GEMINI IMAGING SYSTEM

K013521 · Adac Laboratories · JAK · Nov 7, 2001 · Radiology

Device Facts

• Record ID: K013521
• Device Name: GEMINI IMAGING SYSTEM
• Applicant: Adac Laboratories
• Product Code: JAK · Radiology
• Decision Date: Nov 7, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

GEMINI is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. The GEMINI produces attenuation and non-attenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as x-ray transmission images of these areas. The PET and CT images are registered and displayed in a fused image, providing both functional and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. GEMINI can provide CT data suitable for use in attenuation correction.

Device Story

GEMINI is a hybrid PET/CT imaging system integrating an ADAC ALLEGRO PET scanner and a Marconi MX8000 CT scanner into a single housing. The system acquires PET metabolic data and CT anatomical data, which are registered and fused for clinical interpretation. It operates in three modes: CT-only, PET-only, or combined PET/CT. The system features a separation mechanism to increase distance between PET and CT gantries for improved patient access and a dedicated table to minimize room requirements. Operated by trained health professionals in a clinical setting, the device provides attenuation-corrected PET images using CT-derived transmission maps. This fusion of functional and anatomical data facilitates faster diagnostic decision-making compared to separate imaging procedures.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including performance measurements of the ALLEGRO PET system according to NEMA-NU2 standards, evaluation of image quality using clinical phantoms, and verification of safety standards (IEC 60601-1, IEC 60601-2, IEC 60825-1, UL 2601-1, CAN/CSA-C22.2).

Technological Characteristics

Hybrid PET/CT system. PET component: GSO-based detectors (ALLEGRO). CT component: Dual-slice CT (MX8000). Connectivity: Integrated workstation for image registration and fusion. Standards: 21 CFR 1020.30-33 (CT radiation), IEC 60601-1, IEC 60601-2, IEC 60825-1, UL 2601-1, CAN/CSA-C22.2. Operation: Three modes (CT, PET, combined).

Indications for Use

Indicated for whole-body oncology imaging in patients requiring PET and CT diagnostic scans. Used for functional and anatomical localization of radiopharmaceutical distribution. Intended for use by trained health professionals.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• GE CT-PET (K010641)
• ADAC Allegro PET (K003434)
• EXACT CT PET (K002715)
• Marconi MX 8000 CT (K010817)

Submission Summary (Full Text)

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(012 510(k) SUMMARY OF SAFETY AND EFFECTIVENES

General Information

| 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: | GEMINI<br>Positron Emission Tomography |
| | Classification Name: | Computed Tomography X-Ray<br>System, Emission Computed Tomography, (892.1200)<br>System, Computed Tomography X-Ray, (892.1750) |
| | Device Class: | 21CFR 892.1200, Class II<br>21 CFR 892.1750, Class II |
| | Product Code: | 90 KPS and 90 JAK |
| C. | Date prepared: | October 5, 2000 |
| D. | Predicate Device: | GE CT-PET (K010641) ADAC Allegro PET, K003434<br>EXACT CT PET (K002715) Marconi MX 8000 CT, K010817 |
| E. | | Performance Standards 21 CFR 1020.30 – 1020.33 as applicable |

for Computed Tomography X-Ray, (892.1750)

Intended Use: E.

GEMINI is an imaging system that combines positron emission tomography (PET) and X-ray OLMINI is an imaging System that other attenuation and non-attenuation corrected images computed toniography. - The OEMIX in the head, body and total body as well as x-ray of the distribution of I ET radiophalmater The PET and CT images are registered and displayed in a transmission mages of these arcas: "XX" and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an by transd health professionals: "The RET or CT system. GEMINI can provide CT data suitable for use in attenuation correction.

