Carilex VT Dressing Kits is intended to be used with the Carilex VT device (S1 series) to manage wounds through removal of fluids, and the NPWT system is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of fluids, excess exudates, infectious material, and tissue debris.

The Carilex VT Dressing Kits is indicated for use for patients with the following wounds:

Traumatic
Dehisced wounds
Partial-thickness burns
Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers
Acute wounds
Flaps and grafts

Device Description

Carilex VT Dressing Kits is the wound dressing to be used with the Carilex VT suction pumps for negative pressure wound therapy. This single-use dressing is manufactured using a reticulated flexible polyether and polyurethane hydrophobic material, housed in a medical grade peel pouch, and sterilized by Ethylene Oxide. The Carilex VT Dressing Kits is available in three sizes; 1) small 2) medium and 3) large

AI/ML Overview

The provided text describes the Carilex VT Dressing Kits (K172725) and its equivalence to a predicate device, the DeRoyal Foam Kits (K112458). The document focuses on regulatory approval and substantial equivalence based on non-clinical tests.

Acceptance Criteria and Device Performance:

The document doesn't explicitly list "acceptance criteria" in a typical quantitative sense (e.g., sensitivity, specificity for an AI device). Instead, it states that the dressing kits met "all pre-determined acceptance criteria and passed the tests" during performance/comparison testing against the predicate device. These criteria would likely be related to the physical and functional performance of the dressing kits in managing wounds through fluid removal, as described in their intended use.

The "reported device performance" is implicitly that it performs comparably to the predicate device, thereby demonstrating substantial equivalence. The "Technological Comparison to Predicate Devices" table (pages 4-5) highlights the similarities across various attributes:

Table of Acceptance Criteria and Reported Device Performance (Implied):

Criteria (Implied from comparison with predicate)	Proposed Device (Carilex VT Dressing Kits)	Predicate Device (DeRoyal Foam Kits)
Intended Use	Manage wounds through removal of fluids; promote wound healing by removing fluids, excess exudates, infectious material, tissue debris. Indicated for traumatic, dehisced, partial-thickness burns, chronic (pressure, diabetic foot, venous leg ulcers), acute wounds, flaps, and grafts.	Promote wound healing by removal of wound exudate, debris, infectious material; aspiration/removal of surgical fluids, tissue, gases, bodily fluids, infectious material from airway/respiratory support.
Contraindications	Necrotic Tissue, Malignancy, Untreated Osteomyelitis, Untreated Malnutrition, Exposed Arteries/Veins/Nerves/Organs, Use Over Anastomotic Sites, Use in Non-enteric/Unexplored Fistulas, Use Over Exposed Bone/Tendon.	Necrotic Tissue, Unexplored/Non-enteric Fistulas, Untreated Osteomyelitis, Wound Containing Malignant Tissue, Exposed Arteries/Veins/Internal Organs, Exposed Anastomotic Site.
Single Use/Reusable	Single Use	Single Use
Method of Sterilization	Ethylene Oxide	Ethylene Oxide
Biocompatibility	All components comply with ISO 10993	All components comply with ISO 10993
Packaging	Individually packaged/sterilized components kitted into Tyvek pouch.	Individually packaged/sterilized components kitted into Tyvek pouch.
Shelf-life	2 years	3 years
Dressing Components - Black Foam Material	Reticulated Flexible Polyether Based Polyurethane Foam	Reticulated Flexible Polyether Based Polyurethane Foam
Dressing Components - Film Drape/Transeal Material	Polyurethane Film Coated with Acrylic Adhesive	Polyurethane Film Coated with Acrylic Adhesive
Performance/Comparison Testing	Met all pre-determined acceptance criteria for performance.	(Predicate already established market performance)
Biocompatibility Testing	Passed, shown to be biocompatible for intended use.	(Predicate already established biocompatibility)
Extractable/Leachable Study & Risk Assessment	Carried out to evaluate biocompatibility.	(Not explicitly stated for predicate in this table, but assumed to have met similar standards)

Missing Information:

The provided document is a 510(k) summary for a medical device (wound dressing kits), not an AI/software device. Therefore, many of the requested details, such as sample sizes, ground truth establishment methods, expert qualifications, and MRMC study specifics, are not applicable to this type of submission and are not present in the document.

