(173 days)
The LAPEX BCS 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 LAPEX BCS has a hand-held treatment probe, is noninvasive, low level visible and infrared lamp that provides continuous heat therapy at fixed frequency. The System consists of a Drive Unit, Power Supply and controls and optional treatment probes that contain the visible and infrared radiating elements. Various Cluster Probes are available accessories with the Drive Unit. The LAPEX BCS generator operates automatic calculation of energy output in relation to set treatment parameters and the parameters(treatment time, output power delivered) can be adjusted by using key and treatment specifications and menus as well as treatment progressing are displayed on a LCD display in real time. And the LAPEX BCS generator operates simultaneous and independent management of outputs for connecting probes with laser sources of different wavelength. The LAPEX-BCS generator supplied with 2 completely independent outputs for using two treatment probes and simultaneously, even with laser sources of different wavelengths. The LCD displays operating parameters of both channels. 'This allows two operators to carry out laser therapy independently; just like having two separate instruments.
Here's an analysis of the provided text regarding the LAPEX BCS device, focusing on acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the LAPEX BCS device, as described in the provided document, primarily relate to its ability to generate a specific skin temperature.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Generate a skin temperature of 40°C ± 0.8°C for 5 minutes. | The LAPEX BCS "can generate a skin temperature 40°±0.8° for 5min" |
| Generate a skin temperature of 40°C ± 0.8°C for 20 minutes. | The LAPEX BCS "can generate a skin temperature 40°±0.8° for ... 20min respectively." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 50 subjects.
- Data Provenance: The document states "50 subjects of various ages and races (Oriental, Black, and Caucasian)". This suggests it was likely a prospective clinical test conducted by Meridian Co., Ltd. The country of origin of the data is not explicitly stated beyond the company's location in Seoul, Korea. It is not specified as retrospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts or the establishment of ground truth by experts for the clinical testing. The study focuses on measuring the device's physical effect (skin temperature elevation) rather than expert interpretation of clinical outcomes for ground truth.
4. Adjudication Method for the Test Set
No adjudication method is mentioned. The study appears to be a direct measurement of skin temperature.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The study described focuses on the device's physical performance, not on how it assists human readers or improves their performance.
6. Standalone Performance Study
Yes, a standalone study was performed. The "clinical testing using thermography on 50 subjects" measured the device's ability to generate a specific skin temperature on its own. This is a standalone performance metric for the LAPEX BCS device.
7. Type of Ground Truth Used
The ground truth used in this context is the measured skin temperature. The acceptance criteria are based on achieving a specific, quantifiable physical change (temperature elevation) rather than an expert consensus, pathology, or direct patient outcomes (though pain relief is the ultimate intended use, the study provides a physiological basis for it).
8. Sample Size for the Training Set
No training set is mentioned. This device is an infrared lamp, not an AI or machine learning algorithm that typically requires a training set. The study described is a direct performance measurement.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set or an AI/ML algorithm involved.
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510(K) Summary K081962 Meridian Co., Ltd.. 3F, Poonglim Tech-one B/D, 273-10 , Seongsu-dong 2 ga, Seongdong-gu, Seoul, Korea Tcl: 82-2-2103-3300, Fax: 82-2-2103-3333 Contact: Chulgyu Lee, R&D Deputy Director laser@meridian.co.kr Date prepared: November 30, 2008
DEC 2 9 2008
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- Identification of the device: LAPEX BCS Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: IL Y
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- Equivalent legally marketed devices: The LAPEX BCS is substantially equivalent to other infrared lamps currently in commercial distribution such as the THOR DDII IR lamp System (K033923), THOR International Ltd., and Vectra Genisys Laser System (Intelect XT Laser System) (K040662), Chattanooga Group. The LAPEX BCS has same intended use as and similar technological charactcristics to these predicate devices.
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- Indications for use (intended use): The LAPEX BCS is intended to cmit 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.
-
- Description of the device: The LAPEX BCS has a hand-held treatment probe, is noninvasive, low level visible and infrared lamp that provides continuous heat therapy at fixed frequency. The System consists of a Drive Unit, Power Supply and controls and optional treatment probes that contain the visible and infrared radiating elements. Various Cluster Probes are available accessories with the Drive Unit. The LAPEX BCS generator operates automatic calculation of energy output in relation to set treatment parameters and the parameters(treatment time, output power delivered) can be adjusted by using key and treatment specifications and menus as well as treatment progressing are displayed on a LCD display in real time. And the LAPEX BCS generator operates simultaneous and independent management of outputs for connecting probes with laser sources of different wavelength. The LAPEX-BCS generator supplied with 2 completely independent outputs for using two treatment probes and simultaneously, even with laser sources of different wavelengths. The LCD displays operating parameters of both channels. 'This allows two operators to carry out laser therapy independently; just like having two separate instruments.
