(59 days)
The Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System designed to provide the physicians with general fluoroscopic visualization of a patient, including, but not limited to surgical orthopedic and podiatry use, critical and emergency care procedures, and light anatomy imaging situations.
The Hologic® InSight-FD System, is a portable Mini C-Arm fluoroscopic imaging system with Flat Detector technology used by medical personnel in a variety of diagnostic, surgical and post-operative procedures for imaging extremities, including the hand, wrist, forearm, shoulder, foot, ankle and knee. The hardware enhancements for the InSight-FD System exist primarily within the detector assembly and collimation. The InSight-FD System offers CMOS Flat Detector technology which provides a rectangular viewing area in comparison t the circular view with the conventional image intensifier. For user convenience, additional buttons were added to the X-ray source assembly control panel from the available functions. The software enhancements for the InSight-FD System synchronize the rotation of the X-ray collimator with a manual rotation of +/-90 degrees. The synchronization enables the user to rotate the display image in a rectangular image as compared to the circular view of the image intensifier.
Here's an analysis of the provided text regarding the Hologic® InSight - FD Mini C-Arm Fluoroscopic Imaging System, focusing on the acceptance criteria and the study used to demonstrate conformance:
Summary of Device Performance Study
The provided 510(k) summary describes performance testing for the Hologic® InSight-FD System. The primary goal of the testing was to verify the incorporation and functionality of the flat panel detector technology and to ensure that accompanying software changes did not negatively impact functionality. The study also aimed to demonstrate that the device met its specific acceptance criteria and complied with applicable regulatory performance standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Software Functionality | No negative impact from software changes; functions and features meet specific acceptance criteria. | "accompanying software changes did not negatively impact the functionality, and that the functions and features tested meet their specific acceptance criteria." |
| Flat Panel Detector Functionality | Proper incorporation and functionality. | "incorporation and functionality of the flat panel detector on the Insight-FD System" |
| Radiographic Parameters (e.g., resolution, contrast detail, uniformity, motion) | Comparable to the prior image intensified system. | "Pairs of images were acquired to test the radiographic and fluoroscopic parameters... in comparison with the prior image intensified system." |
| Fluoroscopic Parameters (e.g., resolution, contrast detail, uniformity, motion) | Comparable to the prior image intensified system. | "Pairs of images were acquired to test the radiographic and fluoroscopic parameters... in comparison with the prior image intensified system." |
| Radiation Protection Standards Compliance | Comply with 21 CFR 1020.30 (Diagnostic x-ray systems and their major components) and 21 CFR 1020.32 (Fluoroscopic equipment). | "demonstrate that the new Insight-FD with flat panel detector continues to comply with the applicable regulatory performance standards for radiation protection" |
| Overall Functional Requirements & Performance Specifications | Meets all functional requirements and performance specifications. | "Testing was successfully conducted and demonstrated that the Hologic InSight-FD System meets all of its functional requirements and performance specifications." |
Note on Acceptance Criteria: The document does not explicitly state numerical or specific pass/fail acceptance criteria for most of these metrics. Instead, it broadly states that the device "meets specific acceptance criteria," "did not negatively impact functionality," "comparable to the prior system," and "complies with applicable regulatory performance standards." This is common in 510(k) summaries where detailed criteria are typically found in the full submission documents.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "Pairs of images were acquired" for radiographic and fluoroscopic parameters testing, but the number of pairs or the number of unique test subjects/phantoms is not provided.
- Data Provenance: Not specified. It's unclear if the data was generated in a specific country or if it was retrospective or prospective. Given the nature of a medical device submission, it would almost certainly be prospective testing conducted by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not mentioned. There's no indication of any multi-reader review or consensus process for image assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No. The document does not describe an MRMC study comparing human reader performance with and without AI assistance. The testing described focuses on the device's technical performance characteristics.
- Effect Size: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
- Was it done?: Yes, conceptually. The performance testing described, particularly for resolution, contrast, uniformity, motion, and compliance with radiation standards, assesses the device's intrinsic characteristics. While a human would naturally operate the system, the evaluation of these parameters focuses on the system's output and adherence to specifications, which is a form of standalone performance. However, this is not an AI-driven "algorithm only" study; it's a hardware/software system performance evaluation.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this type of device (an imaging system) would primarily be measurement-based and comparative.
- For radiographic/fluoroscopic parameters (resolution, contrast, uniformity, motion), the ground truth would be established through physical measurements using phantoms and standardized test objects, often compared against a "gold standard" or the performance of the predicate device (the prior image intensified system in this case).
- For software functionality, the ground truth would be defined by pre-established functional requirements and design specifications.
- For radiation protection standards, the ground truth is regulatory compliance as defined by 21 CFR 1020.30 and 1020.32.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document describes the performance testing of an imaging system, not a machine learning or AI model that requires a "training set" in the conventional sense. The "software enhancements" mentioned are likely traditional programming changes, not machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no apparent training set for an AI model. For the software itself, the "ground truth" for development and verification would be its functional design specifications and requirements.