F. Device Description:

The GEMINI hybrid PET/CT system is a combined positron emission tomography and X-100 The OLMIN Hyorathy scanner. This system uses the ADAC ALLEGRO PET system, K003434, Computed tonlogiaply Seather. "This Systems MX8000-v5.0 CT, K010817. The GEMINI integrates the two and the Marcon Meanen of on a single workstation to allow straightforward planning and system system operator consores mo the MX8000 CT system gantries remain intact as major operation. The PEEDOricated within a common integrated housing. It can be used in any subsydent components rocedures, which have been clinically conducted in a separate CT system end/or a PET system. No modifications have been made to either system, which would affect system performance.

performanos:
GEMINI is intended for use primarily as a clinical whole body oncology scanner with high-end dual slice CT capability and high-end GSO based PET performance. It mechanically might one data. Biros of capreater flexibility for above three operation modes. The availability of

GEMINI 510(k) Notification ADAC Laboratories

Section X.-1-1

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K013521
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low dose tomographic data sets implies that a natural extension of the ALLEGRO based cesium source attenuation correction to a CT transmission map attenuation correction exists. The primary purpose, however, of the CT is to provide precise anatomical localization for the metabolically significant positron emission distributions imaged on the PET system. These images when properly registered and displayed as a fused image, provide both functional and anatomical information with reliable spatial correspondence in a single image.

Comparison to Predicate Device: G.

The predicate devices, GE CT-PET (Discovery LS) and the ECAT CT-PET (Biograph) are similar to the GEMINI in that all of the devices consist of a full functional CT and PET. The patient may have a diagnostic CT and PET scan performed consecutively without having to move the patient. The GEMINI provides a mean to reach the diagnostic decision faster than the conventional way of imaging patients with both CT and PET systems in separate locations. The differences are the area of overall system dimensions, room size requirements, scanning length, and ease of use.

The GEMINI CT-PET is designed so that the system can operate in three modes: CT only, PET only and combined CT/PET. The major difference is that the GEMINI imaging system has a separation system that allows the distance of the CT and PET units to be increased. This feature provides easy access to the patient. GEMINI provides a newly developed dedicated PET/CT table to minimize the system room requirements

H. System Performance Test:

- The MX 8000 v.5.0 is manufactured in accordance with Performance Standards in 21 ● CFR 1020.30 -- 33.
- ALLEGRO system performance was measured according to the NEMA-NU2 standard. . In addition, clinical phantoms with clinical protocols were used to evaluate ALLEGRO image quality in terms of the noise texture and contrast of the image.
- The GEMINI complies with voluntary standards for safety and effectiveness (IEC 60601-. 1, IEC 60601-2, IEC 60825-1, UL 2601-1, & CAN/CSA-C22.2 and is tested to demonstrate the hazards, i.e., electrical, mechanical, and radiation have been minimized.

## I. Conclusion:

The GEMINI Imaging System is substantially equivalent to the predicate devices, the GE CT-PET (K010641) and the EXACT CT-PET (K002715) based upon similar intended use, technological comparison, and system performance.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 0 7 2001

ADAC Laboratories % Michael Kwan, Ph.D. Principal Reviewer/Office Coordinator Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169

Re: K013521

Trade/Device Name: GEMINI PET-CT Device Combined PET/CT System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 KPS Product Code: 90 JAK Dated: October 22, 2001 Received: October 23, 2001

Dear Dr. Kwan:

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 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 this 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" (21 CFR Part 807.97). 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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## NOV 0 7 2001

INDICATIONS FOR USE STATEMENT

510 (k) NUMBER (if KNOWN): _ KO1352 / 1

DEVICE NAME:

GEMINI

ADAC Laboratories SPONSOR NAME:

## INDICATIONS FOR USE:

GEMINI is an imaging system that combines positron emission tomography (PET) and CEMINI is an inflaging system that como produces attenuation and non-attenuation A-1ay computed tonlography. corrected images of the distribution of I D F ranspition images of the PET and CT images tolal body as well as x-ray transmission. Integories combined PET and anatomical all registered and displayed in a etation by trained health professionals. The PET and data at different angles for merpretained by ther as an integrated system or as a stand-alone CT portions on the system can or arouvide CT data suitable for use in attenuation correction.

(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) | <span style="text-decoration: overline;">✓</span> |
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OR

| Over-The-Counter-Use (Optional Format 1-2-96) | _________________ |
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✓
Nancy C brigdon

(Division Sign-Off)
Division of Reproductive, Abdominal,