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.

Device Description

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.

AI/ML Overview

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.

Summary

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K112458

JAN - 5 2012

10F7

510(k) Summary of Safety and Effectiveness

Date prepared:	October 21, 2011
510(k) Owner:	Medica-Rents Co LTD2831 Bledsoe Street, Fort Worth TX 76107Telephone: 817-336-5536, Fax: 817-332-9140Owner/Operator #: 1640798
510(k) Contact:	Dina L. Weissman, J.D.P.O. Box 205, Derby CT 06418Telephone: 203-954-9109, Email: dina.weissman@comcast.net
Contract Manufacturer:	Simex Medizintechnik, GmbHBruckstr. 30/1Deisslingen-Lauffen, Baden-Wurtetmberg, 78652 Germany
Trade Name:	Prospera PRO-I, PRO-II and PRO-III Negative Pressure WoundTherapy System
Common Name:	Negative Pressure Wound Therapy Powered Suction Pump
Classification:	Powered Suction Pump, 21 CFR 878.4780Class II, General & Plastic Surgery
Device Product Code:	OMP - Pump, Portable, Aspiration, (Manual or Powered)
Substantial Equivalency:	Medica Rents Powered Suction Pump PRO-I K062456(cleared as the NovaSpine Powered Suction Pump PRO-I)

Indications for Use:

Device Description:

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.

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V112458

20fr

Consumable accessory components include collection canisters (rigid or collapsible), hoses, connectors and drains (tubing), and foam or gauze dressings.

Feature	Predicate:	This submission:
	K062456, PRO-I NPWT pump	PRO-II, PRO-III
Dressing system	Foam or gauze based dressing with an adhesive film drape tocreate a sealed wound environment	Same as predicate
Pressure sensing	Sensors in unit	Same as predicate
Therapy unit	Computer software controlled, battery and AC powered negativepressure pumps using continuous or intermittent modes toremove exudates from the wound to a collection canister	Same as predicate

Summary of Technological Characteristics

Non-Clinical Test (Bench):

The Prospera PRO series of pumps is manufactured in accordance with EEC Directive 93/42/EEC Annex IX. 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. The pump's manufacture and quality systems management are in accordance with certified international standards, including ISO 13485. Testing was also conducted to verify the changes in the design specifications and demonstrated substantial equivalence to the predicate device, the PRO-I.

Basis For Substantial Equivalence:

In order to demonstrate substantial equivalence, Medica-Rents evaluated the indications for use (unchanged), materials (unchanged), technology (unchanged), product specifications (design control verification and validation conducted), and energy requirements of the device (unchanged). Peformance testing and electrical safety has been successfully completed and documented to demonstrate that the modified PRO-I, along with the PRO-II, are substantially equivalent to the previously cleared PRO-1.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Medica-Rents Co., Ltd % Dina L. Weissman, J.D. Legal and Regulatory Affairs Consultant P.O. Box 205 Derby. Connecticut 06418

JAN - 5 2012

Re: K112458

Trade/Device Name: Prospera PRO-I, PRO-II and PRO-III Negative Pressure Wound Therapy Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: December 12, 2011 Received: December 13, 2011

Dear Ms. Weissman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Dina L. Weissman, J.D.

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely yours,

J. N. Mull

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K112458

Device Name:

Prospera PRO-1, PRO-11 and PRO-111 Negative Pressure Wound Therapy System

Indication for Use:

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Knaufu MXM
Division Sign Off

gical. Orthoned

510(k) Number K112458

Regulation Number and Section

§ 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.