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Section 5 -510(k) Summary
APR - 6 2012
Manufacturing Establishment and Contact Information 1
- 1.1 Manufacturer Name and Address:
Hologic, Inc. 35 Crosby Drive Bedford, MA 01730
Establishment Registration Number: 1.2
1221300
Name, Title, and Telephone Number of Contact: 1.3
Name: Eileen M. Boyle Regulatory Affairs Specialist II Title: (781) 999-7781 Phone: (866) 652-8674 Fax : Email: eileen.boyle@hologic.com
2 Device Identification
2.1 Device Trade Name:
Hologic® InSight - FD Mini C-Arm Fluoroscopic Imaging System
Common/Usual Name 2.2
Fluoroscopic Imaging System
2.3 Proposed Intended Use:
The Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System designed to provide the physicians with general fluoroscopic visualization of a patient, including, but not limited to surgical orthopedic and podiatry use, critical and emergency care procedures, and light anatomy imaging situations.
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3 Device Classification
3.1 Classification:
Class II
Classification Name and Rule 3.2
Image-Intensified Fluoroscopic X-Ray System, 21 CFR 892.1650
- Classification Panel 3.3
Radiology
3.4 Product Code
охо
3.5 Predicate Devices
- 510(k) No: K051754 ● Trade Name: Orthoscan, OrthoScan HD (which includes OrthoScan HD with Flat Detector) SE Date: 8/9/2005 Manufacturer: Orthoscan, Inc.
- 510(k) No: K113708 . Trade Name: Orthoscan Mobile DI SE Date: 1/5/2012 Manufacturer: Orthoscan, Inc.
- 510(k) No: K051025 . Trade Name: Fluoroscan InSight Mini C-Arm Fluoroscopic Imaging System SE Date: 5/13/2005 Manufacturer: Hologic, Inc.
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4.0 Device Description
The Hologic® InSight-FD System , is a portable Mini C-Arm fluoroscopic imaging system with Flat Detector technology used by medical personnel in a variety of diagnostic, surgical and post-operative procedures for imaging extremities, including the hand, wrist, forearm, shoulder, foot, ankle and knee.
The hardware enhancements for the InSight-FD System exist primarily within the detector assembly and collimation. The InSight-FD System offers CMOS Flat Detector technology which provides a rectangular viewing area in comparison t the circular view with the conventional image intensifier. For user convenience, additional buttons were added to the X-ray source assembly control panel from the available functions.
The software enhancements for the InSight-FD System synchronize the rotation of the X-ray collimator with a manual rotation of +/-90 degrees. The synchronization enables the user to rotate the display image in a rectangular image as compared to the circular view of the image intensifier.
5 Performance Testing
Software verification and validation test was performed following the recommendations in the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The purpose of the testing was to verify the incorporation and functionality of the flat panel detector on the Insight-FD System, that the accompanying software changes did not negatively impact the functionality, and that the functions and features tested meet their specific acceptance criteria.
Nonclinical and clinical information was provided following the recommendations in the "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices." This included information to characterize the solid state detector. Pairs of images were acquired to test the radiographic and fluoroscopic parameters {e.g., resolution, contrast detail, uniformity and motion) of the new Insight-FD with flat panel detector in comparison with the prior image intensified system.
Testing was also performed to demonstrate that the new Insight-FD with flat panel detector continues to comply with the applicable regulatory performance standards for radiation protection, including: 21 CFR 1020.30 (Diagnostic x-ray systems and their major components) and 21 CFR 1020.32 (Fluoroscopic equipment).
Testing was successfully conducted and demonstrated that the Hologic InSight-FD System meets all of its functional requirements and performance specifications.
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Substantial Equivalence
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7
The InSight-FD System is substantially equivalent to commercially available devices used for fluoroscopic imaging. The predicate devices selected for comparison are the OrthoScan- HD and the OrthoScan–HD with Flat Detector (K051754), OrthoScan Mobile DI (K113708) and the Fluoroscan InSight Mini C-Arm Fluoroscopic Imaging System (K051025). The predicate devices provide substantially equivalent or the same intended use, features and functions as the proposed device.
Conclusion
The features and functions on the InSight-FD System are substantially equivalent to those of the indicated commercially distributed devices: OrthoScan-HD with Flat Detector (K051754), OrthoScan Mobile DI (K113708) and Insight (K051025) with regard to intended use, performance, safety and effectiveness.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Eileen M. Boyle Regulatory Affairs Specialist II Hologic, Inc. 35 Crosby Drive BEDFORD MA 01730
2012
Re: K120388
Trade/Device Name: InSight-FD Mini C-Arm Fluoroscopic Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO Dated: March 12, 2012 Received: March 22, 2012
Dear Ms. Boyle:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device · Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE FORM
510(k) Number (if known):
Device Name: InSight - FD Mini C-Arm Fluoroscopic Imaging System
Indications for Use:
The Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including, but not limited to surgical orthopedic and podiatry use, critical and emergency care procedures, and light anatomy imaging situations.
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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and safety
510(k) K120388
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§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.