Teleflex Medical OEM's Percutaneous Introducer and Kit is used to assist in the introduction of diagnostic or therapeutic devices into a vessel. These devices will be marketed in two configurations:

Percutaneous Introducer only, or
Percutaneous Introducer. Needle, Kit including Introducer Syringe and Guidewire

A description of each individual component is provided below:

Guidewire
The guidewire is designed to allow ease of movement through the vessels of the bodv.

18 Ga Needle
The 18 Ga Needle design allows the syringe to be attached to it and for the guidewire to be inserted through it.

Syringe
The 10ml syringe design allows for insertion into the needle.

Percutaneous Introducer
The Percutaneous Introducer uses a secure locking luer collar hub design and also incorporates an ergonomic handle design. This protects against separation of the dilator and sheath assembly during insertion. The introducer is designed to allow the dilator to be advanced over the guidewire into the vessel thus facilitating the introduction of the sheath into the vessel. This device design is such that after advancement into the vessel the dilator can be removed to allow access through the sheath of the customer's chosen device. For easy removal, the split sheath can be removed by breaking the hub and removing the two halves of the sheath while still within the vessel. The sheath hub is designed to snap cleanly. The sheath peels easily and evenly, thus reducing complications during the procedure.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, the Teleflex Medical Percutaneous Introducer and Kit. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device meeting specific acceptance criteria in the manner typically associated with an AI/algorithm-driven device.

Therefore, many of the requested elements (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are not applicable as this submission pertains to a traditional medical device, not an AI medical device.

Here's the information that can be extracted and a summary of why other points are not relevant based on the provided document:

Acceptance Criteria and Reported Device Performance

The document states that the device was subjected to performance testing with pre-determined acceptance criteria, and it met all acceptance criteria. However, it does not provide an explicit table of these criteria or specific quantitative results for each. It lists general categories of tests.

Acceptance Criteria Category	Reported Device Performance
Dimensional	Met all acceptance criteria
Tensile	Met all acceptance criteria
Radiopacity	Met all acceptance criteria
Corrosion Resistance	Met all acceptance criteria
Leakage	Met all acceptance criteria
Other (not specified)	Met all acceptance criteria

Study Proving Device Meets Acceptance Criteria:

The study consisted of "a full battery of performance testing." The document does not provide a specific name or detailed protocol for this study but indicates it was conducted by Teleflex Medical OEM.

Non-Applicable Information for this Device (as per the provided text):

Since this is a submission for a traditional medical device (percutaneous introducer kit) and not an AI/algorithm-driven device, the following points are not directly addressed or are not relevant to this type of 510(k) submission based on the provided document:

Sample size used for the test set and the data provenance: Not applicable. Performance testing for this type of device typically involves laboratory-based tests on device samples, not patient data in the context of an AI model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI test set is not relevant here.
Adjudication method for the test set: Not applicable.
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 diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be the specifications and standards it must meet (e.g., material strength, dimension tolerances).
The sample size for the training set: Not applicable. This device does not use an AI model that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for Teleflex Medical. The logo is in black and features a stylized "T" followed by the word "Teleflex" in a bold, sans-serif font. Below "Teleflex" is the word "MEDICAL" in a smaller, sans-serif font.

FEB 2 1 2013

510(K) SUMMARY

SUBMITTER: 1.

Manufacturer:

Teleflex Medical 50 Plantation Drive Jaffrey, NH 03452 Telephone #(603) 532-7706 Establishment Registration Number: 1221019

Owner/Operator:

Teleflex Medical 2917 Weck Drive Research Triangle Park, NC 27709 Owner/Operator #9062981

Official Contact:

Dawn I. Moore Telephone: Date Prepared:

Regulatory Affairs Manager 734-368-2214 December 20, 2012

2. DEVICE:

Percutaneous Introducer and Kit Tradename: Classification Name: Introducer, Catheter Class Il Classification: Introducer Kit Common Name: Cardiovascular Classification Panel: DYB Product Code: Regulation Number: 870.1340

PREDICATE DEVICES: 3.

Teleflex Percutaneous Introducer cleared under 510(k) Premarket Notification . #K060219
Greatbatch Medical PTFE Peelable Introducer Kit cleared under 510(k) . Premarket Notification #K102540.

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DEVICE DESCRIPTION: 4.

Teleflex Medical OEM's Percutaneous Introducer and Kit is used to assist in the introduction of diagnostic or therapeutic devices into a vessel. These devices will be marketed in two configurations:

Percutaneous Introducer only, or
- Percutaneous Introducer. Needle, Kit including Introducer Syringe and Guidewire

A description of each individual component is provided below:

Guidewire

The guidewire is designed to allow ease of movement through the vessels of the bodv.

18 Ga Needle

The 18 Ga Needle design allows the syringe to be attached to it and for the guidewire to be inserted through it.

Syringe

The 10ml syringe design allows for insertion into the needle.

Percutaneous Introducer

The Percutaneous Introducer uses a secure locking luer collar hub design and also incorporates an ergonomic handle design. This protects against separation of the dilator and sheath assembly during insertion. The introducer is designed to allow the dilator to be advanced over the guidewire into the vessel thus facilitating the introduction of the sheath into the vessel. This device design is such that after advancement into the vessel the dilator can be removed to allow access through the sheath of the customer's chosen device. For easy removal, the split sheath can be removed by breaking the hub and removing the two halves of the sheath while still within the vessel. The sheath hub is designed to snap cleanly. The sheath peels easily and evenly, thus reducing complications during the procedure.

INDICATIONS FOR USE: ડ.

This product is to assist in the introduction of diagnostic or therapeutic devices into a vessel.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: 6.

Comparisons of the proposed and predicate devices show that the technological characteristics such as intended use, materials, kit components, performance characteristics and packaging are identical or substantially equivalent to the currently marketed predicate devices.

NONCLINICAL PERFORMANCE DATA: 7.

The Percutaneous Introducer and Kit was subjected to a full battery of performance testing including pre-determined acceptance criteria: As expected, the device met all acceptance criteria. The results of the performance testing (i.e., dimensional, tensile, radiopacity, corrosion resistance, leakage, etc.) demonstrate that these devices are substantially equivalent to the currently marketed predicate devices, adequately meets their intended use, and are acceptable for commercial distribution.

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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 eagle or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol.

February 21, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609

Silver Spring, MD 20993-0002

Public Health Service

Teleflex Medical Dawn Moore, Regulatory Affairs Manager 50 Plantation Drive Jaffrey, NH 03452

Re: K123974

Trade/Device Name: Percutaneous Introducer Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer. Catheter Regulatory Class: Class II Product Code: DYB Dated: December 20, 2012 Received: December 26, 2012

Dear Ms. Moore:

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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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 Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K123974

Device Name: Percutaneous Introducer and Kit

Indications for Use:

This product is to assist in the introduction of diagnostic or therapeutic devices into a vessel.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Matthew @ @ @ lebrenner

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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).