CURITY THORACENTESIS TRAY

K964519 · Kendall Healthcare Products Co. Div.Of Tyco Health · GCX · Dec 20, 1996 · General Hospital

Device Facts

• Record ID: K964519
• Device Name: CURITY THORACENTESIS TRAY
• Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
• Product Code: GCX · General Hospital
• Decision Date: Dec 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6740
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kendall Curity Thoracentesis Tray is intended to be used to drain fluid from the pleural cavity.

Device Story

Sterile, single-use procedural tray for thoracentesis; contains aspirating needle, thoracentesis catheter, and associated components. Device features polycarbonate needle hub and polyurethane catheter hub/shaft. Includes optional catheter-over-needle configuration with integrated automatic valve; spring mechanism occludes catheter lumen upon needle withdrawal to prevent air/fluid leakage. Used by clinicians in clinical settings to perform pleural fluid drainage. Output is physical fluid removal; facilitates diagnostic or therapeutic pleural effusion management.

Clinical Evidence

Bench testing only. Biocompatibility testing conducted per ISO-10993; functional/mechanical testing performed for hub pull-off force, leakage, and valve siphoning capability.

Technological Characteristics

Materials: Polycarbonate (needle hub), Polyurethane (catheter hub/shaft). Components: Aspirating needle, catheter, automatic valve with spring mechanism. Sterilization: Sterile, single-use. Design: Catheter-over-needle configuration.

Indications for Use

Indicated for patients requiring drainage of fluid from the pleural cavity (thoracentesis).

Regulatory Classification

Identification

A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Predicate Devices

• Kendall Curity Thoracentesis Tray (K903569)
• Arrow International Pleura-Seal™ Thoracentesis Kit (K870572)
• Sherwood Medical Argyle® Turkel™ Safety Thoracentesis Procedure Tray (K930847)

Submission Summary (Full Text)

{0}

K964519

# EXHIBIT #12

## 510(k) Summary

DEC 20 1996

Kendall Curity® Thoracentesis Tray

In accordance with section 513(i) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:

Kendall Healthcare Products Company
15 Hampshire Street
Mansfield, MA 02048
Date: November 1, 1996

1. **Contact Person**

David A. Olson
Manager Regulatory Affairs
[phone]

2. **Name of Medical Device**

Classification Name: Vacuum-Powered Body Fluid Suction Apparatus
Common or Usual Name: Thoracentesis Tray
Proprietary Name: Curity Thoracentesis Tray

3. **Identification of Legally Marketed Device**

The proposed Kendall Curity Thoracentesis Tray is substantially equivalent in intended use, function and composition to the commercially available Kendall Curity Thoracentesis Tray, 510(k) No. K903569; Arrow International Pleura-Seal™ Thoracentesis Kit, 510(k) No. K870572; and Sherwood Medical Argyle® Turkel™ Safety Thoracentesis Procedure Tray, 510(k) No. K930847.

4. **Device Description**

The proposed Kendall Curity Thoracentesis Tray is a sterile, single use procedural tray containing the components required to perform a thoracentesis. This submission covers proposed changes to the aspirating needle and thoracentesis catheter. An ergonomically designed polycarbonate hub will be insert molded onto the needle cannula and a polyurethane hub insert molded onto the catheter shaft. In addition, the catheter shaft material will change from Teflon® to polyurethane. There

{1}

Exhibit 12 (continued)

will be no changes to the current dimensions or performance specifications.

In addition, a new product code will incorporate Kendall's thoracentesis catheter-over-needle with an automatic valve that acts to occlude the proximal end of the catheter lumen. The valve is an integral part of the catheter. Once the needle is withdrawn from the valve, a spring mechanism occludes the catheter lumen.

5. Device Intended Use

The Kendall Curity Thoracentesis Tray is intended to be used to drain fluid from the pleural cavity.

6. Product Comparison

The Kendall Curity Thoracentesis Tray is equivalent to the referenced predicate devices in that they are fabricated from similar materials have the same function and equivalent indications for use.

7. Nonclinical Testing

Biocompatibility testing was performed on the needle hub, catheter and automatic valve following ISO-10993 Biological Evaluation of Medical Devices. This testing found the material contained no toxic diffusible substances.

Functional/Mechanical testing was performed to determine hub pull-off force, potential for leakage, and siphoning capability of the automatic valve.