(15 days)
Not Found
No
The summary describes a mechanical wound irrigation and suction system with no mention of AI or ML components.
Yes
The device is described as a "Wound Irrigation System" that provides "vacuum assisted drainage and controlled delivery of topical wound treatment solutions" for various types of wounds, indicating its use in treating medical conditions.
No
The device description clearly states its purpose is for "vacuum assisted drainage and irrigation of a wound site by controlled delivery of topical wound treatment solutions over the wound bed." This describes a treatment function, not a diagnostic one.
No
The device description explicitly states it is an "AC-powered, portable suction device with battery back-up," indicating it is a hardware device with 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The ANTILIA 1™ Wound Irrigation System is a device that applies vacuum and delivers topical solutions directly to a wound site on the body. It is used for treatment and drainage, not for analyzing samples taken from the body.
- Intended Use: The intended use clearly describes a system for wound treatment and drainage, not for diagnostic testing of biological samples.
Therefore, the ANTILIA 1™ Wound Irrigation System falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
OMP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound site / wound bed
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
MAY 2 4 2007
ANTLIA I™ WOUND IRRIGATION SYSTEM
| 1. | Name/Address of Submitter: | Innovative Therapies, Inc.
10948 Beaver Dam Road, Suite C
Hunt Valley, MD 21030 |
|----|----------------------------|---------------------------------------------------------------------------------------|
| 2. | Contact Person: | Judith Harbour
Phone: 866-200-0412
e-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 Pump
21 CFR 878.4780
Class II |
| 6. | Predicate Device: | V.A.C.® Instill™
510(k) No.K021501 |
7. Description of Device
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.
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.
1
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.
2
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.
3
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 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.
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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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
. ऐंद्रार
Oulane Buelun
(Division Sign.)
and Neurological Un
510(k) Number K152130