OPTON PRO

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 24, 2014 Zimmer MedizinSysteme GmbH % Ms. Kirsten Langen Tuv Sud America Incorporated 1775 Old Highway, 8 North West New Brighton, Minnesota 55112 Re: K141564 Trade/Device Name: OptonPro Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: September 10, 2014 Received: September 29, 2014 Dear Ms. Langen: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. 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 {1}------------------------------------------------ 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. for Sincerely yours, # David Krause -S Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K141564 Device Name OptonPro Indications for Use (Describe) - · temporary relief of minor muscle and joint aches, pains and stiffness - · temporary relief of muscle spasm - · temporary relief of minor pain and stiffness associated with arthritis - · promoting relaxation of the muscle tissue - · temporary increase in local blood circulation Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z" and "i". Below the word "zimmer" is the phrase "MedizinSysteme" in a smaller, lighter font. The logo is simple and modern, and the use of two different fonts creates a visual hierarchy. Tel. 0731. 9761-0 Fax 0731.9761-118 info@zimmer.de www.zimmer.de # 5. 510(k) Summary The following information is provided as required in 21CFR807.87 and the "Guidance Document for Heating and Cooling Devices 510(k)s". ### a.) General | 510(k) Submitter: | Zimmer MedizinSysteme GmbH<br>Junkersstrasse 9<br>D-89231 Neu-Ulm<br>Germany | |----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | Contact person: | Mr. Armin Petraschka<br>Project Manager<br>Phone: +49-731-9761-140<br>Fax: +49-731-9761-4475<br>E-mail: a.petraschka@zimmer.de | | Establishment<br>Registration: | 8010720 | | Submission Date: | April 25th, 2014 | | Device Names: | | | Device Name: | <i>Opton Pro</i> | | Trade Names: | <i>Opton Pro</i> | | Common Names: | Heating and Cooling Devices | | Regulation Numbers<br>and Classification<br>Names: | 21 CFR 890.5500 – Infrared Lamp | | Classification: | Class II | | Product Codes: | ILY | | Panel: | 89 - Physical Medicine | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The word "zimmer" is in bold, gray letters. Underneath the word "zimmer" is the word "MedizinSysteme" in a smaller, gray font. Fax 0731.9761-11 info@zimmer.de www.zimmer.de #### b.) Predicate Devices | 1. | 2. | |-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | Device<br>K-1200 | Vectra Genisys Laser System | | Manufacturer<br>ELTECH s.r.l<br>Via Castagnole, 20/H<br>31100 Trevisio, Italy | CHATTANOOGA GROUP (Encore Medical)<br>4717 Adams Road. P.O. Box 489<br>Hixson, Tennessee 37343-0489 | | 510(k) number<br>K091497 | K040662 | ### c.) Device Description OptonPro is a topical heat lamp with laser light. It emits energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature. The OptonPro contents a Class IV laser unit with four simultaneously operating diodes with wavelengths of 810nm and 980mm transmitting their energy to an applicator through a flexible fibre optic cable. The applicator has an output spot size of 10 mm. The optimum ration of absorption and penetration depth quarantees efficient stimulation of tissue and pain receptors. The treatment effect of the OptonPro is achieved with 980nm and 810nm. Additionally the OptonPro contains an aiming beam with 650nm. Skin type, indication and desired depth of treatment define the operating mode and the required energy. Two operating modes are possible: continuous wave and serial pulse. The duty cycle can be adapted additionally (1:1 – 1:10). Patient feedback and direct access to the treatment parameters enable to adjust the application for individual requirements and to achieve treatment times of a few minutes. The OptonPro includes comprehensive safety features. In