(316 days)
Not Found
No
The summary describes a passive device (a patch) that enhances airflow in an existing NPWT system. There is no mention of any computational or algorithmic processing, let alone AI/ML.
Yes
The device is used to promote wound healing by removing wound exudates, infectious material, and tissue debris, which are therapeutic claims.
No.
The document describes the device as a ventilation patch used in negative pressure wound therapy to promote wound healing by removing exudates and improving airflow, not for diagnosing conditions.
No
The device description clearly states it is a "patch" with a "proprietary hydrophobic and micro-porous filter membrane," indicating it is a physical component, not solely software.
Based on the provided information, the FloSure Ventilation Patch is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used in conjunction with NPWT systems for applying negative pressure to wounds to promote healing by removing exudates, infectious material, and tissue debris. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on improving airflow through wound dressings to aid in the continuous flow of exudate and prevent blockages. This is a mechanical function related to wound management, not the analysis of biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the FloSure Ventilation Patch is a medical device used for wound therapy, not an IVD.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
OMP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wound
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
UNI NPWT Foam Wound Dressing Kit (K133333)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
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
1
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
2
Indications for Use
510(k) Number (if known) K150459
Device Name FloSure Ventilation Patch
Indications for Use (Describe)
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
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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3
510(K) SUMMARY
| Date Prepared: | January 2, 2016 |
|---|---|
| Sponsor and | |
| Manufacturer: | SIMEX Medizintechnik, GmbH |
| Post Box 1207 | |
| D-78649 Deisslingen, Germany | |
| FDA Registration Number 3005813597 | |
| 510(k) Contact: | Mr. Hamid Khosrowshahi |
| FloSure Technologies LLC | |
| PO Box 123 | |
| Tarrytown, NY 10591 | |
| Telephone: 914-772-7326 | |
| e-mail: hkhosrow@optonline.net | |
| Trade Name: | FloSure Ventilation Patch |
| Common Name: | Occlusive Wound Dressing |
| Classification: | Powered Suction Pump |
| 21 CFR 878.4780 | |
| Class 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 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
4
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 Kit
K133333 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | FloSure Ventilation Patch | UNI NPWT Foam Wound Dressing Kits |
| Product Code | OMP | OMP |
| Description | Accessory for use with occlusive
dressings to allow filtered air to flow
through the occlusive dressing when
desired. Used with SIMEX Negative
Pressure Wound Therapy Systems (EX200
and EX300) | Foam based dressing including an
occlusive drape to create a sealed wound
environment
Used with SIMEX Negative Pressure
Wound Therapy Systems (EX200 and
EX300) |
| Sterility | Provided Sterile | Provided Sterile |
| Mode of operation | The FloSure Ventilation Patch is applied
to the occlusive (transparent) drape of the
NPWT wound dressing. It maintains the
moist environment of the NPWT dressing
and allows the exchange of gases through
a hydrophobic micro-porous filter
membrane. | The occlusive drape of the wound dressing
kit provides a moist wound environment,
and allows the exchange of gases through
the device. |
| Materials | Consists of a piece of synthetic polymeric
material with an adhesive backing. | Occlusive drape consists of a piece of
synthetic polymeric material with an
adhesive backing. |
| Indications for Use | 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 | The UNI NPWT Foam Dressing Kit is
intended to be used in conjunction with the
SIMEX Negative Pressure Wound
Therapy Pumps (K113291) for the
application of negative pressure wound
therapy to the wound. When used in
conjunction with the SIMEX Negative
Pressure Wound Therapy Pumps, the UNI
NPWT Foam Dressing Kit is indicated for
patients who would benefit form a suction
device, particularly as the device
may promote wound healing by removal of
excess exudates, infectious material and
tissue debris.
The UNI NPWT Foam Dressing Kit 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 |
Feature Comparison Chart
5
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.