(297 days)
No
The document describes a system for real-time ultrasound imaging and biopsy, focusing on hardware components (needle, console, MDU) and basic software for image display and storage. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the use of such technologies for analysis, interpretation, or guidance. The performance studies described are bench tests, not clinical studies evaluating algorithmic performance.
No
The device is primarily for imaging and guiding biopsy, which are diagnostic procedures, not therapeutic ones. While it aids in the diagnosis of lesions, it does not directly treat a disease or condition.
Yes
The console's intended use is to "observe and to store real-time ultrasound images of endobronchial lesions, peripheral lung nodules, or lung masses," which is a diagnostic function for visualizing anatomical structures and identifying abnormalities.
No
The device description clearly states that the iNod Ultrasound Guidance System comprises a sterile, single-use biopsy needle, an ultrasound guidance console (which includes hardware like the MDU and a tablet), and a motor drive unit. While software is a component of the console, the system includes significant hardware elements.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens in vitro (outside the body). The iNod Ultrasound Guidance System is used to visualize and biopsy lesions within the body (in the tracheobronchial tree).
- The primary function is imaging and tissue retrieval. While a biopsy is taken, the device itself is not performing an analysis of the collected specimen. The analysis of the biopsy specimen would be done separately in a laboratory, which would involve IVD procedures.
- The device description focuses on imaging and mechanical functions. The components described (ultrasound transducer, biopsy needle, console, motor drive unit) are all related to real-time visualization and tissue collection in vivo.
The device is a medical device used for imaging and biopsy procedures, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The iNod Ultrasound Guidance Console is intended to be used with iNod Ultrasound Guided Biopsy Needle, to observe and to store real-time ultrasound images of endobronchial lesions, peripheral lung nodules, or lung masses located in airways and tracheobronchial tree.
The iNod Ultrasound Guided Biopsy Needle is intended for use through a flexible bronchoscope for intraluminal sonographic imaging in the tracheobronchial tree and retrieval of specimens with endobronchial lesions, peripheral lung nodules, or lung masses.
Product codes (comma separated list FDA assigned to the subject device)
EOO, ITX, IYO, ODG
Device Description
The proposed iNod Ultrasound Guidance System (iNod System), comprises: the sterile, single use iNod Ultrasound Guided Biopsy Needle (also referred to as iNod Single Use Device (SUD), iNod Ultrasound Guidance Console (iNod Console) and the iNod Motor Drive Unit (iNod MDU). The proposed iNod Ultrasound Guidance System is intended to perform pulmonary needle biopsy under real-time visualization using Radial Endobronchial Ultrasound (R-EBUS).
The iNod single-use-device (iNod SUD) is a single use, sterile device that has combined functionality of a radial ultrasound probe and a biopsy needle. The iNod SUD allows real-time visualization of pulmonary lesions with radial ultrasound, while simultaneously allowing biopsy of the pulmonary lesions. The three main parts of iNod SUD are a handle, a radial ultrasound transducer, and biopsy needle. The biopsy needle is actuated at an angle that allows biopsy of eccentric and concentric nodules. A stainless-steel needle indicator strip is housed in the imaging window at distal tip, which provides an ultrasound signature, indicating the orientation of the needle to the user in the ultrasound image. The biopsy needle will exit the iNod SUD distal tip at 180 degrees relative to the needle indicator position visible in the ultrasound image. Once the needle is positioned to biopsy a nodule, the needle is unlocked by user to the exit ramp at 11° angle. Finally, when a sample is collected, the Nitinol stylet can be passed down the needle lumen to expel the sample.
The iNod Console is an electronic device that consists of:
- The iNod MDU, which rotates the ultrasound transducer in the iNod SUD to generate 360° ● images as well as provides patient isolation from the rest of the Console components.
- A software-based touchscreen tablet with battery, which can be mounted to a mobile pole yia . the pole docking station.
- A software-based Acquisition PC that interprets the received ultrasound signals from the ● iNod SUD and generates the image that is displayed on the tablet.
- Functionality that displays ultrasonic image received from iNod SUD through iNod MDU ● and Acquisition PC on the iNod tablet and
- . Ability to save and export procedure images and recordings.
