(29 days)
Not Found
No
The summary describes a passive, temperature-controlled transport system with a timer and temperature display. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is intended for the static hypothermic preservation of hearts during transportation for transplantation, not for direct therapeutic intervention on a patient. It is a transport and preservation system, not a treatment device.
No
The device is designed for the transport and preservation of hearts for transplantation, not for diagnosing medical conditions.
No
The device description explicitly lists physical components including an outer shipper, inner and outer hard shell containers, and a temperature display and timer. This indicates it is a hardware device with some electronic components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient." This describes a device used to maintain the viability of an organ outside the body for the purpose of transplantation.
- Device Description: The description details a system for cold storage and transport of donor hearts. It focuses on maintaining temperature and providing a protective barrier.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's health or condition. IVDs are used to perform tests in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions.
- Anatomical Site: The anatomical site is "Hearts," indicating the device interacts directly with the organ itself, not with patient samples for analysis.
The device is clearly intended for the preservation and transport of a biological specimen (a heart) for a therapeutic procedure (transplantation), not for diagnostic testing.
N/A
Intended Use / Indications for Use
"The Sherpa Pak Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart.
The intended organ storage time for the Sherpa Pak Cardiac Transport System is up to 4 hours.
Donor hearts 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."
Product codes (comma separated list FDA assigned to the subject device)
MSB
Device Description
The Paragonix Sherpa Pak Cardiac Transport System is a device intended to provide a safe, consistent method for cold ischemic storage and transport of donor hearts to recipients for transplantation. The Sherpa Pak System consists of 1) an outer shipper which contains various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell container (i.e. Sherpa Pak/Sherpa Pak Shell) which provides a double, rigid barrier container in which the heart is immersed and suspended in a Cold Storage Fluid cleared for use in storing and transporting donor organs and 3) a temperature display and timer to monitor temperature and elapsed time of transport, respectively. The device is identical to the cleared Sherpa Pak Cardiac Transport System in all respects.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hearts
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)
Descriptive information and laboratory bench testing were provided to demonstrate the device meets its design specifications, performs as intended, and is safe for its intended use.
Specifically, testing to demonstrate that the Sherpa Pak Cardiac Transport System provided a transport system robust enough to protect the donor organ during transport and maintained temperature throughout the duration of transport was included. Thermal qualification demonstrated the ability of the Sherpa Pak Cardiac Transport System to maintain the required temperature through 12 hours.
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.
Not Found
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2014
Paragonix Technologies, Inc. % Mason Diamond Regulatory Consultant Texel Fortis, LLC 150 Levinberg Lane Wayne, NJ 07470
Re: K143074
Trade/Device Name: Sherpa Pak Cardiac Transport System Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated Kidney Perfusion And Transport System And Accessories Regulatory Class: Class II Product Code: MSB. Dated: November 10, 2014 Received: November 13, 2014
Dear Mason Diamond.
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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
1
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for
Benjamin Fisher Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 7.0
Indications for Use Statement
3
Indications for Use
510(k) Number (if known): K143074
Device Name: Paragonix Sherpa Pak Cardiac Transport System
Indications For Use:
"The Sherpa Pak Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart.
The intended organ storage time for the Sherpa Pak Cardiac Transport System is up to 4 hours.
Donor hearts 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."
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
4
Section 8
510(k) Summary
5
Paragonix Sherpa Pak Cardiac Transport System
Premarket Notification: Special 510(k)
510(k) Summary
Paragonix Sherpa Pak Cardiac Transport System Kit
| Submitter: | Paragonix Technologies, Inc.
