(26 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on a manufacturing service for devices designed by the customer's treatment planning system, with no mention of AI/ML in the design or manufacturing process itself.
Yes
The device is used by radiation therapy professionals for the treatment of cancer patients, modifying radiation beams for therapeutic purposes.
No
The device, a Bolus Compensator, is used to modify the shape of a radiation beam during cancer treatment. It does not gather information about a patient's health or provide a diagnosis. Instead, it is a treatment accessory designed to optimize radiation delivery.
No
The device description explicitly states that it is a "manufacturing service" that "manufactures the solid Bolus Compensators," indicating a physical product is being produced, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Bolus Compensator described is a physical device used in radiation therapy to modify the shape of a radiation beam externally to the patient's body. It does not analyze biological samples.
- Intended Use: The intended use is for treating cancer patients by modifying radiation beams, not for diagnosing or monitoring conditions through analysis of bodily fluids or tissues.
Therefore, the Bolus Compensator falls under the category of a therapeutic device used in radiation oncology, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Bolus Compensators are used by radiation therapy professionals for the treatment of cancer patients. They are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. Each Bolus Compensator must be validated and approved by the radiation therapy professional prior to use on a patient.
Product codes
IXI
Device Description
.decimal's Bolus Compensator manufacturing service manufactures the solid Bolus Compensators for intensity modulation of external beam radiation therapy. The Bolus Compensators are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
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
radiation therapy professionals
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
Clinically oriented validation test cases were written and executed in house .decimal personnel including Board Certified Medical Physicists where Bolus Compensators was deemed fit for clinical use.
Summary of Performance Studies
Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Clinically oriented validation test cases were written and executed in house .decimal personnel including Board Certified Medical Physicists where Bolus Compensators was deemed fit for clinical use. A declaration of conformity to this requirement can be found in section 12 of this document.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the word "decimal" in a stylized font, with a registered trademark symbol to the right of the word. Below the word "decimal" is the phrase "the benchmark for custom radiation therapy". The text is in black and the background is white.
JUL 21 2009
Section 7 510(k) Summary or 510(k) Statement
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:
June 2009
Submitter's Name:
.decimal, Inc. 121 Central Park Pl Sanford, Florida 32771
Contact Person:
Daniel L. Bennett Director of Quality and Regulatory Affairs Phone: 407-330-3300 407-322-7546 Fax: Email:dbennett(@dotdecimal.com
Device Name:
Bolus Compensator
Classification Name:
IXI 21 CFR892.5710 Class II
Predicate Device(s):
.decimal Range Compensator (K071078)
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Image /page/1/Picture/0 description: The image shows the word "decimal" in a stylized font, with a small circle and line above the "l". Below the word "decimal" is the phrase "the benchmark for custom radiation therapy". The text is black and the background is white. The image appears to be a logo or advertisement for a company or product related to radiation therapy.
Intended Use:
.decimal's Bolus Compensator manufacturing service manufactures the solid Bolus Compensators for intensity modulation of external beam radiation therapy. The Bolus Compensators are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
Summary of Technological Characteristics:
The device features of Bolus Compensators are similar to the predicate device (.decimal Range Compensators K071078 cleared in 2007). They both are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. Whereas the Bolus Compensator is made using machinable wax, the Range Compensator is made using acrylic, despite the difference in materials they both share very similar densities. Like Range Compensators Each Bolus Compensator must be validated and approved by the radiation therapy professional prior to use on a patient. The target population is identical and the use parameters are also very similar.
A detailed comparison can be found in section 11 of this submittal.
Summary of Clinical Testing:
Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Clinically oriented validation test cases were written and executed in house .decimal personnel including Board Certified Medical Physicists where Bolus Compensators was deemed fit for clinical use. A declaration of conformity to this requirement can be found in section 12 of this document.
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Image /page/2/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person embracing another person. The logo is black and white and appears to be a seal or emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 21 2009
Mr. Daniel L. Bennett Director of Quality and Regulatory Affairs .decimal, Inc. 121 Central Park Pl. SANFORD FL 32771
Re: K091911
Trade/Device Name: Bolus Compensator Regulation Number: 21 CFR 892.5710 · Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: IXI Dated: June 24, 2009 Received: June 25, 2009
Dear Mr. Bennett:
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); medical device reporting (reporting of medical
3
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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he benchmark for custom radiation therapy
| Section 6 | Indications for Use Statement |
|---|---|
| 510(k) Number (if known) | K091911 |
Device Name: Bolus Compensator
Indication for Use: Bolus Compensators are used by radiation therapy professionals for the treatment of cancer patients. They are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. Each Bolus Compensator must be validated and approved by the radiation therapy professional prior to use on a patient.
(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 | ________________ |
|---|---|
| ---------------------- | ------------------ |
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
| 510(k) Number | K091911 |
|---|---|
| --------------- | --------- |