The iNod MDU provides rotation of the iNod SUD's ultrasound transducer, required for generating a 360° ultrasound image. An electromechanical connector interface at the proximal end of the iNod SUD makes the connection to the MDU-catheter interface consists of an integrated mechanical drive hub and electrical connection. The iNod Console interfaces with the iNod SUD through the iNod Motor Drive Unit (iNod MDU), which provides the electromechanics for the rotating parts of the imaging catheter, and the interface between the iNod SUD and the iNod console. The iNod MDU is nearly identical in design to its predicate MDU5 Plus, which is currently used with Avvigo Guidance System II (K212490).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
endobronchial lesions, peripheral lung nodules, or lung masses located in airways and tracheobronchial tree.
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)
Non-clinical (bench) testing was successfully performed on the proposed iNod Ultrasound Guided Biopsy Needle, iNod Ultrasound Guidance Console and the iNod System altogether. Performance testing (bench) that represents device's clinical use was successfully completed. In addition, all necessary software tests were performed for the iNod Software. The following bench testing was conducted to evaluate the changes on the proposed device. All Performance testing (bench) was successfully completed. The results of performance (bench) testing demonstrate that the proposed iNod Ultrasound Guided Biopsy Needle, iNod Ultrasound Guidance Console and iNod Motor Drive Unit (MDU) are considered substantially equivalent to the predicate devices.
The summary table of performance testing shows "Pass" results for all listed product specifications, including:
- iNod SUD: Device Passability, Device Rotation, Needle Actuation Force, Needle Extension Length, Needle Angle, Needle Outer Diameter, Needle Inner Diameter, Needle Sharpness, Needle Aspiration, Stylet Removal Force, Stylet Kink Resistance, Catheter Working Length, Handle to Catheter Tensile, Drive Cable to Handle Tensile, Drive Cable to MDU Connector Tensile, Device Reliability, Pulse Echo Sensitivity, Pulse Echo Bandwidth, Pulse Echo Center Frequency, Pulse Echo Pulse Length, Acoustic Output, NURD (Non-Uniform Rotation Distortion), Needle Lock Override Force, ISO 80369 Small-bore connectors for liquid and gases in healthcare applications, ISO 9626 Stainless Steel Needle Tubing for Manufacture of Medical Devices - Requirements and test methods, Catheter Drive Cable Length, Device Bronchoscopic Visibility, Device Radiopacity, Needle Indicator, Needle Lock Engage/Disengage Force, Handle Grip Area, Actuation Mechanism Location, Needle Locking Mechanism Location, Handle Rotation, Product can be held with scope, Catheter Outer Diameter, Imaging System Compatibility, Motor Drive Compatibility - Torque, Motor Drive Compatibility – Load, Needle Exit Location.
- iNod Console: Archive Case Studies, Create Case Study, Annotate, Patient Display, Add Snapshots, Select and Review Case Studies, Export Event Logs, Export Recordings and Screenshots, Import/Export Case studies, Patient List Query, Select Patient, Mobile Configuration, Record Management, Default Modality, Power-On Self Test Status, Operating System, Power Up Duration, DICOM Archiving Performance, Expected Service Life, System Access to health delivery organization network, User Control, System Displays, Image Artifact Removal, Start Recording, Stop Recording, Linear Measurement on Ultrasound Frame, Imaging Depth, Distance Accuracy on Ultrasound Frame, Image Frame Rate: Ultrasound catheters, Gap detection, Catheter compatibility and Bandwidth, SUD Retention Force.
- iNod MDU: Receive Path Spectral Response, Bi-Polar Tx - P-P Output Voltage Amplitude, Pulse Uniformity – Bi-Polar Pulses, Bi-Polar Output Bandwidth, Receive Path Common Mode Gain, RF Receive Path Noise Figure, Receive Path Spurious Noise, Pull Force and Side Force, Rotational Speed.
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.
K982323, K163537, K121564, K212490
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.
