(139 days)
The V.A.C.Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
Negative Pressure Wound Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.
The V.A.C.Ulta Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
A dressing component of a negative pressure wound therapy system with an instillation feature which allows controlled delivery and drainage of topical wound treatment solutions and suspensions
The V.A.C. VeraFlo Cleanse Dressing System is a dressing component of a negative pressure wound therapy (NPWT) system with an instillation feature. The device allows for controlled delivery and drainage of topical wound treatment solutions and suspensions.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria or specific performance metrics with target values. Instead, it describes various tests conducted to assure "conformance to design specifications" and concludes that the device "was shown to meet all performance requirements."
However, we can infer the general performance aspects evaluated:
| Acceptance Criteria (Inferred from tests) | Reported Device Performance |
|---|---|
| Functional Performance: | |
| Negative pressure distribution | Bench test with simulated wound model was conducted. Result: Device performance met specifications (implied, as it was deemed to meet "all performance requirements"). |
| Fluid distribution in dressing and simulated wound bed (instillation) | Visual observation (bench test with simulated wound model) was conducted. Result: Device performance met specifications (implied, as it was deemed to meet "all performance requirements"). |
| Mechanical Properties (Tensile and Tear Strength) | Tested per ASTM 3574-08 standards. Result: Device performance met specifications (implied, as it was deemed to meet "all performance requirements"). |
| Biological Performance (Wound Healing/Interaction): | |
| Granulation tissue formation and wound fill response | Evaluated in an acute swine model. Result: Device performance met specifications (implied, as it was deemed to meet "all performance requirements"). This indicates the dressing system effectively promotes desired wound healing responses. |
| Biocompatibility (Cytotoxicity, irritation, and sensitization) | Tested in accordance with ISO 10993-1 standards. Result: Demonstrated that the device is biocompatible according to these standards. |
| Overall Equivalence to Predicate Device: | |
| Substantial equivalence in indications for use and technology to predicate product | Conclusion: Testing demonstrates that the V.A.C. VeraFlo Cleanse System is substantially equivalent in terms of both indications for use and technology to the predicate product (V.A.C. VeraFlo Dressing, K100657). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes for each test. For the "acute swine model," it implies at least one swine was used, but the specific number is not provided. Bench tests typically involve multiple units or repetitions but the number is not stated.
- Data Provenance: The studies are described as "design verification and validation tests." They appear to be prospective studies conducted by the manufacturer (KCI, Inc.) for regulatory submission. The country of origin of the data is not explicitly stated, but given the manufacturer's address in San Antonio, Texas, USA, and the FDA submission, it is highly likely the studies were conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies listed are primarily technical performance tests and an animal model study, which typically do not involve human expert consensus for "ground truth" in the same way clinical diagnostic AI studies might. For the swine model, the assessment of "granulation tissue formation and wound fill response" would be made by veterinary or medical researchers with expertise in wound healing, but their specific number or qualifications are not detailed. Biocompatibility testing follows established ISO standards, where the "ground truth" is defined by the test itself.
4. Adjudication Method for the Test Set
This information is not applicable/not provided as the studies are engineering/animal performance tests rather than clinical studies requiring adjudication of human readings or diagnoses.
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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a medical device (dressing system), not a diagnostic AI or imaging interpretation algorithm designed to assist human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not directly applicable to the device. The V.A.C. VeraFlo Cleanse Dressing System is a physical dressing component of a Negative Pressure Wound Therapy system, not an algorithm. The software mentioned provides "controls for both negative pressure wound therapy and delivery of instillation therapy" and "controls for help and alarm functions," but it's an embedded control system, not a standalone diagnostic or interpretative algorithm. The performance evaluation focuses on the physical and biological interaction of the dressing system with the wound, not on standalone algorithm performance.
7. The Type of Ground Truth Used
The ground truth for the various tests can be described as follows:
- Functional Performance (Pressure, Fluid Distribution, Mechanical Properties): The ground truth is defined by engineering specifications and established physical principles. For example, pressure distribution would be compared against a desired range, and mechanical properties against industry standards (ASTM).
- Granulation Tissue Formation and Wound Fill Response: The ground truth is established through histological analysis, gross observation, and quantitative measurements in the animal model, interpreted by domain experts (e.g., veterinary pathologists, wound care researchers). This is akin to pathology findings and observational outcomes data in a controlled model.
- Biocompatibility: The ground truth is defined by international standards (ISO 10993-1), where passing specific cytotoxicity, irritation, and sensitization tests according to the defined protocols constitutes meeting the ground truth for biocompatibility.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The V.A.C. VeraFlo Cleanse Dressing System is a physical medical device. It does not utilize machine learning or AI algorithms in a way that requires a "training set" for model development. The software mentioned provides control functions, which are typically developed through traditional software engineering and testing, not AI model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided as there is no "training set" for this type of medical device.
