(376 days)
The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP Tube Set and the RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity for paracentesis, and remove pleural effusion from the thoracic cavity for thoracentesis.
The Renova RP Centesis Pump is intended to be used by trained healthcare professionals knowledgeable about paracentesis and thoracentesis.
The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP® Tube Set and RenovaRP® Fluid Drainage Bags (provided separately from the pump) to remove fluid from the abdominal cavity for paracentesis, and pleural effusion from the thoracic cavity for thoracentesis.
This document is a 510(k) premarket notification for the RenovaRP® Centesis Pump System. It aims to demonstrate substantial equivalence to a predicate device, the RenovaRP® Paracentesis Pump (K970186), for an expanded indication of use to include thoracentesis in addition to paracentesis.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not contain specific acceptance criteria for a new device's performance in terms of clinical outcomes (e.g., success rate of fluid removal, complication rates). Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device for the expanded indication.
The table below summarizes the technical specifications and aspects of the device that are compared to the predicate, demonstrating their "performance" in terms of equivalence.
| Acceptance Criteria/Characteristic | Reported Device Performance (RenovaRP® Centesis Pump System) | Notes |
|---|---|---|
| Intended Use | Remove ascitic fluid from abdominal cavity (paracentesis) AND remove pleural effusion from thoracic cavity (thoracentesis). | The key change here is the addition of thoracentesis. The manufacturer states that "No performance data was needed to evaluate the expansion of the indications for use to include thoracentesis" because the fundamental design and operational characteristics remain the same. |
| Manufacturer | GI Supply, Inc. | Same as predicate. |
| Device Regulatory Classification | Class II, 21 CFR 878.4780, Product Code BTA | Same as predicate. |
| Device Common Name | Suction Pump, Peristaltic Pump | Same as predicate. |
| Prescription or OTC Use | Prescription Use | Same as predicate. |
| Use Environment | Hospital / Clinic | Same as predicate. |
| Sterility (Pump) | Non-sterile | Same as predicate. |
| Sterility (Disposable Components) | Sterile | Same as predicate. |
| Disposability | Pump is reusable, disposable components are single patient use. | Same as predicate. |
| Pump Physical Specifications | 13x9x13 in (33x23x33 cm), 8.5 lbs (3.9kg) | Same as predicate. |
| Pump Power | AC only model | Same as predicate. |
| Pump Input Voltage | 100-230V | Same as predicate. |
| Pump Input Current | 2.5A | Same as predicate. |
| Pump Input Frequency | 50/60Hz | Same as predicate. |
| Flow Rate | 700 mL/min | Same as predicate. |
| Pump Electrical Requirements | Class I, Type B | Same as predicate. |
| Shelf Life (Pump) | 7-10 years | Same as predicate. |
| Shelf Life (Tube Sets) | 24 months | Same as predicate. |
| Shelf Life (Drainage Bags) | 25 months | Same as predicate. |
| Standards Compliance | IEC 60601-1, 60601-1-2, EN IEC 62366-1:2015, ISO 14971:2019, ISO 17664 | Device successfully evaluated for compliance. |
| Performance Data for Indication Expansion | Not explicitly required or presented for the expanded indication. | The submission explicitly states: "No performance data was needed to evaluate the expansion of the indications for use to include thoracentesis." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that no performance data was needed to evaluate the expansion of indications for use to include thoracentesis. The justification for this is that the subject device's fundamental design, operational, and technological characteristics remain identical to the predicate device.
Therefore, there is no "test set" in the sense of a clinical or simulated diagnostic performance dataset with a specified sample size. This submission is based on the substantial equivalence of the physical device and its existing (previously cleared) performance for a very similar procedure (paracentesis vs. thoracentesis).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical or diagnostic performance test set was used, there were no experts relied upon to establish ground truth for such a dataset. The clearance is based on the technical equivalence and existing safety and effectiveness profile of the predicate device for a related procedure.
4. Adjudication Method for the Test Set
As no test set requiring clinical interpretation or outcome assessment was used, there was no adjudication method applied.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done. The submission seeks clearance based on substantial equivalence of a physical medical device, not an AI or diagnostic algorithm that would typically be evaluated in an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone performance study of an algorithm was done. The device in question is a physical pump, not a diagnostic algorithm.
7. The Type of Ground Truth Used
Given that no new clinical performance data was explicitly required for the expanded indication, there was no new ground truth established in this submission related to clinical outcomes. The "ground truth" for the device's safety and effectiveness for fluid removal relies on the prior clearance of the predicate device (K970186) and general engineering and safety standards.
8. The Sample Size for the Training Set
This submission is for a physical medical device (a pump), not an AI algorithm requiring a training set. Therefore, there is no training set sample size.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI algorithm, this question is not applicable.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.