The HQS introducer (Model 2064-HQS) is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions

Device Description

The High Quality Sealing (HQS) Introducer comprises 4 elements, a radio- opaque introducer sheath equipped with a haemostasis valve, a radio- opaque dilator, a centering wire device and an extension line with 3 ways stopcock. The range of HQS introducer (18F, 20F, 22F, 24F, 26F) permits the insertion, preserving sealing, of large caliber tools, from OF, up to the nominal size of-the-introducer-sheath.. The introducer and its adjustable valve are easily handled with one hand. The distal tip is designed to perform an efficient introduction of the HQS introducer with the dilator in the vessel. The centering device permits to introduce a guidewire through the valve and to keep a perfect sealing. The extension line is connected to the lateral port of the introducer for the injection during the procedure.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "HQS Introducer (Model 2064-HQS)". It describes the device, its intended use, and the non-clinical tests performed to demonstrate its safety and effectiveness for substantial equivalence. It does not describe an AI medical device.

Therefore, the requested information about acceptance criteria and studies (particularly those related to AI performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies) cannot be extracted from this document as it pertains to a physical medical device.

The study described is a series of in-vitro and biocompatibility tests to ensure the physical device meets established standards for safety and performance, not a study to prove AI performance.

Here's what can be extracted about the general acceptance criteria and studies for this physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that the device is in compliance with ISO 11070:1999 for "Sterile, single use intravascular catheter introducers" and ISO 10993-1:2009 for biocompatibility. The specific acceptance criteria for each test (e.g., tensile strength, overpressure resistance, useful dimensions) are not quantitatively reported in this summary, but the general statement is that the results demonstrate that the device is in compliance and meets the requirements.

Acceptance Criteria Category	Specific Tests Performed	Reported Device Performance
Bench/Performance Data (In-vitro)	1. Tensile strength	In compliance with ISO 11070:1999 and product labeling.
	2. Overpressure resistance	In compliance with ISO 11070:1999 and product labeling.
	3. Suction resistance	In compliance with ISO 11070:1999 and product labeling.
	4. Introducer useful dimensions (lengths, Inside and Outside diameters)	In compliance with ISO 11070:1999 and product labeling.
	5. Dilator useful dimensions (lengths, Inside and Outside diameters)	In compliance with ISO 11070:1999 and product labeling.
	6. Sealing of the valve	In compliance with ISO 11070:1999 and product labeling.
	7. Operating mechanism resistance	In compliance with ISO 11070:1999 and product labeling.
	8. Visual control (atraumatic surface)	In compliance with ISO 11070:1999 and product labeling.
	9. Resistance to kinking	In compliance with ISO 11070:1999 and product labeling.
	10. Dilator compatibility (introduction / withdrawal)	In compliance with ISO 11070:1999 and product labeling.
	11. Extension line connection	In compliance with ISO 11070:1999 and product labeling.
	12. Centering device compatibility	In compliance with ISO 11070:1999 and product labeling.
	13. Introducer/dilator distal transition	In compliance with ISO 11070:1999 and product labeling.
	14. Compatibility with vascular tools and guidewire	In compliance with ISO 11070:1999 and product labeling.
	15. Radiodetectability test	In compliance with ISO 11070:1999 and product labeling.
	16. Packaging resistance	In compliance with ISO 11070:1999 and product labeling.
	17. Sterilization tests	In compliance with ISO 11070:1999 and product labeling.
	18. Aging tests	In compliance with ISO 11070:1999 and product labeling.
Biocompatibility Tests	• Cytotoxicity (ISO 10993-5:2009)	Materials meet ISO 10993-1:2009 requirements.
	• Sensitization (ISO 10993-10:2006)	Materials meet ISO 10993-1:2009 requirements.
	• Intracutaneous Toxicity (ISO 10993-10:2006)	Materials meet ISO 10993-1:2009 requirements.
	• Systemic Toxicity (ISO 10993-11:2006)	Materials meet ISO 10993-1:2009 requirements.
	• Pyrogenicity (ISO 10993-11:2006)	Materials meet ISO 10993-1:2009 requirements.
	• Hemolysis (ASTM Guideline F756:2008)	Materials meet ISO 10993-1:2009 requirements.
	• Prothrombin Time (ISO 10993-4:2006)	Materials meet ISO 10993-1:2009 requirements.
	• Coagulation UPTT (ISO 10993-4:2006)	Materials meet ISO 10993-1:2009 requirements.
	• Platelet (ISO 10993-4:2006)	Materials meet ISO 10993-1:2009 requirements.
	• Complement Activation (ISO 10993-4:2006)	Materials meet ISO 10993-1:2009 requirements.
	• Thrombogenicity (ISO 10993-4:2006)	Materials meet ISO 10993-1:2009 requirements.

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical product testing, not a dataset for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for a physical device, not an AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical device, not an AI.
7. The type of ground truth used: For the physical device, the "ground truth" is defined by the performance standards outlined in ISO 11070:1999 and ISO 10993-1:2009, which specify acceptable physical and biological characteristics.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI.
9. How the ground truth for the training set was established: Not applicable. This is a physical device, not an AI.

