K Number
K963663
Device Name
11F GUIDING CATHETER
Date Cleared
1997-01-13

(122 days)

Product Code
Regulation Number
870.1250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IVT 11F Guiding Catheter is a standard quiding catheter intended for use in the coronary vasculature as a conduit for other medical devices such as diagnostic and therapeutic catheters and quidewires. Thus, the IVT 11F Guiding Catheter acts to facilitate access for these other medical devices. This device is intended for single use only. IVT's 11F Guiding Catheter is indicated for use during interventional diagnostic cardiovascular procedures in hospital settings which are appropriate for these types of procedures.
Device Description
The IVT 11F Guiding Catheter is a series of standard cardiovascular guiding catheters with models corresponding to standard catheter curvature types. The IVT 11F Guiding Catheter contains a single lumen which acts as a conduit to provide access for other medical devices to the coronary vasculature. The device's proximal end contains a polycarbonate female luer fitting which can be connected to other equipment used in cardiovascular procedures. The 11F Guiding Catheter device is offered in a catheter working length of 94 cm. The shaft is designed with a braided wire reinforcement and can include side holes to enable vessel perfusion during placement. The 11F Guiding Catheter's distal end is shaped to accommodate various anatomic configurations. The 11F Guiding Catheter curvatures include the FL 3.5, FL 4.0, FL 5.0, FR 3.5, FR 4.0, FR 5.0, Multi-purpose Graft, Modified Amplatz, Left Amplatz, Right Coronary Bypass, and Hockey Stick standard catheter shape types. The distal tip of the device is a "soft" tip design. All IVT 11F Guiding Catheter device packaging configurations are supplied as sterile devices and intended for single use only.
More Information

Not Found

No
The description focuses on the physical characteristics and intended use of a standard guiding catheter, with no mention of AI or ML capabilities.

No
The device acts as a conduit to facilitate access for other medical devices, including therapeutic ones, but it is not therapeutic itself.

No

Explanation: The device is a guiding catheter that "acts to facilitate access for these other medical devices" (diagnostic and therapeutic catheters and guidewires). It is used "during interventional diagnostic cardiovascular procedures," but it is not itself a diagnostic device; rather, it is a conduit for other diagnostic devices.

No

The device description clearly details a physical catheter with a lumen, luer fitting, braided wire reinforcement, and shaped distal end, indicating it is a hardware medical device.

Based on the provided text, the IVT 11F Guiding Catheter is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use clearly states it's for use in the coronary vasculature as a conduit for other medical devices. This is an in vivo (within a living organism) application, not in vitro (outside of a living organism, typically in a lab setting).
  • Device Description: The description details a physical catheter designed to be inserted into blood vessels. This aligns with an in vivo medical device.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a physiological state, health, or disease.

Therefore, the IVT 11F Guiding Catheter is a medical device used in vivo for interventional procedures, not an IVD.

N/A

Intended Use / Indications for Use

The IVT 11F Guiding Catheter is a standard quiding catheter intended for use in the coronary vasculature as a conduit for other medical devices such as diagnostic and therapeutic catheters and quidewires. Thus, the IVT 11F Guiding Catheter acts to facilitate access for these other medical devices. This device is intended for single use only.

IVT's 11F Guiding Catheter is indicated for use during interventional diagnostic cardiovascular procedures in hospital settings which are appropriate for these types of procedures.

Product codes

Not Found

Device Description

The IVT 11F Guiding Catheter is a series of standard cardiovascular guiding catheters with models corresponding to standard catheter curvature types.

The IVT 11F Guiding Catheter contains a single lumen which acts as a conduit to provide access for other medical devices to the coronary vasculature. The device's proximal end contains a polycarbonate female luer fitting which can be connected to other equipment used in cardiovascular procedures. The 11F Guiding Catheter device is offered in a catheter working length of 94 cm. The shaft is designed with a braided wire reinforcement and can include side holes to enable vessel perfusion during placement. The 11F Guiding Catheter's distal end is shaped to accommodate various anatomic configurations. The 11F Guiding Catheter curvatures include the FL 3.5, FL 4.0, FL 5.0, FR 3.5, FR 4.0, FR 5.0, Multi-purpose Graft, Modified Amplatz, Left Amplatz, Right Coronary Bypass, and Hockey Stick standard catheter shape types. The distal tip of the device is a "soft" tip design.