addition to multi-step activation of the laser by the software, with software security key lock and footswitch for starting treatment, protective glasses, an emergency off switch and a hardware interlock are included in the system. The performance of the laser unit can be tested with an integrated power control unit. A thermal threshold test offers a tool to assess the warmth sensitivity and the individual local absorption rate. Additionally the user is assisted with a special reminder function for a delivered particular amount of energy. OptonPro is an intuitive therapy system with touch screen and menu-quided operation. The maximum output power is 7 W. The adjustable output power corresponds with the chosen duty cycle. The OptonPro has a large colour display with 12 inch. A SD card is used as a memory, as a logbook and for updates. Individual adjustments can be made at any time and saved for easy access. A program menu with 3 fixed programs and a favourites and memory menu with 120 memory slots fur custom programs collects the most common settings and shows them when the OptonPro is started if required. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z" and "i". Below the word "zimmer" is the phrase "MedizinSysteme" in a smaller, sans-serif font. The logo is in grayscale. Tel. 0731. 9761-0 Fax 0731.9761-118 info@zimmer.de www.zimmer.de # d.) Statement of indications for use The indications for use of the proposed device are the same as those for the predicate devices: - temporary relief of minor muscle and joint aches, pains, and stiffness ● - temporary relief of muscle spasm . - temporary relief of minor pain and stiffness associated with arthritis . - . promoting relaxation of the muscle tissue - temporary increase of local blood circulation . ### e.) Comparison of Technological Characteristics | No | Feature | OptonPro | K-1200 | Vectra Genisys Laser System | |-----|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | power source | 100 - 240 VAC, 50 / 60Hz | 100 - 240 VAC, 47 - 63 Hz | 120-240VAC, 50 / 60Hz | | 2. | battery powered | - | + | + | | 3. | dimensions<br>(h x w x d) [cm] | 30 x 35 x 20<br>(11.81 x 13.78 x 7.87 in) | 19 x 18 x 20<br>(7.5 x 7 x 8 in) | 16.3 x 28.8 x 32.8<br>(6.4 x 11.3 x 12.9 in) | | 4. | weight [kg] | 3.8<br>(8.38 lb) | 1.3<br>(2.9 lb) | 2.3<br>(5.07 Ib) | | 5. | housing materials | plastic | plastic | plastic | | 6. | laser class | 4 | 4 | 3B | | 7. | applied part | B | B | B | | 8. | protection class | ll | ll | ll | | 9. | laser system | laser diodes,<br>fibre-optical cable | laser diodes,<br>fibre-optical cable | laser diodes | | 10. | software control | + | + | + | | 11. | compliance with<br>voluntary<br>standards | Yes,<br>-IEC/EN 60601-1<br>-IEC/EN 60601-1-2<br>-IEC 60601-2-22<br>-IEC 60825-1 | Yes,<br>-IEC/EN 60601-1<br>-IEC 60825-1 | Yes,<br>-IEC/UL/EN 60601-1<br>-IEC/UL/EN 60601-1-2<br>-IEC/UL/EN 60601-2-22<br>-IEC 60825-1<br>-21CFR 1040.10 & 1040.11<br>-CAN/CSA C22.2 No.601.1-<br>M90 w/A2 | | 12. | prescription use | + | + | + | | 13. | intended use | emit energy in the infrared<br>spectrum to provide topical<br>heating for the purpose of<br>elevating tissue temperature<br>heating for the following<br>indications for use: | emit energy in the infrared<br>spectrum to provide topical<br>heating for the purpose of<br>elevating tissue temperature<br>heating for the following<br>indications for use: | indicated for topical heating for<br>the following indications for<br>use: | | 14. | indications for<br>use | - temporary relief of minor<br>muscle and joint aches, pains<br>and stiffness<br>- temporary relief of muscle<br>spasm<br>- temporary relief of minor pain<br>and stiffness associated with<br>arthritis | - temporary relief of minor<br>muscle and joint pain<br>- temporary relief of muscle<br>spasm<br>- temporary relief of minor pain<br>and stiffness associated with<br>arthritis<br>- promoting relaxation