(282 days)
No
The summary describes a wound care set with a drain assembly for use with negative pressure wound therapy pumps. There is no mention of AI or ML in the intended use, device description, or performance studies. The device is a passive component of a larger system.
Yes.
The device is used for negative pressure wound therapy (NPWT), which is a medical treatment applied to wounds to promote healing by applying continuous negative pressure. This fits the definition of a therapeutic device.
No
This device is a wound care set used for negative pressure wound therapy (NPWT) to remove fluids from wounds. It is therapeutic, not diagnostic.
No
The device description clearly outlines physical components such as gauze, adhesive film dressing, a Portal Drain Assembly (including a portal drain, drain tube, 90° drain tube guide, and pinch clamp), saline solution, measuring tape, and instructions for use. It also mentions a canister in one configuration. These are all hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply negative pressure to wounds for the removal of fluids. This is a therapeutic intervention applied directly to the patient's body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The device consists of wound care components like gauze, dressings, and a drain assembly. These are physical items used in the treatment of a wound, not reagents, instruments, or systems intended for in vitro examination of specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The device's function is purely mechanical (applying negative pressure and removing exudate).
In summary, the Venturi™ Gauze Wound Care Sets with Portal Drain are a therapeutic device used in wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Venturi™ Gauze Wound Care Sets with Portal Drain are intended to be used with the Talley Group range of negative pressure wound therapy pumps. The Talley Group NPWT pumps are indicated use for patients with acute or chronic wounds that may be benefitted by the application of continual negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The device is intended for use by qualified healthcare professionals in a healthcare environment.
NPWT is contraindicated for patients with:
-
- Malignancy in the wound
-
- Untreated osteomyelitis
-
- Non-enteric and unexplored fistulas
-
- Wounds with difficult haemostasis
-
- Necrotic tissue with eschar present
-
- Exposed vasculature, bone, nerves, or organs.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
With the exception of the Portal Drain, there are no changes to the components in the currently marketed gauze dressing kits cleared in 510(K) K080897. The wound care sets connect to Negative Pressure Wound Therapy (NPWT) suction pumps to carry exudate from the wound.
The Venturi™ Gauze Wound Care Sets with Portal Drain consist of the following components:
Venturi™ Gauze Wound Care Set: Kerlix Antimicrobial gauze wound filler, adhesive film dressing, Portal Drain Assembly; 20ml saline solution and comes with measuring tape and instructions for use. These are supplied as sterile and single use.
The Venturi™ MINO Gauze Wound Care sets are have identical contents with the addition of a canister that attaches to the Venturi™ MINO NPWT device to contain the exudate.
Product Code Product Description
97-30-42-102 Venturi™ Gauze Wound Care Set with Portal Drain – Standard
97-30-42-109 Venturi™ Gauze Wound Care Set with Portal Drain - Large
97-30-42-114 Venturi™ MINO Gauze Wound Care Set with Portal Drain – Small
The wound care sets include:
The Portal Drain assembly is consist of the portal drain which is adhered to a window dressing and is connected to the drain tube which connects at the other end to the NPWT pump via the canister connector assembly. There is a 90° drain tube guide and pinch clamp at the pump end of the assembly for additional safety.
The window dressing end of the Portal Drain Assembly is self-adhesive and a small hole is cut in the adhesive film dressing directly over the gauze and the Portal Drain Assembly is placed over the adhesive window dressing ensuring the portal drain is lined up with the hole. The other end of the tubing attaches to the pump to carry exudate from the wound.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The device is intended for use by qualified healthcare professionals in a healthcare environment.
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)
No clinical data was required.
The bench testing has demonstrated that the device does not introduce any additional risks when undertaking Negative Pressure Wound Therapy and meeting the intended use.
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.
