(16 days)
LC Therapy, Model LCT-1000 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
LC Therapy, Model LCT-1000 Laser is a compact medical laser system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight wand. Activation occurs when the operator enables the laser and presses the foot switch. Release the foot switch to deactivate the laser. Depending on laser system configuration, the foot switch can function as on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
The provided document is a 510(k) summary for the LiteCure, LLC. LCT-1000 laser, and it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI/ML or diagnostic accuracy studies.
This summary is focused on demonstrating substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, contraindications, warnings, and cautions, and lists the technological characteristics, including compliance with voluntary consensus standards.
Therefore, I cannot extract the requested information regarding:
- Table of acceptance criteria and reported device performance: This document does not establish performance criteria in terms of sensitivity, specificity, accuracy, or similar metrics typically seen for diagnostic or AI/ML devices.
- Sample size used for the test set and data provenance: No such test set or related data is mentioned.
- Number of experts used to establish ground truth and qualifications: Not applicable as there's no diagnostic performance study involving expert review.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable, as this is a physical medical device (laser system), not an algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
The document states: "According to non-clinical testing, the Litecure LCT 1000 system has the same intended uses, functional and performance characteristics as the predicate devices listed. The testing demonstrated compliance to the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Food and Drug Administration." This indicates non-clinical testing related to therapeutic heat performance but does not provide details on specific acceptance criteria or study methodologies that would fit the requested format, especially concerning AI/ML evaluation.
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Image /page/0/Picture/0 description: The image shows the text "K070400" in a handwritten style. Below this, the date "FEB 2 2007" is printed in a clear, block-letter font. The date indicates the month of February, the second day, and the year 2007.
510(k) SUMMARY
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The Summary of Safety and Effectiveness on the LiteCure, LLC. LCT-1000 laser reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.
| Applicant | Brian PryorLiteCure, LLC930 Old Harmony Road, Suite ANewark, Delaware 19713 |
|---|---|
| Telephone | 302-709-0408 |
| Facsimile | 302-709-0409 |
| Date | December 20, 2006 |
| Name | LC Therapy, Model LCT-1000 Laser |
| Classification | Infrared Lamp, 21 CFR 890.5500 |
| Predicate: | K-Laser Therapy Probe - Cleared under K050070 market clearance date May 25, 2005 ALT Laser, Model VTR 75 - Cleared under K031612 market clearance date December 11, 2003 |
| Description | LC Therapy, Model LCT-1000 Laser is a compact medical laser system.The laser light delivery system consists of a flexible optical fiber threadedthrough a lightweight wand. Activation occurs when the operator enablesthe laser and presses the foot switch. Release the foot switch to deactivatethe laser. Depending on laser system configuration, the foot switch canfunction as on/off switch. A touch-screen display panel allows theoperator to adjust or set laser output level. The laser can operate incontinuous wave mode or controlled pulse mode. |
| Intended Use | LC Therapy, Model LCT-1000 is indicated for emitting energy in theinfrared Spectrum to provide topical heating for the purpose of elevatingtissue temperature for temporary relief of minor muscle and joint pain,muscle spasm, pain and stiffness associated with arthritis and promotingrelaxation of the muscle tissue and to temporarily increase local bloodcirculation. |
| Contraindications | Do not apply infrared light to abdominal or lumbosacral points in pregnant females. Do not apply infrared light to the epiphyseal lines in children. Do not apply infrared light to the thorax or over the pacemaker itself in patients with pacemakers. Do not apply infrared light over the thyroid gland, ovaries and testicles. Do not apply infrared light to patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to certain types of steroids. |
| Warning | Warning: Use carefully. May cause serious burns. Do not use over sensitive skin areas or in the presence of poor circulation. The unattended use of LiteCure LCT-1000 device by children or incapacitated persons may be dangerous. NEVER look directly into the distal end of the optical fiber connected to an active laser device, direct the laser light directly into the eyes, or direct the laser beam at anything other than the area to be treated WITH or WITHOUT the appropriate laser-emission protective eyewear. Indirect or direct eye contact with the output beam or at scattered laser light from any reflective surfaces from the laser will cause serious damage, irreparable corneal and/or retinal damage, and possible blindness to one or both eyes. DO NOT allow any reflective object to fall into or obstruct the path of the laser energy produced by this device. Scattered or