(69 days)
Not Found
No
The description focuses on optical tracking and coupling positioning information with the ultrasound image to display a projected pathway, without mentioning AI or ML for image analysis or prediction. The "predicting its future path" is likely based on the current position and trajectory derived from the optical tracking, not an AI/ML model.
No.
The device is used for augmenting the ultrasonic image of an interventional needle or needle-like rigid device and predicting its future path, which serves as a guidance tool for medical procedures rather than directly treating a condition.
No
The device is described as an accessory that augments ultrasonic images and tracks instrument positioning for guidance during procedures. It does not provide a diagnosis or identify a disease or condition.
No
The device description explicitly states it includes "accessories attached to the transducer probe and needle or needle-like rigid device" and uses "optical detection technology" to track positioning. This indicates the presence of hardware components beyond just software.
Based on the provided information, the AcuSee AS-P1000 system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- AcuSee AS-P1000 Function: The AcuSee AS-P1000 system is described as a device that augments the ultrasonic image of an interventional needle and predicts its future path on a display that also shows the ultrasound image. It tracks the position of the needle and the ultrasound probe using optical detection technology.
- No Specimen Analysis: The description clearly indicates the device is used to guide instruments during a procedure by enhancing the visualization of the needle in relation to the ultrasound image. It does not involve the analysis of any biological specimens taken from the patient.
Therefore, the AcuSee AS-P1000 system falls under the category of a medical device used for image guidance during interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AcuSee AS-P1000 system is indicated for augmenting the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration 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.
The AcuSee AS-P1000 system is intended to be used in a clinical setting.
Product codes (comma separated list FDA assigned to the subject device)
IYO
Device Description
The AcuSee AS-P1000 system is a medical device that tracks instrument positioning during ultrasoundguided procedures to provide instrument guidance to the end user. With accessories attached to the transducer probe and needle or needle-like rigid device, the AcuSee AS-P1000 system identifies and tracks the probe and the device within the field of view through optical detection technology. By coupling positioning information with the ultrasound image, the projected instrument pathway is displayed to the user for guiding instrumentation. The AcuSee AS-P1000 system is an accessory to any compatible ultrasound machine and transducer probe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic image, B-scan (or similar display) of a medical ultrasound imaging system
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Clinical Setting
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)
The performance testing for the AcuSee AS-P1000 System includes software verification/validation testing, system verification/validation testing and testing to compliance standards for electrical and electromagnetic safety. Traceability has been documented between the system specification to verification/validation protocols. The results of performance testing show that the AcuSee AS-P1000 system is as safe and as effective as the predicate device.
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.
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
§ 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.
0
October 7, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and 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.
Weipeng (Suzhou) Medical Devices Co., Ltd. % Geetha Rao, Ph.D. Regulatory and Quality Representative Springborne Life Sciences 750 Menlo Avenue, Suite 200 MENLO PARK CA 94025
Re: K202119
Trade/Device Name: AcuSee AS-P1000 System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO Dated: July 24, 2020 Received: July 30, 2020
Dear Dr. Rao:
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
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202119
Device Name AcuSee AS-P1000 System
Indications for Use (Describe)
The AcuSee AS-P1000 system is indicated for augmenting the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration 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.
The AcuSee AS-P1000 system is intended to be used in a clinical setting.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
Submitter
| Name | Weipeng (Suzhou) Medical Devices Co., Ltd.
Unit 207, Building B2 |
|----------------|----------------------------------------------------------------------|
| Address | 218 Xinghu St., Suzhou Industrial Park
Suzhou, 215123, P.R. China |
| Phone Number | +86 0512-67311267 |
| Fax Number | NA |
| Contact Person | Bin Yang |
| Email | binyang@vibronixinc.com |
| Phone Number | +86 0512-67311267 |
| Fax Number | NA |
| Date Prepared | July 15, 2020 |
Device Information
| Trade Name | AcuSee AS-P1000 System |
|---|---|
| Common Name | Tracking or Guidance System |
| Product Code | IYO, Ultrasonic pulsed echo imaging system |
| Regulation | 21 CFR 892.1560, Ultrasonic pulsed echo imaging system |
| Device Class | II |
Predicate Information
| Device Name | Clear Guide ONE |
|---|---|
| 510(k) Number | K141806 |
Device Overview
The AcuSee AS-P1000 system is a medical device that tracks instrument positioning during ultrasoundguided procedures to provide instrument guidance to the end user. With accessories attached to the transducer probe and needle or needle-like rigid device, the AcuSee AS-P1000 system identifies and tracks the probe and the device within the field of view through optical detection technology. By coupling positioning information with the ultrasound image, the projected instrument pathway is displayed to the user for guiding instrumentation. The AcuSee AS-P1000 system is an accessory to any compatible ultrasound machine and transducer probe.
Indications for Use
The AcuSee AS-P1000 system is indicated for augmenting the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration 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.
4
VibroniX
The AcuSee AS-P1000 system is intended to be used in a clinical setting.
