(26 days)
The ImaSight 4600 is intended for use by a qualified doctor or technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the patients. The ImaSight 4600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. The ImaSight 4600 is not intended for mammography.
The ImaSight 4600 is a digital radiographic sensor which automatically collects x-ray images from an x-ray source. The ImaSight 4600 sensor collects x-rays and converts them into a computer images for display on a computer. The sensor does not have an x-ray source, which is provided by independent manufacturers. The sensor comes with an acquisition box and a computer, which holds the display and processing software.
The provided document is a 510(k) submission for the ImaSight 4600 Digital Radiography Sensor. This submission focuses on demonstrating substantial equivalence to a predicate device rather than establishing new performance criteria through a standalone study with defined acceptance criteria. Therefore, several aspects of the requested information, such as detailed acceptance criteria, specific sample sizes for test sets, expert-driven ground truth, and MRMC studies, are not explicitly provided in the document in the format typically found for a novel device performance study.
Based on the available information, here's an analysis:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit, quantitative acceptance criteria for the ImaSight 4600 as it would for a new device claiming improved performance. Instead, the basis of the submission is substantial equivalence to a predicate device, the Xplorer 1800 Digital Radiographic System (K063247).
| Acceptance Criteria (Implied) | Reported Device Performance (ImaSight 4600) |
|---|---|
| Image Quality Equivalent to Predicate Device | Produces images of similar quality to Xplorer 1800. |
| Performance Characteristics Equivalent to Predicate Device | Performance characteristics are equivalent to those of the Xplorer 1800. |
| Technical Specifications Identical/Similar to Predicate Device | Uses the same 16-megapixel CCD imaging sensor technology as Xplorer 1800. |
| Non-clinical Biocompatibility | Evaluated and found substantially equivalent to predicate device. |
| Effectiveness | Evaluated and found substantially equivalent to predicate device. |
| Thermal Safety | Evaluated and found substantially equivalent to predicate device. |
| Electrical Safety | Evaluated and found substantially equivalent to predicate device. |
| Mechanical Safety | Evaluated and found substantially equivalent to predicate device. |
| Conformance to Quality Systems | Conforms to 892.1680, ISO 9001, and ISO 13485. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for a "test set" in the context of a performance study. It states, "A set of images have been submitted along with the equivalent images from the predicate device." The exact number of images in this "set" is not provided.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the images were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As the submission relies on comparing images to a predicate device, it's possible that qualitative assessments were made, but the involvement and qualifications of experts for establishing ground truth are not detailed.
4. Adjudication method for the test set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
A MRMC comparative effectiveness study was not explicitly conducted or reported in this submission. The basis of the submission is substantial equivalence to the predicate device, not an evaluation of human reader improvement with or without AI (which this device does not claim to incorporate).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a digital radiography sensor, not an AI algorithm. Therefore, a "standalone algorithm performance" study as described is not applicable to this submission. The device's performance is inherently tied to its ability to capture images, which are then interpreted by humans.
7. The Type of Ground Truth Used
The concept of a "ground truth" derived from expert consensus, pathology, or outcomes data, as typically understood in AI/algorithm performance studies, is not directly applicable or specified here. The "truth" in this context is the performance and image quality of the legally marketed predicate device (Xplorer 1800). The ImaSight 4600's "truth" is its ability to produce equivalent images and performance characteristics.
8. The Sample Size for the Training Set
This information is not applicable as the ImaSight 4600 is a digital imaging sensor, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
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Image /page/0/Picture/0 description: The image shows the text "ImaSight GET CLEAR" in a stylized font. The word "ImaSight" is in a larger font size than "GET CLEAR". There is a line above the word "ImaSight". The text is black and the background is white.
AUG 2 5 2009
510K SUBMISSION - ABBREVIATED - SUMMARY 2.
- Device type and name: ImaSight 4600 Digital Radiographic Sensor 1.
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- Submitter
ImaSight Inc. 10-925 de la Carrière Blvd. Gatineau, Quebec Canada J8Y 6W5
Contact person:
Jean Caseault President Tel: (613) 266-4872 Fax: (613) 822-5195 e-mail: ¡caseault@imasight.com
August 11, 2009 Date prepared:
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- Device name: ImaSight 4600 Digital Radiography Sensor
- Device classification: Class II, 892.1680 (KPR) র্বা
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- Product Code: 90MQB
- e. Basis for the submission: New device
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- Predicate device: Xplorer 1800 Digital Radiographic System (K063247)
- The ImaSight 4600 is a digital radiographic sensor which 8. Device description: automatically collects x-ray images from an x-ray source. The ImaSight 4600 sensor collects x-rays and converts them into a computer images for display on a computer. The sensor does not have an x-ray source, which is provided by independent manufacturers. The sensor comes with an acquisition box and a computer, which holds the display and processing software.
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- Indications for use: The ImaSight 4600 is intended for use by a qualified doctor or technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the patients. The Imasight 4600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. The ImaSight 4600 is not intended for mammography.
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FDA Premarket Notification (510k) Submission
22 50 7
Image /page/1/Picture/1 description: The image shows the word "ImaSight" in a stylized font. Below the word "ImaSight" are the words "GET CLEAR" in a smaller, sans-serif font. There is a line above the word "ImaSight".
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- Comparison with predicate device: Based on performance tests, the ImaSight 4600 is substantially equivalent to the Xplorer 1800. The ImaSight 4600 produces images of similar quality and performance characteristics that are equivalent to those of the Xplorer 1800. Both systems use the same 16-megapixel CCD imaging sensor technology.
- tests: The sensor has been evaluated for performance, a. Non-clinical biocompatibility, effectiveness, thermal, electrical and mechanical safety and is substantially equivalent to the predicate device. The design, development and production of the sensor conforms to 892.1680, ISO 9001 and ISO 13485 quality systems.
- Clinical tests: A set of images have been submitted along with the equivalent ﺗﻘ images from the predicate device.
- Conclusion: the device was evaluated against the predicate device (Xplorer ﻥ 1800) and was found to be substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
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
Imasight, Inc. % Mr. Daniel W. Lehtonen Sr. Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 TWINSBURG OH 44087
AUG 2 5 2009
Re: K092307
Trade/Device Name: Imasight 4600 Digital Radiography Sensor Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: KPR Dated: July 29, 2009 Received: July 30, 2009
Dear Mr. Lehtonen:
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 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 (OS) 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/cdrl/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.
Sincerely yours,
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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Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
. ImaSight 4600
The ImaSight 4600 is intended for use by a qualified doctor or technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the patients. The ImaSight 4600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. The ImaSight 4600 is not intended for mammography.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Ove r-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Loaitha 2thaz
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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 radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.