YOLO CURVE

{0}------------------------------------------------ AUG 2 2 2011 K 110342 1 of 3 ### 510(k) Summary for the CURVE This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92. # 1. General Information Submitter: YOLO Medical Inc. #245 - 1959 152™ Street Surrey, British Columbia V4A 9E3 CANADA Tel: (604) 542-2200 Fax: (604) 542-2205 Vinod Podichetty, MD Contact Person: Research Practice Partners, Inc. 3550 SW 148 Avenue, Suite #110 Miramar, FL 33027 Telephone: 954-559-4213 Email: vp@rppmed.com Summary Preparation Date: July 21, 2010 - Names 2. | Device Trade Name: | YOLO CURVE | |----------------------|--------------------------------------| | Common Name: | Infrared lamp | | Classification Name: | Lamp, infrared, therapeutic, heating | | | Product Code: ILY (21 CFR 890.5500) | | | Panel: Physical Medicine | {1}------------------------------------------------ #### 3. Predicate Devices The YOLO CURVE is substantially equivalent to other infrared lamps currently in commercial distribution such as LAPEX BCS (K081962), Meridian Co., Ltd. and LUCIA Meridian Co., Ltd. The YOLO CURVE has the same intended use as and similar technological (K102375). characteristics to these predicate devices. #### Device Description 4. The YOLO CURVE has a hand-held treatment probe, is non-invasive, low level visible lamp that provides continuous heat therapy at fixed frequency. The System consists of a Drive Unit, Power Supply, controls and optional treatment probes that contain the visible radiating elements. The YOLO CURVE generator automatically calculates energy output in relation to set treatment parameters. The parameters (treatment time, output power delivered) can be adjusted by using key, treatment specifications and menus. The progress of the treatment is displayed on the LCD display in real time. The YOLO CURVE generator operates simultaneous and independent management of outputs for connecting probes with laser sources from the Red wavelength. The YOLO CURVE generator is supplied with 2 completely independent outputs for using two treatment probes. The LCD displays operating parameters from both channels. This allows two operators to carry out laser therapy independently: just like having two separate instruments. #### 5. Indications for Use The YOLO CURVE is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle. । ਦ {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows handwritten text that appears to be a combination of letters and numbers. The top line reads 'K110342', and the bottom line reads '3 of 3'. The handwriting is somewhat stylized, with distinct shapes for each character. ### 6. Substantial Equivalence The YOLO CURVE is substantially equivalent to the LUCIA (K102375) manufactured by Meridian Co., Ltd. The YOLO CURVE has the same intended use as and similar technological characteristics as the predicate device. The YOLO CURVE utilizes laser diodes to elevate tissue temperature to a range which is recognized to provide temporary relief of certain muscle and joints pains. The technological characteristics of the predicate device are exactly the same as the YOLO CURVE. The YOLO CURVE described in this 510(k) has the same intended use, indications for use, and technological characteristics as the currently cleared predicate device and is substantially equivalent to the identified predicate device. #### Performance Data 6. Performance data is attached which showed that elevated skin temperature as required for this type of device. (Please See Appendix III) {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Yolo Medical, Inc. % Research Practice Partners. Inc. Vinod Podichetty, MD 3550 SW 148th Avenue, Suite 110 Miramar, Florida 33027 AUG 2222011 Re: K110342 Trade/Device Name: YOLO CURVE Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: July 21, 2011 Received: August 19, 2011 Dear Dr. Podichetty: 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 {4}------------------------------------------------ Page 2 - Vinod Podichetty, MD 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 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/MedicalDevices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (3.01) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Ernst Keith JJ Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### Indications for Use 510(k) Number (if known): K110342 Device Name: YOLO CURVE #### Indications for Use: . . The YOLO CURVE is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over The Counter Use _ (Part 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) (Division Sig Division of Surgical, Orthopedic, and Restorative Devices Page 1 of 1 510(k) Number K110342