Technological Characteristics
The AcuSee AS-P1000 System applies optical tracking technology to augment the ultrasonic image of an interventional needle or needle-like rigid device and for predicting its future path on a display and also show the image of a B-scan (or similar display) of a medical ultrasound imaging system. The relative position and trajectory of the needle is calculated using stereo-vision optical detection of markers on tracking mounts attached to the ultrasound probe and needle device.
| Feature | Subject Device
AcuSee AS-P1000 System | Predicate Device
Clear Guide One | SE Comparison/
Comment |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| 510(k) Number | NA | K141806 | NA |
| Product Code | IYO | IYO | Same |
| Regulation No. | 892.1560 | 892.1560 | Same |
| Risk Class | II | II | Same |
| Regulatory
Pathway | 510(k) | 510(k) | Same |
| Indications for
Use | The AcuSee AS-P1000 System
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. | 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. | Identical |
| Intended Users | Physician | Physician | Same |
| Use
Environment | Clinical Setting | Clinical Setting | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Movability | Main system mounted on
movable cart | Main system mounted on
movable cart | Same |
| Feature | Subject Device
AcuSee AS-P1000 System | Predicate Device
Clear Guide One | SE Comparison/
Comment |
| Fundamental
Technology | Optical Detection | Optical Detection | Same |
| Device Form
Factor | Main system contains camera,
and PC with software on
movable cart, with power cord
for AC power,
Separate tracking accessories
consist of tracking mounts | Main system (Clear Guide
Core) contains hardware and
software with power adapter
and cord,
Separate tracking accessories
include camera (Clear Guide
SuperProbe) and custom
instruments | Similar primary
concept with different
physical configuration |
| Detection
Mechanism | Camera located at a distance
tracks custom tracking mounts
on ultrasound probe and
needle | Camera is directly mounted on
ultrasound probe and tracks
custom needle | Similar concept, with
a variant spatial
geometry |
| Tracking
Algorithm | Automatic | Automatic | Similar |
| Timing for
tracking | Real-time | Real-Time | Same |
| Information
Displayed | Overlay of the detected
instrument positioning and
projected path onto the
ultrasound image | Overlay of the detected
instrument positioning and
projected path onto the
ultrasound image | Same |
| Reusability | Reusable main system with
consumable tracking mounts | Reusable main system and
probe with consumable
tracking needle | Similar |
| Instruments
tracked | Any compatible needle-like
instrument | Requires custom needle (not
known what kind of needle) | Similar |
| Tracking of
instrument tip | Any compatible instrument | Only with custom instrument
with CLEAR GUIDE PercepTIP | Similar |
| Compatibility
with probe | Tracking mount fits any
compatible probe | Optical head with camera fits
any compatible probe | Same functionality |
| Tracking
instruments in
and out-of-plane | Within +/- 90 deg | Within +/- 45 deg | Subject device has
wider performance
range |
| Feature | Subject Device
AcuSee AS-P1000 System | Predicate Device
Clear Guide One | SE Comparison/
Comment |
| Electrical Safety
and
Electromagnetic
Compatibility | IEC 60601-1:2005+A1:2012 -
Medical electrical equipment –
Part 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. | IEC 60601-1 3rd Edition:
Medical Electrical Equipment;
Part 1 General Requirements
for Safety
IEC 60601-1-2 :2007 – Medical
electrical equipment - Part 1-2:
General requirements for
safety – Collateral standard:
Electromagnetic compatibility | Similar - Subject
device meets updated
standard |
| Performance
Testing | Bench testing | Bench testing | Similar |
| Animal Testing | None | None | Same |
| Clinical Testing | None | None | Same |
Device Comparison Table
5
VibroniX
6
Substantial Equivalence Overview
The AcuSee AS-P1000 System has the same intended use and indications for use, as well as similar technological characteristics and principles of operation compared to the previously legally cleared predicate device: Clear Guide ONE (K141806, cleared in 2014).
The AcuSee AS-P1000 System and the predicate device both apply the same optical detection technology in a similar device form factor. The AcuSee AS-P1000 system overlays the detected instrument positioning data onto an existing ultrasound image through proprietary software algorithms, In the same manner as the predicate device. Both devices track targeted instrumentation and provide real-time visual guidance during a clinical procedure. Both devices have reusable main components and some consumable accessories. The AcuSee AS-P1000 System was tested to demonstrate compliance to the same applicable safety standards as the predicate device, but for updated versions of the standards.
The AcuSee AS-P1000 System uses the same primary concept for the detection mechanism but uses a different physical configuration for the camera and tracked targets, resulting in a different spatial geometry. This variation does not alter the fundamental mechanism and raises no new questions of safety. Performance data was collected to demonstrate that the AcuSee AS-P1000 system achieves its intended function in a manner that is as effective as the predicate device.
The AcuSee AS-P1000 system uses tracking mounts that are designed to fit ultrasound probes and instruments that are available on the market. Although specific models of probes (and the associated ultrasound machines with which they are used) and instruments are individually validated to be compatible, the mounts themselves are standardized and may be used with any compatible probe or instrument. Hence unlike the predicate device, the system does not require special patterns to be marked or printed to the shaft of the needle or other tracked instrument.
7
VibroniX
Although there are minor differences in technological characteristics of the AcuSee AS-P1000 System, they do not raise new issues of safety or effectiveness.
Summary of Performance Testing
The performance testing for the AcuSee AS-P1000 System includes software verification/validation testing, system verification/validation testing and testing to compliance standards for electrical and electromagnetic safety. Traceability has been documented between the system specification to verification/validation protocols. The results of performance testing show that the AcuSee AS-P1000 system is as safe and as effective as the predicate device.
The AcuSee AS-P1000 system complies with the following recognized consensus standards:
-
- IEC 60601-1:2005+A1:2012 (Medical electrical equipment Part 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).
Conclusion
The performance of the AcuSee AS-P1000 System is substantially equivalent to that of the Clear Guide ONE system and raises no safety or effectiveness issues and performs as well or better than the predicate device.