PROFA

K981911 · Duncan Hynd Associates, Ltd. · IYE · Nov 12, 1998 · Radiology

Device Facts

• Record ID: K981911
• Device Name: PROFA
• Applicant: Duncan Hynd Associates, Ltd.
• Product Code: IYE · Radiology
• Decision Date: Nov 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

For radiation therapy, patient/body contouring, virtual simulation and verification of the patient's treatment plan. Provides any simulator with a fast, non-contact method for obtaining accurate patient contours. The results can be downloaded to the treatment planning computer. Profa is fully automatic and offers software solution for scanning and simulation of the breast, pelvis, head and neck, treatment masks and sagittal cases. The hand-held Profa plus system is portable and can be used in the radiotherapy room.

Device Story

PROFA is an optical patient contouring device for radiation therapy. System utilizes non-contact scanning to obtain patient body contours; data is downloaded to treatment planning computers for virtual simulation and plan verification. Device is fully automatic; includes a portable, hand-held 'Profa plus' unit for use within the radiotherapy room. Enables rapid, accurate anatomical mapping for clinical radiotherapy workflows; assists clinicians in treatment planning and verification processes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Optical non-contact scanning system; hand-held portable form factor; software-based automated contouring; data output compatible with treatment planning computers.

Indications for Use

Indicated for radiation therapy patients requiring body contouring, virtual simulation, and treatment plan verification. Applicable for breast, pelvis, head, and neck regions, including treatment masks and sagittal cases.

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

NOV 1 2 1998

Duncan Hynd Associates c/o Dancan Upton 719 Catalpa Avenue Teaneck, NJ 07666

Re:

K981911 PROFA an Optical Patient Contouring Device Dated: September 22, 1998 Received: September 22, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Upton:

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 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) 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 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 [phone] or [phone] or at its Internet address "http://www.fda.gow/oddf/dsmaldsmamain.html".

Sincerely yours,

Lillian Yih

Lillian Yin, Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/0/Picture/14 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

D.

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510(k) Number (if known)__

K981911

Patient contouring, simulation, for Radiation Therapy Device Name:

Indications for Use:

For radiation therapy, patient/body contouring, virtual simulation and verification of the patient's treatment plan. Provides any simulator with a fast, non-contact method for obtaining accurate patient contours. The results can be downloaded to the treatment planning computer. Profa is fully automatic and offers software solution for scanning and simulation of the breast, pelvis, head and neck, treatment masks and sagittal cases. The hand-held Profa plus system is portable and can be used in the radiotherapy room.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |
|--------------------------------------------------------|--------------------------|----|----------------------|
| (Division Sign-Off) | | | |
| Division of Reproductive, Abdominal, ENT, | | | |
| | and Radiological Devices | | |
| 510(k) Number | K981911 | | |
| Prescription Use | | OR | Over-the-Counter Use |

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