(235 days)
BAROguard™ is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs.
The intended organ storage time for BAROguard™ is up to 8 hours.
Donor lungs exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.
Note: Partial lungs can be transported via BAROguard™ by packaging lungs per institutional protocol and UNOS guidelines.
The subject BAROguard device results from modifications made to the cleared LUNGguard (previously named, SherpaPak Lung Preservation System) cleared under K192869. The subject BAROguard device consists of the following components:
- BAROguard SherpaCool Pouches Phase Change Material (PCM) pouches (identical to the predicate) to maintain temperature of the cold preservation solution and lung throughout transportation. The BAROguard device maintains the temperature between 4°C to 8°C identical to the predicate with the use SherpaCool pouches throughout preservation and transportation.
- BAROguard Lung Containment Assembly Nested lung containment bags for the packaging of donor lungs and preservation solution. BAROquard Lung Containment Assembly includes pneumatic connections to the donor lung in the inner-most bag, a pneumatic connection to the BAROguard Shipper Airway Pressure Management System, endotracheal connectors to connect the trachea of the donor lungs to the BAROguard Lung Containment Assembly, and tools for the secure attachment of the endotracheal connectors and closure of the BAROguard nested lung containment bags.
- BAROquard Shipper- Outer transport shipper which comprises a protective and insulative package. The BAROguard Shipper is a rigid, molded expanded polystyrene (EPS) insulative container and into which the SherpaCool pouches and donor lung within the BAROguard Lung Containment Assembly are placed. The maintenance of temperature of the donor lung between 4°C to 8°C is assisted by the EPS insulation of the BAROguard Shipper, providing insulation from the exterior environment to the interior components and BAROguard SherpaCool.
The BAROguard Shipper incorporates an Airway Pressure Management System. The Airway Pressure Management System maintains the donor lung airway pressure when connected to the BAROguard Lung Containment Assembly.
The BAROquard Shipper includes an off-the-shelf datalogger (connected to a temperature probe and airway pressure sensor) which monitors and displays the temperature of the solution surrounding the donor lungs and the airway pressure of the donor lungs.
Although the BAROguard is based on the predicate LUNGguard design, it also includes two new design elements:
. Incorporation of a sterile Lung Containment Assembly instead of use of offthe-shelf bags in K192869.
. Incorporation of an Airway Pressure Management System to maintain donor lung airway pressure during preservation and transportation.
The provided text describes the BAROguard device, intended for static hypothermic preservation of lungs during transportation for transplantation. The acceptance criteria and supporting studies are detailed, particularly in comparison to a predicate device (Paragonix LUNGguard, K192869) and a reference device (Auto CPAP System, K211155).
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Characteristic | Reported Device Performance |
|---|---|
| Intended Use | Donor lung preservation and transportation. (Identical to predicate) |
| Indications for Use | Static hypothermic preservation of lungs up to 8 hours during transportation and eventual transplantation, using cold storage solutions. Donor lungs exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon. Partial lungs can be transported per institutional protocol and UNOS guidelines. (Identical to predicate, with the only difference being the respective product name) |
| Operating Principle | Static hypothermic storage (Static Cold Storage) between 4°C to 8°C using FDA-cleared preservation solutions for lung organs, with management of donor lung airway pressure throughout preservation including during air transportation with continuous positive airway pressure of 12-15 cmH2O (±1 cmH2O) above ambient atmospheric pressure. (Substantially equivalent to predicate; provides identical static hypothermic preservation and incorporates Airway Pressure Management System similar to reference device for physiological purpose) |
| Intended Storage Time | Thermal qualification demonstrates the device can maintain 4°C to 8°C through the intended organ maximum cold ischemic time (CIT) with high and low temperature excursions (i.e., up to 8 hours). (Identical to predicate) |
| Temperature Maintenance | Maintains temperature of the cold preservation solution and lung between 4°C to 8°C throughout preservation and transportation. (Achieved, as shown by Thermal and Airway Pressure Validation). Thermal qualification demonstrates the device can maintain 4° C to 8° C through the intended organ maximum cold ischemic time (CIT) with high and low temperature excursions (i.e., up to 8 hours). |
| Airway Pressure Management | Maintains donor lung airway pressure when connected to the BAROguard Lung Containment Assembly. Validation demonstrates the ability of the BAROguard device to maintain airway pressure of the donor lung beyond the intended organ storage time of 8 hours, at 12-15 cmH2O (±1 cmH2O) preset within the device, not user adjustable. The subject device addresses excursions outside of the ISHLT-recommended range observed with the predicate device during simulated air transportation. (Achieved, as shown by Thermal and Airway Pressure Validation; stricter pressure range than reference device) |
