BAROguard

K223874 · Paragonix Technologies · KDN · Aug 15, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K223874
• Device Name: BAROguard
• Applicant: Paragonix Technologies
• Product Code: KDN · Gastroenterology, Urology
• Decision Date: Aug 15, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5880
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Paragonix 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.

Device Story

BAROguard is a single-use, static hypothermic lung preservation and transport system. It consists of a rigid, molded EPS insulative shipper, phase change material (PCM) pouches, and a sterile lung containment assembly. The system maintains donor lungs at 4°C to 8°C. It incorporates an Airway Pressure Management System that maintains a constant positive airway pressure (12-15 cmH2O) within the donor lung during transport, particularly during air travel where ambient pressure changes occur. An integrated off-the-shelf datalogger monitors temperature and airway pressure, with data transferable via Bluetooth to a mobile app. The device is operated by medical personnel during organ retrieval and transport. By maintaining stable airway pressure and temperature, the device aims to preserve lung viability for up to 8 hours, assisting transplant surgeons in ensuring organ quality for recipients.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1), electrical safety/EMC (IEC 60601 series), thermal and airway pressure validation, shipper verification, sterile barrier integrity, and 0.2-micron filter bacterial retention (LRV > 8). Particulate matter testing performed per ISO 18562-2.

Technological Characteristics

Materials: Molded EPS shipper, PCM pouches, sterile nested containment bags. Energy: Battery-powered pneumatic pump and datalogger. Connectivity: Bluetooth Low Energy for data transfer. Sterilization: Gamma radiation (SAL 10^-6) for containment assembly. Airway pressure: 12-15 cmH2O (±1 cmH2O) preset. Filtration: 0.2-micron filter.

Indications for Use

Indicated for static hypothermic preservation of donor lungs during transport for transplantation in recipients. Suitable for whole or partial lungs. Contraindicated for lungs exceeding clinically accepted static hypothermic preservation times unless evaluated by a transplant surgeon.

Regulatory Classification

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.

Predicate Devices

• Paragonix LUNGguard (previously named, SherpaPak Lung Preservation System) (K192869)

Reference Devices

• Auto CPAP System (K211155)

Submission Summary (Full Text)

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August 15, 2023

Paragonix Technologies Nathan Yetton Senior Director of Quality 639 Granite St., Suite 408 Braintree, Massachusetts 02184

> K223874 Trade/Device Name: BAROguard Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated Kidney Perfusion and Transport System and Accessories Regulatory Class: II Product Code: KDN Dated: July 17, 2023 Received: July 18, 2023

Dear Nathan Yetton:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Glenn B. Bell -S

for Gema Gonzalez, MS Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K223874

Device Name BAROguard

### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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| PARAGONIX® | 005_Updated 510k Summary<br>Paragonix Technologies' BAROguard Device (K223874) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Paragonix Technologies Inc.<br>c/o Vaughn & Associates<br>639 Granite Street<br>Braintree, MA02184 |
| Contact Person: | Nathan Yetton<br>Paragonix Technologies, Inc.<br>222 Third St<br>Cambridge, MA 02142<br>413.345.1814 (phone)<br>[e-mail] |
| Date Prepared: | July 14, 2023 |
| Trade Name: | BAROguard |
| Classification Name: | Isolated kidney perfusion and transport system and<br>accessories |
| Classification: | Class II |
| Regulation Number: | 21 CFR § 876.5880 |
| Product Code: | KDN |
| Predicate Device: | Paragonix LUNGguard (previously named, SherpaPak<br>Lung Preservation System) - K192869 |

### Device Description:

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:

- 1) 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.

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PARAGONIX®

### 005 Updated 510k Summary

Paragonix Technologies' BAROguard Device (K223874)

- 2) 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.
- 3) 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.

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PARAGONIX®

### Intended Use:

Donor lung preservation and transportation

### Indications for Use:

The Paragonix 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 quidelines 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.

