(33 days)
Not Found
No
The description focuses on passive temperature control and physical protection during transport, with no mention of AI/ML components or functions.
No.
The device is for the preservation and transportation of organs, not for the treatment or diagnosis of a condition in a living organism.
No
Explanation: The device is intended for the preservation and transportation of kidney organs, not for diagnosing any medical condition. Its function is to maintain temperature and protect the organ during transport.
No
The device description clearly outlines multiple hardware components including a shipper, inner and outer hard shell containers, and a temperature display and timer. It is a physical system for organ transport, not solely software.
Based on the provided text, the Sherpa Pak Kidney Transport System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the "static hypothermic preservation of kidney organs 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, not for analyzing a sample from the body to diagnose a condition.
- Device Description: The description focuses on the physical components for temperature control and containment of the organ during transport. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other bodily fluids.
- Providing diagnostic information about a patient's health status.
- Using reagents or assays to detect specific substances.
- Anatomical Site: The anatomical site is "Kidney organs," which are being transported, not analyzed.
The device is clearly intended for the preservation and transport of a whole organ, which falls under the category of medical devices used in transplantation procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
"The Sherpa Pak Kidney Transport System is intended to be used for the static hypothermic preservation of kidney organs during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with these organs.
The Sherpa Pak Kidney Transport System can maintain the donor organ storage temperature between 4℃ and 8℃ through 24 hours."
Product codes (comma separated list FDA assigned to the subject device)
KDN, PIN
Device Description
The Paragonix Sherpa Pak Kidney Transport System is a device intended to provide a safe, consistent method for cold ischemic storage and transport of donor organs to recipients for transplantation. The Sherpa Pak System consists of 1) an shipper which contains various non-ice based outer 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 kidney 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 Kidney Transport System in all respects.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Kidney organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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: 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. Additional biocompatibility testing was not necessary as there were no material changes from the device cleared under K133694.
Specifically, testing to demonstrate that the Sherpa Pak Kidney 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 Kidney Transport System to maintain the required temperature through 24 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.
K133694, K944866, K091245, K091656, K043461
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 U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. 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: K143054
Trade/Device Name: Sherpa Pak Kidney Transport System Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated Kidney Perfusion And Transport System And Accessories Regulatory Class: Class II Product Code: KDN. PIN Dated: November 7, 2014 Received: November 10, 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,
Benjamin R. Fisher -A
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): K143054
Device Name: Paragonix Sherpa Pak Kidney Transport System
Indications For Use:
"The Sherpa Pak Kidney Transport System is intended to be used for the static hypothermic preservation of kidney organs during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with these organs.
The Sherpa Pak Kidney Transport System can maintain the donor organ storage temperature between 4℃ and 8℃ through 24 hours."
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
Premarket Notification: Special 510(k)
510(k) Summary
Paragonix Sherpa Pak Transport System Kit
K143054
- 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: November 7, 2014 Trade Name: Paragonix Sherpa Pak Kidney Transport System Classification Name: Isolated kidney perfusion and transport system and accessories Regulation Number: 21 CFR 876.5880 Product Codes: Classification - KDN Subsequent - PIN Sherpa Pak Kidney Transport System (Paragonix Predicate Devices: Technologies, Inc) - K133694 Belzer UW Cold Storage Solution (DuPont Merk Pharmaceutical Company) - K944866 CoStorSol (Preservation Solutions Inc) - K091245 SPS-1 (Organ Recovery Systems, Inc) - K091656 Custodiol HTK Solution (Dr Franz Köhler Chemie GmbH) -K043461 Device Description: The Paragonix Sherpa Pak Kidney Transport System is a device intended to provide a safe, consistent method for cold ischemic storage and transport of donor organs to recipients for transplantation. The Sherpa Pak System consists of 1) an shipper which contains various non-ice based outer 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 kidney 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
6
| Submitter:
Paragonix Technologies, Inc. | Paragonix Sherpa Pak Kidney Transport System
Premarket Notification: Special 510(k) | | | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| | and elapsed time of transport, respectively. The device is
identical to the cleared Sherpa Pak Kidney Transport System
in all respects. | | | |
| | The purpose for this change is to allow the Paragonix Sherpa
Pak Kidney 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 Kidney Transport System is intended to be
used for the static hypothermic preservation of kidney organs
during transportation and eventual transplantation into a
recipient, using cold storage solutions indicated for use with
these organs. | | | |
| | The Sherpa Pak Kidney Transport System can maintain the
donor organ storage temperature between 4℃ and 8℃
through 24 hours. | | | |
| 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. Additional biocompatibility testing was not
necessary as there were no material changes from the device
cleared under K133694. | | | |
| | Specifically, testing to demonstrate that the Sherpa Pak
Kidney 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 Kidney Transport System to maintain the
required temperature through 24 hours. | | | |
7
Premarket Notification: Special 510(k)
Device Characteristic Comparison
| Characteristic | Proposed Sherpa Pak
Kidney Transport
System
K143054 | Sherpa Pak Kidney
Transport System -
K133694 | Belzer
UW Cold
Storage
Solution -
K944866 | CoStorS
ol Cold
Storage
Solution
K091245 | SPS-1 -
K091656 | Custodiol
HTK
Solution -
K043461 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | Organ storage and
preservation for
transplantation. | Organ storage and
preservation for
transplantation. |
| Indications for
Use | "The Sherpa Pak
Kidney Transport is
intended to be used for
the static hypothermic
preservation of kidney
organs during
transportation and
eventual
transplantation into a
recipient, using cold
storage solutions
indicated for use with
these organs.
The Sherpa Pak Kidney
Transport can maintain
the donor organ
storage temperature
between 4°C and 8°C
through 24 hours." | "The Sherpa Pak
Kidney Transport is
intended to be used for
the static hypothermic
preservation of kidney
organs during
transportation and
eventual
transplantation into a
recipient, using cold
storage solutions
indicated for use with
these organs.