c/o Vaughn & Associates
639 Granite Street
Braintree, MA 02184 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mason W. Diamond, DDS
Texel Fortis, LLC
150 Levinberg Lane
Wayne, NJ 07470
Phone: 508-333-0108
Fax: 973-305-0213
masonwd@aol.com |
| Date Prepared: | October 24, 2014 |
| Trade Name: | Paragonix Sherpa Cardiac Kidney Transport System |
| Classification Name: | System and Accessories, Isolated Heart, Transport and
Preservation |
| Regulation Number: | 21 CFR 876.5880 |
| Product Code: | MSB |
| Predicate Devices: | Sherpa Pak Cardiac Transport System (Paragonix
Technologies, Inc) - K133432
Celsior Cold Storage Solution (SangStat Medical Corp) -
K991594
Custodiol HTK (Dr Franz Köhler Chemie GmbH) – K032794 |
| Device Description: | The Paragonix Sherpa Pak Cardiac Transport System is a
device intended to provide a safe, consistent method for cold
ischemic storage and transport of donor hearts to recipients
for transplantation. The Sherpa Pak System consists of 1) an
outer shipper which contains various non-ice based
temperature controlled packaging elements, 2) an inner and
outer hard shell container (i.e. Sherpa Pak/Sherpa Pak Shell)
which provides a double, rigid barrier container in which the
heart is immersed and suspended in a Cold Storage Fluid
cleared for use in storing and transporting donor organs and
3) a temperature display and timer to monitor temperature
and elapsed time of transport, respectively. The device is
identical to the cleared Sherpa Pak Cardiac Transport System
in all respects. |
6
| Submitter: | Paragonix Technologies, Inc. |
|---|---|
| Paragonix Sherpa Pak Cardiac Transport System | |
| Premarket Notification: Special 510(k) | |
| The purpose for this change it to allow the Paragonix Sherpa | |
| Pak Cardiac Transport System to be distributed with any | |
| FDA-cleared, commercially-available preservation solution, as | |
| a Convenience Kit. | |
| Intended Use: | Organ storage and preservation for transplantation. |
| Indications for Use: | The Sherpa Pak Cardiac Transport System is intended to be |
| used for the static hypothermic preservation of hearts during | |
| transportation and eventual transplantation into a recipient | |
| using cold storage solutions indicated for use with the heart. | |
| The intended organ storage time for the Sherpa Pak Cardiac | |
| Transport System is up to 4 hours. | |
| Donor hearts 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. | |
| Functional Testing: | Descriptive information and laboratory bench testing were |
| provided to demonstrate the device meets its design | |
| specifications, performs as intended, and is safe for its | |
| intended use. | |
| Specifically, testing to demonstrate that the Sherpa Pak | |
| Cardiac Transport System provided a transport system robust | |
| enough to protect the donor organ during transport and | |
| maintained temperature throughout the duration of transport | |
| was included. Thermal qualification demonstrated the ability | |
| of the Sherpa Pak Cardiac Transport System to maintain the | |
| required temperature through 12 hours. |
7
Premarket Notification: Special 510(k)
Device Characteristic Comparison
| Characteristic | Proposed Sherpa Pak Cardiac
Transport System
[Modification] | Sherpa Pak Cardiac
Transport System - K133432 | Celsior - K991594 | Custodiol HTK-
K032794 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Organ storage and preservation
for transplantation. | Organ storage and preservation
for transplantation. | Organ storage and preservation
for transplantation. | Organ storage and preservation
for transplantation. |
| Indications for
Use | "The Sherpa Pak Cardiac
Transport System is intended
to be used for the static
hypothermic preservation of
hearts during transportation
and eventual transplantation
into a recipient using cold
storage solutions indicated for
use with the heart.
The intended organ storage
time for the Sherpa Pak
Cardiac Transport System is
up to 4 hours.
Donor hearts 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." | "The Sherpa Pak Cardiac
Transport System is intended
to be used for the static
hypothermic preservation of
hearts during transportation
and eventual transplantation
into a recipient using cold
storage solutions indicated for
use with the heart.
The intended organ storage
time for the Sherpa Pak
Cardiac Transport System is
up to 4 hours.
Donor hearts 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." | "Celsior is intended for flushing
and cold storage of a heart at the
time of its removal from a donor
in preparation for storage,
transportation, and eventual
transplantation into a recipient." | "Custodiol HTK Solution is
indicated for perfusion and
flushing donor kidneys, livers,
and hearts prior to removal from
the donor or immediately after
removal from the donor. The
solution is left in the organ
vasculature during hypothermic
storage and transportation (not
for continuous perfusion) to the
recipient." |
| Regulation
Number | 878.5880 | 878.5880 | 878.5880 | 878.5880 |
| Product Code | MSB | MSB | MSB | MSB |
| Device
Classification
Name | Device Classification Name -
System & Accessories, Isolated
Heart, Transport & Preservation | Device Classification Name -
System & Accessories, Isolated
Heart, Transport & Preservation | Device Classification Name -
System & Accessories, Isolated
Heart, Transport & Preservation | Device Classification Name -
Isolated kidney perfusion and
transport system and
accessories |
| Mode of
Operation | Static cold ischemic storage | Static cold ischemic storage | Static cold ischemic storage | Static cold ischemic storage |
| Characteristic | Proposed Sherpa Pak Cardiac
Transport System
[Modification] | Sherpa Pak Cardiac
Transport System - K133432 | Celsior - K991594 | Custodiol HTK-
K032794 |
| Meets UNOS
Policy 51 | Yes | Yes | Yes | Yes |
| Organ container | Two rigid airtight containers one
of which contains the cold
storage solution in which the
heart is immersed. | Two rigid airtight containers one
of which contains the cold
storage solution in which the
heart is immersed. | None. Solution is used by organ
procurement centers but requires
an organ container such as that
used in the proposed Sherpa
Pak Transporter System or the
Avid custom procedure tray tub. | None. Solution is used by organ
procurement centers but requires
an organ container such as that
used in the proposed Sherpa
Pak Transporter System or the
Avid custom procedure tray tub. |
| Cooling | Temperature preconditioned
storage solution and
temperature controlled
packaging including
preconditioned phase change
material cold packs, PIR
insulating panels, and
Expandable Polystyrene panels | Temperature preconditioned
storage solution and
temperature controlled
packaging including
preconditioned phase change
material cold packs, PIR
insulating panels, and
Expandable Polystyrene panels | Temperature preconditioned.
