(86 days)
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No
The provided 510(k) summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses solely on dose measurement for radiation therapy quality assurance.
No
The device is used for dose measurement and quality assurance, not for treating a condition itself.
No
The device is used for dose measurement and verification during radiation therapy, indicating a quality assurance and treatment delivery monitoring function rather than a diagnostic one.
No
The summary describes "In-Vivo Dosimetry systems" which are typically hardware devices used for measuring radiation dose within a patient's body. The lack of information about software components and the description of a "system" strongly suggest a hardware component is involved.
Based on the provided information, the Apollo 5 and Apollo 10 In-Vivo Dosimetry systems are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use is "to provide dose measurement capabilities for dose verification and quality assurance for patients undergoing radiation therapy." This describes a device used on or in a patient during a medical procedure (radiation therapy), not a device used to test samples outside the body (in vitro).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition based on sample analysis.
- Being used in a laboratory setting for testing samples.
The Apollo systems are clearly described as being used for in-vivo (within the living body) dosimetry during radiation therapy. This falls under the category of medical devices used for treatment and quality assurance during that treatment, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The Apollo 5 and Apollo 10 In-Vivo Dosimetry systems are used to provide dose measurement capabilities for dose verification and quality assurance for patients undergoing radiation therapy.
Product codes
90 IYE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1000
Kjell Westerlund President Precitron A.B. Ultanaallen 2 (SE-756 51) Uppsala SWEDEN
Re:
K990383 Apollo 5, Apollo 10 Dated: January 31, 1999 Received: February 8, 1999 Regulatory Class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Westerlund:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 III (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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Statement of indications for use. 8
Indications for use:
The Apollo 5 and Apollo 10 In-Vivo Dosimetry systems are used to provide dose measurement capabilities for dose verification and quality assurance for patients undergoing radiation therapy.
David A. Segmen
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number
Prescription Use
(Per 21 CFR 801.109)