(78 days)
Not Found
No
The description focuses on mechanical and chemical processes for developing X-ray film, controlled by a microprocessor and integrated software for basic automation and parameter adjustment. There is no mention of AI, ML, or any capabilities that would suggest learning or adaptive algorithms for image analysis or processing beyond standard film development.
No.
The device is an automatic X-ray film processor used to process films exposed for medical purposes, not to directly treat or diagnose a medical condition.
No
This device is an X-ray film processor, which develops films that have been exposed for medical purposes. It does not perform diagnostic functions itself, but rather prepares the images for diagnostic interpretation by medical professionals.
No
The device is a physical machine (Automatic X-Ray Film Processor) that uses software to control its mechanical and chemical processes. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: This device is an Automatic X-Ray Film Processor. Its function is to process exposed X-ray films, which are images of the inside of the body, not specimens taken from the body.
- Intended Use: The intended use is to process films exposed for medical purposes, specifically for general radiographic and diagnostic imaging procedures. This is related to imaging, not laboratory testing of biological samples.
- Regulation Number: The regulation number provided (892.1900) is for "Automatic X-Ray Film Processor," which falls under the category of Radiology devices, not In Vitro Diagnostic devices.
Therefore, based on the provided information, this device is not an IVD.
N/A
Intended Use / Indications for Use
The Automatic X-Ray Film Processor is intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films.
This may be used in all general radiographic, diagnostic imaging procedures. Typical users of this system are trained medical professionals, including but not limited to physicians, nurses, and lab technicians.
OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX are all Automatic X-Ray Film Processors (Regulation No. 892.1900).
The devices mentioned above are intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films.
This may be used in all general radiographic, diagnostic imaging procedures.
Product codes (comma separated list FDA assigned to the subject device)
IXW
Device Description
Due to the precise roller transport system, both sheet and roller films can be processed. The automatic film registration is activated immediately when a film is fed in. The transport system starts running. The film material is developed, fixed, rinsed and dried. With the easy to operate micro-processor, the processing conditions can be adjusted to suit the various film and chemical types. The developing solutions are temperature-regulated, circulated and automatically replenished. The feed width of the OPTIMAX®, OPTIMAX® 2010 and ECOMAX™ is 35 cm, the bigger COMPACT™ 2 has 45 cm feed with. The smallest film format of all processors is 10*10 cm.
The photographic processing (developing) technique employed by the Automatic X-Ray Film Processor is the same as the predicate device. The film medium is mechanically transported for immersion in two chemical baths (developer and fixer), is rinsed in water, dried, and then ejected for viewing. The processors use mechanical rollers for transportation, the solutions are temperature-regulated, circulated and automatically replenished, and same additional functions (anti-crystallization cycle, stand-by mode). All are controlled by an integrated software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray Film
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typically users of this system are trained medical professionals, including but not limited to physicians, nurses, and lab technicians.
This may be used in all general radiographic, diagnostic imaging procedures.
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)
The comparison of similarities and differences shows that the new device PROTEC Automatic X-Ray Film Processor, which is intended to market and the predicate device:
-
- have the same intended use
-
- have the same target user group
-
- have the same technological characteristics
There are no new questions about safety and effectiveness. The new device is as safe and effective as the predicate device.
- have the same technological characteristics
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
§ 892.1900 Automatic radiographic film processor.
(a)
Identification. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Section 7
Image /page/0/Picture/1 description: The image shows the word "PROTEC" in large, bold, white letters with a black outline. The word is slightly slanted upwards from left to right. There is a registered trademark symbol to the right of the "C". Underneath the word is a thick, black line that curves upwards from left to right.
