The FloSure Ventilation Patch is intended to be used in conjunction with NPWT Dressing Kits compatible with the SIMEX NPWT Systems EX200 and EX300 for the application of negative pressure wound therapy to the wound. The FloSure Ventilation Patch is to be applied to the occlusive wound dressing. When used in conjunction with the Simex NPWT EX200 and EX300 pumps and dressing kits, the FloSure Ventilation Patch is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of wound exudates, infectious material and tissue debris.

The FloSure Ventilation Patch is appropriate for use on the following wounds:

· Pressure Ulcers
· Diabetic/Neuropathic Ulcers
· Venous Insufficiency Ulcers
· Traumatic Wounds
· Post-Operative and Dehisced Surgical Wounds
· Skin Flap and Grafts

Device Description

The FloSure Ventilation Patch is used with the NPWT wound dressings to improve air-flow through the dressing when desired. The FloSure Ventilation Patch augments the transparent dressing by providing additional gas permeability to the wound dressing site through its proprietary hydrophobic and micro-porous filter membrane. The access to additional air-flow can aid in keeping the vacuum in balance resulting in a continuous flow of exudate. Stagnation in the flow of exudate can cause pooling at the wound site and result in blockage alarms.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "FloSure Ventilation Patch." This device is a medical accessory intended for use with Negative Pressure Wound Therapy (NPWT) systems. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel functionality.

Therefore, the study described is a non-clinical bench testing and biocompatibility assessment for substantial equivalence, not a study to prove acceptance criteria for a new functional performance or algorithm.

Here's a breakdown of the requested information based on the provided text, with significant portions noted as "Not Applicable" or "Not Provided" due to the nature of the submission (510(k) for an accessory, not an AI device or a novel functional device requiring extensive performance metrics):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Testing for Equivalence)	Reported Device Performance (FloSure Ventilation Patch)
Biocompatibility:
Cytotoxicity	Met (Implied by conclusion of substantial equivalence)
Sensitization	Met (Implied by conclusion of substantial equivalence)
Acute Systemic Toxicity	Met (Implied by conclusion of substantial equivalence)
Intracutaneous Reactivity or Irritation	Met (Implied by conclusion of substantial equivalence)
Functional Equivalence with Predicate:
Ability to maintain consistent pressure (with NPWT systems EX200 & EX300)	Demonstrated equivalence with predicate.
Ability to maintain consistent flow (with NPWT systems EX200 & EX300)	Demonstrated equivalence with predicate.
Ability to enable removal of exudate (with NPWT systems EX200 & EX300)	Demonstrated equivalence with predicate.
Non-interference with proper functioning of NPWT pump alarms	Demonstrated.

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not explicitly stated for each test. The non-clinical testing refers to "comparative performance bench testing" and standard biocompatibility assessments. These typically involve a sufficient number of samples to ensure statistical validity for the specific test, but the exact count is not provided in this summary.
Data Provenance: The tests are "non-clinical testing" and "comparative performance bench testing," implying laboratory-based testing conducted by or for the manufacturer. There is no mention of country of origin for data or whether it's retrospective or prospective, as it's not patient-level data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This device is an accessory to a medical device, and the evaluation is for substantial equivalence to a predicate, based on bench testing and biocompatibility, not on interpretation of complex medical data requiring expert consensus or ground truth in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

Not Applicable. See point 3.

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 submission is for a physical medical device accessory (a ventilation patch), not an AI-powered diagnostic or interpretive device. No MRMC study was conducted or relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an algorithmic or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Bench Test Results and Biocompatibility Standards: The "ground truth" or reference for performance was industrial standards for biocompatibility (e.g., ISO standards usually underlie cytotoxicity, sensitization tests) and functional performance metrics of the predicate device (UNI NPWT Foam Wound Dressing Kit) when assessed with SIMEX NPWT Systems EX200 and EX300.

8. The sample size for the training set

Not Applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary

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

January 5, 2016

SIMEX Medizintechnik, GmbH Mr. Hamid Khosrowshahi FloSure Technologies LLC PO Box 123 Tarrytown, New York 10591

Re: K150459

Trade/Device Name: FloSure Ventilation Patch Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: December 3, 2015 Received: December 7, 2015

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

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K150459

Device Name FloSure Ventilation Patch

Indications for Use (Describe)

The FloSure Ventilation Patch is appropriate for use on the following wounds:

· Pressure Ulcers
· Diabetic/Neuropathic Ulcers
· Venous Insufficiency Ulcers
· Traumatic Wounds
· Post-Operative and Dehisced Surgical Wounds
· Skin Flap and Grafts

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

Date Prepared:	January 2, 2016
Sponsor andManufacturer:	SIMEX Medizintechnik, GmbHPost Box 1207D-78649 Deisslingen, GermanyFDA Registration Number 3005813597
510(k) Contact:	Mr. Hamid KhosrowshahiFloSure Technologies LLCPO Box 123Tarrytown, NY 10591Telephone: 914-772-7326e-mail: hkhosrow@optonline.net
Trade Name:	FloSure Ventilation Patch
Common Name:	Occlusive Wound Dressing
Classification:	Powered Suction Pump21 CFR 878.4780Class II
Device Product Code:	OMP - Pump, Portable, Aspiration (manual or powered)
Predicate Device:	UNI NPWT Foam Wound Dressing Kit (K133333)

Indications for Use:

The FloSure Ventilation Patch is appropriate for use on the following wounds:

Pressure Ulcers
. Diabetic/Neuropathic Ulcers
Venous Insufficiency Ulcers
Traumatic Wounds
Post-Operative and Dehisced Surgical Wounds
Skin Flap and Grafts

Device Description:

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proprietary hydrophobic and micro-porous filter membrane. The access to additional air-flow can aid in keeping the vacuum in balance resulting in a continuous flow of exudate. Stagnation in the flow of exudate can cause pooling at the wound site and result in blockage alarms.