Here's why and what can be gleaned:

Sample size used for the test set and the data provenance: Not applicable. This refers to performance testing of the physical medical device and its components, not data-driven AI. The "test set" would be the manufactured dressing kits themselves subjected to various physical and chemical tests (e.g., sterilization validation, material testing, fluid absorption/removal efficiency, biocompatibility). The document mentions "Performance/Comparison Testing of VT Dressing Kits with the predicate" and "The biocompatibility tests were performed with the final finished form of VT Dressing Kits." No details on the exact sample sizes of physical units tested or data provenance (country of origin, retrospective/prospective) are provided, as these are typically part of internal technical reports referenced in the 510(k).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI (e.g., image annotations by radiologists) is not relevant here. The "ground truth" for this device would be established engineering and scientific standards for material properties, sterility, and device function.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This relates to expert consensus for AI ground truth.
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: Not applicable. This is for AI-assisted diagnostic or interpretive devices.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is for AI algorithm performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this physical device relies on established engineering and medical standards for material properties, sterility, and functional performance. Things like ISO 10993 (biocompatibility) are the "ground truth" against which the device is measured.
The sample size for the training set: Not applicable. There is no AI model or algorithm being "trained" for this physical device.
How the ground truth for the training set was established: Not applicable.

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 most prominent.

June 8, 2018

Carilex Medical, Inc. % Maria Griffin Senior Consultant mdi Consultants. Inc. 55 Northern Blvd. Great Neck, New York 11021

Re: K172725

Trade/Device Name: VT Dressing Kits Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: May 7, 2018 Received: May 7, 2018

Dear Maria Griffin:

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, 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 of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in 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.

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 medical devices and radiation-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.

Jennifer R. Stevenson -S3

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) K172725

Device Name Carilex VT Dressing Kits

Indications for Use (Describe)

The Carilex VT Dressing Kits is indicated for use for patients with the following wounds:

Traumatic
Dehisced wounds
Partial-thickness burns
Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers
Acute wounds
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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510(k) SUMMARY

The assigned 510(k) number is: K172725

Submitter's Information 1.

Carilex Medical, Inc. No. 77, Keji 18t Rd., Guishan Dist., Taoyuan City, Taiwan 333 Registration Number: 9710603 Contact: Henry Kao Tel: +886-3-3287882 Fax: +886-3-3288622

Date Summary Prepared: June 6, 2018

Trade Name of the Device: Carilex VT Dressing Kits 2.

1. Common or Usual Name: Wound Dressing for Negative Pressure Wound Therapy
1. Classification Name: Negative Pressure Wound Therapy Powered Suction Pump Regulation Number: 878.4780 Product Code: OMP Panel: General & Plastic Surgery

5. Predicate Device Information:

DeRoyal Foam Kits w/DOME/TR of Prospera PRO-I, PRO-II and PRO-III Negative Pressure Wound Therapy System, K112458

Device Description 6.

7. Intended Use

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Technological Comparison to Predicate Devices: 8.

