The Galt Medical Corp Elite HV Radial is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

Device Description

The Galt Medical Corp Elite HV product has been on the market since February of 2005, and was cleared under 510(k) K043525. The clearance included sizes from 4-9FR, and lengths from 5-110 cm with the following indication for use: The Sheath Introducer system is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature. The purpose of this 510(k) is to expand that indication for use for the Elite HV products to include radial placement. There were no design changes required as the current Galt offering included sizes which are appropriate for radial placement. The only limitation of the Radial placement claim is that the range of sizes is more limited due to the target anatomy. The Elite HV and Elite HV Radial consists of an introducer (valved sheath with sidearm and stopcock and dilator), which are packaged together with a guide wire. The Elite HV product is configured with a silicone valve or a TPE valve cleared under 510(k) K152528. Some product configurations also include an entry needle, guide wire inserter and a flushing syringe. The Elite HV Radial is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain barium sulfate, making these devices visible under fluoroscopy.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Galt Medical Corp. Elite HV Radial device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria for each test. Instead, it describes what types of tests were performed to establish substantial equivalence. It implies that the results of these tests demonstrated substantial equivalence to the predicate device, which is the primary "acceptance criterion" for a 510(k) submission.

Therefore, the table will reflect the types of tests performed and the conclusion reached regarding substantial equivalence.

Acceptance Criterion (Implicit)	Reported Device Performance
Functional Equivalence: Device performs as intended and is comparable to predicate device in key functional aspects.	Functional Testing Results: The Elite HV Radial demonstrated functional equivalence through testing that included: - Particulate Test - Mechanical Properties Test - Lubricity Test - Durability of coating - Dimensional comparison test Accelerated aging to an equivalent age of 4 years was also performed, and the functional testing was repeated, with the implication that results remained acceptable. The submission concludes: "The technological differences between the subject device and predicate device have been evaluated through bench and biocompatibility tests to provide evidence of substantial equivalence."
Biocompatibility: Device materials are safe for human contact.	Biocompatibility Testing Results: Performed in accordance with ISO 10993-1, including: - Cytotoxicity (MEM Elution) - Sensitization (Magnusson - Kligman) - Irritation (Intracutaneous injection) - Systemic Toxicity (Systemic injection) - Hemolysis (Direct Contact) - Hemocompatibility (Complement Activation) - In-Vitro Hemocompatibility (Dog Thrombogenicity) - Systemic Toxicity (Materials Mediated Pyrogen) - EO Residuals (EO, ECH, & EG) This was done "to update the biocompatibility testing to current standards" and the conclusion of substantial equivalence implies these tests were met.
Sterilization Efficacy: Device is effectively sterilized.	Sterilization Efficacy: The subject device was "adopted into the existing ethylene oxide sterilization cycle for the Galt product cleared under K043525 & K152528." This implies the cycle is validated and effective for the new device.
Shelf-Life Stability: Device maintains integrity over shelf life.	Shelf-Life Stability: "Current packaging shelf life testing was provided in the predicate submission." This indicates reliance on previous validation, implying stability for the Elite HV Radial in its unchanged packaging.
Safety and Effectiveness: No new questions regarding safety and effectiveness are raised by the differences to predicate devices.	Conclusion: "It will be shown in this 510(k) submission that the differences between the Galt Elite HV Radial and the predicate devices do not raise any new questions regarding safety and effectiveness. The Galt Elite HV Radial as designed and manufactured is determined to be substantially equivalent to the current marketed predicate device."

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

The document describes bench testing and biocompatibility testing. It does not specify a "test set" in terms of patient data.

Sample Size for Functional/Biocompatibility Tests: The document does not provide specific sample sizes (e.g., number of devices tested for particulate, mechanical properties, etc.). It only mentions that testing was conducted "according to protocols based on international standards and Galt Medical requirements."
Data Provenance: The data provenance is from bench laboratory testing and in vitro biocompatibility studies, not human patient data. There is no mention of country of origin for the data as it's not clinical data. It is inherently retrospective in the sense that the testing was performed, and then the results were compiled for the 510(k) submission.

