(77 days)
The 400um Perforator and Accessory Vein Ablation Kit is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The 400um Perforator and Accessory Vein Ablation Kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for the treatment of incompetent (i.e. refluxing) perforator veins (IPVs).
The 400μm Perforator and Accessory Vein Ablation Kit is used to treat patients with varicose veins. Varicose veins are large, twisted, visibly bulging veins usually located in the legs. Varicose Veins occur when either the blood flow is too slow or valves are not functioning correctly resulting in "pile-up" of blood within the lower extremity veins. AngioDynamics proposes that this include the Incompetent Perforator Veins (IPVs). The 400um Perforator and Accessory Vein Ablation Kit is provided in a procedure kit which includes a 400μm Fiber along with the following accessory components:
- 21G Entry Needle
- . 4F Introducer Sheath/Dilator
- 0.018" Guidewire ●
The 400μm Perforator and Accessory Vein Ablation Kit is presented sterile and contains all of the accessories needed to perform the EVLT procedure, with the exception of generic disposable items routinely found in a well-equipped minor treatment room such as drapes, swabs, bandages etc.
The provided text is a 510(k) summary for the AngioDynamics 400um Perforator and Accessory Vein Ablation Kit. It details the device, its intended use, and substantial equivalence to predicate devices, including a clinical study conducted to evaluate its performance.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The primary acceptance criterion is acute primary ablation success for Incompetent Perforator Veins (IPVs).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Acute Primary Ablation Success (Performance Goal) | 70% (p=0.033) - Stated as "statistically significantly above the performance goal of 70% (p=0.033)" for the primary endpoint. |
| Reported Device Performance | 76.8% (96 of 125 treated IPVs in the ITT Population at the 10-day visit met the primary endpoint) and 76.9% (model success rate in the GEE model). |
2. Sample Size and Data Provenance
- Sample Size for Test Set: 125 Incompetent Perforator Veins (IPVs) were treated (ITT Population). The number of patients in the ITT set was 74 (sum of patients from all sites listed in the table under "Site").
- Data Provenance:
- Country of Origin: Not explicitly stated, but the study was "multi-center" and the sponsor is AngioDynamics, Inc. based in Marlborough, Massachusetts, USA. Given it's an FDA submission, it's highly likely to be US-based or an international study adhering to US regulatory standards.
- Retrospective or Prospective: Prospective. The study is described as a "single-arm, prospective, multi-center, non-blinded clinical trial."
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the number of experts used to establish the ground truth for the test set, nor their qualifications. The study focused on clinical outcomes post-procedure rather than interpretation of diagnostic images by experts. The "ground truth" for acute primary ablation success seems to be determined by clinical assessment at the 10-day visit.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. Given that the primary endpoint is "acute primary ablation success" based on clinical assessment, it's likely that this was determined by the treating clinician or study investigator at each site, rather than a separate panel of adjudicators.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This study evaluated the performance of the device itself for a therapeutic procedure (ablation), not a diagnostic algorithm that assists human readers. Therefore, there's no discussion of human readers improving with or without AI assistance.
6. Standalone (Algorithm Only) Performance
Not applicable. This study is not evaluating an AI algorithm or diagnostic tool. It's evaluating the performance of a medical device (a laser ablation kit) used in a therapeutic procedure. The "performance data" refers to the clinical outcome of the procedure when using the device, not an algorithm's performance.
7. Type of Ground Truth Used
The type of ground truth used is clinical outcome data (acute primary ablation success at the 10-day visit). This is a direct measure of the effectiveness of the therapeutic intervention.
