(459 days)
Not Found
No
The summary describes a stereotactic localization system accessory for a gamma camera, focusing on mechanical localization for needle biopsy. There is no mention of AI, ML, or advanced image processing techniques that would suggest the use of such technologies. The performance studies focus on localization accuracy, not algorithmic performance metrics typically associated with AI/ML.
No
The device is described as a "lesion localization accessory" and a "stereotactic localization system" to perform needle biopsy, which is a diagnostic procedure, not a therapeutic one. It assists in locating lesions, not treating them.
No
Explanation: The device is described as a "lesion localization accessory" that assists in performing needle biopsies. It helps to pinpoint the location of suspicious lesions for biopsy, rather than diagnosing them itself. Although it works with a gamma camera used for imaging, its stated function is to localize, not diagnose.
No
The device is described as a "lesion localization accessory" for a gamma camera, which is a hardware device. The description explicitly mentions "various components of the system" and "integrated unit," implying hardware components beyond just software.
Based on the provided information, the GammaLoc System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a stereotactic localization system for needle biopsy of lesions identified through gamma imaging. This is a localization and guidance function for a medical procedure performed on a patient, not a test performed on a sample taken from the patient.
- Device Description: It's described as an accessory to a gamma camera, which is an imaging device used on a living patient.
- Input Imaging Modality: Gamma imaging is performed on a living patient who has been administered a radiopharmaceutical.
- Anatomical Site: Breast, which is a part of the living patient's body.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The GammaLoc System's function is to help a physician locate a lesion within the patient's body for a biopsy procedure.
N/A
Intended Use / Indications for Use
The GammaLoc System is a lesion localization accessory for the Dilon 6800 Gmma Camera. This stereotactic localization system gives the physician the capability to perform needle biopsy of lesions determined to be suspicious through gamma imaging.
Product codes (comma separated list FDA assigned to the subject device)
IYX
Device Description
The GammaLoc System is a lesion localization accessory to the Dilon 6800 Gamma Camera, previously cleared under K984466 (originally named Dilon 2000 Digital Gamma Camera). The Dilon Gamma Camera is a high resolution, small field of view, portable gamma camera for use in imaging radiopharmaceuticals consisting of three primary components: the detector head, the gantry arm and the mobile cabinet. There are no changes to the gamma camera in this submission. The GammaLoc System integrates the same procedure steps and consumables from legally marketed predicates with functional guided biopsy to provide a gamma-guided stereotactic lesion localization accessory to the Dilon 6800 Gamma Camera. The Dilon GammaLoc® System integrates the gamma camera image with the three steps of a localization procedure that has evolved from the experiences with stereotactic x-ray or MRI guided systems: localization, immobilization/correlation, and verification. The GammaLoc® System use for functional gamma guidance is equivalent to using a gamma probe, currently used to guide biopsy and surgery in clinics today, although gamma probes are not imaging systems. The consumable components have predicates to which the GammaLoc System components are equivalent and the sterile disposables are considered a Convenience Kit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Gamma imaging
Anatomical Site
Breast (implied, from "localization of suspected tumor sites in the breast")
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Clinics
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)
The performance of the GammaLoc® System has been tested to establish that it can be used for localization of suspected tumor sites in the breast. Verification tests were performed on various components of the system to determine their individual performance. Validation tests were also performed on the integrated unit to determine the system performance.
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
510(k) Summary
Submitted by:
Dilon Technologies, Inc. 12050 Jefferson Avenue, Suite 340 Newport News, VA 23606 Telephone 757-269-4910 . Fax 757-269-4912
Email: LFairchild@dilon.com .
Contact person: Lee H. Fairchild
Device name: GammaLoc System, Accessory to Dilon 6800 Gamma Camera Gamma Camera System Common name: Classification name: Scintillation (Gamma) Camera Classification, Regulation, Panel and Procode: Class 1, CFR 892.1100, Radiology Panel, IYX
Device Description:
The GammaLoc System is a lesion localization accessory to the Dilon 6800 Gamma Camera, previously cleared under K984466 (originally named Dilon 2000 Digital Gamma Camera). The Dilon Gamma Camera is a high resolution, small field of view, portable gamma camera for use in imaging radiopharmaceuticals consisting of three primary components: the detector head, the gantry arm and the mobile cabinet. There are no changes to the gamma camera in this submission.
Substantially equivalent to:
The GammaLoc System integrates the same procedure steps and consumables from legally marketed predicates with functional guided biopsy to provide a gamma-guided stereotactic lesion localization accessory to the Dilon 6800 Gamma Camera. The Dilon GammaLoc® System integrates the gamma camera image with the three steps of a localization procedure that has evolved from the experiences with stereotactic x-ray or MRI guided systems: localization, immobilization/correlation, and verification. The GammaLoc® System use for functional gamma guidance is equivalent to using a gamma probe, currently used to guide biopsy and surgery in clinics today, although gamma probes are not imaging systems. The consumable components have predicates to which the GammaLoc System components are equivalent and the sterile disposables are considered a Convenience Kit.
Indications for use:
The GammaLoc System is a lesion localization accessory for the Dilon 6800 Gmma Camera. This stereotactic localization system gives the physician the capability to perform needle biopsy of lesions determined to be suspicious through gamma imaging.
Summary of Testing:
The performance of the GammaLoc® System has been tested to establish that it can be used for localization of suspected tumor sites in the breast. Verification tests were performed on various components of the system to determine their individual performance. Validation tests were also performed on the integrated unit to determine the system performance.
GammaLoc® System 510(k)
DFC 1 1 2009
K08255
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted in blue and is accompanied by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 2 1 2010
Dilon Technologies, Inc. % Ms. Elaine Duncan President Paladin Medical, Inc. P.O. Box 560 STILLWATER MN 55082
Re: K082588
Trade/Device Name: GammaLöc System Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) Camera Regulatory Class: I Product Code: IYX Dated: October 7, 2009 Received: October 9, 2009
Dear Ms. Duncan:
This letter corrects our substantially equivalent letter of December 11, 2009.
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 (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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Cathline M. Morris
Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health