(106 days)
Use of the Venturi™ Negative Pressure Wound Therapy system is indicated for use for patients with acute or chronic wounds that may be benefited by the application of neqative pressure therapy and the potential wound healing effects of removal of fluids including wound exudates, irrigation fluids, and infectious materials. Venturi is intended for use in acute care settings only.
The Talley Venturi™ system consists of a powered suction pump for the application of vacuum to wounds for fluid removal. Consumables for use with the pump include collection canister, connection tubing, drain, and wound dressing products.
The provided document, K080897, is a 510(k) summary for the Talley Venturi™ Negative Pressure Wound Therapy system. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, primarily through technological characteristics and basic performance testing, rather than an elaborate clinical study with detailed acceptance criteria and performance metrics in the way a new, high-risk device might be evaluated.
Therefore, many of the requested elements for a study proving acceptance criteria are not explicitly present or are not applicable in this 510(k) submission. I will extract the information that is available and explain where the requested information is not provided by the document.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Canister Vacuum Test | Criteria: Loss of vacuum measured over a prescribed period. Units pass or fail. (Specific threshold values are not provided in the summary) Performance: Performed on 100% of production units to check for air-tightness and recognition of sensor pins. |
| Vacuum Pump Test | Criteria: Tested flow and pressure levels compared with defined minimum values to determine pass or fail. (Specific minimum values are not provided in the summary) Performance: Performed on 100% of production sub-assemblies. |
| Soak Test | Criteria: Device runs for 48 hours prior to final test. (Pass/fail criteria based on successful operation for 48 hours). Performance: Performed on 100% of assembled production pump units. |
| Final System Test | Criteria: All functions and buttons, correct pressure calibration, air tightness, canister recognition, warning systems and alarms, and charging system operational. (Specific quantitative thresholds for calibration, air tightness, etc., are not provided in the summary). Performance: Performed on 100% of production units. |
| Technological Equivalence | Criteria: Operates at the same pressure ranges as predicate devices; consumable accessories correspond to those of predicate devices. Performance: "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, tubing, drains, and wound dressing components, These accessories correspond with accessories available with the predicate devices." |
Study Details and Missing Information:
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document indicates that all performance tests (Canister Vacuum, Vacuum Pump, Soak, and Final System Tests) were performed on 100% of production units or sub-assemblies. This implies a continuous quality control process for manufacturing rather than a discrete "test set" in the context of a clinical study or performance verification using a limited sample.
- Data Provenance: Not explicitly stated. The tests described are manufacturing quality control checks, so the data would originate from the manufacturing facility. There is no mention of country of origin for clinical data, as this is not a clinical study. The testing described is prospective as it's part of the manufacturing process for each unit.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. The "ground truth" for the engineering performance tests (e.g., proper pressure, air-tightness) is established by predefined engineering specifications and calibration standards for the device components and system, not by clinical experts.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / None specified. The tests described are pass/fail engineering tests based on objective measurements against internal specifications. There is no expert adjudication process mentioned.
-
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 is for a Negative Pressure Wound Therapy system (a physical medical device, essentially a pump), not an AI/imaging diagnostic device. Therefore, MRMC studies and AI effectiveness are not applicable.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. As above, this is a physical medical device, not an algorithm. Performance is assessed based on the device's physical functions.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the engineering performance tests mentioned is based on predefined engineering specifications and calibration standards for vacuum, pressure, and operational functions.
- For the overall substantial equivalence claim, the "ground truth" is the performance and established safety of the predicate devices (Blue Sky Versatile 1 System K042134, K052456 and Boehringer Labs Suction Pump system K061788). The new device is deemed acceptable if its technological characteristics and performance are comparable.
-
The sample size for the training set:
- Not applicable. There is no "training set" in the context of an engineering performance study for a physical device like this. This would typically apply to machine learning algorithms.
-
How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant to the information provided.
{0}------------------------------------------------
510(k) Summary
Date 15 March 2008
Name: Talley Group, Ltd Premier Way, Abbey Park Romsey, Hants SO 51 9 DQ England
JUL 1 5 2008
U.S. Talley Medical 4740 Jadestone Dr. Williamston, MI 48895 Phone: 517-290-0089 Fax: 484-465-5842 Contact: Jack Van Dyke, Director US Operations
Trade Name: Venturi™ Negative Pressure Wound Therapy
Common Name: Powered Suction Pump
| Device Classification: | Class II |
|---|---|
| Product Code: JCX | |
| Regulation 878.4780 | |
| Classification Panel: General and Plastic Surgery | |
| Predicate Devices: | Blue Sky Versatile 1 System K042134, K052456 |
| Boehringer Labs Suction Pump system K061788 |
Device Description: The Talley Venturi™ system consists of a powered suction pump for the application of vacuum to wounds for fluid removal. Consumables for use with the pump include collection canister, connection tubing, drain, and wound dressing products.
Intended Use: The Talley Venturi™ system is intended for use for patients with acute or chronic wounds that may be benefited by the application of negative pressure therapy and the potential wound healing effects of removal of fluids including wound exudates, irrigation fluids, body fluids, and infectious materials.
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, tubing, drains, and wound dressing components, These accessories correspond with accessories available with the predicate devices.
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™ system is substantially equivalent to the predicate devices.
{1}------------------------------------------------
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The text is in all caps and is oriented to follow the curve of the circle.
Public Health Service
'APR - 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Talley Medical % Mr. Jack Van Dyke 4740 Jadestone Drive Williamston, Michigan 48895
Re: K080897
Trade/Device Name: Venturi™ Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: June 3, 2008 Received: June 10, 2008
Dear Mr. Van Dyke:
This letter corrects our substantially equivalent letter of July 15, 2008.
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 (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.
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
{2}------------------------------------------------
Page 2 - Mr. Jack Van Dyke
limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/dsma/dsmamain.html.
Sincerely yours,
Rottmo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for use
Venturi™ Negative Pressure Wound Therapy system
Indications for Use. Use of the Venturi™ Negative Pressure Wound Therapy system is indicated for use for patients with acute or chronic wounds that may be benefited by the application of neqative pressure therapy and the potential wound healing effects of removal of fluids including wound exudates, irrigation fluids, and infectious materials. Venturi is intended for use in acute care settings only.
Contraindications. The Venturi™ Negative Pressure Wound Therapy system is contraindicated in the presence of:
Necrotic tissue Untreated osteomyelitis Fistula Wounds with malignant tissue Exposed vasculature Exposed nerves Exposed anastomotic site Exposed bone or tendons Wounds with difficult hemostasis
Prescription Use × (21 CFR 801 Subpart D)
OR
Over the Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOWATHIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
| Concurrance of CDRH, Office of Device Evaluation (ODE) | A market of the program and the production of the program and the many of the may be |
|---|---|
| -------------------------------------------------------- | -------------------------------------------------------------------------------------- |
Division Sign-O Division of General, Restorative, and Neurological De
510(k) Number LC68977
§ 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.