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510(k) Data Aggregation
(203 days)
The ARTHRO-Pump PA304 is an arthroscopic pump intended to provide fluid distension of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid aspiration during diagnostic and operative arthroscopic procedures.
The ARTHRO-Pump PA304 is a microprocessor controlled single roller pump that functions according to the peristaltic principle. It transports sterile irrigation fluid to distend cavities and provides fluid aspiration for arthroscopic procedures. The pump consists of the following main components: a power supply, a power switch, a touch display, a connection for the suction function, a roller wheel, a pump head and a casing. The pump has to be used with the following tube sets:
- . Standard Irrigation Tube Set (also referred to as "ST261")
- . Suction Tube Set (one connection, "I"-shape; also referred to as "ST287")
- Suction Tube Set (two connections, "Y"-shape; also referred to as "ST282") .
- Vacuum Tube Set (also referred to as "ST291"). .
The provided text describes the 510(k) premarket notification for the ARTHRO-Pump PA304. This device is an arthroscopic pump, and the documentation focuses on demonstrating its substantial equivalence to a predicate device (Arthroscopy Pump A107) rather than providing detailed acceptance criteria and a study specifically designed to prove all aspects of its performance against those criteria in a typical clinical study format.
However, based on the provided information, I can infer the acceptance criteria and summarize the studies performed to demonstrate the device's safety and effectiveness for its intended use, focusing on the available performance data.
Here's an interpretation and structured presentation of the information:
Acceptance Criteria and Device Performance for ARTHRO-Pump PA304
The ARTHRO-Pump PA304 is an arthroscopic pump. The primary goal of the 510(k) submission is to demonstrate its substantial equivalence to a predicate device (Arthroscopy Pump A107) by showing that its performance does not raise new questions of safety and effectiveness. Therefore, the "acceptance criteria" are implicitly tied to meeting established safety and performance standards for arthroscopic pumps and showing comparable or superior performance to the predicate device where applicable.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion (Inferred from testing) | Reported Device Performance |
|---|---|
| Software Performance: | |
| - Adherence to medical device software standards. | - Software developed, tested, and verified in accordance with FDA guidance for software in medical devices and IEC62304:2006. |
| - Device performs as intended. | - Design verification testing demonstrates the device performs as intended, and performance does not raise new questions of safety and effectiveness. |
| Electrical Safety & EMC: | |
| - Compliance with electrical safety and electromagnetic compatibility standards. | - Tested in accordance with AAMI ANSI ES60601-1: 2005/(R)2012 and IEC 60601-1-2:2014. (Implies compliance was achieved). |
| Biocompatibility (Tube Sets): | |
| - Biocompatible materials for patient contact components (tube sets). | - Tested on tube sets in accordance with ISO 10993-1, -5, -10, and -11. (Implies satisfactory biocompatibility). |
| Sterilization (Tube Sets): | |
| - Effective sterilization of tube sets. | - Sterilization validation performed according to ISO 11135-1:2015, ISO 14937:2009. |
| - Residual ethylene oxide and ethyle chlorohydrin within limits. | - Residual EO |
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