(114 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on fluid management for contrast media injection.
No
The device administers contrast media and flushing solutions, but it is not described as having a direct therapeutic effect on the patient's condition. It's an aid for diagnostic procedures.
No
Explanation: The device is indicated for the controlled administration of contrast media and flushing solutions, which are used during diagnostic procedures (angiography) but the device itself does not perform diagnosis. It's an injection system, not primarily a diagnostic tool.
No
The device description is not found, but the intended use clearly describes a "Fluid Management Injection System" which implies hardware for fluid delivery.
Based on the provided information, the MEDRAD Avanta™ Fluid Management Injection System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "controlled administration of intravascular radio-opaque contrast media and common flushing solutions to humans during angiographic procedures." This describes a device used in vivo (within the living body) for diagnostic imaging, not a device used in vitro (outside the body) to examine specimens like blood or tissue.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting specific substances, or providing diagnostic information based on laboratory tests.
Therefore, the MEDRAD Avanta™ Fluid Management Injection System is a medical device used for administering substances during a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MEDRAD Avanta™ Fluid Management Injection System is indicated for the controlled administration of intravascular radio-opaque contrast media and common flushing solutions to humans during angiographic procedures.
Product codes
74 DXT
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping shapes resembling birds in flight, oriented diagonally from the upper right to the lower left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 177 2005
Medrad, Inc. c/o Mr. Geoff M. Fatzinger Manager Regulatory and Compliance One Medrad Plaza Indianola, PA 15051
K050456 Re:
Avanta Fluid Management Injection System Regulation Number: 21 CFR 870.1650 Regulation Name: Injector and Syringe, Angiographic Regulatory Class: II (two) Product Code: 74 DXT Dated: June 8, 2005 Received: June 9, 2005
Dear Mr. Fatzinger:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) premier is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manatinent date of the Medical Device American For to commerce prior to May 20, 1976, the exactions of the Federal Food. Drug, devices that have been reclassined in assess approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvide of the general controls provisions of the Act. The You may, merclore, manxect the devices, becycler to the general controls provisions of the free 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 If your device is classified (500 above) als. Existing major regulations affecting your device can may be subject to such additional combines, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Pourses oncerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri- sissames or our device complies with other requirements of the Act that I DA has made a decemmandis an administered by other Federal agencies. You must or ally rederal statutes and regulations canniness, but not limited to: registration and listing (21 comply with an the Act 31equirements, are and 801); good manufacturing practice requirements as set
1
Page 2 - Mr. Geoff M. Fatzinger
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forul in the quality by tellio (Sections 531-542 of the Act); 21 CFR 1000-1050. product ladiation control providers (Seeting your device as described in your Section 510(k) This letter with anow you to ocgin manisting of substantial equivalence of your device to a legally premits tourneation. The PDF mailing of casification 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 11 you desire specific acries in (240) 276-0120. Also, please note the regulation entitled, Comaci the Ories of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dina R. de Auner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K050456
Device Name: Avanta Fluid Management Injection System
Indications For Use: The MEDRAD Avanta™ Fluid Management Injection System is indicated for the controlled administration of intravascular radio-opaque contrast media and common flushing solutions to humans during angiographic procedures.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Archer
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Koso4 ڪري
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