Carilex VT • 100/VT • 200 is indicated for patients who would benefit from wound management via the application of negative pressure for removal of fluids and excess exudate, infectious material, and tissue debris which may promote wound healing. The VT · 100/VT · 200 suction therapy unit is indicated on use with 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 • 100 and VT • 200 are suction pumps with collection canisters for negative pressure wound therapy. The VT · 100 and VT · 200 are modified from their precursor VOLTERA Powered Suction Pump, S1001-3 Series (K112853). The pump is connected to the wound dressing via a tube connected to a disposable canister. The devices provide negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The devices can operate either by a mains power supply or internal battery. The VT • 200 is developed with technology and components that are almost identical to VT • 100, but for marketing differentiation it is designed with a new outer case which contains extra room to allow incorporation with different types of air compressors in the future.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Carilex VT-100 and VT-200 devices:

Acceptance Criteria and Study for Carilex VT-100 and VT-200 (K173407)

Based on the provided FDA 510(k) summary, the Carilex VT-100 and VT-200 are powered suction pumps for negative pressure wound therapy. The substantial equivalence was primarily determined through non-clinical testing and comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Safety: Device meets general requirements for basic safety and essential performance (based on AAMI/ANSI ES60601-1:2005/(R)2012+A1:2012, C1:2009/(R)2012+A2:2010/(R)2012)	Passed
Electromagnetic Compatibility (EMC): Device meets requirements for EMC (based on IEC 60601-1-2:2007)	Passed
Performance - Suction Pressure: The VT-100/VT-200 maintains suction characteristics within acceptable limits.	Met all pre-determined acceptance criteria
Performance - Fluid Removal Rate: The VT-100/VT-200 achieves a fluid removal rate within acceptable limits.	Met all pre-determined acceptance criteria
Performance - Alarm Functionality: All alarms on the VT-100/VT-200 operate correctly.	Met all pre-determined acceptance criteria
Shelf-Life: Device maintains specified performance over its intended lifespan (3 years).	Shelf-life test reports were analyzed, implying successful demonstration of shelf-life. (Specific performance parameters for shelf-life not detailed, but implied by analysis of reports.)
Software Functionality: Software operates as intended and meets safety and performance requirements.	Software documents were analyzed, implying software functionality was found acceptable. (Specific criteria not detailed.)

2. Sample Size Used for the Test Set and Data Provenance:

The document describes non-clinical tests (bench tests). It does not specify a "test set" in the context of patient data or clinical samples. The testing involved multiple devices (VT-100 and VT-200 models) in a laboratory setting. No information on the number of individual devices tested or their origin (provenance) is provided beyond the company being based in Taoyuan City, Taiwan.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. This was a non-clinical, bench testing study. There was no "ground truth" derived from expert consensus on patient data. The "ground truth" for the bench tests would be the established performance specifications of the predicate device and relevant international standards.

4. Adjudication Method for the Test Set:

Not applicable. As this was non-clinical bench testing, an adjudication method for a test set (e.g., 2+1, 3+1) is not relevant. Pass/fail criteria were based on predetermined engineering specifications and conformity to standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. A MRMC study was not conducted as this was a non-clinical evaluation to demonstrate substantial equivalence to a predicate device, focusing on engineering and performance criteria rather than human reader interpretation of medical images or data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The VT-100 and VT-200 are physical powered suction pumps, not AI algorithms. Their performance is tested directly, not as an algorithm's output.

7. Type of Ground Truth Used:

The "ground truth" for this substantial equivalence determination was based on:

Predicate Device Specifications: The performance characteristics (suction pressure, fluid removal rate, etc.) and safety profile of the legally marketed predicate device (VOLTERA Powered Suction Pump, S1001-3 Series, K112853).
International Standards: Conformity to recognized standards such as AAMI/ANSI ES60601-1 and IEC 60601-1-2 for safety and electromagnetic compatibility.
Engineering Specifications: Pre-determined performance specifications for the VT-100 and VT-200 devices themselves.

8. Sample Size for the Training Set:

Not applicable. There is no concept of a "training set" in the context of this device and study type, as it does not involve machine learning or AI.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there was no training set.

Summary

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August 9, 2018

Carilex Medical, Inc. Henry Kao RA Specialist No. 77 Keji 1st Rd., Guishan Dist. Taoyuan City, Taiwan 333

Re: K173407

Trade/Device Name: VT - 100, VT - 200 Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: July 6, 2018 Received: July 9, 2018

Dear Henry Kao:

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/cdrl/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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,

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.

10(k) Number (if known)	K172407
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Carilex VT · 100/VT · 200 Device Name

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

A Presscription Use (Part 21 CFR 801 Suppart DJ

_ Over-The-Counter Use (2) CFR 801 Support C

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K173407 Carilex VT.100/VT.200 Page 1/4

510(k) SUMMARY

The assigned 510(k) number is: K173407

Submitter's Information 1.

