Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted in a dark color, while the text is in a lighter color, creating a contrast that makes the logo easily recognizable. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 11, 2017 Spiration, Inc. Cheryl Frederick Executive Director, Regulatory Affairs & Quality Assurance 6675 185th Avenue NE Redmond, Washington 98052 Re: K170990 Trade/Device Name: Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator Regulation Number: 21 CFR 882.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI. JOS Dated: March 31, 2017 Received: April 3, 2017 Dear Ms. Frederick: 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 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" (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 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, # Jennifer R. Stevenson -S 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170990 #### Device Name Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator Indications for Use (Describe) The Spiration ANET Electrosurgical Applicator is indicated for coagulation of soft tissue when used in conjunction with a compatible radiofrequency generator. Type of Use (Select one or both, as applicable) | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart ) | |------------------------------------------------------------|----------------------------------------------------------| |------------------------------------------------------------|----------------------------------------------------------| | | 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 the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K170990 - 510(k) Summary March 31, 2017 Date of 510(k) Summary Preparation: Name and Address of Manufacturer: March 31, 2017 ## Spiration, Inc. 6675 185th Avenue NE Redmond, WA 98052 Contact Person: Cheryl Frederick Executive Director, RA/QA Phone:(425) 636-5470 Fax: (425) 497-8802 ## Subject Device Device Trade Name: Common Name: Classification Regulation: Product Code: Review Panel: ## Predicate Device Trade Name: 510(k) Number: Manufacturer: ANET Electrosurgical Applicator RF Electrosurgical Electrode Electrosurgical Cutting and Coagulation Device and Accessories 21 CFR 874.4400 GEI. JOS 79-General Surgery Habib EUS RFA 6700 K150029, K161305 EMcision LTD ## De vice De scription The Active Needle Endoscopic Treatment (ANET) Applicator (Model # ANET-00) is a disposable bipolar electrosurgical applicator intended for the coagulation and necrosis of soft tissue. Each Applicator consists of a needle (proximal electrode) with a coil (distal electrode). The needle and coil serve as the bipolar electrodes, so there is no need for an external ground pad. The ANET Applicator is compatible with the cleared Olympus ESG-100 Electrosurgical Generator (K072307) and endoscopes with a working inner diameter of 2.2mm or greater, such as those cleared in K093395 and K100584. Other radiofrequency generators will be added as compatibility is established. To perform ablation, the flexible catheter portion is first inserted into a compatible ultrasound endoscope working channel, then pushed forward until fully inserted. The handle is then affixed to the channel port of the endoscope via a mechanism locking onto the single use adapter biopsy {4}------------------------------------------------ valve. The handle facilitates advancement of the needle/proximal electrode during puncture of the targeted ablation site. Once the proximal electrode is positioned, a separate handle control facilitates advancement of the distal electrode. Saline and power connections at the handle of the device deliver fluid (1-3cc/min) and energy respectively to the distal portion of the device. The needle size of the device is 19 gauge (19G). During operation, radiofrequency (RF) current is passed between the distal electrode and the proximal electrode to thermally coagulate the tissue. The ANET device is provided sterile and is intended for single patient use. The device should only be used within a healthcare setting by physicians knowledgeable and experienced in RF ablation. #### Device Materials (Patient Contacting) The ANET Applicator is manufactured with materials commonly used in medical device applications. The patient contacting materials are included in Table 5-1 below: | Patient Contacting Materials | |------------------------------------------------| | Acrylonitrile Butadiene Styrene (ABS) | | 304 Stainless Steel,<br>17-7PH Stainless Steel | | Polyether/Polyamide | | ABS, Polycarbonate,<br>304 Stainless Steel | | Polyvinyl Chloride (PVC) Non-DEHP | | Nitinol, Gold | | Polyethylene Terephthalate (PET) | | Silicone | | Cyanoacrylate | | Polytetrafluoroethylene (PTFE) | | Polypropylene | #### Table 5-1 ANET Patient Contacting Materials Biocompatibility testing has been conducted on the ANET device to confirm that it meets the biocompatibility requirements per ENISO 10993-1:2009 as an external communicating device with a limited blood path indirect exposure (<24 hours). ## Ancillary Supplies - . Electrosurgical generator - The ANET Applicator is compatible with the Olympus ESG-100 Electrosurgical Generator (K073207). Additional Olympus generators will be added as compatibility is established. {5}------------------------------------------------ - . Ultrasound endoscope – The ANET Applicator is compatible with ultrasound endoscopes with a minimum inner working channel of 2.2mm or greater, such as those cleared in K093395 and K100584. - Olympus biopsy valve – Model # MAJ-210 or MD-495 #### How Provided The ANET Applicator is provided sterile and is disposable, intended for single patient use. #### Proposed Indication for Use The Spiration ANET Electrosurgical Applicator is indicated for coagulation and ablation of soft tissue when used in conjunction with a compatible radiofrequency generator. #### Comparison to Predicate Spiration has chosen the EMcision Habib EUS RFA 6700 (K150029 & K161305) as the predicate for comparison to the proposed ANET Applicator. The predicate device, the Habib EUS RFA 6700 was initially cleared in K150029. The minor modifications to the device in K161305 were determined by the agency to not raise new issues of safety and effectiveness. The Habib EUS RFA 6700 device described in both cleared 510(k) submissions have the same intended use, function and fundamental technology as the ANET Applicator. A comparison table, Table 5-2, is included below, which illustrates the equivalence of the subject ANET device to the Habib EUS RFA 6700 device. | Device Name→<br>Device Characteristics↓ | ANET<br>Electrosurgical<br>Applicator<br>(Proposed Device) | Habib EUS RFA<br>6700<br>(K150029)<br>(K161305) | Differences | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------| | Classification | II | II | Same | | Code of Federal<br>Regulations | 878.4400 | 878.4400 | Same | | Prescription | Yes | Yes | Same | | Indication for Use | The Spiration ANET<br>Electrosurgical<br>Applicator is indicated<br>for coagulation and<br>ablation of soft tissue<br>when used in<br>conjunction with a<br>compatible | The Habib EUS RFA<br>6700 is indicated for<br>coagulation and<br>ablation of soft tissue<br>when used in<br>conjunction with a<br>compatible<br>radiofrequency | Same | | | radiofrequency<br>generator. | generator. | | | Anatomical Site of Use | Soft Tissue | Soft Tissue | | | Compatible<br>Electrosurgical Unit | Currently compatible<br>with ESG-100<br>radiofrequency<br>generator (K073207) as<br>identified in IFU | Various compatible<br>generators (identified<br>in IFU) | Same - compatible<br>with generators<br>identified in labeling | | Access Methods | Echoendoscope,<br>laparoscope | Echoendoscope,<br>laparoscope, trocar | Same | | Principal of Operation | Operator controlled; RF<br>delivered from<br>compatible RF<br>generator | Operator controlled;<br>RF delivered from<br>compatible RF<br>generator | Same | | Mechanism of Action | Cellular necrosis<br>through thermal<br>coagulation | Cellular necrosis<br>through thermal<br>coagulation | Same | | Operating Mode | Bipolar - no grounding<br>pad required* | Monopolar - requires<br>a patient grounding<br>pad, neutral electrode | ANET is bipolar, Habib<br>is monopolar<br>(grounding pad is<br>required) | | Minimum Scope Inner<br>Channel | 2.2 mm | 2.4 mm | Similar -<br>Difference 0.2 mm | | 19 Gauge Needle | Integrated into Device | Optional FNA Needle | Similar | | Target Lesion Size<br>(diameter) | 10 - 30 mm | 8 X 20 mm (between<br>5-10W) | Similar | | Rated Frequency | Up to 650 kHz | Up to 460 kHz | Similar | | Working Outer<br>Diameter | 2.0 mm | 0.3 mm | ANET larger diameter | | Working Length | 69 cm | 220 cm | Habib longer | | Material Electrode Tip | Stainless Steel Needle<br>with<br>Nitinol Electrode | Stainless Steel | Similar | | Insulation/Coating | PET between<br>electrodes<br>PEBAX over Stainless<br>Steel Needle | Polyimide over<br>Stainless Steel | Similar | | Sterilization | Ethylene Oxide, Single<br>Use | Ethylene Oxide, Single<br>Use | Same | | Shelf Life | 6 months | 3 years | ANET - Real time 1<br>year shelf life in<br>progress | ## Table 5-2: Comparison of Key Characteristics of Proposed Device to Predicate Device {6}------------------------------------------------ {7}------------------------------------------------ *The proposed ANET Electrosurgical Applicator is operated in bipolar rather than monopolar mode as compared to the predicate. The intended use of the subject device is virtually identical to that of the predicate device. In addition, the fundamental scientific technology, principle of operation and mechanism of action are similar enough to be considered substantially equivalent. Bench testing per the FDA Guidance Document, Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, indicates equivalence in performance. Both devices use electrical energy to generate high-frequency (RF) energy as a means to coaqulate tissue. In addition, both devices consist of an electrode for coaqulation, user interface (handpiece) and connector/cable to the generator. And both devices are provided sterile, intended for single use only. Although the predicate device is monopolar and the proposed device bipolar, we believe that RF experience supports that bipolar RF ablation is more controllable. As such, it is considered as safe if not safer than monopolar RF ablation, which also requires external grounding pads. The Habib EUS RFA is designed to be used with a compatible, already cleared radiofrequency generator, same as the ANET Electrosurgical Applicator. ## Performance Data