(38 days)
No
The description focuses on the mechanical and electrical aspects of the device for delivering radiofrequency energy for tissue coagulation. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is indicated for "coagulation of soft tissue," which is a therapeutic intervention.
No
The Spiration ANET Electrosurgical Applicator is used for coagulation and necrosis of soft tissue, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical, disposable electrosurgical applicator with a needle, coil, catheter, and handle, intended for delivering radiofrequency energy to tissue. It is a hardware device.
Based on the provided information, the Spiration ANET Electrosurgical Applicator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "coagulation of soft tissue." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a device used for delivering radiofrequency energy to tissue for thermal coagulation. This is an interventional/surgical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is used inside the body to treat tissue.
N/A
Intended Use / Indications for Use
The Spiration ANET Electrosurgical Applicator is indicated for coagulation of soft tissue when used in conjunction with a compatible radiofrequency generator.
Product codes (comma separated list FDA assigned to the subject device)
GEI. JOS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft Tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
used within a healthcare setting by physicians knowledgeable and experienced in RF ablation.
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 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 verification was performed for patient-contacting components of the ANET Applicator in accordance with ISO 10993-1 requirements, 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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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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
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart ) |
|---|---|
| ------------------------------------------------------------ | ---------------------------------------------------------- |
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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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, |
| 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 (