VELOS CONSTANCY CHECK DEVICE, MODEL 55-145

K970384 · Aktina Medical Physics Corp. · IYE · Jul 29, 1997 · Radiology

Device Facts

• Record ID: K970384
• Device Name: VELOS CONSTANCY CHECK DEVICE, MODEL 55-145
• Applicant: Aktina Medical Physics Corp.
• Product Code: IYE · Radiology
• Decision Date: Jul 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The AKTINA "Velos" Constancy Check Device, model 55-145, is intended for use in external beam radiation therapy in a similar way to that of the Tracker Therapy Beam Evaluation System (by Keithley Instruments, Inc.) previously cleared for marketing under K874893. More specifically, its intended use is for daily, morning checks of machine output by staff technologists, under the supervision of a medical physicist. Not intended as a substitute for machine calibrations or validations of machine beam energy, these checks are quality assurance steps to safeguard accepted standards of good practice in Radiation Oncology.

Device Story

Device functions as quality assurance tool for external beam radiation therapy; verifies machine output consistency. Operates by mounting on standard beamblock trays or placement on treatment table. Facilitates daily checks by staff technologists; enables remote monitoring via CCTV. Reduces setup time; ensures fixed geometry to eliminate distance errors; supports measurements at various gantry angles. Output allows technologists to confirm machine performance against established standards; assists in maintaining safe radiation delivery. Not a substitute for formal calibration.

Clinical Evidence

No clinical data provided; device is a quality assurance tool for radiation therapy equipment.

Technological Characteristics

Mechanical constancy check device; designed for fixed geometry mounting on beamblock trays or table placement. Supports remote reading via CCTV. No software or electronic processing described.

Indications for Use

Indicated for daily quality assurance checks of external beam radiation therapy machine output. Intended for use by staff technologists under medical physicist supervision. Not for machine calibration or beam energy validation.

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.

Predicate Devices

• Keithly Instruments, Inc., Tracker Therapy Beam Evaluation system (K874893)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUL 29 1937

George Zacharopoulos
Certified Radiological Physicist
Aktina Medical Physics Corp.
360 North Route 9W
Congers, NY 10920

Re: K970384
Velos Constancy Check Device (CCD),
Model 55-145
Dated: June 2, 1997
Received: June 5, 1997
Regulatory class: II
21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Zacharopoulos:

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 requirement, 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 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.gov/cdrh/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.
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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x970384

# Summary of Safety and Effectiveness
Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act

January 1, 1997
JUL 29 1997

## 1. General Provisions

Common/Usual Name: Constancy Check Device

Proprietary Name: Velos Constancy Check Device, model 55-145

Applicant Name and Address:
Aktina Medical Physics Corporation
360 North Route 9W
Congers, N.Y. 10920

## 2. Name of Predicate Devices:

(1) Keithly Instruments, Inc., Tracker Therapy Beam Evaluation system (K874893)

## 3. Classification

This device is classified as a class II device according to 21 CFR 892.5050

## 4. Performance Standards

Performance standards for these devices have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.

## 5. Intended Use and Device Description

This device is intended to be used as a means of verifying machine output on a daily basis in the delivery of external beam radiation therapy.

## 6. Biocompatibility

Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, "...a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seq. (1977).

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No issues of biocompatibility are raised with regard to this device.

## 7. Summary of Substantial Equivalence

This device is similar in design and construction, utilizes the same materials, and has the same intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device.

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APR-24-97 THU 11:00
AKTINA MEDICAL PHYSICS
FAX NO. 9142681700
P. 02

# CDRH DRAERD

Page 1 of 1

510(k) Number if known: K970384

Device Name: "Velos" Constancy Check Device

Indications for Use:

The AKTINA "Velos" Constancy Check Device, model 55-145, is intended for use in external beam radiation therapy in a similar way to that of the Tracker Therapy Beam Evaluation System (by Keithley Instruments, Inc.) previously cleared for marketing under K874893.

More specifically, its intended use is for daily, morning checks of machine output by staff technologists, under the supervision of a medical physicist. Not intended as a substitute for machine calibrations or validations of machine beam energy, these checks are quality assurance steps to safeguard accepted standards of good practice in Radiation Oncology.

"Velos" is designed to operate by either:

a. being mounted on standard beamblock trays or,
b. placed on a table, when measurements are needed from various SID's

and functions in an efficient and reliable way through reduction of setup time, remote control readings via CCTV, output constancy checks at all gantry angles (for compliance with TG-43) and fixed geometry for elimination of distance errors.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use ☑
(Per21 CFR 801.109)