(35 days)
No
The summary describes a manufacturing service for physical devices (range compensators) based on designs from a treatment planning system. There is no mention of AI or ML in the device description, intended use, or any of the "Mentions" sections.
No.
The device described, a Range Compensator, is a patient-specific beam modifying device used in proton therapy. It is an accessory to the therapeutic device (the proton delivery machine) and helps guide radiation to the targeted area but does not directly deliver therapy itself. Its function is to modify the radiation beam, not to be a therapeutic device.
No
Explanation: The device described is a range compensator used in proton therapy to modify the beam for treatment, not to diagnose a condition.
No
The device description explicitly states that the device is a "manufacturing service" that produces "solid Range Compensators" made out of "acrylic or wax". This indicates the device is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device, a Range Compensator, is a physical object used in proton therapy to modify the proton beam externally to the patient's body. It is used to shape and control the radiation dose delivered to the tumor.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples from the patient. The device's function is entirely related to the physical delivery of radiation.
The device is a patient-specific accessory used in a radiation therapy treatment system, not a diagnostic test performed on biological samples. The predicate device listed (K040804) also describes a "TISSUE COMPENSATOR / INTENSITY MODULATOR," which aligns with the function of modifying radiation delivery, not performing in vitro diagnostics.
N/A
Intended Use / Indications for Use
.decimal's Range Compensator manufacturing service manufactures the solid Range Compensators for intensity modulation of external beam proton radiation therapy. The Range Compensator 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.
In proton therapy for cancer, a proton beam is aimed at the cancerous tissue using a large "snout". The "snout" is rotated around the patient using a large, three-story gantry. While the patient lies on a treatment table, the gantry rotates around and points the snout at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires two custom-made, beam modifying, patient specific devices: a range compensator and an aperture.
The range compensator is made out of acrylic or wax. The custom shape/design specifications for range compensators are generated out of the treatment planning system and are unique to each patient and each gantry angle (most patients will have 2-3 different gantry angles.) The outer dimensions/specifications are vendor specific, based upon the manufacturer of the proton delivery machines.
Product codes
IXI
Device Description
The device features of .decimal's Apertures are similar to the predicate device .decimal Tissue Compensator and Intensity Modulator. They both are used for external beam radiation therapy treatments, they both are used to block radiation and guide it to affected areas. The target population is identical and the use parameters are also very similar.
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)
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
§ 892.5710 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
Kollorg
Section 807.87 (h) A 510(k) Summary as described in Section 807.92 or a 510(k) statement as described in 807.93
MAY 2 2 2007
Premarket Notification [510(k)] Summary as required by 21 CFR 807.92
Date summary was prepared:
March 2007
Submitter's Name:
.decimal, Inc. 121 Central Park Place 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:
.decimal Range Compensator
Classification Name:
IXI 21 CFR892.5710 Class II
Predicate Device(s):
.decimal, Inc. DECIMAL TISSUE COMPENSATOR / INTENSITY MODULATOR, 510k # K040804
1
Intended Use:
.decimal's Range Compensator manufacturing service manufactures the solid Range Compensators for intensity modulation of external beam proton radiation therapy. The Range Compensator 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 .decimal's Apertures are similar to the predicate device .decimal Tissue Compensator and Intensity Modulator. They both are used for external beam radiation therapy treatments, they both are used to block radiation and guide it to affected areas. The target population is identical and the use parameters are also very similar.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 2 2 2007
Mr. Daniel L. Bennett Director of Quality and Regulatory Affairs .decimal, Inc. 121 Central Park Place SANFORD FL 32771
Re: K071078
Trade/Device Name: .decimal Range Compensator Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: IXI Dated: April 12, 2007 Received: April 17, 2007
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 (Premarket Approval), 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.
Image /page/2/Picture/8 description: The image is a black and white circular logo. The logo contains the text "1826-1926" at the top, and the text "Centennial" at the bottom. The letters "PA" are in the center of the logo, and there are three dots at the very bottom of the logo.
collars and Promoting 9
3
Page 2 -
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.
This letter will allow you to begin marketing your device as described in your Section 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 n you the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Cbrogdon
Nancy 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)
510(k) Number (if known) K071078
Page 1 of 1
Device Name: .decimal Range Compensator
Indication for Use:
In proton therapy for cancer, a proton beam is aimed at the cancerous tissue using a large "snout". The "snout" is rotated around the patient using a large, three-story gantry. While the patient lies on a treatment table, the gantry rotates around and points the snout at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires two custom-made, beam modifying, patient specific devices: a range compensator and an aperture.
The range compensator is made out of acrylic or wax. The custom shape/design specifications for range compensators are generated out of the treatment planning system and are unique to each patient and each gantry angle (most patients will have 2-3 different gantry angles.) The outer dimensions/specifications are vendor specific, based upon the manufacturer of the proton delivery machines.
(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 | K071078 |
|---|---|
| --------------- | --------- |