(59 days)
Not Found
No
The summary describes a standard fluoroscopic imaging system with hardware and software enhancements focused on the flat panel detector and image display synchronization. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
This device is an imaging system designed for visualization and diagnosis, not for treating conditions.
Yes
The "Intended Use / Indications for Use" states that the device is "designed to provide the physicians with general fluoroscopic visualization of a patient". More explicitly, the "Device Description" states it is "used by medical personnel in a variety of diagnostic, surgical and post-operative procedures for imaging extremities".
No
The device description explicitly states it is a "portable Mini C-Arm fluoroscopic imaging system with Flat Detector technology" and details hardware enhancements within the detector assembly and collimation. It also mentions software enhancements that synchronize with manual hardware rotation. This clearly indicates the device is a hardware system with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The Fluoroscan InSight is a fluoroscopic imaging system. It uses X-rays to create real-time images of the inside of a patient's body. This is an in vivo (within the living body) imaging technique.
- Intended Use: The intended use clearly states "general fluoroscopic visualization of a patient," "surgical orthopedic and podiatry use," "critical and emergency care procedures," and "light anatomy imaging situations." These are all applications of medical imaging performed directly on the patient.
- Device Description: The description details the hardware and software related to capturing and displaying X-ray images of the patient's extremities.
- Input Imaging Modality: The input is "Fluoroscopic X-Ray," which is an imaging modality, not a method for analyzing biological samples.
The device is a medical imaging device used for diagnostic and procedural guidance on the patient, not for testing samples from the patient.
N/A
Intended Use / Indications for 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.
Product codes
OXO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-Ray
Anatomical Site
extremities, including the hand, wrist, forearm, shoulder, foot, ankle and knee.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical personnel
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)
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.
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
§ 892.1650 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.
0
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.
1
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.
Page 2 of 4
2
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.
3
Substantial Equivalence
б
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.
4
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
5
Page 2
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
6
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
Page 1 of