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.

Device Description

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.

AI/ML Overview

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.

Summary

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. പ്രേം പ Summary 510(k) Summary of Safety and Effectiveness

AUG 3 0 2012

Safe Medical Devices Act of 1990 (SMDA) 510(k) Summary

SIMEX Medizintechnik, GmbH

D-78649. Deisslingen, Germany

Date Prepared:

March 19, 2012

Post Box 1207

Sponsor and Manufacturer:

510(k) Contact:

ATTN: Mr. Hamid Khosrowshahi

FDA Registration Number 3005813597

FloSure Technologies LLC

PO Box 123

Tarrytown, New York, 10591

Telephone: 914-772-7326

Suction Pumps Series:

e-mail : hkhosrow@optonline.net

Trade Name:

Common Name:

Classification:

Suction/ Aspiration Pump FDA 21 CFR 878.4780 Powered Suction Pump Class II

Suction / Aspiration Pump

Device Product Code

Substantial Equivalency

OMP - Pump, Portable, Aspiration, (Manual or Powered) Code: OMP (previously BTA or JCX)

SIMEX Negative Pressure Wound Therapy Powered

SIM EX200 and SIM EX300

MedicaRent Company	K112458	Prospera PRO-I,PRO-II and PRO-III
NovaSpine	K062456	PRO-I
Kinetic Concepts	K971548	AmbuVAC
Medela	K080357	Invia Liberty
Blue Sky Medical Group,Inc.	K042134	Versatile 1 WoundVacuum System

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Indications for Use:

Device Description:

Non-Clinical Test (Bench):

The SIMEX SIM EX200 and SIM EX300 series pumps are 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 US. Testing also demonstrated that the pumps meet the electromagnetic interference requirements of the above mentioned standards. The pump's manufacture and quality systems management are in accordance with Quality System Regulations and certified international standards, including ISO 13485.

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K113291 Page
3/3

Basis For Substantial Equivalence:

The SIMEX Negative Pressure Wound Therapy Series of pumps SIM EX200 and SIM EX300, like the predicate devices, are portable, powered suction devices. The SIMEX pumps and the predicate devices, particularly the Prospera PRO-I, PRO-II, and PRO-III pumps, have equivalent Indications for Use. Table 1 below provides a comparison of technological characteristics.

Feature	Predicate: K112458,PRO-I, PRO-II and PRO-III NPWT pumps	SIM EX200 andSIM EX300
Dressing System	Gauze based dressing kit with adhesive filmdrape to create a sealed wound environment	Same as predicate
Pressure sensing	Sensors in the unit	Same as predicate
Therapy unit	Computer software controlled, battery and ACpowered negative pressure wound therapypumps using both continuous and intermittentoperations to remove exudates from the woundto the collection canister	Same as predicate

Table 1 Comparison Summary of Technological Characteristics

The SIMEX Negative Pressure Wound Therapy Suction Pumps Series SIM EX200 and SIM EX300 is substantially equivalent to the commercially marketed predicate devices and does not raise any new issues of safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

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

AUG 30 2012

Simex Medizintechnik GmbH % FloSure Technologies LLC Mr. Hamid Khosrowshahi P.O. Box 123 Tarrytown, New York 10591

Re: K113291

Trade/Device Name: SIMEX Negative Pressure Wound Therapy Powered Suction Pumps Series SIM EX200 and SIM EX300 Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: August 20, 2012 Received: August 22, 2012

Dear Mr. Khosrowshahi:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Hamid Khosrowshahi

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 yours,

Eunel Keith

Sy Mark 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:

Device Name:

SIMEX Negative Pressure Wound Therapy Powered Suction Pumps Series SIM EX200 and SIM EX300

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 Kirchner MM

(Division Sigr Division of Surgical, Orthopedic, storative Devices

510(k) Number K113291

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.