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 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:

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

The intended organ storage time for BAROguard™ is up to 8 hours.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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PARAGONIX®	005_Updated 510k SummaryParagonix Technologies' BAROguard Device (K223874)
Submitter:	Paragonix Technologies Inc.c/o Vaughn & Associates639 Granite StreetBraintree, MA02184
Contact Person:	Nathan YettonParagonix Technologies, Inc.222 Third StCambridge, MA 02142413.345.1814 (phone)nathan@paragonixtechnologies.com
Date Prepared:	July 14, 2023
Trade Name:	BAROguard
Classification Name:	Isolated kidney perfusion and transport system andaccessories
Classification:	Class II
Regulation Number:	21 CFR § 876.5880
Product Code:	KDN
Predicate Device:	Paragonix LUNGguard (previously named, SherpaPakLung Preservation System) - K192869

Device Description:

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)

1. 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.
1. 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.

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 DeviceBAROguard(K223874)	Predicate DeviceSherpaPak Lung Preservation System (K192869)	Reference DeviceAuto CPAP System(K211155)	Substantial EquivalenceComparison
IntendedUse	Donor lung preservation and transportation.	Organ preservation and transportation.	To support treatmentof adult ObstructiveSleep Apnea (OSA)	Identical to predicate(substantially equivalent)
Indicationsfor Use	The Paragonix BAROguard is intended to beused for the static hypothermic preservation oflungs during transportation and eventualtransplantation into a recipient using coldstorage solutions indicated for use with thelungs.The intended organ storage time forBAROguard is up to 8 hours.Donor lungs exceeding clinically accepted statichypothermic preservation times should beevaluated by the transplant surgeon todetermine transplantability in accordance withaccepted clinical guidelines and in the bestmedical interest of the intended recipient.Note: Partial lungs can be transported viaBAROguard by packaging lungs per institutionalprotocol and UNOS guidelines.	The Paragonix SherpaPak LungPreservation System (renamed asLUNGguard) is intended to be used for thestatic hypothermic preservation of lungsduring transportation and eventualtransplantation into a recipient using coldstorage solutions indicated for use with thelungs.The intended organ storage time for theParagonix SherpaPak Lung Preservationsystem is up to 8 hours.Donor lungs exceeding clinically acceptedstatic hypothermic preservation times shouldbe evaluated by the transplant surgeon todetermine transplantability in accordancewith accepted clinical guidelines and in thebest medical interest of the intendedrecipient.Note: Partial lungs can be transported viaSherpaPak LPS by packaging lungs perinstitutional protocol and UNOS guidelines.	Auto CPAP Systemis a CPAP(Continuous PositiveAirway Pressure)device designed forthetreatment of adultObstructive SleepApnea (OSA) only,either in the hospitalor at home. AutoCPAP System is forprescription useonly. It is a travelCPAP deviceintended for single-patient use.	Identical to predicate,with the onlydifference being therespective product name(substantially equivalent)
RegulationNumber	876.5880	876.5880	868.5905	Identical to predicate(substantially equivalent)
ProductCode	KDN	KDN	BZD	Identical to predicate(substantially equivalent)
DeviceClassification Name	Isolated kidney perfusion and transport systemand accessories.	Isolated kidney perfusion and transportsystem and accessories.	Noncontinuousventilator	Identical to predicate(substantially equivalent)
Characteristic	Subject DeviceBAROguard(K223874)	Predicate DeviceSherpaPak Lung Preservation System (K192869)	Reference DeviceAuto CPAP System(K211155)	Substantial EquivalenceComparison
OperatingPrinciple	Static hypothermic storage (i.e., Static ColdStorage) between 4° C to 8° C using FDA-cleared preservation solutions for lung organs,with management of donor lung airwaypressure throughout preservation includingduring air transportation with continuouspositive airway pressure of 12-15 cmH2O (±1cmH2O) above ambient atmospheric pressure.	Static hypothermic storage (i.e., Static ColdStorage) between 4° C to 8° C using FDAcleared preservation solutions for lungorgans. Lungs clinically inflated to staticpressure of 12-15 cmH2O prior to storage1	The system providescontinuous positiveairway pressure from4 to 20 cmH2O abovethe ambientatmosphericpressure.	Substantially equivalent topredicateThe subject deviceprovides the identicalstatic hypothermicpreservation as thepredicate and alsoincorporates an AirwayPressure ManagementSystem with positiveairway pressures similarto the reference devicethat is used in the sameanatomy for the samephysiological purpose.(See discussion followingtable on SubstantialEquivalence in OperatingPrinciple)
IntendedStorageTime	Thermal qualification demonstrates the devicecan maintain 4° C to 8° C through the intendedorgan maximum cold ischemic time (CIT) withhigh and low temperature excursions (i.e., up to8 hours).	Thermal qualification demonstrates thedevice can maintain 4° C to 8° C through theintended organ maximum cold ischemic time(CIT) with high and low temperatureexcursions (i.e., up to 8 hours).	N/A	Identical to predicate(substantially equivalent)
Single Use	Entire system is single-use/single-patient only.	Entire system is single-use/single-patientonly.	Reusable system forsingle-patient use	Identical to predicate(substantially equivalent)
Meets UNOSPolicy 162	Yes	Yes	N/A	Identical to predicate(substantially equivalent)
Table 1. Substantial Equivalence Comparison Table
Characteristic	Subject Device	Predicate Device	Reference Device	Substantial Equivalence Comparison
