(28 days)
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).
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.
The provided document describes a 510(k) submission for the Raycell™ Shielded Cabinet X-ray System. This submission is for a medical device that irradiates blood and blood products. It is a declaration of substantial equivalence to an existing predicate device, the RS 3000 Shielded Cabinet X-Ray Blood Irradiator (K974210).
The document does not contain information about studies to prove device performance against acceptance criteria in the context of AI/ML or diagnostic performance. Instead, the "acceptance criteria" here refers to the device's technological characteristics remaining the same as the predicate device, which is the basis for claiming substantial equivalence.
Therefore, many of the requested fields are not applicable to this type of regulatory submission.
Here's an attempt to fill out the information based on the provided text, with clarifications where the requested information is not available or relevant:
Acceptance Criteria and Study Details for Raycell™ Shielded Cabinet X-ray System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Technological Characteristics) | Reported Device Performance (Raycell™) |
|---|---|
| Source: 160 kVdc x-rays | Same (160 kVdc x-rays) |
| Beam filtration: 0.38 mm copper | Same (0.38 mm copper) |
| Single beam HVL, water: Approximately 4 mm | Same (Approximately 4 mm) |
| Dose rate: 3 Gy min⁻¹ | Same (3 Gy min⁻¹) |
| Max/min dose ratio: <1.3 | Same (<1.3) |
| Sample holder: Fixed, presents maximum width, minimum depth | Same (Fixed, presents maximum width, minimum depth) |
| Radiation Safety: Pb shielding, interlocks | Same (Pb shielding, interlocks) |
Notes on Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" are the technological characteristics of the predicate device (RS 3000). The "study" proving the device meets these criteria is essentially the declaration by MDS Nordion that the Raycell™ is "identical to the predicate device with the exception of labeling changes" and has "the same" technological characteristics. There is no performance study against these criteria described, as the claim is identity or sameness regarding these technical specifications.
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission is for a blood irradiator, not an AI/ML or diagnostic device that would involve a "test set" of data or images. The "test" for substantial equivalence relies on comparing the device specifications to those of a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment for a test set is described, as the device is not a diagnostic AI/ML tool.
4. Adjudication method for the test set:
- Not applicable. No test set or human adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a blood irradiator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a blood irradiator. It does not involve an algorithm with standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for diagnostic ground truth. The "ground truth" for this submission is the established technical specifications and safe operation of the legally marketed predicate device (RS 3000), which the Raycell™ is stated to be identical to, except for labeling and manufacturer name. The intended use also refers to existing recommendations for gamma irradiation of blood products.
8. The sample size for the training set:
- Not applicable. This device is a blood irradiator, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set is relevant to this device's regulatory submission.
{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:
| TechnologicalCharacteristics | 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, presentsmaximum 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
N/A