(103 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Paragonix Sherpa Pak Cardiac Transport System based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative "acceptance criteria" for the device's performance in a table format. Instead, it describes general design specifications and functional testing outcomes.
| Characteristic | Acceptance Criteria (Implied / Desired Outcome) | Reported Device Performance |
|---|---|---|
| Protection during Transport (Robustness) | Device should be robust enough to protect the heart during transport. | Testing demonstrated the Sherpa Pak System provided a transport system robust enough to protect the heart during transport. |
| Temperature Maintenance | Device should maintain temperature throughout the duration of transport. | Testing demonstrated the Sherpa Pak System maintained temperature throughout the duration of transport. |
| Biocompatibility | Direct and indirect heart contact materials must be biocompatible (non-toxic, non-sensitizing, etc.). | Biocompatibility testing including cytotoxicity, systemic toxicity, genotoxicity, sensitization, and intracutaneous testing was performed. Direct and indirect heart contact materials have been tested for biocompatibility. (Implied: results were acceptable, as the device was cleared). |
| Intended Use Period | Static hypothermic preservation of hearts up to 4 hours. | The Sherpa Pak Cardiac Transport System is intended to be used for static hypothermic preservation of hearts, up to 4 hours. The marketing clearance implies that the device demonstrated it can achieve this. |
| UNOS Policy 5 Compliance | Conformity to UNOS Policy 5 for organ storage and preservation. | The device's "Meets UNOS Policy 5" characteristic is listed as "Yes" in the comparison table. |
| Sterilization | Specific components (Sherpa Pak, Sherpa Pak Shell, Heart connector) should be sterilized. Other parts non-sterile. | Sherpa Pak, Sherpa Pak Shell, and Heart connector are sterilized by gamma irradiation. All other components are non-sterile. (This is a design characteristic that was met, rather than a performance outcome in the same way as temperature). |
| Single Use/Reuse | Entire system is single use/patient only. | The entire system is single use/patient only. (This is a design characteristic that was met, rather than a performance outcome in the same way as temperature). |
| Overall Performance | Performs as intended and is safe for its intended use, substantially equivalent to predicate devices. | The testing conducted demonstrated 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. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "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."
- Sample Size: The document does not specify any sample sizes for the functional or biocompatibility testing conducted. It refers to "testing" generically.
- Data Provenance: The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned. The testing described appears to be internal lab testing rather than clinical study data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: This information is not provided. The "ground truth" for this device's performance primarily relates to objective physical parameters (temperature stability, structural integrity, biocompatibility) rather than expert interpretation of images or clinical outcomes.
- Qualifications of Experts: This information is not provided.
4. Adjudication Method for the Test Set:
- Adjudication Method: This information is not provided. Given the nature of the tests (bench testing, biocompatibility), there is no indication of an adjudication process typically associated with subjective assessments or clinical outcomes.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or mentioned. This type of study is typically relevant for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a transport system, not a diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
- Yes, a standalone performance study was done in the sense that the "Functional Testing" described ("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") and "biocompatibility testing" were evaluations of the device itself, independent of human interaction during the test. There is no "algorithm" in the conventional AI sense for this device.
7. Type of Ground Truth Used:
The ground truth used was based on objective measurements and laboratory standards:
- Functional Testing: Measuring whether the device maintained temperature, its structural integrity under stress (robustness), and protection of the "heart" (simulated or actual, not specified but likely simulated for bench testing).
- Biocompatibility Testing: Adherence to established standards for cytotoxicity, systemic toxicity, genotoxicity, sensitization, and intracutaneous reactivity.
- UNOS Policy 5: Assessed against a defined policy standard.
8. Sample Size for the Training Set:
This device is a physical medical device, not an AI/machine learning algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established:
As there is no AI/machine learning algorithm with a training set for this device, how ground truth for a training set was established is not applicable.