Relies on transport system for
type of cooling and maintenance
of temperature. | Temperature preconditioned.
Relies on transport system for
type of cooling and maintenance
of temperature. |
| System
components | Image: System components
Outer plastic corrugated container (top and base with wheels) | Image: System components
Outer plastic corrugated container (top and base with wheels) | Plastic bag with cold storage
solution to be used in
combination with some type of
organ transport container (e.g.,
such as the Avid custom
procedure kit and off-the-shelf
cooler). | Plastic bag with cold storage
solution to be used in
combination with some type of
organ transport container (e.g.,
such as the Avid custom
procedure kit and off-the-shelf
cooler). |
| Characteristic | Proposed Sherpa Pak Cardiac
Transport System
[Modification] | Sherpa Pak Cardiac
Transport System - K133432 | Celsior - K991594 | Custodiol HTK–
K032794 |
| | PCM Cold Pack Panels EPS panels Sherpa Pak and Sherpa Pak Shell without connector Temperature data logger Timer Plastic bags with cold storage solution to be used in combination with the Sherpa Pak Kidney Transporter System [supplied in a separate package]. | PCM Cold Pack Panels EPS panels Sherpa Pak and Sherpa Pak Shell without connector Temperature data logger Timer | | |
| Single
Use/Reuse | Entire system is single use/patient only. | Entire system is single use/patient only. | Single use/patient only. | Single use/patient only. |
| Sterilization | Sherpa Pak, Sherpa Pak Shell, and Heart connector are sterilized by gamma irradiation. All other components are non-sterile. | Sherpa Pak, Sherpa Pak Shell, and Heart connector are sterilized by gamma irradiation. All other components are non-sterile. | Sterilized. | Sterilized. |
| Biocompatibility | Direct and indirect heart contact materials have been tested for biocompatibility. | Direct and indirect heart contact materials have been tested for biocompatibility. | Yes. | Yes. |
| Intended
storage time | Up to 4 hours (clinical standard is 4-6 hours) | Up to 4 hours (clinical standard is 4-6 hours) | No time within indication statement | No time within indication statement |
8
Submitter:
Paragonix Technologies, Inc.
Paragonix Sherpa Pak Cardiac Transport System
Premarket Notification: Special 510(k)
1 http://www.optn.transplant.hrsa.gov
9
Submitter:
Paragonix Technologies, Inc.
Paragonix Sherpa Pak Cardiac Transport System
Premarket Notification: Special 510(k)
10
Paragonix Sherpa Pak Cardiac Transport
Submitter: System Paragonix Technologies, Inc. 510(k)
Premarket Notification: Special
Summary of Design
Changes:
The design, indications for use, principles of operation, technological characteristics, and packaging of the Sherpa Pak Cardiac Transport System are exactly the same as the previously cleared Sherpa Pak Cardiac Transport System (K133432). Sherpa Pak Cardiac Transport System is intended to be used with any preservation solution that is cleared by the FDA for use with hearts, and, therefore, the combined kitting of the Paragonix Sherpa Pak Cardiac Transport System and any FDA-Cleared preservation solution (i.e., Celsior, Custodiol HTK, etc.) falls within the current scope of use for the aforementioned devices. The purpose for this change is to allow the Paragonix Sherpa Pak Cardiac Transport System to be distributed with any FDA-cleared, commercially-available donor heart cold storage preservation solution, as a Convenience Kit. According to the FDA "Convenience Kits Interim Regulatory Guidance" (May 20, 1997), the Sherpa Pak Cardiac Transport System falls within the definition of a Convenience Kit. As a result, no further testing is required.