← Product Code MOT · K032684 # RAYCELL (K032684) _Mds Nordion · MOT · Sep 26, 2003 · RA · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K032684 ## Device Facts - **Applicant:** Mds Nordion - **Product Code:** MOT - **Decision Date:** Sep 26, 2003 - **Decision:** SESE - **Submission Type:** Special - **Device Class:** Class U - **Review Panel:** RA - **Attributes:** Therapeutic ## Indications for Use The Raycell™ Shielded Cabinet X-ray System is intended for the irradiation of blood and blood products packaged in transfusion bags when irradiation to reduce the risk of Graft versus Host Disease is indicated, and is used in accordance with "Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products" (22 July 1993 memorandum from Acting Director, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA to all registered blood establishments). ## Device Story Cabinet X-ray system for blood product irradiation; utilizes two vertically opposed X-ray tubes to deliver ionizing radiation to transfusion bags. System components include sample holder (canister), dual power supplies, radiation shielding, control electronics, and cooling assemblies. Operated in clinical/blood establishment settings to mitigate graft-versus-host disease risk. Device functions via fixed-geometry X-ray exposure; operator controls manage irradiation process. Output is irradiated blood product suitable for transfusion. Benefit is reduced risk of transfusion-associated complications. ## Clinical Evidence No clinical data. Substantial equivalence is based on identical technological characteristics and design to the predicate device. ## Technological Characteristics Cabinet X-ray system; 160 kVdc X-ray source; 0.38 mm copper beam filtration; 3 Gy min-1 dose rate; max/min dose ratio <1.3; Pb shielding; safety interlocks; fixed sample holder. ## Predicate Devices - RS 3000 Shielded Cabinet X-Ray Blood Irradiator ([K974210](/device/K974210.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ SEP 2 6 2003 Image /page/0/Picture/1 description: The image shows the logo for MDS Nordion. The logo consists of the text "MDS Nordion" in a bold, sans-serif font, with a curved line above the "MDS" portion. Below the main text, in a smaller, italicized font, is the tagline "Science Advancing Health." 447 March Road Ottawa, ON K2K 1X8 Tel: + 1 613 592 2790 Fax: +1 613 592 6937 www.mds.nordion.com Canada 532684 page 1 of 2 # Section 2.0 ## 510(k) Summarv Prepared Auqust 25, 2003 2.1 Submitter: MDS Nordion Tel: Fax: 447 March Road Ottawa, Ontario K2K 1X8 CANADA 613-592-3400 x2372 613-592-2006 Contact Person: E. S. Martell, Vice President Quality & Regulatory Affairs 447 March Road Ottawa, Ontario K2K 1X8 CANADA - 2.2 Device Manufacturer: MDS Nordion 447 March Road Ottawa, Ontario K2K 1X8 CANADA - 2.3 Device Name: Raycell™ - 2.4 Classification Name: Blood irradiators have not been classified - Common or Usual Name: Cabinet X-Ray System 2.5 - 2.6 Legally Marketed Predicate Device: RS 3000 Shielded Cabinet X-Ray Blood Irradiator (K974210), see Appendix 1 for RS 3000 510(k) Notification. #### 2.7 Description of Device: The Raycell Shielded Cabinet X-ray System consists of a sample holder (canister) between the two (2) x-ray tubes, dual power supplies, radiation shielding, control electronics, cooling assemblies and operator controls. The radiation source of the Raycell™ Shielded Cabinet X-ray System includes of two vertically opposed xray tubes contained in a shielded enclosure. It is identical to the predicate device with the exception of labeling changes to reflect the new product name and identify MDS Nordion as the manufacturer. {1}------------------------------------------------ K032684 Page 2 of 2 #### 2.8 Intended Use of Device: The Raycell™ Shielded Cabinet X-ray System is intended for the irradiation of blood and blood products packaged in transfusion bags when irradiation to reduce the risk of Graft versus Host Disease is indicated, and is used in accordance with "Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products" (22 July 1993 memorandum from Acting Director, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA to all registered blood establishments). #### 2.9 Summary of Technological Characteristics: The Raycell is substantially equivalent to the RS 3000 (K974210). Both are indicated for the irradiation of blood and blood products to reduce the risk of transfusion-associated graft-versus-host disease in recipients at risk of this complication. MDS Nordion has not made any modifications to the RS 3000, with the exception of labeling changes to reflect the new name of the device "Raycell" and MDS Nordion as the manufacturer. The significant technological characteristics of the two devices are as follows: | Technological
Characteristics | RS 3000 | Raycell | |----------------------------------|----------------------------------------------------|---------| | Source | 160 kVdc x-rays | Same | | Beam filtration | 0.38 mm copper | Same | | Single beam HVL,
water | Approximately 4 mm | Same | | Dose rate | 3 Gy min¯¹ | Same | | Max/min dose ratio | <1.3 | Same | | Sample holder | Fixed, presents
maximum width,
minimum depth | Same | | Radiation Safety | Pb shielding, interlocks | Same | ### 2.10 Safety and Effectiveness: The Raycell is the same as the RS 3000 with the labeling changes to reflect the new device name and manufacturer. These labeling changes do not introduce new safety and effectiveness issues. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle. SEP 2 6 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 A. Warbick-Cerone Director, Regulatory Affairs MDS Nordion 447 March Road Ottawa, Ontario K2K 1X8 CANADA Re: K032684 Trade/Device Name: Raycell™, Catalog Number - GR2 Regulation Number: None Regulatory Class: Unclassified Product Code: 90 MOT Dated: August 25, 2003 Received: August 29, 2003 Dear Ms. Warbick-Cerone: 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. {3}------------------------------------------------ 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 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. Ixxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 to proceed to the market. {4}------------------------------------------------ Section 1.0 Indication for Use 510 (k) Number: k032684 Device Name: Raycell™ Indications For Use: The Raycell™ Cabinet X-ray System is intended for the irradiation of blood and blood products packaged in transfusion bags when irradiation to reduce the risk of Graft versus Host Disease is indicated, and is used in accordance with "Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products" (22 July 1993 memorandum from Acting Director, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA to all registered blood establishments). (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) (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number Ko 32684 --- **Source:** [https://fda.innolitics.com/device/K032684](https://fda.innolitics.com/device/K032684) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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