(44 days)
The SynePix 4600 is Thallium-doped Cesium Iodide and amorphous Silicon (a-Si) Digital Radiography (DR) detector intended for use by a qualified/trained doctor or technician and is designed to generate radiographic images of human anatomy. If is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
The detector will be used with Analogic AN6255 and AN6265 (SyneRad Omni and SyneRad Omni RT) Systems. The AN6255 has a single tall stand and single detector, the AN6265 is a dual detector system with a tall stand and short stand.
The detector is not for use for mammography.
The SynePix 4600 is a 17 inch by 17 inch digital detector. It is intended to convert Xrays into electrical signals to create usable images for diagnostic use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Analogic Corporation SynePix 4600 Detector:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the SynePix 4600 Detector. Instead, it relies on a comparison to a predicate device.
Acceptance Criteria (Implied): Substantial equivalence to the legally marketed predicate device (Kodak DirectView DR System Detector, K051483) in terms of technological characteristics and performance.
| Acceptance Criteria (Implied from Predicate Equivalence) | Reported Device Performance (SynePix 4600 Detector) |
|---|---|
| Same technological characteristics as predicate device | "The design of the SynePix 4600 Detector has the same technological characteristics as the predicate device." |
| Performance substantially equivalent to predicate device | "The testing of the SynePix 4600 Detector demonstrates that the performance is substantially equivalent to the predicate device cited above." |
2. Sample Size for the Test Set and Data Provenance
The provided text does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The claim of substantial equivalence is made based on "testing," but details of this testing are absent.
3. Number of Experts and Qualifications for Ground Truth Establishment
The provided text does not mention the number or qualifications of experts used to establish ground truth for any test set. Given the nature of a 510(k) submission primarily focused on substantial equivalence based on technological characteristics and non-clinical testing, explicit details about clinical expert reviews for ground truth are often not included unless a specific clinical study with human review is part of the submission.
4. Adjudication Method for the Test Set
The provided text does not specify an adjudication method for any test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance. This device is a digital radiography detector, not an AI-powered diagnostic tool, so such a study would not typically be part of its clearance.
6. Standalone (Algorithm Only) Performance Study
The provided text does not describe a standalone (algorithm only) performance study. This device is hardware (a detector) that produces images, not an algorithm that performs interpretations.
7. Type of Ground Truth Used
The provided text does not explicitly state the type of ground truth used. Given that the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, it's highly probable that the "ground truth" would be based on technical performance metrics derived from phantom studies, physics measurements, and comparisons of image quality against the predicate device, rather than clinical outcomes or pathology.
8. Sample Size for the Training Set
The provided text does not mention a training set sample size. As a digital detector (hardware), rather than an AI/ML algorithm requiring training, the concept of a "training set" in the context of machine learning does not apply here.
9. How Ground Truth for the Training Set Was Established
Since the device is a digital detector and not an AI/ML algorithm, the concept of a "training set" with established ground truth is not applicable to this submission.
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14 510(K) SUMMARY
510(k) Summary For Analogic Corporation SynePix 4600 Detector MAY - 9 2007
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92
1. Submitter's Name and Address:
Analogic Corporation 8 Centennial Drive Peabody, MA, 01960
2. Date this Summary was Prepared:
March 23, 2007
3. Submission Correspondent:
Donald J Sherratt Director of Corporate Regulatory Affairs Analogic Corporation 8 Centennial Drive Peabody MA 01960 Telephone ( 978 ) 977-3000 extension 4075 Facsimile ( 978 ) 977-6808
4. Device Name:
| Proprietary or Trade Name: | SynePix 4600 Detector |
|---|---|
| Common Name: | Solid State X-Ray Imager (Flat Panel / DigitalImager) |
| Classification Name: | Solid State X-Ray Imager |
| Classification Panel: | Radiology |
| Code of Federal Regulations: | 892.1650 |
| Product Code: | MQB |
ട. Predicate Devices:
The legally marketed device to which equivalence is being claimed is:
Kodak DirectView DR System Detector marketed by Eastman Kodak Company and cleared under K051483.
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6. Device Description
The SynePix 4600 is a 17 inch by 17 inch digital detector. It is intended to convert Xrays into electrical signals to create usable images for diagnostic use. The dimensions of the SynePix 4600 are below:
| Overall length | 488 mm |
|---|---|
| Overall width | 533 mm |
| Overall thickness | 45 mm |
| Weight | 18 kg |
Table 14: SynePix 4600 Dimensions
7. Intended Use
The SynePix 4600 is Thallium-doped Cesium Iodide and amorphous Silicon (a-Si) Digital Radiography (DR) detector intended for use by a qualified/trained doctor or technician and is designed to generate radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
8. Comparison of Technological Characteristics:
The design of the SynePix 4600 Detector has the same technological characteristics as the predicate device.
9. Conclusions from Non-clinical Testing
The testing of the SynePix 4600 Detector demonstrates that the performance is substantially equivalent to the predicate device cited above.
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Image /page/2/Picture/0 description: The image shows the logo of the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three people in profile, and the text "DEPARTMENT OF" is written to the right of the figure. The text is in a bold, sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Donald J. Sherratt Director of Corporate Regulatory Affairs ANALOGIC Corporation 8 Centennial Drive Centennial Industrial Park PEABODY MA 01960
AUG 23 2013
Re: K070829
Trade/Device Name: SynePix 4600 Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: March 23, 2007 Received: March 26, 2007
Dear Mr. Sherratt:
This letter corrects our substantially equivalent letter of May 9, 2007.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rollowed your be 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 r ou may, are corey mixes 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 11 your device is existing major regulations affecting your device can be found in Title 21, additional condors. Extrails images 1954. 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 that I Dr may Intact a and regulations administered by other Federal agencies. You must or any 1 vith 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 nredicate 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 11 you docure spotsion and conce 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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Image /page/4/Picture/0 description: The image shows the word "ANALOGIC" in bold, black letters. The letters are sans-serif and appear to be a custom font. A registered trademark symbol is located to the lower right of the letter "C". A black rectangle is located to the right of the word.
510(k) Number Ko70829 :
Device Name: SynePix 4600 Detector
Indications For Use:
The SynePix 4600 is Thallium-doped Cesium Iodide and amorphous Silicon (a-Si) Digital Radiography (DR) detector intended for use by a qualified/trained doctor or technician and is designed to generate radiographic images of human anatomy. If is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
The detector will be used with Analogic AN6255 and AN6265 (SyneRad Omni and SyneRad Omni RT) Systems. The AN6255 has a single tall stand and single detector, the AN6265 is a dual detector system with a tall stand and short stand.
The detector is not for use for mammography.
Prescription Use X
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070829
Analogic Corporation SynePix 4600 Detector 510(k)
March 23, 2007 Page 10 of 43
§ 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.