(193 days)
Not Found
No
The device description and intended use describe a purely mechanical locking device. There is no mention of software, algorithms, or any features that would suggest AI/ML is involved.
No
The device is described as an adjunctive measure to help secure a catheter to an introducer, reducing inadvertent movement by physical means. It does not directly treat or diagnose a disease or condition.
No
Explanation: The device is described as an adjustable valve to secure a catheter, reducing inadvertent movement. This is a functional/mechanical purpose, not a diagnostic one.
No
The device description clearly states it is comprised of physical components like a body, threaded segments, a gland, and an end cap, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to secure a catheter to an introducer to reduce inadvertent movement. This is a mechanical function performed in vivo (within the body) to manage a medical device.
- Device Description: The description details the physical components and how they function to secure a catheter. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the USCI® Input™ Tuohy-Borst Locking Device is a medical device used for a procedural function, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Input Lock functions as a removable, adjustable valve indicated as an adjunctive measure to help secure a catheter to an introducer in order to reduce the risk of inadvertent movement.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The USCI® Input™ Tuohy-Borst Locking Device (hereinafter referred to as the Input Lock) is comprised of a single channel (body) which at its distal segment connects to the introducer sheath hub and ends proximally with a threaded segment containing an internally seated gland. Attached to this threaded proximal segment is an end cap which when thread tightened compresses the gland and secures the indwelling catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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® Disposable Y-Connector w/Modified Tuohy-Borst Adapter (K890325)
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
§ 870.1340 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
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
AUG 12 1996
Image /page/0/Picture/3 description: The image shows the logo for USCI, which is an acronym. The letters "USCI" are in bold, sans-serif font. The letters are enclosed in an oval shape. The logo is in black and white.
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.
6.1 General Information
- � 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:
January 31, 1996
� Name of Device:
USCI® Input™ Tuohy-Borst Locking Device
� Common/Usual Name of Device:
Angiographic/Angioplasty Accessory Device
� Device Classification:
Cardiopulmonary Bypass Adapter, Stopcock, Manifold or Fitting
Image /page/0/Picture/19 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and modern appearance. The font style is consistent throughout the word, creating a unified and recognizable logo or brand name.
1
Predicate Device: �
USCI® Disposable Y-Connector w/Modified Tuohy-Borst Adapter
� Description and Intended Use of Device:
The USCI® Input™ Tuohy-Borst Locking Device (hereinafter referred to as the Input Lock) is comprised of a single channel (body) which at its distal segment connects to the introducer sheath hub and ends proximally with a threaded segment containing an internally seated gland. Attached to this threaded proximal segment is an end cap which when thread tightened compresses the gland and secures the indwelling catheter.
The Input Lock functions as a removable, adjustable valve indicated as an adjunctive measure to help secure a catheter to an introducer in order to reduce the risk of inadvertent movement.
2
6.2 Summary of Similarities and Differences
Please refer to Exhibit 6.2, on the following page, for a Table of the Similarities and Differences.
The Input Lock is new to the USCI line of accessory devices. It utilizes the "locking" design characteristic of the USCI® Disposable Y-Connector with Modified Tuohy-Borst Adapter (K890325, concurrence received March 15, 1989 and hereinafter referred to as the Disposable Y-Connector). Both devices consist of a body, and an end cap, both which differ in configuration, and a gland. The Disposable Y -Connector differs such that the body contains a distal fitting that rotates (with an internal O-ring for ease of rotating movement) and a washer side by side with the gland. The Disposable Y-Connector also contains a second proximal channel for connection to a manifold. The Input Lock is a less bulky device that attaches to the introducer sheath hub while the Disposable Y-Connector attaches to a catheter hub.
The two devices have the identical mechanism for reducing the risk of inadvertant catheter movement. When the end caps of both devices are thread tightened to the body, the I.D. of the internal gland constricts around the I.D. of the indwelling catheter.
The Disposable Y - Connector is indicated for PTA, PTCA pressure monitoring, dye infusion and flushing. However, the Instructions for Use (IFU) provided in the 510(k) Premarket Notification (K890325) indicate that this device has " ... an adjustable gland adjusting to form a seal with or without a guide wire in place." The IFU contains two precautions "Do not collapse the lumen of the balloon dilatation catheter or impair free movement of the guide wire by adjusting the Tuohy-Borst adapter" (compression of the gland) "too tightly." and "Excessive tightening of the Tuohy-Borst adapter may inhibit the ability to monitor distal pressures, manipulate the steerable guide wire, or deflate the balloon."
38
3
The Input Lock functions as a removable, adjustable valve indicated as an adjunctive measure to help secure a catheter to a USCI Input Introducer in order to reduce the risk of inadvertent catheter movement.
4
Exhibit 6.2
Table of Similarities and Differences
| Component/ | Input Lock | Disposable Y-Connector |
|---|---|---|
| Characteristic | ||
| Body* | ABS** | Polycarbonate |
| End Cap | Nylon | Polycarbonate |
| Gland | Silicone | Silicone |
| Washer | ||
| (side by side | ||
| w/gland) | N/A | Teflon |
| "O" Ring | ||
| (internal to | ||
| distal fitting) | N/A | Silicone |
| Distal Fitting | ||
| (of the body) | threaded & stationary | threaded & rotates |
| Distal Fitting | attaches to introducer | |
| sheath | attaches to catheter hub | |
| Body Length | ||
| (nominal) | 1.0" | 2.6" |
| Gasket I.D. | ||
| (nominal) | .120" | .075" |
| Channel I.D. | ||
| (nominal) | .110" | .125" |
- The Input Lock body with distal fitting is one molded segment. The ◆ Disposable Y-Connector body and distal rotating fitting is comprised of three (3) parts: the molded Y-body , the O-ring and the molded rotating fitting which houses the O-ring.
女大 Acrylonitrile Butadiene Styrene