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

This question is not applicable to this submission. The "ground truth" for this type of device (a medical introducer) in a 510(k) context is established through compliance with recognized standards (e.g., ISO for biocompatibility, internal engineering specifications for functional tests). There isn't a "ground truth" established by human experts in the same way an AI diagnostic device would have radiologists establishing ground truth for images. The "experts" involved would be the engineers, toxicologists, and quality assurance personnel who designed the tests, conducted them, and interpreted the results against established standards.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved. For bench testing and biocompatibility, the results are typically quantitative or qualitative (pass/fail) based on pre-defined criteria in the test protocols and standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where the AI assists human readers. The Elite HV Radial is a physical medical device (catheter introducer) and does not involve AI or human interpretation in its function.

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

No, a standalone performance study was not done. This term also applies to AI algorithms. The Elite HV Radial is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance in the context of the 510(k) submission is derived from:

Compliance with International Standards: e.g., ISO 10993-1 for biocompatibility.
Internal Engineering Specifications/Requirements: Derived from design control processes and the intended function of the device, often benchmarked against predicate device performance.
Predicate Device Performance: The underlying assumption of the 510(k) pathway is that the predicate device is safe and effective when used as labeled. By demonstrating "substantial equivalence," the new device inherits this established "ground truth" of safety and effectiveness.

8. The Sample Size for the Training Set

This question is not applicable as there is no "training set" in the context of a physical medical device. This term is used for machine learning models.

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

This question is not applicable as there is no "training set" for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 21, 2017

Galt Medical Corp. David Derrick Director of Quality and Regulatory Affairs 2220 Merritt Drive Garland, Texas 75087

Re: K173287

Trade/Device Name: Elite HV Radial Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 13, 2017 Received: October 16, 2017

Dear David Derrick:

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., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

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: January 31, 2017 See PRA Statement below

510(k) Number (if known)

K173287

Device Name ELITE HV RADIAL

Indications for Use (Describe)

The Galt Medical Corp Elite HV Radial is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K173287

Section 5 – 510(k) Summary

Application Date:	October 13, 2017
Application Type:	Traditional 510(k)
Applicant Information	Galt Medical Corporation2220 Merritt Dr.Garland, TX 75041Phone: 214-778-1306Fax: 972-271-4706
Official Contact:	David DerrickDirector of Quality and Regulatory AffairsGalt Medical Corporation2220 Merritt Dr.Garland, TX 75041Phone: 214-778-1306Fax: 972-271-4706dderrick@galtmedical.com
Device Name:	Elite HV Radial
Device Model Number:	TBD
Classification Name:	Catheter Introducer (DYB),21 CFR 870.1340
Device Classification:	Class II (Cardiovascular)
Predicate Device:	Glidesheath (K152173)Elite HV (K043525Gateway Hemostasis Valve (152528)
Manufacturer:	Galt Medical2220 Merritt DriveGarland, TX 75041Phone: 214-778-5177Fax: 972-271-4706

Establishment Registration Number: 1649395

Intended Use: The Galt Medical Corp Elite HV Radial is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

Device Description: The Galt Medical Corp Elite HV product has been on the market since February of 2005, and was cleared under 510(k) K043525. The clearance included sizes from 4-9FR, and lengths from 5-110 cm with the following indication for use:

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The Sheath Introducer system is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.

The purpose of this 510(k) is to expand that indication for use for the Elite HV products to include radial placement. There were no design changes required as the current Galt offering included sizes which are appropriate for radial placement. The only limitation of the Radial placement claim is that the range of sizes is more limited due to the target anatomy.

The Elite HV and Elite HV Radial consists of an introducer (valved sheath with sidearm and stopcock and dilator), which are packaged together with a guide wire. The Elite HV product is configured with a silicone valve or a TPE valve cleared under 510(k) K152528. Some product configurations also include an entry needle, guide wire inserter and a flushing syringe. The Elite HV Radial is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain barium sulfate, making these devices visible under fluoroscopy.

Comparison of Technological Characteristics: The subject device Elite HV Radial and the predicate device Terumo Glidesheath have identical indication statements and are of similar design. The subject and predicate device are available in similar configurations.

