Search Results
Found 2 results
510(k) Data Aggregation
(376 days)
GI Supply, Inc.
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.
Ask a specific question about this device
(41 days)
Gi Supply, Inc.
EverLift™ Submucosal Lifting Agent is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal lesions prior to excision with a snare or other appropriate endoscopic device.
The GI Supply EverLift™ Submucosal Lifting Agent (10mL) is a prefilled plastic syringe with attached plunger rod containing 10mL of lifting agent. The syringe has a luer lock connection capable of interfacing with a standard, commercially available endoscopic injection needle.
EverLift™ Submucosal Lifting Agent is an injectable liguid composition for use as a submucosal injection agent during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD), and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, including the esophagus, the stomach, the small intestine, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers, and other pathological lesions by EMR, ESD, or polypectomy.
EverLift™ Submucosal Lifting Agent is injected into the submucosal layer by means of a standard, commercially available endoscopic injection needle, which is inserted into the working channel of the endoscope. The composition, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal layer, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD, or polypectomy).
This document focuses on the EverLift™ Submucosal Lifting Agent (10mL) and its substantial equivalence to a predicate device, the EverLift™ Submucosal Lifting Agent (5mL). This is a medical device, not an AI/ML algorithm, therefore most of the requested information regarding AI/ML studies (such as MRMC studies, standalone performance, training set details, or ground truth establishment methods for AI) is not applicable.
The acceptance criteria and device performance are established through a series of non-clinical performance tests designed to show that the 10mL device is as safe and effective as the previously cleared 5mL predicate device.
Here's the relevant information extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several non-clinical performance tests. For each test, the conclusion is that the subject device (10mL) performed equivalently or met the acceptance criteria used for the predicate device (5mL). The specific numerical acceptance criteria for each test are not explicitly detailed in quantifiable values, but rather referred to as "the same method and acceptance criteria as the predicate device" or conforming to specific ISO/USP standards.
| Test Description | Conforming Standard(s) / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Syringe Tip Cap Removal Force Testing | Same method and acceptance criteria as the predicate device (not explicitly quantified) | Confirmed that the syringe tip cap removal force is equivalent between the subject and predicate devices. |
| Product Color Testing | Same method and acceptance criteria as the predicate device (not explicitly quantified) | Confirmed that product color is identical between the two devices. |
| Injection Flow Rate Testing | Same method and acceptance criteria as the predicate device (not explicitly quantified) | Confirmed that the injection flow rate is equivalent between the subject and predicate devices. |
| Graduation Marking Tolerance | ISO 7886-1:2017, Sterile hypodermic needles for single use – Part 1: Syringes for manual use (specific criteria from standard not detailed) | Confirmed that the marking tolerance meets the acceptance criteria defined in ISO 7886-1. |
| Container Closure Integrity Testing | Same method and acceptance criteria as the predicate device (not explicitly quantified) | Confirmed that the container closure integrity is identical between the subject and predicate devices. |
| Tray Lid Peel Force Testing | Acceptance criteria were met post-distribution simulation (not explicitly quantified) | Confirmed that the differences in secondary packaging do not raise different questions of safety or effectiveness. |
| Sterility Assurance Level (SAL) | ISO 17665-1, Sterilization of healthcare products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | Validation results confirmed that the Sterility Assurance Level (SAL) is identical for both devices (10-6). |
| LAL Testing | USP , Bacterial Endotoxins; USP , Transfusion and Infusion Assemblies and Similar Medical Devices (specific criteria from standards not detailed) | Confirmed that the LAL level is identical between the subject and predicate devices. LAL testing will also be performed on each lot prior to final product release. |
| Distribution and Post-Distribution Testing | D7386-16, ASTM Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems (acceptance criteria from standard not detailed) | Confirmed that package integrity is identical between the subject and predicate devices. |
| Accelerated and Post-Accelerated Aging Studies | F1980-16, ASTM Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices (acceptance criteria from standard not detailed) | Results of the testing were identical between the subject and predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each individual non-clinical performance test. It refers to "the subject device" and "the predicate device" implying that samples of each were tested.
The data provenance is from non-clinical performance testing conducted by the manufacturer, GI Supply. This is typically laboratory or bench testing. There is no mention of human subject data, retrospective, or prospective studies in a clinical setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable as this is a medical device performance study, not a study evaluating an AI/ML algorithm requiring expert ground truth for interpretation of images or other data. The "ground truth" for these tests is defined by the technical specifications of the device and relevant international standards (e.g., ISO, USP, ASTM).
4. Adjudication Method for the Test Set
Not applicable. This is not an AI/ML study requiring adjudication of expert interpretations. The evaluation is based on objective measurements against predefined technical specifications and standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is not mentioned as this is not an AI/ML device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No. This device is a submucosal lifting agent, a physical medical product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" (or basis for acceptance) for these non-clinical performance tests consists of:
- Technical specifications of the device (implying equivalence to the predicate device).
- International standards such as ISO 7886-1:2017, ISO 17665-1, USP , USP , ASTM D7386-16, and ASTM F1980-16.
- The performance of the legally marketed predicate device (K191923) as a benchmark for equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or medical "ground truth" established in this context.
Ask a specific question about this device
Page 1 of 1