Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical system for cold storage and transport of hearts, with no mention of AI or ML components.

Therapeutic

No.
The device facilitates the preservation and transport of hearts for transplantation, which is an ancillary function to the therapeutic act of transplantation itself, rather than a direct therapeutic intervention on a patient.

Diagnostic

No

The device is designed for the static hypothermic preservation of hearts during transportation for eventual transplantation. It maintains the heart's condition rather than diagnosing a medical condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components including an outer shipper, inner and outer hard shell containers, and a temperature display and timer. This indicates it is a hardware-based medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Sherpa Pak Cardiac Transport System is not an In Vitro Diagnostic (IVD).

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, including packaging, containers for the heart and storage fluid, and temperature monitoring. This aligns with a device for organ preservation and transport.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect substances, or provide any diagnostic information about the heart or the recipient. IVDs are typically used to perform tests on biological samples (blood, urine, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions.
Anatomical Site: While the device interacts with the heart, it does so for preservation and transport, not for diagnostic analysis of the heart tissue or function.
Performance Studies: The performance studies focus on the device's ability to maintain temperature, protect the organ during transport, and biocompatibility. These are relevant to a preservation and transport device, not a diagnostic device.
Predicate Devices: The predicate devices listed (Lifeport Kidney Transport System, Avid Custom Procedure Tray, Celsior Cold Flush Storage and Transport Solution) are also related to organ preservation, transport, or surgical procedures, not in vitro diagnostics.

In summary, the Sherpa Pak Cardiac Transport System is a device designed for the physical preservation and transport of a donor organ. It does not perform any diagnostic tests or analyses on biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

"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."

Product codes

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 hearts and 3) a temperature display and timer to monitor temperature and elapsed time of transport, respectively.

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

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)

Descriptive information, laboratory bench testing, and biocompatibility 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 System provided a transport system robust enough to protect the heart during transport and maintained temperature throughout the duration of transport, was included. In addition, biocompatibility testing including cytotoxicity, systemic toxicity, genotoxicity, sensitization, and intracutaneous testing was performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Lifeport Kidney Transport System (K021362), Celsior Cold Flush Storage and Transport Solution for Hearts (K991594), Avid Custom Procedure Tray [Class I 510(k) Exempt]

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 876.5880 Isolated kidney perfusion and transport system and accessories.

(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).

Summary

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K123326
page 1 of 6

510(k) Summary Paragonix Sherpa Pak Cardiac Transport System

イ

FEB 0 6 2013

| Submitter: | Paragonix Technologies, Inc.
Fifth Floor
2 Canal Street
Cambridge, MA 02141
Phone: 617.817.7790
Fax: 617.812.3057 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Leo Basta
NorthStar Biomedical Associates
755 Westminster St., Unit 120
Providence, RI, 02903
Phone: 617.834.9866
lbasta@northstarbiomedical.com |
| Date Prepared: | October 24, 2012 |
| Trade Name: | Paragonix Sherpa Pak Cardiac Transport System |
| Classification Name: | System & Accessories, Isolated Heart, Transport &
Preservation |
| Regulation Number: | 21 CFR 876.5880 |
| Product Code: | MSB |
| Predicate Devices: | Lifeport Kidney Transport System (K021362) |
| | Avid Custom Procedure Tray [Class I 510(k) Exempt] |
| | Celsior Cold Flush Storage and Transport Solution for Hearts
(K991594) |
| 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) |

FDA Response
Rev. A

:

1

K123326
page 2 of 6

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 hearts and 3) a temperature display and timer to monitor temperature and elapsed time of transport, respectively.

Organ storage and preservation for transplantation.

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.

Descriptive information, laboratory bench testing, and biocompatibility 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 System provided a transport system robust enough to protect the heart during transport and maintained temperature throughout the duration of transport, was included. In addition, biocompatibility testing including cytotoxicity, systemic toxicity, genotoxicity, sensitization, and intracutaneous testing was performed.

