K Number
K082670
Device Name
MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET
Manufacturer
Date Cleared
2008-12-04

(80 days)

Product Code
Regulation Number
870.1250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The steerable catheter set is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
Device Description
The Attain Prevail™ 6228CTH80 Steerable Catheter Set contains one 80cm Steerable catheter, one guidewire, one Y-connector with valve, one extension set, 3-way stopcock, one guidewire clip and two guidewire torque tools.
More Information

Not Found

No
The summary describes a mechanical steerable catheter set and does not mention any AI or ML components or functionalities.

No
The device is described as providing a pathway for delivery of other transvenous devices, not performing a therapeutic action itself.

No
The device's intended use is to provide a pathway for delivery of other transvenous devices, not to diagnose a condition.

No

The device description explicitly lists multiple hardware components including a catheter, guidewire, Y-connector, extension set, stopcock, guidewire clip, and torque tools.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart." This describes a device used within the body for a therapeutic or interventional purpose (delivering other devices), not for examining specimens outside the body to diagnose a condition.
  • Device Description: The components listed (catheter, guidewire, connectors, etc.) are all consistent with devices used for accessing and navigating within the cardiovascular system.
  • Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, tissue, etc.) or to provide information for diagnosis based on such analysis.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo (within the body).

N/A

Intended Use / Indications for Use

The steerable catheter set is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

Product codes (comma separated list FDA assigned to the subject device)

DQY

Device Description

The Attain Prevail™ 6228CTH80 Steerable Catheter Set contains one 80cm Steerable catheter, one guidewire, one Y-connector with valve, one extension set, 3-way stopcock, one guidewire clip and two guidewire torque tools.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary sinus and coronary vasculature of the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Device integrity testing was performed to support the equivalency of the Attain Prevail™ 6228CTH80 Steerable Catheter Set to the predicate devices. Testing included bench, sterilisation and biocompatibility testing. The Attain Prevail™ 6228CTH80 Steerable Catheter Set met all specified design and performance requirements.

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.

K031211, K032622

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

§ 870.1250 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

K082670

Image /page/0/Picture/1 description: The image contains the Medtronic logo. The logo consists of a circular symbol on the left and the word "Medtronic" in bold, sans-serif font on the right. The circular symbol appears to depict a stylized representation of the human body.

:

DEC 0 4 2008

510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

Date Prepared:September 12, 2008
Applicant:Medtronic Ireland
Parkmore Business Park West
Galway
Ireland
Submission Correspondent:Beth Claas
Senior Regulatory Affairs Specialist
Medtronic, Inc.
8200 Coral Sea Street
MS MVS11
Mounds View MN 55112
USA
Telephone:(+1-763) 526-2384
Fax:(+1-651) -367-0603
E-Mail:beth.a.claas@medtronic.com
Proprietary Name:Attain Prevail™ 6228CTH80 Steerable Catheter Set
Common Name:Catheter, Percutaneous
Device Classification:Class II, 21 CFR 870.1250
Product Code:DQY
Device Description:The Attain Prevail™ 6228CTH80 Steerable Catheter Set contains one 80cm
Steerable catheter, one guidewire, one Y-connector with valve, one extension set,
3-way stopcock, one guidewire clip and two guidewire torque tools.
Indications For Use:The steerable catheter set is indicated to provide a pathway for delivery of
transvenous devices to the coronary sinus and coronary vasculature of the heart.
Substantially Equivalent Devices:The Attain Prevail™ 6228CTH80 Steerable Catheter Set uses similar technology
and has similar intended uses, function, materials and method of operation to the
following predicate devices:
  • Attain Prevail™ 6228CTH Steerable Catheter Set (510(k) K031211). Also
    commercialized under this 510(k) number is the current Attain Prevail™
    6228CTH80 Steerable Catheter Set.
  • Attain Prevail™ 6228SYS Left-Heart Delivery System, 80 cm Prevail catheter
    (510(k) K032622). |
    | Summary of Studies: | Device integrity testing was performed to support the equivalency of the Attain
    Prevail™ 6228CTH80 Steerable Catheter Set to the predicate devices. Testing
    included bench, sterilisation and biocompatibility testing. The Attain Prevail™
    6228CTH80 Steerable Catheter Set met all specified design and performance
    requirements. |

1

Image /page/1/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular symbol on the left and the word "Medtronic" in bold, sans-serif font on the right. The circular symbol contains a stylized representation of a human figure within a circle.

Biocompatibility Information:

The biocompatibility evaluation completed for the Attain Prevail™ 6228CTH80 Steerable Catheter Set verifies that this device is biocompatible.

The testing which supports the biocompatibility of the Attain Prevail™ 6228CTH80 Steerable Catheter Set is consistent with International Standard ISO10993-1:2003, "Biological Evaluation of Medical devices- Part 1: Evaluation and Testing."

When classified according to this standard, this device is categorized as external communicating devices with limited exposure i.e. whose contact with circulating blood is (less than)