(463 days)
TH0R DDII 830CL3 Laser System (K030226)
Not Found
No
The device description focuses on the hardware components and the mechanism of action (infrared laser light). There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The performance studies rely on nonclinical testing for substantial equivalence, not on the performance metrics typically associated with AI/ML algorithms.
Yes
The "Intended Use / Indications for Use" section states that the devices are indicated for "adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome," which is a therapeutic purpose.
No
The device is described as a therapy device for pain relief, not for diagnosing conditions. Its intended use and description focus on emitting infrared light for treatment.
No
The device description explicitly lists hardware components such as infrared laser diodes, optical fibers, handpiece holder, battery, charging cable, spacers, safety glasses, eye protector, and transportation case. It also describes the physical interaction with the patient via the spacer.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The description clearly states that Therapy EC and Therapy XT are non-heating infrared lamps that emit infrared laser light. Their intended use is for the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
- Mechanism of Action: The device works by applying light energy to the body, not by analyzing a biological sample.
- Intended Use/Indications for Use: The stated intended use is therapeutic (pain relief), not diagnostic.
The device is a therapeutic device that uses light energy, not an in vitro diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
Therapy EC and Therapy XT are non-heating infrared lamps and are indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
Product codes
NHN
Device Description
Therapy EC and Therapy XT are made up of ergonomic equipment that is easy to use and operate. They have one infrared laser diode (808nm). Two optical fibers conduct the laser light emitted by each emitter. The optical power emitted is controlled by the electrical current in the laser diodes.
Therapy EC and Therapy XT are designed to emit infrared laser light. Additionally, they are intended to be used by health care professionals such as physicians, nurses, and physical therapists, for adjunctive use in the temporary relief of hand of wrist pain associated with Carpal Tunnel Syndrome.
Therapy EC and Therapy XT are consisted of components including handpiece holder, battery charging cable, battery, spacer (3 units), safety glasses, eye protector, and transportation case. The only part that touches the patient is the spacer. This component is made of polycarbonate and has the function of creating a safe distance between the Therapy tip and the patient's skin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand and wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care professionals such as physicians, nurses, and physical therapists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical performance testing was conducted to demonstrate substantial equivalence, including:
- IEC 60825-1 Edition 2.0 2007-03 Safety of laser products Part 1: Equipment classification, and . requirements
- IEC 60601-1 Edition 3.2 2020-08 Safety requirements for electrical equipment for measurement, control, ● and laboratory use - Part 1: General requirements
- IEC 60601-2-22: 2019 Edition 4.0 2019-11 Medical electrical equipment Part 2-22: Particular ● requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 62304:2006+AMD1:2015 Edition 1.1 2015-06 Medical device software Software life cycle processes ●
- ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices Part 1: Evaluation and testing . within a risk management process
Substantial equivalence of the subject device to the predicate has been established through the results of nonclinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TH0R DDII 830CL3 Laser System (K030226)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.
December 19, 2024
DMC Importacao e Exportacao de Equipamentos LTDA Homero Santiago Antunes and Tatiana Jabor Botura Regulatory Affairs Specialist PR Servicos Regulatorios Administrativos Ltda Rua Alice Alem Saadi, 855/2402 Ribeirao Preto, Sao Paulo 14096570 Brazil
Re: K232813
Trade/Device Name: Therapy EC, Therapy XT Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: NHN Dated: November 18, 2024 Received: November 18, 2024
Dear Homero Santiago Antunes and Tatiana Jabor Botura:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Amber T. Ballard -S
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K232813
Device Name Therapy EC and Therapy XT
Indications for Use (Describe)
Therapy EC and Therapy XT are non-heating infrared lamps and are indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY - K232813
| Manufacturer/Submitter: | DMC Importação e Exportação de Equipamentos LTDA
Rua Sebastião de Moraes, 831 - Jardim Alvorada
São Carlos, SP – Brazil
Phone: +55 (16) 2107-2323 |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Homero Santiago Antunes and Tatiana Jabor Botura
Regulatory Affairs Specialists
PR Serviços Regulatórios Administrativos Ltda
Phone: +55 (47) 3804-0075
Email: homero@passarini.com.br |
| Date Prepared: | December 17, 2024 |
| Device Trade Name: | Therapy EC and Therapy XT |
| Regulation and
Classification Description: | 21 CFR 890.5500, Infrared lamp |
| Class: | II |
| Product Code: | NHN |
| Predicate Device: | TH0R DDII 830CL3 Laser System (K030226) |
Indications for Use
Therapy EC and Therapy XT are non-heating infrared lamps and are indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
Device Description
Therapy EC and Therapy XT are made up of ergonomic equipment that is easy to use and operate. They have one infrared laser diode (808nm). Two optical fibers conduct the laser light emitted by each emitter. The optical power emitted is controlled by the electrical current in the laser diodes.
