(23 days)
Not Found
No
The description focuses on mechanical accessories for linear accelerators and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
This device is an accessory for a Linear Accelerator (Linac) and assists in shaping the radiation beam; it does not directly provide therapy or interact with the patient in a therapeutic manner.
No
The device is described as an accessory for a Linear Accelerator, used for mounting blocks, compensators, and modulators to shape radiation beams for therapy. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a physical accessory (Blocking Trays) used with a Linear Accelerator, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for mounting blocks and compensators for insertion into a Linear Accelerator head to shape a radiation beam for patient treatment. This is a therapeutic application, not a diagnostic one.
- Device Description: The description clearly states the device is an accessory to a Linac used for stenciling or changing the radiation beam fluence. This is directly related to delivering radiation therapy.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting diseases, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for 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.
This device is intended for mounting blocks and/or compensators/modulators for insertion into a Linear Accelerator head.
Product codes
90 IYE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K913174, K913119, K982513, K963624, K833941, K970137, K991107, K944315
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
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: 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 |
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
2
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
4
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 .