(294 days)
No
The device description and performance studies focus on the physical properties and function of a wound drape, with no mention of AI or ML.
Yes
The device is described as an accessory to Negative Pressure Wound Therapy Systems, which are themselves integrated wound management systems intended to promote wound healing. The drape specifically contributes to creating an environment that allows for the delivery and maintenance of negative pressure at the wound site, directly supporting the therapeutic function of the overall system.
No
The V.A.C. DERMATAC Drape is described as an accessory to Negative Pressure Wound Therapy Systems, intended to create an environment that promotes wound healing by secondary or tertiary intention and to manage the environment of surgical incisions. Its functions, as detailed in the "Device Description" and "Summary of Performance Studies," relate to maintaining a sealed environment, enabling negative pressure delivery, and collecting exudate, which are all therapeutic and protective functions, not diagnostic ones. There is no mention of the device providing information about a patient's medical condition or aiding in diagnosis.
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 a perforated silicone layer. It is an accessory to a Negative Pressure Wound Therapy System which includes a software-controlled unit, but the drape itself is a physical component.
Based on the provided information, the V.A.C. DERMATAC Drape is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device as an accessory to Negative Pressure Wound Therapy Systems. Its function is to create a sealed environment for wound healing by applying negative pressure and removing exudate. This is a direct therapeutic intervention applied to the body.
- Device Description: The description details a physical drape with adhesive properties used to seal a wound. It does not mention any components or processes related to examining specimens derived from the human body for diagnostic purposes.
- Lack of Diagnostic Activity: The document does not describe any analysis of biological samples (blood, tissue, etc.) or any diagnostic claims. The device's function is entirely focused on managing the wound environment.
- Performance Studies: The performance studies listed are related to the physical properties of the drape (biocompatibility, shelf life, adhesive strength, moisture transmission, negative pressure maintenance) and human factors, not diagnostic accuracy or performance.
In Vitro Diagnostic devices are specifically designed to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The V.A.C. DERMATAC Drape does not perform any of these functions.
N/A
Intended Use / Indications for Use
The V.A.C. DERMATACTM Drape is an accessory to the:
· ACTIV.A.C.™, INFOV.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.
· V.A.C.ULTA™ 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, they 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 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 closed environment and removing exudates via the application of negative pressure wound therapy.
Product codes
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 System. The V.A.C. DERMATAC Drape is single-use and it is provided sterile. The V.A.C DERMATAC Drape provides a sealed environment which allows for a moist wound environment and it allows for the delivery and maintenance of negative pressure at the wound site.
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 and the silicone layer primarily provides a seal for negative pressure.
The V.A.C. Therapy System is comprised of the following:
- . Software controlled neqative pressure therapy unit
- . Disposable canister which collects wound exudate
- . Polyurethane foam dressing
- Semi-occlusive wound drape
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wound site, periwound
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Acute, extended and home care settings. 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
Summary of non-clinical tests conducted for determination of substantial equivalence:
- Testing to confirm DERMATAC Drape is biocompatible according to various ISO 10993 parts (1, 10, 11, 12, 17, 18, 3, 5).
- Shelf Life package integrity testing of DERMATAC Drape sterile barrier packaging following 3 cycles of EtO sterilization and ship distribution of product accelerated aged to an equivalent real time of 2 year (T=2yr AA) was conducted using seal strength and bubble emission methods. The drape met all requirements.
- Adhesive Peel Test: drape was adhered to stainless steel plate and the force required to remove the drape was measured. The results documented demonstrate that DERMATAC Drape meets specification requirements.
- Moisture Vapor Transmission Rate Test: drape met minimum requirements when using the ASTM E96/E96M Upright Cup Method at 38°C and 10%RH for MVTR.
- Negative Pressure Maintenance System Test: 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 negative pressure performance test also included re-application cycling to demonstrate that the drape is capable of being applied, lifted and re-applied. The results documented that DERMATAC Drape is capable of maintaining negative pressure within specification.
- Peel Adhesion with Re-Application Cycling Testing: drape was applied, removed and then re-applied multiple times and then subjected to peel force evaluation. Results demonstrated that the drape was capable of meeting specification for peel adhesion after multiple re-application and removals.