Feature	FloSure Ventilation Patch	UNI NPWT Foam Wound Dressing KitK133333
Product Name	FloSure Ventilation Patch	UNI NPWT Foam Wound Dressing Kits
Product Code	OMP	OMP
Description	Accessory for use with occlusivedressings to allow filtered air to flowthrough the occlusive dressing whendesired. Used with SIMEX NegativePressure Wound Therapy Systems (EX200and EX300)	Foam based dressing including anocclusive drape to create a sealed woundenvironmentUsed with SIMEX Negative PressureWound Therapy Systems (EX200 andEX300)
Sterility	Provided Sterile	Provided Sterile
Mode of operation	The FloSure Ventilation Patch is appliedto the occlusive (transparent) drape of theNPWT wound dressing. It maintains themoist environment of the NPWT dressingand allows the exchange of gases througha hydrophobic micro-porous filtermembrane.	The occlusive drape of the wound dressingkit provides a moist wound environment,and allows the exchange of gases throughthe device.
Materials	Consists of a piece of synthetic polymericmaterial with an adhesive backing.	Occlusive drape consists of a piece ofsynthetic polymeric material with anadhesive backing.
Indications for Use	The FloSure Ventilation Patch is intendedto be used in conjunction with NPWTDressing Kits compatible with the SIMEXNPWT Systems EX200 and EX300 for theapplication of negative pressure woundtherapy to the wound. The FloSureVentilation Patch is to be applied to theocclusive wound dressing. When used inconjunction with the Simex NPWT EX200and EX300 pumps and dressing kits, theFloSure Ventilation Patch is indicated forpatients who would benefit from a suctiondevice, particularly as the device maypromote wound healing by removal ofwound exudates, infectious material andtissue debris.The FloSure Ventilation Patch isappropriate for use on the followingwounds:• Pressure Ulcers• Diabetic/Neuropathic Ulcers• Venous Insufficiency Ulcers• Traumatic Wounds• Post-Operative and Dehisced SurgicalWounds	The UNI NPWT Foam Dressing Kit isintended to be used in conjunction with theSIMEX Negative Pressure WoundTherapy Pumps (K113291) for theapplication of negative pressure woundtherapy to the wound. When used inconjunction with the SIMEX NegativePressure Wound Therapy Pumps, the UNINPWT Foam Dressing Kit is indicated forpatients who would benefit form a suctiondevice, particularly as the devicemay promote wound healing by removal ofexcess exudates, infectious material andtissue debris.The UNI NPWT Foam Dressing Kit isappropriate for use on the followingwounds:• Pressure Ulcers• Diabetic/Neuropathic Ulcers• Venous Insufficiency Ulcers• Traumatic Wounds• Post-Operative and Dehisced SurgicalWounds• Skin Flap and Grafts

Feature Comparison Chart

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Non-clinical Testing:

The following non-clinical testing was performed:

Cytotoxicity
Sensitization
Acute Systemic Toxicity
Intracutaneous Reactivity or Irritation

Comparative performance bench testing was performed with the predicate and with the FloSure Ventilation Patch using the SIMEX EX200 and EX300 NPWT systems. Testing demonstrated equivalence in ability to maintain consistent pressure, flow and removal of exudate and demonstrated that the FloSure Ventilation patch did not interfere with the proper functioning of the NPWT pump alarms.

Clinical Testing:

No clinical study was conducted.

Substantial Equivalence:

The FloSure Ventilation Patch is substantially equivalent in function and intended use to the UNI NPWT Foam Dressing Kit (K13333). Like the occlusive drape of the predicate UNI NPWT Foam Dressing Kit, the FloSure Ventilation Patch is semipermeable, maintains a moist environment for the wound by being hydrophobic, allows the exchange of gases, and maintains a protective barrier to the wound site. The FloSure Ventilation Patch performs the same basic function as the occlusive drape of NPWT Wound Dressing Kit. The support layer of the FloSure Ventilation Patch, which adheres to the NPWT occlusive drape, is composed of polvurethane, the same material that the occlusive drape is composed of. Performance testing with the predicate device and with the FloSure Ventilation Patch demonstrated that they were substantially equivalent in the ability to maintain consistent pressure, flow and removal of exudate when tested with the SIMEX EX200 and EX300 NPWT Systems.

Conclusion:

The FloSure Ventilation Patch is substantially equivalent to the currently marketed UNI NPWT Foam Wound Dressing Kits (K13333), in indications for use, basic technological characteristics, and does not raise new issues of safety and effectiveness.

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.