BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER

K051513 · Bipore, Inc. · DYB · Dec 7, 2005 · Cardiovascular

Device Facts

• Record ID: K051513
• Device Name: BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
• Applicant: Bipore, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Dec 7, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Bipore AccuFlex ™ Percutaneous Sheath Introducer is recommended for the introduction of various devices into arteries and/or veins for diagnostic and therapeutic procedures.

Device Story

The Bipore AccuFlex™ Percutaneous Sheath Introducer is a medical device used to facilitate the insertion of diagnostic or therapeutic instruments into the arterial or venous systems. It functions as a conduit, allowing clinicians to safely introduce catheters or other devices into the vasculature. It is intended for use by healthcare professionals in clinical settings during interventional procedures. The device aids in vascular access, potentially improving procedural efficiency and patient outcomes by providing a stable entry point for interventional tools.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Percutaneous sheath introducer for vascular access. Mechanical device; no energy source or software. Materials and dimensions consistent with predicate device (K964814).

Indications for Use

Indicated for the introduction of various devices into arteries and/or veins for diagnostic and therapeutic procedures in patients requiring vascular access.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Bipore Accuflex™ Percutaneous Sheath Introducer (K964814)

Submission Summary (Full Text)

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Abbreviated 510(k): Device modification Bipore Accuflex™ Percutaneous Sheath Introducer

## 510(k) Summary K051513

## Submitted by:

Keith Paluch Consultant Bipore, Inc. 31 Industrial Parkway Northvale, NJ 07647

Date Prepared: May 29,2005 and October 26, 2005

Proposed Device: Bipore Accuflex™ Percutaneous Sheath Introducer

Product Classification: C.F.R. 870.1340 Product code: DYB, Catheter Introducer Class II

FDA registration number: 2248069

Predicate Device: Name 510(k)

> Bipore Accuflex™ Percutaneous Sheath Introducer K964814

## Indications for Use:

The Bipore AccuFlex ™ Percutaneous Sheath Introducer is recommended for The Dipore Acour Ion and therapeutic procedures.

> Bipore Inc Abbreviated 510(k) submission Device modification k964814 Page 3 of 16 Revised 10/27/05

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 7 2005

Bipore, Inc. c/o Mr. Keith Paluch 31 Industrial Parkway Northvale, NJ 07647

Re: K051513

Bipore Accuflex Percutaneous Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (Two) Product Code: DYB Dated: October 28, 2005 Received: November 10, 2005

Dear Mr. Paluch:

We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section 910(x) premained in substantially equivalent (for the indications
referenced above and have determined the device is substantial in interests to referenced above and have decembred the devices marketed predicate devices marketed in interstate for use stated in the encrosule) to regary maneted provice Amendments, or to commerce prior to May 28, 1970, the enactified in accordance with Federal Food. Drug,
devices that have been reclassified in accordance with to were a several englianten (PMA devices that have been reclassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval of the Act . Th and Cosmetic Act (Act) that do not require upproval controls provisions of the Act. The You may, therefore, market the devrees, secycle to the general registration, listing of
general controls provisions of the Act include requirements for annual registration an general controls provisions of the 710 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 If your device is classfficu (see above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations liDA may be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may be found in the Court of Courts concerning your device in the Federal Register.

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Page 2 - Mr. Keith Paluch

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oe advised that I DA Bloodines over device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must or any i cach statutes and registents, including, but not limited to: registration and listing (21 Compry with an the Hot STOC STOCK 801); good manufacturing practice requirements as set CTN in the quality systems (21 CFR Part 820); and if applicable, the electronic (200 101111 m the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro receins (2001) (2006) 1000) 1000 Section 510(k) This icter will anow you to organization of substantial equivalence of your device to a legally prematicated predicated on "The 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 If you desire specific ad its in 10 in [phone]. Also, please note the regulation entitled, Connect the Office of Compunation in (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dma R. Lachner

Image /page/2/Picture/5 description: The image shows a close-up of a handwritten symbol or character. The symbol appears to be composed of curved and angular lines, possibly representing a stylized letter or a unique mark. The lines are thick and dark, contrasting with the white background. The overall impression is that of a quick, possibly abstract, drawing.

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): __K051513

Device Name: _Bipore AccuFlex ™ Percutaneous Sheath Introducer

Indications for Use: The Bipore AccuFlex ™ Percutaneous Sheath Introducer is indications for 500: The Diperty of various devices into arteries and/or veins for diagnostic and therapeutic procedures.

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)

Duna R. Voelmer

(Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices

510(K) Number_________________________________________________________________________________________________________________________________________________________________