| Biocompatibility | Evaluation for new materials contacting the body conducted in accordance with ISO 10993-1:2018. Battery of tests included Cytotoxicity, Sensitization, Irritation, Acute Systemic toxicity, Material Mediated Pyrogenicity, and Hemocompatibility. (Passes, as indicated by "Biocompatibility testing of any new materials that contact the body") |
| Electrical Safety and EMC | Tested in accordance with IEC 60601-1:2005 (AMD1:2012, AMD2:2020), IEC 60601-1-2:2014 (ed. 4.1), IEC 60601-1-6:2010 (AMD1:2013, AMD2:2020), IEC 62366-1:2015 (AMD1:2020), FCC 47CFR Part 15.247:09. (Passes, as indicated by "Electrical Safety and EMC testing in accordance with the following standards") |
| BAROguard Shipper Verification | Shipper meets specifications beyond the intended organ storage time of 8 hours following exposure to worst-case shipping and handling. (Achieved, as indicated by "BAROguard Shipper Verification" and "Design Verification of BAROguard Shipper") |
| Lung Containment Assembly Verification | Sterile Lung Containment Assembly meets specifications following exposure to sterilization and accelerated aging simulating real-time aging. (Achieved, as indicated by "Lung Containment Assembly Verification" and "Design Verification of Lung Containment Assembly for testing conducted on the nested bags") |
| Sterile Packaging Validation | Sterile barrier system maintains sterility following exposure to sterilization and accelerated aging simulating real-time aging. (Achieved, as indicated by "BAROguard Sterile Packaging Validation") |
| 0.2 Micron Filter Validation | Bacterial retention of the filter used within the BAROguard device is demonstrated. (Achieved, as indicated by "0.2 Micron Filter Validation." Also, 0.2 Micron Filter has a log-reduction value (LRV) of B. diminuta greater than 8, providing higher filtration efficiency than the reference device.) |
| ISO 18562-2 (Particulate Matter) | Average total particulate matter for the BAROguard device found to be 10 µg/m3 for the entire 24 hours of continuous airflow through the system. (Achieved, as indicated by numerical result) |
| Monitoring (Temperature & Pressure) | Off-the-shelf Data Logger from Onset Computer Corporation monitors temperature and pressure. Temperature Accuracy: ± 0.2° C from 0° to 50° C. Pressure Accuracy: ± 0.3% of reading. Time Accuracy: ±1 minute/month. (Achieved; subject device uses a different model of data logger from the same vendor that monitors both temperature and pressure, an improvement over the predicate which only monitored temperature.) |
| Operational Altitude/Pressure Range | Sea Level to 8000ft (750-1015 hPa). (Identical to predicate, comparable to reference device) |
| Single Use | Entire system is single-use/single-patient only. (Identical to predicate) |
| Meets UNOS Policy 162 | Yes. (Identical to predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes various bench testing and validation studies for the device's components and overall function (biocompatibility, electrical safety, thermal/airway pressure, shipper durability, component verification, sterile packaging, filter validation).
- Sample sizes for these tests are not explicitly stated in the provided text. For example, while it mentions "Validation demonstrates the ability of the BAROguard device," it doesn't quantify how many devices or trials were part of that validation.
- Data provenance: The studies are described as functional testing and verification/validation studies, implying laboratory or engineering testing. There is no mention of human clinical data, animal studies, country of origin of data, or whether it was retrospective or prospective. The testing focuses on the physical and functional characteristics of the device itself.
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)
This information is not provided in the document. The studies are described as engineering-focused verification and validation, not clinical trials requiring expert consensus on ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. As the testing focuses on objective functional performance rather than subjective interpretation, an adjudication method, as typically used in clinical studies with human assessors, would not apply 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
There is no mention of an MRMC comparative effectiveness study in the provided text. The device is for organ preservation and transport, not for interpretation or diagnosis by human "readers" or involving AI assistance in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the BAROguard device, as it is a medical device for organ preservation and transport, not an algorithm, or AI diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance criteria appears to be based on established engineering specifications, recognized international standards (e.g., ISO, IEC), and clinical guidelines related to organ preservation (e.g., maintaining specific temperature and pressure ranges, sterility, biocompatibility). For example, temperature maintenance is verified against the 4°C to 8°C range; airway pressure is verified against 12-15 cmH2O. These are objective, measurable parameters rather than subjective interpretations or clinical outcomes in the traditional sense of a diagnostic device.
8. The sample size for the training set
This question is not applicable. The BAROguard device is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).