(51 days)
The Profiler 2 is a device that is designed for use as a radiation scanning system that is used to measure beam data in radiotherapy departments for dose modeling in the treatment planning computer.
Profiler 2 is only used by the radiation therapy professionals, and is not used with the patient. A standard commercial power converter converts the power from the wall outlet voltage (100 to 240 VAC) to 18 VDC. The converter is then connected to a power/data interface (PDI) and then supplies the 18 VDC power to the Profiler 2 through a single 8 pin DIN connector. A standard 9 pin serial connectors connects the PDI to a computer. The commercial power converter and PDI device are fully tested for safety. Therefore, Profiler 2 should not generate a shock hazard to the operator.
The provided text describes a medical device, Profiler 2, which is used to measure beam data in radiotherapy for dose modeling. However, the text does not contain any information regarding acceptance criteria, a study proving the device meets those criteria, or specific performance metrics and their supporting data provenance.
The document is primarily a 510(k) premarket notification approval letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance, safety features, and the intended use of the device.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): No information on ground truth establishment for a test set.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set details are provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. Profiler 2 is not an AI-based diagnostic tool for human readers; it's a measurement device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Profiler 2 is a physical device measuring radiation, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no ground truth for a test set is discussed.
- The sample size for the training set: Not applicable as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
The document confirms that "Sun Nuclear has deemed the devices safe and effective for their intended uses as long as they are used in accordance with all of the accompanying labeling and instructions," and "Sun Nuclear believes that responsible design and quality assurance practices were followed during the development and manufacture of Profiler 2 (Model 1174)." However, these are statements of belief and internal assessment, not a description of a study proving specific performance against acceptance criteria.
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KD63021
Safety and Effectiveness Summary for Profiler 2
Profiler 2 is only used by the radiation therapy professionals, and is not used with the patient. A standard commercial power converter converts the power from the wall outlet voltage (100 to 240 VAC) to 18 VDC. The converter is then connected to a power/data interface (PDI) and then supplies the 18 VDC power to the Profiler 2 through a single 8 pin DIN connector. A standard 9 pin serial connectors connects the PDI to a computer. The commercial power converter and PDI device are fully tested for safety. Therefore, Profiler 2 should not generate a shock hazard to the operator.
Sun Nuclear has deemed the devices safe and effective for their intended uses as long as they are used in accordance with all of the accompanying labeling and instructions. When used properly, Profiler2 can collect the useful dosimetry modeling data for radiation therapy treatment planning. Sun Nuclear believes that responsible design and quality assurance practices were followed during the development and manufacture of Profiler 2 (Model 1174).
Safety features of Profiler 2
| Feature | Effect |
|---|---|
| 1. Standard power converter | Eliminate electrical shock |
| 2. Shielded housing | Prevent E&M interference |
| 3. Line mark on device | Protect electronics being under direct radiationbeam |
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Image /page/1/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN" are arranged in a circular pattern around the left side of the eagle, with the word "SERVICES" completing the circle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Noel M. Downey Official Correspondent Sun Nuclear Corporation 425-A Pineda Court MELBOURNE FL 32940
NOV 2 2 2006
Re: K063021
Trade/Device Name: Profiler 2 Model 1174 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 29, 2006 Received: October 2, 2006
Dear Mr. Downey:
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/1/Picture/10 description: The image is a black and white circular logo. The logo contains the letters "FDA" in a stylized font. Above the letters, the numbers "1906-2006" are printed. Below the letters, the word "Centennial" is printed. There are four stars below the word "Centennial".
Protecting and Promoting Public Health
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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 contact 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 C. hogdon
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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510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Profiler 2 is a device that is designed for use as a radiation scanning system that is used to measure beam data in radiotherapy departments for dose modeling in the treatment planning computer.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Percsription Use ✓
OR
Over-The-Counter Use
David A. Szymanski
(Division Sign-Off) Division of Reproductive, Abdominal 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.