(18 days)
The "Easy Moving"M" Mobile X-ray Unit (Model SM-HF) 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.
The "Easy Moving"M" Mobile X-ray Unit (Model SM-HF)" is a mobile unit which operates from 120 V 50-60~ AC or batteries. It is easy to operate and permits a swift radiographic procedure, a feature which applies to all conventional exposure techniques on all parts of the body. The system is composed of a base unit housing the high voltage generator and controls and a turnable arm with rotatable tube head. It allows one to take exposures of patients in standing, sitting or laying position. Owing to its compact design "Easy Moving™™ Mobile X-ray Unit is a low-cost radiography system which takes up little space and is quick to set up and operate.
The provided text describes a 510(k) premarket notification for a mobile X-ray unit. Rather than detailing acceptance criteria and a study proving the device meets them in the traditional sense of a clinical trial with performance metrics, this submission is focused on demonstrating substantial equivalence to a predicate device.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission doesn't present a table of acceptance criteria in terms of specific performance thresholds for diagnostic accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly defined by the characteristics and performance of the predicate device, the IROM IMAGING, INC MXR-2000 MOBILE X-RAY UNIT (K010304). The "performance" of the new device is its similarity to the predicate.
| Characteristic | Acceptance Criteria (Predicate Device K010304) | Reported Device Performance (Easy Moving™ Mobile X-Ray System) |
|---|---|---|
| Intended Use | 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. | SAME |
| Performance Standard | 21 CFR 1020.30 | SAME |
| Electrical Safety | Electrical Safety per Underwriters Laboratories Standard UL-2601 (IEC-60601) and IEC 60601, Underwriters Laboratories Standard UL187: UL Standard for Safety for X-Ray Equipment. | SAME, plus EMC: IEC 60601-1-2 |
| Safety and Effectiveness | Bench and user testing indicates that the predicate device is safe and effective. | Bench and user testing indicates that the new device is as safe and effective as the predicate devices. |
The core acceptance criterion is that the new device is "as safe and effective" and "substantially equivalent" to the predicate device. The performance is reported as meeting or exceeding these equivalency standards for the specified characteristics.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench and user testing" but does not specify a sample size for either. There is no information provided regarding data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Given the nature of a substantial equivalence claim for an X-ray unit, the "ground truth" for comparative effectiveness would likely involve expert evaluation of image quality or overall clinical utility, but no details are given.
4. Adjudication Method for the Test Set
The adjudication method is not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of an MRMC comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. This submission pertains to an X-ray hardware device, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable/not provided. The device is an X-ray unit, not an algorithm. Therefore, a standalone algorithm performance study was not conducted or reported.
7. Type of Ground Truth Used
The type of "ground truth" used for evaluation is not explicitly stated. However, considering "bench and user testing" was performed, the ground truth would likely be based on:
- Technical specifications conformance: Ensuring the device meets relevant electrical and radiation safety standards (e.g., 21 CFR 1020.30, UL standards, IEC standards).
- Qualitative assessment of image quality: During "user testing," qualified personnel (doctors or technicians) would evaluate the diagnostic quality of images produced by the new device in comparison to images from the predicate device. This would implicitly form the "ground truth" for functionality and diagnostic utility.
8. Sample Size for the Training Set
This information is not applicable/not provided. The submission is for a medical device (X-ray unit), not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided as there is no training set for an algorithm.
