(13 days)
K 971128
Not Found
No
The description focuses on the mechanical and optical features of a film projector for viewing cine radiographic images. There is no mention of AI, ML, or advanced image processing beyond basic projection and viewing capabilities.
No.
The device is used for diagnosis and evaluation of radiographic images, and does not provide any therapeutic function or intervention.
Yes
The device is explicitly stated to be used for "the diagnosis and quantitative evaluation of 35 mm cine radiographic images."
No
The device description explicitly mentions hardware components like a visible light source, translucent front, film transport, lamp holder, and a B&W-CCD-TV Camera, indicating it is a physical projector, not software only.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic), although it's not a typical IVD in the sense of analyzing biological samples.
Here's why:
- Intended Use: The primary intended use is for the "diagnosis and quantitative evaluation of 35 mm cine radiographic images." This directly relates to providing information for diagnostic purposes.
- Regulatory Classification: The description explicitly mentions being "intended to be used to view medical cine radiographic images (CFR 21 part 892.1890)." CFR 21 part 892.1890 is the regulation for Radiographic film viewers. Radiographic film viewers are classified as Class I or Class II medical devices used for viewing radiographic images for diagnostic purposes. While not explicitly called an IVD in the regulation title, devices used for viewing diagnostic images for the purpose of diagnosis fall under the broader scope of devices used in the diagnostic process.
- Predicate Device: The predicate device listed, K971128 CAP 35BIII / CINE 275, is also a cine film viewer used for diagnostic purposes. This further supports the classification of this device as a diagnostic tool.
Why it's not a typical IVD:
Traditional IVDs analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information. This device analyzes images. However, the regulatory definition of a medical device includes devices used in the diagnosis of disease or other conditions. Viewing and evaluating diagnostic images is a crucial part of the diagnostic process.
Conclusion:
While not a traditional "wet lab" IVD, the ARRIPRO 35's intended use for the diagnosis and quantitative evaluation of medical images, its classification under a regulation for radiographic film viewers, and its predicate device all strongly indicate that it is considered a medical device used in the diagnostic process and therefore falls under the umbrella of devices regulated for diagnostic purposes, which includes IVDs.
It's important to note that the term "IVD" can sometimes be used more narrowly to refer specifically to devices that analyze biological samples. However, in the broader regulatory context, devices used for diagnostic purposes, including image analysis for diagnosis, are often considered within the scope of IVD regulations or similar regulatory frameworks for diagnostic medical devices.
Therefore, based on the provided information, it is highly probable that this device is considered an IVD or a medical device regulated for diagnostic use.
N/A
Intended Use / Indications for Use
The device is intended to be used for the projection, diagnosis and quantitative evaluation of 35 mm cineradiographic images.
The device is used for the diagnosis and quantitative evaluation of 35 mm cine radiographic images, which is originating from radiographic imaging like Angiography.
The device contains a visible light source covered with a translucent front that is intended to be used to view medical cine radiographic images (CFR 21 part 892.1890). It also allows to be used for wall projection. The medical device is not part of a diagnostic x-ray system.
Product codes (comma separated list FDA assigned to the subject device)
90 LXC
Device Description
The ARRIPRO 35 was designed to fulfil the special requirements in view of an increasing demand for image quality and evaluation precision of 35 mm cardangiofflm material which could only be met with the innovative development of a practice-oriented projector. This projector which was developed using state-of-the-art technology for ease of operation, has an outstanding image quality for the projection, diagnosis and quantitative evaluation of 35 mm cine radiographic images.
The ARRIPRO 35 St / TV has the following functions:
- Rapid Film Transport and Simple Operation: Film transport via a patented internittent film drive system enables a film transport interval of less than 0.01 sec. regardless of projection speed. Constant film tension and reliable film transport is guaranteed through the use of a computer-controlled drive system for the film platter motors. Film loading is both fast and simple as a result of the computer-controlled system.
- Optimized Image Quality with Flicker Free Projection: Image brightness, frame steadiness and image clarity have been optimized for all applications.
- High Speed Shuttle: High speed winding and quick localization of specific film frames is accomplished by using the projector's high speed shuttle mode.
- Revolving Lamp Holder: The ARRIPRO 35 is equipped with a revolving lamp holder containing three (3) lamps, two (2) 300 W halogen lamps and one (1) 400 W HTI-lamp for bright wall projection.
- Optimum Wall Projection: The ARRIPRO 35 also functions as an excellent quality wall projection unit.
- Computer and Video Connections: A video output enables the connection of additional monitors, video recorder and video printer.
- B&W-CCD-TV Camera: B& W-CCD-TV camera with motor-driven x-y zoom carriage as well as motor driven focusing. TV-image can be panned in all directions and zoomed up to 3.0 times.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Cine radiographic images (35 mm film)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professionals
The device may only be operated in cathlabs, lecture halls and doctors' consulting rooms.
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.
K 971128
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
§ 892.1890 Radiographic film illuminator.
