The Vcare a is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is indicated for management of chronic, acute, traumatic, sub-acute and dehisced wounds. partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Vcare a may promote healing by removal of excess exudates, irrigation fluids, and infectious material.

Device Description

The Vcare a - is a Negative Pressure Wound Therapy system that comprises fixed components and disposables. The Vcare a maintains the functionality of existing devices while enhancing safety. The system has features that optimize the delivery of negative pressure to open wounds. The software requires the user to profile the patient and the system then limits the device's operational parameters to be compatible with the patient profile. The system incorporates safety features that control the system to prevent risk to the patient. The sensors and controls monitor and maintain target pressure and alarms, as needed, to help assure that target pressure is maintained and constant therapy is delivered. The safety features of the system include additional alarms, such as those that signal for possible bleeding, tubing blockage, a full or missing collection canister, inactive therapy, low battery and leaks in the seal of the dressing.

AI/ML Overview

The provided text is a 510(k) summary for the Vcare a Negative Pressure Wound Therapy (NPWT) device. It describes the device, its intended use, and compares it to a predicate device (V.A.C. Therapy System). However, it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to a diagnostic or AI-driven performance study.

The document is focused on demonstrating substantial equivalence to a predicate device for regulatory clearance, primarily by outlining features and safety aspects. It is not a clinical study report or a performance study for an AI/diagnostic device.

Therefore, I cannot fulfill your request for the specific points listed below based on the provided text:

A table of acceptance criteria and the reported device performance: The document compares features to a predicate device, but does not define acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or provide performance metrics (e.g., AUC, F1-score) from a study in the way an AI/diagnostic device would.
Sample size used for the test set and the data provenance: Not applicable, as no such performance study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document is a regulatory submission for a physical medical device (NPWT system) and its features, focusing on safety and equivalence to an already marketed device, rather than a performance study of a diagnostic algorithm.

Summary

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510(k) summary

This 510(k) summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

Submitter:

IVT Medical Ltd., 16 Hatidhar St. Raanana 43665 ISRAEL

Name of the Device:

Trade name Vcare a .
Common name Negative Pressure Wound Therapy (NPWT) device. .
Classification name -, Powered suction pump (21 CFR 878.4780, procode . OMP).

Name and address of contact person:

Dr. Eli M. Orbach .
. POB 6718, Efrat 90435, Israel
Tel:/Fax +972.2.993.2768; .
e-mail: orbach@efratnetworks.com �

Predicate Devices: The Vcare a is substantially equivalent to the V.A.C. Therapy System, manufactured by Kinetic Concepts Inc., subject of K062227.

Indications for Use:

Description of the Device:

The system incorporates safety features that control the system to prevent risk to the patient. The sensors and controls monitor and maintain target pressure and alarms, as needed, to help assure that target pressure is maintained and constant therapy is

SEP 17 2013

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delivered. The safety features of the system include additional alarms, such as those that signal for possible bleeding, tubing blockage, a full or missing collection canister, inactive therapy, low battery and leaks in the seal of the dressing.

Category	Features	Vcare a®	KCI
SafetyFeatures	Operationalprogramaccording to riskof bleeding	The treating physician pre-determines the risk of bleedingto the wound	None
	Software controlof useroperation	Hazardous or undesiredoperation is limited according torisk of bleeding determinationby the physician. The softwarepre-limits the vacuum levelrange, maximal flow andalarms.	None
	BleedingDetection	A unique feature that monitorsthe filling rate of the canisterand detects active bleeding.Preset to100, 200 or 300 cc/hr (default100 cc/hour that can only bechanged if the risk of bleeding islow)	None
	BleedingControl	Stops and alarms when flowexceeds the pre-determined flowrate (default is 100 cc/hour)	Stops whencanister isfilled
	Audio & visualalarms	Yes	Yes
	Signals	"check for bleeding", "canisterover-flow", "Low vacuum","High vacuum"	Yes, but not forbleeding
CanisterVolume	CanisterVolumeAvailability	800ml canister with softwarerestriction to maximal volumeof 700ml	800 ml
OverflowProtectionFeatures	OverflowHydrogel packsolidifier forwound exudates	Yes	Yes
NegativePressureSettings	NegativePressure SettingRange	Wide range of negative pressurelevels (30-200 mm Hg) fortreatment of diverse woundtypes limited according to the	Yes (40-200)
		risk of bleeding and accordingto clinical guidelines
	PressureSettings	Pre-set recommended valueswith the ability to set to anyvalue linearly within the range.	Ability to set tovalues only in25 mmincrements
VersatileOperationalModes	power supply	Unique variable 100-240V ACthrough AC/DC power adapterwith output voltage of 15V, orbattery operation (12V).Automatic switching betweenpower adapter and battery whenthe power adapter isdisconnected or connected to thedevice, to allow continuoustreatment.	Battery andPower Line
	Various vacuumintensities	Select different pump intensitiesto accommodate small andlarge, low and high flowwounds	Yes
	Work Modes	Cyclic-Continuous, Continuousand intermittent operationalworking modes	Continuousandintermittentoperationalwork modes
Pump FlowCapacity	Flow Limited byinternal motorcapacity	20 L/Min	Informationnot available
ExternalVacuumAttachment	Dual OperationMode ofInternal Pumpand ConnectionWith ExternalVacuum	Vcare α controls externalvacuum source according todevice settings and resulting inextended motor life.External Pump evacuation flowmay be exceeded as needed.	Non -Compatible
Motor Lifeexpectancy	Extension ofMotor life	Extremely extended under wallsuction operation	Limited byinternal motorlife expectancy(Roughly 1000hours)
Operationunder minorleak	Operation underminor leak	The Vcare alpha can operateunder minor leaks when it isdifficult or impossible to fullyseal the wound	Pre-determinedcessation ofoperation

Device Comparison Table

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Sponge	Sealed outer layer	Yes	No
	Color	Off-white sponge for early and easy detection of bleeding,	Black Sponge
	Soft and flexible Sponge	Easy to conform, allows formation of bridging conduit	Thick and hard to conform
Sealing Drape		Drape stripes are applied only to the sponge margins and are adjusted to sponge size.	Drape sheets that need to be cut and fit to cover and seal sponge.

Review of the comparison table leads demonstrates that any differences in technological characteristics from the predicate device raise no new types of safety or effectiveness questions and leads to the conclusion that the comparison supports substantial equivalence.

August 1, 2013

Date

Dr. Moris Topaz, CEO

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MD 20993-002

September 17, 2013

IVT Medical Ltd. % Dr. Eli M. Orbach P.O. Box 6718 Efrat 90435. Israel

Re: K121817

Trade/Device Name: The Veare a Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: August 01, 2013 Received: August 26, 2013

Dear Dr. Orbach:

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. Iisting 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 cither class 11 (Special Controls) or class 111 (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

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Page 2 - Dr. Eli M. Orbach

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.lda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (2 1 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 Small Manufacturers, International and Consumer Assistance 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,

Mark N. Melkerson -5

Mark N. Melkerson Acting 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): K121817

Device Name: Vcare a

Indications For Use:

The Vcare a is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is indicated for management of chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Vcare a may promote healing by removal of excess exudates, irrigation fluids, and infectious material.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K121817

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.