The Sherpa Pak Kidney
Transport can maintain
the donor organ
storage temperature
between 4°C and 8°C
through 24 hours." | "Belzer UW Cold Storage
Solution is intended for
the flushing and cold
storage of kidney, liver
and pancreas organs at
the time of organ removal
from the donor in
preparation for storage,
transportation and
eventual transplantation
into a recipient." | "CoStorSol® is intended
for the flushing and cold
storage of kidney, liver
and pancreas organs at
the time of organ
removal from the donor
in preparation for
storage, transportation
and eventual
transplantation into a
recipient." | "SPS-1 is intended for the
flushing and cold storage
of kidney, liver and
pancreas organs at the
time of organ removal from
the donor in preparation for
storage, transportation and
eventual transplantation
into a recipient." | "Custodiol HTK Solution is
indicated for perfusion and
flushing donor kidneys, liver,
pancreas and heart 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
eventual transplantation (not
for continuous perfusion) to
the recipient." |
| Regulation
Number | 878.5880 | 878.5880 | 878.5880 | 878.5880 | 878.5880 | 878.5880 |
| Product Code | KDN and PIN | KDN | KDL | KDN | KDN | KDL and MSB |
| Device
Classification
Name | Device Classification
Name - Isolated kidney
perfusion and transport
system and accessories | Device Classification
Name - Isolated kidney
perfusion and transport
system and accessories | Device Classification
Name - Set, perfusion,
kidney, disposable | Device Classification
Name - Isolated kidney
perfusion and transport
system and accessories | Device Classification
Name - Isolated kidney
perfusion and transport
system and accessories | 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 | Static cold ischemic
storage | Static cold ischemic storage |
| Meets UNOS
Policy 5¹ | Yes | Yes | Yes | Yes | Yes | Yes |
| Characteristic | Proposed Sherpa Pak
Kidney Transport
System
K143054 | Sherpa Pak Kidney
Transport System -
K133694 | Belzer
UW Cold
Storage
Solution - | CoStorS
ol Cold
Storage
Solution | SPS-1 -
K091656 | Custodiol
HTK
Solution -
K043461 |
| | | | K944866 | K091245 | | |
| Organ container | Two rigid airtight
containers one of which
contains the cold
storage solution in which
the organ is immersed. | Two rigid airtight
containers one of which
contains the cold
storage solution in which
the organ 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. | 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. | 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 | Outer plastic
corrugated
container (top
and base with | Outer plastic
corrugated
container (top
and base with | Plastic baq 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 baq 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). | 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). |
| | wheels)
PIR insulating
panels | wheels)
PIR insulating
panels | | | | |
| Characteristic | Proposed Sherpa Pak
Kidney Transport
System
K143054 | Sherpa Pak Kidney
Transport System -
K133694 | Belzer
UW Cold
Storage
Solution -
K944866 | CoStorS
ol Cold
Storage
Solution -
K091245 | SPS-1 -
K091656 | Custodiol
HTK
Solution -
K043461 |
| | | | | | | |
| | 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. | Single use/patient only. | Single use/patient only. |
| Sterilization | Sherpa Pak and Sherpa Pak Shell are sterilized by gamma irradiation. All other components are non-sterile. | Sherpa Pak and Sherpa Pak Shell are sterilized by gamma irradiation. All other components are non-sterile. | Sterilized. | Sterilized. | Sterilized. | Sterilized. |
| Characteristic | Proposed Sherpa Pak
Kidney Transport
System
K143054 | Sherpa Pak Kidney
Transport System -
K133694 | Belzer
UW Cold
Storage
Solution -
K944866 | CoStorS
ol Cold
Storage
Solution
l
K091245 | SPS-1 -
K091656 | Custodiol
HTK
Solution -
K043461 |
| Biocompatibility | Direct and indirect organ
contact materials have
been tested for
biocompatibility. | Direct and indirect organ
contact materials have
been tested for
biocompatibility. | Yes. | Yes. | Yes. | Yes. |
| Intended storage
time | Device can maintain 4°
C to 8°C through 24
hours | Device can maintain 4°
C to 8°C through 24
hours | No time within indication
statement | No time within indication
statement | No time within indication
statement | No time within indication
statement |
1 http://www.optn.transplant.hrsa.gov
8
Submitter:
Paragonix Technologies, Inc.
Paragonix Sherpa Pak Kidney Transport System
Premarket Notification: Special 510(k)
9
Submitter:
Paragonix Technologies, Inc.
Paragonix Sherpa Pak Kidney Transport System
Premarket Notification: Special 510(k)
10
Submitter:
Paragonix Sherpa Pak Kidney Transport System
Paragonix Technologies, Inc.
Premarket Notification: Special 510(k)
11
Summary of Design Changes:
The design, indications for use, principles of operation, technological characteristics, and packaging of the Sherpa Pak Kidney Transport System are exactly the same as the previously cleared Sherpa Pak Kidney Transport System (K133694). Sherpa Pak Kidney Transport System is intended to be used with any preservation solution that is cleared by the FDA for use with kidneys, and, therefore, the combined kitting of the Paragonix Sherpa Pak Kidney Transport System and any FDA-Cleared preservation solution (i.e., Belzer UW, CoStorSol, SPS-1, 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 Kidney Transport System to be distributed with any FDA-cleared, commerciallyavailable preservation solution, as a Convenience Kit. According to the FDA "Convenience Kits Interim Regulatory Guidance" (May 20, 1997), the Sherpa Pak Kidney Transport System falls within the definition of a Convenience Kit under the generic heading of a "Kidney Perfusion Kit." As a result, no further testing is required.