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- Safety and effectiveness, comparison to predicate device. Safety testing was conducted according to IEC 60601-2-22:1995 (Second Edition) Medical Electrical Equipment: Particular Requirements for the Safety of diagnostic and therapeutic laser equipment for use in conjunction with IEC 60601-1 :1988 + A1 :1991 + A2:1995 and to IEC 60601-1-2, (2001) Electromagnetic Compatibility. The device conforms to those standards. Clinical testing using thermography on 50 subjects of various ages and races (Oriental, Black, and Caucasian) a revealed that the
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K.281962 pg 2 of 2
LAPEX BCS can generate a skin temperature 40°±0.8° for 5min and 20min respectively. Accordingly, we concluded that the LAPEX BCS can safely and effectively provide the temporary relief in pain associated with joints and muscles. Comparison to the predicates' indications for use and energy levels also supports this conclusion.
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- Substantial equivalence chart
| Feature | Thor DDII IR LampSystemK033923 | Vectra Genisys LaserSystem K040662 | LAPEX BCS |
|---|---|---|---|
| Indications for use | Intended to emit energy in the Visible and near 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 temporary relaxation of muscle | Vectra Genisys (Intelect XT) LASER Module and Vectra Genisys (Intelect XT) LASER Transportable Systems are indicated for topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, relaxation of muscle, temporary relief of muscle spasms, temporary relief of minor pain and stiffness associated with arthritis | Intended to emit energy in the Visible and near 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 temporary relaxation of muscle |
| Power Supply | Rechargeable Battery | 100-240Vac, 50~60Hz | 100-240Vac, 50~60Hz |
| LASER Class | Class IIIbAccording to IEC 60825-1 | Class IIIbAccording to IEC 60825-1 | Class IIIbAccording to IEC 60825-1 |
| Energy Source(LASER / LEDSource) | LASER(LD) / LED1. 660nm, 30mW X 5EA LD2. 660nm, 200mWX5EA LD3. 660nm, 400mWX5EA LD4. 810nm, 50mW X 5EA LD5. 810nm, 200mWX5EA LD | LASER(LD) / LED1. (850nm, 100mWX5EA LD)+ (670nm, 10mWX4EA LED)2. (850nm, 200mWX5EA LD)+ (670nm, 10mWX4EA LED)3. (850nm, 100mWX 3EA LD)(950nm, 15mWX3EA SLD)+ (670nm, 10mWX 7EA LED) | LASER(LD) / LED1. 658nm, 40mW X 8EA LD2. 658nm, 40mW X 1EA LD3. (813nm, 150mWX4EA LD)+ (658nm, 40mWX4EA LD)4. (813nm, 150mWX4EA LD)+ (670nm, 10mWX4EA LED,LD) |
| Diode Source | GaAlAs & GaAlInP | GaAlAs & GaAlInP | GaAlAs & GaAlInP |
| Diode DriveType | Continuous Wave | Continuous Wave& Modulated Continuous | Continuous Wave |
- Conclusion: After analyzing bench, electrical safety, EMC, clinical testing data, and the comparison table above, it is the conclusion of Meridian Co., Ltd. that the LAPEX BCS is as safe and effective as the predicate device has few technological differences and has no new indications for use, thus rendering it substantially equivalent to the predicate device. A laser product report showing compliance with the US Laser Safety standard has been submitted to FDA.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Meridian Co., Ltd., % Kamm Associates Daniel Kamm, P.E. P.O. Box 7007 Deerfield, Illinois 60015
DEC 2 9 2008
Re: K081962
Trade/Device Name: LAPEX BCS Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: November 28, 2008 Received: December 1, 2008
Dear Mr. Kamm:
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 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.
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Page 2 - Daniel Kamm, P.E.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 Mellean
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
<081962 510(k) Number (if known):
PAI off
Device Name: _ LAPEX BCS
Indications For Use:
The LAPEX BCS 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 (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
A
Division Division of General, Restorative, and Neurological D
510(k) Number_
§ 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.