(62 days)
No
The device description details a purely mechanical needle and drainage system with no mention of software, data processing, or any form of intelligent automation.
Yes
The 'Intended Use / Indications for Use' section states the device is used for "removing from cac personed to be used for both diagnostic and therapeutic abdominal paracentesis procedures," indicating a therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section states that the devices are indicated for use in removing fluid from a patient for "both diagnostic and therapeutic abdominal paracentesis procedures." Diagnostic procedures involve identifying the nature of a disease or condition.
No
The device description clearly details physical components like needles, cannulas, and tubing, indicating it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "removing from cac personed to be used for both diagnostic and therapeutic abdominal paracentesis procedures." This describes a procedure to obtain a sample (fluid from the abdominal cavity) and potentially treat a condition (by removing excess fluid). It does not describe a test performed on a sample in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a needle and drainage system designed for physically accessing and draining fluid from the abdominal cavity. It does not mention any components or processes for analyzing or testing the collected fluid.
- Lack of IVD Characteristics: The text does not mention any reagents, assays, or analytical methods that are characteristic of IVD devices.
While the collected fluid can be used for diagnostic purposes after it is obtained using this device, the device itself is a tool for sample collection and therapeutic drainage, not for performing the diagnostic test itself.
N/A
Intended Use / Indications for Use
The Denver® Paracentesis Needle, Paracentesis Needle with The Denver Traracentesis Tray are indicated for use in Drainage Binc, and the peritoneal cavity (abdominal removing from cac personed to be used for both diagnostic and therapeutic abdominal paracentesis procedures.
Product codes
Not Found
Device Description
The Denver® Paracentesis Needle is a sterile device, for single the belief "I is not to be resterilized. Components in the fluid use only. It is is no is device consists of an inner two-part path are non pyrogeniage cannula, and a trocar/cannula housing. The inner two-part trocar is a rounded, closed end tube with side holes, coaxially housed within a sharp-beveled hollow needle and the outer drainage cannula. The outer drainage cannula has a beveled tip and distal side holes to facilitate drainage.
As the two-part trocar penetrates the abdominal wall, the blunt portion of the trocar is forced back within the shaft of the needle portion of the trocar, exposing the sharp-beveled needle. The trocar/cannula housing contains a red indicator which is visible when the sharp-beveled needle is exposed. When the needle encounters low resistance, such as when the abdominal cavity is entered, the blunt portion of the trocar automatically re-extends out beyond the sharp needle, thereby helping protect against inadvertent organ puncture. Once the blunt portion of the trocar re-extends beyond the needle, the red indicator is no longer visible. Proper position in an area of fluid may also be confirmed by attaching a syringe to the end of the device and attempting aspiration.
Once in the abdominal cavity, the two-part trocar is removed, leaving the outer drainage cannula and housing in place for the paracentesis procedure.
The Denver® Paracentesis Needle with Drainage Line is a sterile device intended for single use only. It is not to be resterilized. The product contains one Denver® Paracentesis Needle, one drainage tubing line, and connectors to allow attachment to wall suction or a vacuum bottle.
The Denver® Paracentesis Tray is a sterile device intended for single use only. It is not to be resterilized. The tray contains one Denver® Paracentesis Needle, one drainage tubing line, connectors to allow attachment to wall suction or a vacuum bottle, and the primary components needed for performing the paracentesis procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity (abdominal)
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)
PERFORMANCE TESTING:
Drainage rates for Denver® Paracentesis Needles were compared to Tri-Med Caldwell 15 GA Paracentesis Needle/Cannulas (K932652). The results indicate that the two devices have a similar drainage performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Summary of Safety and Rifectiveness Denver® Paracentesis Needle (#60-1200) Denver® Paracentesis Needle with Drainage Line (60-1100) Denver® Paracentesis Tray (#60-1000)
IDENTIFICATION OF SUBSTANTIALLY EQUIVALENT DEVICE(S)
The Denver® Paracentesis Needle, Paracentesis Needle with Drainage Line, and Paracentesis Tray are substantially equivalent in intended use to the Endovations. Inc. Paracentesis Tray The Denver® and Endovations devices are similar in (K874063) . . that they are both single-use, sterile devices used for draining fluid from the peritoneal cavity (abdominal paracentesis), both for diagnostic and therapeutic purposes. Both trays provide the primary components required to perform paracentesis. The two devices differ in that the Denver® needle has a metal cannula and a two-part, non-coring trocar (the inner rounded end tube extends beyond the outer sharp needle whenever the trocar is in an area of low resistance, such as when the abdominal cavity is entered). The Endovations needle has a plastic cannula and a single noncoring sharp needle trocar. In addition, the Endovations needle is only offered as part of a paracentesis tray, whereas the Denver® needle is also offered alone (Catalog No. 60-1200) and with a drainage line and connectors (Catalog No. 60-1100). Both the Denver® and Endovations needles have sealed housings that prevent leakage of air or fluid into or out of the lumen through which the trocar was placed. This seal also prevents reinsertion of the trocar in both needles. The drainage ports of both devices (a luer port with a sealing diaphragm in the Denver® needle; a three-way stopcock in the Endovations needle) also prevent passage of air or fluid in or out of the port until accessed.
