the device is substantially equivalent to the predicate.
Tensile strength	In compliance with ISO 11070: 1999
Overpressure resistance	In compliance with ISO 11070: 1999
Dimensions and aspect	In compliance with ISO 11070: 1999
Sealing resistance	In compliance with ISO 11070: 1999
Air leak (vacuum) test	In compliance with ISO 11070: 1999
Compatibility with HQS Introducer	In compliance with ISO 11070: 1999
Sealing of the valve	In compliance with ISO 11070: 1999 (ensures sealing while empty or accessed with guide / max dilator)
Free passage of a guide and 9F vascular tool	In compliance with ISO 11070: 1999
Validation of luer and extension lines	In compliance with ISO 11070: 1999
Ease of assembly	In compliance with ISO 11070: 1999
Traction resistance	In compliance with ISO 11070: 1999
Packaging resistance	In compliance with ISO 11070: 1999
Sterilization tests	In compliance with ISO 11070: 1999
Aging tests	In compliance with ISO 11070: 1999

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

The document does not explicitly state the specific sample sizes for each non-clinical performance test. It notes that "The following in vitro testing was performed on the XCath ... to assure reliable design and performance." The data provenance is "in vitro" testing performed by ALSEAL, the manufacturer, in France.

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

This information is not applicable. The device is a medical instrument (catheter introducer accessory), and its performance is evaluated through engineering and biocompatibility bench testing, not through expert review of data like in an AI/diagnostic device study.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human interpretation of data, not for bench testing of a medical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or imaging devices where human readers interpret medical data, often with and without AI assistance. The XCath is a hardware device tested for its physical and functional performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No, a standalone study in the context of an algorithm's performance was not done. This device is a physical medical instrument, not an algorithm. Its "standalone" performance refers to its ability to meet engineering specifications through bench testing.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is established by engineering specifications, ISO standards (specifically ISO 11070: 1999 for intravascular catheters introducers), and internal procedures. For biocompatibility, the ground truth is defined by ISO 10993-1 standards.

8. Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this device is not an AI/machine learning algorithm. The engineering tests are to verify the final product's performance against predefined criteria.

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

This information is not applicable, as there is no training set for this type of device.

Summary

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K133296

FEB 1 4 2014

510(k) Summary 807.92(c)

SPONSOR

807.92(a)(1)

Company Name:	ALSEAL
Company Address	2 rue Paul Milleret25000 BesançonFrance

Telephone:	+33(0)3 81 61 69 93
Fax:	+33(0)3 81 53 47 65

Jean-François DELFORGE Contact Person:

Summary Preparation Date: September 29, 2013

DEVICE NAME

DEVICE NAME		807.92(a)(2)
Trade Name:	XCath (Model 2064-XC)
Common/Usual Name:	Catheter Introducer
Classification Name:	Introducer, Catheter
Regulation Number:	870.1340
Product Code:	DYB
Device Class:	Class II

PREDICATE DEVICE

807.92(a)(3)

K Number	Product Name	Manufacturer
K113849	HQS Introducer	ALSEAL
K121185	Edwards Percutaneous SheathIntroducer	Edwards Life Sciences, LLC

DEVICE DESCRIPTION

807.92(a){4}

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DEVICE INDICATIONS FOR USE

807.92(a)(5)

The whole XCath / HQS allows insertion of several endovascular devices at the same time while minimizing blood loss associated with such insertions.