Shipper	BAROguard(K223874)Outer molded EPS Shipping container with wheels, extending handle, integrated Airway Pressure Management System, and off-the-shelf datalogger	SherpaPak Lung Preservation System (K192869)Outer molded EPS Shipping container with wheels, extending handle, and off-the-shelf datalogger	Auto CPAP System(K211155)N/A	Substantially equivalent to predicateIdentical EPS insulative shipper material and identical phase change (cooling) material are used for the subject and predicate devices.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)See "Monitor" row for details on the datalogger.
Characteristic	Subject DeviceBAROguard(K223874)	Predicate DeviceSherpaPak Lung Preservation System (K192869)	Reference DeviceAuto CPAP System(K211155)	Substantial EquivalenceComparison
OrganContainer	Use of proprietary Lung Containment Assembly(including triple nested bags and endotrachealconnector) which provides an air connectionfrom the lungs to the airway pressuremanagement system. The packaging isconsistent with standard practice and OPTNpolicy.	Use of 3M Steri-Drape isolation bags clearedunder K832318 (Product Code KGY,classification regulation 21 CFR §878.4100).The instructions for use for the subjectdevices recommend triple bagging the lungswhich is consistent with standard practice andOPTN policy.	N/A	Substantially equivalentBoth subject andpredicate devices eachuse three bags fortransporting the lungorgan. The BAROguard'nested-bag' assemblyhas undergone functionaltesting andbiocompatibility testing todemonstrate that theyachieve their intendedeffect and meet the sameperformance as triplebagging with off-the-shelfbags in the cleareddevice.
PhaseChangeMaterial	The nested bag assembly and all connectionsare provided sterile.Sterile components are gamma radiationsterilized to SAL 10-6.All sterile components that come into directcontact or indirect via fluid contact with thedonor lungs have been tested in accordancewith FDA recognized standards.	The cleared, off-the-shelf organ isolationbags are provided sterile, and neither thepackaging or labeling is modified from theOEM's.	N/A	(See 018_UpdatedLaboratory Bench Testingsubsection named DesignVerification of LungContainment Assembly fortesting conducted on thenested bags)Identical to predicate(substantially equivalent)
	Phase change material cold packs to maintain4°-8° C temperature range for the intendedtransport time.SherpaCool made of phase change material:PCM Manufacturer: savERNGCold Packs by Akuratemp (formerly RGEES),LLC	Phase change material cold packs tomaintain 4°-8° C temperature range for theintended transport time.SherpaCool made of phase change material:PCM Manufacturer: savERNGCold Packs by Akuratemp (formerly RGEES),LLC	N/A
Table 1. Substantial Equivalence Comparison Table
Characteristic	Subject Device	Predicate Device	Reference Device	Substantial Equivalence Comparison
Pressure Range	BAROguard(K223874)	SherpaPak Lung Preservation System (K192869)	Auto CPAP System(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 predicateParagonix 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 DeviceBAROguard(K223874)	Predicate DeviceSherpaPak Lung Preservation System (K192869)	Reference DeviceAuto CPAP System(K211155)	Substantial Equivalence Comparison
Air source	Air in the operating room where the retrieved lungs were placed in the BAROguardThis 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 FilterEfficiency	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.Substantially equivalent predicateSee the prior discussion
AirTemperature	4°C-8°C	4°C-8°C	5°C-35°C	Identical to predicateComparable air temperature range as reference device(Substantially equivalent)
PARAGONIX
005_Updated 510k Summary
Paragonix Technologies' BAROguard Device (K223874)
Table 1. Substantial Equivalence Comparison Table
Characteristic	Subject Device	Predicate Device	Reference Device	Substantial EquivalenceComparison
OperatingPressure	BAROguard(K223874)Sea Level to 8000ft (750-1015 hPa)	SherpaPak Lung Preservation System (K192869)Sea Level to 8000ft (750-1015 hPa)	Auto CPAP System(K211155)760 - 1060 hPa	Identical to predicateComparable operating pressure range as reference device(Substantially equivaler
Characteristic	Subject DeviceBAROguard(K223874)BlueTooth Low Energy Enabled Data Logger:	Predicate DeviceSherpaPak Lung Preservation System (K192869)BlueTooth Low Energy Enabled Data Logger:	Reference DeviceAuto CPAP System(K211155)	Substantial Equivalence Comparison
Monitoring	Off-the-shelf Data Logger from OnsetComputer CorporationMonitors temperature and pressure BlueTooth capability to transfer temperature reading to iOS or Android device with HoboConnect App	Off-the-shelf Data Logger from Onset Computer CorporationMonitors temperature BlueTooth capability to transfer temperature reading to iOS or Android device with InTemp App		Substantially equivalentMonitoring of temperature is identical to predicate. Subject device incorporates a different model of data logger from the same vendor that allows for monitoring both temperature and pressure.
	Range: -20° to 70° C (-4° to 158° F)Temperature Accuracy: ± 0.2° C from 0° to 50° C (± 0.4° F from 32° to 122° F)Pressure Accuracy: ± 0.3% of readingTime Accuracy: ±1 minute/monthOptional downloadable mobile app:Allows for viewing temperature, pressure, and time elapsed over the mobile device.The app does not support, supplement, and/or augment the performance of the parent device. The BAROguard device is always accompanied by medical personnel during transport and the medical personnel can view information directly on the datalogger without use of the app.	Range: -30° to 70° C (-22° to 158° F)Temperature Accuracy: ± 0.5° C from 0° to 50° C (± 0.9° F from 32° to 122° F)Pressure Accuracy: N/ATime Accuracy: ±1 minute/monthOptional downloadable mobile app:Allows for viewing temperature and time elapsed over the mobile device.The app does not support, supplement, and/or augment the performance of the parent device. The predicate is always accompanied by medical personnel during transport and the medical personnel can view information directly on the datalogger without use of the app.		Similar pressure accuracy to reference device(See 018_Updated Laboratory Bench Testing subsection named Design Verification of BAROguard Shipper, for testing conducted on the data logger.)Pressure Accuracy: ± (0.5 hPa +4%)

