(24 days)
The Quick-Tap® Paracentesis Kit, Tray and Needle are indicated to relieve pressure by draining fluid from the peritoneal space. The fluid may be undergo diagnostic testing to assess for chemistries, infection or abnormal cells.
Abdominal paracentesis is a procedure used to remove bodily fluid from the peritoneal cavity. Fluid can be the result of liver disease, congestive heart failure or other disease that result in "ascites" fluid. Fluid may also be in the form of blood from perforated organs due to trauma. The fluid is susceptible to infection.
Abdominal paracentesis provides therapeutic relief to patients who experience bloating and difficult breathing. The procedure serves a diagnostic purpose, as well. Typically, fluid specimens are sent to a laboratory for microbiological, chemical and histological analysis.
Abdominal paracentesis can be performed at bedside or in a treatment center. The patient is prepped using sterile technique and local anesthetic. The sitting position is preferred so that gravity can assist. If preferred, a skin nick is performed with a scalpel and a large bore outer cannula is introduced into the peritoneal cavity midline between the umbilicus and pubis. A syringe can be used to collect the first sample of fluid from the patient confirming a suitable puncture site. The inner needle is withdrawn and disposed of leaving the outer cannula in place. Specimen tubes stand ready for specimen collection. The large majority of fluid is drained into bags or large containers and disposed of. There are no guidelines or standard of care that define the amount or rate of ascites fluid evacuation other than to monitor for signs of hypovolemic shock. One to two liters can be evacuated at one session. After paracentesis the cannula is removed and an adhesive bandage is placed over the puncture site. The patient is then monitored briefly for signs of distress such as persistent bleeding from the puncture site, faintness, anxiety, abnormal pulse, temperature etc.
Complications are rare but can include hemorrhage, perforation of abdominal organs, wound infection and hypovolemic shock.
There are a variety of disposable instruments used for paracentesis. These include generic angio-introducer catheters and specific needle/cannula combinations for paracentesis. Figure A-I illustrates the Ballard, Caldwell® Paracentesis Needle/Cannula.
Our proposed paracentesis needles (and thus trays and kits) are substantially equivalent in design, composition, technology and function to our present paracentesis trays (see predicate devices).
The provided text describes the 510(k) Premarket Notification Summary for the Quick-Tap® Paracentesis Kit, Tray and Needle. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria in the way a clinical trial for a novel drug or a new AI diagnostic would.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for a new device's performance. Instead, it asserts substantial equivalence to predicate devices based on design, composition, technology, function, and a limited set of non-clinical tests.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Quick-Tap®) |
|---|---|---|
| Functional Equivalence | Able to drain fluid from the abdominal cavity for therapeutic relief and diagnostic purposes. | Intended to drain fluid from the abdominal cavity (Paracentesis procedure). |
| Technological Characteristics | Similar needle length, diameter, and presence/absence of gradient markings to predicate devices. | Needle Length: 2.25", 3.25", 4.75" (Predicate K950574: 3.25"; Predicate K961863: 3.25") |
| Gradient Markings: Etched gradient markings (Predicate K950574: NA; Predicate K961863: NA) | ||
| Needle Diameter: 15 gauge, 18 gauge (Predicate K950574: 17 gauge; Predicate K961863: 15 gauge, 17 gauge) | ||
| Performance Testing | Safe and effective for intended use, as demonstrated by non-clinical tests (tensile, flow rate, visual). | Passed non-clinical tests: Tensile test, Flow rate, Visual. "Safe and effective for the intended use." |
Note: The acceptance criteria are largely implied by the substantial equivalence framework, meaning the device should perform similarly to its predicates regarding safety and efficacy for the stated intended use. Specific quantitative thresholds for tensile strength, flow rate, or visual inspection are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical data through direct performance testing of the device components (needles), rather than a "test set" of patient data.
- Sample Size: Not specified for the Tensile test, Flow rate, or Visual inspection. It's common for such tests to use a statistically representative sample size, but the exact number isn't mentioned in this summary.
- Data Provenance: Non-clinical (laboratory testing of the device itself), not human or animal data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is a medical device for a procedure, and its safety and efficacy are evaluated through functional and material testing, and comparison to legally marketed predicate devices, not through a diagnostic assessment requiring expert ground truth on a test set.
4. Adjudication Method for the Test Set
N/A. As there's no clinical "test set" requiring expert ground truth or diagnostic assessment, no adjudication method is applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes a 510(k) submission for a medical device (paracentesis kit, tray, and needle), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study regarding human readers with or without AI assistance is not applicable and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
N/A. This is a physical medical device. The concept of an "algorithm only" or "standalone" performance without human interaction does not apply.
7. The Type of Ground Truth Used
The "ground truth" here is the functional integrity and material properties of the device components, relative to established engineering standards and the performance of predicate devices. This is established through:
- Engineering/Material Testing: Tensile strength, flow rate, visual inspection.
- Comparison to Predicate Devices: Demonstrating similar design, composition, technology, and function to previously cleared devices.
8. The Sample Size for the Training Set
N/A. There is no machine learning "training set" involved as this is a physical medical device.
9. How the Ground Truth for the Training Set Was Established
N/A. Same as above, no machine learning training set applies.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.