(89 days)
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.
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. 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.
The provided text does not contain information about acceptance criteria, device performance metrics, or a study demonstrating the device meets such criteria. The document is a 510(k) summary for the "Mechanical Frontpointer," which is a device for medical physics quality assurance, used to provide a reproducible and accurate mechanism for the setup of test objects and equipment.
The document focuses on:
- General Provisions: Trade name, common name, applicant information.
- Predicate Devices: Sears Tape Measure and Elekta Oncology Systems Mechanical Frontpointer K874558.
- Classification: Class I and Class II device classifications.
- Performance Standards: Notes that FDA has not established performance standards for Mechanical Frontpointers.
- Intended Use and Device Description: Explains its function in medical physics quality assurance for reproducible setup of test objects and equipment.
- Biocompatibility: States no studies were undertaken as the device does not contact the patient.
- Summary of Substantial Equivalence: Claims similarity in design, construction, materials, intended use, and performance to predicate devices without introducing new safety/effectiveness issues.
- FDA Clearance Letter: Official communication from FDA stating clearance based on substantial equivalence.
- Indications for Use: Details its role in radiation therapy and diagnostic radiology quality assurance for reproducible setup.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or MRMC studies, as these details are not present in the provided text. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.
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JUN 2 2 1999
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: 914-268-0101 | |
| FAX: 914-268-1700 | |
| 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 (301) 594-4013. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.