The Enpath ViaSeal Valved Peelable Introducer is a small diameter tubular shaped device with integrated proximal handles. The ViaSeal Valved Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system while providing hemostatic sealing to venous pressures. The ViaSeal Valved Peelable Introducer has a "peel-away" feature common to the predicate device. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead.

The ViaSeal Valved Peelable Introducer is packaged in a sterile 5-pack convenience kit containing a ViaSeal Valved Peelable Introducer, a thin-wall needle, a disposable syringe, and a flexible guidewire. The kit is packaged in a PETG tray with a Tyvek lid, and a sealed Tyvek/LDPE pouch.

Introducer sizes of the sheath and dilator range from 7 French to 10.5 French. The materials and construction are the same for all French sizes. Enpath ViaSeal Valved Peelable Introducer kits will be packaged and ETO sterilized for one time use and sealed in a Tyvek/LDPE pouch.

AI/ML Overview

The provided text is a 510(k) summary for the Enpath Medical ViaSeal Valved Peelable Introducer. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial data with specific acceptance criteria in the manner typically seen for novel therapeutic devices or diagnostic AI systems.

Therefore, many of the specific questions about acceptance criteria, detailed study design, and AI model performance metrics cannot be directly answered from this document.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of specific acceptance criteria with quantifiable metrics such as sensitivity, specificity, accuracy, or a detailed breakdown of device performance against these. Instead, it makes a general statement about performance.

Acceptance Criteria Category	Reported Device Performance
Functional Equivalence	Performs per specification requirements and is equivalent to the predicate device.
Safety	Does not create additional risk to the patient or user.
Hemostasis	Performs hemostasis to venous pressures.
Dimensional	Tested for dimensional specifications.
Regulatory	Substantially equivalent to predicate devices (FlowGuard Valved Peelable Introducer, K040150, and Thomas Medical Products Inc. SafeSheath MSP Introducer Kit, K003731).

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

Test set sample size: Not applicable/Not mentioned. The study was primarily non-clinical "performance testing."
Data provenance: Not applicable/Not mentioned for clinical data. The performance testing would have been conducted internally by the manufacturer.

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

Not applicable. This was not a study requiring expert-established ground truth for diagnostic or interpretative tasks. It was performance testing of a medical device.

4. Adjudication method for the test set

Not applicable. This was not a study requiring adjudication of expert interpretations.

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 a non-AI medical device (a catheter introducer). No MRMC study was conducted, and no AI component is involved.

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

Not applicable. This is a non-AI medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of diagnostic performance. For a medical device like this, "ground truth" would relate to engineering specifications, material properties, and functional performance benchmarks (e.g., ability to peel, maintain hemostasis, dimensions). These would be established through engineering and quality control standards.

8. The sample size for the training set

Not applicable. This is a non-AI medical device; no training set for an algorithm was used.

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

Not applicable. No training set for an algorithm was used.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" refers to a series of non-clinical performance tests conducted by Enpath Medical Inc. to demonstrate the device's safety and effectiveness and its substantial equivalence to predicate devices.

Study Title: "Summary of Studies" (as per the 510(k) document)
Study Type: Non-clinical (in vitro/bench testing)
Objective: To verify that the device functions in a safe and effective manner and performs per specification requirements, equivalent to predicate devices, without creating additional risk.
Tests Performed:
- Device specifications verification
- Dimensional testing
- Functional testing
- Hemostasis testing to venous pressures
Results: "Test results verify that the device performs per specification requirements and is equivalent to the predicate device without creating additional risk to the patient or user."
Key Finding for Approval: The device was deemed "substantially equivalent" to the Enpath Medical FlowGuard Valved Peelable Introducer (K040150) and the Thomas Medical Products Inc. SafeSheath MSP Introducer Kit (K003731) based on these non-clinical tests.
Clinical Evaluations: Explicitly stated: "No clinical evaluations for this submission have been conducted."