### Functional Testing:

- Biocompatibility testing of any new materials that contact the body .
- o The biocompatibility evaluation for the modified devices was conducted in accordance with International Standard ISO 10993-1: 2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests: Cytotoxicity, Sensitization, Irritation, Acute Systemic toxicity, Material Mediated Pyrogenicity, and Hemocompatibility
- Electrical Safety and EMC testing in accordance with the following . standards:
- o 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
- Thermal and Airway Pressure Validation ●
- · Validation demonstrates the ability of the BAROguard device to maintain hypothermic preservation and airway pressure of the donor lung beyond the intended organ storage time of 8 hours.

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PARAGONIX®

## 005 Updated 510k Summary

Paragonix Technologies' BAROguard Device (K223874)

- BAROguard Shipper Verification .
- o Verification demonstrates BAROguard Shipper meets specifications beyond the intended organ storage time of 8 hours following exposure to worst-case shipping and handling.
- · Lung Containment Assembly Verification
- ் Verification demonstrates BAROguard sterile Lung Containment Assembly meets specifications following exposure to sterilization and accelerated aging simulating real-time aging.
- BAROquard Sterile Packaging Validation .
- · Verification demonstrates the ability of the BAROguard sterile barrier system to maintain sterility following exposure to sterilization and accelerated aging simulating real-time aging.
- 0.2 Micron Filter Validation .
- · Validation demonstrates the bacterial retention of the filter used within the BAROquard device.
- · ISO 18562-2
- o The average total particulate matter for the BAROgaurd device was found to be 10 µg/m3 for the entire 24 hours of continuous airflow through the system.

### Technological Comparison with Predicate and Reference Device

The following table compares the Paragonix BAROguard device with the predicate and reference devices.