Not Found
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
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 2, 2023
Boston Scientific Corporation Inderdeep Tiwana Principal, Regulatory Affairs 100 Boston Scientific Wav Marlborough, Massachusetts 01752
Re: K221340
Trade/Device Name: iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOO, ITX, IYO, ODG Dated: February 8, 2023 Received: February 9, 2023
Dear Inderdeep Tiwana:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ethan L. Nyberg -S
for James Lee, Ph.D Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221430
Device Name iNod Ultrasound Guidance Console
Indications for Use (Describe)
The iNod Ultrasound Guidance Console is intended to be used with iNod Ultrasound Guided Biopsy Needle, to observe and to store real-time ultrasound images of endobronchial lesions, peripheral lung nodules, or lung masses located in airways and tracheobronchial tree.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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
Indications for Use
510(k) Number (if known) K221430
Device Name iNod Ultrasound Guided Biopsy Needle
Indications for Use (Describe)
The iNod Ultrasound Guided Biopsy Needle is intended for use through a flexible bronchoscope for intraluminal sonographic imaging in the tracheobronchial tree and retrieval of specimens with endobronchial lesions, peripheral lung nodules, or lung masses.
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) |
|---|---|
| ------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------ |
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."
4
510(k) Summary for iNod Ultrasound Guidance System
1. Submitter
Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way Marlborough, MA 01752
Contact:
| Primary Contact: | Inderdeep Tiwana
Principal Regulatory Specialist
Phone: (508) 683-4005
E-mail: Inderdeep.tiwana@bsci.com |
|--------------------|--------------------------------------------------------------------------------------------------------------------------|
| Secondary Contact: | Ashley Santos
Senior Director, Regulatory Affairs-Endoscopy
Phone: (508) 382-0284
Email: Ashley.santos@bsci.com |
Date Prepared: May 06, 2022
5
2. Device
| Trade Name: | iNod Ultrasound Guided Biopsy Needle |
|---|---|
| Common Name: | Diagnostic Ultrasound Transducer |
| Bronchoscope (flexible or rigid) and accessories | |
| Product Code: | ITX and EOQ |
| Device Class: | Class II |
| Device Panel | Ear, Nose & Throat |
| Classification Regulation: | 21 CFR.874.4680 Bronchoscope (flexible or rigid) and |
| accessories | |
| Trade Name: | iNod Ultrasound Guidance Console |
| Common Name: | IYO: System, imaging, pulsed echo, ultrasonic |
| ITX: Diagnostic Ultrasound Transducer | |
| ODG: Endoscopic ultrasound system, gastroenterology- | |
| urology | |
| Product Code: | IYO, ITX and ODG |
| Device Class: | Class II |
| Device Panel | Radiology and Gastroenterology and Urology |
| Classification Regulation: | 21 CFR.892.1560 System, imaging, pulsed echo, ultrasonic |
3. Predicate Devices
| Proposed
| Device | Component | Predicate Devices |
|---|---|---|
| iNod Ultrasound | ||
| Guidance | ||
| System | iNod Ultrasound | |
| Guided Biopsy | ||
| Needle | Probe: | |
| • Olympus Ultrasound Probe (K982323) | ||
| Needle: | ||
| • Arcpoint Pulmonary Needle (K163537) | ||
| iNod Ultrasound | ||
| Guidance | ||
| Console | • EVIS EUS Endoscopic Ultrasound Center | |
| (K121564) | ||
| • Avvigo Ultrasound System II (K212490) | ||
| iNod Motor | ||
| Drive Unit | • MDU5 Plus – 510K cleared with Avvigo Ultrasound | |
| System II (K212490) |
6
4. Device Description
The proposed iNod Ultrasound Guidance System (iNod System), comprises: the sterile, single use iNod Ultrasound Guided Biopsy Needle (also referred to as iNod Single Use Device (SUD), iNod Ultrasound Guidance Console (iNod Console) and the iNod Motor Drive Unit (iNod MDU). The proposed iNod Ultrasound Guidance System is intended to perform pulmonary needle biopsy under real-time visualization using Radial Endobronchial Ultrasound (R-EBUS).
