(108 days)
The AngioDynamics, VenaCure 1470 Laser is indicated 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.
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.
The provided text describes a 510(k) summary for the AngioDynamics VenaCure 1470 Laser, focusing on demonstrating substantial equivalence to predicate devices, rather than a de novo clinical study with specific acceptance criteria and detailed performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in the provided document.
However, based on the information available, here's what can be extracted:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a direct comparison table of predicate vs. new device performance for clinical outcomes. Instead, it relies on demonstrating equivalent performance through a series of engineering and safety tests.
| Acceptance Criterion (Inferred) | Reported Device Performance (Summary) |
|---|---|
| Functional Equivalence | "The results of the qualification/validation demonstrates equivalent performance to the predicate devices..." |
| EMC Compliance | Underwent "EMC Testing" |
| Software Verification | Underwent "Software Verification / Validation" |
| Product Longevity | Underwent "Product Life Time & Life Cycle Testing" |
| Electrical Safety | Underwent "Electrical Safety Testing" |
| Laser Safety | Underwent "Laser Safety Testing" |
| Environmental Robustness | Underwent "Environmental Testing" |
| Optical Output Performance | Underwent "Optical Output Performance" testing (intended for 12 Watts of energy, 1470nm wavelength) |
| Output Power Stability | Underwent "Output Power Stability" testing |
| System Performance | Underwent "System Performance" testing |
| Shock and Vibration | Underwent "Product Shock and Vibration Transit Testing" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily focuses on testing the device itself (e.g., engineering, safety, software) rather than a clinical test set of patients or images. Therefore, clinical sample sizes and data provenance are not applicable or provided. The "tests" mentioned are primarily laboratory-based and engineering evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The provided document does not describe a clinical study with a "test set" requiring expert ground truth establishment for clinical outcomes. The "ground truth" for the engineering and safety tests would be defined by the specifications and standards the device is designed to meet, not by human experts in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no clinical "test set" and thus no adjudication method described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document describes a laser device for medical procedures, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the engineering and safety tests mentioned, the "ground truth" is based on established engineering principles, regulatory standards (e.g., electrical safety standards, laser safety standards), and the design specifications of the device. There is no clinical "ground truth" (like pathology or outcomes data) specifically discussed in the context of this 510(k) summary, as it relies on substantial equivalence to previously approved devices with established clinical safety and effectiveness.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not a device with a "training set."
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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 DriveLatham, NY 12110 |
|---|---|
| Contact Person: | Teri Juckett14 Plaza DriveLatham, NY 12110Phone: 518-795-1142Fax: 518-795-1402 |
| Summary Preparation Date: | January 11, 2011 |
| Names. | |
| Device Name: | AngioDynamics, Inc. VenaCure 1470 Laser |
| Classification Name: | Class IILaser 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.
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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
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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
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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 .
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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
§ 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.