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GABGOONID

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KINODARAA

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(CFS) TECHNOLOGIES, INC.

PARABONIX TECHNOLOGIES, INC.
EDGEWATER CAPITAL PARTNERS
K2 & ASSOCIATES

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ARAGGONI

K223874
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188277) ອວໄທວັນ ການສິງວຽງຈັນ 5 ເຊິ່ງອຸໂດ້ນາງງາມ 200

CHARGING PARAMETERS (K23874)

INPUT: 100-240V~50/60Hz 1.5A
OUTPUT: 12.0V 3.0A 36.0W
TECHNOLOGIES, INC.

oitamional leijhebithoo bus yındainda bir

s-105:68:00 วานยุไรนะบบ ซึ่งเป็นพระราชทาง ค.ศ. 2017 ค.ศ. 2010 ค.ศ. 2010 ค.ศ. 1995 ค.ศ. 1995 ค.ศ. 1995 ค.ศ. 1992 ค.ศ. 1992 ค.ศ. 1992 ค.ศ. 1992 ค.ศ. 1992 ค.ศ. 1992 ค.ศ. 1992 ค.

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K223874
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18877) อวเขาบัน ราชอาณา ระจริงโชเปที่ 200

PARAGONIX TECHNOLOGIES, INC.
STANDARD DEVICE (K2, 23874)

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005 Updated 510k Summary

PARAGONIX®

Paragonix Technologies' BAROguard Device (K223874)

Conclusion

By design, the subject device operates identically to the predicate when there is not a change in the ambient pressure and addresses a potential limitation associated with the use of the predicate device (and traditional ice coolers used within the Standard of Care) when there is a change in the ambient pressure. Testing confirms that the BAROguard meets the same performance specifications as the predicate device and also meets the requirements of maintaining lung airway pressure during air transportation.

The Airway Pressure Management System in the BAROguard device is similar to the pressure control systems reference the Auto CPAP System (K211155) for the maintenance of continuous positive airway pressure within the donor lung. The reference device is used in the same anatomical location (the airway) and for the same physiological purpose (maintaining a constant, set pressure within that airway above ambient atmospheric pressures) as the BAROguard device.

Based on the design and testing conducted, the subject BAROguard device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).