(235 days)
No
The device description focuses on mechanical and thermal preservation systems, with a datalogger for monitoring. There is no mention of AI or ML for analysis, prediction, or control.
No.
The device is designed for the preservation and transportation of donor lungs, not for treating a disease or condition in a living patient.
No
The device is designed for the preservation and transportation of lungs for transplantation, not for diagnosing medical conditions. While it monitors temperature and pressure, these are for maintaining conditions, not for diagnostic purposes.
No
The device description clearly outlines multiple hardware components including pouches, containment bags, a shipper, an airway pressure management system, and a datalogger with sensors.
Based on the provided information, the BAROguard™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the static hypothermic preservation of lungs during transportation and eventual transplantation. This is a device used to maintain the viability of an organ outside of the body for the purpose of transplantation.
- Device Description: The device components and function are focused on maintaining temperature and airway pressure of the lung during transport. It does not involve testing or analyzing biological samples to provide diagnostic information about a patient's health or condition.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the BAROguard™ is a medical device used for organ preservation and transport, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KDN
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.
- BAROquard 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 off-the-shelf bags in K192869.
- Incorporation of an Airway Pressure Management System to maintain donor lung airway pressure during preservation and transportation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
transplant surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional Testing:
- Biocompatibility testing of any new materials that contact the body.
- 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:
- 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.
- BAROguard Shipper Verification
- 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.
- BAROguard 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 BAROguard device.
- ISO 18562-2
- The average total particulate matter for the BAROgaurd device was found to be 10 mug/m3 for the entire 24 hours of continuous airflow through the system.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
| PARAGONIX® | 005_Updated 510k Summary
Paragonix Technologies' BAROguard Device (K223874) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Paragonix Technologies Inc.
c/o Vaughn & Associates
639 Granite Street
Braintree, MA02184 |
| Contact Person: | Nathan Yetton
Paragonix Technologies, Inc.
222 Third St
Cambridge, MA 02142
413.345.1814 (phone)
nathan@paragonixtechnologies.com |
| Date Prepared: | July 14, 2023 |
| Trade Name: | BAROguard |
| Classification Name: | Isolated kidney perfusion and transport system and
accessories |
| Classification: | Class II |
| Regulation Number: | 21 CFR § 876.5880 |
| Product Code: | KDN |
| Predicate Device: | Paragonix LUNGguard (previously named, SherpaPak
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:
-
- 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.
4
PARAGONIX®
005 Updated 510k Summary
Paragonix Technologies' BAROguard Device (K223874)
-
- 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.
5
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.
6
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.
7
| Characteristic | Subject Device
BAROguard
(K223874) | Predicate Device
SherpaPak Lung Preservation System (K192869) | Reference Device
Auto CPAP System
(K211155) | Substantial Equivalence
Comparison |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Donor lung preservation and transportation. | Organ preservation and transportation. | To support treatment
of adult Obstructive
Sleep Apnea (OSA) | Identical to predicate
(substantially equivalent) |
| 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. | The Paragonix SherpaPak Lung
Preservation System (renamed as
LUNGguard) 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 the
Paragonix SherpaPak Lung Preservation
system 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
SherpaPak LPS by packaging lungs per
institutional protocol and UNOS guidelines. | Auto CPAP System
is a CPAP
(Continuous Positive
Airway Pressure)
device designed for
the
treatment of adult
Obstructive Sleep
Apnea (OSA) only,
either in the hospital
or at home. Auto
CPAP System is for
prescription use
only. It is a travel
CPAP device
intended for single-
patient use. | Identical to predicate,
with the only
difference being the
respective product name
(substantially equivalent) |
| Regulation
Number | 876.5880 | 876.5880 | 868.5905 | Identical to predicate
(substantially equivalent) |
| Product
Code | KDN | KDN | BZD | Identical to predicate
(substantially equivalent) |
| Device
Classification Name | Isolated kidney perfusion and transport system
and accessories. | Isolated kidney perfusion and transport
system and accessories. | Noncontinuous
ventilator | Identical to predicate
(substantially equivalent) |
| Characteristic | Subject Device
BAROguard
(K223874) | Predicate Device
SherpaPak Lung Preservation System (K192869) | Reference Device
Auto CPAP System
(K211155) | Substantial Equivalence
Comparison |
| Operating
Principle | Static hypothermic storage (i.e., 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. | Static hypothermic storage (i.e., Static Cold
Storage) between 4° C to 8° C using FDA
cleared preservation solutions for lung
organs. Lungs clinically inflated to static
pressure of 12-15 cmH2O prior to storage1 | The system provides
continuous positive
airway pressure from
4 to 20 cmH2O above
the ambient
atmospheric
pressure. | Substantially equivalent to
predicate
The subject device
provides the identical
static hypothermic
preservation as the
predicate and also
incorporates an Airway
Pressure Management
System with positive
airway pressures similar
to the reference device
that is used in the same
anatomy for the same
physiological purpose.
