(30 days)
The ZIEHM QUANTUM series Mobile C-Arm is intended for use in both Radiographic and Fluoroscopic applications. It is suitable for a wide variety of surgical intervention or guidance procedures requiring X-ray imaging - both inside and outside the operating room. These procedures include Cerebral, Thoracic, Vascular, Biliary, Abdominal, Orthopaedic, Peripheral, Embolization, Stent Placement, Urological Special Vascular-I flow Procedures, and other related fluoroscopic examinations requiring interventional procedures.
The ZIEHM QUANTUM Mobile C-arms are also suitable as a back up for fixed-based X-ray Vascular and Intervention Procedures.
Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.
ZIEHM QUANTUM (Mobile x-ray system)
The provided document is a 510(k) premarket notification approval letter from the FDA for a mobile x-ray system (ZIEHM QUANTUM). This type of document generally approves a device based on its substantial equivalence to a predicate device and does not typically contain detailed information about specific acceptance criteria or comprehensive study designs with the level of detail requested in the prompt (e.g., sample sizes for training/test sets, expert qualifications, adjudication methods for ground truth, MRMC studies, standalone performance).
Therefore, based only on the provided text, it's not possible to describe the acceptance criteria and the study that proves the device meets those criteria with the requested level of detail. The document confirms the device's substantial equivalence to a predicate device for its stated indications for use, but it doesn't elaborate on the specific acceptance criteria or the specifics of studies conducted to demonstrate that equivalence.
The document only states the "Indications for Use" for the ZIEHM QUANTUM, which is a description of how the device is intended to be used, not a set of performance acceptance criteria. It also mentions "Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier," which is a functional description, not a performance metric.
Without more detailed study reports, an answer to your prompt cannot be fully generated from this document.
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Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font. The words are stacked on top of each other, with "Public" and "Health" on the first line and "Service" on the second line.
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MAY 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard Westrich VP Product Development and Regulatory Affairs Ziehm Imaging, Inc. 4181 Latham Street RIVERSIDE CA 92501
Re: K051064
Trade/Device Name: ZIEHM QUANTUM (Mobile x-ray system) Regulation Number: 21 CFR §892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: April 26, 2005 Received: April 26, 2005
Dear Mr. Westrich:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have rowled your coothe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the cholors, to e 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 do not require approvisions of the Act. The general controls provisions provisions of the Act de receiver to the general 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 n your av, it may be subject to such additional controls. Existing major regulations affecting your Apployally, it they of below to 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 I Rase oc advisou that 1971 ion 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 cacal statues and rogalized to registration and listing (21 CFR Part 807); labeling Act 3 requirements, morating practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); 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 5 IC(k) This letter will allow you to begin marketing your antil equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your d premarket notification. The FDA miding of subsantial organities of the promits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleased If you desire specific advice for your device on our laboring organism (
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 prematice notification" (21 CFR Also, please note the regulation entitled, "thisorians of our responsibilities under the Act from the Act from the 807.97). You may obtain other general international at its oll-free number (800)
Division of Small Manufacturers, International and Consumers assuccessfor the Division of Small Manufacturers, International and Octoberts Internet and Products/dsmaldsmamain.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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Indication of Use Statement
| Applicant: | Ziehm Imaging, Inc.4181 Latham StreetRiverside CA. 92501 |
|---|---|
| 510(k) Number: | K051064 |
| Device Name: | ZIEHM QUANTUM(Mobile x-ray system) |
Indications for Use:
The ZIEHM QUANTUM series Mobile C-Arm is intended for use in both Radiographic The ZIEFIN QUANT Only seller no wide variety of surgical intervention or guidance procedures requiring X-ray imaging - both inside and outside the operating room. These procedures requiring X-ray maging overy; Abdominal, Orthopacdic, Peripheral, include Celebral, Thoracio, Vasoura Bagory, Emolization, Stent Placement, Urological Special Vascular-I fow Frocedures, and other related fluoroscopic examinations requiring interventional procedures.
The ZIEHM QUANTUM Mobile C-arms are also suitable as a back up for fixed-based X-ray Vascular and Intervention Procedures.
Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.
Prescription Use
Nancye Bagdon
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.