(32 days)
The X3C 2200 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 can be performed with patient sitting, standing or lying in the prone or supine positions.
The X3C 2200 (510k submission device) is not intended for mammography.
The X3C 2200 is a modification to Xplorer 2200 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 2200 system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 2200 system is manufactured by Imaging Dynamics.
This 510(k) submission, K071401, for the X3C 2200 Digital Radiographic System, explicitly states: "No clinical tests conducted." This means that there is no study described in the provided text that proves the device meets specific acceptance criteria based on clinical performance.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Xplorer 2200, K063039) through non-clinical tests. The acceptance criteria and "device performance" in this context refer to the device's ability to meet safety, effectiveness, and performance requirements comparable to the predicate device through non-clinical evaluations.
Therefore, the requested information elements related to clinical studies, such as sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details, are not applicable or not available from the provided text for this specific submission because no clinical studies were performed.
Here's an attempt to answer the questions based on the available information regarding substantial equivalence and non-clinical testing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (based on substantial equivalence to predicate) | Reported Device Performance (via non-clinical tests) |
|---|---|
| Performance: Device functions as intended without adverse impact due to detector change from predicate. | Evaluated for performance and found substantially equivalent to predicate device. |
| Biocompatibility: Materials in contact with patient are biocompatible. | Evaluated for biocompatibility and found substantially equivalent to predicate device. |
| Effectiveness: Device effectively captures diagnostic radiographic exposures similar to predicate. | Evaluated for effectiveness and found substantially equivalent to predicate device. |
| Thermal Safety: Operates within safe temperature limits. | Evaluated for thermal safety and found substantially equivalent to predicate device. |
| Electrical Safety: Meets electrical safety standards. | Evaluated for electrical safety and found substantially equivalent to predicate device. |
| Mechanical Safety: Mechanically sound and safe for operation. | Evaluated for mechanical safety and found substantially equivalent to predicate device. |
| Intended Use: Matches the predicate device's intended use (diagnostic radiography excluding mammography for adult and pediatric patients). | Device has the same intended use as the predicate device. |
| Manufacturing Quality Systems: Conforms to relevant quality standards. | Manufacturer conforms to 21 CFR part 820, ISO 9001 and ISO 13485 quality systems. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set or patient data was used as "No clinical tests conducted." The evaluation was based on non-clinical performance, safety, and effectiveness testing of the device itself, likely comparing its specifications and outputs to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. As no clinical tests were conducted, there was no "test set" requiring ground truth established by medical experts in this submission. The "ground truth" for substantial equivalence was based on meeting engineering and safety standards, and performance specifications benchmarked against the predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication was used.
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 applicable. This device is a digital radiographic system, not an AI-assisted diagnostic tool. Furthermore, no clinical studies (including MRMC) were conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This submission is for a digital radiographic system hardware, not a standalone algorithm. Also, no clinical studies were performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for evaluating this device's substantial equivalence in non-clinical testing would have been based on engineering specifications, performance metrics (e.g., image quality parameters, dose measurements), safety standards (electrical, thermal, mechanical), and biocompatibility testing results, all compared against the established characteristics of the predicate device. It represents verification against technical and regulatory benchmarks, not clinical disease states.
8. The sample size for the training set
- Not applicable. As this device is a hardware system and "No clinical tests conducted," there was no "training set" of data in the context of an AI/ML algorithm being developed or assessed.
9. How the ground truth for the training set was established
- Not applicable. There was no training set for this device.
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Special 510k Submission X3C 2200 Digital Radiographic System
510k Summary
| 1. Submitter: | Imaging Dynamics Company LtdSuite 151, Pegasus Way NECalgary, AB,Canada T2E 8M5 | JUN 2 2 2007 | ||
|---|---|---|---|---|
| Contact person: | Shirantha SamarappuliManager - Regulatory AffairsTel: 403 251 9939; Fax: 403 251 1771 | |||
| Date Prepared: | May 14, 2007 | |||
| 2. Device Name: | X3C 2200 Digital Radiographic System, | |||
| 3. Device Classification: | Class II, 892.1680 (KPR), 892.1630 (MQB), | |||
| 4. Predicate Device: | Xplorer 2200 Digital Radiographic System, (K063039) |
-
- Device Description: The X3C 2200 is a modification to Xplorer 2200 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 2200 system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 2200 system is manufactured by Imaging Dynamics.
-
- Indications for Use: The X3C 2200 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 2200 (510k submission device) is not intended for mammography,
- Comparison with predicate device: The X3C 2200 is substantially equivalent to the currently 7. marketed Xplorer 2200. X3C 2200 device does not alter the fundamental scientific technology from Xplorer 2200 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 2200 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 2200 -K063039) for all performance, safety & effectiveness requirements and found as substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Shirantha Samarappuli Manager - Regulatory Affairs Imaging Dynamics Company Ltd 151, 2340 Pegasus Way NE Calgary, Alberta, T2E 8M5 CANADA
JUN 2 2 2007
Re: K071401
Trade/Device Name: X3C 2200 Digital Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MQB Dated: May 18, 2007 Received: May 21, 2007
Dear Ms. Samarappuli:
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 (Premarket Approval), it may be subject to such 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.
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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510k Submission X3C 2200 Digital Radiographic System
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: X3C 2200 digital radiographic system
Indications for Use:
The X3C 2200 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 can be performed with patient sitting, standing or lying in the prone or supine positions.
The X3C 2200 (510k submission device) is not intended for mammography.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Nancy Shoglon | ||
| (Division Sign-Off) | ||
| Division of Reproductive, Abdominal, and Radiological Devices | ||
| 510(k) Number | K071401 | |
| Prescription Use(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use(21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
§ 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.