(442 days)
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No
The summary describes a standard negative pressure wound therapy device with a vacuum pump and dressing, and the performance testing focuses on mechanical and electrical functions. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as "continual negative pressure wound therapy" for "patients with acute or chronic wounds" and is used for "removal of fluids, including wound exudate, irrigation fluids, and infectious materials," which are all therapeutic actions.
No.
The device is described as a Negative Pressure Wound Therapy (NPWT) system intended for applying continual negative pressure to wounds for fluid removal, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly mentions a "Vacuum Pump Unit" with physical dimensions and weight, indicating it is a hardware device. The performance studies also describe testing of the pump and physical components like canisters.
Based on the provided information, the Talley Venturi™ MiNO TG600/14 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for applying negative pressure to wounds for the removal of fluids. This is a therapeutic application directly on the patient's body, not for examining specimens in vitro (outside the body).
- Device Description: The description details a vacuum pump unit and its function in applying suction to a wound dressing. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing specimens.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Talley Venturi™ MiNO TG600/14 does not fit this description.
N/A
Intended Use / Indications for Use
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.
Product codes
OMP
Device Description
Negative Pressure Wound Therapy (NPWT) is a wound care therapy that uses suction via an electrical pump and a wound dressing.
The Venturi MiNO NPWT TG600/14 is a Vacuum Pump Unit constructed from Flame Retardant ABS, with dimensions of 105mm x 52mm x 112mm and a weight of 290g. It operates within a pressure range of 80mmHg and 120mmHg.
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence is based on an assessment of non-clinical performance data and no clinical performance data is included.
Non-clinical performance tests include:
- Canister vacuum test: 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: 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: 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: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
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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
1
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:
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.
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.II |
| Talley Group LTD | |
| K090258 | |
| Equivalent device 2 | Venturi |
| Talley Group LTD | |
| K080897 |
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.
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.
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
© Talley Group Ltd
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.
levaroup.com
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.
© Talley Group Ltd