(164 days)
The Convoy Advanced Deliver Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.
The Boston Scientific (BSC) Convoy Advanced Delivery Sheath Kit is identical to the BSC Convoy Advanced Delivery Sheath Kit described in K013866, K022067, and K034061 approved on December 14, 2001, September 11, 2002, and January 30, 2004 respectively.
The Convoy Advanced Delivery Sheath Kit consists of: (1) a disposable Introducer Sheath, (2) a Vessel Dilator and (3) Guidewire with Guidewire Introducer. These devices are designed for the introduction of various types of cardiovascular catheters to the heart. The Introducer Sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The Introducer Sheath configurations covered under the subject 510(k) Premarket Notification include 8.5 F and 9.5 F diameters, angles ranging from 0° - 180°, radius of curvatures ranging from 0.6" - 1.75", lengths of 60 cm - 101.5 cm, and may be configured with either one, two or three curves in a single or dual plane.
I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for a cardiac introducer sheath and primarily focuses on demonstrating substantial equivalence to a predicate device.
Here's why I cannot provide the requested information:
- No Acceptance Criteria or Performance Study: The document does not mention any specific quantitative acceptance criteria for device performance, nor does it describe any study (clinical or analytical) designed to prove the device meets such criteria.
- Focus on Substantial Equivalence: The content outlines the device's description, its intended use, and a comparison to a predicate device, concluding that it is "substantially equivalent." This type of submission relies on demonstrating the new device is as safe and effective as a legally marketed predicate, rather than detailing novel performance studies against specific acceptance metrics.
- Lack of AI-Related Information: All the specific questions you've asked (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth) are highly relevant to the evaluation of AI/ML-driven medical devices. This document describes a physical medical device (introducer sheath) and does not involve any AI components.
Therefore, providing a table of acceptance criteria and reported device performance, or details about studies involving test sets, training sets, experts, or AI performance, is not possible from this document.
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K072719 page 1 of 2
Image /page/0/Picture/1 description: The image shows the logo for Boston Scientific. The text is in a serif font and is black. The word "Boston" is on top of the word "Scientific".
MAR – 7 2008
510(k) Summary
General Information
| Category: | Comments: |
|---|---|
| Sponsor: | Boston Scientific Corporation2710 Orchard ParkwaySan Jose, Ca 95134 |
| Correspondent: | Cindy MorrowPrincipal Regulatory Affairs SpecialistBoston Scientific Corporation2710 Orchard ParkwaySan Jose, CA 95134 |
| Contact Information: | E-mail: morrowc@bsci.comPhone: (408) 895-3931Fax: (408) 895-2202 |
| Device Common Name: | Cardiac Introducer Sheath |
| Device Proprietary Name | Convoy Advanced Delivery Sheath Kit |
| Device Classification | 21 CFR §870.1340Product Code: DYB |
| Predicate Device | Convoy Advanced Delivery Sheath Kit |
| Predicate Device Manufacture(s) | Boston Scientific Corporation |
| Predicate Device Proprietary Name(s) | Convoy Advanced Delivery Sheath Kit |
| Predicate Device Classification | 21 CFR §870.1340 |
| Predicate Device Classification # | Class II |
Date Summary Prepared
November 20, 2007
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Description of the Predicate Device
The Boston Scientific (BSC) Convoy Advanced Delivery Sheath Kit is identical to the BSC Convoy Advanced Delivery Sheath Kit described in K013866, K022067, and K034061 approved on December 14, 2001, September 11, 2002, and January 30, 2004 respectively.
The Convoy Advanced Delivery Sheath Kit consists of: (1) a disposable Introducer Sheath, (2) a Vessel Dilator and (3) Guidewire with Guidewire Introducer. These devices are designed for the introduction of various types of cardiovascular catheters to the heart. The Introducer Sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The Introducer Sheath configurations covered under the subject 510(k) Premarket Notification include 8.5 F and 9.5 F diameters, angles ranging from 0° - 180°, radius of curvatures ranging from 0.6" - 1.75", lengths of 60 cm - 101.5 cm, and may be configured with either one, two or three curves in a single or dual plane.
The Convoy Advanced Delivery Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.
| Predicate Device | Modified Device | |
|---|---|---|
| 510(k) Reference | K034061, K022067, andK013866 | Current Submission |
| Intended Use | Intracardiac Placement ofInterventional Devices | Same |
| Device Description | Intracardiac Introducer Sheath | Same |
| Single Use? | Yes | Same |
| EO Sterilized? | Yes | Same |
| Device Manufacturer | Boston Scientific Corporation | Same |
| Regulatory Class | II | Same |
| Device Classification | 21 CFR §870.1340 | Same |
Comparison to Predicate Device
Change to Labeling Being Effected
A new contraindication has been added to the labeling:
Insertion of the Convoy Advanced Delivery Sheath is contraindicated from the femoral approach in patients who have vena cava embolic filter devices, or from a leg with a known femoral thrombus.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned above a wavy line, possibly representing water or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 7 2008
Ms. Cindy Morrow Principal Regulatory Affairs Specialist Boston Scientific Corporation 2710 Orchard Parkway San Jose, CA 95134
Re: K072719
Trade/Device Name: Convoy Advanced Delivery Sheath Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: December 7, 2007 Received: December 10, 2007
Dear Ms. Morrow:
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.
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
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Page 2 – Ms. Cindy Morrow
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.
Sincerely yours,
Duna R. bochner
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): k 072 719
Device Name: Convoy Advanced Delivery Sheath Kit
Indications for Use:
The Convoy Advanced Deliver Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.
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)
suma R. vchues
on Sign-Off Division of Cardiovascular Devices
510(k) Number K072719
Page _1 of _1
(Posted November 13, 2003)
§ 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).