(292 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on RF power delivery and standard medical device components.
Yes
The device is intended for coagulation-ablation of soft tissue, which is a medical procedure used to treat tissue (e.g., tumors), indicating a therapeutic purpose.
No
Explanation: The device is an ablation system designed for coagulation-ablation of soft tissue, which is a treatment or therapeutic function, not a diagnostic one. While it can be used with imaging techniques (CT, MR, Ultrasound), these are for guiding the ablation, not for the device itself to diagnose conditions.
No
The device description explicitly states it is composed of a durable generator-controller and single-patient-use sterile accessories consisting of four antenna sizes and extension cable sets, which are hardware components.
Based on the provided information, the MedWaves AveCure™ Ablation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "coagulation-ablation of soft tissue" through percutaneous, laparoscopic, and intraoperative procedures. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device delivers RF energy to tissue via an antenna. This is a physical intervention, not a test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to treat tissue, not to diagnose a condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MedWaves AveCure™ Ablation System does not fit this description.
N/A
Intended Use / Indications for Use
The MedWaves AveCure™ Ablation System is intended for use in percutaneous, laparoscopic, and intraoperative coagulation-ablation of soft tissue.
The MedWaves AveCure™ Ablation System is not intended for use in cardiac procedures.
Product codes
NEY
Device Description
The MedWaves AveCure® Ablation System is designed to deliver ultrahigh radiofrequency (RF) through an antenna placed next to or embedded into soft-tissue for coagulating a volume of that tissue.
The MedWaves AveCure® Ablation System is composed of a durable generator-controller, and single-patient-use sterile accessories consisting of four antenna sizes and extension cable sets.
Each antenna-probe assembly is composed of one of the four antennas mounted at the distal end of one of many shaft configurations that are stiff, flexible or combination of both. The extension cable set is used to connect antennas to the generator controller. The material compositions of antennas and extension cables are nonmagnetic in nature and MRI safe. Therefore, the devices can be used in intraoperative, laparoscopic and percutaneous methods with CT, MR and Ultrasound imaging techniques to positions the antenna for ablation of softtissues.
The MedWaves AveCure® Ablation System is very efficient in transmitting RF power from the generator-controller to the antenna. With the low-power loss, the system does not need cooling pump, CO- or other mechanism to irrigate the antenna shaft and RF transmission lines for patient and user safety.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR and Ultrasound imaging techniques
Anatomical Site
soft tissue
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 system meets all design specifications, design risk-analysis, and medical device standards for electrical safety-EMC (IEC 60601 2006 and 2007), biocompatibility (ISO 10993), sterility (ISO 11135 2007), and packaging shelf-life (ISO 11607 2006). The mechanical and coagulation-ablation performance ex-vivo and in-vivo meets the intended design and shows to be similar to the predicated devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K070356, K083537, K122217, K133821
Reference Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image is the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2015
MedWaves Incorporated Mr. Ted Ormsby President/Chief Executive Officer 16760 West Bernardo Drive San Diego, California 92127
Re: K143203
Trade/Device Name: AveCure™ Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NEY Dated: June 22, 2015 Received: June 27, 2015
Dear Mr. Ormsby:
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 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
1
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 contact 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. 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.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Device Name: AveCure™ Ablation System
Common Name: Microwave coagulation-ablation system and accessories
Classification Name: Electrosurgical cutting and coagulation device (21CFR 878.4400, Class II, NEY)
Indications for Use (Describe)
The MedWaves AveCure™ Ablation System is intended for use in percutaneous, laparoscopic, and intraoperative coagulation-ablation of soft tissue.