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| Characteristic | Subject Device<br>BAROguard<br>(K223874) | Predicate Device<br>SherpaPak Lung Preservation System (K192869) | Reference Device<br>Auto CPAP System<br>(K211155) | Substantial Equivalence<br>Comparison |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | Donor lung preservation and transportation. | Organ preservation and transportation. | To support treatment<br>of adult Obstructive<br>Sleep Apnea (OSA) | Identical to predicate<br>(substantially equivalent) |
| Indications<br>for Use | The Paragonix BAROguard is intended to be<br>used for the static hypothermic preservation of<br>lungs during transportation and eventual<br>transplantation into a recipient using cold<br>storage solutions indicated for use with the<br>lungs.<br><br>The intended organ storage time for<br>BAROguard is up to 8 hours.<br><br>Donor lungs exceeding clinically accepted static<br>hypothermic preservation times should be<br>evaluated by the transplant surgeon to<br>determine transplantability in accordance with<br>accepted clinical guidelines and in the best<br>medical interest of the intended recipient.<br><br>Note: Partial lungs can be transported via<br>BAROguard by packaging lungs per institutional<br>protocol and UNOS guidelines. | The Paragonix SherpaPak Lung<br>Preservation System (renamed as<br>LUNGguard) is intended to be used for the<br>static hypothermic preservation of lungs<br>during transportation and eventual<br>transplantation into a recipient using cold<br>storage solutions indicated for use with the<br>lungs.<br><br>The intended organ storage time for the<br>Paragonix SherpaPak Lung Preservation<br>system is up to 8 hours.<br><br>Donor lungs exceeding clinically accepted<br>static hypothermic preservation times should<br>be evaluated by the transplant surgeon to<br>determine transplantability in accordance<br>with accepted clinical guidelines and in the<br>best medical interest of the intended<br>recipient.<br><br>Note: Partial lungs can be transported via<br>SherpaPak LPS by packaging lungs per<br>institutional protocol and UNOS guidelines. | Auto CPAP System<br>is a CPAP<br>(Continuous Positive<br>Airway Pressure)<br>device designed for<br>the<br>treatment of adult<br>Obstructive Sleep<br>Apnea (OSA) only,<br>either in the hospital<br>or at home. Auto<br>CPAP System is for<br>prescription use<br>only. It is a travel<br>CPAP device<br>intended for single-<br>patient use. | Identical to predicate,<br>with the only<br>difference being the<br>respective product name<br>(substantially equivalent) |
| Regulation<br>Number | 876.5880 | 876.5880 | 868.5905 | Identical to predicate<br>(substantially equivalent) |
| Product<br>Code | KDN | KDN | BZD | Identical to predicate<br>(substantially equivalent) |
| Device<br>Classification Name | Isolated kidney perfusion and transport system<br>and accessories. | Isolated kidney perfusion and transport<br>system and accessories. | Noncontinuous<br>ventilator | Identical to predicate<br>(substantially equivalent) |
| Characteristic | Subject Device<br>BAROguard<br>(K223874) | Predicate Device<br>SherpaPak Lung Preservation System (K192869) | Reference Device<br>Auto CPAP System<br>(K211155) | Substantial Equivalence<br>Comparison |
| Operating<br>Principle | Static hypothermic storage (i.e., Static Cold<br>Storage) between 4° C to 8° C using FDA-<br>cleared preservation solutions for lung organs,<br>with management of donor lung airway<br>pressure throughout preservation including<br>during air transportation with continuous<br>positive airway pressure of 12-15 cmH2O (±1<br>cmH2O) above ambient atmospheric pressure. | Static hypothermic storage (i.e., Static Cold<br>Storage) between 4° C to 8° C using FDA<br>cleared preservation solutions for lung<br>organs. Lungs clinically inflated to static<br>pressure of 12-15 cmH2O prior to storage1 | The system provides<br>continuous positive<br>airway pressure from<br>4 to 20 cmH2O above<br>the ambient<br>atmospheric<br>pressure. | Substantially equivalent to<br>predicate<br><br>The subject device<br>provides the identical<br>static hypothermic<br>preservation as the<br>predicate and also<br>incorporates an Airway<br>Pressure Management<br>System with positive<br>airway pressures similar<br>to the reference device<br>that is used in the same<br>anatomy for the same<br>physiological purpose.<br>(See discussion following<br>table on Substantial<br>Equivalence in Operating<br>Principle) |
| Intended<br>Storage<br>Time | Thermal qualification demonstrates the device<br>can maintain 4° C to 8° C through the intended<br>organ maximum cold ischemic time (CIT) with<br>high and low temperature excursions (i.e., up to<br>8 hours). | Thermal qualification demonstrates the<br>device can maintain 4° C to 8° C through the<br>intended organ maximum cold ischemic time<br>(CIT) with high and low temperature<br>excursions (i.e., up to 8 hours). | N/A | Identical to predicate<br>(substantially equivalent) |
| Single Use | Entire system is single-use/single-patient only. | Entire system is single-use/single-patient<br>only. | Reusable system for<br>single-patient use | Identical to predicate<br>(substantially equivalent) |
| Meets UNOS<br>Policy 162 | Yes | Yes | N/A | Identical to predicate<br>(substantially equivalent) |
| Table 1. Substantial Equivalence Comparison Table | | | | |
| Characteristic | Subject Device | Predicate Device | Reference Device | Substantial Equivalence Comparison |
