The ANTILIA 1™ Wound Irrigation System device is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

The ANTLIA 1 TM Wound Irrigation System is intended for patients with chronic, acute, traumatic, subacute, and dehised wounds, diabetic with with with churches, filaps and grafts.

Device Description

The ANTLIA I™ Wound Irrigation System is an AC-powered, portable suction device with battery back-up that provides vacuum assisted drainage and irrigation of a wound site by controlled delivery of topical wound treatment solutions over the wound bed.

The specifically designed Aquarius I™ dressing components are provided for irrigation to a wound with sterile saline or other applicable topical solutions. During and after irrigation, negative pressure can be applied to assist in the removal of infectious materials or other fluids.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the ANTLIA I™ Wound Irrigation System, based on the provided 510(k) summary:

This device is cleared through the 510(k) process, which relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials to prove device performance against specific acceptance criteria. Therefore, the information provided focuses on the technological characteristics and safety standards the device meets, rather than clinical performance metrics.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Standards Met	Reported Device Performance / Assessment
Safety and Electrical Standards	IEC 60601-1 + US deviations (UL60601-1): Medical Electrical Equipment-● Part1:General Requirements for Safety; 1. Collateral Standard: Safety Requirements for Medical electrical Systems	The device has been "independently tested and successfully approved" to these standards.
Electromagnetic Compatibility (EMC)	EN 60601-1-2: 2001 version (244 Edition): Medical Electrical Equipment -- Part 1-2: . Requirements for Safety-2. Collateral Standard: Electromagnetic General Compatibility Requirements and Tests	The device has been "independently tested and successfully approved" to these standards.
Programmable Electrical Medical Systems	IEC 60601-1-4: Medical Electrical Equipment Part 1: General Requirements for . Safety -4.Collateral Standard: Programmable Electrical Medical Systems	The device has been "independently tested and successfully approved" to these standards.
Substantial Equivalence	Same indications, intended use, and technological features as the predicate device (V.A.C.® Instill™ 510(k) No.K021501).	The substantial equivalence is based on these similarities.

Study Details (if applicable)

For 510(k) submissions based on substantial equivalence, robust clinical studies with human participants demonstrating performance against acceptance criteria are typically not required unless there are significant differences in technological characteristics or intended use compared to the predicate device. The provided document for K071301 does not describe a clinical study in the traditional sense, but rather a demonstration of compliance with recognized safety and performance standards and a comparison to a predicate device.

Given that this is a 510(k) summary for a Class II device, the process focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving a specific performance metric against acceptance criteria through a clinical trial. Therefore, the following points address what would typically be included for a clinical performance study, but clarifies their absence or alternative assessment in this 510(k) context.

Sample size used for the test set and the data provenance: Not applicable. The submission refers to independent testing against safety and EMC standards, not a clinical test set for performance. The "test set" would be the device itself undergoing engineering and safety evaluations, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established in this type of submission. The "experts" would be the engineers and regulatory bodies verifying compliance with medical device safety standards.
Adjudication method for the test set: Not applicable. There is no clinical test set requiring adjudication in this document.
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. This device is not an AI-powered diagnostic imaging tool. It is a wound irrigation system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not have an "algorithm" in the sense of AI or image analysis. It's an electro-mechanical system. Its standalone performance refers to its ability to operate according to its specifications (e.g., maintaining negative pressure, controlling fluid delivery). This is assessed through engineering tests and compliance with safety standards, not a clinical trial.
The type of ground truth used: Not applicable in the clinical sense. The "ground truth" here is compliance with recognized engineering and safety standards (e.g., IEC 60601 series) and the functional specifications of the device.
The sample size for the training set: Not applicable. This device does not use machine learning, so there is no training set.
How the ground truth for the training set was established: Not applicable. As there is no training set for machine learning, this is irrelevant.

In conclusion, K071301 demonstrates substantial equivalence by:

Sharing the same indications for use with the predicate device.
Having the same intended use as the predicate device.
Possessing similar technological characteristics to the predicate device.
Successfully passing independent tests against recognized medical device safety and performance standards (IEC 60601-1, EN 60601-1-2, IEC 60601-1-4).

This approach satisfies the requirements for 510(k) clearance for this type of device, focusing on safety and equivalence rather than new clinical efficacy trials against specific performance criteria.

Summary

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K071301

510(k) Summary

MAY 2 4 2007

ANTLIA I™ WOUND IRRIGATION SYSTEM

1.	Name/Address of Submitter:	Innovative Therapies, Inc.10948 Beaver Dam Road, Suite CHunt Valley, MD 21030
2.	Contact Person:	Judith HarbourPhone: 866-200-0412e-mail: jharbour@charter.com
3.	Date Summary Prepared:	May 4, 2007
4.	Name of Device:	ANTLIA I™ Wound Irrigation System
5.	Classification Name:	Powered Suction Pump21 CFR 878.4780Class II
6.	Predicate Device:	V.A.C.® Instill™510(k) No.K021501

7. Description of Device

8. Indication For Use

414

The ANTLLA I™ Wound Irrigation System device is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

The ANTLLA ITM Wound Irrigation System is intended for patients with chronic, acute, traumatic, subacute, and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts.

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9. Technological Characteristics and Substantial Equivalence

The ANTLIA I™ Wound Irrigation Therapy Unit has essentially the same technological characteristics as the previously cleared predicate device and has been independently tested and successfully approved to the following medical safety standards:

IEC 60601-1 + US deviations (UL60601-1), Medical Electrical Equipment-● Part1:General Requirements for Safety; 1. Collateral Standard: Safety Requirements for Medical electrical Systems
EN 60601-1-2: 2001 version (244 Edition), Medical Electrical Equipment -- Part 1-2: . Requirements for Safety-2. Collateral Standard: Electromagnetic General Compatibility Requirements and Tests
IEC 60601-1-4, Medical Electrical Equipment Part 1: General Requirements for . Safety -4.Collateral Standard: Programmable Electrical Medical Systems

10. Conclusion

The substantial equivalence for the ANTLIA I™ Wound Irrigation System is based on the same indications, intended use, and technological features of the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of three human figures.

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

JUL 14 2010

Innovative Therapies, Inc. % Ms. Judith Harbour 12 Meens Avenue, Suite C Gaithersburg, Maryland 20877

Re: K071301

Trade/Device Name: ANTLIA I™ Wound Irrigation System Regulation Number: 21 CFR 878.4780 Regulation Name: Negative Pressure Wound Therapy Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: May 8, 2007 Received: May 9, 2007

Dear Ms. Harbour:

This letter corrects our substantially equivalent letter of May 24, 2007.

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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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/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 A. Millman

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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Indications for Use

K071301 510(k) Number (if known):

Device Name:_ANTLIA_1™ Wound Irrigation System

Indications For Use:

The ANTLIA 1 TM Wound Irrigation System is intended for patients with chronic, acute, traumatic, subacute, and dehised wounds, diabetic with with with churches, filaps and grafts.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

. ऐंद्रार

Oulane Buelun
(Division Sign.)

and Neurological Un

510(k) Number K152130

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.