(23 days)
The X3C 1100 motorized patient table with digital radiographic detector (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe 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, lying in the prone or supine positions.
The X3C 1100 (510k submission device) is not intended for mammography.
The X3C 1100 is a modification to Xplorer 1100 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 1100 system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 1100 system is manufactured by Imaging Dynamics.
This submission (K071408) is for a X3C 1100 motorized patient table with digital radiographic detector. This device is a modification of an existing device, where the digital radiographic detector component has been updated.
The key takeaway is that no clinical studies were conducted for this 510(k) submission. The manufacturer relied on non-clinical tests and demonstrating substantial equivalence to a predicate device (Xplorer 1100, K062417) to meet acceptance criteria.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Description | Reported Device Performance |
|---|---|---|
| Performance | The device's operational capabilities (e.g., image quality, functionality) | Evaluated through non-clinical tests; found to be substantially equivalent to the predicate device. |
| Biocompatibility | Assessment of potential biological risks associated with material contact. | Evaluated through non-clinical tests; found to be substantially equivalent to the predicate device. |
| Effectiveness | The device's ability to achieve its intended diagnostic purpose. | Evaluated through non-clinical tests; found to be substantially equivalent to the predicate device. |
| Thermal Safety | Evaluation of potential thermal hazards. | Evaluated through non-clinical tests; found to be substantially equivalent to the predicate device. |
| Electrical Safety | Evaluation of potential electrical hazards. | Evaluated through non-clinical tests; found to be substantially equivalent to the predicate device. |
| Mechanical Safety | Evaluation of potential mechanical hazards. | Evaluated through non-clinical tests; found to be substantially equivalent to the predicate device. |
| Quality Systems | Compliance with regulatory standards for design and manufacturing. | Conforms to 21 CFR part 820, ISO 9001 and ISO 13485 quality systems. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set was used for this submission. The evaluation was based on non-clinical tests and comparison to a predicate device.
- Data Provenance: Not applicable for clinical data. Non-clinical test data provenance is not specified beyond being generated by Imaging Dynamics Company Ltd.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No clinical test set requiring expert ground truth establishment was conducted for this submission.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication was conducted for this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. The submission explicitly states: "Clinical tests: No clinical tests conducted."
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a digital radiographic detector integrated into an X-ray system, not a standalone algorithm. Also, no clinical studies were performed.
7. Type of Ground Truth Used
- Not applicable for clinical studies. For the non-clinical tests, the "ground truth" would be established by engineering specifications, regulatory standards, and performance against the predicate device through direct comparison testing.
8. Sample Size for the Training Set
- Not applicable. This device does not appear to involve AI/ML requiring a training set in the context of this submission. The evaluation was primarily engineering-based and comparison to a predicate device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set was used.
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Special 510k Submission X3C 1100 motorized patient table with digital radiographic detector
510k Summary
| 1. Submitter: | Imaging Dynamics Company LtdSuite 151, Pegasus Way NECalgary, AB,Canada T2E 8M5 |
|---|---|
| Contact person: | Shirantha SamarappuliManager - Regulatory AffairsTel: 403 251 9939; Fax: 403 251 1771 |
| Date Prepared: | May 14, 2007 |
JUN 13 2007
| 2. Device Name: | X3C 1100 motorized patient table with digital radiographic detector |
|---|---|
| 3. Device Classification: | Class II, 892.1980 (IZZ), 892.1630 (MQB), |
| 4. Predicate Device: | Xplorer 1100 motorized patient table with digital radiographic detector(K062417) |
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- Device Description: The X3C 1100 is a modification to Xplorer 1100 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 1100 system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 1100 system is manufactured by Imaging Dynamics.
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- Indications for Use: The X3C 1100 motorized patient table with digital radiographic detector is integrated in to the user's stationary radiography system. The typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe 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, or lying in the prone or supine positions. The X3C 1100 (510k submission device) is not intended for mammography.
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- Comparison with predicate device: The X3C 1100 is substantially equivalent to the currently marketed Xplorer 1100. X3C 1100 device does not alter the fundamental scientific technology from Xplorer 1100 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 1100 has the same intended use as the predicate device.
- Non-clinical tests: The device has been evaluated for performance, biocompatibility and a. 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.
- ﻔ Clinical tests: No clinical tests conducted.
- Conclusion: The device was evaluated against the predicate device (Xplorer 1100 -C. K062417) 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 is a seal for the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three lines that appear to be a stylized representation of a bird or a human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Shirantha Samarappuli Manager-Regulatory Affairs Imaging Dynamics Company Ltd. 151, 2340 Pegasus Way NE Calgary, Alberta, T2E 8M5 CANADA
JUN 1 3 2007
Re: K071408
Trade/Device Name: X3C 1100 motorized patient table with digital radiographic detector Regulation Number: 21 CFR 8892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: May 18, 2007 Received: May 21, 2007
Dear Mr. 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 indiver use stated in the enclosure) to legally marketed predicate devices marketed in interstate commence 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 Cornetic Act (Act) that do not require approval of a premarket approval application (PMA), Your costi. therefore, market the device, subject to the general controls provisions of the Act. The graneral 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.
Image /page/1/Picture/10 description: The image shows a logo with the text "FDA Centennial" and the years "1906-2006" in a circular design. Below the logo, there is a cursive text that reads "Protecting and Promoting Public Health". The logo appears to be a commemorative emblem for the FDA's centennial anniversary. The text below emphasizes the organization's mission related to public health.
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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/cdrl/industry/support/index.11tm1.
Sincerely yours,
Nancy Chogdon
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 1100 motorized patient table with digital radiographic defector
Indications for Use
510(k) Number (if known): K071408
Device Name: X3C 1100 motorized patient table with digital radiographic detector
Indications for Use:
The X3C 1100 motorized patient table with digital radiographic detector (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe 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, lying in the prone or supine positions.
The X3C 1100 (510k submission device) is not intended for mammography.
Helent Leeman
(Division Sian-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
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.