(30 days)
Not Found
No
The summary describes a manufacturing service for physical filters used in radiation therapy and contains no mention of AI, ML, or related concepts.
No
This device manufactures solid filters for missing tissue and intensity modulation, which are components used in radiation therapy. It is not itself a therapeutic device but rather a service that produces parts for therapeutic devices.
No.
The device's intended use is to manufacture solid filters for missing tissue and intensity modulation for external beam radiation therapy, which is a therapeutic function, not a diagnostic one.
No
The device is described as a "manufacturing service" that produces "solid filters" and "tissue compensators/intensity modulators," which are physical objects used in radiation therapy. This indicates the device involves the creation of hardware components, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manufacture solid filters for missing tissue and intensity modulation for external beam radiation therapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The description refers to a "manufacturing service" for "tissue compensator / intensity modulator." These are physical devices used in radiation therapy treatment delivery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting diseases, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
.decimal tissue compensator/intensity modulator manufacturing service manufactures the solid filters for missing tissue and intensity modulation for external beam radiation therapy.
Product codes (comma separated list FDA assigned to the subject device)
90 IXI
Device Description
.decimal tissue compensator/intensity modulator manufacturing service manufactures the solid filters for missing tissue and intensity modulation for external beam radiation therapy.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K0000137, K940412, K943224, K021987, K880047
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.
0
APR 2 8 2004
K040804
Page 1 of 2
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:
March 24, 2004
Submitter's Name:
Southeastern Radiation Products, Inc. 2651 North Design Court Sanford, Florida 32773
Contact Person:
Linda Moon Quality Manager Phone: 407-330-3300 407-322-7546 Fax: Email:quality(a)seradiation.com
Device Name:
.decimal tissue compensator / intensity modulator manufacturing service
Classification Name:
Class II
Predicate Device(s):
| CMS | K0000137 | |
|---|---|---|
| NOMOS | K940412 | (as referred to in CMS' 510(k) submission) |
| Varian | K943224 | (as referred to in CMS' 510(k) submission) |
| PAR Scientific | K021987 | |
| Huestis | K880047 |
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Ko40804
page 2 of 2
Intended Use:
.decimal tissue compensator/intensity modulator manufacturing service manufactures the solid filters for missing tissue and intensity modulation for external beam radiation therapy.
Technological Characteristics:
The technological characteristics of .decimal are discussed in Southeastern Radiation Product's attached documents:
Device Master Record - . decimal Tissue Compensators DMR-03 PD-03 Processing a .decimal tissue Compensator Work Order MSDS Sheet for 6061-T6 Aluminum and 360 Brass
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2004
Mr. Richard Sweat President Southeastern Radiation Products, Inc. 2651 N. Design Court SANFORD FL 32773
Re: K040804 Trade/Device Name: .decimal Tissue Compensator/Intensity Modulator Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: 90 IXI Dated: March 24, 2004 Received: March 29, 2004
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 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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your finding of substantial equivalence of your device to a legally promaticated predicated 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 If you dosh bpooms at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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. Brygdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known) _ K.O 40 804
Device Name: .decimal Tissue Compensator/Intensity Modulator
Indication for Use:
.decimal tissue compensator/intensity modulator manufacturing service manufactures the solid filters for missing tissue and intensity modulation for external beam radiation therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONFINUE ON A NOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Pcr 21 CFR 801.109) (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device:
510(k) Number K040804