The Spiration ANET Electrosurgical Applicator is indicated for coagulation of soft tissue when used in conjunction with a compatible radiofrequency generator.

Device Description

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 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.

AI/ML Overview

The provided text describes the ANET Electrosurgical Applicator and its substantial equivalence determination to a predicate device (Habib EUS RFA 6700). However, it does not include specific quantitative acceptance criteria or detailed study results (like statistical performance measures, sample sizes, expert qualifications, or ground truth establishment) typically associated with the type of request. The information provided is more general, focusing on the types of tests performed to demonstrate safety and performance.

Therefore, I cannot populate all sections of your requested table and information. I will extract what is available and note what is missing.

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or reported device performance in the format of specific metrics and target values (e.g., "sensitivity > 90%"). Instead, it states that the device "successfully passed all performance testing" and that its "lesion dimensions...are equivalent to those obtained with the predicate device under the same test conditions and specified power levels."

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Meet ISO 10993-1 requirements.	Biocompatibility verification performed for patient-contacting components in accordance with ISO 10993-1, as well as the Guidance Document "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process,' June 2016." (Result: Implied compliance, as the device successfully passed all performance testing.)
Sterilization/Shelf-Life: Achieve sterility assurance level (SAL) of 10^-6*; maintain package integrity and sterility; demonstrate specified shelf-life.	Validated to achieve a sterility assurance level of 10^-6* and adopted into a validated EO sterilization cycle. Packaging validation performed to ensure devices maintain package integrity and sterility. (Shelf-life: ANET has 6 months, versus predicate's 3 years; "Real time 1 year shelf life in progress" for ANET, implying 6-month shelf life was verified for market clearance.)
Electrical Safety and EMC: Comply with applicable standard requirements (e.g., IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2).	Electrical safety and EMC testing completed for applicable components. Results demonstrated compliance to all applicable standard requirements.
Mechanical and Functional Testing: Conform to pre-determined mechanical, functional, and packaging specifications at baseline and 6 months accelerated aging.	Mechanical and Functional testing completed to confirm that the performance of the ANET device conforms to the pre-determined mechanical, functional, and packaging specifications at baseline (post-sterilization, T=0) and 6 months accelerated aging (T=0.5, including devices subjected to sterilization and accelerated aging).
Comparative Bench-Top Validation Testing: Lesion dimensions equivalent to predicate device under same test conditions and specified power levels.	Direct comparative bench top validation testing completed to demonstrate substantially equivalent ablation performance in various tissue types. 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. (No specific quantitative lesion dimensions or acceptable deviation ranges are provided).
Overall: Substantial equivalence to predicate device.	The ANET device successfully passed all performance testing. Spiration believes the data supports a determination of substantial equivalence to the predicate device.

Detailed Study Information (Based on available text)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for any of the performance tests (biocompatibility, sterilization, electrical safety, mechanical/functional, or comparative bench-top). The text only mentions "devices tested."
- Data Provenance: Not specified. These appear to be laboratory bench-top tests conducted by the manufacturer, not clinical studies involving human patients or specific geographic origins.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the reported studies are primarily bench-top validation tests comparing the physical and functional characteristics of the device/ablation lesions, not diagnostic performance studies requiring expert interpretation of medical images or pathologies.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the types of engineering and bench-top performance tests described.
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:
- No MRMC study was mentioned. This device is an electrosurgical applicator used for coagulation/ablation, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not an AI algorithm; therefore, this question is not applicable. The performance tests described (e.g., lesion dimensions, mechanical function) are for the physical device itself.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the comparative bench-top validation testing, the "ground truth" for comparison was the performance of the predicate device (Habib EUS RFA 6700) under the same test conditions and specified power levels. The measurement of "lesion dimensions" would be considered the objective outcome being compared, likely measured directly from the tissue (e.g., using calipers or imaging).
- For other tests (biocompatibility, electrical safety, mechanical/functional), the "ground truth" or reference was adherence to established international standards (e.g., ISO, IEC) and the manufacturer's own pre-determined specifications.
The sample size for the training set:
- Not applicable. This device is a medical instrument, not a machine learning model that undergoes "training."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

Summary

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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

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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

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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)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart )
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| | Over-The-Counter Use (21 CFR 801 Subpart C)

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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 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

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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,17-7PH Stainless Steel
Polyether/Polyamide
ABS, Polycarbonate,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.

