NAVIRFA Scope

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. NaviFUS Corporation % Arthur Lung General Manager 12F., No. 246, Sec. 3, Chengde Rd. Datong Dist., Taipei City, 10367 TAIWAN May 5, 2022 #### Re: K211529 Trade/Device Name: NAVIRFA Scope Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO Dated: March 24, 2022 Received: March 28, 2022 Dear Arthur Lung: 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 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 {1}------------------------------------------------ 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 mediation-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. For Michael D. O'Hara, Ph.D. Deputy Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211529 Device Name NAVIRFA Scope #### Indications for Use (Describe) The NAVIRFA Scope is intended to provide physicians with the trajectory information of needle instruments when used in conjunction with medical ultrasound. Instruments used with the NAVIRFA Scope may include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used interventional procedures that already use ultrasound devices for visualization. The device is intended for prescription use only. 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 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. 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The background is plain white. ## 510(k) Summary K211529 #### Submitter's Information | Name: | NaviFUS Corporation | |-----------------|--------------------------------------------------------------------------------------| | Address: | 12F., No. 246, Sec. 3, Chengde Road<br>Datong District, Taipei City 10367,<br>TAIWAN | | Phone Number: | +886-2-2586-0560 | | Fax: | +886-2-2357-6373 | | Contact person: | Arthur Lung, General Manager | | Date Prepared: | Nov. 30, 2020 | #### Device Information | Trade Name: | NAVIRFA Scope | |----------------------|-------------------------------------------------------------------------------| | Common Name: | Needle Tracking system | | Classification Name: | Ultrasonic pulsed echo imaging system<br>(21 CFR 892.1560, Product Code: IYO) | ## Predicate Device | Device Name: | Clear Guide ONE | |----------------|-----------------| | 510(k) Number: | K141806 | ## Device Description The NAVIRFA Scope utilizes an optical camera and supporting software to integrate the trajectory information of needle instruments towards improving interventional procedures. The NAVIRFA Scope is fixed onto an ultrasonic transducer. The camera observes and detects the motion of a needle with an attached tracking marker (NAVIRFA Tracking Kit). The needle position is calculated and mapped onto a real-time ultrasonic image via NAVIRFA software. The NAVIRFA Scope is compatible with the existing ultrasound system Smartus Ext-1m/3m, TELEMED (K163121). #### Indication for Use The NAVIRFA Scope is intended to provide physicians with the trajectory information of needle instruments when used in conjunction with medical ultrasound. Instruments used with the NAVIRFA Scope may include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used in needle interventional procedures that already use ultrasound devices for visualization. The device is intended for prescription use only. {4}------------------------------------------------ #### Comparison to Predicate The following table provides a comparison of the proposed device to the predicate | Features | Proposed<br>NAVIRFA Scope | Predicate<br>Clear Guide ONE | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for use | The NAVIRFA Scope is intended<br>to provide physicians with the<br>trajectory information of needle<br>instruments when used in<br>conjunction with medical<br>ultrasound. Instruments used<br>with the NAVIRFA Scope may<br>include an interventional needle<br>or needle-like rigid device, such<br>as a biopsy needle, an aspiration<br>needle, or an ablation needle.<br>The device is intended to be<br>used in needle interventional<br>procedures that already use<br>ultrasound devices for<br>visualization. | The Clear Guide ONE is<br>indicated for augmenting the<br>ultrasonic image of an<br>interventional needle or<br>needle-like rigid device, such as<br>a biopsy needle, an aspiration<br>needle, or ablation needle, and<br>for predicting its future path on<br>a display, which also shows the<br>image of a B-scan (or similar<br>display) of a medical ultrasound<br>imaging system. The device is<br>intended to be used in<br>procedures where ultrasound is<br>currently used for visualization. | | Principle of<br>Operation | Optical detection, single camera | Optical detection, stereo<br>camera | | Duration of<br>Use | Multi-use camera | Multi-use camera | | Optical<br>camera | Rigidly fixed on ultrasonic probe<br>with approx. ±30 deg field of<br>view | Rigidly fixed on ultrasonic<br>probe with approx. ±30 deg<br>field of view | | Power source<br>of camera | USB | USB | | Tracking<br>instrument | Needle instrument with<br>attached tracking marker | Any needle-like instrument, but<br>need tracking marker for track<br>tip of instrument as well | | Instrument<br>information | overlays onto an existing<br>ultrasound image | overlays onto an existing<br>ultrasound image | | Software<br>operating<br>platform | Microsoft Windows | Microsoft Windows | The NAVIRFA Scope is viewed as substantially equivalent to the predicate Clear Guide ONE in K141806 because: #### . Indication for use: The proposed indications of use are identical to the predicate device. Both devices are intended to be used in currently used ultrasound-guided interventional procedures and indicate to enhance the ultrasound image by providing the trajectory information of needle-liked instruments. {5}------------------------------------------------ . Technological characteristics: Both NAVIRFA Scope and the predicate device operates using optical detection technology. Similar to the predicate device, the NAVIRFA Scope consists of multi-used optical camera and overlays instrument positioning data onto an existing ultrasound image through proprietary software algorithms. Performance data was collected to demonstrate that the NAVIRFA Scope achieves its intended function in a manner that is as safe and as effective as the predicate device # Summary of Non-Clinical Performance Testing Bench testing was conducted to evaluate the performance characteristics of NAVIRFA Scope. Data of accuracy was collected and showing that the NAVIRFA Scope could accurately achieve its intended use. No clinical data was collected to support a substantial equivalence determination. The NAVIRFA Scope complies with the following recognized consensus standards: - AAMI ES 60601-1:2005/(R)2012 & A1:2012: Medical electrical equipment—Part 1. 1: General requirements for basic safety and essential performance - 2. IEC 60601-1-2: 2014 – Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - 3. ISO 14971: 2019 Medical devices — Application of risk management to medical devices - 4. IEC 62304:2006/AMD 1:2015 Medical device software — Software life cycle processes The results of bench testing demonstrate that the NAVIRFA Scope is as safe and as effective as the predicate device Clear Guide ONE in K141806. ## Substantial Equivalence Conclusion As detailed, the indications for use, technology or principle of operation and performance are substantially equivalent. The differences between the proposed NAVIRFA Scope and the predicate Clear Guide ONE in K141806 based upon the comparative performance testing we can conclude that there are no new safety or effectiveness concerns and thus the proposed device can be determined to be substantially equivalent to the predicate.