(90 days)
Not Found
No
The device description and intended use focus on the physical components and function of a wound drape and negative pressure wound therapy system, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is an accessory to V.A.C. Therapy and V.A.C. VERAFLO Therapy Systems, which are integrated wound management systems 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. These actions represent therapeutic effects.
No
The device is described as an accessory to wound therapy systems intended to promote wound healing by creating a sealed environment and managing exudates. It does not perform any diagnostic function.
No
The device description clearly states that the V.A.C. DERMATAC™ Drape is a physical, semi-occlusive wound drape made of polyurethane film, acrylic adhesive, and silicone. It is an accessory to hardware-based negative pressure wound therapy systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an accessory to Negative Pressure Wound Therapy Systems. These systems are used to manage wounds by applying negative pressure, removing exudate, and promoting healing. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description details a semi-occlusive wound drape used to create a sealed environment for wound therapy. It describes the physical components and how it functions in conjunction with the therapy systems. There is no mention of analyzing samples from the body to provide diagnostic information.
- No mention of diagnostic testing: The document does not describe any process of analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or determine a treatment.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used in vivo (on the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
The V.A.C. DERMATAC™ Drape is an accessory to the following V.A.C.® Therapy Negative Pressure Wound Therapy Systems:
· ACTIV.A.C.M, V.A.C. SIMPLICITY™, V.A.C.VIA™ and V.A.C. FREEDOM™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute, extended and home care settings. · V.A.C.ULTA™ , INFOV.A.C.™ and V.A.C.RX4™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.
When used on open wounds, these systems are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention, reducing granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency) flaps and grafts.
When used on closed surgical incisions, they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
The V.A.C. DERMATAC™ Drape is also an accessory to the V.A.C. VERAFLO Therapy (Instillation) provided by the V.A.C.ULTA™ Therapy Unit.
V.A.C. VERAFLO™ Therapy 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.
V.A.C. VERAFLO™ Therapy 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.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The V.A.C. DERMATAC™ Drape is a semi-occlusive wound drape that is used as an accessory to the V.A.C.® Therapy and V.A.C. VERAFLO™ Therapy Systems. The V.A.C. DERMATAC™ Drape is a single-use, sterile covering that provides a sealed environment for delivery of these therapies. It also allows for a moist wound environment.
The drape consists of a polyurethane film with acrylic adhesive with a perforated silicone layer. The perforations in the silicone layer expose the acrylic adhesive coated on the polyurethane film. The acrylic adhesive secures the drape to the periwound skin, thus creating a sealed wound environment.
The therapy systems with which it is used are comprised of the following: Software controlled therapy unit that provides negative pressure and, in the case of V.A.C. VERAFLO™ Therapy, a pump for controlled delivery of topical wound solutions. Disposable canister which collects wound exudate and, in the case of V.A.C. VERAFLO™ Therapy, instilled solutions Foam dressing for placement into the wound Semi-occlusive drape that covers the dressing Tubing set that connects the dressing to the therapy unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound bed, chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts, closed surgical incisions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
acute, extended and home care settings, acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.
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)
Negative pressure performance testing was conducted using simulated wound exudate, maximum air leak rate, worst case dressing configuration and for the maximum use life of the dressings. The results documented that the V.A.C. DERMATAC Drape™ is capable of maintaining negative pressure within specification.
No clinical tests were required for a demonstration of substantial equivalence.
However, a usability assessment was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 18, 2020
KCI USA, Inc Margaret Marsh Regulatory Affairs Advanced Specialist 6203 Farinon Drive San Antonio, Texas 78249
Re: K200390
Trade/Device Name: V.A.C. DERMATAC Drape Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: February 17, 2020 Received: February 18, 2020
Dear Margaret 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Anjana Jain Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200390
Device Name V.A.C. DERMATACTM Drape
Indications for Use (Describe)
The V.A.C. DERMATACTM Drape is an accessory to the following V.A.C.® Therapy Negative Pressure Wound Therapy Systems:
· ACTIV.A.C.M, V.A.C. SIMPLICITY™, V.A.C.VIA™ and V.A.C. FREEDOM™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute, extended and home care settings. · V.A.C.ULTA™ , INFOV.A.C.™ and V.A.C.RX4™ Negative Pressure Wound Therapy Systems, which are integrated
wound management systems for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.
When used on open wounds, these systems are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention, reducing granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency) flaps and grafts.
When used on closed surgical incisions, they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
The V.A.C. DERMATAC™ Drape is also an accessory to the V.A.C. VERAFLO Therapy (Instillation) provided by the V.A.C.ULTA™ Therapy Unit.
V.A.C. VERAFLO™ Therapy 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.
