(108 days)
Not Found
No
The summary describes a laser device for treating varicose veins and does not mention any AI or ML capabilities. The performance studies focus on electrical, laser, and system performance, not algorithmic performance.
Yes
The device is indicated for the treatment of varicose veins and incompetent refluxing veins, which are medical conditions, meaning it is used to treat or alleviate a disease or injury.
No
The device description and intended use clearly state that it is a laser for the treatment of varicose veins and superficial vein reflux, not for diagnosing these conditions.
No
The device description clearly states it is a Class IV Diode Laser with a wavelength of 1470nm, indicating it is a hardware device that delivers energy. While it mentions "Software Verification / Validation" in the performance studies, this refers to the software controlling the hardware, not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a therapeutic procedure performed on the patient (treatment of varicose veins and varicosities). IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The device is a laser intended for delivering energy into the body for coagulation. This is a direct treatment method, not a diagnostic test performed on a sample.
- Anatomical Site: The device is used on the Greater Saphenous Vein and superficial venous system in the lower limb, which are parts of the patient's body, not specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
The device is a therapeutic medical device used for a surgical procedure.
N/A
Intended Use / Indications for Use
The AngioDynamics VenaCure 1470 Laser is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.
Product codes
GEX
Device Description
The AngioDynamics VenaCure 1470 Laser is a Class IV Diode Laser with a wavelength of 1470nm. The 1470 Laser is intended for use in delivering up to 12 Watts of energy and is intended to be used with AngioDynamics Fiber Optic Delivery System Procedure Kits for use in endovascular coagulation of the Great Saphenous Vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Greater Saphenous Vein, superficial venous system in the lower limb.
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)
The AngioDynamics VenaCure 1470 Laser has undergone a comprehensive series of test protocols, listed below, in order to qualify and validate the performance of the devices. The results of the qualification/validation demonstrates equivalent performance to the predicate devices which themselves have substantial clinical and market evidence of acceptable performance. The AngioDynamics VenaCure 1470 Laser is therefore validated for use on this basis.
EMC Testing Software Verification / Validation Product Life Time & Life Cycle Testing Electrical Safety Testing Laser Safety Testing Environmental Testing Optical Output Performance Output Power Stability System Performance Product Shock and Vibration Transit Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K 110225
MAY 13 2011
510(k) Summary of Safety and Effectiveness for the VenaCure 1470 Laser:
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
ਵ
! .
| Submitter: | AngioDynamics, Inc.
14 Plaza Drive
Latham, NY 12110 |
|---------------------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Teri Juckett
14 Plaza Drive
Latham, NY 12110
Phone: 518-795-1142
Fax: 518-795-1402 |
| Summary Preparation Date: | January 11, 2011 |
| Names. | |
| Device Name: | AngioDynamics, Inc. VenaCure 1470 Laser |
| Classification Name: | Class II
Laser Instrument, Surgical Powered |
3. Predicate Devices
. 2.
The AngioDynamics VenaCure 1470 Laser is substantially equivalent to the AngioDynamics Delta 15 and AngioDynamics Delta 30 Lasers, K051995, and the Biolitec 15W Ceralas D 1470nm Diode Laser, K082225.
Product Code: GEX
4. Device Description
The purpose of this Traditional 510(k) is to notify FDA of the proposed new AngioDynamics VenaCure 1470 Laser, which is equivalent to the AngioDynamics Delta 15 and AngioDynamics Delta 30 Lasers.
1
The AngioDynamics VenaCure 1470 Laser is a Class IV Diode Laser with a wavelength of 1470nm. The predicate Biolitec Laser has the same 1470nm wavelength.
The 1470 Laser is intended for use in delivering up to 12 Watts of energy and is intended to be used with AngioDynamics Fiber Optic Delivery System Procedure Kits for use in endovascular coagulation of the Great Saphenous Vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
5. Indications for Use
ﺮ ﻣ
The AngioDynamics VenaCure 1470 Laser is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.
6. Performance Data
The AngioDynamics VenaCure 1470 Laser has undergone a comprehensive series of test protocols, listed below, in order to qualify and validate the performance of the devices. The results of the qualification/validation demonstrates equivalent performance to the predicate devices which themselves have substantial clinical and market evidence of acceptable performance. The AngioDynamics VenaCure 1470 Laser is therefore validated for use on this basis.
EMC Testing Software Verification / Validation Product Life Time & Life Cycle Testing Electrical Safety Testing Laser Safety Testing Environmental Testing Optical Output Performance Output Power Stability System Performance Product Shock and Vibration Transit Testing
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AngioDynamics, Inc. % Ms. Teri Juckett 14 Plaza Drive Latham, New York 12110
MAY 1 3 2011
Re: K110225
Trade/Device Name: AngioDynamics, Inc. VenaCure 1470 Laser and Accessories Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general surgery and in plastic surgery and in dermatology
Regulatory Class: Class II Product Code: GEX Dated: April 07, 2011 Received: April 11, 2011
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
3
Page 2 - Ms. Teri Juckett
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
AS B. R h
for.
Mark N. Melkersc Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
4
INDICATIONS FOR USE
KI10225 510(k) Application: Traditional 510(k): Device Modification
AngioDynamics, VenaCure 1470 Laser Device Name:
Indications for Use:
The AngioDynamics, VenaCure 1470 Laser is indicated for use in the treatment of rne AngloDynamos, Tontoosities with superficial reflux of the Greater Saphenous Vein, and varieose voms and varioonise weffixing veins in the superficial venous system in the lower limb.
Prescription Use __ X Over-the-Counter Use
(Per 21 CFR 801.109)
Please do not write below this line - continue on another page if needed
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil R.P. Ogden for mxm
(Division Sign-Off)
Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110225