(62 days)
The Denver® Paracentesis Needle, Paracentesis Needle with Drainage Binc, and the Denver Traracentesis Tray are indicated for use in removing from cac personed to be used for both diagnostic and therapeutic abdominal paracentesis procedures.
The Denver® Paracentesis Needle is a sterile device, for single use only. It is not to be resterilized. Components in the fluid path are non pyrogenic. This device consists of an inner two-part trocar, an outer drainage 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.
The provided text describes a medical device, the Denver Paracentesis Needle, and its equivalency to other similar devices. It does not contain information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
The document is a "Summary of Safety and Effectiveness" which is a type of submission to regulatory bodies (like the FDA, indicated by "K960456" which is likely a 510(k) premarket notification number) for medical devices. The purpose of this type of document is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics.
Therefore, the requested information cannot be extracted from the provided text for the following reasons:
- Acceptance criteria and reported device performance (quantitative): The document does not define specific performance metrics (e.g., accuracy, sensitivity, specificity, precision) or acceptance thresholds for the Denver Paracentesis Needle. The "Performance Testing" section only mentions a comparison of "drainage rates" to a predicate device and concludes they have "similar drainage performance." This is a qualitative statement, not a reporting of specific performance values against pre-defined criteria.
- Sample size and data provenance: No information on sample sizes for test sets or data provenance is provided.
- Number and qualifications of experts: Not applicable as there is no mention of expert-established ground truth for a diagnostic or AI-driven device.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable as this is not an AI-assisted diagnostic or imaging device.
- Standalone performance: Not applicable in the context of AI performance. The device's standalone performance is its mechanical function.
- Type of ground truth: Not applicable in the context of AI/diagnostic device ground truth. The "ground truth" for this device would be its functional ability (e.g., draining fluid effectively), which is implicitly assessed by showing substantial equivalence to existing devices.
- Sample size for training set: Not applicable as this is not an AI/machine learning device.
- How ground truth for training set was established: Not applicable.
In summary, the provided document focuses on demonstrating substantial equivalence based on intended use and technological characteristics, along with a functional comparison (drainage rates), rather than an in-depth study of specific performance metrics with defined acceptance criteria typically seen for diagnostic devices or AI algorithms.
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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.
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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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§ 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.