In all instances, V.A.C. DERMATAC Drape functioned as intended and all test results observed were as expected.
No clinical tests were necessary, however human factors engineering assessment with 30 representative users indicated that the new user interface could be safely and effectively used by all test subjects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K063692, K063740, K111280, K032310, K173447, K162790, K160487
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION".
March 28, 2019
KCI USA, Inc. Melanie Avila Senior Manager, Regulatory Affairs 6203 Farinon Drive San Antonio, Texas 78249
Re: K181505
Trade/Device Name: V.A.C. DERMATACTM Drape Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: February 20, 2019 Received: February 21, 2019
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. 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.
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kimberly Ferlin -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) K181505
Device Name V.A.C. DERMATAC Drape
Indications for Use (Describe) The V.A.C. DERMATACTM Drape is an accessory to the:
· ACTIV.A.C.™, INFOV.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.
· V.A.C.ULTA™ 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, they 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 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 closed environment and removing exudates via the application of negative pressure wound therapy.
| 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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Image /page/3/Picture/0 description: The image shows the KCI logo. The logo features a sphere with a purple design on the left side, followed by the letters "KCI" in gray. Below the letters, the text "AN ACELITY COMPANY" is written in a smaller font size.
510(k) SUMMARY V.A.C. DERMATAC Drape
Submitter
KCI USA, Inc.
6203 Farinon San Antonio, TX 78249
Phone: 210-515-4059 Facsimile: 210-255-6727
Contact Person: Melanie Avila
Date Prepared: March 28, 2019
Name of Device: V.A.C. DERMATAC™ Drape
Common or Usual Name: Negative Pressure Wound Therapy System
Classification Name: Negative Pressure Wound Therapy Powered Suction Pump (and components)
Regulatory Class: 878.4780
Product Code: OMP
Predicate Device: V.A.C. Negative Pressure Wound Therapy Dressing System, cleared under 510(k) K133276
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 System. The V.A.C. DERMATAC Drape is single-use and it is provided sterile. The V.A.C DERMATAC Drape provides a sealed environment which allows for a moist wound environment and it allows for the delivery and maintenance of negative pressure at the wound site.
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
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Image /page/4/Picture/0 description: The image is a logo for KCI, an Acelity company. The logo features a sphere with a purple design on the left, followed by the letters "KCI" in a bold, sans-serif font. Below the letters, the words "AN ACELITY COMPANY" are written in a smaller font size.
acrylic adhesive secures the drape to the periwound and the silicone layer primarily provides a seal for negative pressure.
The V.A.C. Therapy System is comprised of the following:
- . Software controlled neqative pressure therapy unit
- . Disposable canister which collects wound exudate
- . Polyurethane foam dressing
- Semi-occlusive wound drape
Indications for Use
The V.A.C. DERMATAC™ Drape is an accessory to the:
· ACTIV.A.C.T™, INFOV.A.C.T™, 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™ 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, they 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 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.
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Image /page/5/Picture/0 description: The image shows the KCI logo. The logo consists of a sphere with a purple and white gradient on the left side and the letters "KCI" in gray on the right side. Below the letters, the words "AN ACELITY COMPANY" are written in a smaller font.
| Summary of the technological characteristics of the device compared to the predicate device
| [21 CFR 807.92(a)(6)] | |||
|---|---|---|---|
| Characteristic | Subject Device: V.A.C. | ||
| DERMATAC Drape | |||
| K181505 | Predicate Device: V.A.C. | ||
| NPWT Dressing System, | |||
| cleared under K133276 | Reference Devices: | ||
| Intended Use | Same as predicate | To provide a sealed | |
| environment, which allows | |||
| for the delivery and | |||
| maintenance of negative | |||
| pressure at the wound site | |||
| as well as protecting the | |||
| wound site from external | |||
| contamination. | Same as predicate | ||
| Indicated Wound Types | Same as predicate | Chronic Acute Traumatic Subacute Dehisced wounds Partial-thickness burns Ulcers (such as | |
| diabetic, pressure or | |||
| venous insufficiency) Flaps and grafts Surgically closed | |||
| incisions | Same as predicate | ||
| Dressing system | |||
| components | Same as predicate | Drape with adhesive Sensing pad and | |
| tubing Foam dressing | Same as predicate | ||
| Care Setting | Same as predicate | The V.A.C. NPWT | |
| Dressing System can be | |||
| used both in the Acute and | |||
| Post-Acute setting. | Same as predicate | ||
| Shelf life | 1 year | 3 years | N/A |
| ACTIVAC Therapy | |||
| Unit (K063692) INFOVAC Therapy | |||
| Unit (K063740) V.A.C. SIMPLICITY | |||
| (K111280) V.A.C. FREEDOM | |||
| (K032310) V.A.C.VIA (K173447) V.A.C.ULTA | |||
| (K162790) V.A.C.RX4 (K160487) |
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Image /page/6/Picture/0 description: The image is a logo for KCI, an Acelity company. The logo features a gray sphere with a purple swirl at the bottom left, followed by the gray letters "KCI" in a sans-serif font. Below the letters, in a smaller font, is the text "AN ACELITY COMPANY".
