(32 days)
Gammacell 1000 Elite, Gammacell 3000 Elan
No
The device description and performance studies focus on basic timing, counting, and safety functions, with no mention of AI or ML terms or concepts.
Yes
The device is used to treat cellular blood products to prevent graft versus host disease, which is a therapeutic purpose.
No
The device is described as an irradiator for cellular blood products to prevent graft versus host disease. Its function is to modify the blood products through irradiation, not to diagnose a medical condition.
No
The device description clearly outlines a physical irradiator with mechanical components (beaker, gammacell, safety door, movement to irradiation position) and a timer, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "irradiate cellular blood products to inactivate T-lymphocytes in order to prevent graft versus host disease." This is a therapeutic or preventative treatment applied to a biological product (blood) before it is administered to a patient.
- Device Description: The description details a process of irradiating blood products. This is a physical process applied to the sample, not a test or analysis performed on the sample to provide diagnostic information about a patient's condition.
- Lack of Diagnostic Elements: There is no mention of analyzing the blood product for any markers, substances, or characteristics to diagnose a disease or condition. The device's function is purely to modify the blood product itself.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such an examination.
N/A
Intended Use / Indications for Use
To irradiate cellular blood products to inactivate T-lymphocytes in order to prevent graft versus host disease.
Product codes
MOT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Gammacell 1000 Elite, Gammacell 3000 Elan
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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 Nordion |
| 447 March Road | |
| Ottawa, Ontario K2K 1X8 | |
| Canada | |
| Tel. (613) 592-3400 | |
| Fax. (613) 592-2006 | |
| Contact Person | Mr. Ross Kachaniwsky |
| Director, Quality & Regulatory Affairs | |
| Device Name | Gammacell 1000 Elite |
| Gammacell 3000 Elan | |
| Common Name | Blood Irradiator |
| Classification Name | Blood irradiators have not been classified |
| Legally Marketed Predicate Device | Gammacell 1000 Elite |
| Gammacell 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.
1
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.
2
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.
3
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
4
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