The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.

Device Description

The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is a single use introducer designed to facilitate insertion of a device into the vasculature. The Peel-Away Sheath/Dilator Introducer Assembly is a unit comprised of a peel-away sheath introducer and a dilator. The Peel-Away sheath has a non-tapered body with a tapered tip to provide a smooth transition from the dilator. The Peel-Away sheath is a radiopaque polyethylene extruded sheath body with a molded polyethylene hub. The hub is designed with wings and a thin-wall peel groove on both sides that facilitate splitting the hub and sheath after a catheter is placed through the sheath. The sheath hub is also designed to allow the dilator to lock into the sheath during the insertion procedure. The polyethylene dilator has a tapered tip and an ergonomic hub that locks into the sheath hub during the insertion procedure. The dilator hub also features a Luer lock connection on the proximal end. The Peel-Away sheath/dilator introducer is available in 3 Fr. - 7 Fr. configurations with usable lengths of 7 and 10 cm.

AI/ML Overview

1. Acceptance Criteria and Device Performance:

The provided document describes a 510(k) submission for a non-AI medical device (Arrow GlideThru Peel-Away Sheath/Dilator Introducer). Therefore, the concept of "acceptance criteria" and "reported device performance" in the context of AI models (e.g., accuracy, sensitivity, specificity) is not directly applicable here.

Instead, the device's performance is demonstrated through a set of nonclinical bench tests, and the acceptance criterion is "substantially equivalent functionality to the predicate device."

Acceptance Criteria (Implied)	Reported Device Performance
Functional equivalence to predicate device (Xentek K000313) in:	Bench testing demonstrated "substantially equivalent functionality" to the predicate device.
- Tensile strength	The results of comparison testing demonstrated that the GlideThru is comparable to the predicate device in: - Tensile strength
- Biocompatibility	Testing completed. While specific quantitative results aren't provided, the conclusion states "substantially equivalent functionality," implying successful completion and acceptable results for biocompatibility.
- Sheath surface free from extraneous matter	Testing completed. Implied to meet acceptance criteria as "substantially equivalent functionality" is concluded.
- Radiodetectability	The results of comparison testing demonstrated that the GlideThru is comparable to the predicate device in: - Radiopacity
- Luer testing	Testing completed. Implied to meet acceptance criteria.
- Simulated Use testing	Testing completed. Implied to meet acceptance criteria.
- Penetration/Insertion force	The results of comparison testing demonstrated that the GlideThru is comparable to the predicate device in: - Penetration/Insertion force
- No new safety or effectiveness issues compared to predicate device	The FDA's conclusion explicitly states: "Any differences between the subject and predicate sheath introducers do not raise new issues of safety or effectiveness. The Arrow GlideThru™ Peel-Away Sheath/Dilator Introducer is substantially equivalent to the Xentek Medical, Inc. Tearaway Introducer Sheath." This confirms the device met the overarching acceptance criteria for 510(k) clearance.

2. Sample size used for the test set and the data provenance:

Not applicable. This is a medical device, not an AI model, and the testing involved bench tests on the device itself, not a 'test set' of data in the AI sense. The document does not specify exact sample sizes for each bench test, but it confirms that these nonclinical tests were performed.
The data provenance is from nonclinical bench testing performed by Arrow International, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device does not use an AI model, so there is no "ground truth" established by experts in the context of AI model evaluation. The "ground truth" for the device's performance is derived from physical measurements and observations during bench testing against predefined specifications or comparison with the predicate device.

4. Adjudication method for the test set:

Not applicable. There is no human adjudication process for a "test set" in the context of this device. The evaluation is based on objective measurements from bench testing.

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 not an AI-assisted device, so no MRMC study or evaluation of human reader improvement with AI assistance was performed.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the device's performance is established through objective physical measurements and observations from nonclinical bench testing comparing the subject device to a legally marketed predicate device (Xentek Medical, Inc. Tearaway Introducer Sheath K000313). This includes:

Tensile strength measurements
Evaluation of biocompatibility (as per relevant standards, though specific details are not provided in this summary)
Visual inspection for extraneous matter
Radiodetection tests
Luer connection tests
Simulated use scenarios
Penetration/Insertion force measurements

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. As there is no AI model and thus no training set, this question is not relevant.

Summary

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K122854

510(k) SUMMARY

JAN 4 2013

SUMMARY OF SUBSTANTIAL EQUIVALENCE FOR ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER

1. Submitter Information

Name:	Arrow International, Inc. (subsidiary of Teleflex Inc.)
Address:	2400 Bernville RoadReading, PA 19605-9607
Telephone Number:	(610) 378-0131
Contact Person:	Julie LawsonRegulatory Affairs Specialist
Telephone Number:	(610) 378-0131 Extension 603256
Fax Number:	(610) 478-3179
Email:	julie.lawson@teleflex.com

Date Prepared: January 3, 2012

2. Device Name

Device Trade Name:	Arrow ® GlideThru™ Peel-Away Sheath/Dilator Introducer
Common Name:	Peel-Away Sheath/Dilator Introducer
Classification Name:	Class II, DYB, Introducer, Catheter, 21CFR 870.1340

3. Predicate Device

Xentech Medical, Inc. Tearaway Introducer Sheath (K000313)

4. Device Description

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5. Intended Use

The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.

6. Technological Characteristics

The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is substantially equivalent to the Xentek Medical, Inc. Tearaway Introducer Sheath (K000313) in terms of intended use, general design, and functional performance.

7. Nonclinical Testing

Bench testing performed on the GlideThru™ Peel-Away Sheath/Dilator Introducer demonstrates substantially equivalent functionality to the predicate device. The following performance testing has been completed for the subject device:

Tensile testing o
Biocompatibility o
O Sheath surface free from extraneous matter
Radiodetectability O
Luer testing o
Simulated Use testing O
Penetration/Insertion force o

8. Conclusions

The subject device is similar in design and intended use to the predicate device. The results of the performance testing have demonstrated substantially equivalent functionality to the predicate device. The results of the comparison testing have demonstrated that the GlideThru is comparable to the predicate device in the following aspects: radiopacity, tensile strength, and penetration/insertion force. Any differences between the subject and predicate sheath introducers do not raise new issues of safety or effectiveness. The Arrow GlideThru™ Peel-Away Sheath/Dilator Introducer is substantially equivalent to the Xentek Medical, Inc. Tearaway Introducer Sheath.

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DEPARTMENT-OF-HEALTH & HUMAN SERVICES

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

JAN 4 2013

Arrow® International, Inc. c/o Julie Lawson Regulatory Affairs Specialist Arrow® International, Inc 2400 Bernville Road Reading, PA 19605

Re: K122854

Trade/Device Name: Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter™ with Chlorag ard® Antimicrobial and Antithrombogenic Technology

Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: December 19, 2012 Received: December 20, 2012

Dear Ms. Lawson:

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

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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 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,

Matthew G. Hillebrenner

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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Indications for Use

510(k) Number (if known): Kl22859

Device Name: Arrow GlideThru™ Peel-Away Sheath/Dilator Introducer

Indications for Use: -

The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.

Indications for Use (JACC product):

The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter™ with Chlorag ard® Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable JACC 100 may not exceed 300 psi. The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.

Chlorag ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness was evaluated using in vivo and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.

Prescription Use x (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)

(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number	K122854

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).