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 19, 2016
Talley Group Ltd. % Phil Bromley Consultant SGR Consulting Services 8 Hollingworth Court, Turkey Mill, Ashford Road Maidstone, Kent ME14 5PP United Kingdom
Re: K151263
Trade/Device Name: Venturi Gauze Wound Care Sets With Portal Drain Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: January 6, 2016 Received: January 11, 2016
Dear Mr. Bromley:
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
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K151263
Device Name
Venturi™ Gauze Wound Care Sets with Portal Drain
Indications for Use (Describe)
Venturi™ Gauze Wound Care Sets with Portal Drain are intended to be used with the Talley Group range of negative pressure wound therapy pumps. The Talley Group NPWT pumps are indicated use for patients with acute or chronic wounds that may be benefitted by the application of continual negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The device is intended for use by qualified healthcare professionals in a healthcare environment.
NPWT is contraindicated for patients with:
-
- Malignancy in the wound
-
- Untreated osteomyelitis
-
- Non-enteric and unexplored fistulas
-
- Wounds with difficult haemostasis
-
- Necrotic tissue with eschar present
-
- Exposed vasculature, bone, nerves, or organs
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for Talley Group. The logo features a red oval with a white "T" inside. Below the oval, the word "TALLEY" is written in a large, blue, sans-serif font. Underneath "TALLEY", the word "GROUP" is written in a smaller, red, sans-serif font, with a line on either side.
Venturi™ Gauze Wound Care Sets with Portal Drain
510(k) Summary
510(k) number K151263
This 510(k) summary is being submitted in accordance with the requirement of 21 CFR 807.92.
| Summary | |
|---|---|
| Submitter's Identification: | Talley Group, Ltd, |
| Premier way, | |
| Abbey park industrial estate | |
| Romsey, Hampshire | |
| SO51 9DQ | |
| England | |
| Registered Establishment Number: | 8010348 |
| Owner/Operator Number: | 8010348 |
| Contact: | Robert Macdonald |
| Quality and Regulatory Affairs Manager | |
| Telephone: | +44 1794 503575 |
| Fax: | +44 1794 503539 |
| Email: | rmacdonald@talleygroup.com |
| Date of Summary: | 16th February 2016 |
| Device/Proprietary Name: | Venturi™ Gauze Wound Care Sets with Portal Drain |
| Common Name: | NPWT Dressing Kits |
| Classification: | Negative pressure wound therapy powered suction pump |
| Product Code: | OMP |
| Product Class: | II |
| Code of Federal Regulation: | 21 CFR 878.4780 |
| Panel | General & Plastic Surgery |
| Substantial Equivalence: | |||
|---|---|---|---|
| Manufacturer | Trade Name | Regulation & Product | |
| Code | 510(k) Number | ||
| Talley Group | VenturiTM NPWT v.II | ||
| Advanced Vacuum | |||
| System | 21 CFR 878.4780; | ||
| OMP | K080897 | ||
| Mölnlycke Health Care | |||
| US, LLC | Avance® Foam | ||
| Dressing Kits | 21 CFR 878.4780; | ||
| OMP | K122132 |
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Image /page/4/Picture/0 description: The image shows the logo for Talley Group. The logo features the word "TALLEY" in a large, bold, blue font. Above the word "TALLEY" is a red circle with a white "T" inside. Below the word "TALLEY" is the word "GROUP" in a smaller, red font with a line on either side.
enturi™ Gauze Wound Care Sets with Portal Drain
Description
Description of Device
With the exception of the Portal Drain, there are no changes to the components in the currently marketed gauze dressing kits cleared in 510(K) K080897. The wound care sets connect to Negative Pressure Wound Therapy (NPWT) suction pumps to carry exudate from the wound.
The Venturi™ Gauze Wound Care Sets with Portal Drain consist of the following components:
Venturi™ Gauze Wound Care Set: Kerlix Antimicrobial gauze wound filler, adhesive film dressing, Portal Drain Assembly; 20ml saline solution and comes with measuring tape and instructions for use. These are supplied as sterile and single use.
The Venturi™ MINO Gauze Wound Care sets are have identical contents with the addition of a canister that attaches to the Venturi™ MINO NPWT device to contain the exudate.
