SKYLIGHT IMAGING SYSTEM

K031705 · Adac Laboratories · KPS · Jun 17, 2003 · Radiology

Device Facts

• Record ID: K031705
• Device Name: SKYLIGHT IMAGING SYSTEM
• Applicant: Adac Laboratories
• Product Code: KPS · Radiology
• Decision Date: Jun 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The SKYLight Imaging System is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

Device Story

SKYLight Imaging System is an open-frame nuclear medicine gamma camera for ECT studies. System comprises gantry, two detector arms, collimator storage, patient table, and remote controller. Detectors move in X, Y, Z, and rotational axes to perform circular/non-circular orbits. Input: single photon and positron emitting radioisotopes. JETStream acquisition software controls gantry motions, collimator exchange, and image acquisition. Output: ECT images exported via DICOM 3.0 to Pegasys workstation or other processing stations. Used in clinical settings by medical personnel. DICOM integration enables worklist management and patient scheduling. System supports diverse procedures including bone, lung, renal, gastric, hepatobiliary, thyroid, and cardiac studies. Benefits include flexible patient positioning (sitting, standing, lying) and multi-energy/multi-isotope imaging capabilities.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and system performance verification of the software modifications.

Technological Characteristics

Open-frame gantry with dual detector arms; X, Y, Z, and rotational motion axes. Supports single or dual detector configurations. Interfaces with Pegasys workstation. Software-based acquisition control for gantry motion, collimator exchange, and image data processing. Connectivity via DICOM 3.0 for image export and worklist management. Native XML to DICOM translation. No changes to mechanical or electrical hardware compared to predicate.

Indications for Use

Indicated for producing images of anatomical distributions of single photon and positron emitting radioisotopes in the human body for interpretation by medical personnel. Used for static, dynamic, gated, total body, circular/non-circular orbit SPECT, and coincidence studies.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. 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

• SKYLight® Imaging System (K013496)

Submission Summary (Full Text)

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KD31705

## 510(k) SUMMARY SAFETY AND EFFECTIVENESS

| A. | Submitted By:<br>ADAC Laboratories<br>540 Alder Dr.<br>Milpitas, CA 95035 | Contact: Coleen Coleman<br>Tel: [phone]<br>Fax: [phone] |
|----|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| B. | Device Trade Name:<br>Common Name:<br>Classification Name:<br>Device Class:<br>Product Code: | SKYLight Imaging System<br>Gamma Camera Systems<br>Emission Computed Tomography System<br>21 CFR 892.1200, Class II<br>90 KPS |
| C. | Date prepared: | May 8, 2003 |
| D. | Predicate Device: | SKYLight® Imaging System (K013496) |
| E. | Intended Use: | |

The SKYLight Imaging System is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

F. Device Description:

The modified SKYLight Imaging System offers all the features of the existing SKYLight Imaging System (K013496) while expanding the Concurrent Imaging feature for Multi-Energy/Multi-Isotope Imaging and the addition of DICOM to the JETStream™ acquisition system. The basic underlying algorithms for concurrent imaging remain the same. Software modifications to the Multi-Energy/Multi-Isotope application extend the current functionality to include acquisition of more image events simultaneously. Acquisition data can be exported to the Pegasys or any other processing station via DICOM by translating image data from the native XML format to a DICOM 3.0 complaint format. The addition of DICOM to the acquisition software will enhance workflow by providing DICOM Worklist and the capability to import patient information for scheduling purposes.

The SKYLight is designed to provide extended imaging functionality relative to a ring style gantry. The SKYLight was designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes a gantry frame, two detector arms (with detectors), a collimator storage structure with an acquisition computer unit, a patient imaging table, and a remote hand controller. The modified SKYLight is capable of accommodating two separate patient tables. The gantry is "open" so that a high degree of imaging flexibility is available to image patients sitting, standing or lying down, with or without the included patient imaging table. The patient imaging tables are mechanized to allow for patient loading access and then raised to an imaging height. The tables do not move during imaging since the gantry is flexible enough to perform all required motions for non-circular orbits. The imaging pallet includes removable arm, leg, breast, and headrest supports for patient positioning during studies that require support.

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SKYLight® is an 'open frame' imaging system, the 'open frame' consisting of an overhead rectangular structure that is supported by 4 (or more) columns that are bolted to the imaging room floor. A detector arm support structure is mounted onto the open frame, which allows for the detector arm support structure (and both detector arms) to move in the longitudinal motion (X-axis). Arms that can telescope up and down (Z-axis) support the detectors. These detector arms are supported by a structure that allows for each detector arm to move toward or away from each other (Y-axis). Each detector has the ability to rotate and acquire images independently

The combination of these four motions (Z, Y, X, and detector rotate), permit the detectors to perform all standard non-circular and circular ECT studies in both the 90-degree and 180-degree relative position. The detectors use two standard collimators, or MCD shields, which may be exchanged using an automatic exchange unit.

The modified JETStream SKYLight acquisition computer uses the same acquisition software (subsystem) as existing SKYLight to acquire ECT imaging studies and interfaces with a Pegasys computer system (workstation). The acquisition CPU is used to install the camera software and to archive and restore acquisition parameters and correction tables. The acquisition software is used to complete pre-programmed gantry motions for setup of imaging studies and exchange of collimators; to perform quality assurance tests on the SK YLight system; and to program image parameters and gantry for clinical studies.

When using either a single detector or dual detectors placed in a relative 90-degree or relative 180-degree positions (as study appropriate), SKYLight can be used to perform static, dynamic, gated, total body, circular-orbit and non-circular orbit SPECT studies, coincidence studies, gated SPECT (circular and non-circular) studies, computerprogrammed protocol strings, and reference scans (dual detectors only). SPECT and total body acquisitions are routinely acquired with two detectors. There are some planar procedures such as bone statics and lung scan also use two detectors. There are many additional nuclear medicine procedures that only use one detector at a time. These single detector procedures are typically renal, gastric emptying, hepatobiliary, flow studies, GI bleed, thyroid, and delayed static views. This acquisition sub-system interfaces with a Pegasys computer system for entry into the database. The Pegasys workstation also includes software used for image processing, database utilities, and archiving utilities.

G. Technological Comparison:

The modified SKYLight Imaging System and existing SKYLight Imaging System have identical intended use and indications for use. The modified SKYLight and the existing SKYLight are technologically identical. They share the identical mechanical and electrical components. No changes or modifications have been made to the mechanical or electrical components. All the features provided on the existing SKYLight are provided on the modified SKYLight. The only change has been to the JETStream acquisition software, which provides the modified SKYLight Imaging System with the expanded feature of Concurrent Multi-Energy/Multi-Isotope Imaging and DICOM Export/Worklist.

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#### H. Conclusion

The modified SK YLight® Imaging System is substantially equivalent to the predicate device SKYLight based upon identical indications for use, technological comparison and overall system performance.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2003

ADAC Laboratories % Mr. Morten Christensen Principal Reviewer/Office Coordinator 510(k) Review Program Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169

Re: K031705

Trade/Device Name: SKYLight™ Imaging System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: May 29, 2003 Received: June 2, 2003

Dear Mr. Christensen:

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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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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d.

## INDICATIONS FOR USE STATEMENT

510 (k) NUMBER (IF KNOWN): KD31705

DEVICE NAME:

SKYlight™ Imaging System

SPONSOR NAME:

ADAC Laboratories

# INDICATIONS FOR USE:

The Skylight Imaging System is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) OR

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

Over-The-Counter-Use (Optional Format 1-2-96)

0001