(84 days)
Class I exemption under registration A 743531
Not Found
No
The description explicitly states the device is "passive" and requires "user evaluation or interpretation" of the film image. There is no mention of automated analysis, algorithms, or learning capabilities.
No
The device is a quality assurance tool for radiation generating equipment, used for testing and validating system parameters, not for treating patients.
No
The device is described as a 'passive device' for quality assurance testing of radiation generating equipment. It aids in visualizing radio-opaque marks on film for operator analysis, rather than diagnosing a disease or condition in a patient.
No
The device is described as a "passive device" with "radio-opaque objects embedded into it," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Mick Radio-Nuclear Isocentric Beam Checker is used for quality assurance of radiation generating equipment. It is a passive device placed in a radiation beam to create an image on film for analysis by an operator.
- No Human Samples: The device does not interact with or analyze any samples taken from the human body. Its purpose is to assess the performance of a medical device (radiation generator), not to diagnose or monitor a patient's health status.
Therefore, the intended use and function of this device clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
90 IYE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic exposure, x-ray film
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
Class I exemption under registration A 743531
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
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.
- (1)
l
| Manufacturer | K Number |
|---|---|
| Med Tec, Inc. Iso-Align | Class I exemption |
| under registration A | |
| 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).
1
K992
fage 20
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.
2
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 (301) 594-4613. 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/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
3
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)