(161 days)
Xinfeng Heating lamp, including CQ-27, CQ-36 and CQ-55A, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help to relieve minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain.
Xinfeng Heating Lamp, including 3 different models CQ-27, CQ-36 and CQ-55A, consists of heating head, swing arm, control box and pedestal with extension. It is used to provide topical heating to the body and is specially engineered using a plate. Model CQ-27 and CQ-36 have only one operating mode, while model CQ-55A has two operating modes. Emission spectrum ranges from 5 to 25 microns for models CQ-27, CQ-36 and state I of CQ-55A. Model CQ-55A also includes an additional operating state (State II) having an emission range of 2 to 50 microns. The emission heating plate shall be replaced after 1,000 hours of usage.
The provided documentation for the Xinfeng Heating Lamp does not contain information about specific acceptance criteria or a dedicated study proving the device meets those criteria in the context of clinical performance or effectiveness.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (TDP CQ-27 Heat Lamp manufactured by Lhasa Medical, Inc.) based on:
- Intended Use: Both devices are infrared lamps for topical heating to relieve pain.
- Materials: Implied to be similar.
- Specifications: A direct comparison of various technical specifications is provided.
Therefore, many of the requested details, such as sample sizes, ground truth establishment, expert qualifications, and MRMC studies, are not available in this type of submission for a Class II medical device demonstrating substantial equivalence. These elements are typically found in clinical studies designed to prove efficacy or performance against defined endpoints, which is not the primary purpose of this 510(k) submission.
However, based on the provided tables comparing the new device to the predicate, we can infer some "acceptance criteria" by looking at where the new device's specifications are considered equivalent to or justify minor differences from the predicate.
Here's a breakdown of what can be extracted from the provided text according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly defined by the predicate device's specifications. The "reported device performance" is the Xinfeng Heating Lamp's specifications. The goal is to show general equivalence or acceptable differences.
Table 1: Xinfeng Heating Lamp CQ-27 vs. Predicate (CQ-27)
| Item | Acceptance Criteria (Predicate Device) | Reported Device Performance (Xinfeng CQ-27) | Conformity / Justification |
|---|---|---|---|
| Components | Heating head, swing arm, control box, pedestal with extension | Heating head, swing arm, control box, pedestal with extension | Equivalent |
| Power Frequency | 50/60 Hz | 50/60 Hz | Equivalent |
| Power | $\leq 250 W$ | $\leq 250 W$ | Equivalent (within acceptable limits) |
| Spectrum Ranges | 2 to 50 microns | 5 to 25 microns | Different, but likely deemed acceptable if the therapeutic effect (topical heating) is maintained within safe parameters. The 5-25 micron range is still infrared. The submission implies that "All the technical data are tested according to GB 9706.1-1995 which is identical to IEC 60601-1," suggesting safety and performance testing for these ranges. |
| Warming Up Time | 15 minutes | 15 minutes | Equivalent |
| Total Working Hours | 1,200 to 1,500 hours | 1,000 hours | Lower working hours for the new device. This is a characteristic difference, not necessarily a failure of "acceptance criteria" but a specification. Users would replace the emission heating plate after 1,000 hours. |
| Operating Timer | Up to 60 minutes | Up to 60 minutes | Equivalent |
| Number of Fuse | 2 | 2 | Equivalent |
| Inner Cover Diameter | 12 cm | 12 cm | Equivalent |
| Number of Casters | 4 | 5 | Different, but this is an improvement in mobility or stability, not a failure. |
| Skin Temperature (°C) at 8" | 45°C | 45°C | Equivalent (at 8" distance) |
| Skin Temperature (°C) at 10" | 43°C | 43°C | Equivalent (at 10" distance) |
| Skin Temperature (°C) at 12" | 41°C | 41°C | Equivalent (at 12" distance) |
Table 2: Xinfeng Heating Lamp CQ-36 vs. Predicate (CQ-27)
| Item | Acceptance Criteria (Predicate Device) | Reported Device Performance (Xinfeng CQ-36) | Conformity / Justification |
|---|---|---|---|
| Components | heating head, swing arm, standard control box, pedestal with extension | heating head, swing arm, control box with digital display, pedestal with extension | Improved control box (digital display) is considered an acceptable difference/improvement. |
| Power Frequency | 50/60 Hz | 50/60 Hz | Equivalent |
| Power | $\leq 250 W$ | $\leq 250 W$ | Equivalent |
| Spectrum Ranges | 2 to 50 microns | 5 to 25 microns | Similar difference as CQ-27 model. |
| Warming Up Time | 15 minutes | 15 minutes | Equivalent |
| Total Working Hours | 1,200 to 1,500 hours | 1,000 hours | Similar difference as CQ-27 model. |
| Operating Timer | Up to 60 minutes | Up to 95 minutes | Increased operating timer is an improvement and considered acceptable. |