Performance testing has been completed to demonstrate substantial equivalence of the subject device to the predicate device. The ANET Applicator was subjected to the following verification and validation tests, as applicable: ## Biocompatibility Biocompatibility verification was performed for patient-contacting components of the ANET Applicator in accordance with ISO 10993-1 requirements, as well as the Guidance Document {8}------------------------------------------------ Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process," June 2016. #### Sterilization/Shelf-Life ANET was validated to achieve a sterility assurance level of 10 ° and adopted into a validated EO sterilization cycle. Packaging validation was performed to ensure that the devices maintain package integrity and sterility. #### Electrical Safety and Electromagnetic Compatibility (EMC) Electrical safety and EMC testing was completed for the applicable components of the ANET Applicator. The results demonstrated compliance of the ANET Applicator to all applicable standard requirements. #### Performance Testing #### Mechanical and Functional Testing Mechanical and Functional testing was completed to confirm that the performance of the ANET device conforms to the pre-determined mechanical, functional and packaging specifications at baseline and 6 months accelerated aging. Devices tested at baseline were post-sterilization (T=0), and devices tested at 6-months (T=0.5) included devices that had been subjected to both sterilization and accelerated aging. #### Comparative Bench-Top Validation Testing to Predicate Direct comparative bench top validation testing was completed to demonstrate the substantially equivalent ablation performance of the subject device and the predicate in various tissue types. The results demonstrated that the lesion dimensions achieved by the ANET Applicator are equivalent to those obtained with the predicate device under the same test conditions and specified power levels. | Applicable Standards | | |-----------------------|-------------------------------------------------------------------------------------------------------| | Version | Title | | EN ISO 14971, 2012 | Medical Devices - Application of Risk Management to Medical<br>Devices | | EN ISO 10993-1, 2009 | Biological Evaluation of Medical Devices - Evaluation and testing<br>within a risk management process | | EN ISO 10993-4:2009 | Biological Evaluation of Medical Devices - Selection of tests for<br>interactions with blood | | EN ISO 10993-5, 2009 | Biological Evaluation of Medical Devices-Tests for in vitro<br>cytotoxicity | | ISO 10993-10: 2013 | Biological Evaluation of Medical Devices: Tests for irritation and<br>skin sensitization | | EN ISO 10993-11: 2009 | Biological Evaluation of Medical Devices: Tests for systemic<br>toxicity | | EN ISO 10993-7, 2008 | Biological evaluation of medical devices. Ethylene oxide<br>sterilization residuals | ## Compliance with Standards {9}------------------------------------------------ | EN ISO 11135-1, 2014 | Sterilization of health care products. Ethylene oxide. Requirements<br>for development, validation and routine control of a sterilization<br>process for medical devices | |-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | EN 556-1: 2001 | Sterilization of medical devices - Requirements for medical devices<br>to be designated "STERILE" - Part 1: Requirements for terminally<br>sterilized medical devices | | AAMI TIR28:2009 | Product adoption and process equivalency for ethylene oxide<br>sterilization | | EN ISO 11607-1, 2009 | Packaging for terminally sterilized medical devices. Requirements<br>for materials, sterile barrier systems and packaging systems | | EN ISO 11607-2, 2006 | Packaging for terminally sterilized medical devices. Validation<br>requirements for forming, sealing and assembly processes | | EN ISO 11737-1:2006/AC:2009 | Sterilization of medical devices. Microbiological methods.<br>Determination of a population of microorganisms on products | | ISTA 3A, 2008 | General Simulation Performance Test Procedure, Packaged<br>Products for Parcel Delivery System Shipments 70 kg (150 lb) or<br>Less | | IEC 60601-1:2005 + CORR. 1<br>(2006) + CORR. 2 2007 | Medical Electrical Equipment - Part 1: General Requirements for<br>Basic Safety and Essential Performance | | IEC 60601-2-2:2009 Medical<br>Electrical Equipment - Part 2-2 | Particular Requirements for the Basic Safety and Essential<br>Performance of High Frequency Surgical Equipment and High<br>Frequency Surgical Accessories | | IEC 60601-1-2:2014 Medical<br>Electrical Equipment - Part 1-2 | General Requirements for the Basic Safety and Essential<br>Performance - Collateral Standard: Electromagnetic Disturbances<br>- Requirements and Tests | | IEC 60601-2-18:2009 Medical<br>Electrical Equipment - Part 2-18 | Particular Requirements for the Basic Safety and Essential<br>Performance of Endoscopic Equipment | # Conclusion (Statement of Equivalence) The ANET device successfully passed all performance testing. Spiration believes that the data and information presented within this 510(k) Premarket Notification (including bench testing) support a determination of substantial equivalence to the predicate device, and market clearance of the ANET Electrosurgical Applicator.