(18 days)
The X3C 1600 PLUS is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. The X3C 1600 Plus (510k submission device) is not intended for mammography.
The X3C 1600 Plus is a modification to Xplorer 1600 Plus where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 1600 Plus system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 1600 Plus system is manufactured by Imaging Dynamics.
The provided text describes a 510(k) submission for the X3C 1600 Plus Digital Radiographic System. However, it explicitly states that no clinical tests were conducted for this device, and its substantial equivalence was determined based on non-clinical tests comparing it to a predicate device. Therefore, it is not possible to provide information on acceptance criteria and a study proving the device meets them, as no such study focusing on clinical performance was performed or referenced in this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Xplorer 1600 Plus) by replacing a detector, and relies on non-clinical tests (performance, biocompatibility, safety) to support this claim.
To address the specific points of your request based on the absence of clinical data in this submission:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified for clinical performance as no clinical study was conducted. Non-clinical acceptance criteria would likely relate to technical specifications, safety standards, and performance against the predicate device in areas like image quality metrics (e.g., DQE, MTF), and electrical/mechanical safety (e.g., IEC 60601). These specific criteria and their reported performance are not detailed in the provided text.
- Reported Device Performance: In terms of clinical performance, none reported as no clinical tests were conducted. The submission states, "The device has been evaluated for performance, biocompatibility and effectiveness as well as thermal, electrical and mechanical safety and has been found to substantially equivalent to predicate device." However, specific quantitative performance metrics are not given.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable for clinical tests as none were performed.
- Data Provenance: Not applicable for clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no clinical study with a test set requiring ground truth establishment by experts was conducted.
4. Adjudication method for the test set
- Not applicable as no clinical study with a test set requiring adjudication was conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not performed. This is a digital radiographic system, not an AI or CAD device. The submission explicitly states "No clinical tests conducted."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical imaging hardware system, not an algorithm being tested for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable as no clinical study requiring ground truth was conducted.
8. The sample size for the training set
- Not applicable as no clinical training set was used for an AI/CAD algorithm.
9. How the ground truth for the training set was established
- Not applicable as no clinical training set was used for an AI/CAD algorithm.
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Special 510k Submission X3C 1600 Plus Digital Radiographic System
510k Summary
| 1. | Submitter: | Imaging Dynamics Company LtdSuite 151, Pegasus Way NECalgary, AB,Canada T2E 8M5 | JUN - 8 2007 |
|---|---|---|---|
| Contact person: | Shirantha SamarappuliManager - Regulatory AffairsTel: 403 251 9939; Fax: 403 251 1771 | ||
| Date Prepared: | May 14, 2007 | ||
| 2. | Device Name: | X3C 1600 Plus Digital Radiographic System, | |
| 3. | Device Classification: | Class II, 892.1680 (KPR), 892.1630 (MQB), | |
| 4. | Predicate Device: | Xplorer 1600 Plus Digital Radiographic System (K062586) | |
| 5. | Device Description: | The X3C 1600 Plus is a modification to Xplorer 1600 Plus where theXplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) inXplorer 1600 Plus system is replaced with X3C digital radiographic detector, previously marketeddevice under K070079. The X3C 1600 Plus system is manufactured by Imaging Dynamics. |
- The X3C 1600 PLUS is intended for use by a qualified/trained doctor or Indications for Use: technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. The X3C 1600 Plus (510k submission device) is not intended for mammography.
-
- Comparison with predicate device: The X3C 1600 PLUS is substantially equivalent to the currently marketed Xplorer 1600 Plus. X3C 1600 Plus device does not alter the fundamental scientific technology from Xplorer 1600 Plus predicate device. The replacement of Xplorer 100 digital radiographic detector (K992955) with X3C digital radiographic detector (K070079) is the only significant change between the 2 devices. X3C 1600 Plus has the same intended use as the predicate device.
- a. Non-clinical tests: The device has been evaluated for performance, biocompatibility and effectiveness as well as thermal, electrical and mechanical safety and has been found to substantially equivalent to predicate device. The design and development process of the manufacturer conforms to 21 CFR part 820, ISO 9001 and ISO 13485 quality systems.
- b. Clinical tests: No clinical tests conducted.
- C. Conclusion: The device was evaluated against the predicate device (Xplorer 1600 Plus -K062586) for all performance, safety & effectiveness requirements and found as substantially equivalent to the predicate device.
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of two parts: a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is written in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Shirantha Samarappuli Manager-Regulatory Affairs Imaging Dynamics Company, Ltd. Suite 151, 2340 Pegasus Way NE CALGARY ALBERTA T2E 8M5 CANADA
AUG - 9 2013
Re: K071402
Trade/Device Name: X3C 1600 Plus Digital Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MQB Dated: May 18, 2007 Received: May 21, 2007
Dear Ms. Samarappuli:
This letter corrects our substantially equivalent letter of June 8, 2007.
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. Iisting 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 1 - 2 ·
1.1 Indications for Use
The U.S. Food and Drug Administration (FDA) requires the following statement to appear in this manual:
"The 1600 Plus is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts but not mammography. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions."
FDA 510(k) for the X4C 1600 Plus: K062586
FDA 510(k) for the X3C 1600 Plus: to be assigned by FDA
FDA 510(k) for the X3C Detector Head: K070079
- · The 1600 Plus digital radiography system is not to be used for mammography.
- · The 1600 Plus digital radiography system should only be operated in conjunction with specified medical x-ray equipment and by trained and licensed personnel.
- WARNING! Only certified and properly trained, authorized personnel should be permitted to take x-ray exposures. No practical design can incorporate complete protection for personnel who do not follow proper safety precautions.
- WARNING! The appropriate x-ray imaging exposure parameters should be consistent with established Federal and Provincial/State radiation protection practices and medical imaging standards in your institution.
Prescription Use
Herbert Hever
vision Sion-Off) ivision of Reproductive. Abdomina Radiological Devices 510(k) Number
Imaging Dynamics Company · PN: 902-0001-015 v1.0 · May 29, 2007
§ 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.