(117 days)
Not Found
No
The device description focuses on the physical components and materials of a percutaneous sheath introducer, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as an introducer for other devices used in diagnostic and therapeutic procedures, but it is not itself performing a therapeutic function.
No
The device is a sheath introducer, used to facilitate the introduction of other devices into arteries and/or veins for diagnostic and therapeutic procedures. It is not itself performing a diagnostic function.
No
The device description clearly details a physical medical device made of materials like nylon, fluoropolymer, stainless steel, PVC, and silicone rubber. It is a percutaneous sheath introducer, which is a hardware component used in medical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "percutaneous introduction of various devices into arteries and/or veins for diagnostic and therapeutic procedures." This describes a device used within the body to facilitate other procedures, not a device used to test samples outside the body.
- Device Description: The description details a physical tube designed for insertion into blood vessels. It mentions components like a hemostasis valve, side port for fluid introduction, and radiopaque markers. These are all characteristics of an invasive medical device used for access, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing conditions based on in vitro testing.
Therefore, the Bipore Accuflex™ Percutaneous Sheath Introducer is a medical device used for vascular access, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arteries and/or veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test results indicate that the modified product is in conformance with Bipore specifications and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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:
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.
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):
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
.