(123 days)
Not Found
No
The summary describes a negative pressure wound therapy system and dressing with no mention of AI or ML capabilities. The performance studies focus on mechanical properties and fluid distribution, not algorithmic performance.
Yes
The device is described as an "integrated wound management system" that "promotes wound healing," "reduces edema," and "removes exudate and infectious material," all of which are therapeutic actions aimed at treating a medical condition.
No
The V.A.C. Ulta Negative Pressure Wound Therapy System is described as an "integrated wound management system" that promotes wound healing and delivers topical wound treatment solutions. Its function is therapeutic, not diagnostic.
No
The device description explicitly details physical components (dressing system with multiple layers) and bench testing of mechanical properties, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system for wound management using negative pressure and instillation of topical solutions. This is a therapeutic and wound care application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical components of a dressing system designed to be used with a negative pressure wound therapy system. This aligns with a medical device for treatment, not a diagnostic device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes) in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly described as a system for treating wounds, not for diagnosing conditions based on in vitro analysis.
N/A
Intended Use / Indications for 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, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
The V.A.C. VeraFlo Cleanse Choice Dressing System is intended to be used with the V.A.C. Ulta Negative Pressure Wound Therapy System.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The V.A.C. VeraFlo Cleanse Choice Dressing System is intended for use with the V.A.C. Ulta Negative Pressure Wound Therapy System to deliver negative pressure wound therapy (NPWT) as well as facilitate the instillation of fluid to the wound.
The V.A.C. VeraFlo Cleanse Choice Dressing System has the same basic components as the predicate V.A.C. VeraFlo Cleanse Dressing cleared under K103156. The only difference between the two systems is the configuration of the dressing.
The subject system has a dressing that is designed with 3 separate layers. The predicate dressing, on the other hand, is a single spiral shaped rod configuration. The materials of the dressing are the same.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Verification testing was performed to confirm:
- mechanical properties (tensile testing)
- the dressing, as part of the V.A.C. Ulta Negative Pressure Wound Therapy System creates negative pressure within the sealed wound bed
- the dressing distributes instillation solution throughout the wound surface
Bench and animal testing have demonstrated that the subject V.A.C VeraFlo Cleanse Choice Dressing System is substantially equivalent to the predicate V.A.C VeraFlo Cleanse Dressing System (K103156).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mechanical Properties (Tensile Strength): Pass (≥230kPa for predicate)
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.
VeraFlo Cleanse Dressing System (K103156)
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.
Not Found
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).
Not Found
§ 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.
0
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 stylized eagle with three overlapping bodies, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2016
Kci Usa, Inc. (kinetic Concepts, Inc.) % Melanie Avila Senior Manager, Regulatory Affairs Kci Usa, Inc. 6203 Farinon Drive San Antonio, Texas 78249
Re: K160451
Trade/Device Name: V. A.c. Veraflo Cleanse Choice Dressing System For Use With The V.a.c. Ulta ... Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: February 16, 2016 Received: February 18, 2016
Dear Melanie Avila:
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 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
2
Indications for Use
510(k) Number (if known) K160451
Device Name
V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta Negative Pressure Wound Therapy System
Indications for Use (Describe)
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. Uta Negative Pressure Wound Therapy System with and without 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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------- |
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3
In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary for the V.A.C. VeraFlo Cleanse Choice Dressing System is provided below.
SUBMITTER 1.
KCI USA, Inc. 6203 Farinon Drive San Antonio, TX 78249
Contact Person: Melanie Avila Senior Manager, Regulatory Affairs KCI USA, Inc. Telephone: 210-515-4059 Fax: 210-255-6727 Email: melanie.avila@kci1.com Date Prepared: February 16, 2016
2. DEVICE
Name of Device: V.A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta Negative Pressure Wound Therapy (NPWT) System Common Name: Negative Pressure Wound Therapy Powered Suction Pump Classification Regulation: 21 CFR 878.4780 Regulatory Class: II Product Code: OMP Panel: General and Plastic Surgery
PREDICATE DEVICE 3.
Predicate Device: VeraFlo Cleanse Dressing System (K103156)
DEVICE DESCRIPTION 4.
The V.A.C. VeraFlo Cleanse Choice Dressing System is intended for use with the V.A.C. Ulta Negative Pressure Wound Therapy System to deliver negative pressure wound therapy (NPWT) as well as facilitate the instillation of fluid to the wound.
The V.A.C. VeraFlo Cleanse Choice Dressing System has the same basic components as the predicate V.A.C. VeraFlo Cleanse Dressing cleared under K103156. The only difference between the two systems is the configuration of the dressing.
The subject system has a dressing that is designed with 3 separate layers. The predicate dressing, on the other hand, is a single spiral shaped rod configuration. The materials of the dressing are the same.
4
INDICATIONS FOR USE 5.
The V.A.C. VeraFlo Cleanse Choice Dressing System is intended to be used with the V.A.C. Ulta Negative Pressure Wound Therapy System. The indications for use as follows:
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.
Both the subject system and the predicate system are intended for use with the V.A.C. Ulta Negative Pressure Wound Therapy System. Both systems have the ability to deliver topical wound solutions and suspensions in the wound bed as well as delivery of negative pressure wound therapy. There is no change to the indications for use.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.
