(290 days)
The Inter-Therm Mini Pediatric HMEF Sterile is for use at the patient connections. The device is to be attached between the breathing circuit and patient connection. It is designed to reduce bacterial/viral transmission between the patient and equipment and to reduce the loss of patient heat and humidity. The filter is for single patient use only and therefore must be disposed of after a single patient usage and/or after its maximum duration of use at 24 hours. The device is a single use device that is required to be changed daily when used with devices (i.e. long-term ventilators) that are design to have patient body contact between 24 hours to
The Inter-Therm Mini Pediatric is a sterile HMEF used for passive humidification in pediatric patients under mechanical ventilation or anesthesia. The HMEF contains a HME paper and electrostatic filter pad incased in a plastic housing. The HME paper traps heat and moisture from the patient's exhaled air which is then returned in the inspiratory air to the patient. Therefore the patient receives heated, humidified air. The electrostatic filter pad prevents bacterial and viral cross-contamination between the breathing system and the patient. The HMEF has an additional luer lock port for CO2 monitoring with a retainable luer port cap to block the port when it is not in use. The HMEF has a 22F/15M connector at the machine end and a 22M/15F connector at the patient end.
The Inter-Therm Mini Pediatric angled HMEF is a sterile HMEF used for passive humidification in pediatric patients under mechanical ventilation or anesthesia. The HMEF contains a HME paper and electrostatic filter pad incased in a plastic housing. The HME paper traps heat and moisture from the patient's exhaled air which is then returned in the inspiratory air to the patient. Therefore the patient receives heated humidified air. The electrostatic filter pad prevents bacterial and viral cross-contamination between the breathing system and the patient. The HMEF has an additional luer lock port for CO2 monitoring with a retainable luer port cap to block the port when it is not in use. The HMEF has an angled 15M machine connecter end, eliminating the need to use an elbow in the breathing circuit. The patient end is a straight 22M/15F connector.
This document describes the safety and effectiveness summary for two medical devices: the Inter-Therm Mini Pediatric HMEF sterile (Product # 1331030S) and the Inter-Therm Mini Pediatric angled HMEF sterile (Product # 1332030S). Both are Heat and Moisture Exchanger Filters (HMEFs) designed for passive humidification and bacterial/viral filtration in pediatric patients under mechanical ventilation or anesthesia. The submission seeks substantial equivalence to the Covidien 355U5430 DAR Infant - Pediatric Electrostatic Filter HME (Small - K941381- Hygroboy).
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comparison table against a predicate device. For the purpose of this analysis, the "Acceptance Criteria" are implicitly defined by the performance characteristics of the predicate device (DAR Infant - Pediatric Electrostatic Filter HME - K941381), signifying that the new devices should perform similarly or better. The "Reported Device Performance" refers to the values for the new Intersurgical devices.
