ANTLIA II SUCTION PUMP SYSTEM

K070904 · Innovative Therapies, Inc. · OMP · Apr 13, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070904
• Device Name: ANTLIA II SUCTION PUMP SYSTEM
• Applicant: Innovative Therapies, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Apr 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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 Story

ANTLIA II Suction Pump System is an AC-powered, portable suction device with battery backup; provides localized negative pressure to wounds. System components include powered suction pump, fluid collection canister, Aquarius II polyurethane foam dressing, canister tubing, and polyurethane drapes. Device removes fluids and infectious materials from wounds to promote healing. Used in clinical settings; operated by healthcare providers. Output is continuous or intermittent negative pressure; healthcare provider monitors wound status and fluid collection. Benefits include enhanced wound healing through vacuum-assisted drainage.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to predicate devices.

Technological Characteristics

Powered suction pump; AC-powered with battery backup. Components include polyurethane foam dressing and polyurethane drapes. System provides negative pressure suction. No specific ASTM standards or software algorithm details provided.

Indications for Use

Indicated for patients requiring negative pressure wound therapy to promote healing and for the removal of wound exudates, irrigation fluids, body fluids, and infectious materials.

Regulatory Classification

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.

Predicate Devices

• Medela Invia™ Healing System (K061435)
• BlueSky Medical Versatile 1™ Wound Vacuum System (K052456)

Submission Summary (Full Text)

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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.<br>10948 Beaver Dam Road, Suite C<br>Hunt 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 Pump<br>21 CFR 878.4780<br>Class II |
| 6. | Predicate Device: | Medela Invia™ Healing System, K061435<br>BlueSky Medical Versatile 1™ Wound Vacuum<br>System, K052456 |

#### 7. Description of Device

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.

### 8. Indication for Use

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.

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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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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:

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.

(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)