Infrared Therapy System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and unity. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 2, 2014 Beijing Huatai Healthcare Technology Company, LTD. % Ms. Helen Nan Wenzhou Cytech Information Service Company, LTD. Room 302, Number 21 Building, Kaiyu Garden, Xishan South Road Wenzhou, 325000, Zhejiang China Re: K142340 Trade/Device Name: Infrared Therapy System (Model: HW-1000) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: October 29, 2013 Received: November 5, 2014 Dear Ms. Nan: 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 {1}------------------------------------------------ Page 2 - Ms. Helen Nan CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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. Sincerely yours, # David Krause -S for 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. #### 510(k) Number (if known) K142340 #### Device Name Infrared Therapy System (Model: HW-1000) #### Indications for Use (Describe) The HW-1000 Infrared Therapy System is intended to emit energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and for the temporary relaxation of muscles. Type of Use (Select one or both, as applicable) > 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) {3}------------------------------------------------ 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with the text "DERHUATAI" in a stylized font. The letters are colored in a gradient, starting with yellow, then blue, red, and finally black. The font is bold and slightly slanted, giving the logo a dynamic appearance. 北京澳尔华泰科技有限公司 Beijing Huatai Healthcare Technology Co., Ltd. ### Section 5 510(k) Summary (As required by 21 CFR 807.92(a)) ### 5.1 Submitter Information - · Company: Beijing Huatai Healthcare Technology Co.,Ltd. - · Address: Rm.216, No.2 Building, No.18, Qinghe Anningzhuang East Road.Haidian District, Beijing City, 100085, P.R. China - ・Phone: 086-10-62931963 - ・ Fax: 086-10-82781040 - · Contact: Bingxian Zheng, General Manager - · Date: October 29, 2013. ## 5.2 Device Information - · Trade/Proprietary Name: Infrared Therapy System; - · Common Name: Infrared Lamp; - Model: VPT-I: - · Classification: Device Class: 2 Review Panel: Physical Medicine Name: Lamp, Infrared, Therapeutic Heating Regulation Number: 21 CFR 890.5500 Product Code: ILY - · Predicate Device: GIGALaser 1801 Submitted by PowerMedic ApS: K Number: K134017 · Device Description: The HW-1000 Infrared Therapy System is an effective, drug-free and non-invasive device which can deliver 850-950nm infrared energy through light emitting diodes (LED) mounted in the therapy pads (the same as light panels, but different expressions). Each pad has 66 diodes. The device consists of mainframe, which contains the user interface panel, the power supply, and the output jack used to connect pad to provide output. and therapeutic pads. When working, the plug of therapeutic pads is connected with the output jack of mainframe and the therapy pads are fixed on the surface of skin directly with matched bandages to provide heating. {5}------------------------------------------------ ., Ltd. • Intended Use: The HW-1000 Infrared Therapy System is intended to emit energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and for the temporary relaxation of muscles. | Item | Subject Device | Predicate Device | |--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Intended to emit energy<br>in the near infrared<br>spectrum to provide<br>topical heating for the<br>purpose of elevating<br>tissue temperature for a<br>temporary relief of<br>minor muscle and joint<br>pain and stiffness,<br>minor arthritis pain, or<br>muscle spasm; the<br>temporary increase in<br>local blood circulation;<br>and for the temporary<br>relaxation of muscles. | Intended to emit energy<br>in the visible and near<br>infrared spectrum to<br>provide topical heating<br>for the purpose of<br>elevating tissue<br>temperature for a<br>temporary relief of<br>minor muscle and joint<br>pain and stiffness,<br>minor arthritis pain, or<br>muscle spasm; the<br>temporary increase in<br>local blood circulation;<br>and for the temporary<br>relaxation of muscles. | | Design Principle | NIR (near-infrared)<br>Therapy | Same | | Energy Source | LED | Same | | Skin Contact Mode | Direct Contact | Same | | Power Supply | 100-240Vac<br>50-60Hz | Unknown | | Device Temperature | 40-45°C | Same | # 5.3 Comparison of Required Technology Characteristics {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo with the text "DERHUATAI" in a stylized font. The text is presented in a mix of colors, with the "DE" in yellow and blue, "RHUA" in red, and "TAI" in black. The font is bold and slightly slanted, giving the logo a dynamic and modern appearance. | Range | | | |----------------------------------|---------------------------------------------------------|--------------------------------------------------------------| | Skin Surface<br>Temperature | 40-45 °C | Same | | Treatment Output | Zero, Moderate, Mild,<br>Strong | 6 treatment programs<br>with variable output<br>power levels | | Treatment Time | 10min±1min,<br>20min±2min,<br>30min±3min,<br>40min±4min | 6 treatment programs<br>with variable exposure<br>times | | Patient Contact<br>Material | Therapeutic Pad Lower<br>Cover - Medical PC | Unknown | | Biocompatibility | Tested according to<br>relevant ISO 10993<br>Standard | Unknown | | Electrical Safety | Tested according to<br>IEC 60601-1 | Tested according to EN<br>60601-1 | | Electromagnetic<br>Compatibility | Tested according to<br>IEC 60601-1-2 | Tested according to EN<br>60601-1-2 | ### Brief Summary: First, the subject device shares almost the same intended use with the predicate device, though there is slight difference in the expression of their intended use, that is, the predicate device also boasts visible spectrum which the subject device don't have, such trivial difference will not influence the core usage of the devices, thus will not influencing the substantial equivalence comparison between the two devices. Secondly, the two devices have similar technological characteristics, for example, they enjoy the same design principle, energy source, skin contact mode, device temperature range and skin surface temperature range. Though they are different in power supply and patient contact material, such differences have been verified by relevant FDA recognized standards - IEC 60601-1, IEC 60601-1-2 and ISO 10993, which supports that the subject device will be as safe for usage as the predicate device. And although they {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "DERHUATAI" in a stylized font. The word is split into four sections, each with a different color. The first section is yellow, the second is blue, the third is red, and the fourth is black. The letters are bold and have a slightly slanted appearance. 北京奥尔华泰科技有限公司 Beijing Huatai Healthcare Technology Co., Ltd. are not identical in treatment output and time, the effectiveness of the subject device has been evaluated by the following clinical test. Moreover, the subject device share the same therapeutic temperature range with the predicate device which is accepted by FDA, which displays that they will enjoy similar therapeutic effects. All these facts show that the subject device will be as safe and effective as the predicate device, that the two devices are substantial equivalent. ### 5.4 Discussion of Tests Performed ### · Clinical Tests: The use of light energy to generate heat for therapeutic use has been well documented and is generally accepted alternative treatment modality for the temporary relief of pain and tissue repair. And in order to evaluate the effectiveness of our subject device, we have sponsored the clinical test with test group receive treatment of the subject device (with power output) and the control group receive treatment of the subject device (without power output), during which no equipment failure or adverse events was discovered and the test result shows that the test group has far better curative effect than the control groups, which further ensures the effectiveness and safety of the subject device. For more details, please refer to Attachment O Clinical Evaluation Report. #### · Non-Clinical Tests The subject device was tested to evaluate its safety according to the following standards: 1) Electrical Safety AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment -Part 1: General Requirements For Basic Safety And Essential Performance (Iec 60601-1:2005, Mod). (General II (ES/EMC)) 2) Electromagnetic Compatibility IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility - Requirements And Tests. (General II (ES/EMC)) {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows a logo with the text "DERHUATAI" in a stylized font. The letters are colored in a gradient, starting with yellow and blue on the left, transitioning to red in the middle, and ending with black on the right. The font is bold and slightly slanted, giving the logo a dynamic appearance. 北京澳尔华泰科技有限公司 Beijing Huatai Healthcare Technology Co., Ltd. ### 3) Photobiological Safety IEC 62471 First edition 2006-07, Photobiological Safety Of Lamps And Lamp Systems. (Radiology) 4) Biocompatibility AAMI / ANSI / ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility) and AAMI / ANSI / ISO 10993-10:2010. Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility) 5) Risk Analysis ISO 14971 Second Edition 2007-03-01, Medical Devices - Application Of Risk Management To Medical Devices. (General I (OS/RM)) Moreover, the company has performed self-inspection test on the subject device in order to further ensure its safety and effectiveness, especially during which the device temperature and skin surface temperature has been confirmed as 40-45℃ which is accepted by the FDA. More details can be found in Attachment N Performance Self-Inspection Report. # 5.5 Conclusion: First, the subject device enjoys almost the same intended use, which forms the foundation of the substantial equivalence between the two devices. Secondly, the subject device shares similar technological characteristics with the predicate device and the differences in the technological characteristics have been either verified by the above FDA recognized standards or the company's own "Performance Self-Inspection Report", which shows that the subject device will be as safe and effective as the predicate device. Moreover, the effectiveness and safety of the subject device has also be evaluated by appropriate clinical report. All of these facts show that the differences between the two devices will not bring new safety and effectiveness concerns. As a result, it is reasonable for us to conclude that the subject device is substantially equivalent to the predicate device according to the above analysis.