(90 days)
The LaserTouchOne™(OTC) is a low level laser and electrical stimulation device. This combination of low level light and electrical stimulation provides symptomatic relief of chronic, intractable pain, and is indicated for adjunctive treatment of post-surgical and post-traumatic acute pain and for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
The LaserTouchOne™ (LTO) device is a rechargeable hand-held pain therapy device. It combines the technology of low level laser and transcutaneous electrical nerve stimulation in one unit. The low level (cold) laser therapy (LLLT) is delivered with a single diode laser of <1 mW, 670 nm. The pulsed electrical stimulation is simultaneously delivered though stainless steel contact points, using an electroconductive gel as the contact medium.
Here's the breakdown of the acceptance criteria and study information for the LaserTouchOne™ (OTC) based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the LaserTouchOne™ (OTC)'s performance. Instead, it refers to prior studies and demonstrates the device's usability for over-the-counter use.
The key performance indicators are implied:
- Symptomatic relief of chronic, intractable pain.
- Adjunctive treatment of post-surgical and post-traumatic acute pain.
- Temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Provides symptomatic relief of chronic, intractable pain. | The LTO performed favorably compared to predicate TENS and LLLT devices in a randomized, controlled clinical trial. |
| Indicated for adjunctive treatment of post-surgical and post-traumatic acute pain. | The LTO performed favorably compared to predicate TENS and LLLT devices in a randomized, controlled clinical trial. |
| Indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin. | The LTO performed favorably compared to predicate TENS and LLLT devices in a randomized, controlled clinical trial. |
| Usability for over-the-counter (OTC) use. | A second study demonstrated the usability of the LTO-OTC device for over-the-counter use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The text does not specify the exact sample size for either of the two studies mentioned.
- Data Provenance:
- The first study (mentioned in K083822, for prescription use) was a "randomized, controlled clinical trial," implying prospective data collection.
- The second study (for OTC use) was "conducted at a clinical research site," also implying prospective data collection.
- The country of origin is not specified, but given the FDA submission, it is likely the United States or a country with clinical trial standards recognized by the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The text does not provide information on the number of experts, their qualifications, or their involvement in establishing ground truth for the test set. This type of detail is more common for imaging or diagnostic devices where expert interpretation is a primary measure. For a pain relief device, the "ground truth" is typically patient-reported pain scores or clinical assessments by treating physicians.
4. Adjudication Method for the Test Set
The text does not specify an adjudication method. For clinical trials of pain relief devices, adjudication usually involves blinded assessments by investigators or independent committees, but the specific process is not detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
- The text does not describe an MRMC study in the context of human readers improving with AI vs. without AI assistance. This concept is not applicable as the LaserTouchOne™ is a physical device for pain therapy, not an AI-driven diagnostic or imaging tool requiring human interpretation comparison.
- The first study was a "randomized, controlled clinical trial in which the LTO performed favorably compared to predicate TENS and LLLT devices." This is a comparative effectiveness study, but not an MRMC study in the typical sense of evaluating human reader performance with AI. The effect size is simply stated as "performed favorably" without specific metrics.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
The concept of a "standalone algorithm" is not applicable to this device. The LaserTouchOne™ is a physical device that is used by a human (the patient or user) to deliver therapy. Its performance is inherently linked to its direct application.
7. The Type of Ground Truth Used
The ground truth for this type of device (pain relief) would typically be based on patient-reported outcomes (e.g., pain scores, quality of life metrics) and potentially clinical assessments by healthcare professionals. The text does not explicitly detail the specific metrics used but refers to "symptomatic relief" and performance compared to predicate devices, implying these types of clinical endpoints were assessed.
8. The Sample Size for the Training Set
The text does not provide information on the sample size for a training set. This is because the device is not an AI/machine learning model that typically requires a distinct "training set." The clinical trials served as the basis for demonstrating efficacy and safety.
9. How the Ground Truth for the Training Set was Established
As this is not an AI/machine learning device, the concept of a "training set" and its "ground truth establishment" in that context is not applicable. The efficacy and safety of the device were established through the clinical trial(s) involving patient outcomes and comparisons to predicate devices.
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Submitter: Laser Health Technologies, LLC
:
LaserTouchOne™(OTC) Traditional 510(k)
510(k) SUMMARY— LaserTouchOne™(OTC)
| Submitter Name: | Laser Health Technologies, LLC |
|---|---|
| Submitter Address: | 10234 North 58 th PlaceParadise Valley, AZ 85253 |
| Contact Person: | James Mantle, Manager |
'APR 1 5 2010
| Phone Number: | 602-821-1659 |
|---|---|
| Date Prepared: | January 12, 2010 |
| Device Trade Name: | LaserTouchOne™ (OTC) |
| Device Common Name: | Low level (cold) laser device and transcutaneous electrical nerve stimulator for pain therapy |
| Classification Numbers: | 21 CFR 890.5500; 21 CFR 882.5890 |
| Classification Names: | Non-heating lamp, for adjunctive use in pain therapy;Transcutaneous electrical nerve stimulator, over-the-counter |
| Product Codes: | NHN; NUH |
| Predicate Devices: | K083822, LaserTouchOne™; Laser Health Technologies, LLCK080513; QLaser System; 2035, Inc.K063743; Rhythm Touch Q 2-Way, Shockim Enterprise Ltd. |
| Statement of Intended Use: | The LaserTouchOne™ (OTC) is a low level laser and electrical stimulation device. This combination of low level light and electrical stimulation provides symptomatic relief of chronic, intractable pain, and is indicated for adjunctive treatment of post-surgical and post-traumatic acute pain and for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin. |
| Device Description: | The LaserTouchOne™ (LTO) device is a rechargeable hand-held pain therapy device. It combines the technology of low level laser and transcutaneous electrical nerve stimulation in one unit. The low level (cold) laser therapy (LLLT) is delivered with a single diode laser of <1 mW, 670 nm. The pulsed electrical stimulation is simultaneously delivered though stainless steel contact points, using an electroconductive gel as the contact medium. |
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Comparison to the Predicate Devices:
This device is identical to the LTO device cleared on May 6. 2009 by FDA for prescription use. The prior 510(k) contained data from a randomized, controlled clinical trial in which the LTO performed favorably compared to predicate TENS and LLLT devices.
This 510(k) contains data from a second study, conducted at a clinical research site, which demonstrated the usability of the LTO-OTC device for over-the-counter use.
The LTO-OTC, with respect to device characteristics is identical to the LTO predicate device, and with respect to technological characteristics and over-the-counter intended uses is substantially equivalent to the LLLT and TENS predicate devices.
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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 consists of a stylized eagle or bird-like figure with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Laser Health Technologies % Trisler Consulting Ms. Patsy J. Trisler Regulatory Consultant 5600 Wisconsin Avenue, #509 Chevy Chase, Maryland 20815
APR 1 5 2010
Re: K100116
Trade/Device Name: LaserTouchOne™ (OTC) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: NUH, NHN Dated: January 12, 2010 Received: January 15, 2010
Dear Ms. Trisler:
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 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
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Page 2 - Ms. Patsy J. Trisler
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/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 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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Submitter: Laser Health Technologies, LLC
510(k) Number (if known):
Device Name:
. ·· .
:
LaserTouchOne™(OTC)
Indications for Use:
The LaserTouchOne™(OTC) is a low level laser and electrical stimulation device. This combination of low level light and electrical stimulation provides symptomatic relief of chronic, intractable pain, and is indicated for adjunctive treatment of post-surgical and post-traumatic acute pain and for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
Prescription Use (Part 21 CFR 801 Subpart D)
(Posted November 13, 2003)
AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100116
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).