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EXHIBIT 2
SEDECAL SA Pelava 9- Poligono Industrial Rio De Janeiro 28110 -Algete Madrid Spain Tel (34) 91-628 0544/91-628 1592 Fax (34) 91-628 0574 (Foreign Manufacturer)
SEDECAL USA, Inc. 2910 N. Arlington Heights Rd. Arlington Heights Illinois 60006 Tel 847-394-6960 Fax 847-394-6966 (Initial Importer)
August 8, 2001
Contact: Gary Fromberg, Official Correspondent 510(k) Summary of Safety and Effectiveness
- Identification of the Device: Proprietary-Trade Name: "Easy Moving™" Mobile X-ray Unit (Model SM-HF) Classification Name: X-Ray, Mobile, Product Code 90 IZL Common/Usual Name: Stationary X-Ray System
- Equivalent legally marketed devices This product is similar in function to the 2. IROM IMAGING, INC MXR-2000 MOBILE X-RAY UNIT K010304
- Indications for Use (intended use) The "Easy Moving™™ Mobile X-ray Unit 3. (Model SM-HF) 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: The "Easy Moving"M" Mobile X-ray Unit (Model SM-HF)" is a mobile unit which operates from 120 V 50-60~ AC or batteries. It is easy to operate and permits a swift radiographic procedure, a feature which applies to all conventional exposure techniques on all parts of the body. The system is composed of a base unit housing the high voltage generator and controls and a turnable arm with rotatable tube head. It allows one to take exposures of patients in standing, sitting or laying position. Owing to its compact design "Easy Moving™™ Mobile X-ray Unit is a low-cost radiography system which takes up little space and is quick to set up and operate.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.
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| Characteristic | IROM IMAGING, INC | "Easy Moving TM, |
|---|---|---|
| MXR-2000 MOBILE | Mobile X-Ray | |
| X-RAY UNIT | System | |
| K010304 | ||
| Intended Use: | Intended for use by a | SAME |
| 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. | ||
| Performance | 21 CFR 1020.30 | SAME |
| Standard | ||
| Electrical safety | Electrical Safety per | SAME, plus EMC: |
| Underwriters Laboratories | IEC 60601-1-2 | |
| Standard UL-2601(IEC- | ||
| 60601) and IEC 60601, | ||
| Underwriters Laboratories | ||
| Standard UL187: UL | ||
| Standard for Safety for X- | ||
| Ray Equipment, |
6. Substantial Equivalence Chart, "Easy Moving™M» Mobile X-Ray System
7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of Sedecal USA that the "Easy Moving"M" Mobile X-ray Unit is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human figures, representing the department's focus on people and their well-being. The figures are depicted in a flowing, abstract manner, suggesting movement and progress.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEDECAL USA, Inc. % Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015 Re: K012663
AUG 31 2001
Easy Moving™ Mobil X-ray Unit (Model SM-HF) (Mobil X-ray System) Dated: August 9, 2001 Received: August 13, 2001 Regulatory Class: II 21 CFR 892.1720/Procode: 90 IZL
Dear Mr. Kamm:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have are in in internets we have revelved your Section 10(k) noticallor of mine and to legally marketed predicate devices marketed in interstate substantally equivalint (ifo the much to the Medical Device Amendments, or to devices that have been chat the device which a favisa which a favisa which a favisa which a favi commerce proble to May 28, 1970, the Chatinen and Cosmetic Act (Act). You may, thecesses market the device, subject to accordatics with the provisions of the Poc, Drag, and Cosmosions of the Act include requirements for annual registration, the genefal controls provisions of the Are. "The general some of thisbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such If your device is cassilied (see above) microsal States (epostal Senately found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent directing your compliance with the Current Good Manufacturing Procice requirements, 800 to 83. A substantiany equivalion (esommation assumination (21 CFR Part 820) and that, through periodic as set official in the Quality System Regulation (QS) to Medical Derrols. Failure to comply with the CMP regulation may QS Inspections, the Food allo Drug Aummistian (1 Dr.) verry sear essenting your device in the Federal Register. Please of Alternato result in Egulatory actubli. In addition submission does not affect any obligation you might have under sections 531 through note. this response to your promation sation. Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of thus of I fills tetler will and w you to begally marked 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:
(301) 594-4591 8xx.1xxx (301) 594-4616 876.2xxx, 3xxx, 4xxx, 5xxx (301) 594-4616 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx (301) 594-4654 892.2xxx, 3xxx, 4,xxx, 5xxx (301) - 594-4692 Other
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general Also, pease note the regulation childer, "Hisolanding by reserved to promotive of Small Manufacturers, International and mornation on your responsible (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications For Use:
Indications for Use (intended use) The "Easy Moving"M" Mobile X-ray Unit (Model SM-HF) 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Nancy C Brogdon | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | 4/1266.3 |
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
510(k) Number ..
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.