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510(k) Data Aggregation
(251 days)
Hemodia SAS
The DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets represents an arthroscopy system using fluid from saline bags (0.9% NaCl). This arthroscopy system is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities, and fluid suction during arthroscopy procedures.
The DOUBLEFLO INFLOW/OUTFLOW PUMP is a micro-processor controlled 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 connects via cable to various interfaces. The pump can be connected to various accessories / shaver systems. The pump has to be used with the following tube sets: DOUBLEFLO DAY TUBE SET, DOUBLEFLO PATIENT TUBE SET, DOUBLEFLO INFLOW TUBE SET, DOUBLEFLO OUTFLOW TUBE SET.
This document is a 510(k) Premarket Notification for a medical device called the "DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets." It concerns a pump used in arthroscopic procedures.
It is crucial to understand that this document does NOT describe the acceptance criteria and study proving a device meets those criteria for an AI/ML-driven medical device.
Instead, this is a traditional 510(k) summary for a physical medical device (a pump). The "software" mentioned refers to the embedded software controlling the pump's mechanical functions, not an AI/ML algorithm that interprets medical data (like images) or assists in diagnosis/treatment decisions.
Therefore, the requested information about acceptance criteria for an AI/ML device, sample sizes for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML is not applicable to this document.
The document discusses performance in terms of safety and effectiveness of the traditional medical device (the pump and its accessories/tubing sets), primarily through:
- Software verification and validation: Ensuring the pump's control software functions correctly and safely.
- Acceptance Criteria (Implied for Software): Software performs as intended, no anomalies, compliant with relevant standards (IEC 62304, FDA guidance for software in medical devices).
- Reported Performance (Software): Unit, integration, system, and validation tests performed; successfully covers RFID-related requirements; software considered "moderate" level of concern.
- Electrical safety and electromagnetic compatibility (EMC): Ensuring the device operates safely in its electromagnetic environment.
- Acceptance Criteria: Compliance with IEC 60601-1 and IEC 60601-1-2 standards.
- Reported Performance: Complies with recognized standards, demonstrated substantial equivalence.
- Biocompatibility testing: Ensuring the tubing sets are safe for contact with the body.
- Acceptance Criteria: Compliance with ISO 10993 series standards and FDA guidance.
- Reported Performance: Tests performed (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Pyrogenicity), met requirements, demonstrated substantial equivalence.
- Sterilization validation: Ensuring the tubing sets can be effectively sterilized.
- Acceptance Criteria: Compliance with ISO 11135, ISO 14937, ISO 10993-7. Residual EO/ECH limits met. SAL of 10^-6. Package integrity confirmed.
- Reported Performance: Validation performed, met requirements, demonstrated substantial equivalence.
- Bench Performance Testing: Functional and usability tests of the pump and tubing sets (e.g., leak, tensile strength, accelerated aging).
- Acceptance Criteria (Implied): Device performs as intended for fluid distension, irrigation, and suction; tubing sets maintain integrity over shelf life.
- Reported Performance: Tests performed, demonstrated substantial equivalence.
In summary, this document is not about an AI/ML device, and thus cannot provide the specific details requested for such a system. The performance data provided relates to the physical and software functionalities of a medical pump, not an AI's analytical or diagnostic capabilities.
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(129 days)
Hemodia SAS
The DOUBLEFLO system represents an arthroscopy system using fluid from saline bags (0.9% NaCl). This arthroscopy system is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities, and fluid suction during arthroscopy procedures.
The DOUBLEFLO system (pump) contains as a main component a microprocessor-controlled 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 connects via cable to various interfaces. The pump can be connected to various shaver systems. The pump has to be used with the following tube sets: DAY TUBE Set, Patient Tube Set, Inflow Tube Set, Outflow Tube Set.
The provided text is a 510(k) summary for the DOUBLEFLO system, an arthroscopy system. It describes the device, its intended use, a comparison with a predicate device, and performance data used to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study information based only on the provided text. Many of the requested fields are not applicable or not explicitly stated in this type of FDA submission.
Acceptance Criteria and Device Performance
The provided document describes various performance tests rather than specific acceptance criteria with numerical targets. The "Results" column largely states that the device "demonstrated to be substantially equivalent to the predicate device." Therefore, numerical acceptance criteria are inferred from the predicate device's performance or general safety/effectiveness standards.
| Test Category | Acceptance Criteria (Implied/Standard) | Reported Device Performance |
|---|---|---|
| Software | Conformity with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304 standard (Medical Device Software - Life Cycle Process) for a "moderate" level of concern. Software should perform as intended, without directly or indirectly causing minor injury. | Software was developed, tested, and verified according to specified FDA guidance and IEC 62304. Unit, integration, system, and verification tests were performed. Overall software validation report confirmed conformity with user needs and intended use. Demonstrated intended performance without raising new safety/effectiveness questions. |
| Electrical Safety and Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility. | The device complies with IEC 60601-1 and IEC 60601-1-2. Evaluation and testing demonstrated substantial equivalence to the predicate device. |
| Biocompatibility | Compliance with FDA Guidance Document: Use of International Standard ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11 for externally communicating devices in indirect contact with tissue/bone for a limited time ( |
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(359 days)
Hemodia SAS
The ZEOS AQUA VISION Pump is an arthroscopy pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during arthroscopy procedures.
The ZEOS AQUA VISION pump is a micro-processor controlled 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 connects via cable to various interfaces. The pump can be connected to various shaver systems.
The provided text describes the 510(k) premarket notification for the ZEOS AQUA VISION PUMP and tube, which is an arthroscopy pump system. The document focuses on demonstrating substantial equivalence to a predicate device (FMS VUE Fluid Management & Tissue Debridement System) through various non-clinical performance tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the format of a typical performance study. Instead, it states compliance with recognized standards and guidelines as the acceptance criteria for each test category. The reported device performance is that the device meets these standards and demonstrated substantial equivalence to the predicate device.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electrical safety and electromagnetic compatibility (EMC) | Compliance with IEC 60601-1 and IEC 60601-1-2 standards | Evaluation and testing demonstrated substantial equivalence to the predicate device. |
| Biocompatibility testing | Compliance with FDA Guidance "Use of International Standard ISO 10993, Biological evaluation of medical Devices Part 1" and ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11. | Cytotoxicity, Sensitization, Irritation, and Acute systemic toxicity tests were performed and demonstrated substantial equivalence to the predicate device. |
| Software Verification and Validation Testing | Compliance with FDA guidance "General Principles of Software Validation" and IEC 62304 | Evaluation and testing demonstrated substantially equivalent performance to the identified predicate device. |
| Sterilization Validation | Compliance with ISO 11135, ISO 11135-1, ISO 14937, and ISO 10993-7 for sterilization and residuals. | Validation demonstrated substantial equivalence to the identified predicate devices. Residual ethylene oxide (EO) |
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