(89 days)
Not Found
No
The device is described as a mechanical frontpointer functioning like a tape measure, with no mention of AI or ML terms or functionalities.
No.
The device is used for quality assurance of radiation therapy equipment, not for directly treating or diagnosing patients. Its function is to facilitate reproducible setup for testing machine output and geometry, not to perform a therapeutic function itself.
No
The device is a "Mechanical Frontpointer" used in quality assurance for radiation therapy and diagnostic radiology equipment to ensure consistent test conditions for validating machine output and geometry. It functions like a specialized tape measure and is not used to diagnose patients.
No
The device description explicitly states it is a "Mechanical Frontpointer" and describes its physical components and how it mounts to a linear accelerator, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for quality assurance in radiation therapy and diagnostic radiology, specifically for setting up test objects and equipment for quality control and calibrations. It is used to ensure reproducible test conditions for machine output and field size measurements.
- Device Description: The device is a mechanical frontpointer that functions like a tape measure, mounted in the accessory slot of a treatment machine. It is explicitly stated that it is not in contact with the patient at any time when in use.
- Nature of IVDs: IVDs are devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not interact with human specimens.
The device is a tool for calibrating and ensuring the proper functioning of medical equipment, not for diagnosing or monitoring a patient's health through the analysis of biological samples.
N/A
Intended Use / Indications for 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.
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 performed under 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.
Product codes (comma separated list FDA assigned to the subject device)
90 IYE
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical Physics Quality Assurance / Radiation Therapy and Diagnostic Radiology
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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.
2
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
3
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