(108 days)
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 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. The changes made to the currently cleared device are labeling changes only. The device subject to this notification is identical to that cleared under K123326.
The provided document is a 510(k) premarket notification for a medical device called the "Paragonix Sherpa Pak Cardiac Transport System." It describes a device intended for the cold ischemic storage and transport of donor hearts.
The key finding from the document is that the submission is for a labeling change only. The device itself has not changed and is identical to a previously cleared device (K123326). Therefore, the substantial equivalence determination is based on the prior clearance and the fact that the labeling change does not alter the device's intended use or technological characteristics.
This means the current document does not contain a new study proving the device meets new acceptance criteria, as the device itself hasn't changed. The original device's performance data and acceptance criteria would be in the K123326 submission, which is not provided here.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
Since this is a labeling change and the device is identical to the cleared predicate (K123326), no new acceptance criteria or performance data are presented in this document. The document states:
- "The device subject to this notification is identical to that cleared under K123326." {1}
- "The testing performed in support of the original 510(k) continues to be supportive of the modified device." {1}
- "The design, intended use, principles of operation, and technological characteristics of the Sherpa Pak Cardiac Transport System are substantially equivalent to the previously cleared Sherpa Pak Cardiac Transport System. The labeling change does not alter the device's intended use. There were no changes to the device itself and it is identical to the device cleared under K123326." {1}
The stated "Intended Use" and "Indications for Use" from the document are:
| Acceptance Criteria (from "Indications for Use") | Reported Device Performance (from "Functional Testing" and "Summary of Substantial Equivalence") |
|---|---|
| Intended Use: Organ storage and preservation for transplantation. | Met by substantial equivalence to K123326. Device design, intended use, principles of operation, and technological characteristics are identical. |
| Indications for Use: - Static hypothermic preservation of hearts during transportation and eventual transplantation. - Use with cold storage solutions indicated for the heart. - Intended organ storage time: up to 4 hours. - Donor hearts exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon. | Met by substantial equivalence to K123326. The device did not change, only the labeling. The original testing for K123326 supports these indications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable for this submission. This 510(k) is for a labeling change, not a new performance study. The document explicitly states: "Functional Testing: The premarket notification was submitted for a labeling change to the device. The device did not change in any respect otherwise. The testing performed in support of the original 510(k) continues to be supportive of the modified device." {1}
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As noted above, no new performance study was conducted for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new performance study was conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical transport system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical transport system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new performance study was conducted. Performance for the device would likely be assessed through engineering testing (e.g., temperature stability, integrity) and potentially clinical outcomes data from the original K123326 submission, but this information is not in the provided document.
8. The sample size for the training set
Not applicable. This device is a physical transport system and does not involve AI or machine learning that would require a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set is relevant for this type of device.
{0}------------------------------------------------
FEB 2 1 2014
.
Paragonix Sherpa Pak Cardiac Transport System
| Submitter: | Paragonix Technologies Inc.c/o Vaughn & Associates639 Granite StreetBraintree, MA02184 |
|---|---|
| Contact Person: | Leo BastaNorthStar Biomedical Associates93 Benefit StreetProvidence, RI, 02904Phone: 617.834.9866lbasta@northstarbiomedical.com |
| Date Prepared: | January 7, 2014 |
| 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: | Sherpa Pak Cardiac Transport System (K123326)Celsior (K991594) |
| Device Description: | The Paragonix Sherpa Pak Cardiac Transport System is adevice intended to provide a safe, consistent method forcold ischemic storage and transport of donor hearts torecipients for transplantation. The Sherpa Pak Systemconsists of 1) an outer shipper which contains various non-ice based temperature controlled packaging elements. 2) aninner and outer hard shell container (i.e. Sherpa Pak/SherpaPak Shell) which provides a double, rigid barrier containerin which the heart is immersed and suspended in a ColdStorage Fluid cleared for use in storing and transportingdonor hearts and 3) a temperature display and timer to |
Paragonix 510(k)
Rev. A
·
{1}------------------------------------------------
monitor temperature and elapsed time of transport. respectively. The changes made to the currently cleared device are labeling changes only. The device subject to this notification is identical to that cleared under K123326.
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: The premarket notification was submitted for a labeling change to the device. The device did not change in any respect otherwise. The testing performed in support of the original 510(k) continues to be supportive of the modified device.
Summary of Substantial The design, intended use, principles of operation, and Equivalence: technological characteristics of the Sherpa Pak Cardiac Transport System are substantially equivalent to the previously cleared Sherpa Pak Cardiac Transport System. The labeling change does not alter the device's intended use. There were no changes to the device itself and it is identical to the device cleared under K123326.
Paragonix 510(k) Rev. A
16
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure embracing a three-lined globe.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2014
Paragonix Technologies, Inc. % Leo Basta Owner NorthStar Biomedical Associates 93 Benefit Street Providence, RI 02904
Re: K133432
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: January 7, 2014 Received: January 10, 2014
Dear Leo 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 (sec above) into cither 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 r heast of acressed a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 - Leo 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/CIDRHOffices/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/Reportal?roblem/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/Industrv/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
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INDICATION FOR USE
510(k) Number (if known): K133432
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: ____________________________________________________________________________________________________________________________________________________________
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 Evaluation (ODE)
Page 1 of 1
Herbert P. Lerner 2014.02.21 07:07:42 -05'00'
Paragonix 510(k) - Response Rev. B
§ 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).