(78 days)
Not Found
No
The device description focuses on the physical components and configurations of a delivery sheath kit, with no mention of software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is described as an introducer sheath kit intended to facilitate the intracardiac placement of interventional devices, rather than directly treating a condition itself. It is a tool for other therapeutic devices.
No
Explanation: The device is an "Advanced Delivery Sheath Kit" intended to facilitate the "intracardiac placement of interventional devices," which means it is used for delivery and not for diagnosis.
No
The device description explicitly lists physical components (disposable Introducer Sheath, Vessel Dilator, Guidewire with Guidewire Introducer) and describes their physical characteristics (diameters, 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 sheath, dilator, and guidewire designed for introducing catheters into the heart. These are all instruments used directly on a patient during a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to laboratory testing for diagnostic purposes.
Therefore, the Convoy Advanced Delivery Sheath Kit is a medical device used for interventional procedures, not an in vitro diagnostic device.
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
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 diameter, 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5520 Immunoglobulin G (Fab fragment specific) immunological test system.
(a)
Identification. An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
0
SEP 1 1 2002
510(k) Summary
| Category: | Comments |
|---|---|
| Sponsor: | Boston Scientific Corporation/EP Technologies, Inc. |
| 2710 Orchard Parkway | |
| San Jose, CA 95134 | |
| Correspondent: | Andrea L. Ruth, RAC |
| Senior Associate, Regulatory Affairs | |
| 2710 Orchard Parkway | |
| San Jose, CA 95134 | |
| Contact Numbers: | Phone: 408.895.3625 |
| Fax: 408.895.2202 | |
| Email: rutha@bsci.com | |
| Device Common Name | Cardiac Introducer Sheath |
| Device Proprietary Name | Convoy™ Advanced Delivery Sheath Kit |
| Device Classification Name | Introducer, Catheter |
| Device Classification | Class II, DYB |
| Predicate Device | Daig Corporation, Fast-Cath Introducing Sheath |
| Predicate Device | |
| Manufacturer(s) | Daig Corporation, A Division of St. Jude Medical |
| Predicate Device Classification | |
| Name(s) | Introducer, Catheter |
| Predicate Device | |
| Classification(s) | Class II, DYB |
Date Summary Was Prepared: June 14, 2002.
Description of the 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
1
and 9.5 F diameter, 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 Devices:
| Predicate Device | Modified Device | |
|---|---|---|
| 510(k) Reference | K964518 | Current Submission |
| Intended Use | Intracardiac Placement of | |
| Interventional Devices | Same | |
| Device Description | Intracardiac Introducing Sheath | Same |
| Single Use? | Yes | Same |
| EO Sterilized? | Yes | Same |
| Manufacturer | Daig Corp | EPT/BSC |
| Device Classification | Class II, DYB; 21 CFR §870.1340 | Same |
CONFIDENTIAL
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head facing left, with three curved lines extending from the back of the head, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle symbol.
Public Health Service
SEP 1 1 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation/ EP Technologies, Inc. Ms. Andrea L. Ruth Senior Associate, Regulatory Affairs 2710 Orchard Parkway San Jose, CA 95134
Re: K022067
Convoy Advanced Delivery Sheath Kit Regulation Number: 870.1340 Regulation Name: Catheter introducer. Regulatory Class: Class II Product Code: DBY Dated: June 24, 2002 Received: June 25, 2002
Dear Ms. Ruth:
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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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. Andrea L. Ruth
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 (21 CFR Part 807); 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 the labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. 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,
H. Douglas Tillett
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Intended Use Statement
510(k) Number (if known): K022067
Device Name:
.
Convoy™ Advanced Delivery Sheath Kit
Indication for Use:
Image /page/4/Picture/5 description: The image shows a close-up of a document with some text. On the right side, the text "Aug 13 1993" is vertically aligned. On the left side, the word "RECEIVED" is also vertically aligned. The rest of the image is blurry.
વિદ્ય નિર્મદા
The Convoy Advanced Delivery Sheath Kit is inter facilitate the intracardiac placement of intervent devices.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K022067
Prescription Use √
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)