| Number of Fuse | 2 | 2 | Equivalent |
| Inner Cover Diameter | 12 cm | 16.6 cm | Larger inner cover diameter is a design difference, likely acceptable as it maintains the intended function. |
| Number of Casters | 4 | 5 | Similar difference as CQ-27 model. |
| Skin Temperature (°C) at 8" | 45°C | 44°C | Slightly lower temperature at 8", but within therapeutic range and deemed acceptable. |
| Skin Temperature (°C) at 10" | 43°C | 42°C | Slightly lower temperature at 10", but within therapeutic range and deemed acceptable. |
| Skin Temperature (°C) at 12" | 41°C | 40°C | Slightly lower temperature at 12", but within therapeutic range and deemed acceptable. |
Table 3: Xinfeng Heating Lamp CQ-55A vs. Predicate (CQ-27)
| Item | Acceptance Criteria (Predicate Device) | Reported Device Performance (Xinfeng CQ-55A) | Conformity / Justification |
|---|---|---|---|
| Components | heating head with one heating unit, swing arm, standard control box, pedestal with extension | heating head with three heating unit, swing arm, control box with digital display, pedestal with extension | Multiple heating units and digital display are design differences/improvements, considered acceptable. |
| Power Frequency | 50/60 Hz | 50/60 Hz | Equivalent |
| Power | $\leq 250 W$ | $\leq 280 W$ | Higher power for CQ-55A, likely due to three heating units. This is an increase, but the overall safety and performance (e.g., skin temperature) are evaluated. |
| Warming Up Time | 15 minutes | 15 minutes | Equivalent |
| Total Working Hours | 1,200 to 1,500 hours | 1,000 hours | Similar difference as other models. |
| Operating Timer | Up to 60 minutes | Up to 95 minutes | Similar improvement as CQ-36 model. |
| Number of heating head | 1 | 3 | Design difference/improvement. |
| Number of Fuse | 2 | 2 | Equivalent |
| Inner Cover Diameter | 12 cm | 8 cm | Smaller inner cover diameter is a design difference, likely acceptable. |
| Number of Casters | 4 | 5 | Similar difference as other models. |
| Spectrum Ranges (State I) | 2 to 50 microns | 5 to 25 microns | Similar difference as other models. |
| Skin Temp. State I (8") | 45°C | 44°C | Slightly lower temperature, but within therapeutic range and deemed acceptable. |
| Skin Temp. State I (10") | 43°C | 42°C | Slightly lower temperature, but within therapeutic range and deemed acceptable. |
| Skin Temp. State I (12") | 41°C | 41°C | Equivalent. |
| Spectrum Ranges (State II) | 2 to 50 microns | 2 to 50 microns | Equivalent. |
| Skin Temp. State II (8") | 45°C | 47°C* | Exceeds predicate's temperature at this distance. This is a critical finding. The note indicates a safety precaution: "*47°C exceeds the safe temperature range and that model CQ-55A should be positioned at least 10 inches from the body surface to be treated." This indicates a deviation from direct equivalence requiring a specific user instruction to ensure safety. |
| Skin Temp. State II (10") | 43°C | 44°C | Slightly higher temperature, but deemed acceptable with the caveat from the 8" distance. |
| Skin Temp. State II (12") | 41°C | 43°C | Slightly higher temperature, but deemed acceptable with the caveat from the 8" distance. |
2. Sample size used for the test set and the data provenance
- The document states: "All the technical data are tested according to GB 9706.1-1995 which is identical to IEC 60601-1". This indicates that electrical and safety performance tests were conducted according to recognized international standards.
- However, specific sample sizes for these tests (e.g., number of devices tested for each parameter like skin temperature, working hours, etc.) are not provided.
- The data provenance is from Chongqing Xinfeng Medical Instrument Co., Ltd., People's Republic of China, which is the manufacturer. The data would be considered prospective for the Xinfeng devices themselves, as they were tested to generate these specifications. The comparison point (predicate) is also based on its own specifications.
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/Not provided. This submission relies on engineering specifications and adherence to safety standards (IEC 60601-1) rather than clinical expert consensus or interpretation of medical images. The "ground truth" here is the measured physical properties and performance characteristics of the devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are typically used in studies involving subjective interpretation (e.g., imaging studies) or complex clinical endpoints, which is not the case here.
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
- Not applicable. This device is a heating lamp, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical infrared lamp, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance data presented (e.g., power, temperature, working hours) would be objective physical measurements taken during engineering and quality control tests, following the principles outlined in international standards like IEC 60601-1.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- See point 8. Not applicable.
§ 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.