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. 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→Device Characteristics↓	ANETElectrosurgicalApplicator(Proposed Device)	Habib EUS RFA6700(K150029)(K161305)	Differences
Classification	II	II	Same
Code of FederalRegulations	878.4400	878.4400	Same
Prescription	Yes	Yes	Same
Indication for Use	The Spiration ANETElectrosurgicalApplicator is indicatedfor coagulation andablation of soft tissuewhen used inconjunction with acompatible	The Habib EUS RFA6700 is indicated forcoagulation andablation of soft tissuewhen used inconjunction with acompatibleradiofrequency	Same
	radiofrequencygenerator.	generator.
Anatomical Site of Use	Soft Tissue	Soft Tissue
CompatibleElectrosurgical Unit	Currently compatiblewith ESG-100radiofrequencygenerator (K073207) asidentified in IFU	Various compatiblegenerators (identifiedin IFU)	Same - compatiblewith generatorsidentified in labeling
Access Methods	Echoendoscope,laparoscope	Echoendoscope,laparoscope, trocar	Same
Principal of Operation	Operator controlled; RFdelivered fromcompatible RFgenerator	Operator controlled;RF delivered fromcompatible RFgenerator	Same
Mechanism of Action	Cellular necrosisthrough thermalcoagulation	Cellular necrosisthrough thermalcoagulation	Same
Operating Mode	Bipolar - no groundingpad required*	Monopolar - requiresa patient groundingpad, neutral electrode	ANET is bipolar, Habibis monopolar(grounding pad isrequired)
Minimum Scope InnerChannel	2.2 mm	2.4 mm	Similar -Difference 0.2 mm
19 Gauge Needle	Integrated into Device	Optional FNA Needle	Similar
Target Lesion Size(diameter)	10 - 30 mm	8 X 20 mm (between5-10W)	Similar
Rated Frequency	Up to 650 kHz	Up to 460 kHz	Similar
Working OuterDiameter	2.0 mm	0.3 mm	ANET larger diameter
Working Length	69 cm	220 cm	Habib longer
Material Electrode Tip	Stainless Steel NeedlewithNitinol Electrode	Stainless Steel	Similar
Insulation/Coating	PET betweenelectrodesPEBAX over StainlessSteel Needle	Polyimide overStainless Steel	Similar
Sterilization	Ethylene Oxide, SingleUse	Ethylene Oxide, SingleUse	Same
Shelf Life	6 months	3 years	ANET - Real time 1year shelf life inprogress

Table 5-2: Comparison of Key Characteristics of Proposed Device to Predicate Device

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*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

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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 MedicalDevices
EN ISO 10993-1, 2009	Biological Evaluation of Medical Devices - Evaluation and testingwithin a risk management process
EN ISO 10993-4:2009	Biological Evaluation of Medical Devices - Selection of tests forinteractions with blood
EN ISO 10993-5, 2009	Biological Evaluation of Medical Devices-Tests for in vitrocytotoxicity
ISO 10993-10: 2013	Biological Evaluation of Medical Devices: Tests for irritation andskin sensitization
EN ISO 10993-11: 2009	Biological Evaluation of Medical Devices: Tests for systemictoxicity
EN ISO 10993-7, 2008	Biological evaluation of medical devices. Ethylene oxidesterilization residuals

Compliance with Standards

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EN ISO 11135-1, 2014	Sterilization of health care products. Ethylene oxide. Requirementsfor development, validation and routine control of a sterilizationprocess for medical devices
EN 556-1: 2001	Sterilization of medical devices - Requirements for medical devicesto be designated "STERILE" - Part 1: Requirements for terminallysterilized medical devices
AAMI TIR28:2009	Product adoption and process equivalency for ethylene oxidesterilization
EN ISO 11607-1, 2009	Packaging for terminally sterilized medical devices. Requirementsfor materials, sterile barrier systems and packaging systems
EN ISO 11607-2, 2006	Packaging for terminally sterilized medical devices. Validationrequirements for forming, sealing and assembly processes
EN ISO 11737-1:2006/AC:2009	Sterilization of medical devices. Microbiological methods.Determination of a population of microorganisms on products
ISTA 3A, 2008	General Simulation Performance Test Procedure, PackagedProducts for Parcel Delivery System Shipments 70 kg (150 lb) orLess
IEC 60601-1:2005 + CORR. 1(2006) + CORR. 2 2007	Medical Electrical Equipment - Part 1: General Requirements forBasic Safety and Essential Performance
IEC 60601-2-2:2009 MedicalElectrical Equipment - Part 2-2	Particular Requirements for the Basic Safety and EssentialPerformance of High Frequency Surgical Equipment and HighFrequency Surgical Accessories
IEC 60601-1-2:2014 MedicalElectrical Equipment - Part 1-2	General Requirements for the Basic Safety and EssentialPerformance - Collateral Standard: Electromagnetic Disturbances- Requirements and Tests
IEC 60601-2-18:2009 MedicalElectrical Equipment - Part 2-18	Particular Requirements for the Basic Safety and EssentialPerformance 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.

Regulation Number and Section

§ 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.