(83 days)
Not Found
Not Found
No
The 510(k) summary describes a simple mechanical device for vascular access and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is used for introduction of other instruments into the vascular system, not for direct treatment of a disease or condition.
No
The device is described as an "Access Kit" for percutaneous introduction of a guidewire or catheter into the vascular system. Its purpose is to facilitate access rather than to diagnose a condition.
No
The device description and intended use clearly describe a physical kit for vascular access, which involves hardware components like needles and guidewires. There is no mention of software as the primary or sole component.
Based on the provided information, the AngioDynamics, Inc. Micro Access Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for percutaneous introduction of a guidewire or catheter into the vascular system. This is an in vivo procedure, meaning it's performed within the living body.
- IVD Definition: In vitro diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
The device's function is to facilitate access to the vascular system for other medical procedures, not to analyze biological samples in a lab setting.
N/A
Intended Use / Indications for Use
The AngioDynamics, Inc. Micro Access Kit is indicated for percutaneous introduction of a guidewire or catheter into the vascular system following a small 21-gauge needle stick.
Product codes
DQR, DQX, DRC, DYB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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
§ 870.1300 Catheter cannula.
(a)
Identification. A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
SEP 1 2 2005
Food and Drug Administratior 9200 Corporate Boulevard Rockville MD 20850
AngioDynamics, Inc. c/o Ms. Teri Juckett Regulatory Affairs Manager 603 Queensburg Avenue Queensburg, NY 12804
K051655 Micro Access Kits Nicio Access Rirs
Regulation Number: 21 CFR 870.1300, 870.1330, 870.1390, 870.1340 Regulation Name: Catheter Cannula, Catheter Guide Wire, Trocar, Catheter Introducer Regulatory Class: II Product Code: DQR, DQX, DRC, DYB Dated: June 20, 2005 Received: June 21, 2005
Dear Ms. Juckett:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becalled is reley presses 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 encreativent of the enactment date of the Medical Device Amendments, or to commerce provision to May 20, 1978, the ecordance with the provisions of the Federal Food, Drug, devices that have been reclasined in assee approval of a premarket approval application (PMA). and Cosmetic Act (110) market the device, subject to the general controls provisions of the Act. The T ou may, therefore, market and act include requirements for annual registration, listing of general controls provisions of the ties, 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 to such additional controls. Existing major regulations affecting your device can may or subject to back acceral Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Ms. Teri Juckett
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); 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. This letter will allow you to begin 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) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. Vochner
( ) Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ದ
INDICATIONS FOR USE
1051655
510(k) Application: New Application
Device Name:
:
.
AngioDynamics, Inc. Micro Access Kit
Indications for Use:
The AngioDynamics, Inc. Micro Access Kit is indicated for percutaneous introduction of a guidewire or catheter into the vascular system following a small 21-gauge needle stick.
Prescription Use X (Per 21 CFR 801.109)
OR Over-the-Counter Use _
Please do not write below this line - continue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K 051655
AngioDynamics Micro Access Kit 510(k) Design History File 377
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