All IVT 11F Guiding Catheter device packaging configurations are supplied as sterile devices and intended for single use only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Coronary vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Hospital settings

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)

Biocompatibility and physical performance testing demonstrate IVT's 11F Guiding Catheter product to be safe and effective. Information provided in the 510(k) submission supports the determination of substantial equivalence.

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.

K911869

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

Not Found

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).

0

0010 K963663

SUMMARY OF SAFETY AND EFFECTIVENESS

149 1 3 1997

InterVentional Technologies, Inc. (IVT) SUBMITTER:

September 12, 1996 DATE:

Guiding Catheter COMMON NAME:

11F Guiding Catheter PROPRIETARY NAME:

Michael E. Klicpera CONTACT: Vice President, Corporate Counsel InterVentional Technologies, Inc. 3574 Ruffin Road San Diego, CA 92123 (619) 268-4488 (phone) (619) 292-8381 (fax)

Class II per 21 CFR 870.1200, Diagnostic Intravascular CLASSIFICATION: Catheter (and 21 CFR 870.1250, Percutaneous Catheter)

PREDICATED DEVICES:

IVT is claiming substantial equivalence to the following predicate medical devices:

  • InterVentional Technologies, Inc., 5 10F Guiding Catheter, 1. K911869
  • Devices for Vascular Intervention, Inc. (DVI), 11F Guiding Catheter 2.
    1. Cordis Webster, Inc., Multipurpose Guiding Catheter
  • Medtronic Interventional Medical, Guiding Catheter K822243 4.

1. DEVICE DESCRIPTION:

The IVT 11F Guiding Catheter is a series of standard cardiovascular guiding catheters with models corresponding to standard catheter curvature types.

The IVT 11F Guiding Catheter contains a single lumen which acts as a conduit to provide access for other medical devices to the coronary vasculature. The device's proximal end contains a polycarbonate female luer fitting which can be connected to other equipment used in cardiovascular procedures. The 11F Guiding Catheter device is offered in a catheter working

1

length of 94 cm. The shaft is designed with a braided wire reinforcement and can include side holes to enable vessel perfusion during placement. The 11F Guiding Catheter's distal end is shaped to accommodate various anatomic configurations. The 11F Guiding Catheter curvatures include the FL 3.5, FL 4.0, FL 5.0, FR 3.5, FR 4.0, FR 5.0, Multi-purpose Graft, Modified Amplatz, Left Amplatz, Right Coronary Bypass, and Hockey Stick standard catheter shape types. The distal tip of the device is a "soft" tip design.

All IVT 11F Guiding Catheter device packaging configurations are supplied as sterile devices and intended for single use only.

2. INTENDED USE, INDICATIONS FOR USE:

The IVT 11F Guiding Catheter is a standard quiding catheter intended for use in the coronary vasculature as a conduit for other medical devices such as diagnostic and therapeutic catheters and quidewires. Thus, the IVT 11F Guiding Catheter acts to facilitate access for these other medical devices. This device is intended for single use only.

IVT's 11F Guiding Catheter is indicated for use during interventional diagnostic cardiovascular procedures in hospital settings which are appropriate for these types of procedures.

3. SUBSTANTIAL EQUIVALENCE:

The intended use of IVT's 11F Guiding Catheter is the same as that for other predicate guiding catheter devices. The materials and design of this device are similar to those of other, previously FDA cleared guiding catheters. The technical characteristics of 11F Guiding Catheter do not introduce new questions regarding safety or effectiveness of cardiovascular guiding catheters. The labeling associated with the 11F Guiding Catheter provides similar information as the predicate devices.

Biocompatibility and physical performance testing demonstrate IVT's 11F Guiding Catheter product to be safe and effective. Information provided in the 510(k) submission supports the determination of substantial equivalence.

In summary IVT has provided evidence that shows the 11F Guiding Catheter to be safe and effective. This device is considered to be substantially equivalent to similar marketed devices.