BLOCKING TRAY

K023636 · Southeastern Radiation Products, Inc. · IYE · Nov 22, 2002 · Radiology

Device Facts

• Record ID: K023636
• Device Name: BLOCKING TRAY
• Applicant: Southeastern Radiation Products, Inc.
• Product Code: IYE · Radiology
• Decision Date: Nov 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

Blocking Trays are to be used as an accessory to a Linac. Custom blocks are mounted onto Blocking trays and slid into the Linac into their accessory holder thereby stenciling the radiation beam onto the patient. Compensators are also mounted on blocking trays and slid into the Linac changing the radiation beam fluence unique to a patient's anatomy.

Device Story

Blocking Trays serve as mechanical accessories for Linear Accelerators (Linacs). Device functions as a mounting platform for custom radiation blocks or beam-modifying compensators. Trays are manually inserted into the Linac accessory holder. By positioning blocks or compensators within the radiation beam path, the device enables stenciling of the beam or modification of beam fluence to match patient-specific anatomy. Used in clinical radiation therapy settings by trained personnel. Benefits include precise radiation delivery tailored to patient anatomy.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical accessory tray constructed from acrylic and polycarbonate materials. Designed for manual insertion into Linac accessory holders. No electronic, software, or energy-emitting components.

Indications for Use

Indicated for mounting blocks and/or compensators/modulators for insertion into a Linear Accelerator head for radiation therapy.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• Varian (K913174)
• Varian (K913119)
• Siemens (K982513)
• Philips (Elekta) (K963624)
• GE/CGR (K833941)
• Mitsubishi (K970137)
• Mick-Radio (K991107)
• Med-Tec Inc (K944315)

Submission Summary (Full Text)

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

## 023636

### Section 807.87 (h) A 510(k) Summary as described in Section 807.92 or a 510(k) statement as described in 807.93

# Premarket Notification [510(k)] Summary as required by 21 CFR 807.92

#### Date summary was prepared:

October 29, 2002

#### Submitter's Name:

Southeastern Radiation Products, Inc. 2651 N. Design Ct. Sanford, FL 32773

#### Contact Person:

Richard L. Sweat President Phone: [phone] FAX: [phone] · Email: [e-mail]

#### Device Name:

Blocking Tray

#### Classification Name:

Accessory to a Linac, Class II

#### Predicate Device(s):

Accessory to Various Linac Manufacturers including:

| Varian | K913174 |
|--------|---------|
| | K913119 |

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

Koz3636

| Siemens | K982513 |
|------------------|---------|
| Philips (Elekta) | K963624 |
| GE/CGR | K833941 |
| Mitsubishi | K970137 |
| Mick-Radio | K991107 |
| Med-Tec Inc | K944315 |

#### Intended Use:

Blocking Trays are to be used as an accessory to a Linac. Custom blocks are mounted onto Blocking trays and slid into the Linac into their accessory holder thereby stenciling the radiation beam onto the patient. Compensators are also mounted on blocking trays and slid into the Linac changing the radiation beam fluence unique to a patient's anatomy.

#### Technological Characteristics:

The technological characteristics of blocking trays are discussed in Southeastern Radiation Products's attached documents:

DMR-02 Device Master Record – Custom Blocking Trays PD-02 Processing a Blocking Tray Work Order Acrylic MSDS Polycarbonate MSDS

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

ond and Drug Administration 00 Corporate Boulevard ockville MD 20850

Mr. Richard L. Sweat President Southeastern Radiation Products, Inc. 2651 N. Design Court SANFORD FL 32773 -

· Re: K023636 Trade/Device Name: Blocking Trays Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: October 29, 2002 Received: October 30, 2002

Dear Mr. Sweat:

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.

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Page 2

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 (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:

| 8xx.1xxx | (301)-594-4591 |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 [phone] or [phone] 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

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023 510 (k) Number (if known):

Device Name: Blocking Trays

Indications for Use:

This device is intended for mounting blocks and/or compensators/modulators for insertion into a Linear Accelerator head.

#### (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

Nancy C. Swagdon

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number .