(11 days)
Not Found
No
The 510(k) summary describes a standard suction pump system for wound care and does not mention any AI or ML components or functionalities.
Yes
The device is described as promoting wound healing, which is a therapeutic effect.
No
The device is described as a suction pump system intended to promote wound healing and remove fluids, not to diagnose medical conditions or diseases.
No
The device description explicitly states that the system consists of a "powered suction pump device" and other physical components like a dressing, tubing, and drapes, indicating it is a hardware-based medical device with potential software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The ANTLIA II™ Suction Pump System is a medical device that applies negative pressure to wounds to remove fluids and promote healing. It operates externally on the body and does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a therapeutic application (wound healing and fluid removal) and not a diagnostic one.
Therefore, the ANTLIA II™ Suction Pump System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OMP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 C
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
21 CFR 878.4780
Class II |
| 6. | Predicate Device: | Medela Invia™ Healing System, K061435
BlueSky Medical Versatile 1™ Wound Vacuum
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.
1
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.
2
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
3
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
4
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)