The ANTLIA II™ Suction Pump System is indicated for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials.

Device Description

The ANTLIA IIm Suction Pump System, an AC-powered, portable suction device with battery back-up, provides localized negative pressure when used with the Aquarius IITM dressing to remove fluids and infectious materials from the wound to promote wound healing. It is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material, irrigation fluids or other body fluids from wounds.

The system consists of a powered suction pump device with a built-in placement holder for a fluid collection canister, the Aquarius II TM polyurethane foam dressing, and canister tubing with clamps and connectors, and two polyurethane drapes with adhesive.

AI/ML Overview

The provided text is a 510(k) summary for the ANTLIA II™ Suction Pump System, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in terms of clinical performance or accuracy of an AI algorithm.

Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement are not applicable to this type of regulatory submission for a physical medical device like a suction pump system. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device.

However, I can extract the relevant information from the document based on the context of a 510(k) submission for a non-AI/diagnostic device:

1. A table of acceptance criteria and the reported device performance

For a physical medical device like a suction pump, "acceptance criteria" generally refer to engineering specifications, performance standards, and safety requirements. The document states:

Acceptance Criteria (Implied by 510(k) Submission for this device type)	Reported Device Performance
Technological Characteristics: Must be substantially equivalent to predicate devices (Medela Invia™ Healing System, K061435; BlueSky Medical Versatile 1™ Wound Vacuum System, K052456).	"The ANTLIA II™ Suction Pump Therapy Unit has the same technological characteristics as the predicate's powered suction pump. The individual dressing components consists of materials that are either identical or substantially equivalent to the predicate's dressing components."
Indications for Use: Must align with predicate devices.	"The ANTLIA II™ Suction Pump System is indicated for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials." (This matches common indications for wound vacuum systems).
Safety and Effectiveness: Must be as safe and effective as predicate devices.	The FDA's substantial equivalence determination implies that the device is deemed as safe and effective as the predicate devices for its stated indications.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable. This 510(k) summary does not describe a clinical study with a test set of data or human subjects for performance evaluation in the context of AI or diagnostics. The submission primarily relies on comparisons to predicate devices for technological characteristics, materials, and intended use. Performance testing, if conducted, would typically be bench testing to technical specifications, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. As there is no "ground truth" establishment in the context of an AI/diagnostic study, no experts were involved for this purpose in this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. No test set requiring adjudication in this context.

5. 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 a physical medical device (suction pump system), not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

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

Not Applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. The concept of "ground truth" in the context of AI/diagnostic evaluation does not apply to this device. The regulatory approval is based on demonstrating equivalence to predicate devices, which means meeting similar performance specifications and safety profiles as established, legally marketed devices.

8. The sample size for the training set

Not Applicable. This device is not an AI model, so there is no training set.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set, there is no ground truth to establish for one.

In summary, the provided document is a 510(k) submission for a non-AI physical medical device. The "study" proving the device meets acceptance criteria is the overall 510(k) submission itself, which primarily demonstrates substantial equivalence to existing predicate devices based on technological characteristics, indications for use, and material composition, rather than conducting a separate clinical performance study with human data or AI-specific evaluations.

Summary

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K070904

510(k) Summary ANTLIA II™ SUCTION PUMP SYSTEM

APR 1 3 2007

1.	Name/Address of Submitter:	Innovative Therapies, Inc.10948 Beaver Dam Road, Suite CHunt Valley, MD 21030
2.	Contact Person:	Dave Tumey
3.	Date Summary Prepared:	March 16, 2007
4.	Name of Device:	ANTLIA II™ Suction Pump System
5.	Classification Name:	Powered Suction Pump21 CFR 878.4780Class II
6.	Predicate Device:	Medela Invia™ Healing System, K061435BlueSky Medical Versatile 1™ Wound VacuumSystem, K052456

7. Description of Device

8. Indication for Use

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9. Technological Characteristics and Substantial Equivalence

The ANTLIA II™ Suction Pump Therapy Unit has the same technological characteristics as the predicate's powered suction pump. The individual dressing components consists of materials that are either identical or substantially equivalent to the predicate's dressing components.

10. Conclusion

. . .

The substantial equivalence for the ANTLIA II™ Suction Pump System is based on the same indications, intended use, and technological features of the predicate devices.

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Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle. The eagle is depicted in a simple, bold line drawing style.

APR - 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Innovative Therapies, Inc. % Mr. David Tumey 8-2 Metropolitan Court Gaithersburg, Maryland 20878

Re: K070904

Trade/Device Name: ANTLIA IITM Suction Pump System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: March 20, 2007 Received: April 2, 2007

Dear Mr. Tumey:

This letter corrects our substantially equivalent letter of April 13, 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 (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.

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

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Page 2 - Mr. David Tumey

limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __ KO70904

Device Name: ANTLIA II™ Suction Pump System

Indications For Use:

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 1070904

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.