AC Wound Management System is indicated for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates, and infectious materials. Examples of appropriate wound types include: Diabetic/Neuropathic ulcers, Pressure ulcers, Chronic wounds, Acute wounds, Dehisced wound, Partial-thickness burns, and Flaps and Grafts.

Device Description

The AC Wound Management System is a powered suction pump that utilizes a pump drive to generate light negative pressure. The pump drive is powered by a rechargeable battery. Optionally the unit can be connected to mains power using an included power converter. AC Wound Management System has a negative pressure setting range of -50 mmHg to -175 mmHg which is electronically monitored and controlled. The system includes a keyboard for user interface as well as audible and visual alarm indicators. The system includes a 300cc canister. The system can be set on a countertop, carried using a shoulder bag or mounted to an IV pole or bedside rail using the AC Wound Management System's mount. The AC Wound Management System includes the following three components: The pump drive, The waste canister, with its suction tube (the two are connected permanently), FDA cleared generic NPWT dressing, which will be distributed by NanoVibronix. The pump drive is a non-disposable unit which contains a motor, a battery and a user interface. The drive has a piston which protrudes the drive and reciprocates to activate the suction pump, which is integral to the canister. In the drive there is also a vacuum level monitor which monitors the vacuum at all times and maintains the required set therapy. The waste canister attaches to the drive. The pump creates vacuum within the waste canister for the purpose of suctioning exudates from the wound and collecting them in the canister. The canister has a hydrophobic filter. The suction tube connects the waste canister to the wound dressing applying the vacuum generated within the waste canister to the wound site. The tube also transfers the exudates from the wound to the waste canister by maintaining flow from the wound site towards the waste canister at all times.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AC Wound Management System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Bench Tests
Stability of operation	Stable operation compared to predicate device.	Both AC NPWT system and predicate device Renasys NPWT system provide stable operation.
Negative pressure accuracy	Deviation of determined negative pressure level from measured average negative pressure level <= 1%.	Deviation no more than 1% for -50mmHg, -100mmHg, and -175mmHg.
Electrical Safety	Compliance with IEC 60601-1.	Test results demonstrated compliance with the standard.
EMC Compatibility	Compliance with IEC 60601-1-2.	Test results demonstrated compliance with the standard.
Firmware verification	Compliance with labeling and standard.	Test results demonstrated compliance with labeling and the standard.
Functionality test	Compliance with labeling and standard.	Test results demonstrated compliance with labeling and the standard.
Pressure stability	Positive results.	Test results positive.
Battery operating time	At least ~20 hours of therapy (max pressure, continuous mode).	Test results demonstrated 20 hours work therapy (max pressure, continuous mode).
Labeling	Compliance with standards.	Device comply with standards.

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

Sample Size for Test Set: The document indicates that the comparative bench tests were performed for "three negative pressure levels: -50mmHg, -100mmHg and -175mmHg." For each level, the test duration was 72 hours. This suggests a sample size related to the number of pressure levels tested and the duration of the testing rather than a patient count. The specific number of devices tested is not explicitly stated, but it was a comparative test against one predicate device.
Data Provenance: The data provenance is from bench testing, meaning it's laboratory-generated data, not from human or animal subjects. There is no information regarding the country of origin of this data, but it's presumed to be from the manufacturer's testing facilities or a contracted testing lab. The study is a prospective test in the sense that the new device was evaluated against defined criteria and a predicate.

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

This device approval is based on bench testing for substantial equivalence to a predicate device, not on clinical performance requiring human expert judgment (like image interpretation). Therefore, no human experts were involved in establishing the "ground truth" for the test set in the traditional sense. The "ground truth" was based on objective measurements against the predicate device and established engineering standards.

4. Adjudication Method for the Test Set

Not applicable. Since the evaluation was based on objective bench tests and engineering measurements, there was no need for an adjudication method by human experts.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical studies were conducted."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a metaphorical sense. The "algorithm" here is the device's mechanical and electronic function. The bench tests evaluated the AC Wound Management System's performance in a standalone capacity against its specifications and the predicate device, without human intervention in the operation being evaluated (other than setting it up).

7. The Type of Ground Truth Used

The ground truth used was based on objective engineering measurements and comparison to a legally marketed predicate device's performance and compliance with international standards (IEC 60601-1, IEC 60601-1-2) and the device's own labeling specifications.

8. The Sample Size for the Training Set

This information is not applicable as this device approval is based on demonstrating substantial equivalence through bench testing, not on a machine learning model that requires a training set.

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

This information is not applicable as no training set was used for this type of device approval.

Summary

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510(k) Summary

JUN 2 9 2012

Date Prepared

June 25, 2012

Sponsor Information

NanoVibronix, Inc. 105 Maxess Road, Suite S124 Melville, NY 11747

807.92(a){1)

Sponsor Contact	Harold Jacob
Title	CEO
Phone	1-516-668-3185
Device Name/Trade Name	AC Wound Management System 807.92(a)(2)
Common/Usual Name	Negative Pressure Wound Therapy Pump
Classification Name	Powered Suction Pump
Regulation Number	21 CFR 878.4780
Product Code	OMP
Review Panel	Surgical, Orthopedic, and Restorative Devices
Device Classification	Class II

Predicate Device

807.92(a)(3)

Company Name	Brand Name	510K Number
Smith & Nephew, Inc.	Renasys™ GO NegativePressure Wound Therapy	K083375

Device Description

807.92(1)(4)

AC Wound Management System has a negative pressure setting range of -50 mmHg to -175 mmHg which is electronically monitored and controlled. The system includes a keyboard for user interface as well as audible and visual alarm indicators. The system includes a 300cc canister. The system can be set on a countertop, carried using a shoulder bag or mounted to an IV pole or bedside rail using the AC Wound Management System's mount.