V.A.C. VERAFLO™ Therapy 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) SUMMARY V.A.C. DÈŘMATAC™ Drape
| Submitter Information [21 CFR 807.92(a)(1)] | |
|---|---|
| Name | KCI USA, Inc. (Kinetic Concepts, Inc.) |
| Address | 6203 Farinon Drive |
| San Antonio, TX 78249 | |
| Phone number | 210 255-6481 |
| Fax number | 210-255-6727 |
| Establishment Registration | |
| Number | 3005178245 |
| Name of contact person | Margaret Marsh |
| Date prepared | May 18, 2020 |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or proprietary name | V.A.C. DERMATAC™ Drape |
| Common or usual name | Negative Pressure Wound Therapy System component |
| Classification name | Negative Pressure Wound Therapy Powered Suction Pump (and components) |
| Classification panel | General and Plastic Surgery |
| Regulation | 878.4780 |
| Product Code(s) | OMP |
| Legally marketed device(s) | |
| to which equivalence is | |
| claimed | |
| [21 CFR 807.92(a)(3)] | V.A.C. DERMATAC™ Drape, cleared under 510(k) K181505. |
| Device description | |
| [21 CFR 807.92(a)(4)] | The V.A.C. DERMATAC™ Drape is a semi-occlusive wound drape that is |
| used as an accessory to the V.A.C.® Therapy and V.A.C. VERAFLO™ | |
| Therapy Systems. The V.A.C. DERMATAC™ Drape is a single-use, | |
| sterile covering that provides a sealed environment for delivery of these | |
| therapies. It also allows for a moist wound environment. |
The drape consists of a polyurethane film with acrylic adhesive with a
perforated silicone layer. The perforations in the silicone layer expose the
acrylic adhesive coated on the polyurethane film. The acrylic adhesive
secures the drape to the periwound skin, thus creating a sealed wound
environment.
The therapy systems with which it is used are comprised of the following:
Software controlled therapy unit that provides negative pressure
and, in the case of V.A.C. VERAFLO™ Therapy, a pump for
controlled delivery of topical wound solutions.Disposable canister which collects wound exudate and, in the case
of V.A.C. VERAFLO™ Therapy, instilled solutionsFoam dressing for placement into the woundSemi-occlusive drape that covers the dressingTubing set that connects the dressing to the therapy unit. |
| | V.A.C. DERMATAC™ Drape |
| Indications for use
[21 CFR 807.92(a)(5)] | The V.A.C. DERMATAC™ Drape is an accessory to the following V.A.C.®
Therapy Negative Pressure Wound Therapy Systems: |
| | ACTIV.A.C.™, V.A.C. SIMPLICITY™, V.A.C.VIA™ and V.A.C.
FREEDOM™ Negative Pressure Wound Therapy Systems, which are
integrated wound management systems for use in acute, extended and
home care settings. The V.A.C.ULTA™, INFOV.A.C™. and V.A.C.RX4™ Negative
Pressure Wound Therapy Systems are integrated wound management
systems for use in acute care settings and other professional
healthcare environments where product use is conducted by or under
the supervision of a qualified healthcare professional. |
| | When used on open wounds, these systems are 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 chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness
burns, ulcers (such as diabetic, pressure or venous insufficiency) flaps and
grafts. |
| | When used on closed surgical incisions, they are intended to manage the
environment of surgical incisions that continue to drain following sutured or
stapled closure by maintaining a closed environment and removing
exudates via the application of negative pressure wound therapy. |
| | The V.A.C. DERMATAC™ Drape is also an accessory to the V.A.C.
VERAFLO™ Therapy (Instillation) provided by the V.A.C.ULTA™ Therapy
Unit. |
| | V.A.C. VERAFLO™ Therapy 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. |
| | V.A.C. VERAFLO™ Therapy 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. |
| Comparison of the Technological Characteristics (i.e., design, material, chemical composition, energy
source) with the Predicate Device [21 CFR 807.92(a)(6)] | |
| | There is no difference between the subject and predicate drapes in terms of materials of construction, |
5
510(k) SUMMARY (
packaging, sterilization, method of application, indicated wound types, as well as use with the V.A.C.® Negative Pressure Wound Therapy provided by the V.A.C.ULTA™, ACTIV.A.C. ™, V.A.C. SIMPLICITY™, V.A.C.VIA™, V.A.C. FREEDOM™, INFOV.A.C™, and V.A.C.RX4™ Therapy Units.
The only significant difference between the subject and predicate drapes is in the intended use, which has been expanded to include use with the V.A.C. VERAFLO™ Therapy, also provided by the V.A.C.ULTA™ Therapy Unit.
6
510(k) SUMMARY V.A.C. DERMATAC™ Drape
Performance Data [21 CFR 807.92(b)]
Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]
- Negative pressure performance testing was conducted using simulated wound exudate, maximum air . leak rate, worst case dressing configuration and for the maximum use life of the dressings. The results documented that the V.A.C. DERMATAC Drape™ is capable of maintaining negative pressure within specification.
Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b)(2)]
No clinical tests were required for a demonstration of substantial equivalence.
However, a usability assessment was conducted.
Conclusions drawn [21 CFR 807.92(b)(3)]
Tthe subject device is substantially equivalent to the predicate device with respect to indications, and technological characteristics. There are no new questions regarding safety or effectiveness.