OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX
Device Facts
| Record ID | K091628 |
|---|---|
| Device Name | OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX |
| Applicant | Protec GmbH & Co. KG |
| Product Code | IXW · Radiology |
| Decision Date | Aug 21, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1900 |
| Device Class | Class 2 |
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.
Device Story
Automatic X-ray film processor; processes exposed medical films via continuous mechanical transport through developer, fixer, wash, and dryer stages. Input: exposed X-ray film. Output: developed, fixed, and dried film for clinical viewing. Operation: film fed into processor; roller transport system moves film through chemical baths; integrated microprocessor controls temperature, circulation, and automatic replenishment of solutions. Used in clinical settings by trained medical professionals (physicians, nurses, lab technicians). Benefits: provides standardized, automated film processing for diagnostic imaging.
Clinical Evidence
No clinical data. Substantial equivalence is based on technological characteristics and performance similarities to the predicate device.
Technological Characteristics
Mechanical roller transport system for film immersion in developer and fixer baths, followed by water rinse and drying. Features temperature-regulated, circulated, and automatically replenished chemical solutions. Includes anti-crystallization cycle and stand-by mode. Controlled by integrated microprocessor software. Feed widths: 35 cm (OPTIMAX, OPTIMAX 2010, ECOMAX) and 45 cm (COMPACT 2).
Indications for Use
Indicated for processing medical X-ray films in general radiographic and diagnostic imaging procedures. Intended for use by trained medical professionals including physicians, nurses, and lab technicians.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- DOOSAN DSP 3800 Automatic X-Ray Film Processor (K954345)
Submission Summary (Full Text)
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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
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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:
- 1. have the same intended use
- 2. have the same target user group
- 3. 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
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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
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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
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# 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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