The iNod single-use-device (iNod SUD) is a single use, sterile device that has combined functionality of a radial ultrasound probe and a biopsy needle. The iNod SUD allows real-time visualization of pulmonary lesions with radial ultrasound, while simultaneously allowing biopsy of the pulmonary lesions. The three main parts of iNod SUD are a handle, a radial ultrasound transducer, and biopsy needle. The biopsy needle is actuated at an angle that allows biopsy of eccentric and concentric nodules. A stainless-steel needle indicator strip is housed in the imaging window at distal tip, which provides an ultrasound signature, indicating the orientation of the needle to the user in the ultrasound image. The biopsy needle will exit the iNod SUD distal tip at 180 degrees relative to the needle indicator position visible in the ultrasound image. Once the needle is positioned to biopsy a nodule, the needle is unlocked by user to the exit ramp at 11° angle. Finally, when a sample is collected, the Nitinol stylet can be passed down the needle lumen to expel the sample.
The iNod Console is an electronic device that consists of:
- The iNod MDU, which rotates the ultrasound transducer in the iNod SUD to generate 360° ● images as well as provides patient isolation from the rest of the Console components.
- A software-based touchscreen tablet with battery, which can be mounted to a mobile pole yia . the pole docking station.
- A software-based Acquisition PC that interprets the received ultrasound signals from the ● iNod SUD and generates the image that is displayed on the tablet.
- Functionality that displays ultrasonic image received from iNod SUD through iNod MDU ● and Acquisition PC on the iNod tablet and
- . Ability to save and export procedure images and recordings.
The iNod MDU provides rotation of the iNod SUD's ultrasound transducer, required for generating a 360° ultrasound image. An electromechanical connector interface at the proximal end of the iNod SUD makes the connection to the MDU-catheter interface consists of an integrated mechanical drive hub and electrical connection. The iNod Console interfaces with the iNod SUD through the iNod Motor Drive Unit (iNod MDU), which provides the electromechanics for the rotating parts of the imaging catheter, and the interface between the iNod SUD and the iNod console. The iNod MDU is nearly identical in design to its predicate MDU5 Plus, which is currently used with Avvigo Guidance System II (K212490).
7
5. Indications for Use
iNod Ultrasound Guided Biopsy Needle:
The iNod Ultrasound Guided Biopsy Needle is intended for use through a flexible bronchoscope for intraluminal sonographic imaging in the tracheobronchial tree and retrieval of specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses. .
iNod Ultrasound Guidance Console:
The iNod Ultrasound Guidance Console is intended to be used with iNod Ultrasound Guided Biopsy Needle, to observe and to store real-time ultrasound images of endobronchial lesions, peripheral lung nodules, or lung masses located in airways and tracheobronchial tree.
6. Technological Characteristics
The iNod Ultrasound Guided Biopsy Needle merges two devices: an ultrasound probe, and a lung biopsy needle, into one device. The vast majority of design characteristics are identical to the predicate devices, however, there are a few key technological differences between iNod SUD and its predicates. Performance testing has been executed to evaluate all design characteristics, as well as those in which there were differences in technological characteristics as compared to the predicates. The results of the bench-top testing were passing and demonstrates the proposed iNod SUD performs substantially equivalent to the predicate devices.
The iNod Ultrasound Guidance Console and its elements including the iNod MDU are nearly identical in design and physical attributes to its predicate AVVIGO Guidance System II (K212490). The main difference is the brand name, intended use as the AVVIGO Guidance System II is intended for use with catheters having cardiovascular indications for use, and removal of cardiovascular feature (pull-back feature) from the iNod MDU. All components and accessories of the proposed iNod Console are identical to the AVVIGO Guidance System II (K212490). In addition, the indications of use of the proposed iNod Console are identical to those of the primary predicate device, EVIS EUS Endoscopic Ultrasound (K203128) and there are no significant design differences between iNod Console and EVIS EUS Endoscopic Ultrasound (K203128).
