(30 days)
The Raycell" X-ray Blood Irradiator is intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease (GVHD) in accordance with applicable FDA, AABB, Health Canada, and European guidelines.
The Raycell" X-ray Blood Irradiator is also intended for use in the irradiation of intra-operative (between three) blood for cancer patients undergoing surgery to assist in the prevention of metastasis.
Not Found
The provided text describes the regulatory approval of the Raycell™ X-ray Blood Irradiator and its intended uses. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria.
Therefore, I cannot extract the information you requested. The document is a 510(k) clearance letter, which means the FDA has determined the device is substantially equivalent to a legally marketed predicate device. This process does not typically involve the presentation of acceptance criteria or performance studies in the way you've outlined for an AI/diagnostic device.
To directly answer your questions based only on the provided text, I would have to state that the information is not present.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 2005
Mr. Ross Kachaniwsky Director, Quality and Regulatory Affairs MDS Nordion 447 March Road Ottawa, ON K2K 1X8 CANADA
Re: K051065 Trade/Device Name: Raycell™ X-ray Blood Irradiator Regulation Number: None Regulatory Class: Unclassified Product Code: MOT Dated: April 20, 2005 Received: April 26, 2005
Dear Mr. Kachaniwsky:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leviewed your becaren b re(s) probatantially equivalent (for the indications for use stated in above and nave deceminiratived predicate devices marketed in interstate commerce prior to the enclosure) to regary manelocal Device Amendments, or to devices that have been May 20, 1970, all chactinent acto 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 do not require approval or a premates provisions of the Act. The general controls provisions of the Act device, subject to the generaliation, 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 (Premarket If your de vice is classilion (controls. Existing major regulations affecting your Apploval), It may or subject to eat.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 I least be advisod mar 1271 to teat 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 I cut at statues and regulation 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) (21 CFR Part 801); 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)
10 legal This letter will allow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence and thus premarket notification. The FDA Inding of substantial equivalier 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), pleased If you desire specific advice for your device on our laboring regulation of 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, "thisornion on your responsibilities under the Act from the 180 807.97). You may obtain other general information on your aspective at its toll-free number (800) Division of 301) 443-6597 or at its Internet address 056-2041 or (2017) v/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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Image /page/2/Picture/0 description: The image shows the logo for MDS Nordion. The logo consists of the text "MDS Nordion" in a bold, sans-serif font. Below the company name is the tagline "Science Advancing Health" in a smaller, italicized font. The logo is simple and professional, and it conveys the company's focus on science and health.
2
Indication for Use Statement
510 (k) Number: K$\phi$51$\phi$65
Device Name: Raycell"
Indications For Use:
The Raycell" X-ray Blood Irradiator is intended for use in the irradiation of blood and blood x roducts (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Products (pashaged in transis a applicable FDA, AABB, Health Canada, and European guidelines.
The Raycell" X-ray Blood Irradiator is also intended for use in the irradiation of intra-I ne nayeen 11 ree) blood for cancer patients undergoing surgery to assist in the prevention of metastasis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use__ OR Over-The-Counter Use
(PER 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal,
Division of Reproductive, Abdon and Radiological Devices 510(k) Number _
Appendix 2
N/A