The ViaPeel Peelable Introducer will be available in 3.5F through 7F (micro), and 7F (macro) in lengths of 5cm or 10cm. The sheath handles are color coded for identification of French size. The locking configuration has been modified on the sheath and dilator to an annular snap fit. The dilator will lock into the hub without the use of a rotating collar allowing the user to lock and secure the dilator to the sheath.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ViaPeel™ Peelable Introducer, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit)	Reported Device Performance
Functional Performance	Device functions per specification requirements.	"Test results verify that the device performs per specification requirements..."
Equivalence to Predicate	Device is equivalent to the predicate device without creating additional risk to the patient or user.	"...equivalent to the predicate device without creating additional risk to the patient or user."
Mechanical/Dimensional	Appropriate dimensions and locking mechanism function (annular snap fit on sheath and dilator, dilator locks into hub).	"The performance testing included the device specifications, functional and dimensional testing of the ViaPeel Peelable Introducer..." (Implied successful adherence to these designs)
Material Biocompatibility	Component materials are biocompatible.	"The material in the components used to create the ViaPeel Peelable Introducer has been demonstrated to be biocompatible through biocompatibility testing."

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

The summary does not provide details on the specific sample sizes used for the non-clinical performance testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any of the non-clinical tests. Since no clinical studies were performed, there is no clinical test set.

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

Since no clinical studies were performed, there was no ground truth established by experts for a clinical test set. The non-clinical performance testing would have relied on engineering and quality assurance standards, not expert medical consensus on patient outcomes.

4. Adjudication Method for the Test Set

As there was no clinical test set involving human judgment, there was no adjudication method described. The non-clinical tests would involve repeatable measurements and objective criteria rather than expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was performed. The summary explicitly states: "No clinical evaluations of this product have been performed." Therefore, there is no information on how much human readers might improve with or without AI assistance, as AI is not part of this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone study was performed as this device is a physical medical instrument (introducer) and does not involve an algorithm or AI.

7. Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" was established by engineering specifications, functional requirements, and material biocompatibility standards. These are objective, measurable criteria rather than expert consensus, pathology, or outcomes data in the typical sense for a diagnostic or AI device.

8. Sample Size for the Training Set

Since no AI or algorithm is involved, there was no training set for this device. The development process would have involved design, prototyping, and testing of physical units.

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

Not applicable, as there was no training set.

Summary

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510(K) Summary

510(k) Number: K072248

NOV 0 9 2007

Date Prepared

October 11, 2007

Submitter Information

Submitter's Name/Address:	Enpath Medical2300 Berkshire Lane NMinneapolis, MN 55441
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dical, Inc. shire Lane North Minneapolis, MN 55441

Establishment Registration: 2183787

Contact Person:

Patrice Stromberg Principal Regulatory Affairs Specialist (763) 951-8181 phone (763) 559-0148 fax pstromberg@enpathmed.com

Device Information

Trade Name: Classification Name: Product Code: Regulation: Panel:

ViaPeel™ Peelable Introducer Introducer, Catheter DYB Class II, 21 CFR 870.1340 Cardiovascular

Performance Standards

No performance standards applicable to this product have been developed under Section 514 of the Act.

Predicate Device

Enpath Medical, Inc. ViaSeal Valved Peelable Introducer (K063182)

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Device Description

Indications for Use

The ViaPeel™ Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Summary of Non-Clinical Testing

Performance Testing: 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, functional and dimensional testing of the ViaPeel Peelable Introducer and other testing as applicable to the device. 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.

Biocompatibility Testing: The material in the components used to create the ViaPeel Peelable Introducer has been demonstrated to be biocompatible through biocompatibility testing.

Summary of Clinical Testing

No clinical evaluations of this product have been performed.

Statement of Equivalence

Through the data and information presented, Enpath Medical, Inc. considers the ViaPeel Peelable Introducer to be substantially equivalent to the cleared Enpath Medical ViaSeal Valved Peelable Introducers based on a comparison of the indications for use and the technological characteristics. The testing performed confirms that the ViaPeel Peelable Introducer will perform as intended.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, composed of three curved lines that resemble feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2007

Enpath Medical, Inc. c/o Ms. Patrice Stromberg, RAC 2300 Berkshire Lane North Minneapolis, MN 55441

Re: K072248

Trade/Device Name: ViaPeel™ Peelable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: October 11, 2007 Received: October 12, 2007

Dear Ms. Stromberg:

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 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

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Page 2 - Ms. Patrice Stromberg

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 premated 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

P. luchner

A 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 Statement

510(k) Number (if known): K072248

Device Name: ViaPeel™ Peelable Introducer

Indications for Use:

The ViaPeel™ Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Holmes

(Division Sich-Off) Division o Cardiovascular Devices

510(k) Number_x b72248

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).