(204 days)
Use of the Venturi™ NPWT v.II Advanced Vacuum System is indicated for use in patients that would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from a patients airway or respiratory support system either during surgery or at the patient's bedside.
The Talley Venturi™ system consists of a powered suction pump for the application of vacuum for fluid removal. Consumables for use with the pump include collection canister and connection tubing.
The provided document is a 510(k) summary for the Talley Venturi™ NPWT v.II Advanced Vacuum System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving clinical effectiveness or meeting specific performance criteria through a detailed study on human patients. Therefore, information typically found in clinical studies (like sample sizes for test sets, expert qualifications, MRMC studies, training set details, or ground truth establishment for clinical outcomes) is not present in this document because it is not required for a 510(k) summary of a powered suction pump.
The document primarily focuses on bench testing to ensure the device functions correctly and is safe, aligning with its substantial equivalence claim to predicate devices.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Internal/Bench Testing) | Reported Device Performance |
|---|---|
| Canister vacuum test: | Performed on 100% of production units. Checks for air-tightness and recognition of sensor pins. Loss of vacuum is measured over a prescribed period. Units pass or fail. |
| Vacuum pump test: | Performed on 100% of production sub-assemblies. Measures flow and pressure. Tested levels are compared with defined minimum values to determine pass or fail. |
| Soak test: | Performed on 100% of assembled production pump units. Units are run for 48 hours prior to final test to ensure durability and continuous operation. |
| Final system test: | Performed on 100% of production units. Tests include all functions and buttons, correct pressure calibration, air tightness, canister recognition, warning systems and alarms, and charging system operational. |
| Substantial Equivalence: | The Talley Venturi™ NPWT v.II Advanced Vacuum System is concluded to be substantially equivalent to the predicate devices (Blue Sky Versatile 1 System K021919 and Prodigy NPWT System K082415), operating at the same pressure ranges. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: The "Specific Performance Testing" section states that tests are performed on 100% of production units or 100% of production sub-assemblies. This implies a continuous quality control process rather than a one-time test set. For the purpose of regulatory submission, it refers to the units tested to demonstrate the device meets its own specifications.
- Data provenance: Not explicitly stated, but these are internal manufacturing and testing data from Talley Medical. There is no indication of country of origin for clinical data as no clinical data is presented. It's prospective testing in the sense that units are tested as they are produced.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for these tests are objective, measurable physical parameters (e.g., pressure, flow, air-tightness) specified by engineering and design requirements, not subjective expert assessment.
4. Adjudication method for the test set:
- Not applicable. The tests are pass/fail based on objective measurements against defined minimum values or specified functionalities. There is no human adjudication process described for these engineering tests.
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 is a mechanical device (powered suction pump), not an AI-assisted diagnostic or interpretative system. Therefore, an MRMC study is not relevant or included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a powered suction pump, not an algorithm or AI system.
7. The type of ground truth used:
- For the described tests, the "ground truth" is defined by engineering specifications and functional requirements (e.g., specific pressure ranges, flow rates, air-tightness, correct operation of buttons, alarms, charging system).
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/ML algorithm for this device. The development of the device would involve engineering design and iterative prototyping and testing, but not a dataset for algorithm training.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set in the context of AI/ML.
In summary: The document describes standard engineering and manufacturing quality control tests to ensure the device performs according to its design specifications and is substantially equivalent to existing predicate devices. It does not involve complex clinical studies or AI/ML evaluations.
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AUG 2 5 2009
510(k) Summary
Name: Tallev Medical 1070 E. Wieland Rd. Lansing, MI 48906
Phone: 888-259-9994 Fax: Same Contact: Jack Van Dyke. President
Trade Name: Venturi™ NPWT v.Il Advanced Vacuum System.
Common Name: Powered Suction Pump
Device Classification:
Gass II Product Code: BTA Requlation 878.4780 Classification Panel: General and Plastic Surgery
Predicate Devices:
Blue Sky Versatile 1 System KOEI919 Prodigy NPWT System K082415
Device Description: The Talley Venturi™ system consists of a powered suction pump for the application of vacuum for fluid removal. Consumables for use with the pump include collection canister and connection tubing.
Intended Use: Use of the Venturi™ NPWT v.Il Advanced Vacuum System is indicated for use in patients that would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from a patients airway or respiratory support system either during surgery or at the patient's bedside.
Technological Characteristics: The Talley Venturi™ system includes the same type suction pump as the predicate devices, operating at the same pressure ranges. Consumable accessories include collection canister and connection tubing.
Specific Performance Testing: a) 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. Units pass or fail. b) Vacuum pump test is performed on 100% of production sub-assemblies measuring flow and pressure. Tested levels are compared with defined minimum values to determine pass or fail. c } Soak test is performed on 100% of assembled production pump units and are run for 48 hours prior to final test. d) 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 and alarms, charging system operational.
Conclusion: The Talley Venturi™ NPWT v.Il Advanced Vacuum System is substantially equivalent to the predicate devices.
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Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is black, and the text is also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Talley Medical % Mr. Jack Van Dyke President 1070 E. Wieland Road Lansing, Michigan 48906
AUG 2 5 2009
Re: K090258
Trade/Device Name: Venturi™ NPWT v.II Advanced Vacuum System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: August 13, 2009 Received: August 13, 2009
Dear Mr. Van Dyke:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Jack Van Dyke
forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for use
510(k) # K090258
Device Name: Venturi™ NPWT v.II Advanced Vacuum System
Indications for Use:
Use of the Venturi™ NPWT v.II Advanced Vacuum System is indicated for use in patients that would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from a patients airway or respiratory support system either during surgery or at the patient's bedside.
Contraindications for Use:
The Venturi™ v.II NPWT system is contraindicated for use in the presence of:
Necrotic tissue Untreated osteomyelitis Fistula Wounds with malignant tissue Exposed vasculature, bone, nerves, or organs,
Prescription Use: X (Part 21 CFR 801 Subparts D) and/or
Over the Counter Use: (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krenzer MKM
(Division Siun-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090258
§ 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.