ISOCENTRIC BEAM CHECKER

K993959 · Mick Radio-Nuclear Instruments, Inc. · IYE · Feb 14, 2000 · Radiology

Device Facts

• Record ID: K993959
• Device Name: ISOCENTRIC BEAM CHECKER
• Applicant: Mick Radio-Nuclear Instruments, Inc.
• Product Code: IYE · Radiology
• Decision Date: Feb 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

In order to ensure the day to day performance of radiation generating equipment, many quality assurance tests are performed. This testing includes such tests as machine output, beam alignment, distance indicators. In all quality assurance testing a test object or measurement device is used to either validate a system parameter or measure some aspect of system performance. These test objects/devices can easily be classified as one of two types, passive or active. An active device is one that can make a measurement or perform a test without user evaluation or interpretation, while a passive device merely provides an environment or condition for testing, but the result requires the user or operator to make an evaluation and determination. Examples of passive devices are test phantoms or film cassettes. The Mick Radio-Nuclear Isocentric Beam Checker is a passive device, designed to be placed between the incident radiation beam and a piece of film. Radiographic exposure of the Isocentric Beam Checker results in the production of an image on the film which can then be analyzed by the operator for consistency from the prior test exposure. The Isocentric Beam Checker does not alter, change or moderate the radiation field in any manner. It has radio-opaque objects embedded into it that are visualized on standard x-ray film when inserted in a radiation beam. The inspection of the radio-opaque marks on the film is then used in quality assurance.

Device Story

Passive radiologic quality assurance instrument; consists of radio-opaque objects embedded in a device. Placed between radiation beam and x-ray film during equipment testing. Device does not alter radiation field. Operator exposes film, then visually inspects resulting image of radio-opaque marks to assess consistency of radiation equipment performance (e.g., beam alignment, distance indicators). Used in clinical settings by qualified personnel. Provides visual reference for manual evaluation of system performance; aids in maintaining equipment quality standards.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Passive radiologic quality assurance device; contains embedded radio-opaque markers. Designed for placement in radiation beam path to produce images on standard x-ray film. Non-electronic; no energy source.

Indications for Use

Indicated for use as a passive quality assurance tool for radiation generating equipment. Used by clinicians/technicians to validate system parameters such as beam alignment and distance indicators by visualizing radio-opaque markers on x-ray film.

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

• Med Tec, Inc. Iso-Align

Submission Summary (Full Text)

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FEB 1 4 2000

K993959
Page 1 of 2

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

October 2, 1999

#### 1. General Provisions

Radiologic Quality Assurance Instrument Common/Usual Name:

Isocentric Beam Checker I/II/III Proprietary Name:

Applicant Name and Address:

Mick Radio-Nuclear Instruments, Inc. 1470 Outlook Avenue Bronx, New York 10465

#### Name of Predicate Devices: 2.

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l

| Manufacturer | K Number |
|-------------------------|-----------------------------------------------------|
| Med Tec, Inc. Iso-Align | Class I exemption<br>under registration A<br>743531 |

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, 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 seg. (1977).

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#### Classification 3.

This device is classified as a class I device according to 21 CFR 892.1940.

#### Performance Standards 4.

Performance standards for radiologic quality assurance instruments have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.

#### ડ. Intended Use and Device Description

In order to ensure the day to day performance of radiation generating equipment, many quality assurance tests are performed. This testing includes such tests as machine output, In all quality assurance testing a test object or beam alignment, distance indicators. measurement device is used to either validate a system parameter or measure some aspect of system performance. These test objects/devices can easily be classified as one of two types, passive or active. An active device is one that can make a measurement or perform a test without user evaluation or interpretation, while a passive device merely provides an environment or condition for testing, but the result requires the user or operator to make an evaluation and determination. Examples of passive devices are test phantoms or film cassettes.

The Mick Radio-Nuclear Isocentric Beam Checkers are a passive device, designed to be placed between the incident radiation beam and a piece of film. Radiographic exposure of the Isocentric Beam Checker results in the production of an image on the film which can then be analyzed by the operator for consistency from the prior test exposure. The Isocentric Beam Checker does not alter, change or moderate the radiation field in any manner. It has radio-opaque objects embedded into it that are visualized on standard xray film when inserted in a radiation beam. The inspections of the radio-opaque marks on the film are then used in quality assurance.

#### 6. Biocompatibility

No new issues of biocompatability are raised with regard to this device.

#### 7. Summary of Substantial Equivalence

This device is similar in design and construction, utilizes the identical 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the serpents. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2000

Felix Mick President Mick Radio-Nuclear Instruments, Inc. P.O. Box 99 Bronx, NY 10465

Re:

K993959 Isocentric Beam Checker Dated: November 15, 1999 Received: November 22, 1999 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Mick:

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 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/odrh/dsma/dsmamain.html".

Sincerely yours,

CAPT 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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## Indications for Use

**510(k) Number:** *To be assigned* k993959

Device Name: Isocentric Beam Checker

### Indications for Use:

In order to ensure the day to day performance of radiation generating equipment, many quality This testing includes such tests as machine output, beam assurance tests are performed. In all quality assurance testing a test object or measurement alignment, distance indicators. device is used to either validate a system parameter or measure some aspect of system performance. These test objects/devices can easily be classified as one of two types, passive or active. An active device is one that can make a measurement or perform a test without user evaluation or interpretation, while a passive device merely provides an environment or condition for testing, but the result requires the user or operator to make an evaluation and determination. Examples of passive devices are test phantoms or film cassettes.

The Mick Radio-Nuclear Isocentric Beam Checker is a passive device, designed to be placed between the incident radiation beam and a piece of film. Radiographic exposure of the Isocentric Beam Checker results in the production of an image on the film which can then be analyzed by the operator for consistency from the prior test exposure. The Isocentric Beam Checker does not alter, change or moderate the radiation field in any manner. It has radio-opaque objects embedded into it that are visualized on standard x-ray film when inserted in a radiation beam. The inspection of the radio-opaque marks on the film is then used in quality assurance.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: /

Over-The-Counter Use: ***_*** (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_193959

Isocentric Beam Checker 510(k)