(100 days)
The Direct Radiography™ device provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.
The Sterling Diagnostic Imaging Direct RadiographyTM device is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a digital network for diagnostic viewing and printing. The device provides digital image capture for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The Direct RadiographyTM device differs from traditional X-ray systems in that instead of exposing a film for subsequent wet chemical processing to create a hardcopy image, a device called a digital array is used to capture the image in electronic form. The digital data are then used to produce hardcopy and softcopy images.
The provided document is a 510(k) summary for the "Sterling Diagnostic Imaging Direct Radiography™" device. This device is described as a system to directly capture and convert conventional projection X-ray images to digital images.
However, the document does not contain information regarding detailed acceptance criteria, specific device performance metrics, or any studies demonstrating that the device meets such criteria.
The document primarily focuses on:
- Device Description: What the device is and how it works (digital image capture instead of film).
- Intended Use: For conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications) wherever screen-film systems are currently used.
- Predicate Device Comparison: It compares the digital nature of the Sterling device to the analog nature and chemical processing of traditional screen-film systems, concluding substantial equivalence for conventional radiographic examinations.
- FDA Clearance Letter: A letter from the FDA stating that the device is substantially equivalent to the predicate and can be marketed.
Since the document is a 510(k) summary, it aims to establish substantial equivalence to a predicate device rather than providing extensive performance studies with detailed acceptance criteria typically found in clinical trial reports or technical specifications for newer, novel devices. The determination of "substantially equivalent" implies that the new device is as safe and effective as a legally marketed predicate device, and thus, extensive de novo performance studies with separate acceptance criteria might not have been required or documented in this specific submission summary.
Therefore, I cannot provide the requested information from the given text.
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Image /page/0/Picture/0 description: The image shows the logo for Sterling Diagnostic Imaging. The logo consists of the word "STERLING" in large, bold letters, with the registered trademark symbol next to the "G". Below the word "STERLING" is the phrase "Diagnostic Imaging" in a smaller font. The alphanumeric code "K973206" is located below the company name.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
س
This summary of 510(k) safety and effectiveness information is being submitted in DEC - 4 1997 accordance with the requirements of SMDA 1990 and 21CFR 807.92,
| Submitter's Name: | Elaine H. Kindell(302) 631-3423Sterling Diagnostic Imaging, Inc.P. O. Box 6020Route 896, Building 600Glasgow Business CommunityNewark, DE 19714-6020Fax# (302) 631-3483 |
|---|---|
| Date of Preparation: | August 22, 1997 |
| Name of Product: | Sterling Diagnostic Imaging Direct RadiographyTM |
| FDA Classification Name: | Solid State X-ray Imaging Device - 90 MBQ |
| Predicate Device: | Radiographic Film (892.1840)Radiographic Intensifying Screen (892.1960) |
| Device Description: | The Sterling Diagnostic Imaging DirectRadiographyTM device is used to directly captureand convert conventional projection X-ray imagesto digital images. A sub-sampled image can bedisplayed on a preview monitor for viewing. Thediagnostic image can be transmitted through adigital network for diagnostic viewing and printing.The device provides digital image capture forconventional radiographic examinations (excludingfluoroscopic, angiographic, and mammographicapplications). The Direct RadiographyTM devicediffers from traditional X-ray systems in that insteadof exposing a film for subsequent wet chemicalprocessing to create a hardcopy image, a devicecalled a digital array is used to capture the image inelectronic form. The digital data are then used toproduce hardcopy and softcopy images. |
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The Direct Radiography™ device provides a digital Intended Use: image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used. The Sterling Direct Radiography™ device uses an Comparison to Predicate electronic readout of an image while conventional Device: screen-film systems require chemical processing to produce an image. The Sterling Direct Radiography™ device produces a digital image while conventional screen-film systems produce an analog image.
Both systems are used for conventional Comments on Substantial Equivalence: radiographic examinations.
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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness. The logo is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Elaine H. Kindell Regulatory Affairs Manager STERLING™ Diagnostic Imaging, Inc. Glasgow Business Community P.O. Box 6020 Newark, DE 19714-6020
Re: K973206 Sterling Diagnostic Imaging Direct RadiographyTM Dated: November 24, 1997 Received: November 25, 1997 Unclassified/Procode: 90 MQB
DEC - 4 1997
Dear Ms. Kindell:
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 interstate in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 requirement, 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 regulatory 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 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 question 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/dsmamain.html".
Sincerely yours,
h)liau Yu
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/3/Picture/0 description: The image shows the logo for Sterling Diagnostic Imaging. The logo consists of the word "STERLING" in large, bold letters, with the registered trademark symbol next to the "G". Below the word "STERLING" is the phrase "Diagnostic Imaging" in a smaller font. The alphanumeric code "K973206" is located below the company name.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
س
This summary of 510(k) safety and effectiveness information is being submitted in DEC - 4 1997 accordance with the requirements of SMDA 1990 and 21CFR 807.92,
| Submitter's Name: | Elaine H. Kindell(302) 631-3423Sterling Diagnostic Imaging, Inc.P. O. Box 6020Route 896, Building 600Glasgow Business CommunityNewark, DE 19714-6020Fax# (302) 631-3483 |
|---|---|
| Date of Preparation: | August 22, 1997 |
| Name of Product: | Sterling Diagnostic Imaging Direct RadiographyTM |
| FDA Classification Name: | Solid State X-ray Imaging Device - 90 MBQ |
| Predicate Device: | Radiographic Film (892.1840)Radiographic Intensifying Screen (892.1960) |
| Device Description: | The Sterling Diagnostic Imaging DirectRadiographyTM device is used to directly captureand convert conventional projection X-ray imagesto digital images. A sub-sampled image can bedisplayed on a preview monitor for viewing. Thediagnostic image can be transmitted through adigital network for diagnostic viewing and printing.The device provides digital image capture forconventional radiographic examinations (excludingfluoroscopic, angiographic, and mammographicapplications). The Direct RadiographyTM devicediffers from traditional X-ray systems in that insteadof exposing a film for subsequent wet chemicalprocessing to create a hardcopy image, a devicecalled a digital array is used to capture the image inelectronic form. The digital data are then used toproduce hardcopy and softcopy images. |
{4}------------------------------------------------
The Direct Radiography™ device provides a digital Intended Use: image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used. The Sterling Direct Radiography™ device uses an Comparison to Predicate electronic readout of an image while conventional Device: screen-film systems require chemical processing to produce an image. The Sterling Direct Radiography™ device produces a digital image while conventional screen-film systems produce an analog image.
Both systems are used for conventional Comments on Substantial Equivalence: radiographic examinations.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion on the left side of the image. To the right of the text is a symbol that appears to be an abstract representation of a human figure or a stylized design. The image is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Elaine H. Kindell Regulatory Affairs Manager STERLING™ Diagnostic Imaging, Inc. Glasgow Business Community P.O. Box 6020 Newark, DE 19714-6020
Re: K973206 Sterling Diagnostic Imaging Direct RadiographyTM Dated: November 24, 1997 Received: November 25, 1997 Unclassified/Procode: 90 MQB
DEC - 4 1997
Dear Ms. Kindell:
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 interstate in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 requirement, 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 regulatory 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 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 question 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/dsmamain.html".
Sincerely yours,
h)liau Yu
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
{6}------------------------------------------------
Indications Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Sterling Diagnostic Imaging Direct Radiography™ Device Name:
Indications for Use:
The Direct Radiography™ device provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | |||
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number ..
Page 8-4
§ 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.