(171 days)
No
The description focuses on passive temperature control and monitoring, with no mention of AI/ML for analysis, prediction, or control.
No.
The device is intended for the preservation and transportation of organs for transplantation, not for direct therapeutic treatment of a patient's condition.
No
The device is described as a transport system for organs, providing a controlled environment for preservation during transportation. Its functions include maintaining temperature and elapsed time monitoring, not diagnosing medical conditions or diseases.
No
The device description explicitly details physical components like an outer shipper, inner and outer hard shell containers, and a temperature display and timer, indicating it is a hardware-based system.
Based on the provided information, the Sherpa Pak Kidney Transport System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "static hypothermic preservation of kidney organs during transportation and eventual transplantation." 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 packaging and temperature control of a donor organ. It does not involve any testing or analysis of a sample from the human body to provide diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening of a disease or condition.
The Sherpa Pak Kidney Transport System is a medical device used for the preservation and transport of a human organ, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
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 this organ. The Sherpa Pak Kidney Transport System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours.
Product codes
KDN
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 kidney organs to recipients for transplantation. The Sherpa Pak Kidney Transport 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 donor 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 Cardiac Transport System with the exception of the indications for use specific to donor organs, and removal of a connector in the canister component.
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
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 K123326. Specifically, testing to demonstrate that the Sherpa Pak Kidney Transport System provides a transport system robust enough to protect the donor organ during transport and maintain temperature throughout the duration of transport, was conducted.
Key Metrics
Not Found
Predicate Device(s)
Sherpa Pak Cardiac Transport System, 21 CFR 876.5880 - Paragonix Technologies, Inc., K123326, Product Code MSB, Avid Medical Custom Procedure Tray, 21 CFR 878.4800 - Avid Medical, Class I exempt, Product Code KDD, CoStorSol, 21 CFR 876.5880. Preservation Solutions Inc. - K091245, Product Code KDN
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY 2 3 2014
. 510(k) Summary Paragonix Sherpa Pak Kidney Transport System
:
.
:
| Submitter: | Paragonix Technologies, Inc.
c/o Vaughn & Associates
639 Granite Street
Braintree, MA02184 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Leo Basta
NorthStar Biomedical Associates
93 Benefit Street
Providence, RI, 02904
Phone: 617.834.9866
lbasta@northstarbiomedical.com |
| Date Prepared: | December 23, 2013 |
| 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 Code: | KDN |
| Predicate Devices: | Sherpa Pak Cardiac Transport System, 21 CFR 876.5880 -
Paragonix Technologies, Inc., K123326, Product Code MSB |
| | Avid Medical Custom Procedure Tray, 21 CFR 878.4800 -
Avid Medical, Class I exempt, Product Code KDD |
| | CoStorSol, 21 CFR 876.5880. Preservation Solutions Inc. -
K091245, Product Code KDN |
| 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 kidney organs to
recipients for transplantation. The Sherpa Pak Kidney
Transport 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 donor 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 Cardiac Transport System with the exception of
the indications for use specific to donor organs, and removal
of a connector in the canister component. |
| 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
this organ. |
| | The Sherpa Pak Kidney Transport System can maintain the
donor organ storage temperature between 4°C and 8°C
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 K123326. |
| | Specifically, testing to demonstrate that the Sherpa Pak
Kidney Transport System provides a transport system robust
enough to protect the donor organ during transport and
maintain temperature throughout the duration of transport, was
|
:
Paragonix Kidney 510(k) Rev. B
.
1
Paragonix Kidney 510(k)
Rev. B
:
2
K133694
Page 3 of 6
| Device Characteristic | Proposed Sherpa Pak Kidney
Transport System
[current 510(k)] | Proposed Sherpa Pak Cardiac
Transport System Device -
K123326 | CoStorSol Cold
Storage Solution -
K091245 | Avid Medical
Custom
Procedure Tray
- Class 1 510(k)
Exempt |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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 this organ.
