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

Device Description

The Bipore Accuflex™ Percutaneous Sheath Introducer is a flexible tube designed for the percutaneous introduction of various devices into arteries and/or veins for a variety of diagnostic and therapeutic procedures. The product consists of a tube fabricated out of nylon based, flouropolymer lined material, reinforced by a flexible stainless steel wire within the tube. Proximally located on the flexible tube is an integral side port/hemostasis valve and/or female luer connection for attachment to a Touhy Borst adaptor. The side port, which provides a means of introducing contrast media or other fluids, is fabricated from non-DEHP PVC. The hemostasis valve is made from silicone rubber. The Touhy Borst adapter is a separate or connected component purchased from B.Braun. This purchased component is used in a manner consistent with B.Braun specification and premarket clearance. The proximal end contains a 24 karat gold radiopaque marker. The stainless steel coil enables the introducer to kink resistant during normal use. The proximal end may also contain a 45° to 180° radius bend. This pre-bend allows the product to be directed by transferring distal torque to steer the proximal tip. The reinforced tube, through which a vessel dilator or catheter is introduced is available in 5,6,7 and 8 French sizes and in lengths ranging from 5 cm to 110 cm.

AI/ML Overview

The provided text is a 510(k) summary for a medical device: "Bipore Accuflex™ Percutaneous Sheath Introducer." This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria or a specific study proving the device meets them in the context of clinical performance or diagnostic accuracy.

The 510(k) summary states: "Test results indicate that the modified product is in conformance with Bipore specifications and is substantially equivalent to the predicate device." However, it does not elaborate on what specific "Bipore specifications" were used as acceptance criteria, nor does it describe the "test results" or the study methodology, sample sizes, ground truth establishment, or expert involvement usually associated with assessing the clinical performance or diagnostic accuracy of a device.

Therefore, most of the requested information cannot be extracted from this document.

Here's an attempt to answer based only on the provided text, highlighting what is missing:

1. Table of acceptance criteria and the reported device performance:

The document mentions "Bipore specifications" are the acceptance criteria, and the reported performance is "conformance" with these specifications. However, the specific metrics and thresholds for these specifications are not provided.

Acceptance Criteria (Specific Metrics & Thresholds)	Reported Device Performance
Not specified in the provided document	In conformance with Bipore specifications

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

Sample size for the test set: Not specified
Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only states "Test results indicate..." without further detail.

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

This information is not provided. The 510(k) process for this type of device typically relies on engineering and performance testing to ensure substantial equivalence, rather than a clinical study requiring expert-established ground truth for diagnostic accuracy.

4. Adjudication method for the test set:

Not applicable/Not specified. There is no mention of a human-read test set or adjudication process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable/Not specified. This is a medical introducer sheath, not an AI-powered diagnostic device. An MRMC study is not relevant to its type.

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

Not applicable/Not specified. This is not an algorithm-based device.

7. The type of ground truth used:

The "ground truth" for this device's performance would primarily be defined by engineering specifications and performance standards for introducer sheaths (e.g., kink resistance, hemostasis valve integrity, material compatibility, dimensions). The document states "Test results indicate that the modified product is in conformance with Bipore specifications." However, the specific ground truth definitions (e.g., a specific tensile strength value, burst pressure, or flow rate) are not detailed.

8. The sample size for the training set:

Not applicable/Not specified. This device does not use a "training set" in the context of machine learning or AI.

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

Not applicable/Not specified. As above, this concept does not apply to this device type.

Summary of what the document does tell us about the "study":

The modifications include changes to the exterior dimensions of the hemostasis valve body, additional size offerings (lengths up to 110cm), and an optional polyethylene dilator.
The modifications aim to improve manufacturability, user handling, and accommodate longer length devices and patient anatomy.
"Test results" were conducted.
These "test results" indicate conformance with "Bipore specifications."
The ultimate conclusion is that the modified product is "substantially equivalent" to the predicate device (Bipore Accuflex™ Percutaneous Sheath Introducer K051513).
The FDA reviewed these "test results" and agreed with the substantial equivalence determination.

Without access to the actual test reports cited in the original 510(k) submission, the detailed information on acceptance criteria and study methodology requested cannot be provided from this summary document alone.

Summary

{0}------------------------------------------------

510(k) Summary K073434

Submitted bv:

Keith Paluch Director of Technical and Regulatory Affairs Bipore Medical Devices, Inc. 31 Industrial Parkway Northvale, NJ 07647

Date Prepared:

March 27, 2008

Proposed Device:

Bipore Accuflex™ Percutaneous Sheath Introducer

Product Classification:

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

FDA registration number:

2248069

Predicate Device:

Bipore Accuflex™ Percutaneous Sheath Introducer K051513

Indications for Use:

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

Device Description:

{1}------------------------------------------------

Summary of Technical Characteristics as compared to the predicate device:

The proposed change modifies the exterior dimensions of hemostasis valve body by and adds additional size offerings to include lengths up to 110cm. The device may also contain an additional Polyethylene dilator for user convenience.

The proposed modification to the hemostasis valve improves the manufacturability of the device. This modification makes the device easier to handle by the user because of the reduction in bulk resulting by a change in length.

The slight increase in overall length to 110cm allows the device to be used with devices that require longer length sheaths.

The additional Polyethylene dilator improves the convenient use of the product when the user prefers a shorter or longer length dilator to accommodate patient anatomy.

Test results indicate that the modified product is in conformance with Bipore specifications and is substantially equivalent to the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 1 2008

Bipore, Inc. c/o Mr. Keith Paluch Director of Technical and Regulatory Affairs 31 Industrial Parkway Northvale, NJ 07647

Re: K073434

Bipore Accuflex™ Percutaneous Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: March 17, 2008 Received: March 17, 2008

Dear Mr. Paluch:

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.

{3}------------------------------------------------

Page 2 – Mr. Keith Paluch

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 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 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.

Sincercly vours.

er R. Kirchner

Bram D. Zuckerman, M.D. Director

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATION FOR USE

510(k) Number (if known):

K073434

Device Name:

Bipore Accuflex™ Percutaneous Sheath Introducer

Intended Use / Indication For Use:

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

Over-The-Counter Use Prescription Use ਮ AND/OR (Part 21 CFR 801 Subpart D) (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)

Sunya R. Ladner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K073434

Confidential

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).