8
7. Substantial Equivalence
The iNod Ultrasound Guided Biopsy Needle, iNod Console and iNod MDU devices are substantially equivalent to the following predicate devices.
| Proposed
| Device | Component | Predicate Devices |
|---|---|---|
| iNod Ultrasound | ||
| Guidance | ||
| System | iNod | |
| Ultrasound | ||
| Guided | ||
| Biopsy | ||
| Needle | Probe: | |
| • Olympus Ultrasound Probe (K982323) | ||
| Needle: | ||
| • Arcpoint Pulmonary Needle (K163537) | ||
| iNod | ||
| Console | • EVIS EUS Endoscopic Ultrasound Center (K121564) | |
| • Avvigo Ultrasound System II (K212490) | ||
| iNod MDU | • MDU5 Plus – 510K cleared with Avvigo Ultrasound | |
| System II (K212490) |
Table 5-1 - Predicate Devices and 510(k) numbers
8. Performance Data
Non-clinical (bench) testing was successfully performed on the proposed iNod Ultrasound Guided Biopsy Needle, iNod Ultrasound Guidance Console and the iNod System altogether. Performance testing (bench) that represents device's clinical use was successfully completed. In addition, all necessary software tests were performed for the iNod Software. The following bench testing was conducted to evaluate the changes on the proposed device. All Performance testing (bench) was successfully completed. The results of performance (bench) testing demonstrate that the proposed iNod Ultrasound Guided Biopsy Needle, iNod Ultrasound Guidance Console and iNod Motor Drive Unit (MDU) are considered substantially equivalent to the predicate devices.
| Component | Product Specification | Results (Pass/Fail) |
|---|---|---|
| iNod SUD | Device Passability | Pass |
| iNod SUD | Device Rotation | Pass |
| iNod SUD | Needle Actuation Force | Pass |
| iNod SUD | Needle Extension Length | Pass |
| iNod SUD | Needle Angle | Pass |
| iNod SUD | Needle Outer Diameter | Pass |
| iNod SUD | Needle Inner Diameter | Pass |
| iNod SUD | Needle Sharpness | Pass |
| iNod SUD | Needle Aspiration | Pass |
| iNod SUD | Stylet Removal Force | Pass |
| iNod SUD | Stylet Kink Resistance | Pass |
| iNod SUD | Catheter Working Length | Pass |
| Component | Product Specification | Results (Pass/Fail) |
| iNod SUD | Handle to Catheter Tensile | Pass |
| iNod SUD | Drive Cable to Handle Tensile | Pass |
| iNod SUD | Drive Cable to MDU Connector Tensile | Pass |
| iNod SUD | Device Reliability | Pass |
| iNod SUD | Pulse Echo Sensitivity | Pass |
| iNod SUD | Pulse Echo Bandwidth | Pass |
| iNod SUD | Pulse Echo Center Frequency | Pass |
| iNod SUD | Pulse Echo Pulse Length | Pass |
| iNod SUD | Acoustic Output | Pass |
| iNod SUD | NURD (Non-Uniform Rotation Distortion) | Pass |
| iNod SUD | Needle Lock Override Force | Pass |
| iNod SUD | ISO 80369 | |
| Small-bore connectors for liquid and gases in | ||
| healthcare applications | Pass | |
| iNod SUD | ISO 9626 Stainless Steel Needle Tubing for | |
| Manufacture of Medical Devices - Requirements and | ||
| test methods | Pass | |
| iNod SUD | Catheter Drive Cable Length | Pass |
| iNod SUD | Device Bronchoscopic Visibility | Pass |
| iNod SUD | Device Radiopacity | Pass |
| iNod SUD | Needle Indicator | Pass |
| iNod SUD | Needle Lock Engage/Disengage Force | Pass |
| iNod SUD | Handle Grip Area | Pass |
| iNod SUD | Actuation Mechanism Location | Pass |
| iNod SUD | Needle Locking Mechanism Location | Pass |
| iNod SUD | Handle Rotation | Pass |
| iNod SUD | Product can be held with scope | Pass |
| iNod SUD | Catheter Outer Diameter | Pass |
| iNod SUD | Imaging System Compatibility | Pass |
| iNod SUD | Motor Drive Compatibility - Torque | Pass |
| iNod SUD | Motor Drive Compatibility – Load | Pass |
| iNod SUD | Needle Exit Location | Pass |
