(164 days)
No
The device description and predicate information indicate a traditional mechanical delivery sheath kit with no mention of AI/ML capabilities or software components that would typically incorporate such technology.
No
This device is an introducer sheath kit designed to facilitate the placement of interventional devices, rather than being a therapeutic device itself.
No
The device is intended to facilitate the intracardiac placement of interventional devices, meaning it is a tool used to deliver other devices, not to diagnose a condition.
No
The device description explicitly lists physical components (Introducer Sheath, Vessel Dilator, Guidewire) and describes their physical characteristics (diameters, angles, lengths, curves), indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the intracardiac placement of interventional devices." This describes a device used in vivo (within the body) for a procedural purpose, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical device (sheath, dilator, guidewire) used for introducing catheters into the heart. This is consistent with an interventional medical device, not a diagnostic test kit.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Convoy Advanced Delivery Sheath Kit is an interventional medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Convoy Advanced Deliver Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.
Product codes
DYB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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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 Corporation |
| 2710 Orchard Parkway | |
| San Jose, Ca 95134 | |
| Correspondent: | Cindy Morrow |
| Principal Regulatory Affairs Specialist | |
| Boston Scientific Corporation | |
| 2710 Orchard Parkway | |
| San Jose, CA 95134 | |
| Contact Information: | E-mail: morrowc@bsci.com |
| Phone: (408) 895-3931 | |
| Fax: (408) 895-2202 | |
| Device Common Name: | Cardiac Introducer Sheath |
| Device Proprietary Name | Convoy Advanced Delivery Sheath Kit |
| Device Classification | 21 CFR §870.1340 |
| Product 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
1
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, and | |
| K013866 | Current Submission | |
| Intended Use | Intracardiac Placement of | |
| Interventional 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.
2
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
3
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
4
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)