Similarities 6.1.
The V.A.C VeraFlo Cleanse Choice Dressing System is nearly identical to that of the predicate V.A.C VeraFlo Cleanse Dressing System (cleared under K103156). Both systems have the same materials, sterilization, and packaging.
The subject V.A.C. VeraFlo Cleanse Choice Dressing System has the same basic components as the predicate V.A.C. VeraFlo Cleanse Dressing System cleared under K103156. Both dressings of these systems are made from the identical open cell, reticulated, grey polyurethane ester foam stock material.
6.2. Differences
The only difference between the proposed and the predicate system is the configuration of the dressing component. The subject system has a dressing that is provided in three separate layers in an oval shape to allow for flexibility in treating wounds of various depths. The predicate dressing is a tubular shaped rod and is split along the longitudinal axis by the user for ease of configuring.
For convenience purposes, the table below compares the subject and predicate systems.
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| Proposed Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K160451 | K103156 |
| Applicant | Same as predicate | KCI USA, Inc. |
| Trade name | V. A.C. VeraFlo Cleanse Choice | |
| Dressing System for use with the | ||
| V.A.C. Ulta Negative Pressure | ||
| Wound Therapy System | V. A.C. VeraFlo Cleanse Dressing System for use | |
| with the V.A.C. Ulta Negative Pressure Wound | ||
| Therapy System | ||
| Classification | ||
| Regulation | Same as predicate | 878.4780 |
| Product Code | Same as predicate | OMP |
| Indications for | ||
| Use | Same as predicate | 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. | ||
| The V.A.C.Ulta Negative Pressure Wound Therapy | ||
| System 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. | ||
| Dressing | ||
| System | ||
| Components | Same as predicate | V.A.C. VeraT.R.A.C. Pad Assembly |
| V.A.C. VeraFlo Cleanse Choice | ||
| Dressing has 3 layer design | V.A.C. VeraFlo Cleanse Dressing has a tubular | |
| shaped rod design | ||
| Same as predicate | V.A.C. Ruler | |
| Same as predicate | 3MTM CavilonTM Skin Prep | |
| Same as predicate | V.A.C. Advanced Drape | |
| NPWT | ||
| Therapy | ||
| System Design | Same as predicate | The VeraFlo Cleanse Dressing System is intended |
| for use with the V.A.C. Ulta NPWT system. | ||
| The NPWT system consists of: | ||
| • Software controlled therapy unit | ||
| • Canister | ||
| Proposed Device | Predicate Device | |
| Negative pressure tubing and sensing pad Instillation tubing and pad Foam wound dressing and polyurethane occlusive drape | ||
| NPWT System | ||
| Operating | ||
| Principle | Same as predicate | The V.A.C. Ulta NPWT system delivers software |
| controlled negative pressure to the wound site. The | ||
| open cells of the foam dressing to which the therapy | ||
| unit is connected enable distribution of the negative | ||
| pressure across the surface of the wound, while the | ||
| tubing transfers accumulated fluids to the canister. | ||
| The NPWT system also provides automated delivery | ||
| of instillation fluids into the wound bed between | ||
| negative pressure therapy cycles. | ||
| Materials | Skin contact material: | |
| Same as predicate | Skin contact material: | |
| Occlusive drape (polyurethane film with acrylic | ||
| adhesive) | ||
| Wound contact material: | ||
| Same as predicate | Wound contact material: | |
| Polyurethane ester foam | ||
| Same as predicate | 0.1% w/v carbon black colorant | |
| Same as predicate | Density in lb/ft3: 5.1 - 6.3 | |
| Performance | ||
| Testing | Same as predicate | Verification testing was performed to confirm: |
| mechanical properties (tensile testing) the dressing, as part of the V.A.C. Ulta Negative | ||
| Pressure Wound Therapy System, delivers | ||
| negative pressure the dressing distributes instillation solution | ||
| throughout the wound surface | ||
| Mechanical | ||
| Properties | ||
| (Tensile | ||
| Strength) | Pass | ≥230kPa |
| Sterilization | Same as predicate | Gamma Irradiation to SAL of 10-6 |
| Sterile | ||
| Packaging | Same as predicate | Thermoformed tray of PETG with a Tyvek lid |
| Shelf life | Same as predicate | 2 years |
6
7
7. PERFORMANCE DATA
Bench Verification testing was performed to confirm:
- mechanical properties (tensile testing) ●
- the dressing, as part of the V.A.C. Ulta Negative Pressure Wound Therapy System creates negative pressure within the sealed wound bed
- the dressing distributes instillation solution throughout the wound surface
CONCLUSIONS 8.
The only difference between the proposed and the predicate dressing systems is the configuration of the dressing. The subject system has a dressing that is provided in three separate layers in an oval shape to allow for flexibility in treating wounds of various depths. The predicate dressing is a tubular shaped rod and is split along the longitudinal axis by the user for ease of configuring.
Bench and animal testing have demonstrated that the subject V.A.C VeraFlo Cleanse Choice Dressing System is substantially equivalent to the predicate V.A.C VeraFlo Cleanse Dressing System (K103156).