Summary

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JUL 3 1 2012

113849

510(k) SUMMARY

As required by section 807.92(c)

Submitter:	ALSEAL
Contacts:	M. DELFORGE Jean-FrançoisVALPARC - ESPACE VALENTIN6 C Rue De Franche-Comté25048 BESANCON Cedex - FrancePhone : 00333.81.61.69.93
Preparation Date:	November 16, 2011
Trade Name:	HQS Introducer (Model 2064-HQS)
Common Name:	Catheter Introducer
Classification Name:	Catheter Introducer
Regulation Number:	870.1340
Product Code:	DYB
Legally Marketed Predicate Devices:	Gore Dryseal Sheath (K093791) Manufactured By W.L. Gore &Associates, Inc
Device Description:	The High Quality Sealing (HQS) Introducer comprises 4 elements, a radio-opaque introducer sheath equipped with a haemostasis valve, a radio-opaque dilator, a centering wire device and an extension line with 3 waysstopcock.The range of HQS introducer (18F, 20F, 22F, 24F, 26F) permits theinsertion, preserving sealing, of large caliber tools, from OF, up to thenominal size of-the-introducer-sheath..The introducer and its adjustable valve are easily handled with one hand.The distal tip is designed to perform an efficient introduction of the HQSintroducer with the dilator in the vessel.The centering device permits to introduce a guidewire through the valveand to keep a perfect sealing.The extension line is connected to the lateral port of the introducer for theinjection during the procedure.
Intended Use:	HQS INTRODUCER (Model 2064-HQS) is intended to be inserted in thevasculature to provide a conduit for the insertion of endovascular deviceswhile minimizing blood loss associated with such insertions.

. . . . . . .

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Bench/ Performance data	The following in-vitro testing was performed on the HQS Introducer(Model 2064-HQS) in accordance with ISO standards and/orinternal procedures to assure reliable design and performance. In-vitro design verification testing data demonstrate that the device isin compliance with ISO 11070:1999 Sterile, single useintravascular catheter introducers and product labeling.
	1. Tensile strength
	2. Overpressure resistance
	3. Suction resistance
	4. Introducer useful dimensions (lengths, Inside and Outside diameters)
	5. Dilator useful dimensions (lengths, Inside and Outside diameters)
	6. Sealing of the valve
	7. Operating mechanism resistance
	8. Visual control (atraumatic surface)
	9. Resistance to kinking
	10. Dilator compatibility (introduction / withdrawal)
	11. Extension line connection
	12. Centering device compatibility
	13. Introducer/dilator distal transition
	14. Compatibility with vascular tools and guidewire
	15. Radiodetectability test
	16. Packaging resistance
	17. Sterilization tests18. Aging tests
Non-Clinical Tests:	Biocompatibility testsIn accordance with ISO 10993-1:2009, the followingbiocompatibility tests were conducted on the HQS Introducer(Model 2064-HQS):
	• Cytotoxicity (ISO 10993-5:2009)
	• Sensitization (ISO 10993-10:2006)
	• Intracutaneous Toxicity (ISO 10993-10:2006)
	• Systemic Toxicity (ISO 10993-11:2006)
	• Pyrogenicity (ISO 10993-11:2006)
	• Hemocompatibility
	o Hemolysis (ASTM Guideline F756:2008)
	o Prothrombin Time (ISO 10993-4:2006)

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KII 3849 D. Zof 3

	Coagulation UPTT (ISO 10993-4:2006)Platelet (ISO 10993-4:2006)Complement Activation (ISO 10993-4:2006)Thrombogencity (ISO 10993-4:2006) Results for all biocompatibility testing demonstrate that the materials used meet the requirements of ISO 10993-1:2009.
Substantial equivalence:	HQS INTRODUCER is compared to predicate legally marketed device GORE DRYSEAL SHEATH (K093791). HQS INTRODUCER is substantially equivalent to its predicate devices in terms of intended use, function and technological characteristics. Any minor differences between these two devices do not raise new questions of safety and effectiveness. Performance data included within this submission demonstrates safety, effectiveness and substantial equivalence.
Conclusion:	The studies conducted on the HQS Introducer (Model 2064-HQS) demonstrate that the device is substantially equivalent to the predicate devices currently in commercial distribution. The proposed device meets the performance criteria of design verification as specified by ISO standards and test protocols. Any differences between the devices do not raise any significant issues of safety or effectiveness.

Coagulation UPTT (ISO 10993-4:2006)Platelet (ISO 10993-4:2006)Complement Activation (ISO 10993-4:2006)Thrombogencity (ISO 10993-4:2006) Results for all biocompatibility testing demonstrate that the materials used meet the requirements of ISO 10993-1:2009.

Substantial equivalence:

HQS INTRODUCER is compared to predicate legally marketed device GORE DRYSEAL SHEATH (K093791). HQS INTRODUCER is substantially equivalent to its predicate devices in terms of intended use, function and technological characteristics. Any minor differences between these two devices do not raise new questions of safety and effectiveness. Performance data included within this submission demonstrates safety, effectiveness and substantial equivalence.

Conclusion:

The studies conducted on the HQS Introducer (Model 2064-HQS) demonstrate that the device is substantially equivalent to the predicate devices currently in commercial distribution. The proposed device meets the performance criteria of design verification as specified by ISO standards and test protocols. Any differences between the devices do not raise any significant issues of safety or effectiveness.

and the comments of the comments of

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

JUL 3 1 2012

ALSEAL c/o Intertek Testing Services Ms. Paula Wilkerson 2307 E. Aurora Rd. Unit B7 Twinsburg, OH 44087

Re: K113849

Trade/Device Name: HQS Introducer (Model 2064 - HQS) Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 2, 2012 Received: July 10, 2012

Dear Ms. Wilkerson:

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 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

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Page 2 – Ms. Paula Wilkerson

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 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,

CMR Hillen

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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INDICATIONS FOR USE

K113849 510(k) Number (if known): _ Device Name: HQS INTRODUCER (Models 2064-HQS) Indications for Use:

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 ANOTHER PAGE OF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Unz Keel

ardiovascular Devices

િની ડેક્કે 510(k) Number

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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).