RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400

K082921 · Rad Source Technologies, Inc. · MOT · Feb 17, 2009 · RA

Device Facts

• Record ID: K082921
• Device Name: RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
• Applicant: Rad Source Technologies, Inc.
• Product Code: MOT · RA
• Decision Date: Feb 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

The RS 3400 Rad Source X-ray Blood Irradiator 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 of Biologics Evaluation and Research, FDA to all registered blood establishments) when irradiation to reduce the risk of Graft Versus Host Disease is indicated.

Device Story

RS 3400 Rad Source X-ray Blood Irradiator; shielded cabinet x-ray system. Input: blood products in transfusion bags. Operation: carousel holds 5 cylindrical containers, rotating them 360 degrees around a central 150kVdc x-ray tube. Output: irradiated blood products. Used in clinical/blood bank settings; operated by trained personnel. Device provides controlled radiation dose to prevent graft-versus-host disease in transfusion recipients. Benefits: reduces risk of transfusion-associated complications via standardized, uniform irradiation.

Clinical Evidence

No clinical data. Bench testing only; measured radiation field and dose delivery within rotating containers using water as a sample to confirm necessary radiation levels for blood product irradiation.

Technological Characteristics

Shielded cabinet x-ray system; 150kVdc x-ray tube; 0.45 mm Cu filter; H2O cooled; Pb shielding; safety interlocks; rotating carousel sample holder; complies with 21 CFR 1020.4.

Indications for Use

Indicated for irradiation of blood and blood products in transfusion bags to reduce risk of transfusion-associated graft-versus-host disease in patients at risk of this complication.

Predicate Devices

• RS 3000 Shielded Cabinet X-ray Radiation Source (K974210)

Submission Summary (Full Text)

{0}------------------------------------------------

K082921

FEB 1 7 2009

# RAD SOURCE TECHNOLOGIES, INC.

6825 Shiloh Road East, Ste. B-2 Alpharetta, GA 30005 [phone] email: [e-mail]

#### 510(k) Summary

#### Owner:

Rad Source Technologies, Inc. 6825 Shiloh Road East, Ste. B-2 Alpharetta, GA 30005 [phone]

#### Contact:

Randy Kirk, President

Device:

Trade name - RS 3400 Rad Source X-ray Blood Irradiator Common name - Blood Irradiator Classification name - N/A

#### Predicate Device:

RS 3000 Shielded Cabinet X-ray Radiation Source. 510(k) number K974210,

Description of Device:

The RS 3400 Rad Source X-ray Blood Irradiator consists of a shielded enclosure containing one x-ray tube capable of emitting radiation in a 360 degree output around its cylindrical design, a power supply and controller. A carousel capable of holding 5 cylindrical containers rotates those cylinders around the cylindrical x-ray tube radiation source causing the blood products contained therein to be irradiated.

#### Intended Us of the Device:

The RS 3400 Rad Source X-ray Blood Irradiator 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 of Biologics Evaluation and Research, FDA to all registered blood

{1}------------------------------------------------

establishments) when irradiation to reduce the risk of Graft Versus Host Disease is indicated. This document is attached in Section 21 - Other.

#### Summary of Technological Characteristics of Device Submitted and Predicate Device:

The RS 3400 Rad Source X-ray Blood Irradiator is substantially equivalent to the RS 3000 Shielded Cabinet X-ray Radiation Source (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. The primary technological characteristic of both machines is the controlled production of X-ray radiation.

| Characteristic | Submitted Device<br>RS 3400 | Predicate Device<br>RS 3000 |
|--------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Source | 150kVdc x-rays, .45 mm Cu filter,<br>hvl app. H₂O cooled | 160kVdc x-rays, .38 mm Cu<br>filter, hvl app. 4 cm H2O |
| Dose Rate | >5 Gy/minute | 3 Gy/minute |
| Max/Min dose ratio: | <1.3 | < 1.3 |
| Sample holder: | Multiple holders in rotation around<br>source, each canister fixes<br>maximum irradiated volume | Fixed, presents maximum<br>width, minimum depth |
| Radiation safety: | Pb shielding, interlocks | Pb shielding, interlocks |
| Federal Regulatory Environment | Requires 510(k). Must comply<br>with 21 CFR 1020.4 | Requires 510(k). Must comply<br>with 21 CFR 1020.4 |

#### Non-Clinical Performance Data Used in Determining Substantial Equivalency:

The submitted device is indicated for the irradiation of blood and therefore the tests performed include measuring the radiation field resulting within the rotating containers when a blood product (using water as a sample) is contained within the rotating containers. The measured dose and field result in producing the necessary radiation to support the Indications for Use substantially equivalent to the predicate device.

Clinical Performance Data Used in Determining Substantial Equivalency:

None.

Conclusions Drawn from the Non-Clinical Tests:

Based on the Non-Clinical tests performed, it is concluded that the Submitted Device is as safe, as effective, and performs as well as or better than the predicate device.

{2}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Randol E. Kirk President Rad Source Technologies, Inc. 6825 Shiloh Road East, Suite B2 ALPHARETTA GA 30005

Re: K082921

.

Trade/Device Name: RS 3400 Rad Source X-ray Blood Irradiator Regulation Number: None Regulatory Class: Unclassified Product Code: MOT Dated: February 5, 2009 Received: February 9, 2009

Dear Mr. Kirk:

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 preval application (PMA). You may, therefore, market the device, subject to the general sontrols 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 such 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.

{3}------------------------------------------------

Page 2

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 (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 this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/edrh/industry.suppor/index.html.

Sincerely yours,

Janine M. Morris

Janine M. Morri Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

K082441

## Indications for Use

# 510(K) Number: (N/A) K082921

### Device Name: RS 3400 Rad Source X-ray Blood Irradiator

Indications for Use:

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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use -(21-CFR-801 Subpart-G),

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ·