(352 days)
Not Found
None
No
The summary does not mention AI, ML, or related terms, and the description focuses on using existing lasers for contour generation, which is a traditional optical measurement technique.
No
The device measures patient contours for radiotherapy treatment planning; it does not directly treat or provide therapy to patients.
No
Explanation: The device measures patient contours for radiotherapy treatment planning, which is a part of the treatment process rather than diagnosing a disease or condition.
No
The device description explicitly states it is an "optical outline system" that "utilizes existing Simulator or Therapy Room patient alignment lasers to generate visible surface anatomy shape contours." This indicates the device includes hardware components (optical system, potentially interfaces with lasers) in addition to any software used for processing the contours.
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.
- OSIRIS Function: The OSIRIS system measures patient contours using lasers to aid in radiotherapy treatment planning. It interacts with the external surface of the patient's body and does not analyze biological samples.
Therefore, the OSIRIS system falls under the category of a medical device used for treatment planning and patient positioning, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OSIRIS optical outline system is used to measure patient contours for the purpose of radiotherapy treatment planning. Its main applications are for breast and abdomen treatment planning. The system utilizes existing Simulator or Therapy Room patient alignment lasers to generate visible surface anatomy shape contours.
Typical application is in the measurement and calculation of missing tissue compensator filters.
Product codes
90 IYE
Device Description
The OSIRIS optical outline system is used to measure patient contours for the purpose of radiotherapy treatment planning.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
optical outline system utilizing existing Simulator or Therapy Room patient alignment lasers to generate visible surface anatomy shape contours.
Anatomical Site
breast and abdomen
Indicated Patient Age Range
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Intended User / Care Setting
Medical staff, radiographers, technicians and medical physicists - all of whom are professionally employed within a radiotherapy department and are specialists in the use of surface contours for radiotherapy treatments. The main users are those who use Radiotherapy Simulators for treatment simulation and verification, and the staff who treat patients on linear accelerator therapy machines. The same groups of staff will use the surface contours for isodose production, where appropriate, and define the setup data and any additional measurements required, according to the QA programs running in that department.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles an abstract representation of an eagle or bird, with stylized lines forming its head and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 1999
Terry Chwalk Executive Vice President Huestis Medical 68 Buttonwood Street Bristol, RI 02809
Re: K981153
OSIRIS (Patient Verification and Contouring System) Dated: December 11, 1998 Received: December 18, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Chwalk:
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 reclassified 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 (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 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 requiration 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,
BART P. L.O. CApit, M.D.
APT 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
HUESTISMEDICAL
Ver/3 — 4/24/96
Huestis Medical 68 Buttonwood Street Bristol, RI 02809
510(k) Number: K981153
"OSIRIS" Patient Position Verification and Contouring System
Indications for Use:
The OSIRIS optical outline system is used to measure patient contours for the purpose of radiotherapy treatment planning. Its main applications are for breast and abdomen treatment planning. The system utilizes existing Simulator or Therapy Room patient alignment lasers to generate visible surface anatomy shape contours.
The professional groups using the OSIRIS system can include Medical staff, radiographers, technicians and medical physicists - all of whom are professionally employed within a radiotherapy department and are specialists in the use of surface contours for radiotherapy treatments. The main users are those who use Radiotherapy Simulators for treatment simulation and verification, and the staff who treat patients on linear accelerator therapy machines. The same groups of staff will use the surface contours for isodose production, where appropriate, and define the setup data and any additional measurements required, according to the QA programs running in that department.
Typical application is in the measurement and calculation of missing tissue compensator filters.
Thind A. Aymer
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Device 510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V
OR Over-The-Counter
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
HUESTISMEDICAL 68 Buttonwood Street, Bristol, RI 02809, USA Telephone: (401) 253-5500 Watts: 800-972-9222 FAX: (401) 253-7350