(286 days)
The Tända Restore System is an over-the-counter device intended for use whenrever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional for the purpose of providing temporary relief of minor aches and pains in muscles and joints.
Tända Restore is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature. Use wherever heat application is prescribed for personal comfort and the temporary relief of minor muscular pain, joint pain and stiffness. Provides temporary relief of minor aches and pains in muscles and joints. Aids in the relaxation of muscles. Helps provide a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief. Provides a temporary increase in local blood circulation.
The Tanda Restore is a modular platform which supports and infrared lamp (LED Array Head) for the purposes of applying infrared heat to the human body. It consists of LED infrared lamps emitting infrared energy in the wavelength of 870 nm.
This is a 510(k) premarket notification for a medical device (K090008) which often relies on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics typically associated with novel or high-risk devices.
Based on the provided document, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance & 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance & 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No specific acceptance criteria or performance metrics table is provided in this 510(k) summary. The submission focuses on demonstrating substantial equivalence.
- No MRMC comparative effectiveness study or standalone AI algorithm performance study was performed or reported. This device is an infrared therapeutic heating lamp, not an AI-powered diagnostic or assistive technology.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. The submission does not describe a clinical study or a test set in the context of evaluating diagnostic or algorithmic performance. The device is an infrared lamp.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. There is no "ground truth" to establish for a test set in this context, as it's not a diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The device is an infrared lamp for therapeutic heating; it does not generate diagnostic data for which "ground truth" would be established. The "ground truth" here would be the physical properties and safety of the device itself.
8. The sample size for the training set & 9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML algorithm that requires training data or a training set.
Summary of Device Acceptance and Supporting Information from the Document:
The acceptance of the Tända Restore System is based on demonstrating substantial equivalence to legally marketed predicate devices, rather than meeting specific performance criteria from a clinical trial.
Here's the relevant information provided:
- Device Name: Tända Restore™
- Intended Use: An over-the-counter device for temporary relief of minor aches and pains in muscles and joints, and whenever recommended by a licensed medical professional for hot applications. It aims to emit energy in the infrared spectrum to provide topical heating for elevating/maintaining tissue temperature, temporary relief of minor muscular pain, joint pain & stiffness, muscle relaxation, improved range of motion, and temporary increase in local blood circulation.
- Regulatory Status: Class II medical device, Product Code ILY, Regulation Number 890.5500 (Infrared Lamp).
Basis for Acceptance (Substantial Equivalence):
- Predicate Devices:
- Comparison of Technological Differences: The document states: "The intended use and technological characteristics of the Tanda Restore are virtually identical to the combined intended uses and technological characteristics of the listed equivalent predicate devices. Any differences between the Tanda Restore System and the equivalent devices have no significant influence on the safety or effectiveness of the Tanda Restore System."
- Additional Safety Data:
- The Tända Restore System underwent certification to IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance).
- Testing and analysis demonstrated compliance to ISO 10993 (Biological evaluation of medical devices - Biocompatibility).
Conclusion based on the provided document:
The FDA determined the Tända Restore™ device to be substantially equivalent to its predicate devices, primarily based on its shared intended use, similar technological characteristics (infrared lamp emitting 870 nm), and compliance with recognized safety and biocompatibility standards (IEC 60601-1 and ISO 10993). There was no need for clinical trial-based acceptance criteria or performance metrics as it's a therapeutic heating lamp demonstrating equivalence, not a novel diagnostic tool.
{0}------------------------------------------------
510(k) Summary of Safety and Effectiveness
Submitted by: Pharos Life Corporation 11-380 Jamieson Parkway Cambridge, Ontario N3C 4N4
1. Date Prepared:
July 16, 2009
OCT 1 5 2009
2. Contact Person:
Gordon Wehner Tel: 519-651-1177 x225 Fax: 519-651-2277 Email: Gordon.wehner@pharoslife.com
3. Device Name and Classification:
| Device | Lamp, infrared, therapeutic heating | |
|---|---|---|
| Regulation Description | Infrared lamp | |
| Regulation Medical Specialty | Physical Medicine | |
| Review Panel | Physical Medicine | |
| Product Code | ILY | |
| Submission Type | 510(k) | |
| Regulation Number | 890.5500 | |
| Device Class | 2 |
4. Intended Use:
The Tända Restore System is an over-the-counter device intended for use whenrever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional for the purpose of providing temporary relief of minor aches and pains in muscles and joints.
{1}------------------------------------------------
5. Substantial Equivalence:
| PredicateDevice Name(s) | Applicant | 510(k) Number | Date of FDAClearance |
|---|---|---|---|
| Light Relief PainRelief Device | Light Relief, LLC | K070974 | May 24, 2007 |
| MedX | MedX Health Corp | K020017 | July 12, 2002 |
| Quantum WARP10 Light DeliverySystem | Quantum Devices | K032229 | Nov 3, 2003 |
6. Device Description
The Tanda Restore is a modular platform which supports and infrared lamp (LED Array Head) for the purposes of applying infrared heat to the human body. It consists of LED infrared lamps emitting infrared energy in the wavelength of 870 nm.
7. Comparison of Technological Differences
The intended use and technological characteristics of the Tanda Restore are virtually identical to the combined intended uses and technological characteristics of the listed equivalent predicate devices. Any differences between the Tanda Restore System and the equivalent devices have no significant influence on the safety or effectiveness of the Tanda Restore System.
8. Additional Safety Data
The Tanda Restore System has undergone certification to IEC 60601-1. In addition, testing and analysis have demonstrated compliance to ISO 10993 (biocompatibility).
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus symbol, which features a staff with a snake winding around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three curved lines representing the wings.
Pharos Life Corporation % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, Northwest Buffalo, Minnesota 55313
Re: K090008
Trade/Device Name: Tända Restore™ Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: September 29, 2009 Received: September 30, 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
OCT 1 5 2009
Dear Mr. Job:
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 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 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.
{3}------------------------------------------------
Page 2 – Mr. Mark Job
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mad A. Mellem
Mark N. Melkerson Director Division of Surgical, Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Number:
Device Name: Tända Restore™
Indications For Use:
Tända Restore is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature. Use wherever heat application is prescribed for personal comfort and the temporary relief of minor muscular pain, joint pain and stiffness. Provides temporary relief of minor aches and pains in muscles and joints. Aids in the relaxation of muscles. Helps provide a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief. Provides a temporary increase in local blood circulation.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vaughn V. Lung FOR M.MELKERSON
(D) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090008
§ 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.