(7 days)
The DXSS Automatic X-ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes. This is the sole purpose of this device.
Dental automatic radiographic film processor
The provided text describes a 510(k) submission for the "DXSS Automatic X-ray Film Processor" and a letter from the FDA stating its substantial equivalence to a predicate device. However, this document does not contain any information regarding acceptance criteria, a study proving device performance, sample sizes, data provenance, ground truth establishment, or expert involvement as requested.
The submission is for an automatic radiographic film processor, which is a physical device that develops, fixes, washes, and dries X-ray film. It is not an AI/ML-enabled diagnostic device that would typically undergo the types of studies described in the request (e.g., MRMC studies, standalone performance with specific metrics like sensitivity/specificity).
Therefore, I cannot provide the requested information from this document. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on specific performance metrics established through clinical or technical studies for an algorithm.
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SEP 3 1999
Section E – 510(k) Summary
| Submitted by: | Jim JacobsonDental X-ray Support Systems2124 196th Street SW, Suite BLynnwood, WA 98036Phone: 888-230-9500Fax: 425-640-2176 |
|---|---|
| Date Submitted: | 08/06/99 |
| Trade Name: | DXSS Automatic X-ray Film Processor |
| Common Name: | Film Processor |
| Classification Name: | Dental Automatic Radiographic Film Processor(Per 21 CFR section 892.1900) |
| Substantial Equivalence: | Gendex Processor K945682 02/09/95 |
| Description of Device: | Dental automatic radiographic film processor |
| Intended Use: | The DXSS Automatic X-ray Film Processor is anautomatic radiographic film processor, a diagnosticdevice intended to be used to develop, fix, wash, and dryautomatically and continuously film exposed for medicalpurposes. This is the sole purpose of this device. |
| Comparison Summary: | Unlike predicate devices which use rollers and gears topull film through a series of open solution tanks, ourprocessor holds film stationary in one processing tank.Furthermore, solutions are contained in 4 sealedreservoirs. Air pressure and vacuum forces the solutionsup to the film, through a valve system. Film is nevertouched by a moving part, which is unlike otherprocessors on the market. Developer temperature and timeis controlled and adjusted automatically by a computerboard. Maintenance is relatively low due to electronicdraining; other processors require frequent manualcleaning and draining. Chemistry life is prolonged due tothe sealed reservoirs, which also prevent the odorsassociated with open solution tanks. No plumbing isrequired as it is in most predicate devices. |
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1999
Mr. Jim Jacobson Owner Dental X-rav Support Systems 2124-19610 Street SW Suite B Lynnwood, WA 98036
Dear Mr. Jacobson:
Re:
K992896 DXSS Automatic X-ray Film Processor Dated: August 24, 1999 Received: August 27, 1999 Requlatory Class: II (two) Product Code: 90 EGY 21 CFR 892,1900
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K992896
Device Name:
Indications For Use:
Device Name: DXSS Automatic X-ray Film Processor
Applicant: Dental X-ray Support Systems, Jim Jacobson
The DXSS Automatic X-ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes. This is the sole purpose of this device.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qimil. A. Seymon
on Sign-Off) vision of Reproductive, Abdominal, E and Radiological D
510(k) Number
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 892.1900 Automatic radiographic film processor.
(a)
Identification. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.