(32 days)
To irradiate cellular blood products to inactivate T-lymphocytes in order to prevent graft versus host disease.
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 moved the beaker to the irradiation position. 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 the unload position and the audible alarm sounds.
This 510(k) summary describes a modification to an existing medical device, the Gammacell 1000 Elite and Gammacell 3000 Elan blood irradiators. The submission focuses on demonstrating substantial equivalence to the previously marketed versions (Gammacell 1000E and 3000E, K963497) due to a specific design change.
Acceptance Criteria and Device Performance Study:
The primary acceptance criteria for this 510(k) submission are related to demonstrating that the modified devices maintain the same safety and effectiveness as their predicate devices, despite the internal design change. Since the change is specifically to replace an obsolete PCB and its associated firmware with a new board and operating system, the performance evaluation centers on ensuring that the core functionality, safety systems, and intended use remain unaffected.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety | Electrical safety compliance with IEC 60601-1 and IEC 60601-1-2 (General requirements for safety and Electromagnetic Compatibility). | "The Gammacell 1000 Elite and 3000 Elan are designed to comply with IEC 60601-1, Medical Electrical Equipment. Part 1; General requirements for safety, and IEC 60601-1-2, Medical Electrical Equipment, Part 1; General requirements for safety; Electromagnetic Compatibility Requirements for Tests." |
| Overall safety equivalent or better than the predicate device. | "The safety of the Gammacell is equivalent or better than the predicate device." | |
| Effectiveness/Functionality | Maintenance of core functional requirements: irradiation process (species, timing, counting functions), ancillary equipment security, safety functions operation sensing system, and operator interface. | "The performance of the device was tested against a set of functional specifications in an environment that simulated, as much as possible, the actual operating environment. The functional requirements included species, timing and counting functions, ancillary equipment security and safety function's operation sensing system, operator interface, etc." |
| Control system design meets the same intended use requirements as the current model. | "The control system is designed to meet the same intended use and is based on the same requirements as the current model." | |
| No changes to interlock circuits, switches, motors, mechanical structure, shielding, outside appearance, irradiation source, or radioactivity of the Caesium-137 source(s). | "There are no changes to any interlock circuits, switches or motors.""There are no changes to the mechanical structure or shielding of the Gammacell and the outside appearance remains the same.""The irradiation source and radioactivity of the caesium-137 source(s) remains unchanged." | |
| Substantial Equivalence | Demonstrates substantial equivalence to the previously cleared predicate devices (K963497). | "The Gammacell 1000 Elite and Gammacell 3000 Elan are substantially equivalent to the previous versions of the Gammacell 1000E and 3000E (K963497)." |
2. Sample Size and Data Provenance:
- Test Set Sample Size: The document does not specify a numerical "sample size" in the context of typical clinical trials. Instead, the testing appears to be functional and engineering-based on the modified device itself. The "functional specifications" against which the device was tested constitute the "test set" in this engineering context.
- Data Provenance: The study is described as having been performed "in an environment that simulated, as much as possible, the actual operating environment." This suggests in-house testing and validation by MDS Nordion, rather than a multi-center clinical study with patient data. The country of origin of the data would be Canada, where MDS Nordion is located. The nature of the study is prospective, as it involves testing the newly modified device.
3. Number of Experts and Qualifications for Ground Truth:
- The document does not mention the use of external experts or a ground truth established by medical professionals in the typical sense for analyzing diagnostic images or clinical outcomes. The "ground truth" here is the established, known performance and safety requirements of the predicate device and relevant international standards (IEC 60601-1). The validation team at MDS Nordion and the independent test house (mentioned implicitly by "Independent body concluded that the device is as safe and effective as the predicate device") would have served as the "experts" in verifying compliance against these predefined engineering and safety standards. Their qualifications would be in electrical engineering, regulatory affairs, and quality assurance.
4. Adjudication Method:
- No adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as this was not a study involving human interpretation of data where consensus among multiple reviewers would be required. The "adjudication" was against predefined engineering specifications and international standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This submission is for an irradiator, a therapeutic device, and the changes are internal component replacements, not changes to the output that would require human interpretation.
6. Standalone (Algorithm Only) Performance Study:
- A standalone performance study was conducted in the sense that the modified device was tested by itself against its functional specifications and safety standards. The new embedded firmware and operating system represent the "algorithm" in this context, and its performance was directly evaluated. The text states: "The performance of the device was tested against a set of functional specifications in an environment that simulated... the actual operating environment." This describes a standalone, functional validation of the device's internal operations.
7. Type of Ground Truth Used:
- The ground truth used was a combination of:
- Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate devices (Gammacell 1000E and 3000E, K963497). The modified device must perform equivalently.
- Functional Specifications: Engineering specifications detailing the required operation of the irradiator, including timing, counting, safety interlocks, and operator interface.
- International Safety Standards: Compliance with electrical safety standards (IEC 60601-1 and IEC 60601-1-2).
8. Sample Size for the Training Set:
- The concept of a "training set" is not applicable here as this is not a machine learning or AI development project that requires data for model training. The "training" for this device's new software would have been part of its development and debugging process, not a distinct "training set" in the context of clinical or image data.
9. How the Ground Truth for the Training Set Was Established:
- As a "training set" in the AI/ML sense is not relevant, this question does not apply. The functional behavior of the device's control system (which includes the new firmware and QNX operating system) was effectively the "product" of its development. The "ground truth" for its correct operation was established by the engineering design requirements and functional specifications, which would have been based on the predicate device's proven functionality and regulatory standards.
