(71 days)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on hardware and standard imaging techniques.
No
The device is used for imaging and diagnostic purposes (depicting anatomical distribution of radioisotopes, aiding in evaluation of lesions), not for treating or preventing diseases.
Yes
The device "produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel" and is "indicated for lymphatic scintigraphy and parathyroid scintigraphy," and to "aid in the evaluation of lesions in the breast and other small body parts," which are all diagnostic activities.
No
The device description explicitly states it incorporates a "Solid State RIM detector design" and mentions "gamma camera performance testing," indicating it includes hardware components for image acquisition.
Based on the provided information, the ergo Imaging System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body. The ergo Imaging System, as described, is used to image the distribution of radionuclides within the body using a photon radiation detector. This is an in vivo (within the living body) imaging technique, not an in vitro (in glass/outside the body) diagnostic test.
- The intended use clearly states it images the distribution of radionuclides in the body.
- The device description focuses on a detector design and imaging capabilities of the body.
Therefore, the ergo Imaging System falls under the category of medical imaging devices used for in vivo diagnosis, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
The ergo Imaging System is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel. The ergo Imaging System is used by trained medical personnel to perform nuclear medicine studies.
It is indicated for lymphatic scintigraphy and parathyroid scintigraphy, It can be used intraoperatively when protected by sterile drapes. It is also indicated to aid in the evaluation of lesions in the breast and other small body parts. When used for breast imaging, it is indicated to serve as an adjunct to mammography or other primary breast imaging modalities.
Product codes (comma separated list FDA assigned to the subject device)
IYX
Device Description
The ergo Imaging System incorporates Digirad's Solid State RIM detector design with 3mm pixels for general purpose planar imaging, cleared under K100838. Sterile drapes are specified for intraoperative use. The ergo Imaging System, in conjunction with the optional Breast Imaging Accessory (BIA), enables the user to perform scintimammography and extremity imaging with stabilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Photon radiation detector / Scintigraphy / Nuclear medicine
Anatomical Site
Body (general), lymphatic, parathyroid, breast, small body parts.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical personnel. Intraoperatively (when protected by sterile drapes).
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
Verification and Validation tests were conducted to demonstrate the ergo Imaging System functions per specification. These tests include Electromagnetic Compatibility. Electrical Safety, and gamma camera performance testing including NEMA standard NU 1-2007 with phantoms.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing results demonstrate that the ergo Imaging System continues to meet the specifications and is substantially equivalent to the predicate devices, based on comparisons of intended use and technology, and overall system performance.
New indications are well-supported in the scientific literature, are routine applications of general-purpose gamma cameras, and have been demonstrated to be within the clinical capability of the ergo Imaging System. Therefore the new indications raise no new questions of safety or efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class I (general controls).
0
JAN 1 5 2013
6 510(K) SUMMARY
A. Sponsor
Digirad® Corporation 13950 Stowe Drive Poway, California 92064 Contact Person: Matthew Olow Director, Quality and Regulatory Affairs Tel: (858) 726-1309 Fax: (858) 726-1467
. . . . . .
B. Date Prepared: November 1, 2012
C. Device Name
| Trade Name: | ergo™ Imaging System |
|---|---|
| Common Name: | Camera, Scintillation (Gamma) |
| Classification Name: | Scintillation (gamma) camera |
| Device Class: | 21CFR 892.1100, Class I |
| Product Code: | IYX |
Cleared/Predicate Devices D.
The ergo Imaging System is substantially equivalent to the following cleared devices:
- . ergo Imaging System, K100838 Cleared on April 23, 2010 Product Code: IYX CFR Section: 892.1100 Device Class: Class I Classification Panel: Radiology
- LumaGEM Molecular Breast Imaging System, K111791 ● Cleared on September 23, 2011 Product Code: IYX CFR Section: 892.1100 Device Class: Class I Classification Panel: Radiology
ட். Device Description
The ergo Imaging System incorporates Digirad's Solid State RIM detector design with 3mm pixels for general purpose planar imaging, cleared under K100838. Sterile drapes are specified for intraoperative use. The ergo Imaging System, in conjunction with the optional
1
Digirad Corporation
Breast Imaging Accessory (BIA), enables the user to perform scintimammography and extremity imaging with stabilization.
F. Intended Use & Indications for Use
The ergo Imaging System is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel. The ergo Imaging System is used by trained medical personnel to perform nuclear medicine studies.
It is indicated for lymphatic scintigraphy and parathyroid scintigraphy, It can be used intraoperatively when protected by sterile drapes. It is also indicated to aid in the evaluation of lesions in the breast and other small body parts. When used for breast imaging, it is indicated to serve as an adjunct to mammography or other primary breast imaging modalities.
G. Technology
The ergo Imaging System utilizes Digirad's solid state detector technology comprised of arrays of thatlium-doped cesium iodide crystal scintillators coupled to silicon photo diodes. Standard and optional collimators are available for different types of imaging.
H. Testing
Verification and Validation tests were conducted to demonstrate the ergo Imaging System functions per specification. These tests include Electromagnetic Compatibility. Electrical Safety, and gamma camera performance testing including NEMA standard NU 1-2007 with phantoms.
l. Conclusion
The ergo Imaging System that is the subject of this submission, is the same device that was cleared under K100838. Testing results demonstrate that the ergo Imaging System continues to meet the specifications and is substantially equivalent to the predicate devices, based on comparisons of intended use and technology, and overall system performance.
New indications are well-supported in the scientific literature, are routine applications of general-purpose gamma cameras, and have been demonstrated to be within the clinical capability of the ergo Imaging System. Therefore the new indications raise no new questions of safety or efficacy.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle or bird-like figure with three wavy lines extending from its body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Mr. Matthew Olow Director, Quality and Regulatory Affairs DIGIRAD Corporation 13950 Stowe Drive POWAY CA 92064-8803
January 15, 2013
Re: K123408
Trade/Device Name: ergo Imaging System Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: I Product Code: IYX Dated: November 1, 2012 Received: November 5, 2012
Dear Mr. Olow:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2-Mr. Olow
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K123408
Device Name: ergo Imaging System
Indications for Use:
The ergo Imaging System is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel. The ergo Imaging System is used by trained medical personnel to perform nuclear medicine studies.
It is indicated for lymphatic scintigraphy and parathyroid scintigraphy, It can be used intraoperatively when protected by sterile drapes. It is also indicated to aid in the evaluation of lesions in the breast and other small body parts. When used for breast imaging, it is indicated to serve as an adjunct to mammography or other primary breast imaging modalities.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Arshad D. Khan
Division Sign Of Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K/23408
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