Functional Testing:

Indications for Use:

Intended Use:

2

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------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Characteristic	Device Characteristic Comparison
	Proposed Sherpa Pak Cardiac
Transport System Device
[current 510(k)]	Celsior Cold Storage
Solution - K991594	Lifeport
Kidney
Transporter
K021362	Avid Medical
Custom
Procedure Tray
Class I 510(k)
Exempt	Transport System Device
[current 510(k)]	Two rigid airtight containers one of
which contains the cold storage solution
in which the heart is immersed.	Preconditioned storage solution and
temperature controlled packaging
including preconditioned phase change
material cold packs, PIR insulating
panels, and Expandable Polystyrene
panels	Outer plastic corrugated
container (top and base with
wheels)
PIR insulating panels
PCM Cold Pack Panels
EPS panels
Sherpa Pak and Sherpa Pak
Shell with heart connector
Temperature data logger
Timer
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	Solution - K991594	None. Solution is used by organ
procurement centers in various
containers or bags.	Preconditioned. Relies on transport
system for type of cooling and
maintenance of temperature	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).
Indications for
Use	"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."	"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."	"LifePortTM, Kidney Perfusion
Transporter (KTR) is intended to
be used for the continuous
hypothermic machine perfusion
of kidneys for the preservation,
transportation and eventual
transplantation into a recipient."	Specific indication statement is
unknown. However, the Avid
procedure tray is sold to an
organ procurement center, Avid
NEOB0005-03, for heart
packaging with Celsior Cold
Storage Solution for
transportation to recipient for
transplantation.	Lifeport
Kidney
Transporter -
K021362	Cassette well with top.	Preconditioned storage solution,
ice and water. Case has
insulated cover.	Ice container
Cassette
Insulating cover
Infusion pump
Cannula
Control panel
Batteries
Pressure sensor
Organ cradle
Regulation
Number
Product Code	878.5880
MSB	878.5880
MSB	878.5880
KDN	876.4800
KDD	Avid Medical
Custom
Procedure Tray

Class I 510(k)
Exempt | Plastic tub with lid and bags. | Preconditioned storage solution
ice and water. Requires use of
commercial cooler (e.g., igloo
style). | 64 oz. tub with lid
Polyethylene bags
Procedure wrap
Twill tape

K123326
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K123326

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4

| Characteristic | Proposed Sherpa Pak Cardiac
Transport System Device
(current 510(k)) | Celsior Cold Storage
Solution-K991594 | Liteport
Kidney
Transporter
K021362 | Avid Medical
Custom
Procedure Tray
Class I 510(k)
Exempt |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Single Use/Reuse | Entire system is single use/patient only. | Single use/patient only. | Some components are single
use/patient only; others are
reusable. | Single use/patient only.
Commercial cooler may be
reused. |
| Sterilization | Sherpa Pak, Sherpa Pak Shell, and Heart
connector are sterilized by gamma
irradiation. All other components are
non-sterile. | Sterilized. | Disposable accessories are EO
sterilized; other components are
non-sterile. | EO sterilized. |
| Biocompatibility | Direct and indirect heart contact
materials have been tested for
biocompatibility. | Yes. | Kidney contact materials have
been tested for biocompatibility. | Unknown. |
| Intended storage
time | Up to 4 hours (clinical standard is 4-6
hours) | Unspecified. | Unspecified | Unspecified |

K123326
Page Soft

จะของรวม VCIJ

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K123326 page 6 of 6

Summary of Substantial Equivalence:

The design, intended use, principles of operation, and technological characteristics of the Sherpa Pak Cardiac Transport System are substantially equivalent to those of the predicate devices cited above. 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 heart at a clinically acceptable temperature range to a recipient for transplantation.

FDA Response Rev. A

6

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 6, 2013

Paragonix Technologies, Inc. % Mr. Leo Basta Owner NorthStar Biomedical Associates 755 Westminister Street Unit 120 PROVIDENCE RI 02903

Re: K123326

Trade/Device Name: Paragonix Sherpa Pak Cardiac Transport System Regulation Number: 21 CFR§ 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: MSB Dated: December 17, 2012 Received: December 20, 2012

Dear Mr. 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. Iisting 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.

7

Page 2 - Mr. Leo Basta

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Herbert P.Lerner -S

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): K123326

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, up to 4 hours, during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the heart.

Prescription Use: ____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The Counter Use:

(Per 21 CFR 801 Subpart D) ...................................................................................................................................................

(Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Bvaluation (ODE)

Page 1 of 1

Herbert P. Lerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number

FDA Response Res. A