Product Code Product Description 97-30-42-102 Venturi™ Gauze Wound Care Set with Portal Drain – Standard 97-30-42-109 Venturi™ Gauze Wound Care Set with Portal Drain - Large 97-30-42-114 Venturi™ MINO Gauze Wound Care Set with Portal Drain – Small
The wound care sets include:
The Portal Drain assembly is consist of the portal drain which is adhered to a window dressing and is connected to the drain tube which connects at the other end to the NPWT pump via the canister connector assembly. There is a 90° drain tube guide and pinch clamp at the pump end of the assembly for additional safety.
The window dressing end of the Portal Drain Assembly is self-adhesive and a small hole is cut in the adhesive film dressing directly over the gauze and the Portal Drain Assembly is placed over the adhesive window dressing ensuring the portal drain is lined up with the hole. The other end of the tubing attaches to the pump to carry exudate from the wound.
Indications for Use:
Venturi™ Gauze Would Care Sets with Portal Drain are intended to be used with the Talley Group range of negative pressure wound therapy pumps. The Talley Group NPWT pumps are indicated use for patients with acute or chronic wounds that may be benefitted by the application of continual negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The device is intended for use by qualified healthcare professionals in a healthcare environment.
NPWT is contraindicated for patients with:
-
- Malignancy in the wound
-
- Untreated osteomyelitis
-
- Non-enteric and unexplored fistulas
-
- Wounds with difficult haemostasis
-
- Necrotic tissue with eschar present
-
- Exposed vasculature, bone, nerves, or organs.
Summary of the Determination of Substantial Equivalence & Performance Data
All of kits components with the exception of the Portal Drain Assembly have been cleared for use as a NPWT dressing kit under K080897. The components used in the Venturi™ Gauze Wound
5
Image /page/5/Picture/0 description: The image shows the logo for Talley Group. The logo features the word "TALLEY" in large, blue, bold letters. Above the word "TALLEY" is a red circle containing a white symbol that resembles a stylized letter "T". Below the word "TALLEY" is the word "GROUP" in smaller, red letters.
Venturi™ Gauze Wound Care Sets with Portal Drain
Care Sets are identical to those in material, function and sterility (except the Portal Drain Assembly). The dressing kits in K080897 used a flat or channel drain that was placed underneath the adhesive film dressing and contacted the skin whereas the portal drain is placed over the adhesive film dressing and a small hole is cut above the gauze to ensure the portal drain and hole line up and there is no intended patient contact. The Portal Drain Assembly performs the same function as the flat or channel drain in the predicate (K080897).
The Venturi™ Gauze Wound Care Sets are equivalent in function to the Mölnlycke Avance® Dressing Kits incl. Transparent Film, Transfer Pad (K122132) and the Portal Drain Assembly is the equivalent of the Transfer Pad in the Avance® Dressing Kits (K122132). The Portal Drain Assembly and Transfer Pad are placed over a small cut hole on the adhesive film over the gauze and connect to the NPWT device to transport exudate to the canister in the pump.
The Venturi™ Gauze Wound Care Sets have equivalent intended uses to the predicates and are intended to contact the patient in the same way and the for same period of time and except for the Portal Drain Assembly have the same component parts as the predicate (K080897).
The component parts of the device and the predicates are all provided individually packaged, sterilised and have an equivalent shelf life. The devices have similar labelling and instructions for use.
The bench testing has demonstrated that the device does not introduce any additional risks when undertaking Negative Pressure Wound Therapy and meeting the intended use.
Clinical Testing
No clinical data was required.
Conclusion
Based on the information presented in this submission, it is concluded that the Venturi™ Gauze Wound Care Sets with Portal Drain are equivalent to the Avance® Dressing Kits (K122132) and the Venturi™ NPWT v.Il Advanced Vacuum System (K080897) with respect to intended use, design and technological characteristics.
The Venturi™ Gauze Wound Care Sets with Portal Drain is as safe and effective as the predicate devices for facilitating Negative Pressure Wound Therapy and there are no new indications for use and therefore by following the FDA 510(k) "Substantial Equivalence" decision making process, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134783.htm it is substantially equivalent to the predicate device.