K Number

Device Name

VCARE A

Manufacturer

IVT MEDICAL LTD

Date Cleared

2013-09-17

(454 days)

Product Code

OMP

Regulation Number

878.4780

Intended 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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K062227

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard negative pressure wound therapy functionality, safety features, and parameter limitations based on user input, without mentioning AI or ML.

Therapeutic

Yes
The device is a Negative Pressure Wound Therapy system intended for wound management, which means it provides therapy to promote healing.

Diagnostic

This device is a Negative Pressure Wound Therapy (NPWT) system designed for wound management through the application of negative pressure. It promotes healing by removing fluids and does not involve diagnosing conditions or identifying diseases. Its function is purely therapeutic.

SaMD (Software as a Medical Device)

The device description explicitly states that the Vcare a is a "Negative Pressure Wound Therapy system that comprises fixed components and disposables," indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device for wound management through the application of negative pressure. This is a therapeutic intervention applied directly to the body, not a test performed on a sample taken from the body.
Device Description: The description details a system for delivering negative pressure, monitoring pressure, and managing fluids from a wound. This aligns with a therapeutic device, not a diagnostic one.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to treat a wound directly.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

OMP

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

wound

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K062227

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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:

SEP 17 2013

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®
Safety
Features	Operational
program
according to risk
of bleeding	The treating physician pre-
determines the risk of bleeding
to the wound	None
	Software control
of user
operation	Hazardous or undesired
operation is limited according to
risk of bleeding determination
by the physician. The software
pre-limits the vacuum level
range, maximal flow and
alarms.	None
	Bleeding
Detection	A unique feature that monitors
the filling rate of the canister
and detects active bleeding.
Preset to
100, 200 or 300 cc/hr (default
100 cc/hour that can only be
changed if the risk of bleeding is
low)	None
	Bleeding
Control	Stops and alarms when flow
exceeds the pre-determined flow
rate (default is 100 cc/hour)	Stops when
canister is
filled
	Audio & visual
alarms	Yes	Yes
	Signals	"check for bleeding", "canister
over-flow", "Low vacuum",
"High vacuum"	Yes, but not for
bleeding
Canister
Volume	Canister
Volume
Availability	800ml canister with software
restriction to maximal volume
of 700ml	800 ml
Overflow
Protection
Features	Overflow
Hydrogel pack
solidifier for
wound exudates	Yes	Yes
Negative
Pressure
Settings	Negative
Pressure Setting
Range	Wide range of negative pressure
levels (30-200 mm Hg) for
treatment of diverse wound
types limited according to the	Yes (40-200)
		risk of bleeding and according
to clinical guidelines
	Pressure
Settings	Pre-set recommended values
with the ability to set to any
value linearly within the range.	Ability to set to
values only in
25 mm
increments
Versatile
Operational
Modes	power supply	Unique variable 100-240V AC
through AC/DC power adapter
with output voltage of 15V, or
battery operation (12V).
Automatic switching between
power adapter and battery when
the power adapter is
disconnected or connected to the
device, to allow continuous
treatment.	Battery and
Power Line
	Various vacuum
intensities	Select different pump intensities
to accommodate small and
large, low and high flow
wounds	Yes
	Work Modes	Cyclic-Continuous, Continuous
and intermittent operational
working modes	Continuous
and
intermittent
operational
work modes
Pump Flow
Capacity	Flow Limited by
internal motor
capacity	20 L/Min	Information
not available
External
Vacuum
Attachment	Dual Operation
Mode of
Internal Pump
and Connection
With External
Vacuum	Vcare α controls external
vacuum source according to
device settings and resulting in
extended motor life.
External Pump evacuation flow
may be exceeded as needed.	Non -
Compatible
Motor Life
expectancy	Extension of
Motor life	Extremely extended under wall
suction operation	Limited by
internal motor
life expectancy
(Roughly 1000
hours)
Operation
under minor
leak	Operation under
minor leak	The Vcare alpha can operate
under minor leaks when it is
difficult or impossible to fully
seal the wound	Pre-determined
cessation of
operation

Device Comparison Table

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

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

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

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