(82 days)
No
The summary describes a standard percutaneous introducer set with no mention of AI/ML, image processing, or data-driven performance metrics.
No.
The device facilitates the placement of a catheter but does not directly treat a medical condition itself.
No
Explanation: The device is described as an introducer used to facilitate placing a catheter, not for diagnosing conditions. Its function is to provide access, not to obtain diagnostic information.
No
The device description explicitly lists physical components: an introducer sheath, a locking dilator, a guide wire, and potentially a locking obturator. These are hardware components, not software.
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 the physical placement of catheters into veins or arteries for procedures. This is a direct intervention on the patient's body.
- Device Description: The components (introducer sheath, dilator, guide wire, obturator) are all physical tools used for accessing blood vessels.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information. IVDs are designed to analyze samples to detect diseases, conditions, or states of health.
The device described is a medical device used for interventional procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Input TS & TL are indicated as percutaneous introducers that are used to facilitate placing a catheter through the skin into a vein or artery. Input TS & TL 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 (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Input TS & TL consists of an introducer sheath (uncoated), a locking dilator (may contain a single or double dilator), and a guide wire. Certain model numbers will also contain a locking obturator. These devices are supplied sterile and are intended for one time use only.
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
physician / cardiac catheterization laboratory
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)
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 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
ical and Regulatory Affairs echnology Park Drive ca. MA 01821 8) 667-1300 (508) 670-4326
USCI
will in 12 198
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:
December 18, 1995
Name of Device:
USCI® Input® TS and Input TL Percutaneous Arterial/Venous Catheter Introducer Set
Common/Usual Name of Device:
Catheter Introducer
Device Classification:
Cardiopulmonary Bypass Adapter, Stopcock, Manifold or Fitting
1
Predicate Device:
USCI® Input™ Introducer Set (K940092, concurrence received August 10, I dat )
Description and Intended Use of Device:
Input TS & TL consists of an introducer sheath (uncoated), a locking dilator (may contain a single or double dilator), and a guide wire. Certain model numbers will also contain a locking obturator. These components are presented in Section 3.0, Exhibit 3.2. The components described in this submission are equivalent to those mentioned in the USCI Input Introducer Set, 510(k) #K940092. The latex gasket, teflon sheath with polyurethane strain relief and black PE materials, although new to the Input Introducer line of products, are not new to USCI. These materials are currently used in various other USCI introducers such as the Hemaquet Introducer (K781954/concurrence received November 29, 1978) and the Hemaflex Introducer (K915553/concurrence received February 21, 1991). Both the Hemaquet and Hemaflex Introducers have a latex gasket, a teflon sheath with a polyurethane strain relief and a black PE dilator.
olpuadd
The Input Introducer Set (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.
Input TS & TL are indicated as percutaneous introducers that are used to facilitate placing a catheter through the skin into a vein or artery. Input TS & TL 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 Introducer Set 510(k) #K940092.
2
During cardiac catheterization laboratory procedures, through either angiographic diagnostic or angioplasty therapeutic approaches, a physician may elect to leave an introducer in place (within the vessel). The current practice is for patients to lay flat on their backs for several hours post-PTCA. Without the support of a catheter the introducer sheath may collapse or kink. This introducer kit supplies an obturator (the obturator is also supplied as an individual component) to be used as a means of support while the introducer remains in place. The obturator material is flexible, thereby allowing the patient to sit-up in bed in the Semi-Fowler position (up to a 60° angle) post-PTCA rather than lying flat. Allowing the patient to sit up in bed at a 60° angle has the potential to enhance their comfort.
The current Input Introducer Set (predicate device), with a pebax sheath, was described in K940092 (concurrence received August 10, 1995) as a device which allows for this alternative post-PTCA patient care procedure. A statement and illustration was added to the Instructions for Use that advises physicians that patients may sit up-right (up to a 60° angle) post-procedure. The devices covered under this 510(k) Premarket Notification, with a teflon sheath, will include the same statement and illustration.
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Input TS & TL contains an obturator to be used as a means of support while the introducer remains in place.
These devices are supplied sterile and are intended for one time use only.