reflected laser energy can cause serious damage to eyes. The operator, all assistants, and the patient must remove all reflective objects (such as rings, metal watchbands, and jewelry) prior to treatment with this device. Indirect or direct eye contact with the output beam or at scattered laser light from any reflective surfaces from the laser will cause serious damage, irreparable corneal and/or retinal damage, and possible blindness to one or both eyes. DO NOT remove protective eyewear until the operator returns the laser device to Standby mode. DO NOT use the System Controls or performance of procedures other than those specified in this manual may result in hazardous radiation exposure. DO NOT attempt to gain access to any internal device component. THERE ARE NO USER-SERVICEABLE COMPONENTS inside this laser device. Doing so may cause serious and/or irreversible injury. AVOID THE USE of flammable solvents, anesthetics, oxidizing gases such as nitrous oxide (N 2O) and oxygen or endogenous gases The high temperatures produced in normal use of the laser equipment may ignite some material, for example cotton or wool, when saturated with oxygen. The solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the laser equipment is used. FAILURE TO COMPLY with all safety instructions and warnings may expose all participants to harmful levels of laser radiation and/or dangerous levels of electrical current. |
| Cautions: | Never allow untrained personnel to operate this advice unless directly supervised by a properly trained and experienced individual The protective eyewear supplied with this device has an optical density rating >5 in the 350nm~2000nm (see specification sheet) region. All personnel present during device operation must ware this eyewear. Contact LiteCure, LLC. at 302-709-0408 to purchase additional sets of protective eyewear for this device. Select a secure, properly equipped, and well-ventilated location in which to install and operate the laser. Place "Laser in use" signs at location entrances where people will use the LiteCure, LLC. laser device. Always put the laser in Standby mode or switch the device off prior to adjusting or preparing the wand or fiber optic. Never leave this device in the READY mode unattended. See the STANDBY to READY Mode in the Operations section of this manual. Remove the key from the device's key switch when not in use to prevent unauthorized and/or unqualified use of the device as well as inadvertent laser emissions. Turn the device off before relocating equipment in the same vicinity. Never press the foot switch without first verifying the safe orientation and proper positioning of the wand and distal end of the optical fiber and ensuring compliance to all safety precautions. During any laser procedure, do not allow any nonessential personnel into the treatment area. Never allow the untrained personnel to operate this device unless directly supervised by a properly trained and experienced individual. ALWAYS clean the SMA fiber tip before inserting into the SMA emission port. A dirty tip could result in damage to the unit. Federal law (USA) restricts this device to sale by or on the order of a physician. |
| SubstantialEquivalencyInformation | According to non-clinical testing, the Litecure LCT 1000 system has the same intended uses, functional and performance characteristics as the predicate devices listed. The testing demonstrated compliance to the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Food and Drug Administration. The identified differences were determined to be minor and do not raise any concerns regarding the overall safety and effectiveness of the device. |
| TechnologicalCharacteristics | The device is subject to the following voluntary consensus standards: 21 C.F.R. § 1040.10 & 1040.11; IEC 60601-1; IEC 60601-1-2; IEC 60601-1-4; IEC 60601-2-22; IEC 61000-3-2; IEC 61000-3-3; and IEC 60825-1. |
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510(k) SUMMARY continued
The Summary of Safety and Effectiveness on the LiteCure, LLC. LC Therapy, Model LCT-1000 reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.
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510(k) SUMMARY continued
The Summary of Safety and Effectiveness on the LiteCure, LLC. LCT-1000 Laser reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of fature studies and or tests may require alterations of the conclusions or recommendations set forth.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller font size.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Litecure, LLC % Intertek Testing Services Mr. Neil E. Devine, Jr. 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087
FEB 2 8 2007
Re: K070400
Trade/Device Name: LC Therapy, Model LCT-1000 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: February 9, 2007 Received: February 12, 2007
Dear Mr. Devine:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 - Mr. Neil E. Devine, Jr.
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Mark N. Melkerson
Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication For Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
LC Therapy, Model LCT-1000 Device Name: _ _______________________________________________________________________________________________________________________________________________________________
Indications For Use:
LC Therapy, Model LCT-1000 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.