(15 days)
The AMX5 and AMX5D are indicated for use in generating radiographic images of human anatomy in all general purpose X-ray diagnostic procedures. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, pediatrics, orthopedics, and clinics.
The AMX5 is a power driven mobile unit including an X-ray generator, X-ray tube, and beam limiting device, along with control electronics for the drive mechanism, and embedded software. The AMX5D is the same as the AMX5 but is used in conjunction with a portable digital X-ray detector.
The provided 510(k) summary for the AMX5 and AMX5D Mobile X-ray Systems states that "Clinical Tests: None required." These devices are considered substantially equivalent to the predicate device (AMX4 Plus Mobile X-ray system, K021016) based on comparable technological characteristics, safety, and effectiveness. Therefore, the information requested regarding acceptance criteria and studies to prove meeting them, in the typical sense of a new technology demonstrating diagnostic performance, is not applicable in this case.
Instead, the submission focuses on demonstrating equivalence through:
- Safety Standards: The devices were "evaluated for electrical, mechanical, and radiation safety, and conforms with applicable medical device safety standards." Compliance was verified through independent evaluation with factory surveillance.
- Intended Use and Technology Comparison: The AMX5 and AMX5D have the "same intended uses; incorporate the same technology; and use similar design, construction, materials, and features as the legally marketed AMX 4 Plus Mobile X-ray system."
Since no clinical studies were deemed necessary, there is no information available within the provided text for the following:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- Multi reader multi case (MRMC) comparative effectiveness study
- Standalone (i.e. algorithm only without human-in-the-loop performance) study
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
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510(k): AMX5 and AMX 5D GE Healthcare September 13, 2004
NOV - 2 2004
GE Healthcare
Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
| Submitter: | GE Medical Systems |
|---|---|
| PO Box 414Milwaukee, WI 53201 | |
| Contact Person: | D. DuerstelerSafety and Regulatory EngineeringTelephone: 262-312-7029; Fax: 262-312-7144 |
| Date Prepared: | September 13, 2004 |
| Device Name: | AMX5 and AMX 5D Mobile X-ray SystemsMobile X-ray System, 21CFR892.1720 (90IZL) |
| Marketed Device: | AMX4 Plus Mobile X-ray system described in 510(k) No. K021016, currently in |
commercial distribution.
Device Description: The AMX5 is a power driven mobile unit including an X-ray generator, X-ray tube, and beam limiting device, along with control electronics for the drive mechanism, and embedded software. The AMX5D is the same as the AMX5 but is used in conjunction with a portable digital X-ray detector.
Indications for Use: The AMX5D are indicated for use in generating radiographic images of human anatomy in all general purpose X-ray diagnostic procedures. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, pediatrics, orthopedics, and clinics.
Comparison with Predicate Device: The AMX5 and AMX5D are of a comparable type and substantially equivalent to the currently marketed AMX4 Plus Mobile X-ray system. They have the same technological characteristics and are comparable in key safety and effectiveness features. They use the same basic design, construction, and materials, and have the same intended uses as the predicate device.
Summary of Studies: The device has been evaluated for electrical, mechanical, and radiation safety, and conforms with applicable medical device safety standards.
Clinical Tests: None required.
Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA quidelines, and established methods of patient examination. The AMX5 and AMX5D have the same intended uses; incorporate the same technology; and use similar design, construction, materials, and features as the legally marketed AMX 4 Plus Mobile X-ray system. The devices conform to applicable medical device safety standards and compliance is verified through independent evaluation with factory surveillance. Therefore, it is the opinion of GE Medical Systems that the AMX5D Mobile X-ray Systems are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three lines extending from the head, representing growth and development.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 2 2004
GE Healthcare Technologies % Mr. Tamas Borsai Division Manager, Medical Division, and Program Manager, Third Party Review Program TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K042866
Trade/Device Name: AMX5 and AMX5D Mobile X-ray Systems Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: 90 IZL Dated: October 14, 2004 Received: October 18, 2004
Dear Mr. Borsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your betermined the 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 rear 20, 1710, the clarent 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 do increative approvisions of the Act. The general controls provisions of the Act as not to the regurements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
ff 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 Applo rary, it 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.
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 I carat statues and roganding, but not limited to registration and listing (21 CFR Part 807); labeling (2) CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 Cr Fe r at 00 75, Bart 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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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.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" (21 CFR 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 (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
Enclosure
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510(k): AMX5 and AMX 5D GE Healthcare September 13, 2004
STATEMENT OF INDICATIONS FOR USE
): K042866
510(k) Number (if known):
Device Name: AMX5 and AMX5D Mobile X-ray Systems
Indications for Use
The AMX5 and AMX5D are indicated for use in generating radiographic images of human anatomy The AMAS and AMAOD are indication forcedures. It may be used in radiology departments, In all general purpose X ray didgite its prooms, pediatrics, orthopedics, and clinics.
(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 Over-The-Counter Use_______________________________________________________________________________________________________________________________________________________
Nancy C. Gordon
(Division Sign-C Division of Reproductive, Abdo and Radiological Devices 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.