(41 days)
The DEL-IMS has application wherever the transmission of radiographic images and associated patient text data is desired to take place from an input, such as radiographic equipment which employs a digital image capture device, to an output device such as hardcopy, softcopy, or archive device.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
The DEL-IMS is intended to provide a network connection via DICOM protocol to various output (e.g. hardcopy, softcopy and archive) devices from a radiographic system which uses a digital image capture device. It synchronizes the ready states of the digital image capture device and the radiographic equipment when a single x-ray console is desired, to provide the x-ray console features (e.g. technique selection) of the radiographic equipment.
The provided text describes a 510(k) summary for the DEL-IMS device, which is an operator console and imaging workstation for stationary digital X-ray systems. It outlines the device's function, its intended use, and its claim of substantial equivalence to a predicate device.
However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on the administrative aspects of the 510(k) submission, such as:
- Submitter and Contact Information: Del Medical Imaging, Bill Engel.
- Date Prepared: October 17, 2006.
- Trade Name & Common Name: DEL-IMS, Operator Console and Imaging Workstation for Stationary Digital X-Ray Systems.
- Classification: 21 CFR 892.2050 Picture Archiving and Communications Device, Class II.
- Predicate Device: Sterling DROC (K980970).
- Product Description: Provides network connection via DICOM protocol for image output, synchronizes digital image capture device and radiographic equipment.
- Indication for Use: Transmission of radiographic images and patient text data from digital image capture devices to output devices (hardcopy, softcopy, archive). Important caveat: Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary interpretations, and mammographic images require an FDA-approved monitor with specific resolution.
- Rationale for Substantial Equivalence: Same indication for use, same technological characteristics as the predicate. Minor technological differences do not raise new questions on safety or effectiveness.
- Safety and Effectiveness Information: Mentions operating instructions, software development processes (design, verification, validation), final device validation, and risk assessment prior to marketing. Also states compliance testing to IEC 60601-1-2.
- Conclusion: Performs same functions, equal safety and effectiveness, introduces no new safety risks, substantially equivalent to predicate.
Because the document is a 510(k) summary focused on substantial equivalence (comparing to a predicate device) rather than a de novo clinical validation study against specific performance criteria, the requested information about acceptance criteria and a study proving their fulfillment is not present in the provided text.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, sample sizes, expert involvement, or adjudication methods from this document. The document confirms the device's regulatory approval based on substantial equivalence to an existing device, which is a different type of assessment than proving performance against defined acceptance criteria through a specific study.
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长06 3188
510 (k) Summary
:
This summary of safety and effectiveness information is submitted in accordance with the requirements of
21 CEP 807 92 21 CFR 807.92.
| Submitter: | Del Medical Imaging11550 W. King St.Franklin Park, IL 60131 |
|---|---|
| Contact Person: | Bill EngelManager, QA/RAPhone: 847-288-7948Fax: 847-288-7011Email: wengel@delmedical.com |
| Date Prepared: | October 17, 2006 |
| Trade Name: | DEL-IMS |
| Common Name: | Operator Console and Imaging Workstation for Stationary Digital X-Ray Systems |
| Classification Name: | 892.2050 Picture Archiving and Communications Device |
| Predicate Device: | Sterling DROC, (K980970). |
| Product Description: | The DEL-IMS is intended to provide a network connection via DICOM protocol to various output(e.g. hardcopy, softcopy and archive) devices from a radiographic system which uses a digitalimage capture device. It synchronizes the ready states of the digital image capture device and theradiographic equipment when a single x-ray console is desired, to provide the x-ray consolefeatures (e.g. technique selection) of the radiographic equipment. |
| Indication for Use: | The DEL-IMS has application wherever the transmission of radiographic images andassociated patient text data is desired to take place from an input, such as radiographicequipment which employs a digital image capture device, to an output device such ashardcopy, softcopy, or archive device.Lossy compressed mammographic images and digitized film screen images must not bereviewed for primary image interpretations. Mammographic images may only be interpretedusing an FDA approved monitor that offers at least 5 Mpixel resolution and meets othertechnical specifications reviewed and accepted by FDA. |
| Rationale forSubstantial Equivalence: | The DEL-IMS has the same indication for use as the predicate device. It shares the sametechnological characteristics as the predicate device. Minor technological differences do not raiseany new questions regarding safety or effectiveness of the device. |
| Safety andEffectiveness Information: | The device labeling contains operating instructions for safe and effective use of the DEL-IMS. Thesoftware development for this device follows documented processes for software design,verification and validation testing. Final device validation and risk assessment will be completedprior to marketing, to identify potential design hazards that could cause an error or injury based onthe use of this device. Appropriate steps will be taken to control all identified risks. The device willbe tested for compliance to IEC 60601-1- 2 Medical Electrical Equipment Part 1: GeneralRequirements for Safety. |
| Conclusion: | The DEL-IMS performs the same functions in the same environment as the predict device(DROC). It is as safe and effective as the predict device. We believe it does not introduce any newpotential safety risks and is substantially equivalent to the predict device. |
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Image /page/1/Picture/1 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Blvd., Rockville MD 20850. The text is black and the background is white. The text is left-aligned.
NOV 3 0 2006
Mr. William J. Engel Manager, Quality Assurance/Regulatory Affairs Del Medical Systems Group 11550 West King Street FRANKLIN PARK IL 60131
Re: K063188
Trade/Device Name: DEL-IMS Digital Operator Console Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 17, 2006 Received: October 23, 2006
Dear Mr. Engel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/9 description: The image is a circular logo or emblem. The text "1906-2006" is at the top, and the letters "FDA" are prominently displayed in the center. Below "FDA" is the word "Centennial". There are three small dots arranged horizontally beneath the word "Centennial". The entire design is enclosed within a circular border.
Protecting and Promoting Public Health
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA S ISSuance of a succession of the requirements of the Act
that FDA has made a determination that your device complies with connise. You must that FDA has made a delemination that your as recess. Your crederal agencies. You must of or any Federal statules and regulations administers of ey not limited to: registration and listing (21 comply with all the Act Stequirements, mercess, confecturing practice requirements as set CFR Part 807); iabeling (21 CFR Parts of ); good frances (20); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applic forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin maketing your over articlequivalence of your device to a legally premarket notification. The FDA midnig of succement of the more 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 If you desire specific advice for your device on one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology). | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Also, please note the regulation other general information on your responsibilities under (21CFR Part 807.97). Tou may obtain other general and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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 for Use Statement
510k Number: (if known): Ko 3188
Device Name: DEL-IMS Digital Operator Console
Indications for Use:
The DEL-IMS has application wherever the transmission of radiographic images The DEL-IMS flas application wherever the transmission of the an input, such as input, such as and associated patient text data is abon a digital image capture device, to an output device such as hardcopy, softcopy, or archive device.
Lossy compressed mammographic images and digitized film screen images must Lossy contipressed manihographic image interpretations. Mammographic images may not be leviewed for primary intage into proved monitor that offers at least 5 Mpixel orny be interpreted using an PDA upproved monton reviewed and accepted by FDA.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter |
|---|---|---|---|
| ------------------ | -------------- | ---- | ------------------ |
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
| (Division Sign-Off) | Nancy C Brogdon |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K063188 |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).