The MedWaves AveCure™ Ablation System is not intended for use in cardiac procedures.
| 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) |
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MedWaves Incorporated 16760 W Bernardo Drive San Diego, CA 92127 August 26, 2015
MedWaves
INCORPORATED
Traditional 510k Submission Request for Further Informati K143203
510(k) Summary
510(K) submitter information
MedWaves Incorporated 16760 West Bernardo Drive San Diego, CA 92127 Phone: 858-946-0015 Fax: 858-946-0016
Contact
Ted Ormsby President/CEO Phone: 760-807-1000 Email: tedormsby@avecure.com
The Device
| Trade name: | AveCure® Ablation System |
|---|---|
| Common name: | Ablation system and accessories |
| Classification name: | Class II, 21 CFR 878.4400, Electrosurgical Cutting and Coagulation Device and Accessories |
| Product Code: | NEY |
Purpose of Submission
The purpose of this submission is to gain clearance for expanded indication for use.
Predicate Devices
| MedWaves Microwave Coagulation/Ablation System: | K070356 |
|---|---|
| MedWaves Microwave Coagulation/Ablation System: | K083537 |
| NeuWave Medical Curtis 140™ Microwave Ablation System and Accessories: | K122217 |
| Covidien Emprint™ Ablation System: | K133821 |
System Description
The MedWaves AveCure® Ablation System is designed to deliver ultrahigh radiofrequency (RF) through an antenna placed next to or embedded into soft-tissue for coagulating a volume of that tissue.
The MedWaves AveCure® Ablation System is composed of a durable generator-controller, and single-patient-use sterile accessories consisting of four antenna sizes and extension cable sets.
4
Image /page/4/Picture/0 description: The image shows the logo for MedWaves Incorporated. The word "MedWaves" is written in red, with the "M" being the largest letter. Below the word "MedWaves" is the word "INCORPORATED" in a smaller, blue font. To the right of the word "MedWaves" are three red concentric circles.
MedWaves Incorporated 16760 W Bernardo Drive San Diego, CA 92127 August 26, 2015
Traditional 510k Submission Request for Further Informati K143203
Each antenna-probe assembly is composed of one of the four antennas mounted at the distal end of one of many shaft configurations that are stiff, flexible or combination of both. The extension cable set is used to connect antennas to the generator controller. The material compositions of antennas and extension cables are nonmagnetic in nature and MRI safe. Therefore, the devices can be used in intraoperative, laparoscopic and percutaneous methods with CT, MR and Ultrasound imaging techniques to positions the antenna for ablation of softtissues.
The MedWaves AveCure® Ablation System is very efficient in transmitting RF power from the generator-controller to the antenna. With the low-power loss, the system does not need cooling pump, CO- or other mechanism to irrigate the antenna shaft and RF transmission lines for patient and user safety.
Indications for Use
The MedWaves AveCure® Ablation System is intended for use in percutaneous, laparoscopic, and intraoperative coagulation-ablation of soft tissue.
The MedWaves Ablation System is not intended for use in cardiac procedures.
Technology Characteristics
The characteristics and operation of the MedWaves AveCure® Ablation System to a large extent is similar to the predicate group of devices. The system is powered by the 47-63Hz, 100-240VAC international current range, which is selected automatically. It is capable of generating 40 watts of radiofrequency (RF) power signal between 902 MHz and 928 MHz (ISM band), and composed of digital and analog circuits, and control firmware for user-interface and ablation processes controls. During the ablation processes, RF power is modulated to achieve and maintain programmed temperature set points between 60℃ and 130℃ for a programmed time interval. Frequency is scanned within the band and selected to minimize reflected power and maximizes antenna-tissue power transfer. Since its RF transmission loss is small, it uses relatively low power level of 40 watts and therefore, no need for a cooling mechanism. Therefore, the generator-controller is not blinded from seeing the tissue temperature at the antenna for safe and effective processes.
Performance Data
Characterization of the performance of the MedWaves AveCure® Ablation System to a large extent is similar to the predicate group of devices. The system meets all design specifications, design risk-analysis, and medical device standards for electrical safety-EMC (IEC 60601 2006 and 2007), biocompatibility (ISO 10993), sterility (ISO 11135 2007), and packaging shelf-life (ISO 11607 2006). The mechanical and coagulation-ablation performance ex-vivo and in-vivo meets the intended design and shows to be similar to the predicated devices.