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K111949
p. 2 of 5

The AC Wound Management System includes the following three components:

The pump drive. .
The waste canister, with its suction tube (the two are connected . permanently).
FDA cleared generic NPWT dressing, which will be distributed by ● NanoVibronix.

The pump drive is a non-disposable unit which contains a motor, a battery and a user interface. The drive has a piston which protrudes the drive and reciprocates to activate the suction pump, which is integral to the canister. In the drive there is also a vacuum level monitor which monitors the vacuum at all times and maintains the reguired set therapy.

The waste canister attaches to the drive. The pump creates vacuum within the waste canister for the purpose of suctioning exudates from the wound and collecting them in the canister. The canister has a hydrophobic filter.

The suction tube connects the waste canister to the wound dressing applying the vacuum generated within the waste canister to the wound site. The tube also transfers the exudates from the wound to the waste canister by maintaining flow from the wound site towards the waste canister at all times.

Indications for Use

807.92(a)(5)

Predicate Product Comparison Table

807.92(1){6}

Parameters	NanoVibronix, Inc.AC Wound ManagementSystem	Smith & Nephew, Inc.Renasys Go
510(k) Number		K083375
Indications for Use	AC Wound ManagementSystem is indicated forpatients who would benefitfrom a suction device(negative pressure) to helppromote wound healing by	Renasys Go is indicated forpatients who would benefitfrom a suction device(negative pressure) to helppromote wound healing byremoving fluids including

	removing fluids, includingirrigation and body fluids,wound exudates, andinfectious materials.Examples of appropriatewound types include:Diabetic/Neuropathic ulcers,Pressure ulcers, Chronicwounds, Acute wounds,Dehisced wound, Partial-thickness burns, and Flapsand Grafts.	irrigation and body fluids,wound exudates andinfectious materials.Examples of appropriatewound types include: chronic,acute, traumatic, sub-acuteand dehisced wounds, ulcers(such as pressure or diabetic),partial-thickness burns, flapsand grafts.
Mode of Operation	Continuous or Intermittent	Continuous or Intermittent
Maximum negativepressure	-175mmHg	-200 mmHg
Negative PressureTherapy Settings	-50mmHg, -75mmHg,-100mmHg, -125mmHg,-150mmHg, -175mmHg	From -40 mmHg to-200mmHg
Power Requirements	Input: 100-240V AC 50/60Hz0.6AOutput: 12V DC, 2.08A, 5W	Input: 100-240V AC 50/60Hz0.9AOutput: 21V DC, 1.71A, 36W
Battery Type	Lithium ion rechargeable	Lithium ion rechargeable
Battery Operating Time	~20 hours (therapy)	~ 20 hours (therapy)
Dimensions	190x140x70mm(7.4 x 5.5 x 2.7 inches)	175x210x85mm(7 x 8.3 x 3.5 inches)
Weight	0.82kg (1.8 lbs)	1.1kg (2.4lbs)
Operating Environment	5-35°C (41-95°F)30 to 70% RH700 to 1060 mbaratmospheric pressure	5-35°C (41-95°F)30 to 70% RH700 to 1060 mbaratmospheric pressure
Canister Capacity	300 ml	300 ml

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Comparative Bench Testing

807.92(b)(1)

A comparative bench test was performed to determine the substantial equivalence of the AC Wound Management System to the Renasys™ Negative Pressure Wound Therapy System.

1. The results of the tests show that both AC NPWT system and predicated device Renasys NPWT system - provide stable operation.
  3

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K111949
p. 4 of 5

1. The results were obtained for three negative pressure levels: -50mmHg, -100mmHg and -175mmHg. Test duration was 72 hours for each level..
1. For both systems the deviation between determined negative pressure level and measured average negative pressure level was no more then 1% ( in four measurement points).
1. We conclude that AC NPWT system overcomes the acceptance criteria

Electrical and Bench Tests

AC Wound Management System complies with IEC 60601-1 and IEC 60601-1-2 Standards.

Bench test	Results
Electrical Safety	Test results demonstrated compliancewith the standard.
EMC Compatibility	Test results demonstrated compliancewith the standard.
Firmware verification	Test results demonstrated compliancewith labeling and the standard.
Functionality test	Test results demonstrated compliancewith labeling and the standard.
Pressure stability test for pump	Test results positive
Battery test	Test results demonstrated 20 hours worktherapy (max pressure, continuousmode)
Labeling	Device comply with standards

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Device comply with requirements

Clinical Tests

807.92(b)(2)

No clinical studies were conducted.

Conclusion

807.92(b)(3)

The AC Wound Management System and the Renasys™ Negative Pressure Wound Therapy System have the same indications for use and modes of operation. Both products use rechargeable battery, have same canister capacity, use similar pressure settings and have similar dimensions & weight. Therefore, the AC Wound Management System does not raise any new issues of safety and effectiveness. The AC Wound Management System is substantially equivalent to the Renasys™ marketed device and is safe and effective for the intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

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

AC Wound Treatment System % Smith Associates ·Mr. EJ Smith 1468 Harwell Avenue Crofton, Maryland 21114

JUN 2 9 2012

Re: K11949

Trade/Device Name: AC Wound Management System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered sunction pump Regulatory Class: Class II Product Code: OMP Dated: June 15, 2012 Received: June 15, 2012

Dear Mr. Smith:

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.

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Page 2- Mr. EJ Smith

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 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.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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 (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 vours.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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< 111949

Indications for Use

510(k) Number (if known):

Device Name: AC Wound Management System

Indications for Use:

Prescription Use _ V (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Kane for MMM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K11949

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.