GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0

K963497 · Nordion International, Inc. · MOT · Nov 8, 1996 · RA

Device Facts

• Record ID: K963497
• Device Name: GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0
• Applicant: Nordion International, Inc.
• Product Code: MOT · RA
• Decision Date: Nov 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

Both the improved and the predicate device effectively irradiate blood and blood components to inactivate leukocytes and lymphocytes.

Device Story

Blood irradiator; uses Caesium-137 source to inactivate leukocytes/lymphocytes in blood products. Operator places blood in beaker; loads into unit; closes safety door; initiates cycle via start button. Device moves beaker to irradiation position; rotates continuously for uniform dose; timer counts down pre-programmed duration. Upon completion, sample returns to unload position; audible alarm sounds; status displayed on panel. Used in clinical/laboratory settings; operated by trained personnel. Modified control system (Version 1.0) improves user interface; simplifies display panel; enhances security/access controls; improves electromagnetic interference (EMI) resistance. Output confirms cycle completion or displays specific error messages. Benefits include consistent, controlled irradiation of blood components.

Clinical Evidence

Bench testing only. Performance validated against functional specifications in simulated operating environment. Testing covered security, safety functions, operational features, timing/counting, backup timer, beaker rotation sensing, and operator interface. Results demonstrate the device meets functional requirements and is as safe and effective as the predicate.

Technological Characteristics

Blood irradiator using Caesium-137 source. Control system Version 1.0. Features include beaker rotation mechanism, independent backup timer, and beaker rotation sensing system. Designed for electromagnetic compatibility (EMC) and electrical safety per Canadian Standards Association (CSA) standards.

Indications for Use

Indicated for the irradiation of blood and blood components to inactivate leukocytes and lymphocytes.

Predicate Devices

• Gammacell 3000 Elan, Version 2.09 (K952291)
• Gammacell 1000 Elite, Version 2.09 (K952291)

Submission Summary (Full Text)

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A Tradition of Excellence
1946-1996
NORDION INTERNATIONAL INC.
K963497
NOV - 8 1996

# 510K SUMMARY OF SAFETY AND EFFECTIVENESS

1. Submitter’s Name: Nordion International Inc.
Submitter’s Address: 447 March Road
Kanata, Ontario
CANADA K2K 1X8
Submitter’s Telephone No.: [phone]
Contact Person: Mr. Grant Malkoske
Vice-President
Quality, Regulatory Affairs and Operations
Services
Date Summary Prepared: August 27, 1996

2. Common or Usual Name: Blood irradiator.
Proprietary Name: Gammacell 3000 ELAN, Version 1.0
Gammacell 1000 ELITE, Version 1.0

3. Legally Marketed Device: Gammacell 3000 Elan, Version 2.09
Gammacell 1000 Elite, Version 2.09
File Number of Last 510(k): K952291

447 March Road, Kanata, Ontario, Canada K2K 1X8 Tel.: [phone] Fax: [phone]

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## 4. Product description:

The modified Gammacell E- series Blood Irradiator models, the 1000 Elite and the 3000 Elan use the new software version 1.0 control system. With the exception of the modified control system, the 1000 Elite and 3000 Elan are identical to previously cleared models.

The basic operation of an irradiator involves placing of the blood product into the beaker, loading the beaker into the Gammacell, closing the safety door and pressing the “start” button. Upon start of the cycle, the unit moves the beaker to irradiate position and rotates the blood product continuously at a uniform speed to provide a consistent dose of irradiation. Concurrently, the timer begins to count down (irradiation time is pre-programmed by the site supervisor) from the set time and when the time reaches zero, the sample returns to unload position and the audible alarm sounds. If the cycle is completed as pre-programmed the message “cycle completed OK:” is displayed. Any problems in the irradiation cycle will be displayed specifically and clearly.

## 5. Intended Use:

The intended use of the modified Gammacell with version 1.0 control system remains unchanged. Both the improved and the predicate device effectively irradiate blood and blood components to inactivate leukocytes and lymphocytes.

## 6. Technological Comparison:

The basic function of the Gammacell 1000 Elite and Gammacell 3000 Elan with the modified control system has not been changed from the predicate Gammacell 1000E and 3000E. However, some technological changes are being made to the control system primarily to make the unit more user friendly. Precisely, the operator display panel has been simplified, and the information and error messages displayed on the panel have been written so that they can be readily understood by the operator. The access to the machine is effectively controlled through enhanced security and access controls. In addition, the modified unit is proven to withstand any electromagnetic interference that may affect the function of the control system.

## 7. Safety and Efficacy:

### Safety:

The safety of the Gammacell is equivalent or better than the predicate device. The irradiation source and the radioactivity of the caesium-137 source(s) remains unchanged.

In terms of electrical safety, all units are designed to comply with applicable standards of the Canadian Standards Association and are certified as such by the CSA. In addition, the modified units are tested and demonstrated for compliance with Electromagnetic Compatibility (EMC).

### Efficacy:

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The performance of the device was tested against a set of functional specifications in an environment which simulated, as much as possible, the actual operating environment. The functional requirements included security and safety functions, operational features, timing and counting functions, ancillary equipment such as independent Backup Timer and Beaker Rotation Sensing System, operator interface etc. Validation testing results provide documented evidence that the equipment design tested, adequately meets the functional requirements and the device is as safe and effective as the predicate device.

## 8. Conclusion:

Although some new features have been added to the new control system, mainly for the purpose of operator conveniences, these new features in no way compromise the intended use, safety or effectiveness of the device. The modified device models, with Version 1.0, are substantially equivalent to the 510(k) cleared models with Version 2.09

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