medical systems
PROTEC GmbH & Co. KG - Lichtenberger Str. 35 - 71720 Oberstenfeld
510(k) Summary
K 09162815001
AUG 21, 2009
PROTEC GmbH & Co. KG Lichtenberger Str. 35 - 71720 Oberstenfeld Telefon: +49 [0] 7062 - 92 55 0 +49 (0) 7062 - 22 68 5 Fax: e-Mail: protec@protec-med.com Internet: www.protec-med.com
From Contact Person Mr. Jochen Krupp
e-mall jochen.krupp@protec-med.com Telephone +49-7062-9255-25 Date October 17, 2007
This Summary of Safety and Effectiveness is in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
Device:
Common name: Automatic X-Ray Film Processor OPTIMAX®, ECOMAX™ Trade name: COMPACT™ 2, OPTIMAX® 2010
Classification name: Processor, Radiographic-Film, Automatic
Predicate Device:
The Predicate Device is a legally marketed, postamendments device:
K954345 DOOSAN DSP 3800 Automatic X-Ray Film Processor
Device Description
Due to the precise roller transport system, both sheet and roller films can be processed. The automatic film registration is activated immediately when a film is fed in. The transport system starts running. The film material is developed, fixed, rinsed and dried. With the easy to operate micro-processor, the processing conditions can be adjusted to suit the various film and chemical types. The developing solutions are temperature-regulated, circulated and automatically replenished. The feed width of the OPTIMAX®, OPTIMAX® 2010 and ECOMAX™ is 35 cm, the bigger COMPACT™ 2 has 45 cm feed with. The smallest film format of all processors is 10*10 cm.
Landesbank Baden-Württemberg (LBBW) BLZ 600 501 01 - Konto-Nr.: 800 38 03 Kreissparkasse Ludwigsburg BLZ 604 500 50 - Kanto-Nr. 40 42 150
7-1 Dresdner Bank BLZ 620 800 12 - Konto-Nr.: 719 547 300
Image /page/0/Picture/21 description: The image shows a logo with the words "Quality Management" in an arc shape at the top. Below the text is a graphic that appears to be a stylized representation of the letters "DG" or a similar design. The logo has a simple, professional look and is likely used to represent a company or organization focused on quality management.
Jerman
Healthcare
Export Group
1
Image /page/1/Picture/1 description: The image shows the logo for Protec Medical Systems. The word "PROTEC" is in large, bold, sans-serif font. Below the word "PROTEC" is a thick, black line that extends from left to right. Below the line, the words "medical systems" are written in a smaller, sans-serif font.
Intended Use
The Automatic X-Ray Film Processor is intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films.
This may be used in all general radiographic, diagnostic imaging procedures. Typical users of this system are trained medical professionals, including but not limited to physicians, nurses, and lab technicians.
Summary of Substantial Equivalence Comparison
The comparison of similarities and differences shows that the new device PROTEC Automatic X-Ray Film Processor, which is intended to market and the predicate device:
-
- have the same intended use
-
- have the same target user group
-
- have the same technological characteristics
There are no new questions about safety and effectiveness. The new device is as safe and effective as the predicate device.
The Automatic X-Ray Film Processor is substantially equivalent to the DOOSAN DSP 3800 Automatic X-Ray Film Processor.
Technological Characteristics
The photographic processing (developing) technique employed by the Automatic X-Ray Film Processor is the same as the predicate device. The film medium is mechanically transported for immersion in two chemical baths (developer and fixer), is rinsed in water, dried, and then ejected for viewing. The processors use mechanical rollers for transportation, the solutions are temperature-regulated, circulated and automatically replenished, and same additional functions (anti-crystallization cycle, stand-by mode). All are controlled by an integrated software.
PROTEC GmbH & Co KG
J. Kryg
chen Krupp (Technical Manager Analogue Systems)
p. 2 of 2
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Jochen Krupp Technical Manager Analogue Systems PROTEC GmbH & Co., KG Lichtenberger Straße 35 Oberstenfeld, Baden-Württemburg 71720 GERMANY
Re: K091628
Trade/Device Name: Optimax, Compact 2, Optimax 2010, Ecomax Regulation Number: 21 CFR 892.1900 Regulation Name: Automatic radiographic film processor Regulatory Class: II Product Code: IXW Dated: June 29, 2009 Reccived: July 2, 2009
Dear Mr. Krupp:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.
AUG 21 2009
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Lamur M. Monul
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_K091628
Device Name: OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX
Indications For Use:
OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX are all Automatic X-Ray Film Processors (Regulation No. 892.1900).
The devices mentioned above are intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films.
This may be used in all general radiographic, diagnostic imaging procedures.
Typical users of this system are trained medical professionals, including but not limited to physicians, nurses and lab technicians.
PROTECT
PROTEC GmbH & Co. KG medical systems htenberger Straße 35 720 Oberstenfeld
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
hory Mthly
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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