The Talley Venturi™ MiNO TG600/14 is intended for use for patients with acute or chronic wounds that may be benefitted by the application of continual negative pressure wound therapy 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.

Device Description

Negative Pressure Wound Therapy (NPWT) is a wound care therapy that uses suction via an electrical pump and a wound dressing.

Vacuum Pump Unit: Venturi MiNO NPWT TG600/14
Construction: Flame Retardant ABS
Dimensions / Weight: 105mm x 52mm x 112mm / 290g
Pressure Range: 80mmHg and 120mmHg

AI/ML Overview

Here's an analysis of the provided text regarding the Venturi MiNO TG600/14 device, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes performance tests but does not explicitly state "acceptance criteria" in a quantitative, pass/fail threshold manner that would be typical for clinical studies. Instead, it describes general performance checks and comparisons to predicate devices.

Performance Characteristic	Acceptance Criteria (Implied/Description)	Reported Device Performance
Air-tightness (Canister)	Pass for air-tightness, recognition of sensor pins, and acceptable loss of vacuum over a prescribed period.	Performed on 100% of production units. Confirmed.
Vacuum Pump Pressure	Achieve 120mmHg; measured flow and pressure meet defined minimum values.	Performed on 100% of production sub-assemblies. Confirmed.
Vacuum Pressure Levels	Maintain vacuum pressure levels over 48 hours.	Performed on 100% of assembled production pump units. Confirmed.
Final System Functionality	All functions, buttons, correct pressure calibration, air tightness, canister recognition, warning systems/alarms, and charging system operational.	Performed on 100% of production units. Confirmed.

Important Note: The document focuses on production unit testing for quality control and comparison to predicate devices, rather than a clinical study with quantifiable clinical outcome-based acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) typically seen for diagnostic or AI-based devices. The "performance" here refers to the device meeting its specified technical functionalities.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a test set in the context of clinical or AI performance evaluation. The "tests" described are manufacturing quality control checks performed on 100% of production units (canister vacuum test, vacuum pump test, soak test, final system test).

Sample Size for Test Set: Not applicable as this is a manufacturing quality control and non-clinical comparison for substantial equivalence, not a clinical study or AI model evaluation. The tests are applied to 100% of manufactured units.
Data Provenance: The data comes from internal manufacturing testing of Talley Group Ltd. in Great Britain. This is non-clinical, internal test data.

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

Not applicable. Ground truth, in the context of clinical or AI studies, involves expert-derived labels or diagnoses. The tests described are functional and performance-based, where the "truth" is whether the device meets its engineering specifications. There is no mention of experts establishing a "ground truth" for these engineering tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple experts when establishing ground truth for clinical or image-based studies. This document describes functional engineering tests, not a study requiring expert adjudication.

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

No. This document does not describe an AI medical device, nor does it present any MRMC comparative effectiveness study. The device is a "Negative pressure wound therapy pump," which is a physical medical device, not an AI or diagnostic imaging tool.

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

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests described is the engineering specification and expected functional behavior of the device (e.g., maintaining 120mmHg vacuum, air-tightness, correct alarm function). This is determined by the device's design and manufacturing standards, not by expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This device is not an AI algorithm.

Summary

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right, suggesting a sense of community and support.

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

January 5, 2016

Talley Group Ltd. Mr. Robert Macdonald Quality and Regulatory Affairs Manager Premier Way Abbey Park Industrial Estate Romsey, Hampshire SO51 9DO Great Britain

Re: K143004

Trade/Device Name: Venturi MiNO TG600/14 Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: November 23, 2015 Received: December 7, 2015

Dear Mr. Macdonald:

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

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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 of medical 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/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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Venturi™ MiNO TG600/14

510(k) number K143004 Indications for Use

510(k) Number (if known):

Device Name: Venturi™ MiNO TG600/14

Indications for Use:

Prescription Use Yes And/Or Over the Counter Use No

(21 CFR Part 801 Subpart D)

(21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for Talley. The logo consists of the word "Talley" in large, bold, blue letters. To the left of the word is a graphic of three curved lines, one red and two blue, that form a crescent shape. The background is a light blue color.