| Characteristic Compared | Acceptance Criteria (Predicate: DAR Infant - Pediatric Electrostatic Filter HME) | Reported Device Performance (Inter-Therm Mini Pediatric HMEF sterile) | Reported Device Performance (Inter-Therm Mini Pediatric angled HMEF sterile) |
|---|---|---|---|
| Intended Use: | |||
| Target Population | Pediatric patients mechanically ventilated requiring heated humidified air | Pediatric patients mechanically ventilated requiring heated humidified air | Pediatric patients mechanically ventilated requiring heated humidified air |
| Indications for Use | Provide heated humidified air, prevent cross-contamination, CO2 monitoring possible. Single patient use, max 24 hours. Only for pediatric patients and prescribed by a physician. | Reduce bacterial/viral transmission, reduce heat/humidity loss. Single patient use, max 24 hours, change daily with long-term ventilators (>24h to 24h to 99.99 | 99.98 BFE, 99.95 VFE |
| Tapers | ISO standard 15mm and 22mm | PASS | PASS |
| Ageing: 5 months | N/A (not explicitly listed for predicate) | PASS | PASS |
| Ageing: 5 years | N/A (not explicitly listed for predicate) | PASS | PASS |
| Materials | - (not specified in detail for predicate) | Acrylonitrile Butadiene Styrene (HMEF housing), Polypropylene-based fiber blend (Electrostatic filter), Cellulose-based paper (HME paper), Thermoplastic Elastomer with green color (Retainable luer port cap) | Acrylonitrile Butadiene Styrene (HMEF housing), Polypropylene-based fiber blend (Electrostatic filter), Cellulose-based paper (HME paper), Thermoplastic Elastomer with green color (Retainable luer port cap) |
| Energy Used/Delivered | Warm humidified air is extracted from expiratory air and delivered to the patient's inspiratory air. | Warm humidified air is extracted from expiratory air and delivered to the patient's inspiratory air. | Warm humidified air is extracted from expiratory air and delivered to the patient's inspiratory air. |
| Compatibility | Designed for use with breathing systems, elbows, catheter mounts and CO2 monitoring lines. | Designed for use with breathing systems, elbows, catheter mounts and CO2 monitoring lines. | Designed for use with breathing systems, elbows, catheter mounts and CO2 monitoring lines. |
| Biocompatibility | - (presumably meets standards) | Meets requirements of Bluebook Memo, General Program Memorandum G95-1 (cytotoxicity, sensitization, irritation) | Meets requirements of Bluebook Memo, General Program Memorandum G95-1 (cytotoxicity, sensitization, irritation) |
| Sterility | Clean | Sterile | Sterile |
| Standards Met (HME) | ISO 9360-1:1992 | ISO 9360-1:1992 | ISO 9360-1:1992 |
| Standards Met (Conical Connector ends) | ISO 5356-1:2004 | ISO 5356-1:2004 | ISO 5356-1:2004 |
| Standards Met (Luer lock connectors) | - (not specified for predicate) | ISO 594-2:1998 | ISO 594-2:1998 |
2. Sample size used for the test set and the data provenance:
The document explicitly states: "Non-clinical test results are submitted to confirm product safety and substantial equivalence to predicate device." and "Nonclinical tests submitted to demonstrate substantial equivalence for moisture return, resistance to flow, weight, tapers and filtration efficiency."
- Sample Size for Test Set: Not explicitly stated as a number of devices tested. The data presented in the comparison table are performance metrics, implying that testing was conducted on a sufficient number of units to obtain these typical or representative values.
- Data Provenance: The tests are "non-clinical," meaning they were likely conducted in a laboratory or engineering environment. The country of origin for the data is not specified. It is a prospective evaluation as these tests were conducted on the new devices to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable in this context. The document describes a 510(k) submission for substantial equivalence based on non-clinical, performance testing of a medical device, not an AI or diagnostic tool where expert ground truth interpretation would be required. The "ground truth" here is objective physical and performance measurements (e.g., moisture return, resistance to flow, weight) as per established international standards.
4. Adjudication method for the test set:
This information is not applicable. As stated above, this is non-clinical performance testing against objective standards and comparison with a predicate device, not a study involving human interpretation of medical data that would require an adjudication method.
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:
This information is not applicable. This is a 510(k) submission for a physical medical device (HMEF) and not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI improvement metrics are provided or relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This submission is for a physical medical device (HMEF) and does not involve an algorithm or AI.
7. The type of ground truth used:
The "ground truth" for this submission are the performance specifications and measurements obtained through standardized non-clinical testing. These include:
- Objective physical measurements (e.g., compressible volume, weight).
- Functional performance measurements according to international standards (e.g., moisture return per ISO 9360-1:1992, resistance to flow, filtration efficiency).
- Compliance with connector standards (ISO 5356-1:2004, ISO 594-2:1998).
- Biocompatibility testing against a regulatory memo (Bluebook Memo, G95-1).
The ground truth is established by these objective, reproducible tests and comparison to a legally marketed predicate device.
8. The sample size for the training set:
This information is not applicable. This medical device submission does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
This information is not applicable. As explained above, there is no "training set" for this device submission.
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).