{0}------------------------------------------------
K123326
page 1 of 6
510(k) Summary Paragonix Sherpa Pak Cardiac Transport System
イ
FEB 0 6 2013
| Submitter: | Paragonix Technologies, Inc.Fifth Floor2 Canal StreetCambridge, MA 02141Phone: 617.817.7790Fax: 617.812.3057 |
|---|---|
| Contact Person: | Leo BastaNorthStar Biomedical Associates755 Westminster St., Unit 120Providence, RI, 02903Phone: 617.834.9866lbasta@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 adevice intended to provide a safe, consistent method for cold.ischemic storage and transport of donor hearts to recipients fortransplantation. The Sherpa Pak System consists of 1) anouter shipper which contains various non-ice basedtemperature controlled packaging elements, 2) an inner andouter 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}------------------------------------------------
| .v3Яទនបល់ ជនជួន ជួរA | ACFFนามเป็นพระพระอาหารสามารถเมื่อวันที่มี และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ และ |
|---|---|
| ------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
ง 3 ธราที่ 1 กิโยโนรที่ 1 เทคโนะ พ.พ.พ. 1 จาก 1 ปี 2 จาก 1 ปี 2 จาก 2 ของ 2 รายการเรื่อง การเลือก การเล
| Characteristic | Device Characteristic Comparison | Characteristic | Organ container | Cooling | System components | |||
|---|---|---|---|---|---|---|---|---|
| Proposed Sherpa Pak CardiacTransport System Device[current 510(k)] | Celsior Cold StorageSolution - K991594 | LifeportKidneyTransporterK021362 | Avid MedicalCustomProcedure TrayClass I 510(k)Exempt | Transport System Device[current 510(k)] | Two rigid airtight containers one ofwhich contains the cold storage solutionin which the heart is immersed. | Preconditioned storage solution andtemperature controlled packagingincluding preconditioned phase changematerial cold packs, PIR insulatingpanels, and Expandable Polystyrenepanels | Outer plastic corrugatedcontainer (top and base withwheels)PIR insulating panelsPCM Cold Pack PanelsEPS panelsSherpa Pak and Sherpa PakShell with heart connectorTemperature data loggerTimer | |
| Intended Use | Organ storage and preservation fortransplantation. | Organ storage and preservation fortransplantation. | Organ storage and preservationfor transplantation. | Organ storage and preservationfor transplantation | Solution - K991594 | None. Solution is used by organprocurement centers in variouscontainers or bags. | Preconditioned. Relies on transportsystem for type of cooling andmaintenance of temperature | Plastic bag with coldstorage solution to be usedin combination with sometype of organ transportcontainer (e.g., such as theAvid custom procedure kitand off-the-shelf cooler). |
| Indications forUse | "The Sherpa Pak Cardiac TransportSystem is intended to be used for thestatic hypothermic preservation ofhearts, up to 4 hours, duringtransportation and eventualtransplantation into a recipient, usingcold storage solutions indicated for usewith the heart." | "Celsior is intended for flushing andcold storage of a heart at the time ofits removal from a donor inpreparation for storage,transportation, and eventualtransplantation into a recipient." | "LifePortTM, Kidney PerfusionTransporter (KTR) is intended tobe used for the continuoushypothermic machine perfusionof kidneys for the preservation,transportation and eventualtransplantation into a recipient." | Specific indication statement isunknown. However, the Avidprocedure tray is sold to anorgan procurement center, AvidNEOB0005-03, for heartpackaging with Celsior ColdStorage Solution fortransportation to recipient fortransplantation. | LifeportKidneyTransporter -K021362 | Cassette well with top. | Preconditioned storage solution,ice and water. Case hasinsulated cover. | Ice containerCassetteInsulating coverInfusion pumpCannulaControl panelBatteriesPressure sensorOrgan cradle |
| RegulationNumberProduct Code | 878.5880MSB | 878.5880MSB | 878.5880KDN | 876.4800KDD | Avid MedicalCustomProcedure Tray- Class I 510(k)Exempt | Plastic tub with lid and bags. | Preconditioned storage solutionice and water. Requires use ofcommercial cooler (e.g., igloostyle). | 64 oz. tub with lidPolyethylene bagsProcedure wrapTwill tapeOnce heart is packaged, kit isstored on ice in a standardcooler. |
| DeviceClassificationName | Device Classification Name – System &Accessories, Isolated Heart, Transport& Preservation | Device Classification Name – System& Accessories, Isolated Heart,Transport & Preservation | System, Perfusion, Kidney | Kit, surgical instrument,disposable. | FDA Response | |||
| Mode ofOperation | Static cold ischemic storage | Static cold ischemic storage | Cold ischemic perfusion storage | Static cold ischemic storage | ||||
| Meets UNOSPolicy 5¹ | Yes | Yes | Yes | Yes |
K123326
page 3 of 6
{3}------------------------------------------------
K123326
Page 4 of 6
nodsay tradi
{4}------------------------------------------------
| Characteristic | Proposed Sherpa Pak CardiacTransport System Device(current 510(k)) | Celsior Cold StorageSolution-K991594 | LiteportKidneyTransporterK021362 | Avid MedicalCustomProcedure TrayClass I 510(k)Exempt |
|---|---|---|---|---|
| Single Use/Reuse | Entire system is single use/patient only. | Single use/patient only. | Some components are singleuse/patient only; others arereusable. | Single use/patient only.Commercial cooler may bereused. |
| Sterilization | Sherpa Pak, Sherpa Pak Shell, and Heartconnector are sterilized by gammairradiation. All other components arenon-sterile. | Sterilized. | Disposable accessories are EOsterilized; other components arenon-sterile. | EO sterilized. |
| Biocompatibility | Direct and indirect heart contactmaterials have been tested forbiocompatibility. | Yes. | Kidney contact materials havebeen tested for biocompatibility. | Unknown. |
| Intended storagetime | Up to 4 hours (clinical standard is 4-6hours) | Unspecified. | Unspecified | Unspecified |
K123326
Page Soft
จะของรวม VCIJ
{5}------------------------------------------------
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
§ 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).