	Subject Device	Predicate Device	Predicate Device	Predicate Device
Mfr. /Product	Galt Medical / EliteHV Radial	Galt Medical / EliteHV	Terumo /Glidesheath™	Galt Medical /Gateway HemostasisValve
510(k)Number		K043525	K152173	K152528
DeviceClassificationn	870.1340	870.1340	870.1340	870.4290
ProductCode	DYB	DYB	DYB	DTL
Intendeduse	The Galt MedicalCorp Elite HV Radialis indicated tofacilitate placing acatheter through theskin into a vein orartery including butnot limited to theradial artery.	The Galt Medical CorpElite HV is indicatedfor use inpercutaneousprocedures tointroduce cathetersand otherintravascular devicesinto the vasculature.	The Glidesheath™ isindicated to facilitateplacing a catheterthrough the skin intoa vein or arteryincluding but notlimited to the radialartery.	The attachable CathLab Hemostasis Valveis indicated tominimize blood lossduring introductionof catheters,guidewires and otherintravascular devicesinto the vasculature.
Design	Introducer with valvedsheath and dilator in arange of sizes andlengths	Introducer with valvedsheath and dilator in arange of sizes andlengths	Introducer with valvedsheath and dilator in arange of sizes andlengths	Introducer with valvedhub and luer lockconnector
Color	Sheath Hub – White	Sheath Hub - White	Sheath Hub - Various	Sheath Hub - White

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	Subject Device	Predicate Device	Predicate Device	Predicate Device
	Sheath cannula-WhiteSheath cap- Variousindicating Fr sizeDilator hub- WhiteDilator cannula- BlueSidearm withstopcock - ClearValve silicone - clearnaturalValve TPE - clearnatural	Sheath cannula- WhiteSheath cap- Variousindicating Fr sizeDilator hub- WhiteDilator cannula- BlueSidearm with stopcock- ClearValve silicone - clearnatural	Sheath cannula-WhiteSheath cap- Variousindicating Fr sizeDilator hub- Variousindicating Fr sizeDilator cannula- BlueSidearm withstopcock - ClearValve - clear	Sheath cap- Variousindicating Fr sizeSidearm withstopcock - ClearValve TPE - clearnatural
Sizes	4F - 6F5cm to 25cm lengths	4F - 9F5cm to 110cm lengths	4F - 6F10cm to 25cmlengths	Maximum 8FR
Dilator Lock	Dilator is retained insheath cap	Dilator is retained insheath cap	Dilator is retained onsheath cap	Not applicable

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Substantial Equivalence and Summary of Bench Testing: The technological differences between the subject device and predicate device have been evaluated through bench and biocompatibility tests to provide evidence of substantial equivalence. The Elite HV Radial is substantially equivalent to the specified predicate device based on comparisons of the devices functionality, compatibility, technological characteristics, and indications for use.

Testing was conducted according to protocols based on international standards and Galt Medical requirements. Functional Testing included the following:

. Particulate Test
Mechanical Properties Test
Lubricity Test
. Durability of coating
. Dimensional comparison test

Additionally, accelerated aging was performed on the subject devices to an equivalent age of 4 years, and the functional testing was repeated.

Biocompatibility testing was performed on the subject device in accordance with ISO 10993-1. This was done in order to update the biocompatibility testing to current standards, and was not done as a result of any changes to the product. Biocompatibility testing included the following:

Cytotoxicity (MEM Elution)
Sensitization (Magnusson - Kligman)
. Irritation (Intracutaneous injection)
Systemic Toxicity (Systemic injection)
Hemolysis (Direct Contact)
Hemocompatibility (Complement Activation)
In-Vitro Hemocompatibility (Dog Thrombogenicity)
Systemic Toxicity (Materials Mediated Pyrogen)
EO Residuals (EO, ECH, & EG)

Additionally the subject device was adopted into the existing ethylene oxide sterilization cycle for the Galt product cleared under K043525 & K152528.

Packaging of the subject device will remain unchanged from the Galt Elite HV products. Current packaging shelf life testing was provided in the predicate submission.

Conclusion: It will be shown in this 510(k) submission that the differences between the Galt Elite HV Radial and the predicate devices do not raise any new questions regarding safety and effectiveness. The Galt Elite HV Radial as designed and manufactured is determined to be substantially equivalent to the current marketed predicate device.

End of Section

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).