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510(k) Data Aggregation
(126 days)
OLIZ LTB-1000A
The OLIZ LTB-1000A is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of min, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
The OLIZ LTB-1000A is a highly shapeable LED panel designed to fit the contours of the target areas of the anatomy, covered with biocompatible material, which uses specific wavelengths of light. OLIZ LTB-1000A produces light in the near infrared region of the spectrum (850nm) intended to provide topical heating for temporary pain relief. This device provides a soothing vibration function for the purpose of enhancing the user's satisfaction.
Here's a breakdown of the acceptance criteria and study information for the OLIZ LTB-1000A, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance is based on the device being "substantially equivalent" to a predicate device (BioPhotas Celluma3 K152280). Therefore, the acceptance criteria are implicitly those of the predicate device, and the device performance is demonstrated through a comparison to ensure no new questions of safety or effectiveness are raised. Explicit, numerical acceptance criteria for clinical efficacy are not provided in this document as it's a 510(k) for an infrared lamp, which typically relies on established performance standards and comparison to a legally marketed predicate.
| Feature / Acceptance Criteria Category | Reported Device Performance (OLIZ LTB-1000A) |
|---|---|
| Regulation Number | 21CFR§890.5500, Infrared Lamp (Same as predicate) |
| Product Code | ILY (Same as predicate for relevant functions) |
| Indications for Use | For topical heating to elevate tissue temperature; for temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation. (Same as predicate, excluding acne and wrinkle treatment) |
| Mechanism of Action | Use of red light for elevating tissue temperature and IR light. (Same as predicate, excluding blue light for acne and IR for wrinkles) |
| Maximum Device Surface Temperature | Less than 40°C |
| Wavelengths | 655nm, 850nm (Predicate includes 465nm, 640nm, 880nm. Difference noted due to absence of blue light for acne in proposed device.) |
| Electrical Power | Use Li-ion batteries (3.7v_1800mA x2) (Predicate uses 110-120 V. Difference noted, safety proven by IEC 60601-1.) |
| Treatment Regimen | 15 min. Twice a day (Total 210 min. per week) (Predicate: 3 times a week for 30 min., 4 weeks - Total 90 min. per week. Difference noted, performance/safety not affected when following recommended usage.) |
| Electrical Safety | Complies with IEC 60601-1 & collateral standards (Same as predicate) |
| Use | OTC (Same as predicate) |
| Biocompatibility | Patient contact materials tested for biocompatibility. |
| Design Specifications | Met all design specifications as verified by performance testing. |
| International/FDA Recognized Consensus Standards | Complies with EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 60601-1-11, EN/IEC 62304, ISO 10993-1, ISO 10993-5, ISO 10993-10. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set with human participants for determining the device's efficacy. The performance evaluation is based on non-clinical (bench) testing and comparison to a predicate device. Therefore, a sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As no clinical test set for efficacy/diagnostic performance was conducted, there were no experts used to establish ground truth in that sense. The "ground truth" for the device's substantial equivalence relies on established engineering standards and comparison with the predicate.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set with human data requiring adjudication was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document states "Clinical performance: Not applicable."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, this device is an infrared lamp, not an algorithm, so the concept of standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is derived from:
- Established industry standards: Specifically, international and FDA-recognized consensus standards for medical electrical equipment (IEC 60601 series), software (IEC 62304), and biological evaluation of medical devices (ISO 10993 series).
- Performance of the predicate device: The BioPhotas Celluma3 (K152280) established the safety and effectiveness profile for similar infrared lamps, and the OLIZ LTB-1000A demonstrated equivalence to this predicate.
8. The Sample Size for the Training Set
Not applicable. This device is an infrared lamp; it does not involve machine learning or algorithms that require a "training set" of data. Testing was based on engineering and biocompatibility standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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