(296 days)
The SIMEX Negative Pressure Wound Therapy System is indicated for patients that would benefit from a suction device particularly as the device may promote wound healing by removal of wound exudate, debris, and infectious material or for the aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from the patient's airway or respiratory support system. The SIM EX200 and SIM EX300 Negative Pressure Wound Therapy may be used during surgery or at the patient's bedside.
The SIMEX Negative Pressure Wound Therapy Powered Suction Pumps Series: SIM EX200 and SIM EX300 are lightweight, self contained, portable battery powered (or line powered), suction pumps for medical procedures where secretions and other body fluids and infectious materials must be removed through the application of continuous or intermittent negative pressure. The pumps are operated through computer software, having help and alarm features. The device is indicted for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The pumps may be used at patient's bedside. SIM EX200 and SIM EX300 are suitable for use in either hospitals or long term care facilities and nursing homes.
The SIMEX Negative Pressure Wound Therapy Powered Suction Pumps series is provided in two models, the SIM EX200 and the SIM EX300. Both pumps are powered with rechargeable lithium batteries and include ports for an external power supply and/or battery charger. The pumps can also be externally powered from a 12V automotive battery source. The SIMEX pumps vary in weight from 2.9lbs and in size from 90mm x 165mm x 220mm x 359mm x 250mm. The SIMEX pumps can be programmed to operate in either continuous or intermittent settings.
The disposable and replacement parts of the SIMEX Negative Pressure Wound Therapy series of pumps include collection canisters, canister liners, pump filters, hoses, connectors and drains (tubing), gauze dressings, and transparent film and drape dressings.
The provided text describes a 510(k) submission for the SIMEX Negative Pressure Wound Therapy (NPWT) Powered Suction Pumps Series (SIM EX200 and SIM EX300). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way a de novo or PMA submission might.
Therefore, the information you've requested about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not explicitly present or applicable in the context of this 510(k) summary.
Here's an analysis based on the information provided and the nature of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: No specific numerical acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy, or wound healing rates) are defined or measured in this document. The "acceptance criteria" for a 510(k) revolve around demonstrating safety and effectiveness by showing substantial equivalence to a legally marketed predicate device. This typically involves performance benchmarking in non-clinical (bench) tests and comparison of technological characteristics.
- Reported Device Performance: The reported "performance" is primarily in terms of compliance with electrical safety and electromagnetic compatibility standards, and direct comparison of technological characteristics with predicate devices.
| Feature | Acceptance Criteria (Implied for 510(k)) | Reported Device Performance (SIM EX200 and SIM EX300) |
|---|---|---|
| Electrical Safety | Meet requirements of IEC 60601-1-2 (including US National Differences) | Meets requirements for IEC 60601-1-2 (including National Differences for the US). Test conducted to ensure compliance. |
| EMC | Meet electromagnetic interference requirements of IEC 60601-1-2 | Meets the electromagnetic interference requirements of the above-mentioned standards (IEC 60601-1-2). Test conducted to demonstrate compliance. |
| Manufacturing/QA | Adherence to Quality System Regulations and ISO 13485 | Manufacture and quality systems management are in accordance with Quality System Regulations and certified international standards, including ISO 13485. |
| Dressing System | Substantially equivalent to predicate (K112458) | Same as predicate: Gauze based dressing kit with adhesive film drape to create a sealed wound environment. |
| Pressure Sensing | Substantially equivalent to predicate (K112458) | Same as predicate: Sensors in the unit. |
| Therapy Unit Design | Substantially equivalent to predicate (K112458) | Same as predicate: Computer software controlled, battery and AC powered negative pressure wound therapy pumps using both continuous and intermittent operations to remove exudates from the wound to the collection canister. (Also noted: lightweight, self-contained, portable, rechargeable lithium batteries, external power/charger ports, 12V automotive battery source compatibility, continuous or intermittent operation, various sizes/weights). |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of this 510(k) summary for clinical performance. The "test set" for this submission primarily consists of the device itself undergoing bench testing for safety and electrical compatibility, and a comparison of its features to predicate devices. There is no mention of human subject test sets or clinical trial data.
- Data Provenance: The data provided pertains to bench testing (electrical safety, EMC) and design comparison with predicate devices. No human data (retrospective or prospective) is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. There is no mention of a "ground truth" in the clinical sense (e.g., disease presence, wound healing outcome) established by experts for human test data. The "ground truth" for the non-clinical tests would be the specifications of the standards (e.g., IEC 60601-1-2) which are verified by qualified test engineers/labs.
4. Adjudication Method for the Test Set:
- Not applicable. As there is no clinical test set requiring expert interpretation or consensus, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a powered suction pump, not an AI-assisted diagnostic or interpretative tool. No MRMC studies were conducted or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is hardware with software control, not an algorithm in the sense of a diagnostic or predictive model. Its "performance" is its ability to generate negative pressure, collect exudate, and comply with safety standards, not a standalone algorithmic output that would be evaluated for accuracy.
7. The Type of Ground Truth Used:
- For the non-clinical tests (electrical safety, EMC): The "ground truth" is adherence to the specifications of the referenced international standards (e.g., IEC 60601-1-2).
- For the substantial equivalence claim: The "ground truth" is the established characteristics and performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the traditional sense for an algorithm. Device design and engineering would be based on general principles and standards, not a specific data training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable for the same reasons as point 8.
§ 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.