(193 days)
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.
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 provided text describes a medical device, the USCI® Input™ Tuohy-Borst Locking Device, and compares it to a predicate device, the USCI® Disposable Y-Connector w/Modified Tuohy-Borst Adapter.
However, the document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a full study report with performance metrics.
Based only on the provided text, I can infer the intended function of the device, which serves as a proxy for what would be tested, but no specific acceptance criteria or study results are explicitly stated.
Therefore, I cannot populate the requested table with "reported device performance" against "acceptance criteria" because these are not present in the provided text. I also cannot answer many of the specific questions about sample size, ground truth, expert qualifications, adjudication, or MRMC studies, as this information is not included in a 510(k) summary from 1996 for this type of device.
Here's what I can extract and infer based on your request and the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from device function) | Reported Device Performance (Not explicit in summary) |
|---|---|
| Ability to secure a catheter to an introducer | (Not stated in the provided text) |
| Ability to reduce the risk of inadvertent catheter movement | (Not stated in the provided text) |
| Removable and adjustable valve function | (Not stated in the provided text) |
| Compatibility with USCI Input Introducer | (Not stated in the provided text) |
| Does not overly constrict the catheter lumen or impede guidewire movement (based on predicate device precautions) | (Not stated in the provided text) |
| Mechanical integrity (e.g., locking mechanism effectiveness, material strength) | (Not stated in the provided text) |
| Biocompatibility (implied for medical device) | (Not stated in the provided text) |
| Sterility (implied for medical device) | (Not stated in the provided text) |
Reasoning for Inference: The "Description and Intended Use" sections clearly state the device's purpose: "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." The similarities and differences section also discusses the "identical mechanism for reducing the risk of inadvertent catheter movement." Precautions from the predicate device (not collapsing the lumen or impairing guidewire movement) imply performance criteria related to not causing harm.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. This document is a regulatory submission, not a clinical study report. Substantial equivalence for this type of device often relies on engineering testing and comparison to predicate devices, rather than large clinical trials in this era.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The development and regulatory approval of a mechanical medical device like this in 1996 would not typically involve "experts establishing ground truth" in the way it's understood for AI/diagnostic studies.
4. Adjudication method for the test set
- Not applicable and not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a mechanical medical device for securing catheters, not an imaging or diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of "ground truth" as typically discussed for AI studies. For a mechanical device, performance would be assessed through engineering tests (e.g., tensile strength, leak testing, functional testing of the locking mechanism, material compatibility). The "truth" would be whether the device performed its intended mechanical function within specified parameters.
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. This device does not use a "training set."
In summary: The provided document is a 510(k) summary for a mechanical medical device from 1996. It focuses on describing the device, its intended use, and demonstrating substantial equivalence to a predicate device. It does not contain the detailed (and often proprietary) results of performance testing, much less information about AI-related metrics like training sets, ground truth establishment by experts, or MRMC studies.
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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.
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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.
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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."
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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.
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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 sidew/gland) | N/A | Teflon |
| "O" Ring(internal todistal fitting) | N/A | Silicone |
| Distal Fitting(of the body) | threaded & stationary | threaded & rotates |
| Distal Fitting | attaches to introducersheath | 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
§ 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).