(132 days)
The Prospera 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 Prospera Negative Pressure Wound Therapy may be used during surgery or at the patient's bedside and is indicated for home use.
The Prospera PRO Series of Powered Suction Pump is a portable, AC-powered device to be used to remove fluids, including wound exudate, irrigation fluids, and infectious materials from a wound. The pump is operated through computer software, having help and alarm functions. The software settings permit continuous or intermittent negative pressure to be applied for proscribed time periods. The device is indicated 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 a patient's bedside. Some models are portable. The Prospera series of pumps are sutiable for use in either a hospital or home, with proper training and supervision.
The Prospera Negative Pressure Wound Therapy Powered Suction Pump is available in three models. The PRO-I was previously cleared in K062456 and is again included here because a relief valve was added. The PRO-II is a smaller, more portable unit having an integrated disposable canister. Both the PRO-II and PRO-III have a lithium ion battery while the PRO-I has a Nickel-metal Hydride (NiMh) battery. All three models are rechargeable and include a port for an external power supply and/or a battery charger. The pump can also be externally powered from a 12V automotive battery source.
All models provide suction at the rate of 9 liters per minute; have a maximum vacuum of -200 mmHg (negative pressure); weigh between 1.8 and 2.8 kg; and operate in continuous or intermittent modes. Maximum dimensions of the unit are 290mmX359mmX130mm (PRO-1).
Consumable accessory components include collection canisters (rigid or collapsible), hoses, connectors and drains (tubing), and foam or gauze dressings.
The device provides negative pressure wound therapy at a range of pressure settings and removes exudates from the wound site through tubing and microbial filters to a disposable canister. The pumps are compatible with a variety of wound dressing kits, using either gauze or foam dressings.
Here's a breakdown of the acceptance criteria and study information for the Prospera PRO-I, PRO-II, and PRO-III Negative Pressure Wound Therapy System, based on the provided 510(k) summary:
This device is a Negative Pressure Wound Therapy (NPWT) system, which typically involves demonstrating functional equivalence and safety rather than diagnostic or predictive performance metrics (like sensitivity/specificity) common in AI/ML medical devices. The "acceptance criteria" here refer to meeting established safety, performance, and regulatory standards for a powered suction pump and NPWT system, primarily through comparison to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criteria | Acceptance Criteria (typically met by predicate) | Reported Device Performance (Prospera PRO-I, PRO-II, PRO-III) |
|---|---|---|
| Indications for Use | Promote wound healing by removal of wound exudate, debris, infectious material; aspiration/removal of surgical fluids, tissue, gases, bodily fluids, infectious material from airway/respiratory system. Usage during surgery, bedside, home. Management of chronic, acute, traumatic, subacute, dehisced wounds, partial-thickness burns, ulcers, flaps, grafts. | Same as predicate. The indications for use are explicitly stated as "unchanged" from the predicate. The device is indicated for promoting 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. It can be used during surgery, at the patient's bedside, and for home use. |
| Materials | Materials used in the predicate device. | Same as predicate. Explicitly stated as "unchanged." |
| Technology | Technology used in the predicate device (computer software controlled, battery/AC powered negative pressure pumps, continuous/intermittent modes, exudate removal to collection canister). | Same as predicate. Explicitly stated as "unchanged." The Prospera PRO series utilizes computer software, battery and AC power, and offers continuous or intermittent modes for removing exudates to a collection canister. |
| Product Specifications (Design Control) | Verified and validated as per design controls (e.g., flow rate, maximum vacuum, weight, dimensions, operating modes, battery type, power sources). | Design control verification and validation conducted. The PRO-I has a relief valve added. The PRO-II and PRO-III are smaller/more portable with integrated disposable canisters. All models: 9 liters/minute suction rate, -200 mmHg max vacuum, 1.8-2.8 kg weight, max dimensions 290mmX359mmX130mm (PRO-I). Continuous or intermittent modes. PRO-II/III use Lithium-ion, PRO-I uses NiMh battery. All rechargeable, with external power/charger port, and 12V automotive battery compatibility. |
| Energy Requirements | Energy requirements of the predicate device. | Same as predicate. Explicitly stated as "unchanged." |
| Dressing System Compatibility | Compatible with foam or gauze-based dressings with adhesive film drape to create a sealed wound environment. | Same as predicate. The device is compatible with a variety of wound dressing kits, using either gauze or foam dressings. |
| Pressure Sensing | Sensors in the unit for pressure monitoring. | Same as predicate. Sensors are in the unit. |
| Electrical Safety | Meets IEC 60601-1-2 including U.S. National Differences. | Testing for electrical safety was conducted to ensure it meets the requirements for IEC 60601-1-2 including the National Differences for the U.S. |
| Quality Systems | Manufactured in accordance with relevant international standards. | Manufactured in accordance with EEC Directive 93/42/EEC Annex IX. The pump's manufacture and quality systems management are in accordance with certified international standards, including ISO 13485. |
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets its acceptance criteria is a substantial equivalence determination based on non-clinical (bench) testing and comparison to a legally marketed predicate device (Medica Rents Powered Suction Pump PRO-I, K062456).
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the traditional sense of a clinical or imaging dataset. The "test set" here refers to the physical devices (PRO-I with relief valve, PRO-II, PRO-III) undergoing bench testing. The document does not specify the number of units tested.
- Data Provenance: The testing was conducted by Simex Medizintechnik, GmbH (contract manufacturer in Germany) in accordance with European and international standards (EEC Directive 93/42/EEC Annex IX, ISO 13485) and electrical safety standards (IEC 60601-1-2, including U.S. National Differences). This is a prospective bench testing of manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The ground truth for this type of device is established by engineering specifications, regulatory standards (e.g., electrical safety, quality management), and direct physical performance measurements (e.g., suction rate, vacuum level) during bench testing, not by expert interpretation of patient data.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication typically refers to resolving discrepancies in expert interpretations (e.g., radiologists reviewing images). For bench testing, results are typically objective measurements compared against pre-defined engineering and regulatory thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human readers interpret medical data (e.g., images), and an AI might assist that interpretation. The Prospera system is a therapeutic/suction device, not a diagnostic one.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. While the pump is "operated through computer software," this is for controlling the pump's physical functions (continuous/intermittent modes, pressure settings, alarms), not for performing diagnostic or analytical tasks that an AI algorithm would do in "standalone" mode. The device's performance is its physical suction capabilities and safety features.
7. The Type of Ground Truth Used
- The ground truth is based on engineering specifications, direct physical measurements (bench testing results), and compliance with international and national regulatory/safety standards. For example, the "ground truth" for electrical safety is whether the device actually passes the IEC 60601-1-2 tests. The "ground truth" for suction rate is the measured flow rate, compared to the specified 9 liters per minute.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML device in the sense that it is trained on a dataset. Its software controls the pump's mechanical functions, but it does not "learn" from data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
§ 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.