	Subject Device	Predicate Device	Predicate Device
Manufacturer	ALSEAL	ALSEAL	Edwards Life Sciences, LLC
Trade Name	XCath (model 2064-XC)	HQS Introducer	Edwards PercutaneousSheath IntroducerAVA 3Xi andAVA High Flow
K number		K113849	K 121185
Product Code	DYB	DYB	DYB
Regulation No.	870.1340	870.1340	870.1340
Indications forUse	XCath (model 2064-XC) isintended to be insertedinto the HQS Introducer(model 2064-HQS) toestablish multiple andsimultaneous conduitsthrough the same vascularaccess (previouslyestablished by the HQSintroducer).The whole XCath / HQSallows insertion of severalendovascular devices atthe same time whileminimizing blood lossassociated with suchinsertions.	The HQS Introducer (Model2064-HQS) is intended to beinserted in the vasculatureto provide a conduit for theinsertion of endovasculardevices while minimizingblood loss associated withsuch insertions	The Edwards PercutaneousSheath Introducer isindicated for use in patientsrequiring access of thevenous system and tofacilitate catheter insertion(e.g. pulmonary artery orinfusion catheter).
Principle ofOperation	Transitions the HQS witha single insertion into amulti lumen devicebased on the number ofaccess conduits requiredby the use of multiplesilicone valves.	The tools are introduced inthe vasculature by placing aguide through the deviceand going through a siliconevalve minimizing blood loss	Transitions from anintroducer to a triple lumendevice with a fixed ordetachable introducer valveas treatment changesaccomplished through singlepercutaneous introducer
Device Design	Each channel of XCathaccessory has anapproaching design of HQSintroducer (sheathequipped with a siliconevalve and a lateral	Sheath equipped with asilicone valve and a lateralextension line with LuerLock connectors / 3 waystopcock.	Introducers are composedof valve housing to which asheath is attached distallyand three sidearm/extension tubes areconnected proximally.
	extension line with LuerLock connectors / 3 waystopcock).	Furnished with a dilator forfacilitating the introductioninto vasculature.	The valves located in thehousing body provide a sealaround a catheter wheninserted through theintroducer and preventbackflow when no catheteris present
Number ofchannels forvasculature access	As an accessory to the HQSIntroducer:2 way3 way4 way	1 channel Introducer	Triple lumen with 4th accessvia the fixed or detachableintroducer valve
Valve comparison	Silicone valve ensuressealing while empty oraccessed with guide / maxdilator.	Silicone valve ensuressealing while empty oraccessed with guide / maxdilator	Valve ensures sealing whileempty or insertion easedwith provided dilator
BiocompatibilityTesting	ISO 10993-1 for Externalcommunicating device,direct circulating bloodpath, duration ≥ 24 hours	ISO 10993-1 for Externalcommunicating device,direct circulating bloodpath, duration ≥ 24 hours	ISO 10993-1 for Externalcommunicating device,direct circulating bloodpath, duration ≥ 24 hours
Sterilization	Provide sterile;Single use.	Provide sterile; Single use.	Provide sterile; Single use.

COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

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NON-CLINICAL PERFORMANCE DATA

807.92(b)(1)

SAFETY BENCH TESTING

In accordance with ISO 10993-1, XCath (Model 2064-XCath) is categorized as externally communicating devices in contact with circulating blood for less than 24 hours. The following tests are recommended by ISO 10993-1.

PERFORMANCE TESTING

The following in vitro testing was performed on the XCath (Model 2064-XCath) in accordance with ISO standards and/or internal procedures to assure reliable design and performance. In vitro design verification testing data demonstrates that the device is in compliance with ISO 11070: 1999 Sterile, single use intravascular catheters introducers and product labeling.

1. Tensile strength
1. Overpressure resistance
1. Dimensions and aspect
1. Sealing resistance
1. Air leak (vacuum) test
1. Compatible with HQS introducer
1. Sealing of the valve
Free passage a guide and 9F vascular tool 8.
1. Validation of luer and extension lines
1. Ease of assembly
1. Traction resistance
1. Packaging resistance

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1. Sterilization tests
1. Aging tests

CONCLUSION

807.92(b)(3)

XCath (model 2064-XC) is substantially equivalent to the predicate device in Indications for Use, Materials and design. Safety and performance testing to ISO 11070 and Biocompatibility testing has concluded that the device does not introduce significant questions of safety and is substantially equivalent to the predicate.

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Image /page/4/Picture/10 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 14, 2014

Alseal C/O Yolanda Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, MD 21114 US

Re: K133296

Trade/Device Name: XCath Model 2064-XC Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Accessory Regulatory Class: Class II Product Code: DYB Dated: January 8, 2014 Received: January 10, 2014

Dear Ms. Smith:

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.

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Page 2 - Ms. Yolanda Smith

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 CFR Part 807); labeling (21 CFR Part 801; medical device reporting of medical devicerelated 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 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" (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. Z. Lilliencron

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K133296

Device Name XCath (Model 2064-XC)

Indications for Use (Describe)

The whole XCath / HQS allows insertion of several endovascular devices at the same time while minimizing blood loss associated with such insertions.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

[] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

M.A. Hillerman

ﺮ

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).