(188 days)
The Bipore AccuFlex ™ Percutaneous Sheath Introducer is recommended for The Dipore Acour Ion and therapeutic procedures.
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.
Bipore Accuflex™ Percutaneous Sheath Introducer
The provided text is related to a 510(k) submission for a medical device modification, specifically the "Bipore Accuflex™ Percutaneous Sheath Introducer." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or performance against extensive clinical criteria. As such, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, human reader performance, or ground truth establishment.
Here's why the requested information is absent and what can be inferred from the document:
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Type of Device and Submission: The device is a "Percutaneous Sheath Introducer," which is a relatively standard medical tool. The submission is an "Abbreviated 510(k) Device modification," indicating that it's for changes to an already cleared device (K964814, the predicate). This regulatory pathway is less stringent than a PMA (Premarket Approval) and typically doesn't require new, comprehensive clinical studies to establish acceptance criteria or performance metrics in the way a novel AI diagnostic or therapeutic device would.
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Focus on Substantial Equivalence: The core of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This usually involves comparing design, materials, intended use, and performance characteristics to show they are similar enough that the new device raises no new questions of safety or effectiveness.
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Lack of Performance Study Details: The document mentions "Indications for Use" but does not define specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) or provide details of studies designed to measure these metrics against a predetermined acceptance criterion. There's no mention of a test set, ground truth, expert opinions, or human reader studies.
Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document is a regulatory communication for a device modification, not a performance study report.
In summary, the provided document does not contain the information required to answer your prompt.
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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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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's emblem, which consists of a stylized caduceus with three snakes intertwined around a staff. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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_________________________________________________________________________________________________________________________________________________________________
§ 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).