(a)
Identification. A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
p.1 of 2
407
ARNOLD & RICHTER CINE TECHNIK GMBH & CO. BETRIEBS KG
TÜRKENSTRASSE 89 · D-80799 MÜNCHEN
ARNOLD & RICHTER CINE TECHNIK · POSTFACH 4001 49 · D-80701 MUNCHEN
Summary of Safety and Effectiveness Information for 510 [k] Submission Radiographic film illuminator 3
FP - 2 1997
| General Information: | |
|---|---|
| Proprietary name: | Arripro 35 St / TV |
| Common name: | -- |
| Classification Name: | Radiographic film illuminator |
| Classification: | Class II |
| Classification Number: | |
| Intended use: | The device is intended to be used for the projection, diagnosis and quantitative evaluation of 35 mm cineradiographic images |
| Legally marketed device: | CAP 35BIII / CINE 275 |
| Proprietary Name: | Cineangiogram projector |
| Common Name: | -- |
| Classification Name: | Class II |
| Classification: | |
| Classification Number: | K 971128 |
| Date of submission: | -- |
| DIN-Standards applied for the Arripro 35 St /TV | |
| 1. DIN 6856, Part 1 | |
| Demands for the manufacture and the operation | 6. EN 60950 |
| IEC 950 |
| | Demands for the manufacture and the operation
of viewing apparatus for the evaluation of
transparent images in medical diagnostics. | | - IEC 950
-
DIN EN 60950
-
VDE 0805 |
|----|-------------------------------------------------------------------------------------------------------------------------------------------|----|-------------------------------------------|
| 2. | DIN 6856, Part 2
Quality-guaranteeing measures in medical
diagnostics, -
testing procedures, measuring instruments | 7. | EN-61010-1 |
| 3. | DIN 19045, Part 8
Projection of still pictures and motion pictures
for educational and home use. | 8. | EN-60555-2 |
| 4. | EN 55011 -
CISPR 11 | 9. | EN 60555-3 |
-
DIN NDE 0875-TI I
-
VDE 0875-TII
ડ. EN 50082-2
- DIN EN 20082-2
1
Image /page/1/Picture/0 description: The image shows the logo for ARRI, a motion picture technology company. The logo is in black and white and features the company name in bold, sans-serif letters. To the right of the name is a small circle with the letters "ARR" inside.
K4 73115 p. 2 of 2
Technological Characteristics and the intended use of the device
The ARRIPRO 35 was designed to fulfil the special requirements in view of an increasing demand for image quality and evaluation precision of 35 mm cardangiofflm material which could only be met with the innovative development of a practice-oriented projector. This projector which was developed using state-of-the-art technology for ease of operation, has an outstanding image quality for the projection, diagnosis and quantitative evaluation of 35 mm cine radiographic images.
The ARRIPRO 35 St / TV has the following functions:
Rapid Film Transport and Simple Operation
Film transport via a patented internittent film drive system enables a film transport interval of less than 0.01 sec. regardless of projection speed. Constant film tension and reliable film transport is guaranteed through the use of a computer-controlled drive system for the film platter motors.
Film loading is both fast and simple as a result of the computer-controlled system.
Optimized Image Quality with Flicker Free Projection
Image brightness, frame steadiness and image clarity have been optimized for all applications.
High Speed Shuttle
High speed winding and quick localization of specific film frames is accomplished by using the projector's high speed shuttle mode.
Revolving Lamp Holder
The ARRIPRO 35 is equipped with a revolving lamp holder containing three (3) lamps, two (2) 300 W halogen lamps and one (1) 400 W HTI-lamp for bright wall projection.
Optimum Wall Projection
The ARRIPRO 35 also functions as an excellent quality wall projection unit.
Computer and Video Connections
A video output enables the connection of additional monitors, video recorder and video printer.
B&W-CCD-TV Camera
B& W-CCD-TV camera with motor-driven x-y zoom carriage as well as motor driven focusing. TV-image can be panned in all directions and zoomed up to 3.0 times.
DIN-Standards applied for the Arripro 35 St /TV
| 1. | DIN 6856, Part 1
Demands for the manufacture and the operation
of viewing apparatus for the evaluation of
transparent images in medical diagnostics. | 5. | EN 60950
- IEC 950
- DIN EN 60950
- VDE 0805 |
|----|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----|-------------------------------------------------------|
| 2. | DIN 6856, Part 2
Quality-guaranteeing measures in medical
diagnostics, - testing procedures, measuring instruments | 6. | EN-61010-1 |
| 3. | DIN 19045, Part 8
Projection of still pictures and motion pictures
for educational and home use. | 7. | EN-60555-2 |
| 4. | EN 55011 - CISPR 11
- DIN VDE 0875-T11
- VDE 0875-T11 | 8. | EN 60555-3 |
| | | 9. | EN 50082-2 - DIN EN 50082-2
- VDE 839-T82-2 |
2
Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arnold & Richter Cine Technik GmbH & Co. Betriebs KG c/o Carole Stamp TUV Product Service ... 1775 Old Highway 8 New Brighton, MN 55112-1891 Re: K973115
Arrioro 35 St / TV (35 mm film viewer) Dated: August 18, 1997 Received: August 20, 1997 Regulatory Class: I 21 CFR 892.1890/Procode: 90 LXC
SEP - 2 1397
Dear Ms. Stamp:
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 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or 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 requirement, 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 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/cdrh/dsmamain.html".
Sincereiv yours
h.J. Liao Yin
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Radiographic Film Illuminator
Indications For Use:
The device is used for the diagnosis and quantitative. evaluation of 35 mm cine radiographic images, which i originating from radiographic imaging like Angiography.
The device contains a visible light source covered with a translucent front that is intended to be used to view medical cine radiographic images (CFR 21 part 892.1890). It also allows to be used for wall projection. The medical device is not part of a diagnostic x-ray system.
The device may only be operated in cathlabs, lecture halls and doctors' consulting rooms. The device is only for use by medical professionals.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiologigel Du
Radiological Devices
510(k) Number_k972115
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-7