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.

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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Venturi Gauze Wound Care Sets With Portal Drain" and the FDA's determination of substantial equivalence. This document does not describe a study involving an AI/Machine Learning device or its acceptance criteria and performance.

The device in question is a medical dressing kit for Negative Pressure Wound Therapy (NPWT), and its substantial equivalence was determined based on its similarity to existing predicate devices and bench testing, not clinical or AI-related studies.

Therefore, I cannot provide the requested information as it pertains to AI acceptance criteria and study details. However, I can extract information about the predicate devices and the general testing approach for this non-AI medical device:

Device: Venturi™ Gauze Wound Care Sets with Portal Drain (K151263)

Predicate Devices:

Venturi™ NPWT v.II Advanced Vacuum System (K080897) - Manufacturer: Talley Group
Avance® Foam Dressing Kits (K122132) - Manufacturer: Mölnlycke Health Care US, LLC

Testing Approach Summary (for this non-AI device):
The device's substantial equivalence was established through:

Comparison of intended use, design, and technological characteristics to predicate devices.
Confirmation that the new component (Portal Drain Assembly) performs the same function as equivalent components in predicate devices.
Bench testing to demonstrate that the device does not introduce any additional risks and meets its intended use.

Specific answers to your questions based on the provided text (and why most cannot be answered for an AI device):

A table of acceptance criteria and the reported device performance:
- Cannot provide this for AI. The document states "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." No specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, AUC) are listed because it's a physical device, not an AI algorithm.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot provide this for AI. This device underwent "bench testing." Details about the sample size or provenance of data for bench tests are not provided in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This was bench testing for a physical device, not expert-adjudicated ground truth for an AI algorithm.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This was bench testing for a physical device.
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:
- No, this was not done. This is a physical wound care device, not an AI system. The document explicitly states "No clinical data was required."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable for AI. For the physical device, conformity to established engineering standards and functional performance during bench testing served as the "ground truth" to show safety and effectiveness.
The sample size for the training set:
- Not applicable. As this is a physical device, there is no "training set" in the context of machine learning.
How the ground truth for the training set was established:
- Not applicable. There is no training set for an AI algorithm here.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K151263

Device Name

Venturi™ Gauze Wound Care Sets with Portal Drain

Indications for Use (Describe)

NPWT is contraindicated for patients with:

1. Malignancy in the wound
1. Untreated osteomyelitis
1. Non-enteric and unexplored fistulas
1. Wounds with difficult haemostasis
1. Necrotic tissue with eschar present
1. 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 estateRomsey, HampshireSO51 9DQEngland
Registered Establishment Number:	8010348
Owner/Operator Number:	8010348
Contact:	Robert MacdonaldQuality 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 & ProductCode	510(k) Number
Talley Group	VenturiTM NPWT v.IIAdvanced VacuumSystem	21 CFR 878.4780;OMP	K080897
Mölnlycke Health CareUS, LLC	Avance® FoamDressing 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

The Venturi™ Gauze Wound Care Sets with Portal Drain consist of the following components:

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:

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:

1. Malignancy in the wound
1. Untreated osteomyelitis
1. Non-enteric and unexplored fistulas
1. Wounds with difficult haemostasis
1. Necrotic tissue with eschar present
1. 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

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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.

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.