FORTE

K982911 · Adac Laboratories · KPS · Nov 16, 1998 · Radiology

Device Facts

• Record ID: K982911
• Device Name: FORTE
• Applicant: Adac Laboratories
• Product Code: KPS · Radiology
• Decision Date: Nov 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

Vertex Ultra is intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

Device Story

Vertex Ultra is a gantry-based gamma camera system for nuclear medicine imaging. It utilizes single or dual detectors to capture emissions from radioisotopes within the patient. The system includes a gantry, detectors, collimator storage, acquisition computer, patient table, and remote controller. It supports various imaging modes: static, dynamic, gated, total body, ECT, and gated SPECT. The open-frame gantry accommodates standing, seated, or supine patients, with a removable table for wheelchair or gurney access. Acquisition software manages detector motion and protocol strings for customized clinical procedures. Medical personnel operate the system to acquire images, which are then interpreted to assess anatomical distribution of radioisotopes, aiding in clinical diagnosis and treatment planning.

Clinical Evidence

Bench testing only. Evidence includes flood phantom images to demonstrate field uniformity and center of rotation (COR) testing to verify detector alignment.

Technological Characteristics

Gantry-based gamma camera system with single or dual detectors. Features open-frame design, mechanized patient table, and acquisition computer. Supports circular and non-circular orbital ECT, coincidence imaging, and gated SPECT. Connectivity includes acquisition software for protocol management. No specific materials or software architecture details provided.

Indications for Use

Indicated for patients requiring nuclear imaging to visualize the anatomical distribution of single photon and positron emitting radioisotopes. Used for static, dynamic, gated, total body, ECT, and gated SPECT 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

• Siemens E.CAM Profile AC
• Millennium MT & MG

Submission Summary (Full Text)

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K982911

Vertex Ultra ADAC Laboratories 510(k) Premarket Notification

Appendix VIII, 510(k) Summary of Safety and Effectiveness Data Page 1 of 2

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

#### I. General Information

| A. | Submitted By: | ADAC Laboratories<br>540 Alder Drive<br>Milpitas, CA 95035<br>Tel: [phone]<br>Fax: [phone] |
|----|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| | Contact Person: | Dennis Henkelman at address above |
| B. | Device Trade Name:<br>Common Name:<br>Classification Name: | Vertex Ultra<br>Gamma Camera System<br>System, Emission Computed Tomography |
| C. | Predicate Device: | Siemens E.CAM Profile AC<br>Millennium MT & MG |

#### D. Device Description:

Vertex Ultra is a gantry (ring type) device designed for single- or dual-detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes the gantry frame, two detectors, a collimator storage cabinet with acquisition computer unit, a patient imaging table, and a remote hand controller. The Vertex Ultra gantry is an "open" frame permitting easier access for imaging of standing, seated, and supine patients. The patient imaging table (pallet) is mechanized for patient loading access and for movement during imaging studies; or the pallet may be removed by the operator for imaging of patients in wheelchairs, beds, or gurneys.

Vertex Ultra 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 relative 90° or relative 180° positions (as study appropriate),

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static, dynamic, gated, total body and ECT studies (circular orbit), non-circular orbital ECT, coincidence imaging, and gated SPECT (circular and non-circular orbit) imaging studies can be performed with or without a previously cleared ADAC attenuation correction option. In addition, Vertex Ultra acquisition software can be programmed to complete multiple imaging studies called protocol strings, which involve a combination of several imaging studies collected for use in customized clinical procedures.

- Indications for Use: E.
Vertex Ultra is intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

- F. Technological Comparison:
Vertex Ultra, Siemens E. CAM, and GE Millennium have similar indications for use as well as open and/or ring type gantries and pre-programmed detector motions, and perform the same type of study acquisitions.

#### II. Testing

Flood phantom images were produced to demonstrate acceptable field uniformity. In addition, center of rotation (COR) testing was performed to verify proper alignment.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dennis W. Henkelman Director, Regulatory Affairs and Quality Assurance ADAC Laboratories 540 Alder Drive Milpitas, CA 95035

Re: K982911

> Gamma Camera System Dated: August 17, 1998 Received: August 18, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Henkelman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrividsmadsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/2/Picture/14 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and is composed of three curved lines that form the head, body, and tail feathers.

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): 《9829 //

Device Name: Vertex Ultra

Sponsor Name: ADAC Laboratories

### Indications for Use

Vertex Ultra is intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Over-The-Counter Use

David h. Symon
__

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number