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Image /page/0/Picture/0 description: The image shows the logo for MDS Nordion. The logo consists of the text "MDS Nordion" in bold, black letters. Below the text is the tagline "Science Advancing Health" in a smaller, italicized font. There is a curved line above the "MDS" part of the logo.
510(k) SUMMARY
MAY 2 0 2005
KOSOGG
| Date Summary Prepared | April 13, 2005 |
|---|---|
| Submitted by | MDS Nordion447 March RoadOttawa, Ontario K2K 1X8CanadaTel. (613) 592-3400Fax. (613) 592-2006 |
| Contact Person | Mr. Ross KachaniwskyDirector, Quality & Regulatory Affairs |
| Device Name | Gammacell 1000 EliteGammacell 3000 Elan |
| Common Name | Blood Irradiator |
| Classification Name | Blood irradiators have not been classified |
| Legally Marketed Predicate Device | Gammacell 1000 EliteGammacell 3000 Elan |
Description of Device
The basic operation of an irradiator involves placing of the blood product into the beaker, loading the The backs operation and and the safety door and pressing the 'start' button. Upon start of the beaker into the cammadoli, olosing the career in and rotates the blood product continuously at a eyole, the anit moved the boater to the hradiation. 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 the unload position and the audible alarm sounds.
Intended Use of Device
To irradiate cellular blood products to inactivate T-lymphocytes in order to prevent graft versus host disease.
Summary of Technological Characteristics
The Gammacell 1000 Elite and Gammacell 3000 Elan are substantially equivalent to the previous versions of the Gammacell 1000E and 3000E (K963497).
The design change is to replace an obsolete PCB, which is programmed with embedded firmware, with a The dooigh onange to to to the new board has a QNX operating system and functional software applications. There are no changes to any interlock circuits, switches or motors. The operator interface applications: There are no the existing microprocessors and embedded firmware. There are no significant remains anonanya min oad for control of the power supply circuit. The control system is designed to oneet the same intended use and is based on the same requirements as the current model. There are no new features.
There are no changes to the mechanical structure or shielding of the Gammacell and the outside appearance remains the same.
The irradiation source and radioactivity of the caesium-137 source(s) remains unchanged.
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Safety & Effectiveness
The safety of the Gammacell is equivalent or better than the predicate device.
In terms of electrical safety, the Gammacell 1000 Elite and 3000 Elan are designed to comply with
- IEC 60601-1, Medical Electrical Equipment. Part 1; General requirements for safety, and .
- IEC 60601-1-2, Medical Electrical Equipment, Part 1;General requirements for safety; .
- Electromagnetic Compatibility Requirements for Tests The performance of the device was tested against a set of functional specifications in an environment that i rie penominance of the actual operating environment. The functional requirements included
Simulated, as must as poolible, the actual species, timing and counting functions, ancillary equipment security and barry fanolion's operation sensing system, operator interface, etc. Such as Indopendont backed that the device is as safe and effective as the predicate device.
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Image /page/2/Picture/1 description: The image shows a circular logo with a stylized depiction of an eagle or similar bird with three prominent lines representing its body or wings. The logo is encircled by text, which appears to be part of the organization's name or a related phrase. The overall design is simple and symbolic, likely representing a government agency or organization.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2005
Mr. R. Kachaniwshy Director, Quality & Regulatory Affairs MDS Nordion 447 March Road Ottawa, ON K2K 1X8 CANADA
Re: K050963 Trade/Device Name: Gammacell 1000 Elite Gammacell 3000 Elan Regulation Number: None Unclassified Product Code: MOT Dated: April 15, 2005 Received: April 20, 2005
Dear Mr. Kachaniwshy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your boonon 970(s) personalially equivalent (for the indications for use stated in above and have decemined the ad predicate devices marketed in interstate commerce prior to the enclosules to regary maneloa problem Medical Device Amendments, or to devices that have been May 26, 1976, the Chacultion and of the Federal Food, Drug, and Cosmetic Act (Act) that reciassified in accordation while provision (PMA). You may, therefore, market the do not require approvat of a prematice approvisions of the Act. The general controls provisions of the Act device, subject to the general controls provises, 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 It your device is classified (35c above) into only in the major regulations affecting your Approval), It may of Subject to Such assist Regulations, Title 21, Parts 800 to 898. In addition, FDA device can be found in the observents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that I DA's Issualled of a successions with other requirements of the Act or any
FDA has made a determination that your device complies with other requireme FDA has made a delemination mar your ao rout as received agences. You must comply with all the Federal statues and regulations administer of variation and listing (21 CFR Part 807); abeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set forth (21 CFR Part 801), good namazoning practice to product radiation control 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) This letter will anow you to begin marketing your as not of your device of your device to a legally premarket notification. The FDA finding of substantial of 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 If you desire specific advice for your device of var labeling regulation (
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "frisornation on your responsibilities under the Act from the 807.97). You may obtain other getteral information on your respensions of its toll-free number (800) DIVISion of 301) 443-6597 or at its Internet address 056-2011-01-01-01-2019/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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
510(k) Number: K050963
Device Name:
Gammacell 1000 Elite Gammacell 3000 Elan
Indications For Use:
To irradiate cellular blood products to inactivate T-lymphocytes in order to prevent graft versus host disease.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Nancy C Brogdon
(Division Sign-Off)
Division of Remediation
and Radiologica 12070662
N/A