Therapy EC and Therapy XT are designed to emit infrared laser light. Additionally, they are intended to be used by health care professionals such as physicians, nurses, and physical therapists, for adjunctive use in the temporary relief of hand of wrist pain associated with Carpal Tunnel Syndrome.
Therapy EC and Therapy XT are consisted of components including handpiece holder, battery charging cable, battery, spacer (3 units), safety glasses, eye protector, and transportation case. The only part that touches the patient is the spacer. This component is made of polycarbonate and has the function of creating a safe distance between the Therapy tip and the patient's skin.
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Comparison of Technological Characteristics with the Predicate Device
Table 1: Comparison of Subject and Predicate Devices
| Contents | Subject device | Primary Predicate |
|---|---|---|
| (K030226) | ||
| Device name | Therapy EC and Therapy XT | THOR DDII 830CL3 Laser System |
| Product code | NHN | NHN |
| Regulation | ||
| Number | 21 CFR 890.5500 | 21 CFR 890.5500 |
| Class | Class II | Class II |
| Indications for | ||
| use | Therapy EC and Therapy XT are non- | |
| heating infrared lamps and are indicated | ||
| for adjunctive use in the temporary relief | ||
| of hand and wrist pain associated with | ||
| Carpal Tunnel Syndrome. | The THOR DDII 830CL3 Laser | |
| System is a non-heating infrared lamp and is | ||
| indicated for adjunctive use in the temporary | ||
| relief of hand and wrist pain associated with | ||
| Carpal Tunnel Syndrome. | ||
| Operation | ||
| principle | Light emission | Light emission |
| Emitters | ||
| technology | Diode Laser (Semiconductor) | Diode Laser (Semiconductor) |
| Optical power | 100 mW per emitter | Three 30 mW Gallium Aluminum Arsenide |
| (GaAlAs) laser diodes delivering a total | ||
| output power of 90 mW | ||
| Wavelengths | 808 nm | 830 nm |
| Interaction with | ||
| the patient | Luminous energy absorption | Luminous energy absorption |
The indication for use (IFU) statements of the subject and the predicate devices are identical. The subject and the predicate devices are non-heating infrared laser as defined in 21 CFR 890.5500. Both the subject and the predicate devices use diode lasers to emit photonic energy to tissue. The differences between the subject device and predicate are explained below:
Optical power: According to 60601-2-22 Edition 3.1 2012-10 (Recognition Number 12-268), a tolerance of 20% is accepted, justifying the difference between the subject (100 mW) and the predicate (90 mW) devices.
Wavelength: The absorption coefficient of laser light by melanin, hemoglobin and water at wavelengths 808 and 830 nm are similar.
6
Non-clinical Performance Testing
The following nonclinical performance testing was conducted to demonstrate substantial equivalence.
- IEC 60825-1 Edition 2.0 2007-03 Safety of laser products Part 1: Equipment classification, and . requirements
- IEC 60601-1 Edition 3.2 2020-08 Safety requirements for electrical equipment for measurement, control, ● and laboratory use - Part 1: General requirements
- IEC 60601-2-22: 2019 Edition 4.0 2019-11 Medical electrical equipment Part 2-22: Particular ● requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 62304:2006+AMD1:2015 Edition 1.1 2015-06 Medical device software Software life cycle processes ●
- ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices Part 1: Evaluation and testing . within a risk management process
Clinical Testing
Substantial equivalence of the subject device to the predicate has been established through the results of nonclinical testing.
Conclusion
The Therapy EC and Therapy XT have the same intended use, indications for use, and principles of operation, and highly similar technological characteristics as the predicate device. The technological differences identified do not raise new questions of safety or effectiveness compared to the predicate device. Therefore, the subject device is substantially equivalent to the predicate device.