(239 days)
The InVision System is indicated for enhancing 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 stereoscopic computer monitor screen 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 visualizing such procedures.
The InVision System is an accessory to ultrasound systems that provides guidance for the placement of needle-like rigid objects, such as biopsy needles and ablation probes. The system enables a physician to accurately place a needle into a target anatomical structure by overlaying the image of the needle and its predicted future path on the ultrasound image of the internal organs in real time on a stereo monitor, for a "3D" effect (cf. IMAX 3D theaters).
The InVision System consists of four (4) principal components:
- a passive infrared position tracking system; (1)
- (2) tracking mounts for the ultrasound transducer and the needle;
- custom guidance software installed on a computer; and (3)
- (4) a stereoscopic monitor with passive glasses for viewing the monitor.
Acceptance Criteria and Study for the InVision System
Based on the provided K083728 510(k) Premarket Application for the InVision System, the following information can be extracted regarding its acceptance criteria and the study conducted to demonstrate compliance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes bench tests that were conducted. However, it does not explicitly state specific quantifiable acceptance criteria with corresponding reported performance metrics. Instead, it offers a general statement about the study's outcome.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance (as stated in the document) |
|---|---|
| Capable of safely performing the stated intended use | "The results of these studies demonstrate that the InVision System is capable of safely and accurately performing the stated intended use." |
| Capable of accurately performing the stated intended use | "The results of these studies demonstrate that the InVision System is capable of safely and accurately performing the stated intended use." |
| Similar effectiveness to the Ultraguide 1000 predicate device (K974432) | "The results also show similar effectiveness to the Ultraguide 1000 predicate device (K974432)." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Bench tests were conducted." This implies an artificial or controlled environment rather than a clinical trial with human subjects.
- Sample Size: The specific sample size for the "bench tests" is not provided.
- Data Provenance: The data provenance is laboratory/bench testing, not human subjects. Therefore, there is no country of origin or retrospective/prospective designation in the traditional clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that the testing involved "bench tests" and not clinical data requiring expert interpretation, there is no mention of experts used to establish ground truth for a test set in the traditional sense linked to medical imaging diagnosis or intervention. The ground truth for bench tests would typically be established through precise measurements and known physical parameters.
4. Adjudication Method for the Test Set
As the testing was "bench tests" and did not involve human expert interpretation of medical images for ground truth, an adjudication method (like 2+1, 3+1) is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted according to the provided text. The study focused on bench testing and comparison to a predicate device's effectiveness, not on the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document refers to "bench tests" to evaluate the "performance characteristics of the InVision System." Since the InVision System is an accessory that enhances the ultrasonic image and predicts the needle path for physician guidance, the "standalone" performance in this context would likely refer to the accuracy of its tracking system, prediction algorithms, and display overlay in a controlled environment. The results of these bench tests are the closest indication of standalone performance, demonstrating its capability of "safely and accurately performing the stated intended use."
7. Type of Ground Truth Used
The "bench tests" would likely use known physical parameters and precise measurements as the ground truth. For instance, the ground truth for needle position and predicted path would be established by physical measurements in a phantom or controlled setup, and the system's output would be compared against these known values. No mention of expert consensus, pathology, or outcomes data as ground truth is made, which aligns with bench testing rather than clinical study.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This suggests that either:
- The system was not developed using machine learning that requires a distinct training set in the modern sense.
- The details of any internal development/training data were not deemed necessary to include in the 510(k) summary for this type of device and submission.
9. How the Ground Truth for the Training Set Was Established
Since no training set information is provided (as per point 8), there is no information on how ground truth for a training set was established.
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K0837228
InVision System
510k Premarket Application
AUG 1 2 2009
Section 5: 510(k) Summary
Submitted by:
InnerOptic Technology, Inc
Contact:
Caroline K. Green Quality and Regulatory Manager 106-A N. Churton St. Chapel Hill, NC 27278 Ph. 919-722-2090 Fax. 413-581-3269 Email: caroline@inneroptic.com
Date of Submission: December 15, 2008 Proprietary Name: InVision System Common Name: Ultrasonic pulsed echo imaging system Class II per 21 CFR 892.1560 Regulatory Class: IYO: system, imaging, pulsed echo, ultrasonic Product Codes: OEW: tracking, soft tissue, intraoperative
Device Description: The InVision System is an accessory to ultrasound systems that provides guidance for the placement of needle-like rigid objects, such as biopsy needles and ablation probes. The system enables a physician to accurately place a needle into a target anatomical structure by overlaying the image of the needle and its predicted future path on the ultrasound image of the internal organs in real time on a stereo monitor, for a "3D" effect (cf. IMAX 3D theaters).
The InVision System consists of four (4) principal components:
- a passive infrared position tracking system; (1)
- (2) tracking mounts for the ultrasound transducer and the needle;
- custom guidance software installed on a computer; and (3)
- (4) a stereoscopic monitor with passive glasses for viewing the monitor.
Intended Use: The InVision System is indicated for enhancing 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
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stereoscopic computer monitor screen 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 visualizing such procedures.
Technological characteristics, comparison to predicate device: The technological charactcristics and indications for use of the InVision System are the same or similar to those found in the predicate devices. The InVision System is substantially equivalent to the following FDA cleared guidance systems:
| System Name | ProductCode | 510(k) Approval Number |
|---|---|---|
| Ultraguide 1000 | IYO: system, imaging,pulsed echo, ultrasonic | K974432 |
| IG4 Image Guided System | JAK: system, x-ray,tomography, computed | K060903 |
| Linasys Image-Guided Liver SurgerySystem | OEW: tracking, softtissue, intraoperative | K071063 |
| Karl Storz 3D Video System | GCI: laryngoscope,endoscope | K001362 |
The device labeling contains instructions for use, including indications for use, cautions, contraindications, warnings and planning guidance. This information assures safe and effective use of this device.
Discussion of performance testing: Bench tests were conducted to evaluate the performance characteristics of the InVision System. The results of these studies demonstrate that the InVision System is capable of safely and accurately performing the stated intended use. The results also show similar effectiveness to the Ultraguide 1000 predicate device (K974432).
Conclusion: The InVision System is equivalent to the predicate devices in safety and effectiveness.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 1 2 2009
Ms. Caroline Green Quality & Regulatory Manager InnerOptic Technology, Inc. 106-A North Churton Street HILLSBOROUGH NC 27278
Re: K083728
Trade/Device Name: InVision System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO Dated: July 10, 2009 Received: July 16, 2009
Dear Ms. Green;
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. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Lammy M. Morsel
Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use Statement
510(k) Number: Device Name:
InVision System
Indications for Use:
The InVision System is indicated for enhancing 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 stereoscopic computer monitor screen 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 visualizing such procedures.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
InnerOptic Technology, Inc. December 15, 2008
Aopith thay
on Sign-Off on of Reproductive, Abdominal, and Radiological Devices
510(k) Number.
§ 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.