(353 days)
No
The description focuses on optical tracking and mapping, with no mention of AI/ML terms or concepts like learning, training, or complex pattern recognition beyond basic motion detection.
No
The device provides trajectory information for needle instruments during interventional procedures, assisting physicians but not directly treating a disease or condition.
No
The device is intended to provide trajectory information of needle instruments during interventional procedures that already use ultrasound devices for visualization. It assists with guiding interventional needles (e.g., biopsy, aspiration, ablation) rather than diagnosing conditions.
No
The device description explicitly states that the NAVIRFA Scope utilizes an optical camera and is fixed onto an ultrasonic transducer, indicating the presence of hardware components beyond just software.
Based on the provided information, the NAVIRFA Scope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The NAVIRFA Scope's intended use is to provide trajectory information of needle instruments during interventional procedures, using ultrasound for visualization. It does not analyze biological samples like blood, urine, or tissue.
- The device description focuses on real-time guidance during a procedure. It uses an optical camera and software to track a needle and overlay its position on an ultrasound image. This is a tool for procedural guidance, not for analyzing biological samples to diagnose or monitor a condition.
The NAVIRFA Scope is a medical device used in conjunction with ultrasound for image-guided interventions. Its function is to assist the physician in accurately placing a needle within the body, which is a procedural aid, not an in vitro diagnostic test.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
IYO
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Medical ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / Interventional procedures
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)
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.
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
§ 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.
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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
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
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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 Road |
| Datong 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 | Proposed
NAVIRFA Scope | Predicate
Clear Guide ONE |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Clear Guide ONE is
indicated for augmenting the
ultrasonic image of an
interventional needle or
needle-like rigid device, such as
a biopsy needle, an aspiration
needle, or ablation needle, and
for predicting its future path on
a display, which also shows the
image of a B-scan (or similar
display) of a medical ultrasound
imaging system. The device is
intended to be used in
procedures where ultrasound is
currently used for visualization. |
| Principle of
Operation | Optical detection, single camera | Optical detection, stereo
camera |
| Duration of
Use | Multi-use camera | Multi-use camera |
| Optical
camera | Rigidly fixed on ultrasonic probe
with approx. ±30 deg field of
view | Rigidly fixed on ultrasonic
probe with approx. ±30 deg
field of view |
| Power source
of camera | USB | USB |
| Tracking
instrument | Needle instrument with
attached tracking marker | Any needle-like instrument, but
need tracking marker for track
tip of instrument as well |
| Instrument
information | overlays onto an existing
ultrasound image | overlays onto an existing
ultrasound image |
| Software
operating
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
-
- 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
-
- ISO 14971: 2019 Medical devices — Application of risk management to medical devices
-
- 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.