(23 days)
This device is intended for mounting blocks and/or compensators/modulators for insertion into a Linear Accelerator head.
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.
This 510(k) submission does not contain information on acceptance criteria, device performance, or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for a "Blocking Tray" accessory to a Linac, and the FDA's response indicating substantial equivalence to predicate devices.
The document primarily focuses on:
- Device Name: Blocking Tray
- Intended Use: For mounting blocks and/or compensators/modulators for insertion into a Linear Accelerator head.
- Technological Characteristics: References internal documents (DMR-02 Device Master Record, PD-02 Processing a Blocking Tray Work Order, Acrylic MSDS, Polycarbonate MSDS) which are not provided.
- Predicate Devices: A list of previously cleared accessory devices from various manufacturers.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, or study details because it is not present in the provided text.
This type of 510(k) summary typically establishes substantial equivalence by demonstrating that the new device has the same intended use and similar technological characteristics to a legally marketed predicate device, and does not raise different questions of safety and effectiveness. It does not generally include detailed performance studies with acceptance criteria in the public summary document itself, especially for such a relatively simple accessory device.
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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: 407-330-3300 FAX: 407-322-7546 · Email: rsweat@seradiation.com
Device Name:
Blocking Tray
Classification Name:
Accessory to a Linac, Class II
Predicate Device(s):
Accessory to Various Linac Manufacturers including:
| Varian | K913174 |
|---|---|
| K913119 |
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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 | (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" (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 (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
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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 .
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.