V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U

• K Number: K100657
• Device Name: V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U
• Manufacturer: KCI USA, INC. (KINETIC CONCEPTS, INC.)
• Date Cleared: 2010-09-17 ( 193 days)
• Product Code: OMP
• Regulation Number: 878.4780
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K021501 , K091585

Intended Use

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, partialthickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

Device Description

A negative pressure wound therapy system with an instillation feature which allows controlled delivery and drainage of topical wound treatment solutions and suspensions

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the V.A.C.Ulta™ Negative Pressure Wound Therapy System, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Negative Pressure Wound Therapy (NPWT) Delivery: Delivery of NPWT at -50, -125, and -200 mmHg in a comparable manner to currently marketed V.A.C. NPWT Systems.	Equivalent negative pressure wound therapy delivered. Testing demonstrated that the V.A.C.Ulta System delivers equivalent negative pressure wound therapy at -50, -125 and -200 mmHg compared to currently marketed V.A.C. NPWT Systems.
Combined NPWT and Intermittent Fluid Instillation Performance: Ability to deliver both NPWT and intermittent fluid instillation within specification over a continuous 96-hour period.	System met performance specifications. Testing demonstrated the system met performance specifications over a continuous 96-hour period for the delivery of both NPWT and intermittent fluid instillation.
Fluid Instillation Accuracy and Safety: Ability to instill fluids within specified ranges and volumes, provide alarms and controls during negative pressure and instillation therapy, and provide a maximum flow rate equivalent to the predicate device.	All requirements were met. Testing demonstrated that all requirements pertaining to fluid instillation accuracy, volume, alarm and control functions during therapy, and maximum flow rate equivalence to the predicate device were met.
New Foam Dressing Mechanical Properties: Demonstrate appropriate mechanical properties for use during instillation.	Appropriate mechanical properties confirmed. Mechanical properties testing of the new foam dressing confirmed appropriate mechanical properties for use during instillation.
New Drape Peel Force: Peel force equivalent to the currently marketed V.A.C. Drape.	Equivalent to currently marketed V.A.C. Drape. Peel force testing of the new drape documents that it is equivalent to the currently marketed V.A.C. Drape.
Software Verification and Validation: Conformance of software to the requirements of the software requirements specification.	Software meets requirements. Software verification and validation testing confirms that the software meets the requirements of the software requirements specification.
Biocompatibility: Conformance to ISO 10993-1 standards.	Device is biocompatible. Biocompatibility testing was performed in accordance with ISO 10993-1 standards, and results demonstrated that the device is biocompatible according to these standards.

Study Details

1. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document does not specify sample sizes for the test set (number of devices tested, number of dressings, etc.).
   • The document does not specify the data provenance (country of origin, retrospective/prospective). All tests appear to be bench tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • The document does not mention the use of experts to establish a ground truth for the test set. The tests described are engineering/bench tests against specified performance parameters.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This is not applicable as the studies described are bench tests with quantifiable outcomes against design specifications, not subjective assessments requiring adjudication.

4. 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 therapy system, not an AI or imaging diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is a medical device, not an algorithm. The "standalone" performance here refers to the device's ability to meet its specifications independently, which was assessed through the described bench testing.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" for the tests appears to be the design specifications and established predicate device performance for the V.A.C.Ulta™ System. For example, NPWT delivery was compared to "currently marketed V.A.C. NPWT Systems," and flow rates were compared to the "predicate." Biocompatibility was assessed against ISO 10993-1 standards.

7. The sample size for the training set:

   • This is not applicable. The device is a physical medical system, not a machine learning model, so there is no "training set."

8. How the ground truth for the training set was established:

   • This is not applicable. As there is no training set for a machine learning model, no ground truth was established for it.

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.