· 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.

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

AI/ML Overview

The provided text describes the V.A.C. DERMATAC Drape, an accessory for Negative Pressure Wound Therapy (NPWT) Systems, and its substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the format requested (e.g., performance metrics like sensitivity, specificity, AUC, or comparative effectiveness with human readers).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and a human factors assessment. The "study" mentioned is a set of engineering and biocompatibility tests, not a clinical trial or an AI performance study with ground truth established by experts.

Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, or training set details as that information is not present in the provided text.

Here's what I can extract based on the provided document:

1. A table of acceptance criteria and the reported device performance

| Acceptance Criteria (Stated Requirements) | Reported Device Performance |
| Biocompatibility | Met requirements according to ISO 10993 series testing (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Genotoxicity, Chemical Characterization, Leachable Substances). |
| Shelf Life (Packaging Integrity) | Met all requirements after 3 cycles of EtO sterilization and simulated shipping, for an accelerated aged equivalent of 2 years real time (shelf life stated as 1 year). |
| Adhesive Peel Test (Force required to remove drape) | Met specification requirements. |
| Moisture Vapor Transmission Rate (MVTR) | Met minimum requirements when using ASTM E96/E96M (Upright Cup Method at 38°C and 10%RH). |
| Negative Pressure Maintenance System Test (Maintain negative pressure with simulated wound exudate, maximum air leak, worst-case dressing, max use life, re-application cycling) | Capable of maintaining negative pressure within specification, including after re-application cycling. |
| Peel Adhesion with Re-Application Cycling Testing (Peel force after multiple re-applications) | Capable of meeting specification for peel adhesion after multiple re-applications and removals. |
| Human Factors (Safe and effective use by representative users) | 30 representative users found the new user interface could be safely and effectively used. |

2. Sample size used for the test set and the data provenance:

Test Set Sample Size:
- Biocompatibility: Not specified, but involved testing according to ISO standards.
- Shelf Life: Not specified for unit count.
- Adhesive Peel Test: Not specified for unit count.
- Moisture Vapor Transmission Rate Test: Not specified for unit count.
- Negative Pressure Maintenance System Test: Not specified for unit count.
- Peel Adhesion with Re-Application Cycling Testing: Not specified for unit count.
- Human Factors: 30 representative users.
Data Provenance: The tests described are laboratory/engineering tests conducted to assess physical and biological properties. A "country of origin for data" is not applicable in the context of these non-clinical tests. These are considered prospective tests performed on the device to prove its characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the evaluations were non-clinical engineering and biocompatibility tests, not studies requiring expert-adjudicated ground truth. The human factors study involved "representative users" but didn't establish ground truth for a diagnostic task.

4. Adjudication method for the test set:

This information is not applicable as the evaluations were non-clinical engineering and biocompatibility tests.

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, an MRMC comparative effectiveness study was not done. The device is a wound drape, not an AI diagnostic tool for human readers.

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

This question is not applicable as the device is a wound drape, not an algorithm or AI system.

7. The type of ground truth used:

Not applicable in the context of diagnostic ground truth. The "ground truth" for these tests was established by meeting engineering specifications and ISO standards (e.g., passing a biocompatibility test means no cytotoxic effect, maintaining negative pressure within a specified range).

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no "training set" as this is not an AI/machine learning device.

Summary

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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.

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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

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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:

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.

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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.

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 DrapeK181505	Predicate Device: V.A.C.NPWT Dressing System,cleared under K133276	Reference Devices:
Intended Use	Same as predicate	To provide a sealedenvironment, which allowsfor the delivery andmaintenance of negativepressure at the wound siteas well as protecting thewound site from externalcontamination.	Same as predicate
Indicated Wound Types	Same as predicate	Chronic Acute Traumatic Subacute Dehisced wounds Partial-thickness burns Ulcers (such asdiabetic, pressure orvenous insufficiency) Flaps and grafts Surgically closedincisions	Same as predicate
Dressing systemcomponents	Same as predicate	Drape with adhesive Sensing pad andtubing Foam dressing	Same as predicate
Care Setting	Same as predicate	The V.A.C. NPWTDressing System can beused both in the Acute andPost-Acute setting.	Same as predicate
Shelf life	1 year	3 years	N/A
			ACTIVAC TherapyUnit (K063692) INFOVAC TherapyUnit (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.

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.