(30 days)
Not Found
No
The device description and summary of performance studies do not mention any AI or ML components or capabilities. The device appears to be a purely mechanical delivery system.
No.
The device is intended to facilitate the intracardiac placement of interventional devices, acting as a delivery sheath, rather than directly treating a disease or condition.
No
Explanation: The device is described as an "introducer sheath" used to facilitate the placement of interventional devices and cardiovascular catheters. Its function is to provide access for other devices, not to diagnose a condition.
No
The device description explicitly lists physical components (disposable Introducer Sheath, Vessel Dilator, Guidewire with Guidewire Introducer) and describes their physical characteristics (diameters, angles, radius of curvatures, lengths), indicating it is a hardware medical device, not software-only.
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 components like sheaths, dilators, and guidewires used for introducing catheters into the heart. These are all tools for a medical procedure performed on a patient, not for laboratory testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the Convoy Advanced Delivery Sheath Kit is a medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Convoy Advanced Delivery Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
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
Intracardiac
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)
non-clinical testing conducted for the device showed the device met its design-input criteria, and was safe and effective for its intended
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
Attachment 5 510(k) Summary
General Information
| Category: | Comments: |
|---|---|
| Sponsor: | Boston Scientific Corporation |
| 2710 Orchard Parkway | |
| San Jose, Ca 95134 | |
| Correspondent: | Christina L. Rowe |
| Senior Regulatory Affairs Specialist | |
| Boston Scientific Corporation | |
| 2710 Orchard Parkway | |
| San Jose, CA 95134 | |
| Contact Information: | E-mail: rowec@bsci.com |
| Phone: (408) 895-3526 | |
| Fax: (408) 895-2202 | |
| Device Common Name: | Cardiac Introducer Sheath |
| Device Proprietary Name | Convoy Advanced Delivery Sheath Kit |
| Device Classification | 21 CFR §870.1340 |
| 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
December 30, 2003
1
Description of the Predicate Device
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.
Intended Use
The Convoy Advanced Delivery Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.
Comparison to Predicate Device
| Predicate Device | Modified Device | |
|---|---|---|
| 510(k) Reference | K022067 | 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 |
Summary of the Non-clinical Data
Where appropriate, testing conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices (GLP)). Specifically, non-clinical testing conducted for the device showed the device met its design-input criteria, and was safe and effective for its intended
Boston Scientific Corporation Special 510(k) Submission
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2004
Boston Scientific Corporation c/o Ms. Christina L. Rowe Senior Regulatory Affairs Specialist 2710 Orchard Parkway San Jose, CA 95134
K034061 Convoy Advanced Delivery Sheath Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: December 30, 2003 Received: January 2, 2004
Dear Ms. Rowe:
Re:
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 - Ms. Christina L. Rowe
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least oc advisou that I Drive letting that your device complies with other requirements of the Act that I DX has intable a and regulations administered by other Federal agencies. You must or any I caelar statutes and registements, including, but not limited to: registration and listing (21 Comply with an the Not 8 requirements)01); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quant) of bections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections (Section in your Section 510(k) I ms letter will anow you to ough mating of substantial equivalence of your device to a legally prematication on " 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 Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Echorers, 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/dsma/dsmamain.html
Sincerely yours,
Dunia R. Vu Chiner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 3 Premarket Notification Intended Use Statement
1634061 510(k) Number (if known):_
Convoy Advanced Delivery Sheath Kit Device Name:
Indication for Use:
The intended use for the Convoy Advanced Delivery Sheath Kit is as follows:
The Convoy Advanced Deliver Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Diving R. Ve Anet
Division of Cardiovascular & Respiratory Devices
510(k) Number K034061
Prescription Use_
Over-the-Counter Use OR (Per 21 CFR §801.109)
(Optional Format 1-2-96)
Boston Scientific Corporation Special 510(k) Submission