OSIRIS

K981153 · Huestis Medical · IYE · Mar 17, 1999 · Radiology

Device Facts

• Record ID: K981153
• Device Name: OSIRIS
• Applicant: Huestis Medical
• Product Code: IYE · Radiology
• Decision Date: Mar 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended 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.

Device Story

OSIRIS system measures patient surface contours for radiotherapy planning; utilizes existing room alignment lasers to project visible lines on patient anatomy; system captures these contours for isodose production and setup data definition; used by medical staff, radiographers, and physicists in radiotherapy departments; output assists in calculating missing tissue compensator filters; aids clinical decision-making by providing accurate anatomical surface data for treatment simulation and verification.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Optical contouring system; utilizes existing radiotherapy room alignment lasers; standalone system for surface anatomy measurement; no specific materials or software architecture details provided.

Indications for Use

Indicated for radiotherapy treatment planning, specifically breast and abdomen, to measure patient contours and calculate missing tissue compensator filters.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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## 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: [phone] Watts: 800-972-9222 FAX: [phone]