(140 days)
The RS 3000 Shielded Cabinet X-ray Radiation Source is intended for the irradiation of blood or blood products packaged in transfusion bags 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) when irradiation to reduce the risk of Graft Versus Host Disease is indicated.
The RS 3000 Shielded Cabinet X-ray Radiation Source consists of A shielded enclosure containing 2 vertically opposed x-ray tubes with provision for a sample holder (canister) between them, a power supply and a controller.
This document is a 510(k) premarket notification for the RS 3000 Shielded Cabinet X-ray Radiation Source, a blood irradiator. It focuses on demonstrating substantial equivalence to a predicate device (IBL 437C Blood Irradiator), rather than presenting a study with acceptance criteria and device performance in the typical sense of a diagnostic or therapeutic device that would involve a clinical study with human subjects.
Therefore, many of the requested categories for a clinical study are not applicable to this type of submission. However, I can extract information related to the device's technical specifications and how they compare to the predicate, which serves as the "performance" data in this context for demonstrating substantial equivalence.
Here's the breakdown of the information provided in the input, tailored to what's available for this specific type of device submission:
1. Table of "Acceptance Criteria" (Predicate Device Specifications) and Reported Device Performance (RS 3000)
In the context of a 510(k) for a blood irradiator, "acceptance criteria" are effectively the specifications and performance characteristics of the predicate device, which the new device (RS 3000) aims to meet or be substantially equivalent to.
| Criteria (Predicate: IBL 437C) | RS 3000 Performance |
|---|---|
| Source: | 160 kVdc x-rays, .38 mm Cu filter, hvl app. 4 cm H₂0 |
| Cs-137, 662 keV | |
| Dose rate: | 3 Gy min⁻¹ |
| > 4 Gy min⁻¹ | |
| Max/min dose ratio: | < 1.3 |
| < 1.67 | |
| Sample holder: | fixed, presents maximum width, minimum depth |
| rotates in beam | |
| Radiation safety: | Pb shielding, interlocks |
| Pb shielding, interlocks | |
| Federal Regulatory Environment: | Requires 510(k). Must comply with 21 CFR 1020.40 |
| Requires 510(k), user must have NRC license and radiation safety officer, operators must be film-badged. |
2. Sample size used for the test set and the data provenance: Not applicable. This is a technical comparison for a blood irradiator, not a diagnostic or therapeutic device evaluated on patient data. The "test set" here refers to the device's physical and functional characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. "Ground truth" in this context is established by the known specifications and performance of both the RS 3000 and the predicate IBL 437C, which are typically derived from engineering specifications, calibration, and testing.
4. Adjudication method for the test set: Not applicable. There's no "adjudication" in the sense of expert review of clinical cases. The comparison is based on objective, measurable technical specifications.
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 for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This phrase usually applies to AI algorithms. The RS 3000 is a physical device that performs irradiation; its "performance" is its ability to deliver the specified radiation dose safely and effectively, which is likely validated through physical measurements and calibration.
7. The type of ground truth used:
The "ground truth" for this submission are the established technical specifications and performance data of both the new device (RS 3000) and the predicate device (IBL 437C), verified through physical testing, engineering design, and adherence to relevant standards (e.g., radiation safety regulations). The primary "ground truth" for demonstrating substantial equivalence rests on objective, measurable characteristics rather than clinical outcomes on human subjects for this type of device. The FDA's "Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products" (22 July 1993 memorandum) also serves as a regulatory "ground truth" for the intended use and irradiation parameters.
8. The sample size for the training set: Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable. As above, this phrase refers to AI algorithms, which this device is not.
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Image /page/0/Picture/0 description: The image shows a logo for "RAD-SOURCE". The logo features the word "RAD" stacked on top of the word "SOURCE". There are two triangles on the left and right side of the text. There are also several horizontal lines on the right side of the text.
MAR 3 0 100
510 (k) Summary as required by 807.92 (c) for the RS 3000 Shielded Cabinet X-ray Radiation Source Prepared November 6, 1997
Rad-Source, Inc.. Submitted by: 475 Ramblewood Dr. #207 Coral Springs, Florida 33071 Tel. 954 755-0328
Randol E. Kirk Contact Person: President
- Device Trade Name:
ﺴﯿﺴﺎ
RS 3000 Shielded Cabinet X-ray Radiation Source.
- blood irradiator. Common Name:
- not classified. Classification:
- IBL 437C (K865027) manufactured by Predicate Device: CIS-US, Inc. 10 DeAngelo Drive Bedford, Massachusetts 01730
Description of Device:
The RS 3000 Shielded Cabinet X-ray Radiation Source consists of A shielded enclosure containing 2 vertically opposed x-ray tubes with provision for a sample holder (canister) between them, a power supply and a controller. (Brief physical description of the device and its function)
Intended Use of Device:
The RS 3000 Shielded Cabinet X-ray Radiation Source is intended for the irradiation of blood or blood products packaged in transfusion bags in accordance with "Recommendations Reqarding 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) when irradiation to reduce the risk of Graft Versus Host Disease is indicated.
475 Ramblewood Dr #207 Coral Springs F1 33071 (954) 755 0328
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Image /page/1/Picture/0 description: The image shows a logo for "RAD SOURCE". The logo features the text "RAD SOURCE" in a bold, sans-serif font. The word "RAD" is on the left, and the word "SOURCE" is on the right. There are two black triangles, one above and one below the text, pointing towards the center. There are also horizontal lines above and below the text, creating a visual effect of radiation.
Substantial Equivalence to Predicate Device:
The RS 3000 Shielded Cabinet X-ray Radiation Source is substantially equivalent to the IBL 437C Blood Irradiator (K865027). Both are indicated for the irradiation of blood and blood products to reduce the risk of transfusionassociated graft-versus-host disease in recipients at risk of this complication. The significant clinical characteristics of the two devices are compared below.
| RS 3000 | IBL 437C | |
|---|---|---|
| Source: | 160 kVdc x-rays.38 mm Cu filterhvl app. 4 cm H₂0 | Cs-137, 662 keV |
| Dose rate: | 3 Gy min⁻¹. | > 4 Gy min⁻¹ |
| Max/min dose ratio: | < 1.3 | < 1.67 |
| Sample holder: | fixed, presents maximumwidth, minimum depth | rotates in beam |
| Radiation safety: | Pb shielding, interlocks | Pb shielding, interlocks |
| Federal RegulatoryEnvironment: | Requires 510(k).Must comply with 21 CFR1020.40 | Requires 510(k), user musthave NRC license andradiation safety officer,operators must be film-badged. |
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 30 1998
Ronald E. Kirk Rad-Source, Inc. 475 Ramblewood Drive, Suite 207 Coral Spring, FL 33071
Re:
RS 3000 Shielded Cabinet X-Ray Radiation Source (Blood Irradiator) Dated: February 18, 1998 Received: February 20, 1998 Unclassified Procode: 90 MOT
Dear Mr. Kirk:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 Counctic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially ecuivalent determination assumes with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 to proceed to the market.
If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdr.idsmamain.html".
Sincerely yours,
Kilian Yi
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
(For Indications for Use Statement and Section 8 of Premarket Submission Cover Letter)
The RS 3000 Shielded Cabinet X-ray Radiation Source is intended for the irradiation of blood or blood products packaged in transfusion bags 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) when irradiation to reduce the risk of Graft Versus Host Disease is indicated.
Daniel le. Simpson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
N/A