ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING]

K031872 · Adac Laboratories · KPS · Jun 20, 2003 · Radiology

Device Facts

• Record ID: K031872
• Device Name: ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING]
• Applicant: Adac Laboratories
• Product Code: KPS · Radiology
• Decision Date: Jun 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Ultra-High Energy General Purpose Collimator (UHGP) is intended to be used to detect and image the distribution of high-energy photons from an administered positron-emitting radioactive agent in the human body, specifically cardiac imaging. The Ultra-High Energy General Purpose Collimator (UHGP) will be used on the dual detector Forte Gamma Camera (K982911) and on the dual detector Vertex Gamma Camera (K922080).

Device Story

UHGP collimator is an optional accessory for Forte and Vertex gamma cameras; designed for 511 keV ultra-high energy radiopharmaceuticals. Device consists of lead core, frame, and cover; functions by collimating gamma rays emitted from patient to detector to form images. Used in nuclear medicine clinics by trained professionals. Includes collision sensor (2-2.75 psi threshold) and fail-safe latching mechanism for patient safety. Exchange process is manual or semi-automatic via preprogrammed camera motion. Output is raw data for standard gamma camera processing/display software. Improved spatial resolution compared to predicate; enables cardiac imaging with positron-emitting agents.

Clinical Evidence

Bench testing only. Performance measured per NEMA NU1:1994 standards. Verification testing, risk assessment, and stress analysis performed. No clinical study data provided.

Technological Characteristics

Lead core collimator; 300 lbs; 2.7 mm hole size, 60 mm septal length, 2.3 mm septal thickness. Includes collision sensor and fail-safe latching mechanism. Designed for 511 keV energy range. Compatible with Forte and Vertex gamma camera systems. No new software or electronics; utilizes existing camera system software for exchange and imaging.

Indications for Use

Indicated for detection and imaging of high-energy photons from administered positron-emitting radioactive agents in the human body for cardiac imaging (planar and SPECT). Used on Forte and Vertex gamma camera systems.

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

• UHE Collimator (Option to the PRISM 3000 Gamma Camera System) (K963406)

Reference Devices

• Forte Gamma Camera (K982911)
• Vertex Gamma Camera (K922080)

Submission Summary (Full Text)

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JUN 2 0 2003

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## General Information

| A. | Submitted By:<br>ADAC Laboratories<br>540 Alder Dr.<br>Milpitas, CA 95035 | Contact: Charlene Brumbaugh<br>Tel: [phone]<br>Fax: [phone] |
|----|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| B. | Device Trade Name: | Ultra-High Energy General Purpose Collimator<br>[for cardiac imaging] |
| | Models: | Ultra-High Energy General Purpose Collimator<br>(UHGP) |
| | Common Name: | Collimator |
| | Classification Name: | 511 keV Ultra-High Energy Collimator (UHEC) for<br>SPECT (21CFR 892.1200) |
| | Device Class: | 21CFR 892.1200, Class II |
| | Product Code: | 90 KPS |
| C. | Date prepared: | June 3, 2003 |
| D. | Predicate Device: | UHE Collimator (Option to the<br>PRISM 3000 Gamma Camera System) K963406 |

E. Intended Use:

> The Ultra-High Energy General Purpose Collimator (UHGP) is intended to be used to detect and image the distribution of high-energy photons from an administered positron-emitting radioactive agent in the human body, specifically cardiac imaging. The Ultra-High Energy General Purpose Collimator (UHGP) will be used on the dual detector Forte Gamma Camera (K982911) and on the dual detector Vertex Gamma Camera (K922080).

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#### Device Description: F.

The Ultra-High Energy General Purpose Collimator (UHGP) is an optional device for the Forte™ and Vertex™ gamma camera systems, similar to conventional low energy collimators. It was developed to collimate the gamma rays emitted perpendicularly from a patient to a gamma ray detector, so that a proper image can be formed. This design concept is essentially the same as other conventional lower energy collimators used in Nuclear Medicine clinics, except that the current device is intended for ultra-high energy (511 keV) radiopharmaceuticals. Hence, the focus of the design elements are 1) proper hole size and thickness to provide proper spatial resolution and sensitivity for clinical use and 2) a proper mechanical mechanism to ensure safety.

The UHGP collimator consists of three major components: the collimation core, collimator frame, and collimator cover. The weight of this collimator is 300 pounds. The detailed parameters are shown on the following page in Table 4-1. The collimator core is made of lead. The hole size, the septal length, and septal thickness are 2.7, 60 and 2.3 mm, respectively. The collimator frame is used to support the core and connect to the detector buckets. For the Forte and Vertex systems, the frame and core size are the same as shown by the specification for the imaging Field of View (FOV). See the table below. The collimator cover is used to prevent direct patient contact with the lead core. More importantly, it has a collision sensor to prevent any unexpected detector motion resulting in collimator contact with patient, including un-intended detector radius move-in by operators.

Similar to other conventional low energy collimators, the UHGP collimator can be stored in a standard collimator storage device shipped with the base camera. The collimator storage devices are different for different base cameras (as shown in Figures 3 and 5), but all of the storage designs take the dimensions and mechanical strength of the UHGP into consideration.