(See discussion following
table on Substantial
Equivalence in Operating
Principle) |
| 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). | 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). | N/A | Identical to predicate
(substantially equivalent) |
| Single Use | Entire system is single-use/single-patient only. | Entire system is single-use/single-patient
only. | Reusable system for
single-patient use | Identical to predicate
(substantially equivalent) |
| Meets UNOS
Policy 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 predicate
Identical 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 Device
BAROguard
(K223874) | Predicate Device
SherpaPak Lung Preservation System (K192869) | Reference Device
Auto CPAP System
(K211155) | Substantial Equivalence
Comparison |
| Organ
Container | Use of proprietary Lung Containment Assembly
(including triple nested bags and endotracheal
connector) which provides an air connection
from the lungs to the airway pressure
management system. The packaging is
consistent with standard practice and OPTN
policy. | Use of 3M Steri-Drape isolation bags cleared
under K832318 (Product Code KGY,
classification regulation 21 CFR §878.4100).
The instructions for use for the subject
devices recommend triple bagging the lungs
which is consistent with standard practice and
OPTN policy. | N/A | Substantially equivalent
Both subject and
predicate devices each
use three bags for
transporting the lung
organ. The BAROguard
'nested-bag' assembly
has undergone functional
testing and
biocompatibility testing to
demonstrate that they
achieve their intended
effect and meet the same
performance as triple
bagging with off-the-shelf
bags in the cleared
device. |
| Phase
Change
Material | The nested bag assembly and all connections
are provided sterile.
Sterile components are gamma radiation
sterilized to SAL 10-6.
All sterile components that come into direct
contact or indirect via fluid contact with the
donor lungs have been tested in accordance
with FDA recognized standards. | The cleared, off-the-shelf organ isolation
bags are provided sterile, and neither the
packaging or labeling is modified from the
OEM's. | N/A | (See 018_Updated
Laboratory Bench Testing
subsection named Design
Verification of Lung
Containment Assembly for
testing conducted on the
nested bags)
Identical to predicate
(substantially equivalent) |
| | Phase change material cold packs to maintain
4°-8° C temperature range for the intended
transport time.
SherpaCool made of phase change material:
PCM Manufacturer: savERNG
Cold Packs by Akuratemp (formerly RGEES),
LLC | Phase change material cold packs to
maintain 4°-8° C temperature range for the
intended transport time.
SherpaCool made of phase change material:
PCM Manufacturer: savERNG
Cold 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 predicate
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
BAROguard
(K223874) | Predicate Device
SherpaPak Lung Preservation System (K192869) | Reference Device
Auto CPAP System
(K211155) | Substantial Equivalence Comparison |
| Air source | Air in the operating room where the retrieved lungs were placed in the BAROguard
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
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.
Substantially equivalent predicate
See the prior discussion |
| Air
Temperature | 4°C-8°C | 4°C-8°C | 5°C-35°C | Identical to predicate
Comparable 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 Equivalence
Comparison |
| Operating
Pressure | 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 predicate
Comparable operating pressure range as reference device
(Substantially equivaler |
| Characteristic | Subject Device
BAROguard
(K223874)
BlueTooth Low Energy Enabled Data Logger: | Predicate Device
SherpaPak Lung Preservation System (K192869)
BlueTooth Low Energy Enabled Data Logger: | Reference Device
Auto CPAP System
(K211155) | Substantial Equivalence Comparison |
| Monitoring | Off-the-shelf Data Logger from Onset
Computer Corporation
Monitors 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 Corporation
Monitors temperature BlueTooth capability to transfer temperature reading to iOS or Android device with InTemp App | | Substantially equivalent
Monitoring 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 reading
Time Accuracy: ±1 minute/month
Optional 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/A
Time Accuracy: ±1 minute/month
Optional 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%) |
K223874 Page 5 of 13
GABGOONID
ร์ธรรม) อวเขาได้ พันธุ์ วันที่ 2 มิถุนิยังสุดที่ 200
8
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Հ-Լ05:65:07:02 xuridsuren Burry 1 ,'usuation 4 :μυθωρησοια θαυρίνει την μουσια της 19 μυθρίος
K223874 Page 6 of 13
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K223874 Page 7 of 13
(CFS) TECHNOLOGIES, INC.
- PARABONIX TECHNOLOGIES, INC.
- EDGEWATER CAPITAL PARTNERS
- K2 & ASSOCIATES
ວເນີຣພາບານ) ໄຣເງິນອຸນາງແທວປີ ໄດ້ຮັບປະຊາຊົນ
10
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้เทดอลลิลิ
รรยรวม) อวเขาร์ต ทางกรุงสูง รัฐอาณาจา สุเขตสูง
11
ARAGGONI
K223874
Page 9 of 13
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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GABGOONID
K223874
Page 10 of 13
18877) อวเขาบัน ราชอาณา ระจริงโชเปที่ 200
PARAGONIX TECHNOLOGIES, INC.
STANDARD DEVICE (K2, 23874)
13
14
15
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.