(40 days)
No
The summary describes a physical introducer device and its components, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is described as an introducer used to facilitate placing other catheters, not as a device that provides therapy itself.
No
The device is described as an introducer for placing catheters, not for diagnosing conditions. Its function is to facilitate access into a vein or artery for other medical procedures, not to identify or characterize diseases or conditions.
No
The device description clearly states it consists of physical components: an introducer sheath, a locking dilator, and a guide wire. There is no mention of software as a component of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used to facilitate placing a catheter through the skin into a vein or artery. This is an invasive procedure performed directly on the patient's body.
- Device Description: The components (introducer sheath, dilator, guide wire) are all tools used for accessing blood vessels within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly access or manipulate structures within the body.
N/A
Intended Use / Indications for Use
Input 10F/11F are indicated as percutaneous introducers that are used to facilitate placing a catheter through the skin into a vein or artery. Input 10F/11F are recommended for initial percutaneous introduction of a closed end catheter, temporary pacing electrode catheter or probe, or a balloon catheter. They may also be used as an instrument to exchange catheters during a procedure.
Product codes
Not Found
Device Description
Input 10F/11F consists of an introducer sheath (uncoated), a locking dilator (may contain a single or double dilator), and a guide wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vein or artery
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)
Not Found
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.
USCI® Input™ Introducer Set (K940092), Daig 11F Introducer
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.
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).
0
USCI Division C.R. Bard, Inc. Clinical and Regulatory Affairs 1200 Technology Park Drive P.O. Box 7025 Billerica, MA 01821 (508) 667-1300 FAX: (508) 670-4326
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SECTION 6.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
As required under Section 12, part (a)(i)(3A) of the Safe Medical Device Act of 1990, an adequate summary of any information respecting safety and effectiveness follows.
General Information 6.1
� Name and Address of Submitter:
USCI Division of C.R. Bard, Inc. 1200 Technology Park Drive Billerica, MA 01821
� Contact:
Robert T. Miragliuolo Director, Regulatory Affairs
� Date of Summary:
March 20, 1996
Name of Device: �
USCI® Input® 10F/11F Percutaneous Arterial/Venous Catheter Introducer Set
� Common/Usual Name of Device:
Catheter Introducer
� Device Classification:
Cardiopulmonary Bypass Adapter, Stopcock, Manifold or Fitting
◆ Predicate Devices:
USCI® Input™ Introducer Set (K940092, concurrence received August 10, 1995); referred to as Input SC in this submission for identification purposes. Daig 11F Introducer
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1
Description and Intended Use of Device: �
Input 10F/11F consists of an introducer sheath (uncoated), a locking dilator (may contain a single or double dilator), and a guide wire. These components are presented in Exhibit 3.1 of this section with the exception of the guide wire since there are no changes to this sub-assembly. Refer to Exhibit 3.3 in this section for a photograph of the Input 10F/11F introducer.
The components described in this submission are equivalent to those mentioned in the USCI Input Introducer with Sit-Up Claim (termed Input SC in this submission for identification purposes), 510(k) #K940092. The FEP sheath and black PE materials, although new to the Input Introducer line of products, are not new to USCI. These materials are used in various other USCI introducers such as the Hemaquet Introducer (K781954/concurrence received November 29, 1978) and the Hemaflex Introducer (K897041/concurrence received March 16, 1990). Both the Hemaquet and Hemaflex Introducers have a black PE dilator. The Hemaquet Introducer also contains the FEP sheath with the polyurethane strain relief.
Input 10F/11F are indicated as percutaneous introducers that are used to facilitate placing a catheter through the skin into a vein or artery. Input 10F/11F are recommended for initial percutaneous introduction of a closed end catheter, temporary pacing electrode catheter or probe, or a balloon catheter. They may also be used as an instrument to exchange catheters during a procedure. This indication statement is identical to the indication provided in the Input SC 510(k) #K940092.
The Input SC (K940092), the predicate device, consists of an introducer sheath (hydrophilic coated), a locking dilator (that may contain a single or double dilator), and a guide wire. Certain model numbers also contain a locking obturator. The Input 10F/11F, covered under this 510(k), will not include a locking obturator.
2
The current Input SC (as described in K940092, concurrence received August 10, 1995) allows the patient to sit up in bed at a 60° angle, post-PTCA procedure. A statement and illustration was added to the Instructions for Use (IFU) that advises physicians that patients may sit up-right (up to a 60° angle) post-procedure. However, the IFU for the Input 10F/11F introducer will not include the option of allowing the patient to sit up in bed at a 60° angle, post-PTCA procedure
Input 10F/11F are indicated as percutaneous introducers that are used to facilitate placing a catheter through the skin into a vein or artery. Input 10F/11F are recommended for initial percutaneous introduction of a closed end catheter, temporary pacing electrode catheter or probe, or a balloon catheter. They may also be used as an instrument to exchange catheters during a procedure.