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510(k) SUMMARY
MAR 1 4 2011
| Date prepared | February 16, 2011 |
|---|---|
| 510(k) owner | KCI, Inc. |
| Name | KCI USA, Inc. (Kinetic Concepts, Inc.) |
| Address | 6203 Farinon Drive; San Antonio, Texas 78249 |
| Fax number | 210 255-6727 |
| Name of contact person | Margaret Marsh |
| Contact telephone number | 1 800 275-4524; Request Regulatory Affairs. |
| Name of the device | |
| Trade or proprietary name | V.A.C. VeraFlo Cleanse Dressing System |
| Common or usual name | Negative pressure wound therapy dressing |
| Classification name | Dressing component for use with a Negative Pressure Wound TherapyPowered Suction Pump |
| Legally marketed device(s) to which equivalence is claimed | V.A.C. VeraFlo Dressing, a component of the V.A.C.Ulta NegativePressure Wound Therapy System (K100657) |
| Device description | A dressing component of a negative pressure wound therapy system withan instillation feature which allows controlled delivery and drainage oftopical wound treatment solutions and suspensions |
| Device design | Negative pressure wound therapy system, in which instillation of topicalwound treatment solutions and suspensions and negative pressurewound therapy is provided via software controlled pumps. Instillationsolutions and negative pressure are delivered through tubing to foamdressings in the wound covered by an occlusive drape. Softwareprovides controls for both negative pressure wound therapy and deliveryof instillation therapy. Software also provides controls for help and alarmfunctions. |
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| Intended use of thedevice | The V.A.C.Ulta Negative Pressure Wound Therapy System is anintegrated wound management system that provides Negative PressureWound Therapy with an instillation option. | ||
|---|---|---|---|
| Negative Pressure Wound Therapy in the absence of instillation isintended to create an environment that promotes wound healing bysecondary or tertiary (delayed primary) intention by preparing the woundbed for closure, reducing edema, promoting granulation tissue formationand perfusion, and by removing exudate and infectious material. | |||
| The instillation option is indicated for patients who would benefit fromvacuum assisted drainage and controlled delivery of topical woundtreatment solutions and suspensions over the wound bed. | |||
| The V.A.C.Ulta Negative Pressure Wound Therapy System with andwithout instillation is indicated for patients with chronic, acute, traumatic,sub-acute and dehisced wounds, partial-thickness burns, ulcers (such asdiabetic, pressure and venous insufficiency), flaps and grafts. | |||
| Summary of thetechnologicalcharacteristics ofthe device,compared to thepredicate device. | Feature | VeraFlo CleanseDressing | VeraFlo Dressing(predicate) |
| Dressingsystemcomponents | Same as predicate | Foam based dressing withocclusive drape andnegative pressure/instillation tubing | |
| Patientcontactmaterials ofconstruction | Same as predicate, exceptfor slightly less colorant | Polyurethane ester foamwith polyurethane drape |
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| Summary of testsconducted | The V.A.C. VeraFlo Cleanse System was evaluated under a number ofdesign verification and validation tests that assure conformance to designspecifications.The following tests were conducted on the V.A.C. VeraFlo CleanseSystem: Negative pressure distribution measurements (bench test withsimulated wound model). Visual observation of fluid distribution in the dressing andsimulated wound bed (bench test with simulated wound model). Mechanical properties (tensile and tear strength per ASTM 3574-08 tests) Granulation tissue formation and wound fill response in an acuteswine model. Cytotoxicity, irritation, and sensitization testing was performed inaccordance to ISO 10993-1 standards, and results demonstratedthat the device is biocompatible according to these standards. The device was shown to meet all performance requirements. |
|---|---|
| Conclusions drawn | Testing demonstrates that the V.A.C. VeraFlo Cleanse System issubstantially equivalent in terms of both indications for use andtechnology to the predicate product. |
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
KCI USA % Ms. Margaret Marsh Regulatory Affairs Technical Director 6203 Farinon Drive San Antonio, Texas 78249
MAR 1 4 201
Re: K103156
Trade/Device Name: V.A.C. VeraFlo Cleanse Dressing System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: February 16, 2011 Received: February 17, 2011
Dear Ms. Marsh:
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. Ilsting 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
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Page 2 - Ms. Margaret Marsh
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 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 Pat 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/MedicalDevices/Safcty/Reportal?roblem/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 Small Manufacturers, International and Consumer Assistance 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.
Alig 13. R. h
for
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) Number (if known):
Device Name: V.A.C. VeraFlo Cleanse Dressing System
Indications for Use:
(Posted November 13, 2003)
The V.A.C.Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
Negative Pressure Wound Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.
The V.A.C.Ulta Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krosky MXM
(Division Sign-Off) Page _ of _
Division of Surgical, Othopedic, and Restorative Devices
510(k) Number K03156
§ 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.