Summary of Technological Characteristics
At a high level, the subject and predicate devices are based on the following same technological elements.
Performance Data
Summary of non-clinical tests conducted for determination of substantial equivalence
- . Testing to confirm DERMATAC Drape is biocompatible:
- ISO 10993-1. (2009). Biological evaluation of medical devices -- Part 1: o Evaluation and testing within a risk management process.
- O ISO 10993-10. (2010). Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization.
- ISO 10993-11. (2006). Biological evaluation of medical devices Part 11: O Tests for systemic toxicity.
- ISO 10993-12. (2012). Biological evaluation of medical devices Part 12: o Sample preparation and reference materials.
- ISO 10993-17. (2002). Biological evaluation of medical devices Part 17: o Establishment of allowable limits for leachable substances.
- ISO 10993-18. (2005). Biological evaluation of medical devices Part 18: O Chemical characterization of materials.
- ISO 10993-3. (2014). Biological evaluation of medical devices Part 3: Tests O for genotoxicity, carcinogenicity and reproductive toxicity.
- ISO 10993-5. (2009). Biological evaluation of medical devices Part 5: Tests o for in vitro cytotoxicity.
- Shelf Life package integrity testing of DERMATAC Drape sterile barrier packaging . following 3 cycles of EtO sterilization and ship distribution of product accelerated aged to an equivalent real time of 2 year (T=2yr AA) was conducted using seal strength and bubble emission methods. The drape met all requirements.
- Adhesive Peel Test drape was adhered to stainless steel plate and the force ● required to remove the drape was measured. The results documented demonstrate that DERMATAC Drape meets specification requirements.
- . Moisture Vapor Transmission Rate Test - drape met minimum requirements when using the ASTM E96/E96M Upright Cup Method at 38°C and 10%RH for MVTR.
- . Negative Pressure Maintenance System Test - 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 negative pressure performance test also included re-application cycling to demonstrate that the drape is capable of being applied, lifted and re-applied. The results documented that DERMATAC Drape is capable of maintaining negative pressure within specification.
- Peel Adhesion with Re-Application Cycling Testing drape was applied, . removed and then re-applied multiple times and then subjected to peel force
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Image /page/7/Picture/1 description: The image is a logo for KCI, an Acelity company. The logo features a stylized sphere on the left, with a purple and white gradient. To the right of the sphere is the text "KCI" in a bold, sans-serif font. Below the "KCI" text is the text "AN ACELITY COMPANY" in a smaller, sans-serif font.
evaluation. Results demonstrated that the drape was capable of meeting specification for peel adhesion after multiple re-application and removals.
In all instances, V.A.C. DERMATAC Drape functioned as intended and all test results observed were as expected.
No clinical tests were necessary, however human factors engineering assessment with 30 representative users indicated that the new user interface could be safely and effectively used by all test subjects.
Conclusions
The V.A.C. DERMATAC Drape is as safe and effective as the V.A.C. NPWT Dressing System. The V.A.C. DERMATAC Drape has the same intended uses and similar indications, and technological characteristics as its predicate device. The minor differences in indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. Performance data demonstrate that the V.A.C. DERMATAC Drape is as safe and effective as the V.A.C. Negative Pressure Wound Therapy (NPWT) Dressing System. Thus, the V.A.C. DERMATAC Drape is substantially equivalent.