8. Sample Size for the Training Set
Not applicable. This study is a clinical trial evaluating a physical medical device (laser ablation kit) for a therapeutic procedure. It does not involve machine learning or AI, and therefore there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the provided text.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
AngioDynamics, Inc. % Mr. Deepa Godhiya Specialist, Global Regulatory Affairs 26 Forest Street Marlborough, Massachusetts 01752
Re: K181044
Trade/Device Name: 400um Perforator and Accessory Vein Ablation Kit Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for use in General and Plastic Surgery and n Dermatology Regulatory Class: Class II Product Code: GEX Dated: April 17, 2018 Received: April 19, 2018
Dear Mr. Godhiya:
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. Isting of devices, good manufacturing practice, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Peter L. Hudson -S 2018.07.03 14:06:42 -04'00'
For: Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
| Food and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020 |
|---|---|
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known)Unknown | |
| Device Name400um Perforator and Accessory Vein Ablation Kit | |
| Indications for Use (Describe)The 400um Perforator and Accessory Vein Ablation Kit is intended for use in the treatment of superficial vein reflux ofthe greater saphenous vein associated with varicosities. The 400um Perforator and Accessory Vein Ablation Kit isindicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for the treatment ofincompetent (i.e. refluxing) perforator veins (IPVs). | |
| Type of Use (Select one or both, as applicable) | |
| > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information Officer | |
| Paperwork Reduction Act (PRA) StaffPRAStaff(@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number." |
{3}------------------------------------------------
510(K) SUMMARY – 400μ.M PERFORATOR AND ACCESSORY VEIN ABLATION KIT Date Prepared: April 17, 2018
A. SPONSOR
AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752
B. CONTACT
Deepa R. Godhiya Specialist, Global Regulatory Affairs T: 1-508-658-7923 F: 1-508-658-7976 E: dgodhiya@angiodynamics.com
OR
Brandon M. Brackett, RAC Manager, Global Regulatory Affairs T: 1-508-658-7984 F: 1-508-658-7976 E: bbrackett@angiodynamics.com
C. DEVICE NAME
| Trade Name: | 400μm Perforator and Accessory Vein Ablation Kit |
|---|---|
| Common/Usual Name: | Laser Vein Ablation Procedure Kit |
| Classification Name: | Power Laser Surgical Instrument (ProCode: GEX) |
| Classification Panel: | General and Plastic Surgery |
| D. PREDICATE DEVICE(S) | |
|---|---|
| 510(k) Number | K041957 |
| Trade Name: | AngioDynamics, Inc. (Diomed, Ltd.) EVLT Kit and thD15 Plus and D30 Plus Diode Lasers |
| Common/Usual Name: | Laser Vein Ablation Procedure Kit |
| Classification Name: | Power Laser Surgical Instrument (ProCode: GEX) |
| Classification Panel: | Dermatology and Plastic Surgery |
{4}------------------------------------------------
K181044, pg. 2 of 3
| 510(k) Number | K052003 |
|---|---|
| Trade Name: | VNUS RFS and VNUS RFS Flex |
| Common/Usual Name: | Bipolar Electrosurgical Instrument |
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories(ProCode: GEI) |
| Classification Panel: | Dermatology and Plastic Surgery |
E. DEVICE DESCRIPTION
The 400μm Perforator and Accessory Vein Ablation Kit is used to treat patients with varicose veins. Varicose veins are large, twisted, visibly bulging veins usually located in the legs. Varicose Veins occur when either the blood flow is too slow or valves are not functioning correctly resulting in "pile-up" of blood within the lower extremity veins. AngioDynamics proposes that this include the Incompetent Perforator Veins (IPVs). The 400um Perforator and Accessory Vein Ablation Kit is provided in a procedure kit which includes a 400μm Fiber along with the following accessory components:
- 21G Entry Needle
- . 4F Introducer Sheath/Dilator
- 0.018" Guidewire ●
The 400μm Perforator and Accessory Vein Ablation Kit is presented sterile and contains all of the accessories needed to perform the EVLT procedure, with the exception of generic disposable items routinely found in a well-equipped minor treatment room such as drapes, swabs, bandages etc.