| iNod Console | Archive Case Studies | Pass |
| iNod Console | Create Case Study | Pass |
| iNod Console | Annotate | Pass |
| iNod Console | Patient Display | Pass |
| iNod Console | Add Snapshots | Pass |
| iNod Console | Select and Review Case Studies | Pass |
| iNod Console | Export Event Logs | Pass |
| iNod Console | Export Recordings and Screenshots | Pass |
| iNod Console | Import/Export Case studies | Pass |
| iNod Console | Patient List Query | Pass |
| iNod Console | Select Patient | Pass |
| iNod Console | Mobile Configuration | Pass |
| iNod Console | Record Management | Pass |
| iNod Console | Default Modality | Pass |
| iNod Console | Power-On Self Test Status | Pass |
| iNod Console | Operating System | Pass |
| iNod Console | Power Up Duration | Pass |
| iNod Console | DICOM Archiving Performance | Pass |
| iNod Console | Expected Service Life | Pass |
| Component | Product Specification | Results (Pass/Fail) |
| iNod Console | System Access to health delivery organization | |
| network | Pass | |
| iNod Console | User Control | Pass |
| iNod Console | System Displays | Pass |
| iNod Console | Image Artifact Removal | Pass |
| iNod Console | Start Recording | Pass |
| iNod Console | Stop Recording | Pass |
| iNod Console | Linear Measurement on Ultrasound Frame | Pass |
| iNod Console | Imaging Depth | Pass |
| iNod Console | Distance Accuracy on Ultrasound Frame | Pass |
| iNod Console | Image Frame Rate: Ultrasound catheters | Pass |
| iNod Console | Gap detection | Pass |
| iNod Console | Catheter compatibility and Bandwidth | Pass |
| iNod Console | SUD Retention Force | Pass |
| iNod MDU | Receive Path Spectral Response | Pass |
| iNod MDU | Bi-Polar Tx - P-P Output Voltage Amplitude | Pass |
| iNod MDU | Pulse Uniformity – Bi-Polar Pulses | Pass |
| iNod MDU | Bi-Polar Output Bandwidth | Pass |
| iNod MDU | Receive Path Common Mode Gain | Pass |
| iNod MDU | RF Receive Path Noise Figure | Pass |
| iNod MDU | Receive Path Spurious Noise | Pass |
| iNod MDU | Pull Force and Side Force | Pass |
| iNod MDU | Rotational Speed | Pass |
Table 5-2 Bench/ Performance Testing Summary
9
10
iNod Ultrasound Guided Biopsy Needle is sterilized using E-beam sterilization method and E-Beam Radiation cycle is validated per Method VDmax27.5 to a sterility assurance level of 100 in accordance with EN ISO 11137-1: 2006, EN ISO 11137-2: 2013, and ISO TS13004:2014. Validation included dose mapping, bioburden assessment, and dose audit / dose verification testing to validate an SAL of 106 in routine sterilization processing. All relevant aspects of the applicable standards were met. In addition, the iNod Ultrasound Guided Biopsy Needle is undergoing routine bacterial endotoxins test (BET), also known as the Limulus amebocyte lysate (LAL) test, in accordance with standard AAMI/ANSI ST72: Bacterial endotoxin - test methods, routine monitoring and alternatives to batch resting (Sterility).
Biocompatibility of the proposed iNod Ultrasound Guided Biopsy Needle was evaluated in accordance with ISO 10993-1. Based on the biocompatibility classification of the device the following biocompatibility tests were conducted: Cytotoxicity, Sensitization, Toxicity, and Pyrogen Testing.
Lastly, iNod Ultrasound Guidance System was evaluated for electrical safety under electoral safety standards ISO 60601-1, ISO 60601-1-2, ISO 60601-1-6, 60601-2-18 and ISO 60601-2-37. All tests met the predefined requirements and further support the safety of the proposed devices.
9. Conclusion
Boston Scientific has demonstrated that the proposed iNod Ultrasound Guidance System is substantially equivalent to the currently marketed predicate devices.