The collimator exchange is done either manually as in the case of the Vertex manual camera , or semi-automatically as in case of the Forte camera and the Vertex auto camera. In all cases, the operator needs to activate the preprogrammed exchange motion program. The program will prompt the operator to proceed through the steps necessary for the exchange. In addition, the preprogrammed program will provide pre-cautionary warnings to the operator during the critical steps for safety precaution. These exchange procedures are the same as in the case of conventional collimator exchange.

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The mechanical design of the gantry for the above named camera systems, Forte and Vertex, was reviewed for strength, deflection and motion control. It was deemed that these systems are capable of supporting the weights of collimators specified. A separate risk assessment is provided in Section 9.

The detector bucket in each of the above named cameras has the same design, and the detector bucket in each camera is well shielded against 511 kev. The shielding thickness varies from 0.9" close to the front of PMT tubes to 0.7" close to the back of PMT tubes. This provides enough shielding from both the random activity caused by other patients walking through the hall way and the scatter activity from the patient himself.

The UHGP collimator has two mechanisms to safeguard patients. The first one is the collimator collision sensor. It will halt any camera motion when the collimator surface is subjected to a pressure of 2 - 2.75 psi. The second safeguard is the fail-safe latching mechanism that locks the collimator all the time, unless it is activated intentionally by the operator. There is no additional software development for UHGP collimator itself. The pre-programmed collimator exchange program in the Forte camera and the Vertex camera is the exactly the same program used for the conventional collimator. Additionally, there is no new processing/display software for this collimator. Any processing and display software, which is used for other conventional collimators, can be used by trained medical professionals with their discretion.

#### G. Comparison to Predicate Device:

Since collimators are very straightforward devices, the key performance index of the devices are the resolution, sensitivity, and mechanical safety. The current device provides a better resolution than the predicate device. This, in turn, will improve the image quality. However, the sensitivity for the current device is lower than the predicate device due to the better resolution. It is 174 cpm/uCi. But, this is very comparable to the low energy collimators. Hence, it is deemed adequate from the sensitivity point of view.

The table on the following page shows the specifications of the Picker UHE - the predicate device - compared to the UHGP. For comparison, a conventional collimator, HEGP - High Energy General Purpose, is also listed in the table. One item to note is the weight of the HEGP: it is heavier than the Picker Predicate Device.

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ーー。 :

## Comparison To Predicate Device

| Specifications | This application (Current device)<br>UHGP Collimator<br><br>For use on the<br>Forte Gamma Camera<br>and the Vertex Gamma<br>Camera | Predicate device<br>Picker UHE collimator<br>Triple head camera<br>K963406 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| intrinsic resolution= | <3.5 | 3.9 |
| Septal length (mm)= | 60 | 77 |
| hole size(mm)= | 2.7 | 5.08 |
| sep. thickness(mm)= | 2.3 | 3.43 |
| Weights/per collimator | 300 lbs | 220 lbs |
| Collimation per camera | 2 | 3 |
| Imaging FOV | 20x15" | 20x15" |
| Latching mechanism | Software control | Software control |
| Bucket shielding | 0.7-0.9" | Unknown |
| Planar Resolution:<br>Distance (cm) | Resolution | Resolution |
| 0 | <=6.0 mm | 7.01 |
| 5 | <=8.0 mm | 10.65 |
| 10 | <=10.0 mm | 14.53 |
| 15 | <=14.5 mm | 18.50 |
| 20 | <=17.0 mm | 22.51 |
| sensitivity<br>(cpm/μCi) - 511keV | <174 | 435 |
| Septal penetration(%) | 4.6 | 3.5 |

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### H. System Performance Test:

The Ultra-High Energy General Purpose Collimator (UHGP) performance was measured according to the NEMA NU1: Performance Measurements of Scintillation Cameras (1994). Clinical images were also examined.

In addition, a Verification Test was performed to test the functionality, as well as Risk Assessment and Stress Analysis were performed.

- I. Conclusion:
The Ultra-High Energy General Purpose Collimator (UHGP) [for cardiac imaging] is substantially equivalent to the predicate device based upon similar intended use, technological comparison, and system performance.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle or bird-like figure with three stylized lines forming its body and wings. The text is arranged around the top half of the circle, with the symbol occupying the center.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 0 2003

ADAC Laboratories % Mr. Morten Christensen Office Coordinator, 510(k) Review Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169 Re: K031872

Trade/Device Name: Ultra-High Energy General Purpose Collimator (UHGP) [for cardiac imaging] Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: June 13, 2003 Received: June 17, 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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# INDICATIONS FOR USE STATEMENT

510(k) NUMBER (IF KNOWN): KC31872

The Ultra-High Energy General Purpose Collimator (UHGP) DEVICE NAME: [for cardiac imaging]

ADAC Laboratories SPONSOR NAME:

### Nuclear Medicine Device

### Indications For Use:

To detect and image the distribution of high-energy photons from an administered positron-emitting radioactive agent (radionuclides) in the human body, specifically cardiac imaging. The Ultra-High Energy General Purpose Collimator (UHGP) will be used on the dual detector Forte Gamma Camera (K982911) and on the dual detector Vertex Gamma Camera (K922080).

| | Technique | Yes | Imaging method | Energy Range (keV) |
|----|---------------------------|-----|-----------------------------------------|--------------------|
| A. | Planar Cardiac<br>Imaging | X | Positron imaging<br>without coincidence | 511 keV emitters |
| B. | SPECT Cardiac<br>Imaging | X | Positron imaging<br>without coincidence | 511 keV emitters |

(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

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

David R. Seaman

510(k) Numl