of the | - temporary increase in local<br>blood circulation<br>- temporary relief of minor<br>muscle and joint aches, pains<br>and stiffness<br>- relaxation of muscles<br>- temporary relief of muscle<br>spasm | | | | - promoting relaxation of the<br>muscle tissue<br>- temporary increase in local<br>blood circulation | muscle tissue<br>- temporary increase local<br>blood circulation | - temporary relief of minor pain<br>and stiffness associated with<br>arthritis | | 15. | touch screen<br>interface | + | + | | | 16. | color LCD screen | + | + | - | | 17. | external memory | + | + | - | | 18. | functional cart<br>option | + | + | + | | 19. | number of output<br>channels | 1 | 1 | 1 | | 20. | modifiable<br>waveform<br>parameters /<br>customize<br>treatment<br>parameters | + | + | + | | 21. | possibility to<br>switch the laser<br>on and off | + | + | + | | 22. | interlock | + | + | + | | 23. | emergency off<br>switch | + | + | + | | 24. | laser warning<br>signal | + | + | + | | 25. | spacer | + (optional) | + | - | | 26. | number of output<br>modes | 2 | 3 | 2 | | 27. | output modes | continuous wave, serial pulse, | continuous wave, serial pulse,<br>intense super pulse | continuous wave, serial pulse | | 28. | favorites / named<br>user defined<br>programs | + | + | + | | 29. | laser<br>performance<br>testing | + | N/A | + | | 30. | electronic key<br>lock | + | N/A | + | | 31. | calculated and<br>displayed energy | + | + | + | | 32. | displayed<br>treatment time | + | + | + | | 33. | wavelength<br>aiming beam [nm] | 650 | 635 or 650 | 670 | | 34. | wavelength laser<br>beam [nm] | 810 and 980 | 800 and / or 970 | 820 or 850 | | 35. | output power [W] | 1 - 7 | 0.1 - 12 | 0.1 - 1.44 | | 36. | repetition rate f<br>(Hz) | 1 - 50<br>CW | 1 - 20 000<br>CW<br>Intense Super Pulse (ISP) | 8 - 10 000<br>CW | | 37. | area output spot<br>size [cm2] | 0.8 | 1 - 5 | 0.07 - 31.2 | | 38. | duty cycle [%] | 10 - 50 | 50 | 90 | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The word "zimmer" is in a bold, sans-serif font, with a horizontal line above the "z". Below the word "zimmer" is the word "MedizinSysteme" in a smaller, sans-serif font. The logo is in grayscale. Tel. 0731. 9761-0 Fax 0731. 9761-118 info@zimmer.de www.zimmer.de 5 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo is in a dark gray color. The word "zimmer" is in a bold, sans-serif font, and the words "MedizinSysteme" are in a smaller, lighter font below the word "zimmer." Tel 0731 9761-0 Fax 0731.9761-118 info@zimmer.de www.zimmer.de # f.) Summary Comparison with predicate devices The OptonPro shares the same intended use and the same or similar basic characteristics and features as the predicate devices. In addition, any differences in their technological characteristics are explained to demonstrate in this submission that these differences do not raise any new questions of safety and effectiveness. # q.) Non-clinical Tests Performed Validation documentation, product testing and a comparison of the technical characteristics and features according to relevant standards were provided to demonstrate that OptonPro is as safe and effective in its intended use. The OptonPro achieves a therapeutic temperature range of 40 – 45°C as accepted by the FDA. The maximal transition time for reaching this therapeutic temperature range is 5 min. The therapeutic temperature range was maintained for a recommended treatment time of 10 min. The temperature measurements were conducted on a few test candidates on different physical locations. # h.) Conclusion Substantial Equivalence Drawn from the comparison between the predicate devices and the OptonPro devices it demonstrates that the OptonPro device is as safe and effective as the predicate devices and therefore are substantially equivalent to the compared devices on the basis of similarities in operating principles, intended use and functional performance.