(90 days)
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No
The summary describes a traditional ionization chamber for radiation measurement and calibration, with no mention of AI or ML capabilities.
No
The device is described as an instrument for calibrating and measuring radiation outputs from medical therapy machines, not for providing therapeutic treatment itself.
No
Explanation: The device is described as an instrument for calibrating and measuring ionizing radiation outputs from medical therapy machines, specifically for absolute dosimetry measurements. It does not diagnose diseases or conditions in patients.
No
The device description explicitly details physical components like an ionization chamber, buildup cap, cable, and carrying case, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "calibrating and measuring the ionizing radiation outputs from medical therapy machines." This is a measurement and calibration function related to medical equipment, not a diagnostic test performed on biological samples (in vitro).
- Device Description: The description details an "Ionization Chamber" used for "absolute dosimetry measurements." This is a physics-based measurement tool for radiation, not a device designed to analyze biological specimens.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of diagnosing a disease or condition based on biological markers.
Therefore, this device falls under the category of a medical device used for quality control and calibration of radiation therapy equipment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This instrument is intended for the purpose of calibrating and measuring the ionizing radiation outputs from medical therapy machines.
This instrument is intended for the purpose of calibrating and measuring the ionizating radiation outputs for medicas therapy machines.
Product codes (comma separated list FDA assigned to the subject device)
90 LHN
Device Description
The Model 580-006 Radiation Therapy Ionization Chamber is modeled after the traditional 0.6cm Farmer-type chamber used for absolute dosimetry measurements of medical linear accelerators and 900 machines. Each chamber includes an energy response chart, a PMMA 600 buildup cap, a convenient low noise one meter cable with triaxial BNC connector and a custom carrying case.
The 580-006 and the predicate device are similar. Both units are an air filled ionization chamber that produce a current when exposed to ionizing radiation produced by a medical therapy machine. The 580-006 and the 500-6 are connected to an approved electrometer by a triaxial BNC connector.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
used only by a qualified medical physicist
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
Victoreen, LLC
Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The characters appear to be a combination of letters and numbers. The string is "K982937". The handwriting is somewhat stylized, with some characters connected and others distinct.
EXHIBIT A
Image /page/0/Picture/4 description: The image shows the word "VICTOREEN" in bold, black letters. The letters are capitalized and evenly spaced. The word is set against a white background and is enclosed in a black border.
Premarket notification [510(k)] Summary as required by section 807.92 (c)
Date Summary was prepared:
August 18, 1998
Submitter's Name:
Victoreen, LLC 6000 Cochran Road Cleveland, OH 44139-3395
Contact Person:
Mary Jo Nero Quality Assurance Associate Phone: (440) 248-9300 ext. 215 Fax: (440) 248-9301
Device Name:
Model 580-006 Radiation Therapy Ionization Chamber
Classification Name:
Medical Charged-Particle Radiation Therapy System
Predicate Device Name:
Model 500-6 Radiation Therapy Ionization Chamber 510(k) Number: K932342
6000 Cochran Road Cleveland. Ohio 44139-3395 (440) 248-9300 FAX (440) 248-9301 (800) 850-4608
1
Performance Standards Under Section 514:
Labeling:
Label: Advertising Brochure: (Product Data Sheet)
Model 580-006 New Device No Performance Standard established for this device
Reference Exhibit C
Model 500-6 Predicate Device
No Performance Standard established for this device
500-6 Reference Exhibit B
Intended Use:
This instrument is intended for the purpose of calibrating and measuring the ionizing radiation outputs from medical therapy machines.
580-006
Product Description
The Model 580-006 Radiation Therapy Ionization Chamber is modeled after the traditional 0.6cm Farmer-type chamber used for absolute dosimetry measurements of medical linear accelerators and 900 machines. Each chamber includes an energy response chart, a PMMA 600 buildup cap, a convenient low noise one meter cable with triaxial BNC connector and a custom carrying case.
2
Specification Comparison Table
| Feature | New Device
Model 580-006 | Predicate Device
Model 500-6 |
|--------------------------------------------------------|----------------------------------------------|---------------------------------|
| Volume | 0.61 cm³ | 0.6 cm³ |
| Sensitivity | 2.0 x 10⁻⁸ cGy⁻¹ | 2 x 10⁻¹⁰ A/R/s |
| Leakage |