(232 days)
The HTP-1500 Localized Heat Therapy Pump is intended for use in those situations where a physician determines that heat therapy is necessary or desirable.
The HTP-1500 Localized Heat Therapy Pump is a small electronically controlled electric water heater containing a water reservoir, an electric resistance heater, a heat exchanger, an integral electric pump and associated tubing, hoses and fittings that allow it to be connected to a separate external pad. In use, the pump circulates water from the reservoir through the heat exchanger, associated tubing, hoses and fittings into and through the external pad. The operator, using a membrane switch keypad, selects the desired water temperature as observed and confirmed on a digital display. The electronic controller selectively turns on and off the electric resistance heater to heat the heat exchanger, thereby heating the water to the desired temperature. The actual water temperature is monitored and displayed on a digital display.
The provided document is a 510(k) summary for the HTP-1500 Localized Heat Therapy Pump, submitted to the FDA in 1997. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing new clinical study data with specific acceptance criteria, performance metrics, or ground truth establishment relevant to AI/ML device evaluations.
Therefore, many of the requested details regarding acceptance criteria, study design for performance evaluation, sample sizes, expert qualifications, and ground truth establishment methods (which are standard for modern AI/ML device submissions) are not present in this document because they were not required for this type of submission at that time.
Here's an attempt to extract and interpret the information based on the prompt, acknowledging the limitations of the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the way it would for a performance study. Instead, it presents a "SPECIFICATION COMPARISON" table to demonstrate substantial equivalence to predicate devices (Seabrook SMS-2000 and SMS-1000). The implicit acceptance criteria are that the HTP-1500's specifications are comparable or superior to the predicate devices.
| Specification Category | Acceptance Criteria (based on predicate equivalence to SMS-2000/SMS-1000) | Reported Device Performance (Adroit HTP-1500) |
|---|---|---|
| Physical (examples) | Comparable in terms of size, weight, connector, housing material/color | See table below |
| Electrical System | Comparable electrical specifications (voltage, current, fuse, cord) | See table below |
| Heating System | Comparable temperature range, heating element wattage | See table below |
| Control System | Acceptable type, accuracy, readouts, self-calibrating capabilities | See table below |
| Safety Concerns | Comparable or improved safety limits and warning systems | See table below |
| Circulating System | Comparable reservoir capacity, fluid, fill cap, flow rate | See table below |
SPECIFICATION COMPARISON (Directly from document)
| SPECIFICATION COMPARISON | Adroit HTP-1500 | Seabrook SMS-2000 | Seabrook SMS-1000 |
|---|---|---|---|
| Physical | |||
| Size | 7" Diameter. 8.5" High | 8.5" Wide, 6.0625" Deep, | |
| 5.75" High | 8.5" Wide, 6.0625" Deep, | ||
| 5.75" High | |||
| Weight (empty) | 7 Pounds | 5.25 Pounds | 4.7 Pounds |
| Connector Fitting Type | Quick-Connect | Quick-Connect | Quick-Connect |
| Housing Material | Polypropylene | G.E. Noryl Plastic | G.E. Noryl Plastic |
| Housing Color | Off White | Off White | Off White |
| Electrical System | |||
| Voltage | 115 Volt, 60 Hz. | 115 Volt, 60 Hz. | 115 Volt, 60 Hz. |
| Current | 2.2 Amp. | 1.75 Amp. | 1.75 Amp. |
| Fuse | 3 Amp., Type 3AG | 3 Amp., Type 3 AG | 3 Amp., Type 3AG |
| Power Cord | 3 Conductor, 18 AWG, 10 | ||
| Feet Long, Hospital Grade | |||
| Plug | 3 Conductor, 18 AWG, 10 | ||
| Feet Long, Hospital Grade | |||
| Plug | 3 Conductor, 18 AWG, 10 | ||
| Feet Long, Hospital Grade | |||
| Plug | |||
| Leakage Current | Less Than 50 Microamp | Less Than 50 Microamp | Less Than 50 Microamp |
| Heating System | |||
| Temperature Range | 75 °F to 107 °F | 78 °F to 107 °F | 86 °F to 107 °F |
| Heating Element | 200 Watts | 150 Watts | 150 Watts |
| Control System | |||
| Type | Digital, Solid State | ||
| (Microprocessor based) | Digital, Solid State | ||
| (Microprocessor based) | Analog, Solid State | ||
| Accuracy | +/- 1 °F (95 °F to 107 °F) | +/- 1 °F (Range ??) | +/- 1 °F (Range ??) |
| Self-Calibrating | No | Yes | Yes |
| Set Point Read Out | Digital Display | Digital Display | Analog Dial |
| Water Temperature | |||
| Readout | Digital Display | Digital Display | None |
| Water Temperature | |||
| Display Range | 32 °F to 122 °F | 31 °F to 121 °F | None |
| Safety Range | |||
| Primary Limit Thermostat | Software Set at 109 °F | Hardware set at 113 °F +/- | |
| 3 °F | Hardware set at 113 °F +/- | ||
| 3 °F | |||
| Secondary Limit Thermostat | Hardware set at 115 °F +/- | ||
| 5 °F | Hardware set at 117 °F +/- | ||
| 5 °F | Hardware set at 117 °F +/- | ||
| 5 °F | |||
| Warning Lights | Flashing Display for Over | ||
| Temperature | Light for Low Water and | ||
| Over Temperature | Light for Low Water and | ||
| Over Temperature | |||
| Audible Alarms | Over Temperature | Low Water and Over | |
| Temperature | None | ||
| Circulating System | |||
| Reservoir Capacity | 1.5 Liter (50.72) | 0.89 Liter (30 Ounces) | 0.89 Liter (30 Ounces) |
| Reservoir Fluid | Distilled Water | Distilled Water | Distilled Water |
| Fill Cap | Vented | Vented | Vented |
| Flow Rate Through Pad | 10 to 14 GPH Average | 10 to 14 GPH Average | 10 to 14 GPH Average |
2. Sample size used for the test set and the data provenance
The document explicitly states: "This section is not required for this submission because substantial equivalence is based on intended use and device characteristics and specifications, and not on an assessment of performance data." (b, page 2).
Therefore, no separate "test set" or performance data (in the sense of a clinical or analytical study with a defined sample size and provenance) was provided or required for this 510(k) submission. The comparison is based on published specifications of existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, no performance evaluation requiring expert ground truth for a test set was conducted or submitted.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication was used.
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 is a submission for a hardware medical device (heat therapy pump), not an AI/ML device. Therefore, no MRMC study or assessment of AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth was established for "performance data" as no such data was submitted. The "ground truth" for the comparison is the published specifications of the predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires ground truth for a training set.
§ 890.5720 Water circulating hot or cold pack.
(a)
Identification. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.