(210 days)
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No
The summary describes a mechanical treatment chair and does not mention any computational or data-driven features indicative of AI/ML.
No
Explanation: A therapeutic device is one that treats a disease or condition. This device is described as a "versatile Treatment Chair" that provides upright positioning for patients during treatments, specifically on a Medical Linear Accelerator treatment couch. While it supports patients during therapy, it does not, by itself, provide therapy or treat any condition. It is an accessory for the delivery of therapy.
No
The device is described as a treatment chair used for positioning patients during medical treatments, specifically on a Medical Linear Accelerator. Its purpose is to provide comfort and improve physiological conditions (lung volume, respiratory motion) during treatment, not to diagnose a disease or condition.
No
The device is described as a "Treatment Chair," which is a physical piece of equipment, 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a "Treatment Chair" used for positioning patients during medical treatments (specifically radiation therapy on a linear accelerator). It is a physical support device, not a device that analyzes biological samples.
- Intended Use: The intended use is for patient positioning and comfort during treatment, not for diagnostic testing.
Therefore, this device falls under the category of a medical device used for treatment support, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This versatile Treatment Chair provides upright positioning for specialty treatment cases of head, neck, thorax, breast and lung or for patients who have difficulty lying supine for treatments. The seated patient has improved comfort increased lung volume and reduced respiratory motion.
The treatment chair will be used on Medical Linear Accelerator treatment couch located in a hospital or clinic. A physician and physicist will prescribe its use for a treatment on a patient.
Product codes
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
head, neck, thorax, breast and lung
Indicated Patient Age Range
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Intended User / Care Setting
A physician and physicist will prescribe its use for a treatment on a patient. THE TREATMENT CHAIR IS NOT STERILE AND IS TO BE USED BY HOSPITAL OR CLINICAL AUTHORIZED PERSONEL ONLY.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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)
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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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads in profile, representing the department's focus on health, human services, and well-being. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2015
Radiation Products Design, Inc. % Mr. Howard Larson CEO 5218 Barthel Industrial Drive NE ALBERTVILLE MN 55301
Re: K150382
Trade/Device Name: Radio Therapy Treatment Chair Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: February 5, 2015 Received: August 12, 2015
Dear Mr. Larson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510 (k) Number: K150382
Radiation Therapy Treatment Chair Device Name:
Indications for use:
This versatile Treatment Chair provides upright positioning for specialty treatment cases of head, neck, thorax, breast and lung or for patients who have difficulty lying supine for treatments. The seated patient has improved comfort increased lung volume and reduced respiratory motion.
The treatment chair will be used on Medical Linear Accelerator treatment couch located in a hospital or clinic. A physician and physicist will prescribe its use for a treatment on a patient.
"Caution Federal law (USA) restricts the sale of this device for use only by (or at the order of) a physician."
THE TREATMENT CHAIR IS NOT STERILE AND IS TO BE USED BY HOSPITAL OR CLINICAL AUTHORIZED PERSONEL ONLY.
Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (Part 21 CFR 801 Subpart C)