Tallev Group Limited Premier Way, Abbey Park Industrial Estate Romsey, Hampshire SO51 9DQ, England TEL: +44(0) 1794 503500

FAX: +44(0) 1794 503555 EMAIL: sales@talleygroup.com

510(k) Summary Venturi Mino TG600/14 4th January 2016

510(K) number K143004

Manufacturer and submitter:

Robert Macdonald. Talley Group, Ltd. Premier way. Abbev park industrial estate Romsey, Hampshire SO51 9DQ England. rmacdonald@talleygroup.com Phone 0044 1794 503575 Fax 0044 1794 503539

Device name:	Venturi™ MINO TG600/14
Common Name:	Negative pressure wound therapy pump
Classification name:	Negative pressure wound therapy powered suction pump
Classification code:	OMP
Regulation number:	878.4780
Class:	2
Equivalent device 1	Venturi V.IITalley Group LTDK090258
Equivalent device 2	VenturiTalley Group LTDK080897

There have been no prior submissions (pre-submission, IDE or 510(k)) for the Venturi MiNO TG600/14 Negative Pressure Wound Therapy device.

How the device functions, and scientific concepts that form the basis for the device.

Negative Pressure Wound Therapy (NPWT) is a wound care therapy that uses suction via an electrical pump and a wound dressing.

The significant physical and performance characteristics of the device, such as device design material used and physical properties.

Vacuum Pump Unit:	Venturi MiNO NPWT TG600/14
Construction:	Flame Retardant ABS
Dimensions / Weight:	105mm x 52mm x 112mm / 290g
Pressure Range:	80mmHg and 120mmHg

Intended Use.

Image /page/3/Picture/14 description: The image is a circular logo with the words "GREAT BRITISH DESIGN AND MANUFACTURING" written around the top half of the circle. The words "SINCE 1953" are written around the bottom half of the circle. There are four dots separating the top and bottom text. In the center of the circle is a British flag.

K143004

ww.tallevaroup.

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Image /page/4/Picture/0 description: The image shows the logo for Talley. The logo consists of the word "Talley" in a bold, blue font. To the left of the word is a graphic of two curved lines, one red and one blue, that form a crescent shape. The background is a light blue color.

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A general description of the diseases or conditions that the device will diagnose, prevent, cure, or mitigate,

For management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Substantial equivalence:

All predicate products provide a combination of an electrically powered suction pump and a patient wound dressing kit, sealed with a clear dressing over the wound, and a tubing connection set to attach the sealed dressing to the suction pump for fluid removal. All predicate devices also include a single-patient-use fluid collection vessel (canister) for containment and disposal of evacuated fluids. The consumable dressing kit items are widely available on the market and packaged with the powered suction pumps as a convenience to the clinical users of the device. Talley believes this information supports substantial equivalence of the Venturi™ MiNO to the predicate devices.

If the determination of substantial equivalence is also based on an assessment of nonclinical performance data, the summary includes a brief discussion of the nonclinical tests submitted

The performance testing of the pump with the predicates that shows the performance is comparable to the predicates

Canister vacuum test is performed on 100% of production units to check for air-tightness and recognition of sensor pins. Loss of vacuum is measured over a prescribed period. Vacuum pump test is performed on 100% of production sub-assemblies measuring flow and pressure, ensuring 120mmHg is achieved.

Tested levels are compared with defined minimum values to determine pass or fail. Soak test is performed on 100% of assembled production pump units and are run for 48 hours prior to final test to confirm vacuum pressure levels.

Final system test is performed on 100% of production units. Tests include all functions and buttons, correct pressure calibration, air tightness, canister recognition, warning systems / alarms and that the charging system operational.

If the determination of substantial equivalence is also based on an assessment of clinical performance data

Substantial equivalence is based on an assessment of non-clinical performance data and no clinical performance data is included.

Conclusion

The working pressures, non-clinical tests, alarm functions, general concert and intended use supports substantial equivalence of the Venturi™ Mino Vacuum System to the predicate devices. The Venturi MiNO TG600/14 is substantially equivalent to the predicate devices non-clinical tests demonstrates that the device is as safe, as effective, and performs as well as or better than the predicate devices.

Image /page/4/Picture/15 description: The image is a logo with a circular design. The words "GREAT BRITISH DESIGN AND MANUFACTURING" are arranged around the top half of the circle, while "SINCE 1953" is positioned at the bottom. The central element of the logo is a stylized depiction of the Union Jack, the flag of the United Kingdom. The flag is shown with a wavy effect, adding a dynamic feel to the design. Small black dots are placed between the text at the top and bottom of the circle, serving as visual separators.

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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.