The Sherpa Pak Kidney Transport
System can maintain the donor organ
storage temperature between 4°C and
8°C through 24 hours." | "The Sherpa Pak Cardiac Transport
System is intended to be used for the
static hypothermic preservation of
hearts, up to 4 hours, during
transportation and eventual
transplantation into a recipient, using
cold storage solutions indicated for
use with the heart." | "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." | Specific indication statement is
unknown. However, the Avid
procedure tray is sold to organ
procurement centers, for organ
packaging with Cold Storage
Solutions for transportation to
recipient for transplantation. |
| Regulation
Number | 878.5880 | 878.5880 | 878.5880 | 878.4800 |
| Product Code | KDN | MSB | KDN | KDD |
| Device
Classification
Name | Device Classification Name – Isolated
kidney perfusion and transport system
and accessories | Device Classification Name – System
& Accessories, Isolated Heart,
Transport & Preservation | Device Classification Name –
Isolated kidney perfusion and
transport system and accessories | Kit, surgical instrument,
disposable. |
| Mode of
Operation | Static cold ischemic storage | Static cold ischemic storage | Static cold ischemic storage | Static cold ischemic storage |
| Meets UNOS
Policy 5¹ | Yes | Yes | Yes | Yes |
.
' http://www.optn.transplant.hrsa.gov
Paragonix Kidney 510(k)
Rev. B
3
4
K133694
Page 5 of 6
| Characteristic | Proposed Sherpa Pak Kidney
Transport System
[current 510(k)] | Proposed Sherpa Pak Cardiac
Transport System Device –
K123326 | CoStorSol Cold
Storage Solution –
K091245 | Avid Medical
Custom
Procedure Tray
- Class I 510(k) Exempt |
|--------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|---------------------------------------------------------------------|
| 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.
Commercial cooler may be reused. |
| Sterilization | Sherpa Pak and Sherpa Pak Shell 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. | EO sterilized. |
| Biocompatibility | Direct and indirect organ contact
materials have been tested for
biocompatibility. | Direct and indirect heart contact
materials have been tested for
biocompatibility. | Yes. | Unknown. |
| Intended storage
time | Device can maintain 4° C to 8° C
through 24 hours | Currently indicated for up to 4 hours.
Device testing demonstrates
maintenance of 4° C to 8° C range
through 12 hours. | No time within indication statement | Unspecified |
Paragonix Kidney 510(k)
Rev. B
5
Summary of Substantial Equivalence:
The design, intended use, principles of operation, and technological characteristics of the Sherpa Pak Kidney Transport System are substantially equivalent to the previously cleared Sherpa Pak Cardiac Transport System (K123326). The intended use of the subject device is the same as all the cited predicates and the labeled indications for use is similar for each device. Substantial equivalence is based upon descriptive characteristics of the various cited predicate devices and upon the testing conducted to demonstrate that the subject device performs as intended and is substantially equivalent to the predicate devices in terms of its ability to safely store and transport a donor organ at a clinically acceptable temperature range to a recipient for transplantation.
Paragonix Kidney 510(k) Rev. B
6
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2014 '
Paragonix Technologies, Inc. % Leo L. Basta Owner NorthStar Biomedical Associates 93 Benefit Street Providence, RI 02904
Re: K133694
:
Trade/Device Name: Paragonix Sherpa Pak Kidney Transport System Regulation Number: 21 CFR§ 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: KDN Dated: May 15, 2014 Received: May 16, 2014
Dear Leo L. Basta,
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. 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.
7
Page 2 - Leo L. Basta
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,
Image /page/7/Picture/7 description: The image shows the name "Herbert P. Lerner - S" in a bold, sans-serif font. The name is written in black ink on a white background. The letters are evenly spaced and easy to read. The text appears to be a signature or a title.
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
INDICATION FOR USE
510(k) Number (if known): K133694
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 this organ.
The Sherpa Pak Kidney Transport System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours.
Prescription Use: ____________________________________________________________________________________________________________________________________________________________ Over-The Counter Use: (Per 21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D) ...................................................................................................................................................
(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
Image /page/8/Picture/10 description: The image shows the name "Herbert P. Lerner" in bold, black font at the top. Below the name is the date and time "2014.05.23 07:10:27 -04'00'" also in bold, black font. The text appears to be a timestamp or record of some kind.
Paragonix Kidney 510(k) Rev. B