(28 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image acquisition, transmission, storage, and basic 3D reconstruction, without mentioning any AI/ML-specific functionalities or performance metrics.
No
The device is used for acquiring, transmitting, viewing, and storing image or patient data, including reconstructing 3D ultrasound images for obstetric exams. However, the 3D images are explicitly stated as "not intended for use in diagnosis or quantitative measurements," indicating it does not provide therapeutic benefit or direct treatment. Its function is primarily data management and visualization, not therapeutic intervention.
No
The "Intended Use / Indications for Use" states that "The 3D images are not intended for use in diagnosis or quantitative measurements."
No
The device description explicitly states it is comprised of components that connect to analog or digital medical imaging devices, indicating hardware components beyond just software.
Based on the provided information, neither the Obsidian PACS System nor the 3D Ultrasound Image Router are IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens derived from the human body. The descriptions of both devices focus on acquiring, transmitting, viewing, and storing medical images (ultrasound, CT, MRI, etc.) and patient data. They do not mention analyzing biological samples like blood, urine, or tissue.
- The intended use of both devices is related to medical imaging and data management. The PACS system is for handling image and patient data, and the 3D Ultrasound Image Router is for creating 3D representations from ultrasound images for obstetric exams. Neither of these activities falls under the definition of an in vitro diagnostic test.
- The 3D Ultrasound Image Router explicitly states the images are "not intended for use in diagnosis or quantitative measurements." This further reinforces that it's not performing a diagnostic test on a biological sample.
In summary, these devices are medical imaging and data management tools, not IVDs.
N/A
Intended Use / Indications for Use
The Obsidian PACS System is used to acquire, transmit, view, and store image or patient data. This data can be transmitted, stored, and viewed over a computer network or off-site using an Internet connection. The typical users of this system are trained professionals, including but not limited to, radiologist, physicians, technicians, and nurses.
The 3D Ultrasound Image Router is indicated for capture and storage of 2D images from an ultrasound system and reconstructing them into 3D ultrasound images. These images provide an approximate representation of the 3D volume for use in obstetric exams. The 3D images are not intended for use in diagnosis or quantitative measurements.
Product codes
LLZ
Device Description
The Obsidian PACS System is comprised of components that connect to an analog or digital medical imaging device (ultrasound, CT, MRI, digitizer), transmit image or patient data, and store image or patient data. The transmission of data can occur internally or externally using a local area network or Internet connection.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound, CT, MRI, digitizer
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, including but not limited to, radiologist, physicians, technicians, and nurses.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for Obsidian Medical Technology. The logo features the word "OBSIDIAN" in large, bold, sans-serif font, with the words "MEDICAL TECHNOLOGY" in a smaller font size underneath. Above the word "OBSIDIAN" is a graphic of a globe with binary code (1s and 0s) encircling it.
5108 Corona Court · Pleasanton, CA 94588 · tel: (925) 426-3111 · www.obsidianmedical.com
510(k) Summary of Safety and Effectiveness
Date Prepared: April 22, 2002 Submitter's Information: 21 CFR 807.92(a)(1) Obsidian Medical Technology, Inc. Contact: Bianca Green 5108 Corona Court Pleasanton, CA 94588 Tel: (925) 426-3111 Fax: (925) 426-3001 Trade name, Common Name and Classification: 21 CFR 807.92(a)(2) The Obsidian PACS System Trade Name: Picture Archiving Communications System Common Name: Device Classification: 892 2050 Name: System, Image Processing, Radiology Predicate Device: 21 CFR 892.92(a)(3) Manufacturer: Echo Tech 3D Imaging Systems, Inc. Device: Echo Tech Easy 3D 510(k) Number: K013088 Date Received: 03/06/2002 Decision Date: 04/04/2002 Substantially Equivalent Decision: Panel Code device reviewed by: Radiology Panel Code device classified by:Radiology Product Code: LLZ
Class II - 892.2050 Classification:
Device Description: 21 CFR 807 92(a)(4)
The Obsidian PACS System is comprised of components that connect to an analog or digital medical imaging device (ultrasound, CT, MRI, digitizer), transmit image or patient data, and store image or patient data. The transmission of data can occur internally or externally using a local area network or Internet connection.
Indications for Use: 21 CFR 807 92(a)(5)
The Obsidian PACS System is used to acquire, transmit, view, and store image or patient data. This data can be transmitted, stored, and viewed over a computer network or off-site using an Internet connection. The typical users of this system are trained professionals, including but not limited to, radiologist, physicians, technicians, and nurses.
The 3D Ultrasound Image Router is indicated for capture and storage of 2D images from an ultrasound system and reconstructing them into 3D ultrasound images. These images provide an approximate representation of the 3D volume for use in obstetric exams. The 3D images are not intended for use in diagnosis or quantitative measurements. This device is intended to provide an approximate representation of the 3D volume for use in obstetric exams.
1
Technological Characteristics: 21 CFR 807 92(a)(6)
The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed. This device transmits data on and off-site.
Conclusion: 21 CFR 807 92(b)(3)
In accordance with the FDA document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," the level of risk of the Obsidian PACS System was considered to be minor. The documentation submitted on the device system reflects this level of risk and consist of the following documents:
- . Architectural design chart
- . Hazard analysis
- DICOM conformance statement .
These documents contain adequate information and data to enable FDA – CDRH to determine substantial equivalence to the predicate device. The Obsidian PACS System will be manufactured in accordance with the standards listed in the enclosed specifications documentation.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three horizontal lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2003
Obsidian Medical Technology, Inc. % Ms. Laura Danielson 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891 Re: K030635
Trade/Device Name: Obsidian PACS System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: March 18, 2003 Received: March 20, 2003
Dear Ms. Danielson:
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 (PMA), it may be subject to 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.
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 Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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
4
INDICATIONS FOR USE
510(k) Number (if known): _K & ك ك ك ك ك
Device Name: The Obsidian PACS System
Indications for Use:
The Obsidian PACS System is used to acquire, transmit, view, and store image or patient data. This data can be transmitted, stored, and viewed over a computer network or off-site using an Internet connection. The typical users of this system are trained professionals, including but not limited to, radiologist, physicians, technicians, and nurses.
The 3D Ultrasound Image Router is indicated for capture and storage of 2D images from an ultrasound system and reconstructing them into 3D ultrasound images. These images provide an approximate representation of the 3D volume for use in obstetric exams. The 3D images are not intended for use in diagnosis or quantitative measurements.
Prescription Use
David R. Seymm
(Division Sign-O Division of Reproductive and Radiological D 510(k) Number