(308 days)
Not Found
No
The summary describes a laser procedure kit for treating varicose veins and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for endovascular coagulation, treatment of varicose veins and variocosities, and treatment of incompetence and reflux of superficial veins, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device is indicated for endovascular coagulation and treatment of varicose veins and superficial venous reflux, which are therapeutic procedures, not diagnostic ones.
No
The device description is not available, but the intended use clearly describes a "Procedure Kit" and mentions a "Percutaneous Introducer" and "Diode Lasers." These are hardware components, indicating the device is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure performed on the patient's veins (endovascular coagulation) for the treatment of varicose veins and reflux. This is a therapeutic procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: While the description is "Not Found," the intended use clearly indicates a device used for a surgical/interventional procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to treat a condition within the body.
N/A
Intended Use / Indications for Use
The AngioDynamics, Inc. VenaCureEVLT Procedure Kit with Percutaneous Introducer is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
The AngioDynamics, Inc. VenaCureEVLT Procedure Kit is indicated for use with 810 nm and 980 nm Diode Lasers with SMA 905 connectors.
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Great Saphenous Vein (GSV), superficial veins of the lower extremity
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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
AngioDynamics Inc. c/o Ms. Teri Juckett 603 Queensbury Ave Queensbury, NY 12804
NOV 2-6 2010
Re: K100199
Trade/Device Name: AngioDynamics Percutaneous Introducer and VenCureEVLT Procedure Kit Regulation Number: 21 CFR 878.4810 Regulation Name: Powered Laser Surgical Instrument Regulatory Class: Class II Product Code: GEX Dated: November 8, 2010 Received: November 10, 2010
Dear Ms. Juckett:
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.
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
1
Page 2 - Ms. Juckett
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/CDRH0ffices/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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
W.M.
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
Image /page/2/Picture/1 description: The image shows the text 'K100199' on the top line. The second line of text says 'Nov. 2 6 2010'. The text appears to be handwritten and is in black ink. The image is a close-up of the text.
510(k) Application: Traditional 510(k): Device Modification
Device Name: AngioDynamics, Inc. Percutaneous Introducer and VenaCureEVLT Procedure Kit
Indications for Use:
The AngioDynamics, Inc. VenaCureEVLT Procedure Kit with Percutaneous Introducer is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
The AngioDynamics, Inc. VenaCureEVLT Procedure Kit is indicated for use with 810 nm and 980 nm Diode Lasers with SMA 905 connectors.
OR
Prescription Use X (Per 21 CFR 801.109)
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)
W.M.A.
iovascular Devices
510(k) Number K100044