| Shipper | BAROguard<br>(K223874)<br>Outer molded EPS Shipping container with wheels, extending handle, integrated Airway Pressure Management System, and off-the-shelf datalogger | SherpaPak Lung Preservation System (K192869)<br>Outer molded EPS Shipping container with wheels, extending handle, and off-the-shelf datalogger | Auto CPAP System<br>(K211155)<br>N/A | Substantially equivalent to predicate<br>Identical EPS insulative shipper material and identical phase change (cooling) material are used for the subject and predicate devices.<br>The subject device differs from predicate in that it incorporates an Airway Pressure Management System. (See discussion following table on Substantial Equivalence in Operating Principle)<br>See "Monitor" row for details on the datalogger. |
| Characteristic | Subject Device<br>BAROguard<br>(K223874) | Predicate Device<br>SherpaPak Lung Preservation System (K192869) | Reference Device<br>Auto CPAP System<br>(K211155) | Substantial Equivalence<br>Comparison |
| Organ<br>Container | Use of proprietary Lung Containment Assembly<br>(including triple nested bags and endotracheal<br>connector) which provides an air connection<br>from the lungs to the airway pressure<br>management system. The packaging is<br>consistent with standard practice and OPTN<br>policy. | Use of 3M Steri-Drape isolation bags cleared<br>under K832318 (Product Code KGY,<br>classification regulation 21 CFR §878.4100).<br>The instructions for use for the subject<br>devices recommend triple bagging the lungs<br>which is consistent with standard practice and<br>OPTN policy. | N/A | Substantially equivalent<br><br>Both subject and<br>predicate devices each<br>use three bags for<br>transporting the lung<br>organ. The BAROguard<br>'nested-bag' assembly<br>has undergone functional<br>testing and<br>biocompatibility testing to<br>demonstrate that they<br>achieve their intended<br>effect and meet the same<br>performance as triple<br>bagging with off-the-shelf<br>bags in the cleared<br>device. |
| Phase<br>Change<br>Material | The nested bag assembly and all connections<br>are provided sterile.<br><br>Sterile components are gamma radiation<br>sterilized to SAL 10-6.<br><br>All sterile components that come into direct<br>contact or indirect via fluid contact with the<br>donor lungs have been tested in accordance<br>with FDA recognized standards. | The cleared, off-the-shelf organ isolation<br>bags are provided sterile, and neither the<br>packaging or labeling is modified from the<br>OEM's. | N/A | (See 018_Updated<br>Laboratory Bench Testing<br>subsection named Design<br>Verification of Lung<br>Containment Assembly for<br>testing conducted on the<br>nested bags)<br><br>Identical to predicate<br>(substantially equivalent) |
| | Phase change material cold packs to maintain<br>4°-8° C temperature range for the intended<br>transport time.<br><br>SherpaCool made of phase change material:<br>PCM Manufacturer: savERNG<br><br>Cold Packs by Akuratemp (formerly RGEES),<br>LLC | Phase change material cold packs to<br>maintain 4°-8° C temperature range for the<br>intended transport time.<br><br>SherpaCool made of phase change material:<br>PCM Manufacturer: savERNG<br><br>Cold Packs by Akuratemp (formerly RGEES),<br>LLC | N/A | |
| Table 1. Substantial Equivalence Comparison Table | | | | |
| Characteristic | Subject Device | Predicate Device | Reference Device | Substantial Equivalence Comparison |
| Pressure Range | BAROguard<br>(K223874) | SherpaPak Lung Preservation System (K192869) | Auto CPAP System<br>(K211155) | |
| | 12-15 cmH2O (±1 cmH2O) preset within device, not user adjustable | Standard of care static pressure of 12-15 cmH2O...the lungs should not be over- or underinflated."3 | 4-20 cm H2O (in 0.5 cm H2O increments), ≤30 cm H20 under single fault conditions | Substantially equivalent to predicate<br><br>Paragonix observed pressures between 4-35 cmH2O during simulated air transportation with the predicate device and has thus designed the subject device to address the excursions outside of the ISHLT-recommended range. The subject device has a tighter airway pressure range than reference device. (See discussion following table on Substantial Equivalence in Operating Principle) |
| Characteristic | Subject Device<br>BAROguard<br>(K223874) | Predicate Device<br>SherpaPak Lung Preservation System (K192869) | Reference Device<br>Auto CPAP System<br>(K211155) | Substantial Equivalence Comparison |
| Air source | Air in the operating room where the retrieved lungs were placed in the BAROguard<br><br>This air in the internal chamber of the non-sterile BAROguard Shipper is drawn by the pneumatic pump and delivered to donor lungs through sterile organ containment assembly only when needed. | Donor lungs inflated and closed within operating room prior to loading into device | Room air delivered through non-sterile device with a blower | Substantially equivalent predicate |
| Air Filter<br>Efficiency | 0.2 Micron Filter has a log-reduction value (LRV) of B. diminuta greater than 8 | N/A | Greater than 20% retentive for 10 micron particulates | Similar to reference device. Both systems provide air to airway non-sterile. In addition, subject device has a with higher filtration efficiency than the reference device. Further, the amount of air to be delivered to the lungs the subject device is negligible when compared to the reference device. Therefore, the air source does not raise a different question of safety or effectiveness.<br>Substantially equivalent predicate<br>See the prior discussion |
| Air<br>Temperature | 4°C-8°C | 4°C-8°C | 5°C-35°C…