Carilex Medical, Inc. No. 77, Keji 186 Rd., Guishan Dist., Taoyuan City, Taiwan 333 Registration Number: 9710603 Contact: Henry Kao Tel: +886-3-3287882 Fax: +886-3-3288622 Email: henry.kao@carilexmedical.com

Date Summary Prepared: October 27, 2017

Trade Name of the Device: Carilex VT · 100 & VT · 200 2.
1. Common or Usual Name: Powered Suction Pump
1. Classification Name: Negative Pressure Wound Therapy Powered Suction Pump Regulation Number: 878.4780 Product Code: ОМР Panel: General & Plastic Surgery

5. Predicate Device Information:

VOLTERA Powered Suction Pump, S1001-3 Series, K112853

6. Device Description

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7. Intended Use

Item	Proposed Devices		Predicate Device
Device Name	VT · 200	VT · 100	VOLTERA Powered SuctionPump
Model	S1002-0012	S1001-0032	S1001-3 Series
Classification	Class II	Class II	Class II
Code for FederalRegulations	878.4780	878.4780	878.4780
Product Code	OMP	OMP	OMP
Prescription MedicalDevice	YES	YES	YES
Compatible NPWTDressing	DeRoyal Foam Kits(K112458)	DeRoyal Foam Kits(K112458)	DeRoyal Foam Kits(K112458)
Intended Use	Carilex VT · 200 is indicatedfor patients who would benefitfrom wound management viathe application of negativepressure for removal of fluidsand excess exudate, infectiousmaterial, and tissue debriswhich may promote woundhealing.	Carilex VT · 100 is indicatedfor patients who would benefitfrom wound management viathe application of negativepressure for removal of fluidsand excess exudate, infectiousmaterial, and tissue debriswhich may promote woundhealing.	The VOLTERA PoweredSuction Pump, S1001-3 Seriesis indicated for patients whowould benefit from woundmanagement via theapplication of negativepressure for removal of fluidsand excess exudate, infectiousmaterial, and tissue debriswhich may promote woundhealing.
	The VT • 200 suction therapy	The VT • 100 suction therapy	The VOLTERA suction pump
	unit is indicated on use with	unit is indicated on use with	is indicated on use with
	patients with the following	patients with the following	patients with the following
	wounds:	wounds:	wounds:
	> Traumatic	> Traumatic	> Traumatic
	> Dehisced wounds	> Dehisced wounds	> Dehisced wounds
	> Partial thickness burns	> Partial thickness burns	> Partial thickness burns
Indications for Use	> Chronic woundsincluding pressureulcers, diabetic footulcers, and venous legulcers	> Chronic woundsincluding pressureulcers, diabetic footulcers, and venous legulcers	> Chronic woundsincluding pressureulcers, diabetic footulcers, and venous legulcers
	> Acute wounds	> Acute wounds	> Acute wounds
	> Flaps and grafts	> Flaps and grafts	> Flaps and grafts
	> Presence of necrotictissue	> Presence of necrotictissue	> Presence of necrotictissue
	> Malignancy	> Malignancy	> Malignancy
	> Untreated Osteomyelitis	> Untreated Osteomyelitis	> Untreated Osteomyelitis
	> Untreated malnutrition	> Untreated malnutrition	> Untreated malnutrition
Contraindications	> Exposed arteries, veins,nerves, or organs.	> Exposed arteries, veins,nerves, or organs.	> Exposed arteries, veins,nerves, or organs.
	> Use over anastomoticsites	> Use over anastomoticsites	> Use over anastomoticsites
	> Unexplored ornon-enteric fistulas	> Unexplored ornon-enteric fistulas
	> Exposed bone or tendons	> Exposed bone or tendons
Suction Capacity	9.5 Liter / min	2.5 Liter / min	2.5 Liter / min
Max. Vacuum	-200 mmHg	-200 mmHg	-200 mmHg
Power Input	AC 100-240V / 50-60 Hz	AC 100-240V / 50-60 Hz	AC 100-240V / 47-63 Hz
Power Output	DC 9.1V / 3.3A	DC 9.1V / 3.3A	DC 9V / 3A
Battery Type	Lithium-ion	Lithium-ion	Lithium-ion
Operating Time(Battery)	At least 24 hours,depend on use	At least 24 hours,depend on use	At least 24 hours,depend on use
Dimensions	18 x 17.5 x 9 cm	18 x 17 x 9 cm	17 x 16 x 9 cm
Weight	1.35 kg	1.35 kg	1.35 kg
Operating Mode	Continuous & Intermittent	Continuous & Intermittent	Continuous & Intermittent
Canister	300/500 ml	300/500 ml	300/800 ml
Life-time	3 years	3 years	3 years

Technological Comparison to Predicate Devices: 8.

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

The following tests were performed to determine substantial equivalence:

AAMI/ANSI ES60601-1:2005/(R)2012+A1:2012, C1:2009/(R)2012+A2:2010/(R)2012 Medical Electrical Equipment – Part 1:General Requirements for basic safety and essential performance

IEC 60601-1-2:2007

Medical Electrical Equipment – Part 1-2: General Requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility-Requirements and Tests

Performance/Comparison Testing of VT · 100/VT · 200 with the predicate. The pumps met all pre-determined acceptance criteria and passed the tests (suction pressure, fluid removal rate, alarm functionality).

10. Discussion of Clinical Tests Performed

Clinical tests were not performed.

11. Conclusion

After analyzing intended use, indications for use, technology, bench test report, shelf-life test reports, software documents, and EMC and electrical safety test reports, it can be concluded that Carilex VT • 100 and VT • 200 are substantially equivalent to the predicate device (K112853).

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.