(38 days)
Not Found
No
The description focuses on material and design changes to a mechanical device (needle, catheter, valve) and does not mention any computational or data-driven components.
No
The device is used for draining fluid, which is a diagnostic or interventional procedure, not a therapeutic treatment itself.
No
The device is intended to drain fluid, which is a therapeutic rather than a diagnostic action.
No
The device description clearly outlines physical components like needles, catheters, hubs, and a valve, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to drain fluid from the pleural cavity." This is a direct medical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a procedural tray containing components for performing a thoracentesis, which is a physical procedure. The components described (needles, catheters, valves) are all instruments used in this procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical/procedural tool.
N/A
Intended Use / Indications for Use
The Kendall Curity Thoracentesis Tray is intended to be used to drain fluid from the pleural cavity.
Product codes
Not Found
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 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 Once the needle is withdrawn from the valve, a spring mechanism occludes the catheter lumen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pleural cavity
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6740 Vacuum-powered body fluid suction apparatus.
(a)
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).(b)
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.
0
EXHIBIT #12
510(k) Summary
DEC 2 0 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 7, 1996
Contact Person 1.
David A. Olson Manager Regulatory Affairs (508) 261-8530
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.
র্বা 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.
ട. 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.