(32 days)
This radiographic system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
This diagnostic x-ray system consists of a tubehead/collimator assembly mounted on a ceiling suspension along with a generator, generator control, and an elevating x-ray table. Power ratings for the available generators are in the rage of 32 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 -100 mA. Exposure time is 1 ms - 10 s.
This 510(k) submission describes a diagnostic X-ray system and does not involve Artificial Intelligence (AI) or machine learning. Therefore, many of the requested criteria, such as those related to AI performance, sample sizes for training/test sets in an AI context, expert ground truth establishment for AI, MRMC studies for AI, or standalone AI performance, are not applicable to this document.
The acceptance criteria and "device performance" described in this document relate to the substantial equivalence of the new device (RADVISION ET) to a predicate device (RADVISION E and RADVISION EU) based on safety and effectiveness.
Here's the information that can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria here are implicitly met if the new device is deemed "substantially equivalent" to the predicate device. The performance is compared based on functional and safety characteristics.
| Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (RADVISION ET) |
|---|---|---|
| Intended Use | Intended for diagnostic radiographic exposures of skull, spinal column, chest, abdomen, extremities, and other body parts on adult and pediatric subjects, with patient sitting, standing, or lying in prone/supine position. | SAME (substantially equivalent) |
| Configuration | Column mount | Ceiling suspension (Technological difference, deemed not to raise new safety/effectiveness questions) |
| Performance Standard | 21 CFR 1020.30 | SAME (substantially equivalent) |
| Generator | High frequency generator made by Sedecal | Uses same generator made by Sedecal (substantially equivalent) |
| Electrical Safety | Electrical Safety per IEC-60601, UL listed | SAME (substantially equivalent) |
The "study that proves the device meets the acceptance criteria" is described as:
- "The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices."
- "After analyzing bench and external laboratory testing to applicable standards, it is the conclusion of Almana Medical Imaging that the RADVISION ET Diagnostic X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission references "bench and test laboratory" studies without specifying sample sizes for physical testing.
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)
This is not applicable as this is a traditional medical device submission, not an AI/ML submission requiring expert ground truth for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as this is a traditional medical device submission.
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
This is not applicable as this is a traditional medical device submission, not involving AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is a traditional medical device submission, not involving an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the safety and effectiveness of the predicate device, established through its existing legal marketing and compliance with standards. The new device is compared to this established benchmark through technical specifications and bench/laboratory testing. There's no specific "ground truth" for diagnostic accuracy in the way it's used for AI algorithms.
8. The sample size for the training set
This is not applicable as this is a traditional medical device submission, not an AI/ML submission.
9. How the ground truth for the training set was established
This is not applicable as this is a traditional medical device submission, not an AI/ML submission.
{0}------------------------------------------------
510(k) Summary 510(k) Number KO82064 Almana Medical Imaging P.O. Box 3568 Alkhobar 31952 Kingdom of Saudi Arabia T: +966 3 8679400 F: +966 3 8962421 Date Prepared: July 14, 2008 Mohammed Irfanullah Farooqui, Sales and Marketing Manager Contact:
-
- Identification of the Device: Proprietary-Trade Name: RADVISION ET Diagnostic X-Ray Systems Classification Name: Stationary x-ray system, Product Code 90 KPR Common/Usual Name: Stationary Diagnostic X-Ray
- Equivalent legally marketed device: RADVISION E and RADVISION EU Diagnostic X-Ray 2. Systems, K072659.
-
- Indications for Use (intended use) This radiographic system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
-
- Description of the Device: This diagnostic x-ray system consists of a tubehead/collimator assembly mounted on a ceiling suspension along with a generator, generator control, and an elevating x-ray table. Power ratings for the available generators are in the rage of 32 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 -100 mA. Exposure time is 1 ms - 10 s.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices. Rad Vision E Rad Vision eu RADVISION ET
Image /page/0/Figure/7 description: The image shows three different X-ray machines. The machine on the left has a horizontal table with a vertical X-ray tube above it. The machine in the center has a similar table, but the X-ray tube is mounted on a vertical column. The machine on the right is a more modern version of the X-ray machine, with a digital display.
{1}------------------------------------------------
6. Substantial Equivalence Chart
| Characteristic | RADVISION E andRADVISION EUK072659 | RADVISION ET |
|---|---|---|
| Intended Use: | Intended for use by aqualified/trained doctoror technician on bothadult and pediatricsubjects for takingdiagnostic radiographicexposures of the skull,spinal column, chest,abdomen, extremities,and other body parts.Applications can beperformed with thepatient sitting, standing,or lying in the prone orsupine position. | SAME |
| Configuration | Column mount | Ceiling suspension |
| PerformanceStandard | 21 CFR 1020.30 | SAME |
| Generator | High frequency madeby Sedecal | Uses same generatormade by Sedecal |
| Electrical safety | Electrical Safety perIEC-60601. UL listed | SAME |
7. Conclusion
After analyzing bench and external laboratory testing to applicable standards, it is the conclusion of Almana Medical Imaging that the RADVISION ET Diagnostic X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2008
Almana Medical Imaging % Mr. Daniel Kamm, P.E. Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015
Re: K082064
Trade/Device Name: RADVISION ET Diagnostic X-Ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: July 15, 2008 Received: July 23, 2008
Dear Mr. Kamm:
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 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.
{3}------------------------------------------------
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K082064
Device Name: RADVISION ET Diagnostic X-Ray System
Indications For Use:
This Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Arzu Tan Wh
(Division Sign Off)
(Divis Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __
Page 15 of 1258
§ 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.