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.

Device Description

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.

AI/ML Overview

The provided text describes a 510(k) summary for the YOLO CURVE, an infrared lamp device. However, it does not contain information related to acceptance criteria, specific performance data with numerical results, or detailed study methodologies that would typically be associated with proving a device meets acceptance criteria through a clinical trial or extensive performance testing.

Instead, the document primarily focuses on establishing "substantial equivalence" to predicate devices, which is a regulatory pathway for lower-risk medical devices.

Here's an analysis based on the information available in the text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The text states "Performance data is attached which showed that elevated skin temperature as required for this type of device. (Please See Appendix III)", but Appendix III is not included in the provided excerpt. Therefore, no specific acceptance criteria or numerical performance metrics are available.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The document makes a general statement about "Performance data" but does not specify any test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The document does not describe any test set where ground truth would need to be established by experts.

4. Adjudication Method for the Test Set

This information is not provided. As there's no described test set requiring expert ground truth establishment, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided document. The focus is on substantial equivalence to existing devices rather than a comparative study with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the YOLO CURVE is described as a medical device (infrared lamp) for direct therapeutic application, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant to this device description.

7. The Type of Ground Truth Used

This information is not provided. No specific test data or ground truth establishment is detailed. The performance data mentioned (likely about elevated skin temperature) would imply physiological measurements as "ground truth," but the specifics are absent.

8. The Sample Size for the Training Set

This information is not provided. There is no mention of a "training set" as this device is not described as involving machine learning or AI algorithms that would require such data.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable as there is no training set described for an AI/ML algorithm.

Summary of Device and Regulatory Context (Based on available text):

The YOLO CURVE is an infrared lamp cleared through the 510(k) pathway, which means it demonstrated "substantial equivalence" to legally marketed predicate devices (LAPEX BCS K081962 and LUCIA K102375). Its intended use is to emit visible and infrared energy for topical heating to provide temporary relief of minor muscle/joint pain, stiffness, arthritis pain, or muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscle.

The argument for substantial equivalence relies on the device having the "same intended use as and similar technological characteristics" as the predicate devices, specifically utilizing laser diodes to elevate tissue temperature. While "Performance data is attached which showed that elevated skin temperature as required for this type of device," the details of this data, including acceptance criteria and specific results, are in an unprovided "Appendix III."

In conclusion, the provided text from the 510(k) summary focuses on the regulatory clearance process through substantial equivalence and does not offer the detailed performance study information with acceptance criteria and numerical results that your request outline specifies.

Summary

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AUG 2 2 2011

K 110342
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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

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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.

5. Indications for Use

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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)

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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

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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

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Indications for Use

510(k) Number (if known): K110342

Device Name: YOLO CURVE

Indications for Use:

. .

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

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510(k) Number K110342

Regulation Number and Section

N/A