F. INTENDED USE/INDICATIONS FOR USE
"The 400 µm Perforator and Accessory Vein Ablation Kit is indicated for use in the treatment of superficial vein reflux of greater saphenous vein associated with varicosities. The 400 m Perforator and Accessory Vein Ablation Kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for the treatment of Incompetent (i.e. refluxing) Perforator Veins (IPVs)."
G. SUMMARY OF SIMILARITIES AND DIFFERENCES IN TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE
The proposed 400μm Perforator and Accessory Vein Ablation Kit is substantially equivalent to the predicate devices, both previously reviewed and cleared by the Agency, based upon the following conclusions:
- . to K041957 (EVLT Kit and the D15 Plus and D30 Plus Diode Lasers) in terms of overall design, materials, kitted accessories, labeling, and other design-related attributes - please refer to the table below for a side-by-side comparison of the Kit Accessories of the proposed device to that cleared via this predicate 510(k),
| Proposed Kit | Predicate Kit (K041957) |
|---|---|
| 21G Entry Needle | 19G Entry Needle |
| 0.018" Guidewire | 0.035" Guidewire |
| 4F Introducer Sheath/Dilator | 4F & 5F Introducer Sheath/Dilator |
- . to K052003 (VNUS RFS and RFS Flex Devices) in regards to the Indications for Use, which includes for use in perforator veins – AngioDynamics' intended expansion in regards to its Indications for Use.
{5}------------------------------------------------
H. PERFORMANCE DATA
standard, including:
The performance evaluation of the proposed 400μm Perforator and Accessory Vein Ablation Kit is centered around the clinical study 'SECURE Study', which was performed in compliance with Good Clinical Practice (GCP) and in accordance to the international standard AAMI/ANSI/ISO 14155:2011 – "Clinical Investigation of Medical Devices for Human Subjects: Good Clinical Practice". Furthermore, the proposed 400µm Perforator and Accessory Vein Ablation Kit has demonstrated successful results based upon the conclusions of the clinical testing per the above guidance and
- . Primary objective of acute primary ablation success; and,
- Secondary objectives to evaluate the post-procedural clinical outcomes. ●
I. CLINICAL STUDY (For Perforator Study)
The SECURE STUDY was conducted to evaluate the safety and effectiveness of the 400um Perforator and Accessory Vein Ablation Kit when used to treat Incompetent Perforator Veins (IPVs). This was a singlearm, prospective, multi-center, non-blinded clinical trial. The study population included patients diagnosed with perforating vein insufficiency who were deemed by their treating clinician to be eligible for treatment by endovascular ablation. The primary objective of the study was to evaluate the VenaCure EVLT 400 µm Fiber Procedure Kit when used to treat Incompetent Perforator Veins (IPVs). For the primary endpoint of "acute primary ablation success," 96 of 125 treated IPVs (ITT Population) at the 10-day visit met the primary endpoint of acute primary ablation success, for a success rate of 76.8%. In the generalized estimating equation (GEE) model specified in the protocol and used to evaluate the primary endpoint, this resulted in a 76.9% model success rate, statistically significantly above the performance goal of 70% (p=0.033). The table below provides details of the SECURE STUDY.
| Intent to Treat (ITT) Set | |||
|---|---|---|---|
| Site | Number of Patients | Number of IPVs Treated | Number of IPV Successes Range of % Success |
| 100 | 11 | 11 | 2 – 4328.6 – 100.0% |
| 101 | 29 | 56 | |
| 102 | 9 | 11 | |
| 103 | 13 | 18 | |
| 104 | 11 | 15 | |
| 106 | 4 | 7 | |
| 107 | 6 | 7 |
Adverse Events (Safety Population)
A total of 6 adverse events were reported during this clinical study, that were either procedure and/or device related. They include the following: deep vein thrombosis; venous thrombosis limb; thrombophlebitis superficial; skin ulcer; wound; procedural pain.
J. CONCLUSION
Based upon successful results of clinical testing, in addition to the responses to questions posed within FDA's 510(k) Decision-Making Tree, the proposed device is determined to be substantially equivalent to the predicate devices.
§ 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.