(49 days)
No
The summary describes a physical medical device (needle electrode system) used for thermal coagulation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on physical and electrical properties, not algorithmic performance.
Yes
The device is intended for the thermal coagulation necrosis of soft tissues, including ablation of nonresectable liver lesions, which is a therapeutic intervention aiming to treat a medical condition.
No
The device is intended for the thermal coagulation necrosis of soft tissues, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components like electrode arrays, cannulas, handles, and connections to a generator and ground pad, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions." This describes a therapeutic procedure performed directly on the patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The device is a needle electrode system used in conjunction with an RF generator to deliver energy to tissue. This is consistent with a surgical or therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is used for direct treatment of tissue within the body.
N/A
Intended Use / Indications for Use
The LeVeen™ Needle Electrode Family (which includes the LeVeen™ Standard Needle Electrode System and the LeVeen™ CoAccess™ Need Electrode System') is intended to be used in coniunction with the RF3000 Generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
Product codes
GEI
Device Description
LeVeen Standard Needle Electrode System:
The description of the proposed LeVeen Standard Needle Electrode System is the same as the predicate LeVeen Standard Needle Electrode System. The LeVeen Standard Needle Electrode System consists of a pre-shaped, multi-armed electrode array which is contained within a delivery cannula. The array is attached to a handle mechanism that deploys the array into targeted tissue. The device is connected to a generator so that RF.energy passes from the array to a patient ground pad and heats the tissue surrounding the array.
LeVeen CoAccess Needle Electrode System:
The description of the proposed LeVcen CoAccess Needle Electrode System is the same as the predicate LeVeen CoAccess Needle Electrode System. The LeVeen CoAccess Needle Flectrode System is a disposable, monopolar electrosurgical device used for the coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions.
The LeVeen CoAccess Needle Electrode System consists of the CoAccess' Introducer (an insulated cannula with a locking stylet) and the LeVeen CoAccess Electrode (array with integrated deployment handle) capable of fixed coaxial placement within the insulated cannula. The LeVeen CoAccess Electrode also has an array of wires that is deployed into the targeted soft tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, including partial or complete ablation of nonresectable liver lesions.
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)
Performance bench testing, biocompatibility testing, and electrical testing were performed on the proposed LeVeen Standard Needle Electrode System and LeVeen CoAccess Needle Electrode System with PEEK insulation, which demonstrates the PEEK insulation met the required specifications for the completed design verification, biocompatibility tests, and electrical tests.
Also, performance bench testing and biocompatibility testing were performed on the proposed CoAccess introducer with the Lexan hub to demonstrate that the Lexan hub met the required specifications for the completed design verification and biocompatibility tests.
The following performance bench tests were performed:
- LeVeen Standard Needle Electrode System:
- Insulated Cannula Outer Diameter (OD) o
- Cannula Insulation Adhesion o
- Cannula Tensile
- Cannula/Array Housing Handle Compression Strength
- Insulated Cannula Outer Diameter (OD) o
- LeVeen CoAccess Needle Electrode System:
- Introducer Cannula Length o
- Insulated Introducer Cannula OD
- Introducer Insulation Adhesion o
- o Introducer Cannula Luminal Access
- Introducer-Electrode Connection Strength 0
- Introducer Tensile Strength o
- Introducer Cannula Compression Strength 0
- Introducer Insulation o
- Stylet Protrusion from Introducer Cannula o
- Array Housing Protrusion from Introducer Cannula o
- 0 Insulation Protrusion
- Introducer Cannula Luer
The following biocompatibility tests were performed:
- Cytotoxicity o
- Sensitization .
- Irritation
- Acute Systemic Toxicity .
- Latex .
Testing was performed per the requirements of the following electrical standards:
- IEC 60601-1:2005 Medical Electrical Equipment, Part 1: General Safety . Requirements
- IEC 60601-2-2:2009 Medical Electrical Equipment, Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Boston Scientific Corporation
SECTION 6 510(K) SUMMARY (K140495) . page 1 of 4
1. Submitter:
Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311-1566 Telephone: 763-494-1789 Fax: 763-494-2222
Contact: Matt Beauchane Regulatory Affairs Specialist Date Prepared: 'April 8, 2014
- Device:
Trade Name: LeVeen™ Standard Needle Electrode System and LeVeen™ CoAccess™ Needle Electrode System Electrode, Electrosurgical Common Name: Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 878.4400 Product Code: GEI Panel: General & Plastic Surgery Classification: Class II
3. Predicate Device:
Boston Scientific Corporation's LeVeen™ Standard Needle Electrode System (K982556) Boston Scientific Corporation's LeVecn™ CoAccess™ Needle Electrode System (K012315) ·
4. Device Description:
LeVeen Standard Needle Electrode System:
The description of the proposed LeVeen Standard Needle Electrode System is the same as the predicate LeVeen Standard Needle Electrode System. The LeVeen Standard Needle Electrode System consists of a pre-shaped, multi-armed electrode array which is contained within a delivery cannula. The array is attached to a handle mechanism that deploys the array into targeted tissue. The device is connected to a generator so that RF.energy passes from the array to a patient ground pad and heats the tissue surrounding the array.