δ. Item	Proposed Device	Predicate Device
Device Name	Carilex VT Dressing Kits	DeRoyal Foam Kits
Classification	Class II	Class II
Code for FederalRegulations	878.4780	878.4780
Prescription MedicalDevice	YES	YES
Product Code	OMP	OMP
Compatible NPWTpump	Carilex VT Device(S1 series K112853, K161410)	Prospera PRO-I, PRO- II and PRO-III
Indications for Use	Carilex VT Dressing Kits is intended tobe used with the Carilex VT device (S1series) to manage wounds throughremoval of fluids, and the NPWT systemis indicated for patients who wouldbenefit from a suction device,particularly as the device may promotewound healing by removal of fluids,excess exudates, infectious material, andtissue debris. The Carilex VT DressingKits is indicated for use for patients withthe following wounds:Traumatic Dehisced wounds Partial-thickness burns Chronic wounds including pressureulcers, diabetic foot ulcers andvenous leg ulcers Acute wounds Flaps and grafts	The Prospera Negative Pressure WoundTherapy System is indicated for patientsthat would benefit from a suction deviceparticularly as the device may promotewound healing by removal of woundexudate, debris, and infectious materialor for the aspiration and removal ofsurgical fluids, tissue (including bone),gases, bodily fluids or infectious materialfrom the patient's airway or respiratorysupport system. The Prospera NegativePressure Wound Therapy may be usedduring surgery or at the patient's bedsideand is indicated for home use.
Contraindications	Presence of Necrotic Tissue Malignancy Untreated Osteomyelitis Untreated Malnutrition Exposed Arteries, Veins, Nerves,or Organs Use Over Anastomotic Sites Use in Non-enteric andUnexplored Fistulas, as well forUse Over Exposed Bone or Tendon	Necrotic Tissue Unexplored or Non-enteric Fistulas Untreated Osteomyelitis Wound Containing MalignantTissue Exposed Arteries, Veins, or InternalOrgans Exposed Anastomotic Site
Single Use or Reusable	Single Use	Single Use
Method of Sterilization	Ethylene Oxide	Ethylene Oxide
Biocompatibility	All components comply with ISO 10993	All components comply with ISO 10993
Packaging	Individually packaged and sterilizedcomponents are kitted into Tyvek pouch.	Individually packaged and sterilizedcomponents are kitted into Tyvek pouch.
Shelf-life	2 years	3 years
Dressing KitsComponents	Black Foam, Film Drape, Port Set(composed of Circle Drape, ConnectingTube, Port, Clip, Lockable Connector)	Black Foam, Transeal, Dome Connector(composed of Circle Drape, ConnectingTube, Port, Clip, Connector)

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Image /page/5/Picture/0 description: The image shows the word "carilex" in a light blue color. The font is sans-serif and appears to be a custom design. A small registered trademark symbol is located to the right of the word.

BlackFoam	Dimension	Small: 80x100x30 mm	Small: 80x100x30 mm
		Medium: 125x200x30 mm	Medium: 125x200x30 mm
		Large: 150x250x30 mm	Large: 150x250x30 mm
	Material	Reticulated Flexible Polyether BasedPolyurethane Foam	Reticulated Flexible Polyether BasedPolyurethane Foam
		FilmDrape/Transeal	Dimension	250x216mm	203x305mm	Quantity	Large Kits: 3 pcsMedium Kits: 2 pcsSmall Kits: 1 pc
FilmDrape/Transeal	Dimension		250x216mm	203x305mm
	Quantity		Large Kits: 3 pcsMedium Kits: 2 pcsSmall Kits: 1 pc	Large Kits: 3 pcsMedium Kits: 2 pcsSmall Kits: 1 pc
	Material		Polyurethane Film Coated with AcrylicAdhesive	Polyurethane Film Coated with AcrylicAdhesive

9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The following tests were performed to determine substantial equivalence:

The biocompatibility tests were performed with the final finished form of VT Dressing Kits in accordance with ISO 10993. In addition, an extractable/leachable study and associated risk assessment were carried out to evaluate the biocompatibility of the device. The dressing kits have been shown to be biocompatible for the intended use.

Performance/Comparison Testing of VT Dressing Kits with the predicate. The dressing kits met all pre-determined acceptance criteria and passed the tests.

10. Clinical Test

Clinical tests were not performed.

11. Conclusion

After analyzing intended use, indications for use, technology, bench test reports, shelf-life reports, sterilization reports, and biocompatibility reports, it can be concluded that Carilex VT Dressing Kits is substantially equivalent to the predicate device DeRoyal Foam Kits (K112458).

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.