Carilex VT·One/VT·One 60days is indicated for patients who benefit from removal of fluids and excess exudates, infectious material, and tissue debris, which may promote wound healing. The VT-One/VT-One 60days 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 One and VT One 60days are suction pumps with collection canisters for negative pressure wound therapy. Carilex VT.One 60days are modified from its precursor VOLTERA Powered Suction Pump, S1001-3 Series (K112853), and they are smaller, portable and lighter in weight. The pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides 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 device can operate either by a mains power supply or internal battery. The intended use, performance, and technology for Carilex VT·One and VT·One 60days are mostly identical. However, the VT·One 60days is programmed to stop working after 60 days of use and will not re-start after this time. This feature makes VT One 60days a single patient use NPWT pump that has a lifetime of 60 days; while VT-One is a durable medical device with a minimum lifetime of 3 years.

AI/ML Overview

This document describes the FDA's 510(k) summary for the Carilex VT.One/VT.One 60days powered suction pump. The device is a negative pressure wound therapy (NPWT) system.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The pumps met all pre-determined acceptance criteria and passed the tests." However, it does not provide a specific table of acceptance criteria or detailed reported device performance values for the non-clinical tests beyond confirming they passed. It only lists the tests performed.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with IEC60601-1:2005+COR1(2006)+COR2(2007)+AMD1(2012) Basic Safety and Essential Performance	Met (passed the tests)
Compliance with IEC60601-1-2:2007 Electromagnetic Compatibility	Met (passed the tests)
Performance/Comparison Testing with predicate device	Met (passed the tests)

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

The document does not specify the sample size used for the test set in the non-clinical performance/comparison testing. It only states that "Performance/Comparison Testing of VT.One 60days with the predicate" was conducted. This implies a comparison between the proposed device and the predicate. The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), but given it's non-clinical testing of a medical device, it would have been conducted in a lab environment.

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

This question is not applicable. The study described is non-clinical performance and safety testing of a medical device against established standards and a predicate device. It does not involve establishing ground truth from expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

This question is not applicable as the study involved non-clinical performance testing against technical standards and a predicate, not human adjudication of medical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical tests were not performed."

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

This question is not applicable. The device is a powered suction pump, not an AI algorithm. Its performance is mechanical and electrical, not algorithmic. The term "standalone" in this context typically refers to the performance of an AI model without human intervention.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was compliance with established international standards (IEC60601-1, IEC60601-1-2) for medical electrical equipment safety and essential performance, and comparability to the predicate device's performance specifications. This is a technical, rather than medical, ground truth.

8. The Sample Size for the Training Set

This question is not applicable. The device is a mechanical/electrical pump, not an AI/ML algorithm that requires a "training set."

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

This question is not applicable for the same reason as above (not an AI/ML algorithm).

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 13, 2016

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

Re: K161410

Trade/Device Name: VT.One, VT.One 60days Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: September 8, 2016 Received: September 9, 2016

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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

510(k) Number (if known) K161410

Device Name Carilex VT.One/VT.One 60days

Carilex VT One/VT One 60days is indicated for patients who benefit from removal of fluids and excess exudates. infectious material, and tissue debris, which may promote wound healing. The VT One 60days 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

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)

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510(K) SUMMARY

The assigned 510(k) number is: K161410

1. Submitter's Identification:

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 Email: henry.kao@carilexmedical.com

Date Summary Prepared: May 20, 2016

1. Trade Name of the Devices: Carilex VT.One/ VT.One 60days
Common or Usual Name: Powered Suction Pump 3.
Classification Name: 4. Regulation Number: Product code: Panel:

Negative Pressure Wound Therapy Powered Suction Pump 878.4780 OMP General & Plastic Surgery

ട്. Predicate Device Information:

VOLTERA Powered Suction Pump, S1001-3 Series, K112853

6. Device Description:

The intended use, performance, and technology for Carilex VT·One and VT·One 60days are mostly identical. However, the VT·One 60days is programmed to stop working after 60 days of use and will not re-start after this time. This feature makes VT One 60days a single patient use NPWT pump that has a lifetime of 60 days; while VT-One is a durable medical device with a minimum lifetime of 3 years.

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carilex®

Intended Use: 7.

Item	Proposed Devices		Predicate Device
Device Name	VT-One	VT-One 60days	VOLTERA Powered Suction Pump, S1001-3 Series
Classification	Class II		Class II
Code for FederalRegulations	878.4780		878.4780
PrescriptionMedical Device	YES		YES
Model	S1004-0012	S1004-0022	S1001-3 Series
CompatibleNPWT Dressing	DeRoyal Foam Kits (K112458)		DeRoyal Foam Kits (K112458)
Intended Use	Carilex VT-One/VT-One 60days isindicated for patients who benefit fromremoval of fluids and excess exudates,infectious material, and tissue debris,which may promote wound healing.		The VOLTERA Powered Suction Pump, S1001-3 Series is indicated for patients who wouldbenefit from wound management via theapplication of negative pressure for removal offluids and excess exudate, infectious material,and tissue debris which may promote woundhealing.
Indications forUse	The VT-One/ VT-One 60days suctiontherapy unit is indicated on use withpatients with the following wounds:Traumatic Dehisced wounds Partial thickness burns Chronic wounds including pressureulcers, diabetic foot ulcers, andvenous leg ulcers Acute wounds Flaps and grafts		The VOLTERA suction pump is indicated onuse 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
Contraindications	Presence of necrotic tissue Malignancy Untreated Osteomyelitis Untreated malnutrition Exposed arteries, veins, nerves, ororgans. Use over anastomotic sites		Presence of necrotic tissue Malignancy Untreated Osteomyelitis Untreated malnutrition Exposed arteries, veins, nerves, or organs. Use over anastomotic sites
Suction Capacity	0.8 Liter / min	0.6 Liter / min	2.5 Liter / min
Max. Vacuum	- 150 mmHg		- 200 mmHg
Power Input	AC 100-240V / 50-60 Hz		AC 110-240V / 47-63 Hz

8. Technological Comparison to Predicate Devices:

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carilex®

Power Output	DC 12V / 1.25A	DC 9V / 3A
Battery Type	Lithium ion	Lithium ion
Operating Time(Battery)	16 hours, depend on use	24~48 hours, depend on use
Dimensions	150 mm x 85 mm x 50 mm	170 mm x 160 mm x 90 mm
Weight	350g	1.35 kg
Operating Mode	Continuous & Intermittent	Continuous & Intermittent
Canister	150 ml	300 ml
Life-time	3 years	3 years
SoftwareSetting	Programmed tobe repetitivelyused duringlifetime	Programmed to be repetitively used duringlifetime

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

The following tests were performed to determine substantial equivalence:

IEC60601-1:2005+COR1(2006)+COR2(2007)+AMD1(2012) Medical Electrical Equipment – Part 1:General Requirements for basic safety and essential performance

IEC60601-1-2:2007 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.One 60days with the predicate. The pumps met all pre-determined acceptance criteria and passed the tests.

Discussion of Clinical Tests Performed: 10.

Clinical tests were not performed.

11. Conclusions:

After analyzing intended use, indications for use, technology, bench test reports, shelflife reports, and EMC and electrical safety tests, it can be concluded that Carilex VT·One/ VT·One 60days is substantially equivalent to the predicate device VOLTERA Powered Suction Pump, S1001-3 Series (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.