(394 days)
The LAPEX-2000 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
The LAPEX-2000 is a low level laser therapy device.
This 510(k) submission (K034009) for the LAPEX-2000 low-level laser therapy device asserts substantial equivalence to predicate devices rather than providing a new clinical study with defined acceptance criteria and performance metrics. Therefore, many of the requested details are not available.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the submission. The submission relies on demonstrating substantial equivalence to predicate devices, implying that if it is equivalent, it meets the inherent safety and effectiveness standards of those previously cleared devices. There are no explicit acceptance criteria or reported performance metrics (like sensitivity, specificity, or improvement effect size) for the LAPEX-2000 itself in this document.
The comparison table provided focuses on technical specifications and intended use to show similarity to predicate devices:
| Feature | LAPEX-2000 | Predicate: THOR DDII 830CL3 Laser System (K030226) | Predicate: MicroLight 830 (K010175) |
|---|---|---|---|
| Probe | |||
| Source | Diode GaAlAs | Diode GaAlAs | Diode GaAlAs |
| Type | Continuous & Modulated Continuous | Continuous & Modulated Continuous | Continuous & Modulated Continuous |
| Wavelength | 830nm | 830nm | 830nm |
| Output Power | 30mW x 3 | 30mW x 3 | 30mW x 3 |
| Intended Use | Adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome | Adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome | Adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome |
The conclusion states that the device is "as safe and effective as the predicate device" based on "bench, electrical safety, EMC, and user testing data," but the details of this testing (acceptance criteria, performance results) are not elaborated upon.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. This submission does not include a clinical study with a "test set" in the context of device performance metrics. The mention of "user testing" is too vague to determine sample size or data provenance. The focus is on demonstrating technical equivalence and shared intended use with existing devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable/Not provided. As there is no clinical study with a test set requiring ground truth establishment, this information is not relevant to this submission type.
4. Adjudication Method for the Test Set
Not applicable/Not provided. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study was not conducted or reported in this submission. The submission does not discuss human reader performance or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a therapeutic laser, not an algorithm, so a standalone performance study in the context of AI is not relevant.
7. The Type of Ground Truth Used
Not applicable/Not provided. For a substantial equivalence claim, the "ground truth" is largely established by the regulatory clearance of the predicate devices for their indicated uses and the technical similarity of the new device. No specific ground truth type (like pathology or outcomes data) for a novel clinical study is detailed for the LAPEX-2000.
8. The Sample Size for the Training Set
Not applicable/Not provided. This device is hardware, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. This information is not relevant for this type of device and submission.
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JAN 2 1 2005 K034009 1/2
EXHIBIT 2 510(k) Summary Meridian Co., Ltd.. 4FL., Hongsung Bldg. 197-3 Jamsil-Dong, Songpa-Gu, Seoul 138-220 Korea 82-2-2103-3300 Phone: 82-2-2103-3333 Fax: November 22, 2004
Contact: Soorang Lee, R&D Director
- l . Identification of the Device: Proprietary-Trade Name: Lapex 2000 Classification Name: Lamp, non-heating, for adjunctive use in pain therapy NHN Common/Usual Name: Infrared Lamp
- Equivalent legally marketed devices LAPEX-2000 is substantially equivalent to other low 2. level therapeutic lasers currently in commercial distribution. These predicate devices include THOR International Ltd. THOR DDII 830CL3 Laser System (K030226),and the MicroLight 830 (K010175). The LAPEX-2000 has same intended use as and similar technological characteristics to these predicate devices.
-
- Indications for Use (intended use) The LAPEX-2000 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
| Semiconductor LaserTherapy System | • Non-invasive digital semiconductor laser therapy |
|---|---|
| Safe treatment | • Non-invasive therapy type• Non-painful & security therapy for a patient |
| Light and portable | • A small volume by using semiconductor laser diodes• Easy operation and portable |
| User friendly operation | • Therapy information display on LCD monitor• Easy key operation |
- Description of the Device: The LAPEX-2000 is a low level laser therapy device. 4.
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- Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.
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K034009 2/2
| Feature | LAPEX-2000 | Predicates | |
|---|---|---|---|
| THOR DDII 830CL3 LaserSystem (K030226) | MicroLight830, (K010175) | ||
| PROBE | |||
| Source | Diode GaAlAs | Diode GaAlAs | Diode GaAlAs |
| Type | Continuous &Modulated Continuous | Continuous &Modulated Continuous | Continuous &Modulated Continuous |
| Wavelength | 830nm | 830nm | 830nm |
| Output Power | 30mW x 3 | 30mW x 3 | 30mW x 3 |
| Intended use | The LAPEX-2000 isindicated foradjunctive use in thetemporary relief ofhand and wrist painassociated with CarpalTunnel Syndrome | The THOR DDII 830CL3Laser System is non-Heating infrared lamp andis indicated foradjunctive use in thetemporary relief ofhand and wrist painassociated with carpaltunnel syndrome | Adjunctive use in thetemporary relief ofhand and wrist painassociated with CarpalTunnel Syndrome |
Substantial Equivalence Chart
7. Conclusion
After analyzing bench, electrical safety, EMC, and user testing data, it is the conclusion of Meridian Co. Ltd.. that the Lapex 2000 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person's profile. The symbol is black and the background is white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2005
Meridian Company, Ltd. c/o Mr. Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K034009
Trade/Device Name: Lapex 2000 Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, non-heating for adjunctive use in pain therapy Regulatory Class: II Product Code: NHN Dated: November 22, 2004 Received: November 23, 2004
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encrosals) to trg. 3)
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commence prior to May 20, 1976, the exactions of the Federal Food, Drug, de necs that have been recuire approval of a premarket approval application (PMA). and Cosmetic 710-1710-11-18, that do novice, subject to the general controls provisions of the Act. The Tou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the rest 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 If your device is elassified (boo are rotrols. Existing major regulations affecting your device can may be subject to sater additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that FDA issuance verour device complies with other requirements of the Act that I DT has made a about regulations administered by other Federal agencies. You must or any I cacial statutes and submitted to: registration and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); adomig (Dr CFR Part 820); and if applicable, the electronic forth in the quality bybells (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Mr. Daniel Kamm, P.E.
This letter will allow you to begin marketing your device as described in your Section 510(k) I his ietter will anow you to oegin manteanig your and equivalence of your device to a legally premarket nothcation. The PDA maing of backanial reportunation of 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 If you desire specific acvice for your acon (240) 276-0115. Also, please note the regulation entitled, p Colliact the Office of Compitalion in (21CFR Part 807.97). You may obtain Missuranting by Iciercher to premaintentibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. 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
K034009 510(k) Number (if known):_
Device Name:
Indications For Use: The LAPEX-2000 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
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
uriam C. Parvost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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.