AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER

K990997 · Aktina Medical Physics Corp. · IYE · Jun 22, 1999 · Radiology

Device Facts

• Record ID: K990997
• Device Name: AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER
• Applicant: Aktina Medical Physics Corp.
• Product Code: IYE · Radiology
• Decision Date: Jun 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The AKTINA Medical Physics Corporation Mechanical Frontpointer is intended for use in Medical Physics Quality Assurance. The intended use of this device is to provide a reproducible and accurate mechanism for the setup of test objects and equipment used in quality control and calibrations by medical physicists.

Device Story

Mechanical device for medical physics quality assurance; mounts into linear accelerator accessory slot. Provides rigid, reproducible distance measurement from beam source to test objects. Functions as mechanical tape measure attached to frame. Operated by medical physicists in clinical settings. Ensures consistent geometry for daily/monthly/annual machine output and field size validation. Benefits patient care by maintaining accuracy of radiation therapy and diagnostic radiology equipment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical device; mounts to linear accelerator accessory slot; provides fixed, rigid geometry for distance measurement. No software, electronics, or patient contact.

Indications for Use

Indicated for medical physicists performing quality assurance, calibration, and setup of test objects/equipment in radiation therapy and diagnostic radiology to ensure reproducible machine geometry, field size, and output measurements.

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

• Sears Tape Measure
• Elekta Oncology Systems Mechanical Frontpointer (K874558)

Submission Summary (Full Text)

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JUN 2 2 1999

K990997

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

March 15, 1999

#### 1. General Provisions

| Trade Name: | Mechanical Frontpointer |
|--------------|---------------------------|
| Common Name: | Distance Indicator, Ruler |

| Applicant Name and Address: | AKTINA Medical Physics Corporation |
|-----------------------------|------------------------------------|
| | 360 North Route 9 W |
| | Congers, New York, 10920 |
| | Phone: [phone] |
| | FAX: [phone] |
| | Registration Number: 2436865 |

### 2. Name of Predicate Devices

Sears Tape Measure and Elekta Oncology Systems Mechanical Frontpointer K874558. 1

Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product oan 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 Art 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).

#### 3. Classification

This device is classified as a class I device according to 21 CFR 892.1940 and a class II device according to 21 CFR 892.5050.

### Performance Standards 4.

The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for Mechanical Frontpointers.

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#### 5. Intended Use and Device Description

The AKTINA Medical Physics Corporation Mechanical Frontpointer is intended for use in Medical Physics Quality Assurance. The intended use of this device is to provide a reproducible and accurate mechanism for the setup of test objects and equipment used in quality control and calibrations by medical physicists.

#### 6. Biocompatibility

The Mechanical Frontpointer is mounted in the accessory slot of the treatment machine and is not in contact with the patient at any time when in use. Therefore, no biocompatibility studies were undertaken for the device.

#### 7. Summary of Substantial Equivalence

This device is similar in design, construction, materials, 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 1999

Joan Zacharopoulos Vice-President AKTINA Medical Physics Corp. 360 North Route 9 W Congers, New York 10920

Re:

K990997 AKTINA Mechanical Frontpointer Dated: March 15, 1999 Received: March 25, 1999 Regulatory Class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Ms. 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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment to federally Medical Device Amendments, or to devices that have been redassified 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 , inting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Special Controls) or dass 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 (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 diagnoetic 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel C. Schultz, M.D.

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: K990997

Device Name: Mechanical Frontpointer

Indications for Usc:

In Radiation Therapy and Diagnostic Radiology, an ongoing quality assurance program is essential for ensuring the overall quality of patient care. As part of the overall quality assurance program daily, monthly and annual tests to validate machine output, field size indicators, and general machine geometry are performed. In order to obtain reproducible results, these tests must be Since machine with the same conditions, with the same physical parameters. Since machine output and field size are directly related to the geometry of the test conditions it is important that the distance from the beam source to the test device is consistent. The Aktina Medical Physics Corporation Mechanical Frontpointer is designed to provide this ability. By utilizing the fixed geometry of the accessory mount system on a linear accelerator, a rigid based for measuring distance can be obtained. The Mechanical Frontpointer presented in this notification functions exactly as a standard mechanical tape measure however by being attached to a frame which slides into the accessory mount a reproducible setup is ensured.

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

Prescription Use:
(Per 21 CFR 801.109)

Over-The Counter Use:

Uid A. Slegman
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices and Radiological Devices