K Number

Device Name

APOLLO GAMMA CAMERA SYSTEM

Manufacturer

ADAC LABORATORIES

Date Cleared

2006-08-23

(15 days)

Product Code

KPS

Regulation Number

892.1200

Intended Use

The Apollo Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

Device Description

The Apollo Gamma Camera System offers all the features of the Forte™ Gamma Camera System (K033254) while adding the following new features: Caudal/Cephalic Imaging, a second LEHR collimator with improved sensitivity, new CHR collimator, larger Field of View (FOV) with square cornered detectors, < 3-inch brain reach, 3/4' detector crystal (in lieu of 5/8"), Automatic Body Contouring (ABC) with BodyGuard™, MegaBody Mode Imaging, 9-axis ring gantry, extra large patient bore (38" diameter), cart-based semi-automatic exchanger, optional chamfered pallet for low edge attenuation, DICOM MPPS, additional Data Management features (Audit Trail & Patient Privacy), support for new detector, and port server applications from Solaris to LINUX. Caudal/Cephalic Imaging will allow rotational "tilt" motion of at least one of the detectors about an axis of the detector (parallel to the face of the ring) of at least ±15 degrees. MegaBody mode imaging provides independent variable height positioning of the detectors which includes caudal/cephalic angulations. The detector FOV reach for brain imaging will be less than 3 inches while the detector FOV will be larger (15.5" x 21" instead of 15" x 20") due to the use of the square cornered detectors. In all these cases, the basic functionality of the detector will remain the same (as the detector in the Forte™), while adding detector flexibility to provide a better view of the heart and brain and improve image quality. The use of ¾" crystal in lieu of the 5/8" crystal for applications that require higher energy isotopes is now a common trend in the medical device industry. The ¾" crystal has higher system sensitivity (per NEMA NU-1, Section 3.8) than the 5/8" crystal. Another improvement to the system sensitivity is the use of a second type of LEHR collimator in the Apollo System. Higher system sensitivity will improve image quality and may reduce acquisition time and/or applied radiopharmaceutical dosage to the patient. A new collimator will also be used, CHR (aka Rembrandt™ Collimators) which is long-bore collimation that eliminates dead-space in the 90° corner and preserving resolution at depth. This collimator is a variation of the VXGP collimator used in the Forte™ System. The ABC mode with BodyGuard™ is an addition to the current manual mapping feature available in the Forte System. It is a refinement of the non-circular SPECT and learn-mode TB currently used in Forte™. Also, the BodyGuard™ is the sensing mechanism providing the same functionality as the Collision Avoidance feature in Forte™. The 9-axis gantry frame provides additional gantry motions designed to improve image quality. Also, the larger bore diameter provides openness for even the largest patients. The cart-based collimator exchanger uses a semi-automatic approach to simultaneously change both collimators. The chamfered pallet option is the same material and basic design as the standard pallet used for the Apollo System. It may be used in lieu of the standard pallet for certain studies that require low edge attenuation. DICOM MPPS completes the DICOM suite and is a computerized notification stating the type of study being done and when it has been completed. Audit Trail and Patient Privacy are Data Management programs to comply with HIPAA requirements. The remote desktop feature is used in the Forte™ system by remote service personnel. To enhance this feature, remote monitoring will be added to the Apollo System. The Apollo System is designed to provide extended imaging functionality relative to a ring style gantry. It is designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes the gantry frame, display panel, two detectors, a collimator storage unit, an acquisition computer unit (with an optional customer desk), a patient imaging table (includes pallet catcher), and a hand controller. The patient imaging table (pallet) is mechanized for patient loading access and for movement during imaging studies. The table may be removed by the operator for imaging of patients in wheelchairs, beds, or gurneys. The pallet includes removable arm, leg/knee, shoulder and headrest supports for patient positioning during studies that require support. The Apollo is designed to allow acquisition of a broad range of imaging studies using single or dual detectors. When using either a single detector or dual detectors placed in a relative 90-degree or relative 180-degree positions (as study appropriate). Apollo can be used to perform static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT studies, coincidence studies, gated SPECT (circular and noncircular) studies, computer-programmed 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 that 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.

More Information

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Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

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Street 2

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State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K033254 Forte™ Gamma Camera System

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on hardware improvements, new imaging modes, and data management features, with no mention of AI or ML for image analysis or other functions. The "Automatic Body Contouring (ABC) with BodyGuard™" is described as a refinement of existing features and a sensing mechanism, not an AI/ML system.

Therapeutic

No.
The device is intended to produce images for diagnostic purposes, not to treat a disease or condition.

Diagnostic

Yes

The device is intended to produce images depicting anatomical distributions of radioisotopes within the human body for interpretation by medical personnel, which is a diagnostic function.

SaMD (Software as a Medical Device)

The device description clearly details numerous hardware components including detectors, gantry frame, display panel, collimator storage unit, acquisition computer unit, patient imaging table, and hand controller. While it mentions software updates (Solaris to LINUX, DICOM MPPS, Data Management features), the core functionality and description are centered around physical hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the Apollo Gamma Camera System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to "produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel." This describes an in-vivo imaging system, where the radioisotopes are administered to the patient, and the device detects the radiation emitted from within the body.
Device Description: The description details a gamma camera system with detectors, collimators, gantry, and patient table. These are components of an imaging system used to visualize the distribution of radioactive tracers within a living organism.
Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body. IVD devices are designed for testing samples taken from the human body.

Therefore, the Apollo Gamma Camera System is an in-vivo imaging device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

KPS

Device Description

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
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.(b)
Classification. Class II.

Summary

AUG 2 3 2006

510(k) SUMMARY SAFETY AND EFFECTIVENES

| A. | Submitted By:
ADAC Laboratories
540 Alder Dr.
Milpitas, CA 95035 | Contact: Annie Wright
Tel: (408) 468-3779
Fax: (408) 965-2026 |
|----|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| B. | Device Trade Name:
Common Name:
Classification Name:
Device Class:
Product Code: | Apollo Gamma Camera System
Gamma Camera Systems
Emission Computed Tomography System
21 CFR 892.1200, Class II
90 KPS |
| C. | Date prepared: | July 21, 2006 |
| D. | Predicate Device: | Forte™ Gamma Camera System (K033254) |

E. Intended Use:
The Apollo Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

Intended Use / Indications for Use

Product codes

Device Description

§ 892.1200 Emission computed tomography system.

510(k) SUMMARY SAFETY AND EFFECTIVENES

Device Description: F.