The Denver® Paracentesis Needle, Paracentesis Needle with Drainage Line, and Paracentesis Tray are also substantially equivalent in intended use to the Tri-Med Specialties, Inc. Paracentesis Tray (K932652). The Denver® and Tri-Med devices are similar in that they are both single-use, sterile devices used for draining fluid from the peritoneal cavity, and both incorporate a metal drainage cannula. Both trays provide the primary components required to perform paracentesis. The two devices differ in that the Denver® needle has a two-part, noncoring trocar and the Tri-Med needle has a single non-coring sharp needle trocar. In addition, the Denver® needle has a sealed housing that prevents leakage into or out of the lumen through which the trocar was placed, and prevents reinsertion of The Tri-Med needle has no seal in the housing; thus the trocar.
1
fluid leakage out of the needle can occur with the trocar either in place or removed. Similar to the Denver® needle, the Tri-Med in place of removed. Bamilar to one oge line, and as part of a complete paracentesis tray.
DEVICE DESCRIPTION:
The Denver® Paracentesis Needle is a sterile device, for single the belief "I is not to be resterilized. Components in the fluid use only. It is is no is device consists of an inner two-part path are non pyrogeniage cannula, and a trocar/cannula housing. The inner two-part trocar is a rounded, closed end tube with side holes, coaxially housed within a sharp-beveled hollow needle and the outer drainage cannula. The outer drainage cannula has a beveled tip and distal side holes to facilitate drainage.
As the two-part trocar penetrates the abdominal wall, the blunt portion of the trocar is forced back within the shaft of the needle portion of the trocar, exposing the sharp-beveled needle. The trocar/cannula housing contains a red indicator which is visible when the sharp-beveled needle is exposed. When the needle encounters low resistance, such as when the abdominal cavity is entered, the blunt portion of the trocar automatically re-extends out beyond the sharp needle, thereby helping protect against inadvertent organ puncture. Once the blunt portion of the trocar re-extends beyond the needle, the red indicator is no longer visible. Proper position in an area of fluid may also be confirmed by attaching a syringe to the end of the device and attempting aspiration.
Once in the abdominal cavity, the two-part trocar is removed, leaving the outer drainage cannula and housing in place for the paracentesis procedure.
The Denver® Paracentesis Needle with Drainage Line is a sterile device intended for single use only. It is not to be resterilized. The product contains one Denver® Paracentesis Needle, one drainage tubing line, and connectors to allow attachment to wall suction or a vacuum bottle.
The Denver® Paracentesis Tray is a sterile device intended for single use only. It is not to be resterilized. The tray contains one Denver® Paracentesis Needle, one drainage tubing line, connectors to allow attachment to wall suction or a vacuum bottle, and the primary components needed for performing the paracentesis procedure.
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INTENDED USE
The Denver® Paracentesis Needle, Paracentesis Needle with The Denver Traracentesis Tray are indicated for use in Drainage Binc, and the peritoneal cavity (abdominal removing from cac personed to be used for both diagnostic and therapeutic abdominal paracentesis procedures.
SCIENTIFIC LITERATURE
Published studies indicate that abdominal paracentesis is a safe and effective procedure.
PERFORMANCE TESTING:
Drainage rates for Denver® Paracentesis Needles were compared to Tri-Med Caldwell 15 GA Paracentesis Needle/Cannulas (K932652). The results indicate that the two devices have a similar drainage performance.
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