LeVeen™Standard Necdle Electrode System and LeVeen™ CoAccess™ Needle Electrode System 6-1
APR 1 7 2014
1
Boston Scientific Corporation
510(K) SUMMARY (K140495) page 2 of 4
LeVeen CoAccess Needle Electrode System:
The description of the proposed LeVcen CoAccess Needle Electrode System is the same as the predicate LeVeen CoAccess Needle Electrode System. The LeVeen CoAccess Needle Flectrode System is a disposable, monopolar electrosurgical device used for the coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions.
The LeVeen CoAccess Needle Electrode System consists of the CoAccess' Introducer (an insulated cannula with a locking stylet) and the LeVeen CoAccess Electrode (array with integrated deployment handle) capable of fixed coaxial placement within the insulated cannula. The LeVeen CoAccess Electrode also has an array of wires that is deployed into the targeted soft tissue.
5. Intended Use:
The LeVeen™ Needle Electrode Family (which includes the LeVeen™ Standard Needle Electrode System and the LeVeen™ CoAccess™ Need Electrode System') is intended to be used in coniunction with the RF3000 Generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
6. Technological Characteristics:
The proposed LeVeen Standard Needle Electrode System and LeVeen CoAccess Needle Electrode System devices will have PEEK insulation. The currently cleared LeVeen Standard Needle Electrode System (K982556) and LeVeen CoAccess Needle Electrode System (K012315) insulation material is FEP. This change is identical to the LeVeen™ SuperSlim™ Meedle Electrode System cannula insulation material change that received 510(k) clearance per K113090.
The proposed CoAccess Introducer will have a hub made of Lexan resin material. The currently cleared CoAccess Introducer (K012315) has a hub made of Eastalloy resin material.
7. Performance Data:
Performance bench testing, biocompatibility testing, and electrical testing were performed on the proposed LeVeen Standard Needle Electrode System and LeVeen CoAccess Needle Electrode System with PEEK insulation, which demonstrates the PEEK insulation met the required specifications for the completed design verification, biocompatibility tests, and electrical tests.
LeVeen™ Standard Needle Electrode System and LeVeen™ Needle Electrode System 6-2
2
Boston Scientific Corporation
510(K) SUMMARY (K140495) page 3 of 4
6-3
Also, performance bench testing and biocompatibility testing were performed on the proposed CoAccess introducer with the Lexan hub to demonstrate that the Lexan hub met the required specifications for the completed design verification and biocompatibility tests.
The following performance bench tests were performed:
- LeVeen Standard Needle Electrode System: .
- Insulated Cannula Outer Diameter (OD) o
- Cannula Insulation Adhesion o
- Cannula Tensile ಂ
- Cannula/Array Housing Handle Compression Strength ಂ
- Insulated Cannula Outer Diameter (OD) o
- LeVeen CoAccess Needle Electrode System:
- Introducer Cannula Length o
- Insulated Introducer Cannula OD ্র
- Introducer Insulation Adhesion ס
- o Introducer Cannula Luminal Access
- Introducer-Electrode Connection Strength 0
- Introducer Tensile Strength o
- Introducer Cannula Compression Strength 0
- Introducer Insulation ০
- Stylet Protrusion from Introducer Cannula o
- Array Housing Protrusion from Introducer Cannula o
- 0 Insulation Protrusion
- Introducer Cannula Luer ಂ
The following biocompatibility tests were performed:
- Cytotoxicity o
- Sensitization .
- Irritation
- Acute Systemic Toxicity .
- Latex .
Testing was performed per the requirements of the following electrical standards:
- IEC 60601-1:2005 Medical Electrical Equipment, Part 1: General Safety . Requirements
- IEC 60601-2-2:2009 Medical Electrical Equipment, Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment
Traditional 510(k) Premarket Notification Frankleika 970(1) Promation System and LeVeen™ CoAccess™ Needle Electrode System
3
Boston Scientific Corporation .
·
510(K) SUMMARY (K140495) page 4 of 4
. 1
8. Conclusion:
The LeVeen Standard Needle Electrode System and LeVeen CoAccess Needle Electrode System are substantially equivalent to the currently cleared LeVeen Standard Needle Electrode System (K982556) and LeVeen CoAccess Needle Electrode System (K012315) as they are similar to the predicate devices in Intended Use / Indications for Use, fundamental design, function, device materials, packaging, sterilization, operating principles, and fundamental scientific technology.
.
Traditional 510(k) Premarket Notification LeVeen™ Standard Needle Electrode System and LeVeen™ CoAccess™ Needle Electrode System 6-4
'
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17. 2014
Boston Scientific Corporation Mr. Matt Beauchane Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311
Re: K140495
Trade/Device Name: LeVeen" Standard Electrode System and Leveen" CoAccess" Need Electrode System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 26, 2014 Received: February 27, 2014
Dear Mr. Beauchane:
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 complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21
5
Page 2 - Mr. Matt Beauchane
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
SECTION 5 INDICATIONS FOR USE STATEMENT
510(k) Number: K 140495
Device Name:
LeVeen™ Standard Needle Electrode System and LeVeen™ CoAccess™ Need Electrode System
Indications for Use:
The LeVeen™ Needle Electrode Family (which includes the LeVeen™ Standard Needle Electrode System and the LeVeen™ CoAccess™ Need Electrode System) is intended to be used in conjunction with the RF3000 Generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)