GAMMALOC SYSTEM, MODEL 03-00001

K082588 · Dilon Technologies, LLC · IYX · Dec 11, 2009 · Radiology

Device Facts

• Record ID: K082588
• Device Name: GAMMALOC SYSTEM, MODEL 03-00001
• Applicant: Dilon Technologies, LLC
• Product Code: IYX · Radiology
• Decision Date: Dec 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1100
• Device Class: Class 1

Intended 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.

Device Story

GammaLoc System acts as a stereotactic localization accessory for the Dilon 6800 Gamma Camera. It enables physicians to perform needle biopsies on suspicious breast lesions identified through gamma imaging. The system integrates gamma camera images with a three-step procedure: localization, immobilization/correlation, and verification. It functions similarly to stereotactic x-ray or MRI-guided systems and gamma probes. Used in clinical settings by physicians, the device provides guidance for biopsy procedures, potentially improving the accuracy of targeting suspicious tissue for diagnostic sampling.

Clinical Evidence

Bench testing only. Verification and validation tests were performed on individual components and the integrated system to confirm performance for the localization of suspected breast tumor sites.

Technological Characteristics

Stereotactic localization accessory for the Dilon 6800 Gamma Camera. Consists of a convenience kit of sterile disposables. Operates as a mechanical/imaging guidance system. No changes to the underlying gamma camera hardware (detector head, gantry arm, mobile cabinet).

Indications for Use

Indicated for use as a lesion localization accessory for the Dilon 6800 Gamma Camera to facilitate needle biopsy of suspicious breast lesions identified via gamma imaging.

Regulatory Classification

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.

Predicate Devices

• Dilon 6800 Gamma Camera (K984466)

Submission Summary (Full Text)

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# 510(k) Summary

## Submitted by:

Dilon Technologies, Inc. 12050 Jefferson Avenue, Suite 340 Newport News, VA 23606 Telephone [phone] . Fax [phone]

Email: [e-mail] .

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

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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

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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 [phone] or [phone] 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