(353 days)
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.
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).
The information provided in the document focuses on the substantial equivalence of the NAVIRFA Scope to a predicate device, rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria for image analysis or diagnostic performance. Instead, it describes bench testing for performance characteristics, specifically accuracy, to support its intended use.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria followed by quantitative device performance against those criteria. It states: "Data of accuracy was collected and showing that the NAVIRFA Scope could accurately achieve its intended use." However, specific numerical values for accuracy or other performance metrics, and the acceptance thresholds for these metrics, are not provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Bench testing was conducted to evaluate the performance characteristics of NAVIRFA Scope." It does not specify the sample size (e.g., number of tests, number of needles, number of simulated procedures) used for this bench testing. There is no information regarding the data provenance (e.g., country of origin, retrospective or prospective nature) as it refers to bench testing rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the testing described is "bench testing" and not a study involving human interpretation of medical images or diagnoses. Ground truth, in this context, would likely refer to engineered precision or known values in a laboratory setting, not expert consensus on medical findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for bench testing. Adjudication methods are typically used in clinical studies involving multiple human readers for diagnostic accuracy.
5. If a multi-reader multicase (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
The document explicitly states: "No clinical data was collected to support a substantial equivalence determination." Therefore, no MRMC comparative effectiveness study was conducted with human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions "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." This bench testing would be considered a standalone performance evaluation of the device's ability to provide trajectory information, as it doesn't involve human interpretation loops. However, specific metrics of "standalone" performance are not quantified beyond a general statement of "accuracy."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given it was "bench testing" for a needle tracking system, the ground truth would most likely be precisely measured or known physical positions and trajectories of needles in a controlled experimental setup, rather than expert consensus, pathology, or outcomes data, which are relevant to clinical diagnostic accuracy. The document does not explicitly state the specific method used to establish this ground truth.
8. The sample size for the training set
The document does not mention any training set size. The context is a 510(k) submission focused on substantial equivalence based on performance characteristics, and there is no indication that the device utilizes machine learning or AI that would require a distinct training set in the conventional sense for image interpretation. The "proprietary software algorithms" are used for optical detection and mapping, which may or may not involve machine learning models that require training data.
9. How the ground truth for the training set was established
As no training set is mentioned or implied to be used for machine learning models that generate diagnostic outputs, this information is not provided.
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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
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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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Submitter's Information
| Name: | NaviFUS Corporation |
|---|---|
| Address: | 12F., No. 246, Sec. 3, Chengde RoadDatong District, Taipei City 10367,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(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.
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Comparison to Predicate
The following table provides a comparison of the proposed device to the predicate
| Features | ProposedNAVIRFA Scope | PredicateClear Guide ONE |
|---|---|---|
| Indication for use | The NAVIRFA Scope is intendedto provide physicians with thetrajectory information of needleinstruments when used inconjunction with medicalultrasound. Instruments usedwith the NAVIRFA Scope mayinclude an interventional needleor needle-like rigid device, suchas a biopsy needle, an aspirationneedle, or an ablation needle.The device is intended to beused in needle interventionalprocedures that already useultrasound devices forvisualization. | The Clear Guide ONE isindicated for augmenting theultrasonic image of aninterventional needle orneedle-like rigid device, such asa biopsy needle, an aspirationneedle, or ablation needle, andfor predicting its future path ona display, which also shows theimage of a B-scan (or similardisplay) of a medical ultrasoundimaging system. The device isintended to be used inprocedures where ultrasound iscurrently used for visualization. |
| Principle ofOperation | Optical detection, single camera | Optical detection, stereocamera |
| Duration ofUse | Multi-use camera | Multi-use camera |
| Opticalcamera | Rigidly fixed on ultrasonic probewith approx. ±30 deg field ofview | Rigidly fixed on ultrasonicprobe with approx. ±30 degfield of view |
| Power sourceof camera | USB | USB |
| Trackinginstrument | Needle instrument withattached tracking marker | Any needle-like instrument, butneed tracking marker for tracktip of instrument as well |
| Instrumentinformation | overlays onto an existingultrasound image | overlays onto an existingultrasound image |
| Softwareoperatingplatform | 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.
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. 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
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- 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
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- ISO 14971: 2019 Medical devices — Application of risk management to medical devices
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- 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.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.