The Bi-Directional Tunneler is indicated for use in creating subcutaneous tunnels for the placement of vascular prostheses or autogenous grafts for arteriovenous access, peripheral vascular and extra-anatomic bypass procedures.

Device Description

The Bi-Directional Tunneler is a stainless steel device composed of a knurled handle, shafts in different lengths and curvatures, bullet tips from 4mm to 12 mm diameter, and a vein tip with a luer adapter. Each tunneler shaft is manufactured with internal threaded ends and a locking mechanism on each end for interchangeable tip and handle attachment. Each tip is manufactured with an external threaded end for luer adapter and shaft attachment. The Bi-Directional Tunneler is supplied non-sterile to the user in a stainless steel perforated case. The perforations are intended to facilitate steam sterilization.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Bi-Directional Tunneler." This clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to establish acceptance criteria and performance. Therefore, the information requested in your prompt regarding acceptance criteria, sample sizes, expert involvement, and specific study types is not available in the provided document.

Here's why and what can be extracted:

510(k) Premarket Notification: This regulatory pathway primarily relies on demonstrating that a new device is "substantially equivalent" to an already legally marketed device (the predicate device) in terms of intended use, technological characteristics, and safety/effectiveness. It generally does not require extensive new clinical trials with clearly defined acceptance criteria in the same way a Premarket Approval (PMA) application might.
Focus on Substantial Equivalence: The document explicitly states: "The Bi-Directional Tunneler is substantially equivalent in intended use, design, technology/operating principles, materials and performance to the Kelly-Wick Tunneler. Differences between the two devices do not raise any significant issues of safety or effectiveness." This statement is the core of the submission, implying that the safety and effectiveness profile is considered similar to the predicate, which has already met regulatory requirements.

Information that CAN be extracted:

Device Name: Bi-Directional Tunneler
Predicate Device: Kelly-Wick Tunneler
Intended Use: Creating subcutaneous tunnels for the placement of vascular prostheses or autogenous grafts for arteriovenous access, peripheral vascular and extra-anatomic bypass procedures.
Technological Characteristics Summary: Made from stainless steel, supplied non-sterile, equivalent in size and configuration to the predicate. The main difference is the "bi-directional feature," which is stated not to affect safety or effectiveness.
Regulatory Status: Cleared via 510(k) (K991027), classified as Class II, Product Code 74 DSY.

Regarding your specific points:

A table of acceptance criteria and the reported device performance: Not available. The document asserts substantial equivalence, meaning its performance is considered equivalent to the predicate, without citing specific performance metrics or acceptance criteria for a new study.
Sample sized used for the test set and the data provenance: Not applicable. No new "test set" or clinical data is presented for this substantial equivalence submission.
Number of experts used to establish the ground truth... and qualifications: Not applicable. No new ground truth establishment is described.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
Standalone (algorithm only) performance: Not applicable (this is a physical surgical tool, not an algorithm).
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) submission showing substantial equivalence, not a clinical study outlining specific acceptance criteria or performance metrics derived from new testing.

Summary

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4/22/99

K991027

IMPRA

A Subsidiary of C. R. Bard, Inc. 1625 West 3rd Street P. O. Box 1740 Tempe, AZ 85280-1740 TEL: 800-321-4254 602-894-9515 FAX: 602-966-7062

510(k) Premarket Notification Bi-Directional Tunneler

510(k) SUMMARY

A. Submitter Information

Submitter's Name:	IMPRA, Inc.
	A Subsidiary of C. R. Bard, Inc.
Address:	1625 West Third Street
	Tempe, Arizona 85281
Telephone:	(480) 894-9515
Fax:	(480) 966-7062
Contact Person:	Kristi M. Kistner
	Manager, Regulatory Affairs
Date of Preparation:	March 26, 1999

B. Device Name

Trade Name:	Bi-Directional Tunneler
Common/Usual Name:	Vascular Tunneler
Classification Name:	An accessory to a vascular graft prosthesis

C. Predicate Device Name

Trade Name(s):

Kelly-Wick Tunneler

IMPRA, Inc., A Subsidiary of C. R. Bard, Inc, C:\MyFiles\REGULATO\510K\TUNNELER\Tun510k.wpd22

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000027

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Device Description D.

The Bi-Directional Tunneler is supplied non-sterile to the user in a stainless steel perforated case. The perforations are intended to facilitate steam sterilization.

E. Intended Use

F. Technological Characteristics Summary

The Bi-Directional Tunneler has the same indications for use as the predicate device. All components for both the Bi-Directional Tunneler and the predicate device are made from stainless steel, are equivalent in size and configuration, and are provided non-sterile to the user. The only significant difference between the Bi-Directional Tunneler and the Kelly-Wick Tunneler is the bi-directional feature. This bi-directionality is a change in the operating principle of the tunneler and does not affect safety or effectiveness of the device.

G. Summary of Substantial Equivalence

The Bi-Directional Tunneler is substantially equivalent in intended use, design, technology/operating principles, materials and performance to the Kelly-Wick Tunneler. Differences between the two devices do not raise any significant issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular arrangement of text surrounding a stylized symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular fashion. The symbol in the center appears to be three abstract human profiles connected by a flowing line, possibly representing interconnectedness or the provision of services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 1999

Ms. Kristi Kistner IMPRA, Inc. A Subsidiary of C.R. Bard, Inc. P.O. Box 1740 Tempe, AZ 85280-1740

Re: K991027 Impra Bi-Directional Tunneler Requlatory Class: II (Two) Product Code: 74 DSY Dated: March 26, 1999 Received: March 29, 1999

Dear Ms. Kistner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2 - Ms. Kristi Kistner

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Also, please note the regulation Compliance at (301) 594-4639. entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological 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): __ K991027_

Device Name:__ Impra Bi-Directional Tunneler

Indications For Use: The Bi-Driectional Tunneler is indicated for use in creating subcutaneous tunnels for the placement of vascular prostheses or autologous grafts for arteriovenous access, peripheral vascular and extra-anatomic bypass procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Beebe & Temple Co.

(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_K99 1027

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.3450 Vascular graft prosthesis.

(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”