Summary

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Enpath Medical, Inc. ViaSeal Valved Peelable Introducer Traditional 510(k) Submission

510(k) Summary

Submitter

Enpath Medical Inc. 15301 Highway 55 West Minneapolis, MN 55447 Main: 763-559-2613 763-559-0148 Fax: email: www.enpathmed.com

Contact Person

James Jenkins Regulatory Associate 952-653-2412

Date Prepared

December 14, 2006

Trade Name Enpath Medical ViaSeal Valved Peelable Introducer

Common Name Catheter Introducer

Classification Name

Catheter Introducer (21 CFR 870.1340, Product Code DYB)

Predicate Device

Enpath Medical FlowGuard Valved Peelable Introducer; K040150. Thomas Medical Products Inc., SafeSheath MSP Introducer Kit with Integral Hemostasis Valve; K003731

Device Description

The ViaSeal Valved Peelable Introducer is packaged in a sterile 5-pack convenience kit containing a ViaSeal Valved Peelable Introducer, a thin-wall

510(k) Summary K063182 page 1 of 2

レビしな | 2006

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Enpath Medical, Inc. ViaSeal Valved Peelable Introducer Traditional 510(k) Submission

510(k) Summary
K063182 page 2 of 2

needle, a disposable syringe, and a flexible guidewire. The kit is packaged in a PETG tray with a Tyvek lid, and a sealed Tyvek/LDPE pouch.

Intended Use

The Enpath ViaSeal Valved Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Comparison of Technological Characteristics

All technological characteristics of the Enpath ViaSeal Valved Peelable Introducer are substantially equivalent to the predicate device; FlowGuard Valved Peelable Introducer (K040150) including indications for use, operation, manufacturing process, biocompatibility, sterilization method, and packaging. The Enpath ViaSeal Valved Peelable Introducer is also substantially equivalent to the Thomas Medical Products Inc. SafeSheath Introducer Kit with Integral Hemostasis Valve, K003731, with respect to indications for use, sterilization method, materials, packaging, hemostatic sealing to venous pressures, French sizes, and available lengths (13 and 25 cm).

Summary of Studies

The performance testing for this device included testing to verify that the device functions in a safe and effective manner. The performance testing included the device specifications, dimensional and functional testing, and hemostatsis of the device to venous pressures. Test results verify that the device performs per specification requirements and is equivalent to the predicate device without creating additional risk to the patient or user.

No clinical evaluations for this submission have been conducted.

Substantial Equivalence

The ViaSeal Valved Peelable Introducer is as safe, as effective, and performs as well as, and is substantially equivalent to the original "cleared" FlowGuard Valved Peelable Introducer, K040150. The ViaSeal Valved Peelable Introducer is also substantially equivalent to the Thomas Medical Products Inc. SafeSheath Introducer Kit with Integral Hemostasis Valve (K003731) with respect to intended use (the introduction of various pacing leads and catheters), device classification (Class II, 21 CFR 870.1340), product code (DYB), and hemostatic sealing to venous pressures.

(Note: This document uses the term "substantial equivalence" as intended in 21 CFR 807.88, and not as defined in Title 35 of the U.S. Code.)

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three lines forming the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2006

Enpath Medical Inc. James Jenkins, Regulatory Associate 15301 Highway 55 West Minneapolis MN 55447

Re: K063182

Trade/Device Name: Enpath Medical ViaSeal Valved Peelable Introducer Regulation Number: 21 CFR Sec. 870.1340 Regulation Name: Catheter, Introducer Regulatory Class: Class II Product Code: DYB Dated: December 14, 2006 Received: December 15, 2006

Dear Mr. Jenkins

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2 - Mr. James Jenkins

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B/Simmons 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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Enpath Medical, Inc. ViaSeal Valved Peelable Introducer Traditional 510(k) Submission

2.0 Indications for Use

510(k) Number (if known):

Device Name: ViaSeal Valved Peelable Introducer

Indications for Use: The Enpath ViaSeal Valved Peelable Introducer is indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Prescription Use な (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)

K043182

(Division Sign Off)

Division of Cardiovascular Devices

510(k) Number
Blimonume

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).