(189 days)
The Lucia 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.
The Lucia 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 Lucia 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 Lucia generator operates simultaneous and independent management of outputs for connecting probes with laser sources from the Red wavelength. The Lucia generator is supplied with 2 completely independent outputs for using two freatment 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.
Here's a breakdown of the acceptance criteria and study information for the Lucia device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Goal: Elevate skin temperature for therapeutic purposes. | "Performance data was presented which showed that skin temperature was elevated as required for this type of device." |
| Intended Use Safety: Provide topical heating for temporary relief of minor muscle/joint pain, stiffness, minor arthritis pain, muscle spasm; temporary increase in local blood circulation; and/or temporary muscle relaxation. | The device met regulatory requirements and was deemed substantially equivalent to a predicate device (LAPEX BCS) with the same intended use. This implies the device safely and effectively achieves the stated therapeutic effects through topical heating. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance data was presented which showed that skin temperature was elevated as required for this type of device." This suggests a test was conducted, but details are not included in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The study appears to be a technical performance evaluation (skin temperature elevation) rather than one requiring clinical interpretation needing expert consensus.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. Given the nature of the stated performance data ("skin temperature was elevated as required"), it's likely a direct measurement rather than an expert-adjudicated outcome.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. This type of study is more common for diagnostic devices where human interpretation is a key component. The Lucia is a therapeutic heating device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The concept of "standalone" performance typically applies to AI algorithms. The Lucia is a physical infrared lamp device, so this question is not applicable in the traditional sense. The performance data would directly reflect the device's physical output.
7. The Type of Ground Truth Used
The ground truth for the "Performance data" was likely direct measurement of skin temperature elevation. The statement "skin temperature was elevated as required for this type of device" implies a quantitative measurement against predefined physiological or regulatory targets.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This is expected as the Lucia is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set (as the device is not an AI algorithm), this question is not applicable.
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510(k) Summary for the Lucia
FEB 2 5 2011
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92(c).
1. General Information
Submitter:
Meridian Co., Ltd. Poonglim Tech-one Bldg.. 273-10 3F, Seongsu-dong 2 ga, Seongdong-gu Seoul, Korea Tel: 82-2-2103-3300, Fax: 82-2-2103-3333
Chulgyu Lee, R&D Deputy Director Contact Person: laser@meridian.co.kr
Summary Preparation Date: August 19, 2010
2. Names
Lucia Device Trade Name: Common Name: Classification Name:
Infrared lamp Lamp, infrared, therapeutic, heating Product Code: ILY (21 CFR 890.5500) Panel: Physical Medicine
3. Predicate Device
LAPEX BCS (K081962), Meridian Co., Ltd.
4. Device Description
The Lucia 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
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that contain the visible radiating elements. The Lucia 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 Lucia generator operates simultaneous and independent management of outputs for connecting probes with laser sources from the Red wavelength. The Lucia generator is supplied with 2 completely independent outputs for using two freatment 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 Lucia 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.
Substantial Equivalence 6.
The Lucia is substantially equivalent to the LAPEX BCS (K081962) which is also manufactured by Meridian Co., Ltd. The Lucia has the same intended use as and similar technological characteristics as the predicate device. The Lucia 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 Lucia. The Lucia 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.
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7. Performance Data
. . . . .
Performance data was presented which showed that skin temperature was elevated as required for this type of device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Meridian Co., Ltd. % Research Practice Partners, Inc. Vinod Podichetty, M.D. 3550 SW 148th Avenue, Suite 110 Miramar, Florida 33027
FEB 2 5 201
Re: K102375
Trade/Device Name: Lucia Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: February 18, 2011 -Received: February 22, 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, M.D.
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 liating (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of morning 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 ellectronic 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/ucm1 1.5809.html 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 1807.97). 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
Aty B. R h
for
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): K102375
Device Name: Lucia___
Indications for Use:
The Lucia 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 | |
|---|---|
| -------------------- | -- |
AND/OR
| Over The Counter Use | |
|---|---|
| ---------------------- | -- |
| (Part 21 CFR 801 Subpart D) | |
|---|---|
| Subpart C) |
| (Part 21 CFR 801 | |
|---|---|
| ------------------ | -- |
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) | ||
| Division of Surgical, Orthopedic, | ||
| and Restorative Devices |
. 510(k) Number K102375
§ 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.